Defendant Exhibits To Response in Oppo To Motion For Prelim Injunction Rodden V Biden 23-1-8

Case 3:21-cv-00317 Document 23-1 Filed on 11/22/21 in TXSD Page 1 of 209
EXHIBIT A
IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF TEXAS
GALVESTON DIVISION
JAMES RODDEN, et al.,
Plaintiffs, Civil Action 3:21-cv-00317
v.
DR. ANTHONY FAUCI, in his official

capacity, et al.,
Defendants.
DECLARATION OF PETER MARKS, M.D., Ph.D.

I, Peter Marks, declare as follows:
1. I am the Director of the Center for Biologics Evaluation and Research (“CBER”),
United States Food and Drug Administration (“FDA”), a position I have held since 2016. In this
role, I direct the development and implementation of programs and policies for assuring the
safety, purity, and potency of biological products, including vaccines, allergenic products, blood
and blood products, and cellular, tissue, and gene therapies.
2. I joined FDA in 2012 as the Deputy Director for CBER, after practicing medicine, and
working in industry and academia for several years. I received my graduate degree in cell and
molecular biology and my medical degree at New York University, am board certified in internal
medicine, hematology and medical oncology, and am a Fellow of the American College of
Physicians.
3. In my capacity as Director of CBER, I am fully familiar with the instant matter and the
facts stated herein. This declaration is based on my personal knowledge, my background,
training, and experience and my review and consideration of information available to me in my
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official capacity, including information furnished by FDA personnel in the course of their
official duties. My conclusions have been reached in accordance therewith.
4. Vaccines are biological products that are regulated under the Public Health Service
Act (“PHSA”), 42 U.S.C. § 262(i)(1), as well as “drugs” subject to regulation under the Federal
Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 321(g)(1)(B). Vaccines are approved for
marketing through applications known as Biologics License Applications (“BLA”); a vaccine
that is the subject of an approved BLA need not also obtain approval of a new drug application
(“NDA”) under 21 U.S.C. § 355. 42 U.S.C. § 262(a), (j).
5. Under the PHSA, FDA approves a BLA on the basis of a demonstration that: (1) the
vaccine is “safe, pure, and potent”1; (2) the facility in which the vaccine is produced meets
standards designed to assure that the vaccine continues to be safe, pure, and potent; and (3) the
applicant consents to inspection of the manufacturing facility. 42 U.S.C. § 262(a)(2)(C). FDA
may, but is not required to, consult with its standing advisory committee with scientific expertise
in biological products, the Vaccines and Related Biological Products Advisory Committee, as
part of the approval process. See 21 C.F.R. § 14.171(a). FDA has also issued several guidances
and other public documents on biologics and vaccine development. See generally Biologics
License Applications (BLA) Process, https://www.fda.gov/vaccines-blood-
biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber;
Guidance, Compliance & Regulatory Information (Biologics), https://www.fda.gov/vaccines-
blood-biologics/guidance-compliance-regulatory-information-biologics; Vaccine and Related
1
The standard for licensure of a biological product as potent under 42 U.S.C. § 262 has long
been interpreted by FDA to include effectiveness. See 21 C.F.R. § 600.3(s); FDA Guidance,
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products at 4 (May
1998), available at https://www.fda.gov/media/71655/download.
2
Biological Product Guidances, https://www.fda.gov/vaccines-blood-biologics/biologics-
guidances/vaccine-and-related-biological-product-guidances; Vaccine Development 101,
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-
development-101.
6. On August 23, 2021, FDA approved a BLA for a COVID-19 vaccine known as
Comirnaty, for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age
and older. See Comirnaty Approval Letter (August 23, 2021), attached as Exhibit A. Comirnaty
is a mRNA vaccine. It contains a piece of the SARS-CoV-2 virus’s genetic material that instructs
cells in the body to make the virus’s distinctive “spike” protein. After a person is vaccinated,
their body produces copies of the spike protein, which does not cause disease, and triggers the
immune system to learn to react defensively, producing an immune response against SARS-
CoV-2. After delivering instructions, the mRNA is rapidly broken down. It does not enter the
nucleus of the cell and does not affect DNA.
7. Prior to approval, beginning in December 2020, the same formulation of the vaccine,
known as Pfizer-BioNTech Covid-19 vaccine, was available under an emergency use
authorization (“EUA”). See https://www.fda.gov/news-events/press-announcements/fda-takes-
key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19. FDA has
discretion to issue an EUA for an FDA-regulated product if: (1) the Secretary of the Department
of Health and Human Services has declared a public health emergency involving a biological or
other agent that can cause a serious or life-threatening disease or condition; (2) it is reasonable to
believe that the product may be effective in diagnosing, treating, or preventing that disease or
condition, and the known and potential benefits of the product outweigh the known and potential
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risks of the product; and (3) there is no “adequate, approved, and available” alternative to the
product. 21 U.S.C. § 360bbb-3(c).2
8. Even after FDA approved Comirnaty, FDA authorized continued use of the Pfizer-
BioNTech Covid-19 vaccine under an EUA for indications that included the approved use. FDA
determined that there is not sufficient approved vaccine available for distribution to the 16 years
and older population in its entirety at the time of FDA’s reissuance of the EUA. See Letter to
Pfizer, Inc. reissuing EUA authorization for Covid-19 vaccine, p. 8, n.15 (November 19, 2021),
attached as Exhibit B. FDA also determined that there are no products that are approved to
prevent COVID-19 in additional populations covered by the EUA, as the vaccine remains
available under the EUA for uses that have not been approved, specifically for individuals ages 5
through 15 years old; for a third dose in certain populations; and for a “booster” dose in certain
circumstances.
9. The licensed vaccine has the same formulation as the originally authorized Pfizer-
BioNTech vaccine. The products are legally distinct with certain differences that do not impact
safety or effectiveness. Exhibit B at 10.
10. On October 29, 2021, FDA authorized a new formulation of the Pfizer-BioNTech
vaccine for use in children 5 to 11 years of age when diluted to a lower strength. Id. at 2-3 n.12.
FDA also authorized the new formulation, without dilution, for individuals 12 years of age and
older. Id. The new formulation contains the same mRNA and lipids, and the same quantity of
these ingredients, per 0.3 mL dose. Id. at 10. The two formulations differ only with respect to
2
Distribution of a product pursuant to an EUA is not a “clinical trial” subject to the requirements
for clinical trials conducted under an investigational new drug (“IND”) application. 21 U.S.C.
§§ 360bbb-3(k); 355(i). Clinical trials must be conducted in accordance with an approved IND
and involve only enrolled study participants. Only clinical trial participants enrolled in a clinical
study conducted according to an approved IND receive the study drug.
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certain inactive ingredients and have been shown to be analytically comparable. Id. Therefore,
FDA determined that “for individuals 12 years of age and older, COMIRNATY (COVID-19
Vaccine, mRNA) and the[] two formulations of the Pfizer-BioNTech COVID-19 Vaccine, when
prepared according to their respective instructions for use, can be used interchangeably without
presenting any safety or effectiveness concerns.” Id. at 11. FDA provided this information in
the Letter of Authorization to make clear that pharmacies and other healthcare practitioners
could provide the vaccination series to recipients using Pfizer-BioNTech, Comirnaty, or both
(e.g., first dose of Pfizer-BioNTech followed by second dose of Comirnaty, or vice versa), since
the products have an identical formulation and are made by the same manufacturer under current
good manufacturing practice requirements. FDA included this clarification in the authorization
letter to avoid the unnecessary operational complications that may have resulted if pharmacies or
other healthcare practitioners had believed that the authorization did not include use in
individuals who had received Pfizer-BioNTech for the first dose and Comirnaty for the second
dose, or vice versa. Nevertheless, for individuals 12 years of age and older, only the original
formulation is available at this time in the United States. See https://www.fda.gov/emergency-
preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-
covid-19-vaccine. As a result, all currently available Pfizer-BioNTech vaccine in the United
States for use in individuals 12 years of age and older has the same formulation as the approved
Comirnaty vaccine.
11. The determination that FDA made for Comirnaty and Pfizer-BioNTech Covid-19
vaccine should not be confused with the statutory interchangeability determination that FDA
may make when reviewing a BLA for a biological product manufactured by one company and
comparing it with a biological product manufactured by a different company. Under 42 U.S.C.
5
§ 262(k)(4), FDA may determine that a biological product is “interchangeable” with a “reference
product.” “Reference product” is defined at 42 U.S.C. § 262(i)(4) as a “single biological product
licensed under [42 U.S.C. § 262(a)] against which a biological product is evaluated in an
application submitted under [42 U.S.C. § 262(k)].” The statutory interchangeability
determination requires a licensed reference product and a subsequent applicant seeking licensure,
which is not present here. The PHSA interchangeability provision also contains obligations
related to exclusivity and exchange of patent information for interchangeable products, which
would not make sense for two products produced by a single company. See 42 U.S.C.
§ 242(k)(6), (l).
12. While FDA determined Comirnaty and Pfizer-BioNTech Covid-19 vaccine are
medically interchangeable, there are legal distinctions between BLA-approved and EUA-
authorized products. For example, products approved under BLAs are required to have the
labeling that was approved as part of the BLA, whereas products authorized under the EUA
would have the EUA labeling, and there may also be differences in manufacturing sites for BLA
and EUA vaccine. Both the EUA and BLA processes have required the sponsor to identify
specific facilities that will manufacture the vaccine. See Summary Basis for Regulatory Action –
Comirnaty, pp. 12-13 (August 23, 2021), available at
https://www.fda.gov/media/151733/download.
13. Vaccine manufactured at sites listed in the BLA also undergoes lot release, which is
designed to ensure conformity with standards applicable to the product. 21 C.F.R. § 610.1; see
also https://www.fda.gov/vaccines-blood-biologics/biologics-post-market-activities/lot-
release#lotrelease. Vaccine manufactured at sites that are not listed in the BLA is not subject to
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the lot release requirement.3 Manufacturing of the BLA and EUA vaccine must adhere to FDA’s
current good manufacturing practice regulations, which are designed to ensure that the products
meet specified standards of safety, purity, and potency. See 21 C.F.R. Part 211 (CGMP
regulations for drugs), § 211.1(b) (applicability of CGMP regulations to drugs that are also
biological products); Exhibit B at 15.
14. In conjunction with the approval of Comirnaty, FDA asked the applicant to identify
available lots of vaccine that were manufactured at facilities listed in the BLA that had
undergone lot release. For these lots and other lots produced at facilities listed in the BLA, at this
time, FDA is exercising its enforcement discretion with respect to certain labeling requirements,
in that FDA is not taking enforcement with respect to vials that bear the EUA label.4 FDA
considers these lots to be manufactured in compliance with the BLA and they are not subject to
the EUA requirements when used for the approved indication. Thus, the conditions in the Letter
of Authorization for the EUA—including the condition requiring vaccination providers to
provide recipients with the Fact Sheet for Recipients, which advises recipients that “under the
EUA, it is your choice to receive or not receive the vaccine”—do not apply when these lots or
other BLA-compliant lots are used for the approved indication. FDA worked with the Applicant
to develop a Dear Health Care Provider letter and website to identify those lots. Summary Basis
3
Although not subject to lot release, as a condition of the EUA, Pfizer submits to the EUA file
Certificates of Analysis for each drug product lot at least 48 hours prior to vaccine distribution;
these Certificates include the established specifications and specific results for each quality
control test performed on the final drug product lot. Additionally, also as a condition of the
EUA, Pfizer submits quarterly manufacturing reports to the EUA file that include specified
information about each lot of vaccine manufactured. See Exhibit B at 15.
4
Each vial contains six doses of vaccine and a dose is withdrawn from the vial immediately
before injection into a recipient, who would not ordinarily be handling the vial or viewing its
label. Fact Sheet for Healthcare Providers Administering Vaccine, pp. 6-12 (Oct. 29, 2021),
available at https://www.fda.gov/media/153713/download.
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for Regulatory Action – Comirnaty (“SBRA”), p. 27 (Nov. 8, 2021), attached as Exhibit C.
Also, for operational efficiency, to account for the fact that recipients may receive either the
BLA or EUA vaccine, after licensure of Comirnaty, vaccine has been distributed with unified
Fact Sheets, one for providers and one for recipients, that provide information regarding the
EUA product, as well as information about the licensed product. See Fact Sheet for Recipients
and Caregivers 12 Years of Age and Older (Oct. 29, 2021), available at
15. FDA has programs to expedite the development of drugs that are being studied to
treat life-threatening or severely debilitating diseases. 21 U.S.C. § 356. These programs, one of
which is “Fast Track” designation, are designed to help ensure that therapies for serious
conditions are approved and available for patients as soon as it can be concluded that the
therapies’ benefits outweigh their risks. See Guidance for Industry, Expedited Programs for
Serious Conditions – Drugs and Biologics (May 2014), available at
https://www.fda.gov/media/86377/download. Fast Track designation was granted for Comirnaty
on July 7, 2020. See Exhibit C, SBRA at 5. As explained on FDA’s website, “Once a drug
receives Fast Track designation, early and frequent communication between the FDA and a drug
company is encouraged throughout the entire drug development and review process. The
frequency of communication assures that questions and issues are resolved quickly, often leading
to earlier drug approval and access by patients.” https://www.fda.gov/patients/fast-track-
breakthrough-therapy-accelerated-approval-priority-review/fast-track.
16. In addition to granting Comirnaty “Fast Track” designation, FDA took other steps to
speed development and review of COVID-19 vaccines in response to the urgent public health
threat posed by SARS-CoV-2, without sacrificing the stringent statutory requirements for
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approval. Vaccines typically undergo three phases of clinical trial. See
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-
development-101. Phase 1 generally involves 20 to 100 healthy volunteers and focuses on
safety. Id. Phases 2 and 3 studies typically enroll more subjects and are designed to gather more
safety information on common short-term side effects and risks, examine the relationship
between the dose administered and the immune response, and generate critical efficacy data. Id.
In the case of the COVID-19 vaccines, those phases overlapped to speed the development
process; no phases were skipped. See 21 C.F.R. § 312.21 (“Although in general the phases are
conducted sequentially, they may overlap.”). Also, because COVID-19 continues to be
widespread, the vaccine clinical trials have been conducted more quickly than if the disease were
less common.
17. The Comirnaty BLA was approved based on six months of safety and efficacy data
from two ongoing clinical trials, C4591001 and BNT162-01, as well as safety information from
the millions of vaccine doses administered under the EUA. C4591001 is a randomized, placebo-
controlled, combined Phase 1, 2, and 3 study that has enrolled more than 43,000 participants.
See Exhibit C, SBRA at 15. Initially, during Phases 2 and 3, study participants, as well as study
investigators/personnel collecting and evaluating safety and efficacy information were blinded to
the participants’ treatment assignment (observer-blinded).5 The study population for Phase 2/3
5
“Blind” means that one or more parties of the clinical trial are kept unaware of the treatment
assignment. Study participants, investigators, and health care providers may all be blinded to the
treatment a participant is receiving, for example, whether a study participant is receiving the
study drug or a placebo. Glossary of Clinical Trial Terms, available at
https://www.fda.gov/media/108378/download#:~:text=A%20document%20that%20describes%2
0the,in%20other%20protocol%20referenced%20documents). Blinding may be done to prevent
skewing of the data by the placebo effect, by risk-seeking behavior, by unconscious bias or by
other factors. Blinding may impose a significant burden on the volunteer trial participants, and
medical ethicists generally agree that researchers are sometimes ethically bound to unblind a
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includes participants at higher risk for acquiring COVID-19 and at higher risk of severe COVID-
19, such as participants working in the healthcare field, participants with autoimmune disease,
and participants with chronic but stable medical conditions such as hypertension, asthma,
diabetes, and infection with HIV, hepatitis B or hepatitis C. Id. at 16.
18. In accordance with C4591001’s study protocol (the plan that describes the
objectives, design, methodology, statistical considerations, and organization of a clinical trial,
see Glossary of Clinical Trial Terms, available at
https://www.fda.gov/media/108378/download#:~:text=A%20document%20that%20describes%2
0the,in%20other%20protocol%20referenced%20documents), participants ages 16 and older in
C4591001 have been progressively “unblinded” since the December 2020 issuance of the EUA
for the Pfizer-BioNTech Covid-19 vaccine and offered the vaccine if they were randomized to
the placebo group. Exhibit C, SBRA at 17. The study was unblinded in stages, either when
participants were eligible according to local recommendations for vaccination or after conclusion
of their six-month post–Dose 2 study visit (whichever was earlier). Id. Despite the unblinding,
the data collected during the clinical trial still allowed FDA to evaluate the safety and
effectiveness of the vaccine, considering the data collected during the blinded stage and the other
information submitted supporting safety and effectiveness. Although C4591001 is ongoing and
safety will be evaluated for the duration of the study for blinded and unblinded participants,
because most adverse events linked to vaccination occur within two months of vaccination (see
Table VI. National Vaccine Injury Compensation Program. Rockville, MD: Health Resources
study and permit placebo recipients to receive an effective treatment at some point. The
knowledge that treatment will be made available at some point to placebo recipients if it proves
to be effective also encourages participation in clinical trials. Overall, the decision regarding
when to “unblind” a clinical trial involves a delicate balance of competing priorities.
10
and Services Administration, 2017, https://www.hrsa.gov/sites/default/files/hrsa/vaccine-
compensation/vaccine-injury-table.pdf), FDA determined that a BLA for a COVID-19 vaccine
could be supported by six months of safety data.6 See FDA Guidance, Development and
Licensure of Vaccines to Prevent COVID-19, at 15 (June 2020), attached as Exhibit D. Because
the applicant submitted sufficient safety and efficacy data, the ongoing nature of the phase 3
clinical trial was not a basis for declining to license Comirnaty. The estimated completion date
for C4591001 is May 2023, see
https://www.clinicaltrials.gov/ct2/show/NCT04368728?term=C4591001&draw=2&rank=4).
19. BNT162-01 an ongoing Phase 1/2, open-label, dose-finding study with 24
participants, designed to evaluate the safety and immunogenicity of several candidate vaccines,
including the dose that was approved by FDA on August 23, 2021. See Exhibit C, SBRA at 15.
Safety data from the study was included in the BLA for Comirnaty and supported selection of the
final vaccine candidate and dose level. Id. at 21. Although FDA did not refer the BLA to its
advisory committee, the agency considered the committee’s feedback from prior meetings
considering the EUA for the Pfizer-BioNTech Covid-19 vaccine. Id. at 26-27.
20. In addition to reviewing clinical data, before approving the Comirnaty BLA, FDA
assessed, among other things, its chemistry, manufacturing, and controls (“CMC”); nonclinical
6
Indeed, requesting six-months of follow-up safety data is not unique to Covid-19 vaccines.
See Guidance for Industry Clinical Data Needed to Support the Licensure of Pandemic Influenza
Vaccines, at 5,7, 10 (May 2007), available at https://www.fda.gov/files/vaccines, blood &
biologics/published/Guidance-for-Industry--Clinical-Data-Needed-to-Support-the-Licensure-of-
Pandemic-Influenza-Vaccines.pdf (generally recommending six-months of safety data to support
influenza vaccines). FDA explained the rationale for requesting at least six-months of safety
data to support licensure of Comirnaty in its response to a Citizen Petition submitted by the
Informed Consent Action Network (“ICAN”), raising concerns similar to those raised by
Plaintiffs. See Response to ICAN Citizen Petition, Docket FDA-2021-P-0529, at 9-10 (August
23, 2021), available at https://www.regulations.gov/document/FDA-2021-P-0529-1077.
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and clinical pharmacology and nonclinical toxicology data; safety and pharmacovigilance data;
labeling; and manufacturing facilities. See 21 C.F.R. § 601.2 (requirements for contents of BLA
application). Along with the Summary Basis for Regulatory Action for Comirnaty, also
available on FDA’s website for the Comirnaty BLA review are three Statistical Reviews; an
assessment of Real World Evidence; two Pharmacovigilance Plan Reviews; two CMC Reviews,
Clinical Review; CBER Sentinel Program Sufficiency Review; Bioresearch Monitoring Review;
Benefit-Risk Assessment Review; Analytical Method Review; and Toxicology Review. See
https://www.fda.gov/vaccines-blood-biologics/comirnaty (click on Approval History, Letters,
Reviews, and Related Document – COMIRNATY).
21. FDA approved Comirnaty based on data from the two clinical studies that
demonstrated that the overall efficacy rate in the 16 and older subject population was 91.1% for
the prevention of COVID-19 infection and between 95% and 100% for the avoidance of severe
infection. Exhibit C, SBRA at 19-20. FDA also considered the safety data from the two clinical
studies, in addition to safety information from EUA use. Id. at 22-25. In sum, based on its
review of the clinical, pre-clinical, and product-related data submitted in the Comirnaty BLA,
FDA determined that the product had a favorable benefit/risk balance, and was safe, pure, and
potent. The agency approved the license for Comirnaty on August 23, 2021. Id. at 27-28;
Exhibit A, FDA Approval Letter (Aug. 23, 2021).
22. Comirnaty is subject to specified post market requirements and commitments. See
21 U.S.C. §§ 355(o)(2)(B)(ii) and 356b. Those requirements and commitments are: (1) Study
C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech
COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and
pericarditis following administration of COMIRNATY; (2) Study C4591021, entitled “Post
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Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the
Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence
of myocarditis and pericarditis following administration of COMIRNATY; (3) Study C4591021
sub-study to describe the natural history of myocarditis and pericarditis following administration
of COMIRNATY; (4) Study C4591036, a prospective cohort study with at least 5 years of
follow-up for potential long-term sequelae of myocarditis after vaccination; (5) Study C4591007
sub-study to prospectively assess the incidence of subclinical myocarditis following
administration of the second dose of COMIRNATY in a subset of participants 5 through 15
years of age; (6) Study C4591031 sub-study to prospectively assess the incidence of subclinical
myocarditis following administration of a third dose of COMIRNATY in a subset of participants
16 to 30 years of age; (7) Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine
Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and
Infant Outcomes in the Organization of Teratology Information Specialists
(OTIS)/MotherToBaby Pregnancy Registry”; (8) Study C4591007 sub-study to evaluate the
immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through < 30
years of age; (9) Study C4591012, entitled “Post-emergency Use Authorization Active Safety
Surveillance Study Among Individuals in the Veteran’s Affairs Health System Receiving Pfizer-
BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine”; (10) Study C4591014, entitled
“Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study - Kaiser Permanente
Southern California”; (11) Deferred pediatric study C4591001 to evaluate the safety and
effectiveness of COMIRNATY in children 12 years through 15 years of age; (12) Deferred
pediatric study C4591007 to evaluate the safety and effectiveness of COMIRNATY in children 6
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months to < 12 years of age; and (13) Deferred pediatric study C4591023 to evaluate the safety
and effectiveness of COMIRNATY in infants < 6 months of age. Exhibit C, SBRA at 29-30.
23. FDA also collects adverse event reports from the general population receiving the
vaccine via the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national
passive surveillance vaccine safety database that receives unconfirmed reports of possible
adverse events following the use of a vaccine licensed or authorized in the United States.
VAERS reports provide a very important tool in monitoring vaccine safety, but these reports
alone cannot be used to determine if a vaccine caused or contributed to an adverse event or
illness. See VAERS Data Disclaimer, https://vaers.hhs.gov/data.html. There are particular
scientific limitations in comparing VAERS reports for COVID-19 vaccines with reports for
previously approved vaccines for other conditions. For example, under the EUAs for the
authorized COVID-19 vaccines, unlike for previously approved vaccines, vaccination providers
are required to report to VAERS serious adverse events following vaccination with the COVID-
19 vaccines “irrespective of attribution to vaccination” and regardless of how long after
vaccination the adverse event occurs. In addition, CDC deployed the smartphone-based active-
surveillance “v-safe” system only for the COVID-19 vaccines. V-safe has solicited adverse
event reports directly from patients, which are then included in VAERS, but this system has only
been deployed for COVID-19 vaccines and not for other vaccines. Finally, another potential
factor that limits comparisons between VAERS reports for COVID-19 vaccines and reports for
other vaccines is the concept of “stimulated reporting.” Because of extensive media coverage
and awareness of the public health emergency – and of the authorized COVID-19 vaccines and
their reported side effects – vaccine recipients, health care providers, and others are more likely
to report adverse events for these vaccines than for other vaccines that have been widely
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available for longer periods of time. Although VAERS is not designed to assess causality, FDA
and CDC actively monitor VAERS reports and engage in additional studies or investigations if
VAERS monitoring suggests that a vaccine might be causing a health problem. See Children’s
Health Defense Petition Response, Docket FDA-2021-P-0460, at 17-28 (Aug. 23, 2021),
attached as Exhibit E.
24. On the same day that FDA approved the license for Comirnaty, the agency
responded to a Citizen Petition submitted by the Coalition Advocating for Adequately Licensed
Medicines (CAALM) on July 23, 2021. CAALM Petition, Docket FDA-2021-P-0786, attached
as Exhibit F. Among other things, the petition requested that FDA require “substantial evidence
of clinical effectiveness that outweighs harms in special populations such as: infants, children,
and adolescents; those with past SARS-CoV-2 infection; immunocompromised; pregnant
women; nursing women; frail older adults; and individuals with cancer, autoimmune disorders,
and hematological conditions” before licensing a Covid-19 vaccine, and that there should be
information about “what kind of efficacy” exists for these populations, referring to “reduction in
risk of symptomatic COVID-19 vs. reduction in risk of hospitalization or death.” Id. at 2. Some
of the populations identified by petitioners participated in the clinical trials and additional
information will be obtained from post-marketing studies. For example, approximately 3% of
the clinical trial participants had evidence of prior COVID-19 infection (see Clinical Review
Memo at 35, referenced in paragraph 20, above). Additionally, although pregnant individuals
were excluded from participation in the trial and the applicant has committed to study the
vaccine in this population segment as described in paragraph 22 above, participants in both the
treatment and placebo arms of the trial became pregnant during the trial, and pregnancy
outcomes of spontaneous abortion, miscarriages and elective abortions was similar between the
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vaccine and the placebo group. Id. at 84. In response to CAALM’s Citizen Petition, FDA
concluded that petitioners had not provided sufficient scientific justification for requiring
effectiveness data from clinical trials specific to each population group and specifically designed
to evaluate disease endpoints of varying severity, and petitioner’s argument was not consistent
with “scientifically valid methods of assessing safety and effectiveness,” such as
immunobridging or extrapolation across population groups. CAALM Petition Response, Docket
FDA-2021-P-0786, at 7-8, attached as Exhibit G.
25. FDA also considered and responded to petitioner’s claims that people previously
affected with COVID-19 “are likely to have immunity to subsequent infections for as long or
longer than immunity conferred by vaccine” and “may also be at heightened risk for adverse
effects” from the vaccine, finding there was scientific uncertainty about the duration of immunity
from natural infection and that petitioners had not provided sufficient scientific support for the
latter claim. CAALM Petition Response at 8-9, n.31. In reaching that conclusion, FDA
evaluated each study put forward by petitioners and carefully explained why the studies did not
support petitioner’s arguments. Id.; see also Response to ICAN Citizen Petition at 13-15. To
the contrary, while there is scientific uncertainty about the duration of protection provided by
previous natural infection, evidence is emerging that people get better protection by being fully
vaccinated compared with having had COVID-19 natural infection. See CDC, COVID-19
Frequently Asked Questions, last updated August 2021, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/faq.html; Boyton, R. and D Altmann, 2021, Risk of SARS-CoV-2 reinfection after
natural infection, Lancet, 397(10280):1161-1163, https://doi.org/10.1016/S0140-6736(21)00662-
0. In addition, FDA and CDC medical officers conduct on-going active surveillance of serious
adverse event reports for COVID-19 vaccines, including examination of narrative and other
16
fields of adverse event reports that allow participants to input relevant information, which could
include information about past COVID-19 infection. The reviewers conducting these
surveillance efforts have not identified patterns of adverse events associated with receiving a
COVID-19 vaccine after prior COVID-19 infection. See CAALM Petition Response at 8-9,
n.31. In summary, FDA has not observed a heightened risk of adverse events for people who
receive a COVID-19 vaccine after natural infection, either in the Comirnaty clinical study
population (which included participants with evidence of prior COVID-19 infection) or in
adverse event reports from the general population.
26. Safety surveillance reports received by FDA and CDC identified the risk of
myocarditis and pericarditis following administration of Comirnaty. Comirnaty Summary Basis
for Regulatory Action at 23 (Nov. 8, 2021). Reporting rates for medical chart-confirmed
myocarditis/pericarditis in VAERS have been higher among males under 40 years of age than
among females and older males and have been highest in males 12-17 years of age (65 cases per
million doses administered as per CDC communication on August 20, 2021), particularly
following the second dose, and onset of symptoms within 7 days following vaccination. Id.
Although some cases of vaccine-associated myocarditis/pericarditis required intensive care
support, available data from short-term follow up suggest that the large majority of individuals
have had resolution of symptoms with conservative management. Id. Because vaccine-
associated myocarditis/pericarditis is the most clinically significant identified risk, FDA
developed a quantitative model to compare the excess risk of myocarditis/pericarditis to the
expected benefits of preventing COVID-19 and associated hospitalizations, ICU admissions, and
deaths. Id. at 24. The model used an estimate of risk of myocarditis/pericarditis far higher than
the rates estimated from reports to VAERS and assessed the benefit over a range of COVID-19
17
prevalence scenarios. Id. For males and females 18 years of age and older, even before
accounting for morbidity prevented from non-hospitalized COVID-19, the model predicts that
the benefits of prevented COVID-19 hospitalizations, ICU admissions and deaths would clearly
outweigh the predicted excess risk of vaccine-associated myocarditis/pericarditis under all
conditions examined. Id.7 FDA further adopted measures to mitigate the risk of
myocarditis/pericarditis, including through labeling statements, continued safety surveillance,
postmarketing studies (as described in Paragraph 22), and prescriber information and public
health messaging. Id. Myocarditis remains a manageable adverse event with risks that are far
outweighed by the benefits of preventing COVID-19, including the resultant risks of death,
hospitalization, and myocarditis induced by COVID-19.
27. In approving the BLA for Comirnaty, FDA applied its scientific expertise to evaluate
the data contained in the application and determined that Comirnaty’s benefits outweigh its risks
and that it is safe, pure, potent, and effective for its proposed use. In response to the urgent
public health emergency presented by COVID-19, FDA worked expeditiously to provide
guidance to entities seeking to develop vaccines for this disease, and to review the BLA for
Comirnaty once it was submitted to the agency to ensure it fully met the statutory standards for
approval, to further the objective of protecting the public health.
7
The same was true for females 16-17 years of age. Id. For males 16-17 years of age, the model
predicts that the benefits of prevented COVID-19 hospitalizations, ICU admissions and deaths
would clearly outweigh the predicted excess risk of vaccine-associated myocarditis/pericarditis
under the “most likely” scenario, but that predicted excess cases of vaccine-associated
myocarditis/pericarditis would exceed COVID-19 hospitalizations and deaths under the “worst
case” scenario. Id. However, this predicted numerical imbalance does not account for the
greater severity and length of hospitalization, on average, for COVID-19 compared with vaccine-
associated myocarditis/pericarditis. Id. It also does not account for the risks of non-hospitalized
COVID-19, or the societal benefits of vaccination. Id.
18
28. An injunction affecting the licensure of Comirnaty would cause irreparable harm.
Safe and effective vaccines are currently the most powerful tool we have against the pandemic
and have been estimated to have already saved hundreds of thousands of lives. An injunction
based on the Court’s evaluation of the vaccine would call into question the data supporting
FDA’s determination that Comirnaty is safe and effective. The consequence could be to
undermine the vaccine development process, if vaccine developers see that courts are willing to
disregard FDA’s rigorous review process and remove products from the market on the basis of
mere allegations. In addition, another serious consequence could be to undermine the
government’s efforts to encourage vaccination in all eligible populations by exacerbating vaccine
hesitancy. One of the most significant barriers to widespread vaccination is vaccine hesitancy
and vaccine misinformation. It would also create considerable public and administrative
confusion as to the effect of the injunction because the identical formulation has been authorized
pursuant to an EUA. Even a more limited injunction, somehow limited to these plaintiffs, would
generate extraordinary doubt and confusion.
19
I declare under penalty of perjury that the foregoing is true and correct to the best of my
information, knowledge, and belief.
Dated: November 22, 2021
______________________________________
Peter Marks, M.D., Ph.D.
Director, Center for Biologics Evaluation
and Research
United States Food and Drug Administration
20
Marks Decl.
Exhibit A
Our STN: BL 125742/0 BLA APPROVAL
BioNTech Manufacturing GmbH August 23, 2021

Attention: Amit Patel
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Dear Mr. Patel:
Please refer to your Biologics License Application (BLA) submitted and received on
May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for
COVID-19 Vaccine, mRNA.
LICENSING
We are issuing Department of Health and Human Services U.S. License No. 2229 to
BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section
351(a) of the PHS Act controlling the manufacture and sale of biological products. The
license authorizes you to introduce or deliver for introduction into interstate commerce,
those products for which your company has demonstrated compliance with
establishment and product standards.
Under this license, you are authorized to manufacture the product, COVID-19 Vaccine,
mRNA, which is indicated for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
in individuals 16 years of age and older.
The review of this product was associated with the following National Clinical Trial
(NCT) numbers: NCT04368728 and NCT04380701.
MANUFACTURING LOCATIONS
Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug
substance at Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, 1 Burtt Road,
Andover, Massachusetts. The final formulated product will be manufactured, filled,
labeled and packaged at Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs,
Belgium and at Pharmacia & Upjohn Company LLC, 7000 Portage Road, Kalamazoo,
Michigan. The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at
Hospira, Inc., (b) (4) and at Fresenius Kabi
USA, LLC, (b) (4) .
U.S. Food & Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20993
w ww.fda.gov
Page 2 – STN BL 125742/0 – Elisa Harkins
You may label your product with the proprietary name, COMIRNATY, and market it in
2.0 mL glass vials, in packages of 25 and 195 vials.
We did not refer your application to the Vaccines and Related Biological Products
Advisory Committee because our review of information submitted in your BLA, including
the clinical study design and trial results, did not raise concerns or controversial issues
that would have benefited from an advisory committee discussion.
DATING PERIOD
The dating period for COVID-19 Vaccine, mRNA shall be 9 months from the date of
manufacture when stored between -90ºC to -60ºC (-130ºF to -76ºF). The date of
manufacture shall be no later than the date of final sterile filtration of the formulated
drug product (at Pharmacia & Upjohn Company LLC in Kalamazoo, Michigan, the date
of manufacture is defined as the date of sterile filtration for the final drug product; at
Pfizer Manufacturing Belgium NV in Puurs, Belgium, it is defined as the date of the (b) (4)
Following the final sterile filtration, (b) (4)

, no
reprocessing/reworking is allowed without prior approval from the Agency. The dating
period for your drug substance shall be (b) (4) when stored at (b) (4) We have
approved the stability protocols in your license application for the purpose of extending
the expiration dating period of your drug substance and drug product under 21 CFR
601.12.
FDA LOT RELEASE
Please submit final container samples of the product in final containers together with
protocols showing results of all applicable tests. You may not distribute any lots of
product until you receive a notification of release from the Director, Center for Biologics
Evaluation and Research (CBER).
BIOLOGICAL PRODUCT DEVIATIONS
You must submit reports of biological product deviations under 21 CFR 600.14. You
should identify and investigate all manufacturing deviations promptly, including those
associated with processing, testing, packaging, labeling, storage, holding and
distribution. If the deviation involves a distributed product, may affect the safety, purity,
or potency of the product, and meets the other criteria in the regulation, you must
submit a report on Form FDA 3486 to the Director, Office of Compliance and Biologics
Quality, electronically through the eBPDR web application or at the address below.
Links for the instructions on completing the electronic form (eBPDR) may be found on
CBER's web site at https://www.fda.gov/vaccines-blood-biologics/report-problem-center-
biologics-evaluation-research/biological-product-deviations:
Food and Drug Administration

Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.

WO71-G112
Silver Spring, MD 20993-0002
MANUFACTURING CHANGES
You must submit information to your BLA for our review and written approval under 21
CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing,
packaging or labeling of COVID-19 Vaccine, mRNA, or in the manufacturing facilities.
LABELING
We hereby approve the draft content of labeling including Package Insert, submitted
under amendment 74, dated August 21, 2021, and the draft carton and container labels
submitted under amendment 63, dated August 19, 2021.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, please submit
the final content of labeling (21 CFR 601.14) in Structured Product Labeling (SPL)
format via the FDA automated drug registration and listing system, (eLIST) as described
at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/
default.htm. Content of labeling must be identical to the Package Insert submitted on
August 21, 2021. Information on submitting SPL files using eLIST may be found in the
guidance for industry SPL Standard for Content of Labeling Technical Qs and As at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
nces/UCM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
CARTON AND CONTAINER LABELS
Please electronically submit final printed carton and container labels identical to the
carton and container labels submitted on August 19, 2021, according to the guidance
for industry Providing Regulatory Submissions in Electronic Format — Certain Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD
Specifications at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/providing-regulatory-submissions-electronic-format-certain-human-
pharmaceutical-product-applications.
All final labeling should be submitted as Product Correspondence to this BLA STN BL
125742 at the time of use and include implementation information on Form FDA 356h.
ADVERTISING AND PROMOTIONAL LABELING

You may submit two draft copies of the proposed introductory advertising and
promotional labeling with Form FDA 2253 to the Advertising and Promotional Labeling
Branch at the following address:
Document Control Center
10903 New Hampshire Ave.
WO71-G112
Silver Spring, MD 20993-0002
You must submit copies of your final advertising and promotional labeling at the time of
initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR
601.12(f)(4)).
All promotional claims must be consistent with and not contrary to approved labeling.
You should not make a comparative promotional claim or claim of superiority over other
products unless you have substantial evidence or substantial clinical experience to
support such claims (21 CFR 202.1(e)(6)).
ADVERSE EVENT REPORTING
You must submit adverse experience reports in accordance with the adverse
experience reporting requirements for licensed biological products (21 CFR 600.80),
and you must submit distribution reports at monthly intervals as described in 21 CFR
600.81. For information on adverse experience reporting, please refer to the guidance
for industry Providing Submissions in Electronic Format —Postmarketing Safety
Reports for Vaccines at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/providing-submissions-electronic-format-postmarketing-safety-
reports-vaccines. For information on distribution reporting, please refer to the guidance
for industry Electronic Submission of Lot Distribution Reports at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation
/Post-MarketActivities/LotReleases/ucm061966.htm.
PEDIATRIC REQUIREMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
new active ingredients, new indications, new dosage forms, new dosing regimens, or
new routes of administration are required to contain an assessment of the safety and
effectiveness of the product for the claimed indication in pediatric patients unless this
requirement is waived, deferred, or inapplicable.
We are deferring submission of your pediatric studies for ages younger than 16 years
for this application because this product is ready for approval for use in individuals 16
years of age and older, and the pediatric studies for younger ages have not been
completed.
Your deferred pediatric studies required under section 505B(a) of the Federal Food,
Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of
these postmarketing studies must be reported according to 21 CFR 601.28 and section
505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70
require you to report annually on the status of any postmarketing commitments or
required studies or clinical trials.
Label your annual report as an “Annual Status Report of Postmarketing Study

Requirement/Commitments” and submit it to the FDA each year within 60 calendar
days of the anniversary date of this letter until all Requirements and Commitments
subject to the reporting requirements under section 506B of the FDCA are released or
fulfilled. These required studies are listed below:
1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of

COMIRNATY in children 12 years through 15 years of age.
Final Protocol Submission: October 7, 2020
Study Completion: May 31, 2023
Final Report Submission: October 31, 2023

COMIRNATY in infants and children 6 months to <12 years of age.
Final Protocol Submission: February 8, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024

COMIRNATY in infants <6 months of age.
Final Protocol Submission: January 31, 2022
Study Completion: July 31, 2024
Submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN
BL 125742 explaining that these protocols were submitted to the IND. Please refer to
the PMR sequential number for each study/clinical trial and the submission number as
shown in this letter.
Submit final study reports to this BLA STN BL 125742. In order for your PREA PMRs to
be considered fulfilled, you must submit and receive approval of an efficacy or a labeling
supplement. For administrative purposes, all submissions related to these required

pediatric postmarketing studies must be clearly designated as:
• Required Pediatric Assessment(s)
We note that you have fulfilled the pediatric study requirement for ages 16 through 17
years for this application.
POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to
require holders of approved drug and biological product applications to conduct
postmarketing studies and clinical trials for certain purposes, if FDA makes certain
findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)).
We have determined that an analysis of spontaneous postmarketing adverse events

reported under section 505(k)(1) of the FDCA will not be sufficient to assess known
serious risks of myocarditis and pericarditis and identify an unexpected serious risk of
subclinical myocarditis.
Furthermore, the pharmacovigilance system that FDA is required to maintain under

section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are
required to conduct the following studies:
4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of

the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate
the occurrence of myocarditis and pericarditis following administration of
COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states
that you will conduct this study according to the following schedule:
Final Protocol Submission: August 31, 2021
Monitoring Report Submission: October 31, 2022
Interim Report Submission: October 31, 2023
Study Completion: June 30, 2025
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study

Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis

and pericarditis following administration of COMIRNATY.
Progress Report Submission: September 30, 2021
Interim Report 1 Submission: March 31, 2022
Interim Report 2 Submission: September 30, 2022
Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
6. Study C4591021 substudy to describe the natural history of myocarditis and

pericarditis following administration of COMIRNATY.
7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for
potential long-term sequelae of myocarditis after vaccination (in collaboration
with Pediatric Heart Network).
Final Protocol Submission: November 30, 2021
Study Completion: December 31, 2026

8. Study C4591007 substudy to prospectively assess the incidence of subclinical

myocarditis following administration of the second dose of COMIRNATY in a
subset of participants 5 through 15 years of age.
that you will conduct this assessment according to the following schedule:
Final Protocol Submission: September 30, 2021

myocarditis following administration of a third dose of COMIRNATY in a subset of
participants 16 to 30 years of age.
Final Report Submission: December 31, 2022
Please submit the protocols to your IND 19736, with a cross-reference letter to this BLA
STN BL 125742 explaining that these protocols were submitted to the IND. Please refer
to the PMR sequential number for each study/clinical trial and the submission number
as shown in this letter.
Please submit final study reports to the BLA. If the information in the final study report
supports a change in the label, the final study report must be submitted as a
supplement to this BLA STN BL 125742. For administrative purposes, all submissions
related to these postmarketing studies required under section 505(o) must be submitted
to this BLA and be clearly designated as:
• Required Postmarketing Correspondence under Section 505(o)

• Required Postmarketing Final Report under Section 505(o)
• Supplement contains Required Postmarketing Final Report under Section
505(o)
Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of
any study or clinical trial required under this section. This section also requires you to
periodically report to FDA on the status of any study or clinical trial otherwise
undertaken to investigate a safety issue. In addition, section 506B of the FDCA and 21
CFR 601.70 require you to report annually on the status of any postmarketing
commitments or required studies or clinical trials.
You must describe the status in an annual report on postmarketing studies for this
product. Label your annual report as an Annual Status Report of Postmarketing
Requirements/Commitments and submit it to the FDA each year within 60 calendar
subject to the reporting requirements of section 506B of the FDCA are fulfilled or
released. The status report for each study should include:
• the sequential number for each study as shown in this letter;

• information to identify and describe the postmarketing requirement;
• the original milestone schedule for the requirement;
• the revised milestone schedule for the requirement, if appropriate;
• the current status of the requirement (i.e., pending, ongoing, delayed, terminated,
or submitted); and,
• an explanation of the status for the study or clinical trial. The explanation should
include how the study is progressing in reference to the original projected
schedule, including, the patient accrual rate (i.e., number enrolled to date and the
total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding

these postmarketing studies on our website at http://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.
We will consider the submission of your annual report under section 506B of the FDCA
and 21 CFR 601.70 to satisfy the periodic reporting requirement under section
505(o)(3)(E)(ii) provided that you include the elements listed in section 505(o) and 21
CFR 601.70. We remind you that to comply with section 505(o), your annual report
must also include a report on the status of any study or clinical trial otherwise
undertaken to investigate a safety issue. Failure to periodically report on the status of
studies or clinical trials required under section 505(o) may be a violation of FDCA
section 505(o)(3)(E)(ii) and could result in regulatory action.
POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS

UNDER SECTION 506B
We acknowledge your written commitments as described in your letter of

August 21, 2021 as outlined below:
10. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during

Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and
Infant Outcomes in the Organization of Teratology Information Specialists
(OTIS)/MotherToBaby Pregnancy Registry.”
Final Protocol Submission: July 1, 2021

11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower
dose levels of COMIRNATY in individuals 12 through <30 years of age.
12. Study C4591012, entitled “Post-emergency Use Authorization Active Safety

Surveillance Study Among Individuals in the Veteran’s Affairs Health System
Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine.”
13. Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine

Effectiveness Study - Kaiser Permanente Southern California.”
Final Protocol Submission: March 22, 2021
Final Report Submission: June 30, 2023
Please submit clinical protocols to your IND 19736, and a cross-reference letter to this
BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please
refer to the PMC sequential number for each study/clinical trial and the submission
number as shown in this letter.
If the information in the final study report supports a change in the label, the final study
report must be submitted as a supplement. Please use the following designators to
prominently label all submissions, including supplements, relating to these
postmarketing study commitments as appropriate:
• Postmarketing Commitment – Correspondence Study Update

• Postmarketing Commitment – Final Study Report
• Supplement contains Postmarketing Commitment – Final Study Report
For each postmarketing study subject to the reporting requirements of 21 CFR 601.70,
you must describe the status in an annual report on postmarketing studies for this
product. Label your annual report as an Annual Status Report of Postmarketing
Requirements/Commitments and submit it to the FDA each year within 60 calendar
subject to the reporting requirements of section 506B of the FDCA are fulfilled or
released. The status report for each study should include:
• the sequential number for each study as shown in this letter;

• information to identify and describe the postmarketing commitment;
• the original schedule for the commitment;
• the status of the commitment (i.e., pending, ongoing, delayed, terminated, or
submitted); and,
• an explanation of the status including, for clinical studies, the patient accrual rate
(i.e., number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding

these postmarketing studies on our website at http://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.
POST APPROVAL FEEDBACK MEETING
New biological products qualify for a post approval feedback meeting. Such meetings
are used to discuss the quality of the application and to evaluate the communication
process during drug development and marketing application review. The purpose is to
learn from successful aspects of the review process and to identify areas that could
benefit from improvement. If you would like to have such a meeting with us, please
contact the Regulatory Project Manager for this application.
Sincerely,
Mary A. Malarkey Marion F. Gruber, PhD

Director Director
Office of Compliance Office of Vaccines
and Biologics Quality Research and Review
Center for Biologics Center for Biologics
Evaluation and Research Evaluation and Research
Marks Decl.
Exhibit B
November 19, 2021
Pfizer Inc.
Attention: Mr. Amit Patel
235 East 42nd St
New York, NY 10017
Dear Mr. Patel:
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services
(HHS) determined that there is a public health emergency that has a significant potential to affect
national security or the health and security of United States citizens living abroad, and that
involves the virus that causes Coronavirus Disease 2019 (COVID-19). 1 On the basis of such
determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist
justifying the authorization of emergency use of drugs and biological products during the
COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms
of any authorization issued under that section. 2
On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use
Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the
prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the
Act. FDA reissued the letter of authorization on: December 23, 2020, 3 February 25, 2021, 4 May
1
U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that
Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act, 21 U.S.C. § 360bbb-3,
February 4, 2020.
2
U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations
Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250
(April 1, 2020).
3
In the December 23, 2020 revision, FDA removed reference to the number of doses per vial after dilution from the
letter of authorization, clarified the instructions for vaccination providers reporting to VAERS, and made other
technical corrections. FDA also revised the Fact Sheet for Healthcare Providers Administering Vaccine
(Vaccination Providers) to clarify the number of doses of vaccine per vial after dilution and the instructions for
reporting to VAERS. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination
Providers) and the Fact Sheet for Recipients and Caregivers were revised to include additional information on safety
monitoring and to clarify information about the availability of other COVID-19 vaccines.
4
In the February 25, 2021 revision, FDA allowed flexibility on the date of submission of monthly periodic safety
reports and revised the requirements for reporting of vaccine administration errors by Pfizer Inc. The Fact Sheet for
Health Care Providers Administering Vaccine (Vaccination Providers) was revised to provide an update to the
storage and transportation temperature for frozen vials, direct the provider to the correct CDC website for
information on monitoring vaccine recipients for the occurrence of immediate adverse reactions, to include data
from a developmental toxicity study, and add adverse reactions that have been identified during post authorization
use. The Fact Sheet for Recipients and Caregivers was revised to add adverse reactions that have been identified
during post authorization use.
Page 2 – Pfizer Inc.
10, 2021, 5 June 25, 2021, 6 and August 12, 2021. 7 On August 23, 2021, FDA approved
COMIRNATY (COVID-19 Vaccine, mRNA) 8 and reissued the letter in its entirety for both
Pfizer-BioNTech COVID‑19 Vaccine and certain uses of COMIRNATY (COVID-19 Vaccine,
mRNA). 9 Subsequently, FDA reissued the letter of authorization on September 22, 2021, 10
October 20, 2021, 11 and October 29, 2021. 12
5
In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech Vaccine for the prevention of COVID-19 in
individuals 12 through 15 years of age, as well as for individuals 16 years of age and older. In addition, FDA
revised the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include the
following Warning: “Syncope (fainting) may occur in association with administration of injectable vaccines, in
particular in adolescents. Procedures should be in place to avoid injury from fainting.” In addition, the Fact Sheet
for Recipients and Caregivers was revised to instruct vaccine recipients or their caregivers to tell the vaccination
provider about fainting in association with a previous injection.
6
In the June 25, 2021 revision, FDA clarified terms and conditions that relate to export of Pfizer-BioNTech
COVID‑19 Vaccine from the United States. In addition, the Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) was revised to include a Warning about myocarditis and pericarditis following
administration of the Pfizer-BioNTech COVID-19 Vaccine. The Fact Sheet for Recipients and Caregivers was
updated to include information about myocarditis and pericarditis following administration of the Pfizer-BioNTech
COVID‑19 Vaccine.
7
In the August 12, 2021 revision, FDA authorized a third dose of the Pfizer-BioNTech COVID-19 Vaccine
administered at least 28 days following the two dose regimen of this vaccine in individuals 12 years of age or older
who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with
conditions that are considered to have an equivalent level of immunocompromise.
8
COMIRNATY (COVID-19 Vaccine, mRNA) was approved for active immunization to prevent COVID-19 caused
by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
9
In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval of COMIRNATY (COVID-
19 Vaccine, mRNA) for the prevention of COVID-19 for individuals 16 years of age and older, this EUA would
remain in place for the Pfizer-BioNTech COVID-19 Vaccine for the previously-authorized indication and uses. It
also authorized COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included
in the approved biologics license application (BLA). In addition, the Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the
authorized Pfizer-BioNTech COVID-19 Vaccine and updated language regarding warnings and precautions related
to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine
Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-
BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19
Vaccine, mRNA).
10
In the September 22, 2021 revision, FDA authorized the administration of a single booster dose of COMIRNATY
(COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine at least 6 months after completing the
primary series of this vaccine in individuals: 65 years of age and older; 18 through 64 years of age at high risk of
severe COVID-19; and 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-
CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
11
In the October 20, 2021 revision, FDA clarified eligibility for the booster dose of COMIRNATY (COVID-19
Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine and authorized the administration of a single booster
dose of Pfizer-BioNTech COVID‑19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) as a heterologous
booster dose following completion of primary vaccination with another authorized COVID-19 vaccine. The eligible
population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster
dose of the vaccine used for primary vaccination.
12
In the October 29, 2021 revision, FDA authorized: 1) the use of Pfizer-BioNTech COVID-19 Vaccine for children
5 through 11 years of age; and 2) a manufacturing change to include an additional formulation of the Pfizer-
On November 19, 2021, having concluded that revising this EUA is appropriate to protect the
public health or safety under Section 564(g)(2) of the Act, FDA is again reissuing the October
29, 2021 letter of authorization in its entirety with revisions incorporated to amend the EUA for
COMIRNATY (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to
authorize use of the vaccine as a single booster dose in individuals 18 years of age or older, at
least 6 months after completing the primary series of this vaccine (i.e., as a homologous booster
dose), and to authorize use of the vaccine as a single booster dose following completion of
primary vaccination with another authorized COVID-19 vaccine (i.e., as a heterologous booster
dose) in individuals 18 years of age or older. The dosing interval for the heterologous booster
dose is the same as that authorized for a booster dose of the vaccine used for primary
vaccination. The authorized uses, as well as the two formulations that have three presentations,
are described in the Scope of Authorization section of this letter (Section II).
For the December 11, 2020 authorization for individuals 16 years of age and older, FDA
reviewed safety and effectiveness data from an ongoing Phase 1/2/3 trial in approximately
44,000 participants randomized 1:1 to receive Pfizer-BioNTech COVID‑19 Vaccine or saline
control. The trial enrolled participants 12 years of age and older. FDA’s review at that time
considered the safety and effectiveness data as they relate to the request for emergency use
authorization in individuals 16 years of age and older. FDA’s review of the available safety data
from 37,586 of the participants 16 years of age and older, who were followed for a median of
two months after receiving the second dose, did not identify specific safety concerns that would
preclude issuance of an EUA. FDA’s analysis of the available efficacy data from 36,523
participants 12 years of age and older without evidence of SARS-CoV-2 infection prior to 7 days
after dose 2 confirmed that the vaccine was 95% effective (95% credible interval 90.3, 97.6) in
preventing COVID-19 occurring at least 7 days after the second dose (with 8 COVID-19 cases in
the vaccine group compared to 162 COVID-19 cases in the placebo group). Based on these data,
and review of manufacturing information regarding product quality and consistency, FDA
concluded that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be
effective. Additionally, FDA determined it is reasonable to conclude, based on the totality of the
scientific evidence available, that the known and potential benefits of Pfizer-BioNTech
COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of
COVID-19 in individuals 16 years of age and older. Finally, on December 10, 2020, the
Vaccines and Related Biological Products Advisory Committee voted in agreement with this
conclusion.
For the May 10, 2021 authorization for individuals 12 through 15 years of age, FDA reviewed
safety and effectiveness data from the above-referenced, ongoing Phase 1/2/3 trial that enrolled
approximately 46,000 participants, including 2,260 participants 12 through 15 years of age.
BioNTech COVID-19 Vaccine that uses tromethamine (Tris) buffer instead of phosphate buffered saline (PBS) used
in the originally authorized Pfizer-BioNTech COVID-19 Vaccine. The formulation of the Pfizer-BioNTech COVID-
19 Vaccine that uses Tris buffer was authorized in two presentations: 1) Multiple dose vials, with gray caps and
labels with a gray border, formulated to provide, without need for dilution, doses (each 0.3 mL dose containing 30
µg nucleoside-modified messenger RNA (modRNA)) for individuals 12 years of age and older; and 2) Multiple dose
vials, with orange caps and labels with an orange border, formulated to provide, after dilution, doses (each 0.2 mL
dose containing 10 µg modRNA) for individuals 5 through 11 years of age. The formulation that uses Tris buffer is
the only formulation that is authorized for use in individuals 5 through 11 years of age.
Trial participants were randomized 1:1 to receive Pfizer-BioNTech COVID-19 Vaccine or saline
control. FDA’s review of the available safety data from 2,260 participants 12 through 15 years
of age, who were followed for a median of 2 months after receiving the second dose, did not
identify specific safety concerns that would preclude issuance of an EUA. FDA’s analysis of
SARS-CoV-2 50% neutralizing antibody titers 1 month after the second dose of Pfizer-
BioNTech COVID-19 Vaccine in a subset of participants who had no serological or virological
evidence of past SARS-CoV-2 infection confirm that the geometric mean antibody titer in
participants 12 through 15 years of age was non-inferior to the geometric mean antibody titer in
participants 16 through 25 years of age. FDA’s analysis of available descriptive efficacy data
from 1,983 participants 12 through 15 years of age without evidence of SARS-CoV-2 infection
prior to 7 days after dose 2 confirm that the vaccine was 100% effective (95% confidence
interval 75.3, 100.0) in preventing COVID-19 occurring at least 7 days after the second dose
(with no COVID-19 cases in the vaccine group compared to 16 COVID-19 cases in the placebo
group). Based on these data, FDA concluded that it is reasonable to believe that Pfizer-
BioNTech COVID‑19 Vaccine may be effective in individuals 12 through 15 years of age.
Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific
evidence available, that the known and potential benefits of Pfizer-BioNTech COVID‑19
Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19
in individuals 12 through 15 years of age.
For the August 12, 2021 authorization of a third primary series dose in individuals 12 years of
age or older who have undergone solid organ transplantation, or individuals 12 years of age or
older who are diagnosed with conditions that are considered to have an equivalent level of
immunocompromise, FDA reviewed safety and effectiveness data reported in two manuscripts
on solid organ transplant recipients. The first study was a single arm study conducted in 101
individuals who had undergone various solid organ transplant procedures (heart, kidney, liver,
lung, pancreas) a median of 97±8 months earlier. A third dose of the Pfizer-BioNTech COVID-
19 Vaccine was administered to 99 of these individuals approximately 2 months after they had
received a second dose. Levels of total SARS-CoV-2 binding antibodies meeting the pre-
specified criteria for success occurred four weeks after the third dose in 26/59 (44.0%) of those
who were initially considered to be seronegative and received a third dose of the Pfizer-
BioNTech COVID-19 Vaccine; 67/99 (68%) of the entire group receiving a third vaccination
were subsequently considered to have levels of antibodies indicative of a significant response. In
those who received a third vaccine dose, the adverse event profile was similar to that after the
second dose and no grade 3 or grade 4 events were reported. A supportive secondary study
describes a double-blind, randomized-controlled study conducted in 120 individuals who had
undergone various solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung,
pancreas) a median of 3.57 years earlier (range 1.99-6.75 years). A third dose of a similar
messenger RNA vaccine (the Moderna COVID-19 vaccine) was administered to 60 individuals
approximately 2 months after they had received a second dose (i.e., doses at 0, 1 and 3 months);
saline placebo was given to 60 individuals for comparison. The primary outcome was anti-RBD
antibody at 4 months greater than 100 U/mL. This titer was selected based on NHP challenge
studies as well as a large clinical cohort study to indicate this antibody titer was protective.
Secondary outcomes were based on a virus neutralization assay and polyfunctional T cell
responses. Baseline characteristics were comparable between the two study arms as were pre-
intervention anti-RBD titer and neutralizing antibodies. Levels of total SARS-CoV-2 binding
antibodies indicative of a significant response occurred four weeks after the third dose in 33/60
(55.0%) of the Moderna COVID-19 vaccinated group and 10/57 (17.5%) of the placebo
individuals. In the 60 individuals who received a third vaccine dose, the adverse event profile
was similar to that after the second dose and no grade 3 or grade 4 adverse events were reported.
Despite the moderate enhancement in antibody titers, the totality of data (i.e., supportive paper
by Hall et al. demonstrated efficacy of the product in the elderly and persons with co-
morbidities) supports the conclusion that a third dose of the Pfizer-BioNTech COVID-19
Vaccine may be effective in this population, and that the known and potential benefits of a third
dose of Pfizer-BioNTech COVID-19 Vaccine outweigh the known and potential risks of the
vaccine for immunocompromised individuals at least 12 years of age who have received two
doses of the Pfizer-BioNTech COVID-19 Vaccine and who have undergone solid organ
transplantation, or who are diagnosed with conditions that are considered to have an equivalent
level of immunocompromise.
For the September 22, 2021 authorization of a single booster dose administered at least 6 months
after completing the primary series in individuals: 65 years of age and older; 18 through 64 years
of age at high risk of severe COVID-19; and 18 through 64 years of age whose frequent
institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious
complications of COVID-19 including severe COVID-19, FDA reviewed safety and
effectiveness data from the above-referenced, ongoing Phase 1/2/3 trial in which 329 participants
18 through 75 years of age received a booster dose of the Pfizer-BioNTech COVID-19 Vaccine
approximately 6 months (range 4.8 to 8.8 months) after completion of the primary series. FDA’s
review of the available safety data from 329 participants 18 through 75 years of age, who had
been followed for a median of 2.6 months after receiving the booster dose, did not identify
specific safety concerns that would preclude issuance of an EUA. The effectiveness of the
booster dose of the Pfizer-BioNTech COVID-19 Vaccine is based on an assessment of 50%
neutralizing antibody titers (NT50) against SARS-CoV-2 (USA_WA1/2020). FDA’s analysis of
SARS-CoV-2 NT50 one month after the booster dose compared to 1 month after the primary
series in study participants 18 through 55 years of age who had no serological or virological
evidence of past SARS-CoV-2 infection up to 1 month after the booster dose confirmed
noninferiority for both geometric mean ratio and difference in seroresponse rates. Based on the
totality of the scientific evidence available, including data from the above-referenced clinical
trial, FDA concluded that a booster dose the Pfizer-BioNTech COVID-19 Vaccine may be
effective, and that the known and potential benefits of a single booster dose at least 6 months
after completing the primary series outweigh the known and potential risks for individuals 65
years of age and older; individuals 18 through 64 years of age at high risk of severe COVID-19;
and individuals 18 through 64 years of age whose frequent institutional or occupational exposure
to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe
COVID-19.
For the October 20, 2021 authorization of a single booster dose as a heterologous booster dose
following completion of primary vaccination with another authorized COVID-19 vaccine, FDA
reviewed data from an ongoing Phase1/2 clinical trial in participants 19-85 years of age. In this
trial, adults who had completed primary vaccination with a Moderna COVID-19 Vaccine 2-dose
series (N=151), a Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-BioNTech

COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior to enrollment and who
reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of
one of three vaccines: Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-
BioNTech COVID-19 Vaccine. Adverse events were assessed through 28 days after the booster
dose. An overall review of adverse reactions reported following the Pfizer-BioNTech COVID-
19 Vaccine heterologous booster dose did not identify any new safety concerns, as compared
with adverse reactions reported following Pfizer-BioNTech COVID-19 Vaccine primary series
doses or homologous booster dose. Neutralizing antibody titers, as measured by a pseudovirus
neutralization assay using a lentivirus expressing the SARS-CoV-2 Spike protein with D614G
mutation, were assessed on Day 1 prior to administration of the booster dose and on Day 15 after
the booster dose. A booster response to the Pfizer-BioNTech COVID-19 Vaccine was
demonstrated regardless of primary vaccination. Based on the on the totality of the scientific
evidence available, including data from the above-referenced clinical trial, FDA concluded that a
heterologous booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be effective, and
that the known and potential benefits of a heterologous booster dose of the Pfizer-BioNTech
COVID-19 Vaccine following completion of primary vaccination with another authorized
COVID-19 vaccine outweigh the known and potential risks.
For the October 29, 2021 authorization for the Pfizer-BioNTech COVID-19 Vaccine that uses
Tris buffer for individuals 5 through 11 years of age, FDA reviewed safety and effectiveness data
from an ongoing Phase 1/2/3 trial that has enrolled 4,695 participants 5 through 11 years of age,
of whom 3,109 participants received Pfizer-BioNTech COVID-19 Vaccine (containing 10 µg
modRNA) formulated using PBS buffer and approximately 1,538 participants received saline
control in Phase 2/3. FDA’s review of the available safety data from 3,109 participants 5
through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine (containing 10 µg
modRNA), including 1,444 who were followed for at least 2 months after receiving the second
dose, did not identify specific safety concerns that would preclude issuance of an EUA. SARS-
CoV-2 50% neutralizing antibody titers 1 month after the second dose were compared between a
subset of participants 5 through 11 years of age who received Pfizer-BioNTech COVID-19
Vaccine (containing 10 µg modRNA) and a subset of participants 16 through 25 years of age
who received Pfizer-BioNTech COVID-19 Vaccine (containing 30 µg modRNA) in the above-
referenced ongoing Phase 1/2/3 trial that enrolled approximately 46,000 participants.
Immunobridging analyses included a subset of participants from each study who had no
serological or virological evidence of past SARS-CoV-2 infection. FDA’s analyses confirm that
immunobridging criteria were met for both geometric mean antibody titers and seroresponse
rates. FDA’s analysis of available descriptive efficacy data from 1,968 participants 5 through 11
years of age without evidence of SARS-CoV-2 infection prior to 7 days after dose 2 confirm that
the vaccine was 90.7% effective (95% confidence interval 67.7, 98.3) in preventing COVID-19
occurring at least 7 days after the second dose (with 3 COVID-19 cases in the vaccine group
compared to 16 COVID-19 cases in the placebo group). Based on these data, FDA concluded
that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in
individuals 5 through 11 years of age. Additionally, FDA determined it is reasonable to
conclude, based on the totality of the scientific evidence available, that the known and potential
benefits of Pfizer-BioNTech COVID‑19 Vaccine outweigh the known and potential risks of the
vaccine, for the prevention of COVID-19 in individuals 5 through 11 years of age. Finally, on
October 26, 2021, the Vaccines and Related Biological Products Advisory Committee voted in
agreement with this conclusion.
For the October 29, 2021 authorization of the manufacturing change to include an additional
formulation of the Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer instead of PBS
buffer used in the originally authorized Pfizer-BioNTech COVID-19 Vaccine, FDA reviewed
data on analytical comparability, which uses laboratory testing to demonstrate that a change in
product formulation is not expected to impact safety or effectiveness. In the case of Pfizer-
BioNTech COVID-19 Vaccine, multiple different release parameters were evaluated, ranging
from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the
product. Release and characterization tests include tests for purity, composition, and critical
attributes of mRNA associated with the activity of the vaccine. In this case, analytical
comparability to the current PBS formulation of the Pfizer-BioNTech COVID-19 Vaccine was
demonstrated for the Tris formulation of the Pfizer-BioNTech COVID-19 Vaccine through a
combination of release and characterization testing.
For the November 19, 2021 authorization expanding the eligible population for the homologous
and heterologous booster doses to individuals 18 years of age and older, FDA reviewed data
provided by the sponsor and other data available to FDA, including real world evidence. Data
previously reviewed to support the September 22, 2021 authorization of a homologous booster
dose, together with new real-world data indicating increasing COVID-19 cases in the United
States, including among vaccinated individuals, and suggesting a decreased risk of myocarditis
following mRNA COVID-19 vaccine booster doses compared with second primary series doses,
support expansion of the population eligible for a Pfizer-BioNTech COVID-19 vaccine
homologous booster dose to include all individuals 18 years of age and older who completed the
primary series at least 6 months previously. Data previously reviewed to support the October 20,
2021 authorization of a heterologous booster dose, together with data and information to support
authorization of the EUA amendment to expand the eligible population for a homologous booster
dose of the Moderna COVID-19 Vaccine, support a revision to the Pfizer-BioNTech COVID-19
Vaccine EUA such that the eligible population for a heterologous booster dose of the Pfizer-
BioNTech COVID-19 Vaccine is all adults 18 years of age and older who completed primary
vaccination with another authorized COVID-19 vaccine. Based on the totality of the scientific
evidence available, FDA concludes that a homologous or heterologous booster dose of the
Pfizer-BioNTech COVID-19 Vaccine may be effective, and that the known and potential
benefits of the booster dose of the Pfizer-BioNTech Vaccine following completion of primary
vaccination with Pfizer-BioNTech COVID-19 Vaccine or another authorized COVID-19
vaccine, outweigh the known and potential risks in individuals 18 years of age and older.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine 13 for
the prevention of COVID-19, as described in the Scope of Authorization section of this letter
(Section II) and subject to the terms of this authorization. Additionally, as specified in
13
Reference to the Pfizer-BioNTech COVID-19 Vaccine hereinafter refers to both the PBS and Tris formulations,
unless specifically delineated otherwise.
subsection III.BB., I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under

this EUA as described in the Scope of Authorization section of this letter (Section II).
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine 14 for the
prevention of COVID-19 when administered as described in the Scope of Authorization (Section
II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:
A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including

severe respiratory illness, to humans infected by this virus;
B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe

that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19,
and that, when used under the conditions described in this authorization, the known and
potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent
COVID-19 outweigh its known and potential risks; and
C. There is no adequate, approved, and available alternative 15 Pfizer-BioNTech

COVID‑19 Vaccine to prevent COVID-19. 16
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited as follows:
• Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through
authorized distributor(s), 17 to emergency response stakeholders 18 as directed by the U.S.
14
In this section (Section I), references to Pfizer-BioNTech COVID‑19 Vaccine also apply to COMIRNATY
(COVID-19 Vaccine, mRNA).
15
Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years
of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at
the time of reissuance of this EUA. Additionally, there are no COVID-19 vaccines that are approved to provide:
COVID-19 vaccination in individuals 5 through 15 years of age; a third primary series dose to certain
immunocompromised populations described in this EUA; a homologous booster dose to the authorized population
described in this EUA; or a heterologous booster dose following completion of primary vaccination with another
authorized COVID-19 vaccine.
16
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
17
“Authorized Distributor(s)” are identified by Pfizer Inc. or, if applicable, by a U.S. government entity, such as the
Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to
distribute authorized Pfizer-BioNTech COVID‑19 Vaccine.
18
For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates
that have legal responsibility and authority for responding to an incident, based on political or geographical
boundary lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public
health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some
cases (e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans),
government, including the Centers for Disease Control and Prevention (CDC) and/or
other designee, for use consistent with the terms and conditions of this EUA; and
• Pfizer-BioNTech COVID‑19 Vaccine may be administered by a vaccination provider 19
without an individual prescription for each vaccine recipient.
For use in individuals 12 years of age and older

• The Pfizer-BioNTech COVID-19 Vaccine formulations that use Tris and PBS buffers
(each 0.3 mL dose containing 30 µg modRNA), as described in more detail under
Product Description below, covered by this authorization will be administered by
vaccination providers and used only to prevent COVID-19 in individuals 12 years of age
and older with a two-dose primary regimen (3 weeks apart) and to provide:
o a third primary series dose at least 28 days following the second dose to
individuals 12 years of age or older who have undergone solid organ
transplantation, or who are diagnosed with conditions that are considered to have
an equivalent level of immunocompromise;
o a single booster dose at least 6 months after completion of a primary series of the
vaccine to individuals 18 years of age or older; and
o a single booster dose as a heterologous booster dose following completion of
primary vaccination with another authorized COVID-19 vaccine, in individuals
18 years of age and older, where the dosing interval for the heterologous booster
dose is the same as that authorized for a booster dose of the vaccine used for
primary vaccination.
For use in individuals 5 through 11 years of age

• The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer (each 0.2 mL dose
containing 10 µg modRNA), as described in more detail under Product Description
below, covered by this authorization will be administered by vaccination providers and
there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination
providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an
official capacity under the authority of the state health department to administer COVID-19 vaccines). In such
cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and
vaccination providers will all be met.
19
For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider
licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare
professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health
officer) to administer or provide vaccination services in accordance with the applicable emergency response
stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC
COVID-19 Vaccination Program. If the vaccine is exported from the United States, a “vaccination provider” is a
provider that is authorized to administer this vaccine in accordance with the laws of the country in which it is
administered. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S.
Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical Countermeasures
against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and
State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth
Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020).
used only to prevent COVID-19 in individuals 5 through 11 years of age with a two-dose
primary regimen (3 weeks apart).
For use in individuals who are 11 years old at the time of the first dose, and turn 12 years old
before the second dose:
• Notwithstanding the age limitations for use of the different formulations and
presentations described above, individuals who will turn from 11 years to 12 years of age
between their first and second dose in the primary regimen may receive, for either dose,
either: (1) the Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer (each 0.2 mL
dose containing 10 µg modRNA) covered by this authorization; or (2) the Pfizer-
BioNTech COVID-19 Vaccine and COMIRNATY formulations provided in one of the
presentations for individuals 12 years of age and older (each 0.3 mL dose containing 30
µg modRNA) covered by this authorization.
• The vaccine will be administered by vaccination providers and used only to prevent
COVID-19 with a two-dose primary regimen (3 weeks apart).
This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine,
mRNA) product when used to provide: (1) a two-dose primary regimen (0.3 mL each, 3 weeks
apart) for individuals 12 through 15 years of age; (2) a third primary series dose at least 28 days
following the second dose to individuals 12 years of age or older who have undergone solid
organ transplantation or who are diagnosed with conditions that are considered to have an
equivalent level of immunocompromise; (3) a single booster dose (0.3 mL) at least 6 months
after completion of the primary series to individuals 18 years of age and older; and (4) a single
booster dose (0.3 mL) as a heterologous booster dose following completion of primary
vaccination with another authorized COVID-19 vaccine in individuals 18 years of age and older,
where the dosing interval for the heterologous booster dose is the same as that authorized for a
booster dose of the vaccine used for primary vaccination.
The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19
Vaccine, mRNA) have the same formulation. The products are legally distinct with certain
differences that do not impact safety or effectiveness. Accordingly, under this EUA, the Pfizer-
BioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19 Vaccine,
mRNA) can be used interchangeably as described above, without presenting any safety or
effectiveness concerns.
As described below under Product Description, the Pfizer-BioNTech COVID-19 Vaccine

formulations that use Tris and PBS buffers, which are covered by this authorization for use in
individuals 12 years of age and older, contain the same modRNA and lipids, and the same
quantity of these ingredients, per 0.3 mL dose. The two formulations differ with respect to
certain inactive ingredients only and have been shown to be analytically comparable. 20
20
Analytical comparability assessments use laboratory testing to demonstrate that a change in product formulation
does not impact a product's safety or effectiveness. For the Pfizer-BioNTech COVID-19 Vaccine, multiple different
release parameters were evaluated to assess the comparability of the modified formulation (the formulation with the
Tris buffer) to the originally-authorized formulation (the formulation with the PBS buffer). These release
parameters ranged from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the
Accordingly, under this EUA, for individuals 12 years of age and older, COMIRNATY
(COVID-19 Vaccine, mRNA) and these two formulations of the Pfizer-BioNTech COVID-19
Vaccine, when prepared according to their respective instructions for use, can be used
interchangeably without presenting any safety or effectiveness concerns.
Therefore, for individuals 12 years of age and older, COMIRNATY (COVID-19 Vaccine,
mRNA) is authorized to complete the primary regimen or provide a booster dose for individuals
who received their initial primary dose(s) with the Pfizer-BioNTech COVID-19 Vaccine
(whether the PBS formulation or Tris formulation), and the Pfizer-BioNTech COVID-19
Vaccine (whether the PBS formulation or Tris formulation) is authorized to complete the
primary regimen or provide a booster for individuals who received their initial primary dose(s)
with COMIRNATY (COVID-19 Vaccine, mRNA).
Product Description 21
The Pfizer-BioNTech COVID-19 Vaccine, supplied in two formulations, is provided in three

different vials:

• The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer is available in multiple
dose vials with purple caps. It is formulated to provide, after dilution, 0.3 mL doses
(each containing 30 µg modRNA) and can be used for all authorized indications in
individuals 12 years of age and older.
• The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer, and is available in
multiple dose vials with gray caps and labels with gray borders, is formulated to provide,
after dilution, 0.3 mL doses (each containing 30 µg modRNA) and can be used for all
authorized indications in individuals 12 years of age and older.

• The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer, and is available in
multiple dose vials with orange caps and labels with orange borders, is formulated to
provide, after dilution, 0.2 mL doses (each containing 10 µg modRNA) and can be used
for administration to individuals 5 through 11 years of age.

The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer (supplied in multiple dose vials
with purple caps) is supplied as a frozen suspension; each vial must be diluted with 1.8 mL of
sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. The Pfizer-
product. Release and characterization tests include tests for purity, composition, and critical attributes of mRNA
associated with the activity of the vaccine. The combination of release testing and characterization testing
demonstrated that the modified formulation is analytically comparable to the original formulation.
For COMIRNATY (COVID-19 Vaccine, mRNA) product description, please see the COMIRNATY (COVID-19
21
Vaccine, mRNA) prescribing information, found here: https://www.fda.gov/media/151707/download.

BioNTech COVID-19 Vaccine does not contain a preservative. Each 0.3 mL dose of the Pfizer-
BioNTech COVID-19 Vaccine contains 30 µg of modRNA encoding the viral spike (S)
glycoprotein of SARS-CoV-2. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also
includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-
diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylee glycol)-2000]-N,N-ditetradecylacetamide,
0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg
potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg
dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride
Injection) contributes an additional 2.16 mg sodium chloride per dose.
The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer and that is supplied in multiple
dose vials with gray caps is supplied as a frozen suspension and should not be diluted. The
Pfizer-BioNTech COVID-19 Vaccine does not contain a preservative. Each 0.3 mL dose of the
Pfizer-BioNTech COVID-19 Vaccine contains 30 µg of a modRNA encoding the viral spike (S)
glycoprotein of SARS-CoV-2. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also
includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-
diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide,
0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg
tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose.

The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer and that is supplied in multiple
dose vials with orange caps is supplied as a frozen suspension; each vial must be diluted with
1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each
dose of the Pfizer-BioNTech COVID-19 Vaccine contains 10 µg of a modRNA encoding the
viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Pfizer-BioNTech COVID-19
Vaccine also includes the following ingredients: lipids (0.14 mg (4-
hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene
glycol)-2000]-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine,
and 0.06 mg cholesterol), 10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine
hydrochloride. The diluent (0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium
chloride per dose.
The manufacture of the authorized Pfizer-BioNTech COVID‑19 Vaccine is limited to those

facilities identified and agreed upon in Pfizer’s request for authorization.
The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for
“Emergency Use Authorization.” The Pfizer-BioNTech COVID‑19 Vaccine is authorized to be
distributed, stored, further redistributed, and administered by emergency response stakeholders
when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the
fact that the vial and carton labels may not contain information that otherwise would be required
under the FD&C Act.
Pfizer-BioNTech COVID‑19 Vaccine is authorized for emergency use with the following
product-specific information required to be made available to vaccination providers and
recipients, respectively (referred to as “authorized labeling”):
• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers):

Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‑19 Vaccine to Prevent
Coronavirus Disease 2019 (COVID-19) - For 12 Years of Age and Older Dilute Before
Use
Coronavirus Disease 2019 (COVID-19) - For 12 Years of Age and Older Do Not Dilute
Coronavirus Disease 2019 (COVID-19) - For 5 Through 11 Years of Age Dilute Prior To
Use
• Vaccine Information Fact Sheet for Recipients and Caregivers About COMIRNATY
(COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to Prevent
Coronavirus Disease (COVID-19) For Use in Individuals 12 Years of Age and Older
• Vaccine Information Fact Sheet for Recipients and Caregivers About the Pfizer-
BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease (COVID-19) for Use in
Individuals 5 Through 11 Years of Age
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that
the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine,22 when used to
prevent COVID-19 and used in accordance with this Scope of Authorization (Section II),
outweigh its known and potential risks.
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that Pfizer-BioNTech COVID‑19
Vaccine may be effective in preventing COVID-19 when used in accordance with this Scope of
Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act.
Having reviewed the scientific information available to FDA, including the information
supporting the conclusions described in Section I above, I have concluded that Pfizer-BioNTech
COVID‑19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set
forth in Section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of Pfizer-BioNTech COVID‑19 Vaccine under this EUA must be consistent
with, and may not exceed, the terms of the Authorization, including the Scope of Authorization
(Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and
under the circumstances set forth in the Secretary of HHS’s determination under Section
564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section
564(b)(1), Pfizer-BioNTech COVID‑19 Vaccine is authorized to prevent COVID-19 as described in
22
The conclusions supporting authorization stated in this section (Section II) also apply to COMIRNATY (COVID-
19 Vaccine, mRNA).
the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain
requirements otherwise required by applicable federal law.
III. Conditions of Authorization
Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization:
Pfizer Inc. and Authorized Distributor(s)
A. Pfizer Inc. and authorized distributor(s) will ensure that the authorized Pfizer-
BioNTech COVID‑19 Vaccine is distributed, as directed by the U.S. government,
including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets)
will be made available to vaccination providers, recipients, and caregivers consistent
with the terms of this letter.
B. Pfizer Inc. and authorized distributor(s) will ensure that appropriate storage and cold
chain is maintained until delivered to emergency response stakeholders’ receipt sites.
C. Pfizer Inc. will ensure that the terms of this EUA are made available to all relevant
stakeholders (e.g., emergency response stakeholders, authorized distributors, and
vaccination providers) involved in distributing or receiving authorized Pfizer-
BioNTech COVID‑19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a
copy of this letter of authorization and communicate any subsequent amendments that
might be made to this letter of authorization and its authorized labeling.
D. Pfizer Inc. may develop and disseminate instructional and educational materials (e.g.,
video regarding vaccine handling, storage/cold-chain management, preparation,
disposal) that are consistent with the authorized emergency use of the vaccine as
described in the letter of authorization and authorized labeling, without FDA’s review
and concurrence, when necessary to meet public health needs during an emergency.
Any instructional and educational materials that are inconsistent with the authorized
labeling are prohibited.
E. Pfizer Inc. may request changes to this authorization, including to the authorized Fact
Sheets for the vaccine. Any request for changes to this EUA must be submitted to
Office of Vaccines Research and Review (OVRR)/Center for Biologics Evaluation
and Research (CBER). Such changes require appropriate authorization prior to
implementation.23
23
The following types of revisions may be authorized without reissuing this letter: (1) changes to the authorized
labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new
fact sheets; (4) new carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing
processes, including tests or other authorized components of manufacturing; (7) new conditions of authorization to
require data collection or study. For changes to the authorization, including the authorized labeling, of the type
listed in (3), (6), or (7), review and concurrence is required from the Preparedness and Response Team
(PREP)/Office of the Center Director (OD)/CBER and the Office of Counterterrorism and Emerging Threats
(OCET)/Office of the Chief Scientist (OCS).
F. Pfizer Inc. will report to Vaccine Adverse Event Reporting System (VAERS):
• Serious adverse events (irrespective of attribution to vaccination);
• Cases of Multisystem Inflammatory Syndrome in children and adults; and
• Cases of COVID-19 that result in hospitalization or death, that are reported to
Pfizer Inc.
These reports should be submitted to VAERS as soon as possible but no later than
15 calendar days from initial receipt of the information by Pfizer Inc.
G. Pfizer Inc. must submit to Investigational New Drug application (IND) number
19736 periodic safety reports at monthly intervals in accordance with a due date
agreed upon with the Office of Biostatistics and Epidemiology (OBE)/CBER
beginning after the first full calendar month after authorization. Each periodic safety
report is required to contain descriptive information which includes:
• A narrative summary and analysis of adverse events submitted during the
reporting interval, including interval and cumulative counts by age groups, special
populations (e.g., pregnant women), and adverse events of special interest;
• A narrative summary and analysis of vaccine administration errors, whether or
not associated with an adverse event, that were identified since the last reporting
interval;
• Newly identified safety concerns in the interval; and
• Actions taken since the last report because of adverse experiences (for example,
changes made to Healthcare Providers Administering Vaccine (Vaccination
Providers) Fact Sheet, changes made to studies or studies initiated).
H. No changes will be implemented to the description of the product, manufacturing

process, facilities, or equipment without notification to and concurrence by FDA.
I. All manufacturing facilities will comply with Current Good Manufacturing Practice
requirements.
J. Pfizer Inc. will submit to the EUA file Certificates of Analysis (CoA) for each drug
product lot at least 48 hours prior to vaccine distribution. The CoA will include the
established specifications and specific results for each quality control test performed
on the final drug product lot.
K. Pfizer Inc. will submit to the EUA file quarterly manufacturing reports, starting in
July 2021, that include a listing of all Drug Substance and Drug Product lots
produced after issuance of this authorization. This report must include lot number,
manufacturing site, date of manufacture, and lot disposition, including those lots that
were quarantined for investigation or those lots that were rejected. Information on the
reasons for lot quarantine or rejection must be included in the report.
L. Pfizer Inc. and authorized distributor(s) will maintain records regarding release of
Pfizer-BioNTech COVID‑19 Vaccine for distribution (i.e., lot numbers, quantity,
release date).
M. Pfizer Inc. and authorized distributor(s) will make available to FDA upon request any
records maintained in connection with this EUA.
N. Pfizer Inc. will conduct post-authorization observational studies to evaluate the

association between Pfizer-BioNTech COVID-19 Vaccine and a pre-specified list of
adverse events of special interest, including myocarditis and pericarditis, along with
deaths and hospitalizations, and severe COVID-19. The study population should
include individuals administered the authorized Pfizer-BioNTech COVID-19
Vaccine under this EUA in the general U.S. population (5 years of age and older),
individuals who receive a booster dose, populations of interest such as healthcare
workers, pregnant women, immunocompromised individuals, subpopulations with
specific comorbidities. The studies should be conducted in large scale databases with
an active comparator. Pfizer Inc. will provide protocols and status update reports to
the IND 19736 with agreed-upon study designs and milestone dates.
Emergency Response Stakeholders
O. Emergency response stakeholders will identify vaccination sites to receive authorized

Pfizer-BioNTech COVID‑19 Vaccine and ensure its distribution and administration,
consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.
P. Emergency response stakeholders will ensure that vaccination providers within their
jurisdictions are aware of this letter of authorization, and the terms herein and any
subsequent amendments that might be made to the letter of authorization, instruct
them about the means through which they are to obtain and administer the vaccine
under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers) and Vaccine Information
Fact Sheet for Recipients and Caregivers] is made available to vaccination providers
through appropriate means (e.g., e-mail, website).
Q. Emergency response stakeholders receiving authorized Pfizer-BioNTech COVID‑19

Vaccine will ensure that appropriate storage and cold chain is maintained.
Vaccination Providers
R. Vaccination providers will administer the vaccine in accordance with the

authorization and will participate and comply with the terms and training required by
CDC’s COVID-19 Vaccination Program.
S. Vaccination providers will provide the Vaccine Information Fact Sheet for Recipients
and Caregivers to each individual receiving vaccination and provide the necessary
information for receiving their second dose and/or third dose.
T. Vaccination providers administering the vaccine must report the following

information associated with the administration of the vaccine of which they become
aware to VAERS in accordance with the Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers):
• Vaccine administration errors whether or not associated with an adverse event
• Serious adverse events (irrespective of attribution to vaccination)
• Cases of Multisystem Inflammatory Syndrome in children and adults
• Cases of COVID-19 that result in hospitalization or death
Complete and submit reports to VAERS online at
https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the
words “Pfizer-BioNTech COVID‑19 Vaccine EUA” in the description section of
the report. More information is available at vaers.hhs.gov or by calling 1-800-822-
7967. To the extent feasible, report to Pfizer Inc. by contacting 1-800-438-1985 or
by providing a copy of the VAERS form to Pfizer Inc.; Fax: 1-866-635-8337.
U. Vaccination providers will conduct any follow-up requested by the U.S

government, including CDC, FDA, or other designee, regarding adverse events to
the extent feasible given the emergency circumstances.
V. Vaccination providers will monitor and comply with CDC and/or emergency
response stakeholder vaccine management requirements (e.g., requirements
concerning obtaining, tracking, and handling vaccine) and with requirements
concerning reporting of vaccine administration data to CDC.
W. Vaccination providers will ensure that any records associated with this EUA are
maintained until notified by FDA. Such records will be made available to CDC,
and FDA for inspection upon request.
Conditions Related to Printed Matter, Advertising, and Promotion
X. All descriptive printed matter, advertising, and promotional material, relating to the
use of the Pfizer-BioNTech COVID‑19 Vaccine shall be consistent with the
authorized labeling, as well as the terms set forth in this EUA, and meet the
requirements set forth in Section 502(a) and (n) of the FD&C Act and FDA
implementing regulations.
Y. All descriptive printed matter, advertising, and promotional material relating to the
use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state
that:
• This product has not been approved or licensed by FDA, but has been authorized
for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019
(COVID-19) for use either in individuals 12 years of age and older, or in
individuals 5 through 11 years of age, as appropriate; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency use
of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
Condition Related to Export
Z. If the Pfizer-BioNTech COVID‑19 Vaccine is exported from the United States,

conditions C, D, and O through Y do not apply, but export is permitted only if 1) the
regulatory authorities of the country in which the vaccine will be used are fully
informed that this vaccine is subject to an EUA and is not approved or licensed by
FDA and 2) the intended use of the vaccine will comply in all respects with the laws
of the country in which the product will be used. The requirement in this letter that
the authorized labeling (i.e., Fact Sheets) be made available to vaccination providers,
recipients, and caregivers in condition A will not apply if the authorized labeling (i.e.,
Fact Sheets) are made available to the regulatory authorities of the country in which
the vaccine will be used.
Conditions With Respect to Use of Licensed Product
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is licensed for individuals 16 years of

age and older. There remains, however, a significant amount of Pfizer-BioNTech
COVID-19 Vaccine that was manufactured and labeled in accordance with this
emergency use authorization. The authorization remains in place with respect to the
Pfizer-BioNTech COVID-19 Vaccine for this population.
BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19
Vaccine, mRNA) product when used to provide: (1) a two-dose primary regimen for
individuals 12 through 15 years of age; 24 (2) a third primary series dose to individuals
12 years of age or older who have undergone solid organ transplantation or who are
diagnosed with conditions that are considered to have an equivalent level of
immunocompromise; (3) a single booster dose at least 6 months after completing the
primary series to individuals 18 years of age or older; and (4) a heterologous booster
dose in individuals 18 years of age and older who have completed primary
vaccination with a different authorized COVID-19 vaccine as described in the Scope
of Authorization (Section II) under this EUA. Conditions A through W in this letter
apply when COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses
described in this subsection III.BB., except that product manufactured and labeled in
accordance with the approved BLA is deemed to satisfy the manufacturing, labeling,
and distribution requirements of this authorization.
IV. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products during the COVID-19
pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section
564(g) of the Act.
24
As noted above, this includes the first dose of a two-dose primary regimen for individuals who are 11 years old
and will turn 12 years of age between their first and second dose in the primary regimen.
Sincerely,
--/S/--
____________________________
Jacqueline A. O'Shaughnessy, Ph.D.
Acting Chief Scientist
Enclosures
Marks Decl.
Exhibit C
Summary Basis for Regulatory Action

Date: 11/8/2021
From: Ramachandra Naik, PhD, Review Committee Chair,
DVRPA/OVRR
BLA STN: 125742/0

BioNTech Manufacturing GmbH (in partnership with
Applicant:
Pfizer, Inc.)
Submission Receipt
May 18, 2021
Date:
PDUFA Action Due Date: January 16, 2022
Proper Name: COVID-19 Vaccine, mRNA
Proprietary Name: COMIRNATY
Active immunization to prevent coronavirus disease
2019 (COVID-19) caused by severe acute respiratory
Indication:
syndrome coronavirus 2 (SARS-CoV-2) in individuals 16
years of age and older
Recommended Action: The Review Committee recommends approval of this product.
______________________________________________________________________
Director, Office of Vaccines Research and Review
______________________________________________________________________
Director, Office of Compliance and Biologics Quality
Discipline Reviews Reviewer / Consultant - Office/Division

CMC
• CMC Product (OVRR) Xiao Wang, PhD, OVRR/DVP
Anissa Cheung, MSc, OVRR/DVP
• Facilities Review (OCBQ/DMPQ) Kathleen Jones, PhD, OCBQ/DMPQ
Laura Fontan, PhD, OCBQ/DMPQ
Gregory Price, PhD, OCBQ/DMPQ
CDR Donald Ertel, MS, OCBQ/DMPQ
Nicole Li, MS, OCBQ/DMPQ
Christian Lynch, OCBQ/DMPQ
Alifiya Ghadiali, OCBQ/DMPQ
• Facilities Inspection (OCBQ/DMPQ and Zhongren Wu, PhD, OCBQ/DMPQ
OVRR/DVP) Ekaterina Allen, PhD, OCBQ/DMPQ
• Lot Release, QC, Test Methods, Product Hsiaoling Wang, PhD, OCBQ/DBSQC
Quality (OCBQ/DBSQC) Emnet Yitbarek, PhD, OCBQ/DBSQC
Karla Garcia, MS, OCBQ/DBSQC
Anil Choudhary, PhD, MBA, OCBQ/DBSQC
Esmeralda Alvarado Facundo, PhD, OCBQ/DBSQC
Marie Anderson, PhD, OCBQ/DBSQC
Cheryl Hulme, OCBQ/DMPQ
Clinical
• Clinical (OVRR) Susan Wollersheim, MD, OVRR/DVRPA
CAPT Ann T. Schwartz, MD, OVRR/DVRPA
Lucia Lee, MD, OVRR/DVRPA
• Postmarketing Safety, Epidemiological Deborah Thompson, MD, MSPH, OBE/DE
Review (OBE/DE)
• Real World Evidence Yun Lu, PhD, OBE
• Benefit-Risk Assessment Hong Yang, PhD, OBE
Osman Yogurtcu, PhD, OBE
Patrick Funk, PhD, OBE
• BIMO Haecin Chun, MT (ASCP) SSB, MS, OCBQ/DIS
Statistical
• Clinical Data (OBE/DB) Lei Huang, PhD, OBE/DB
Ye Yang, PhD, OBE/DB
• Nonclinical Data Xinyu Tang, PhD, OBE/DB
Nonclinical/Pharmacology/Toxicology
• Toxicology (OVRR)
Nabil Al-Humadi, PhD, OVRR/DVRPA
• Developmental Toxicology (OVRR)
Labeling
• Promotional (OCBQ/APLB) CAPT Oluchi Elekwachi, PharmD, MPH,
OCBQ/APLB
• Carton and Container Labels Daphne Stewart, OVRR/DVRPA
• Labeling Review Laura Gottschalk, PhD, OVRR/DVRPA
• Consults (CDISC, Datasets) Brenda Baldwin, PhD, OVRR/DVRPA
• Documentation Review CAPT Michael Smith, PhD, OVRR/DVRPA
Advisory Committee Summary No Advisory Committee meeting held
2
Table of Contents
1. Introduction .................................................................................................................3
2. Background ................................................................................................................4
3. Chemistry, Manufacturing and Controls (CMC) ..........................................................6
a. Product Quality ............................................................................................. 6
b. Testing Specifications ................................................................................. 10
c. CBER Lot Release ..................................................................................... 11
d. Facilities Review / Inspection...................................................................... 11
e. Container/Closure System .......................................................................... 14
f. Environmental Assessment ........................................................................... 14
4. Nonclinical Pharmacology/Toxicology ......................................................................14
5. Clinical Pharmacology ..............................................................................................15
6. Clinical/Statistical ......................................................................................................15
a. Clinical Program ......................................................................................... 15
b. Bioresearch Monitoring (BIMO) – Clinical/Statistical/Pharmacovigilance ... 22
7. Safety and Pharmacovigilance .................................................................................22
8. Labeling ....................................................................................................................25
9. Advisory Committee Meetings ..................................................................................26
10. Other Relevant Regulatory Issues ............................................................................27
11. Recommendations and Benefit/Risk Assessment ....................................................27
a. Recommended Regulatory Action .............................................................. 27
b. Benefit/Risk Assessment ............................................................................ 28
c. Recommendation for Postmarketing Activities ........................................... 28
1. Introduction
BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.) submitted a Biologics
License Application (BLA) STN BL 125742 for licensure of COVID-19 Vaccine, mRNA.
The proprietary name of the vaccine is COMIRNATY. COMIRNATY is a vaccine
indicated for active immunization to prevent coronavirus disease 2019 (COVID-19)
caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals
16 years of age and older. The vaccine is administered intramuscularly (IM) as a series
of two 30 μg doses (0.3 mL each) 3 weeks apart.
COMIRNATY (also referred to as BNT162b2 in this document) contains a nucleoside-

modified messenger RNA (mRNA) encoding the viral spike glycoprotein (S) of SARS-
CoV-2 that is formulated in lipids including ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-
diyl)bis(2-hexyldecanoate), 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 1,2-
distearoyl-sn-glycero-3-phosphocholine, and cholesterol.
3
COMIRNATY is supplied as a concentrated multi-dose liquid formulation (0.45 mL

volume) stored frozen at -90°C to -60°C in a 2 mL Type 1 glass vial. A sterile diluent,
0.9% Sodium Chloride Injection, USP, is supplied separately in 2 mL glass vials
manufactured by Fresenius Kabi LLC and in 10 mL vials manufactured by Hospira, Inc.
The diluent is stored at 20°C to 25°C and will be shipped in parallel with shipments of
COMIRNATY, with arrivals synchronized so that the diluent is delivered before the
vaccine is delivered. Healthcare providers may also use other sources of sterile 0.9%
Sodium Chloride Injection, USP as a diluent for COMIRNATY, if necessary.
The COMIRNATY Multiple Dose Vial is thawed in a refrigerator (2°C to 8°C) for 2 to 3
hours or at room temperature (up to 25°C) for 30 minutes. The vial must be warmed to
room temperature for dilution. Once at room temperature, the COMIRNATY Multiple
Dose Vial is diluted with 1.8 mL of the diluent. After dilution, each vial of COMIRNATY
contain six doses of 0.3 mL of vaccine. Each 0.3 mL dose of COMIRNATY contains 30
μg of mRNA encoding the spike glycoprotein of SARS-CoV-2 and the following
ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-
hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09
mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg
potassium chloride, 0.01 mg monobasic potassium phosphate, 2.52 mg sodium chloride,
0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. After dilution, the vials
are stored at 2°C to 25°C and must be used within 6 hours from the time of dilution.
COMIRNATY is preservative-free.
The expiry dating period for COMIRNATY Multiple Dose Vial is 9 months from the date
of manufacture when stored at -90°C to -60°C. The date of manufacture shall be no later
than the date of final sterile filtration of the formulated drug product (at Pharmacia &
Upjohn Company LLC in Kalamazoo, Michigan, the date of manufacture is defined as
the date of sterile filtration for the final drug product; at Pfizer Manufacturing Belgium
NV in Puurs, Belgium, it is defined as the date of the (b) (4)
.
2. Background
SARS-CoV-2 is a novel, zoonotic coronavirus that emerged in late 2019 and was
identified in patients with pneumonia of unknown cause. The virus was named SARS-
CoV-2 because of its similarity to the coronavirus responsible for severe acute
respiratory syndrome (SARS-CoV, a lineage B betacoronavirus). SARS-CoV-2 is an
enveloped, positive-sense, single-stranded RNA virus sharing more than 70% of its
sequence with SARS-CoV, and ~50% with the coronavirus responsible for Middle
Eastern respiratory syndrome (MERS-CoV). SARS-CoV-2 is the causative agent of
COVID-19, an infectious disease with respiratory and systemic manifestations. Disease
symptoms vary, with many persons presenting with asymptomatic or mild disease and
some progressing to severe respiratory tract disease including pneumonia and acute
respiratory distress syndrome (ARDS), leading to multiorgan failure and death.
The SARS-CoV-2 pandemic continues to present a challenge to global health and, as of

August 2021, has caused approximately 208 million cases of COVID-19, including 4.3
million deaths worldwide. In the United States (U.S.), more than 37 million cases have
4
been reported to the Centers for Disease Control and Prevention (CDC), of which 90%
have occurred in individuals 16 years of age or older. While the pandemic has caused
morbidity and mortality on an individual level, the continuing spread of SARS-CoV-2 and
emerging variants has caused significant challenges and disruptions in worldwide
healthcare systems, economies, and many aspects of human activity (travel,
employment, education).
In the U.S., there are no licensed vaccines or anti-viral drugs for the prevention of
COVID-19. In December 2020, the FDA issued emergency use authorizations (EUAs) for
two mRNA vaccines which encode the SARS-CoV-2 spike glycoprotein: Pfizer-BioNTech
COVID-19 Vaccine (manufactured by Pfizer, Inc. in partnership with BioNTech
manufacturing GmbH) for use in individuals 16 years of age and older, and Moderna
COVID-19 Vaccine (manufactured by ModernaTX, Inc.) for use in individuals 18 years of
age and older. In February 2021, the FDA issued an EUA for a replication-incompetent
adenovirus type 26 (Ad26)-vectored vaccine encoding a stabilized variant of the SARS-
CoV-2 spike glycoprotein, manufactured by Janssen Biotech, Inc. (Janssen COVID-19
Vaccine) for use in individuals 18 years of age and older. In May 2021, the FDA
expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine
to include adolescents 12 through 15 years of age. On October 22, 2020, FDA approved
remdesivir for use in adult and pediatric patients 12 years of age and older and weighing
at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring
hospitalization. Several other therapies are currently available under emergency use.
Table 1. Regulatory History

Regulatory Events / Milestones Date
April 6, 2020 (Part 1)
1. Pre-IND meeting (Written Responses)
April 10, 2020 (Part 2)
2. IND submission April 22, 2020
3. Fast Track designation granted July 7, 2020
4. Submission of EUA request for individuals ≥16 years of
November 20, 2020
age
5. Issuance of EUA for individuals ≥16 years December 11, 2020
6. Submission of EUA request for individuals 12-15 years of
April 9, 2021
age
7. Issuance of EUA for individuals 12-15 years of age May 10, 2021
Clinical: March 9, 2021
8. Pre-BLA meeting (Written Responses)
CMC: March 31, 2021
9. BLA STN 125742/0 received May 18, 2021
10. BLA filed July 15, 2021
The Applicant
11. Mid-Cycle communication
canceled
The Applicant
12. Late-Cycle meeting
canceled
13. Action Due Date January 16, 2022
5
3. Chemistry, Manufacturing and Controls (CMC)
a. Product Quality
COMIRNATY Manufacturing Overview

COMIRNATY contains a nucleoside-modified messenger RNA (mRNA) encoding the
viral spike glycoprotein (S) of SARS-CoV-2 that is formulated in lipids including ((4-
hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2- hexyldecanoate), 2-(polyethylene
glycol 2000)-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine,
and cholesterol. COMIRNATY is supplied as a frozen suspension to be diluted with a
diluent, 0.9% Sodium Chloride Injection, USP, that is supplied separately or can be
acquired elsewhere, if necessary. Manufacture of the mRNA drug substance will take
place in Andover, MA, USA. The final formulated drug product will be manufactured,
filled, finished, labeled and packaged in Puurs, Belgium or in Kalamazoo, MI, USA. The
0.9% Sodium Chloride Injection, USP diluent will be manufactured by Fresenius-Kabi
USA, LLC ((b) (4) ) and Hospira, Inc. ((b) (4) ).
The mRNA in COMIRNATY is a single-stranded, 5’-capped mRNA encoding the full-

length SARS-CoV-2 spike glycoprotein derived from the Wuhan-Hu-1 isolate (GenBank
MN908947.3 and GenBank QHD43416.1). The antigen-coding RNA sequence is codon-
optimized and contains two proline mutations ((b) (4) 87P), which ensures an
antigenically optimal trimerized pre-fusion confirmation (S-2P). The RNA also contains
common structural elements, including 5’-cap, 5’-UTR, 3’-UTR, and poly(A) tail, all of
which are designed for mediating high RNA stability and translation efficiency. During
RNA transcription, (b) (4) is replaced with the (b) (4) . This
nucleoside substitution has been demonstrated to enhance translation of in vitro
transcribed mRNA while reducing its reactogenicity.
Drug Substance (DS)

(b) (4)
The manufacture of mRNA DS is divided into major manufacturing process stages:
(b) (4)
6
Drug Product (DP)

The manufacturing process of the DP is divided into the following critical steps:
• Preparation of the DS: (b) (4)
• Formation of LNP: In this step, (b) (4)
• Formulation of the bulk DP: The bulk DP is formulated by (b) (4)
• Filling: The bulk DP is sterile filtered and aseptically filled into 2 mL Type I
borosilicate glass vials manufactured by (b) (4)
.
• Labeling and storage: The filled vials are visually inspected, labeled, and frozen at
-90°C to -60°C.
Composition
The composition of the formulation of COMIRNATY and the function of the ingredients
are provided in Table 2.
Table 2. Composition of COMIRNATY Multiple Dose Vial
Ingredients Amount per vial Function
SARS-CoV-2 spike glycoprotein mRNA

225 μg Active Ingredient
(UNII: 5085ZFP6SJ)
ALC-0315 [4-hydroxybutyl)azanediyl)bis (hexane-6,1-
diyl)bis(2-hexyldecanoate) 3.23 mg Lipid component
(UNII: AVX8DX713V)
ALC-0159 [2-(polyethylene glycol 2000)-N,N-
ditetradecylacetamide] 0.4 mg Lipid component
(UNII: PJH39UMU6H)
DSPC [1,2-distearoyl-sn-glycero-3-phosphocholine]
0.7 mg Lipid component
(UNII: 043IPI2M0K)
Cholesterol
1.4 mg Lipid component
(UNII: 97C5T2UQ7J)
Potassium chloride
0.07 mg Excipient
(UNII: 660YQ98I10)
Monobasic potassium phosphate
0.07 mg Excipient
(UNII: 4J9FJ0HL51)
Sodium Chloride 2.7 mg Excipient
7
Ingredients Amount per vial Function
(UNII: 451W47IQ8X)
Dibasic sodium phosphate dihydrate
0.49 mg Excipient
(UNII: GR686LBA74)
Sucrose
46.0 mg Excipient
(UNII: C151H8M554)
Water for Injection
q.s. Excipient
(UNII: 059QF0KO0R)
UNII: Unique Ingredient Identifier
q.s. = quantum satis (as much as may suffice)
Stability of COMIRNATY in Multiple Dose Vial

(b) (4)
For the long-term storage condition study, parameters monitored are Appearance, by
(b) (4) , LNP (b) (4) , RNA content
and (b) (4) Assay, Lipid (ALC-0315, ALC-0159, DSPC, and
Cholesterol) Content by (b) (4)
, Container closure integrity test by (b) (4)

, Endotoxin content by (b) (4) , and Sterility.
The stability data provided in the submission support a dating period of 9 months from
the date of manufacture when stored at -90°C to -60°C for the COMIRNATY DP filled in
2 mL Type I borosilicate glass vials. Stability data on emergency use and process
performance qualification lots also support storage at -20°C ± 5°C for up to 2 weeks as
well as short term storage at 5°C ± 3°C for up to one month (within the 9-month expiry
dating period).
The Diluent for COMIRNATY

The contents of the vaccine vial are diluted with sterile 0.9% Sodium Chloride Injection,
USP. Vials of sterile 0.9% Sodium Chloride Injection, USP are provided but shipped
separately. The provided diluent or another sterile 0.9% Sodium Chloride Injection, USP
should be used as the diluent.
The provided 0.9% Sodium Chloride Injection, USP diluent will be supplied either as
cartons of 10 mL single-use vials manufactured by Hospira, Inc (NDC 0409-4888-10), or
2 mL single-use vials manufactured by Fresenius Kabi USA, LLC (NDC 63323-186-02).
The composition of the saline diluent and the function of the ingredients are provided in
Table 3.
Table 3. Composition of the Diluent

Quantity
Ingredients Function
(per 0.3 mL dose)
SODIUM CHLORIDE
2.16 mg Excipient
(UNII: 451W47IQ8X)
Water for Injection
0.3 mL Excipient
(UNII: 059QF0KO0R)
UNII: Unique Ingredient Identifier
8
COMIRNATY
Product Composition
COMIRNATY Multiple Dose Vial is supplied as a frozen suspension that is diluted at the
time of use with 1.8 mL of saline diluent. A single dose of COMIRNATY contains 30 ug
mRNA in a volume of 0.3 mL, and it does not contain preservative. [See section 10.b
regarding exception to the 21 CFR 610.15(a) requirement for a preservative.]
Stability of COMIRNATY
The Applicant conducted in-use stability studies to support the maximum temperature
and time period that COMIRNATY can retain its physicochemical properties. Based on
the data generated, COMIRNATY retains its quality attributes for up to 6 hours when
stored between 2°C to 25°C (35°F to 77°F).
The carton labels and the Package Insert (PI) state that after dilution, vials should be
stored between 2°C to 25°C (35°F to 77°F) and used within 6 hours from the time of
dilution. During storage, exposure to room light should be minimized, and direct
exposure to sunlight and ultraviolet light should be avoided. Any vaccine remaining in
vials must be discarded after 6 hours and cannot be refrozen.
Assays used in clinical studies
Diagnostic Assays Used to Support Clinical Efficacy Endpoints

Two clinical diagnostic assays (Cepheid Xpert Xpress RT-PCR assay for the detection of
SARS-CoV-2 in clinical specimens and Roche Elecsys Anti-SARS-CoV-2 assay for the
evaluation of serostatus to SARS-CoV-2) were used to assess clinical endpoints. Both
assays have received FDA authorization under EUA.
The Cepheid Xpert Xpress RT-PCR assay is a rapid, automated in vitro diagnostic test
for the qualitative detection of the N and E gene sequences from nasopharyngeal, nasal,
or mid-turbinate swab and/or nasal wash/aspirate specimens collected from patients
suspected of having COVID-19. This assay is used to assess viral infection of the
participants before vaccination and to confirm COVID-19 cases during study follow-up.
The Roche Elecsys Anti-SARS-CoV-2 assay is a rapid, automated in vitro diagnostic test
for detecting the presence of antibodies to nucleocapsid (N) protein of SARS-CoV-2
(antigen not present in COMIRNATY) in serum or plasma samples. This is a qualitative
assay marketed as an aid in identifying individuals with an adaptive immune response to
SARS-CoV-2, which would indicate a recent or prior infection. This assay is used to
assess serostatus of the participants before vaccination.
Data were submitted to support the suitability of both the Cepheid Xpert Xpress assay
and the Roche Elecsys Anti-SARS-CoV-2 assay for their intended uses in Phase 2/3
clinical studies when performed at Pfizer’s testing facility (Pfizer Vaccine Research and
Development; Pearl River, NY).
Immunogenicity Assays Used for Exploratory Immunogenicity Endpoints

Two immunogenicity assays (SARS-CoV-2 mNeonGreen (mNG) virus
microneutralization assay and (b) (4) direct Luminex assay (dLIA) for IgG
9
quantification) were used for evaluating the immune responses from clinical trial
samples.
The SARS-CoV-2 mNG microneutralization assay measures neutralizing antibodies

(50% inhibition titers) against SARS-CoV-2 using Vero cell monolayers in a 96-well plate
format. The SARS-CoV-2 mNG virus is derived from the USA_WA1/2020 strain that had
been rescued by reverse genetics and engineered to express a fluorescent reporter
gene (mNeonGreen) upon productive infection of cells. The validation protocol (that
includes evaluation of dilutional linearity, precision, limits of quantification, and limit of
detection) and the results of the validation study, executed at Pfizer Hackensack
Meridian Health Center (Nutley, New Jersey), were submitted to support the suitability of
the assay for testing of clinical trial immunogenicity samples.
The (b) (4) S1 IgG dLIA measures IgG antibody levels to the subunit 1 (S1) of the
SARS-CoV-2 spike protein in human serum samples. Qualification data provided in the
submission support the (b) (4) dLIA for quantification of human IgG antibodies that
bind to the S1 protein of SARS-CoV-2 and confirm that the assay is suitable for its
intended use.
b. Testing Specifications
Specifications and Methods

The tests and specifications applied for routine release of COMIRNATY are shown in
Table 4.
Table 4. Control of COMIRNATY: Tests and Specifications

Quality Attribute Analytical Procedure Acceptance Criteria
Appearance Appearance (Visual) White to off-white suspension
Appearance
Appearance (Particles) May contain white to off-white
(Visible
Particulates) (b) (4) opaque, amorphous particles
(b) (4) (b) (4)

(b) (4)
(b) (4) (b) (4) (b) (4)
(b) (4) (b) (4) (b) (4)
LNP (b) (4) (b) (4) (b) (4)

LNP (b) (4) (b) (4) (b) (4)
RNA (b) (4) (b) (4) assay (b) (4)
RNA content (b) (4) assay (b) (4)
ALC-0315 content (b) (4) (b) (4)
ALC-0159 content (b) (4) (b) (4)
DSPC content (b) (4) (b) (4)
Cholesterol content (b) (4) (b) (4)
Vial content (volume) Container content Not less than (b) (4)
(b) (4)
Lipid identities (b) (4) (ALC-0315, ALC-
0159, Cholesterol, DSPC)
10
Quality Attribute Analytical Procedure Acceptance Criteria

Identity of
encoded RNA (b) (4) Identity confirmed
(b) (4) (b) (4) (b) (4)
RNA (b) (4) (b) (4) (b) (4)

Endotoxin ((b) (4) )
Bacterial Endotoxin
(b) (4)
(b) (4)
Sterility Sterility ((b) (4) ) No Growth Detected
Container
Closure Integrity
(b) (4) Pass
Abbreviations: LNP = Lipid nanoparticles; (b) (4)
The analytical methods and their validations and/or qualifications for the COMIRNATY
DS and DP were found to be adequate for their intended use.
c. CBER Lot Release

The lot release protocol template was submitted to CBER for review and found to be
acceptable after revisions. A lot release testing plan was developed by CBER and will be
used for routine lot release.
d. Facilities Review / Inspection

Facility information and data provided in the BLA were reviewed by CBER and found to
be sufficient and acceptable. The facilities involved in the manufacture of COMIRNATY
are listed in Table 5 below. The activities performed and inspectional histories are also
noted in Table 5 and are further described in the paragraphs that follow.
11
Table 5. Facilities involved in the manufacture of COMIRNATY

FEI DUNS Inspection/ Results/
Name/address
Number number waiver Justification
Pfizer Inc.
875 Chesterfield Parkway
West
Chesterfield, MO 63017
ORA
(b) (4) Surveillance
Manufacture 1940118 004954111 Waiver
August 19-20, 2019
NAI
Drug Substance
Release and stability testing
Drug Product
Wyeth BioPharma Division
of Wyeth Pharmaceuticals
LLC
1 Burtt Road CBER
Andover, MA 01810 Pre-license
Pre-License
1222181 174350868 inspection
Drug Substance Inspection
July 19-23, 2021
Manufacture, release and
VAI
stability testing
Drug Product
Pharmacia & Upjohn
Company LLC
7000 Portage Road
Kalamazoo, MI 49001
ORA/OBPO
Surveillance
Drug Product 1810189 618054084 Waiver
May 11-20, 2021
LNP production, bulk drug
VAI
product formulation, fill and
finish, primary packaging,
secondary packaging,
release and stability testing
Pfizer Manufacturing
Belgium NV
Rijksweg 12
Puurs, 2870
CBER
Belgium
Pre-license
Pre-license
1000654629 370156507 inspection
Drug Product inspection
June 24-July 2, 2021
LNP production, bulk drug
NAI
product formulation, fill and
finish, primary packaging,
secondary packaging,
release and stability testing
12
FEI DUNS Inspection/ Results/

Name/address
Number number waiver Justification
Pfizer Ireland
Pharmaceuticals
Grange Castle Business
Park ORA Surveillance
Clondalkin, Dublin 22 3004145594 985586408 Waiver November 4-12, 2019
Ireland VAI
Drug Product
(b) (4) CDER

Pre-approval
inspection
(b) (4) (b) (4) Waiver
(b) (4)
Drug Product
VAI
Release testing (sterility)
(b) (4)
ORA
Surveillance
(b) (4) (b) (4) Waiver (b) (4)
Drug Product VAI
Release testing (sterility)
ORA conducted a surveillance inspection of Pfizer Inc., Chesterfield, MO, from August
19 – 20, 2019. No Form FDA 483 was issued, and the inspection was classified as No
Action Indicated (NAI).
CBER conducted a pre-license inspection (PLI) of Wyeth BioPharma Division of Wyeth

Pharmaceuticals LLC from July 19 – 23, 2021. All inspectional issues were resolved, and
the inspection was classified as Voluntary Action Indicated (VAI).
ORA conducted a surveillance inspection of Pharmacia & Upjohn Company LLC from
May 11 – 20, 2021. All inspectional issues were resolved, and the inspection was
classified as VAI.
CBER conducted a PLI of Pfizer Manufacturing Belgium NV from June 24 - July 2, 2021.
No Form FDA 483 was issued, and the inspection was classified as NAI.
ORA conducted a surveillance inspection of Pfizer Ireland Pharmaceuticals from

November 4 – 12, 2019. All inspectional issues were resolved, and the inspection was
classified as VAI.
CDER conducted a pre-approval inspection of (b) (4) from (b) (4)

. All inspectional issues were resolved, and the inspection was classified as VAI.
ORA conducted a surveillance inspection of (b) (4) from (b) (4)

. All inspectional issues were resolved, and the inspection was classified as VAI.
13
e. Container/Closure System
The COMIRNATY drug product is filled and stored at -90°C to -60°C in a 2 mL glass vial
sealed with a bromobutyl rubber stopper and an aluminum seal with flip-off plastic cap.
The glass vials are supplied by (b) (4)
The stopper and caps are supplied by (b) (4)

, respectively.
Pfizer performed container closure integrity testing (CCIT) on the filled 2 mL glass vials
using a (b) (4) test method. All acceptance criteria were met.
f. Environmental Assessment
The BLA included a request for categorical exclusion from an Environmental
Assessment under 21 CFR 25.31. The FDA concluded that this request is justified, and
no extraordinary circumstances exist that would require an environmental assessment.
4. Nonclinical Pharmacology/Toxicology
Nonclinical Toxicology
For the nonclinical safety evaluation, COMIRNATY was evaluated in two repeat dose
toxicity studies in Wistar Han rats and a Combined Fertility and Developmental Study
(Including Teratogenicity and Postnatal Investigations) in Wistar Han rats.
The repeat dose toxicity evaluations were conducted on COMIRNATY and a similar
vaccine termed BNT162b2 (V8). COMIRNATY and BNT162b2 (V8) have identical amino
acid sequences of the encoded antigens but COMIRNATY includes the presence of
optimized codons to improve antigen expression. The IM route of exposure was selected
as it is the route of clinical administration. Generation of an immune response to
COMIRNATY was confirmed in rats in both repeat-dose toxicity studies. In both repeat-
dose toxicity studies, administration of COMIRNATY by IM injection to male and female
rats once every week for a total of 3 doses was tolerated without evidence of systemic
toxicity. Edema and erythema at the injection sites, transient elevation in body
temperature, elevations in white blood cells and acute phase reactants and decreased
albumin:globulin ratios were observed. Injection site reactions were common in all
vaccine-administered animals and were greater after boost immunizations.
For the Combined Fertility and Developmental Study, COMIRNATY was administered to
female rats twice before the start of mating and twice during gestation at the human
clinical dose (30 μg RNA/dosing day). There were some effects (change in body weight
and food consumption and effects localized to the injection site) observed in rats in these
studies following administration of COMIRNATY that were not considered adverse and a
relationship to COMIRNATY was not established. There were no effects on mating
performance, fertility, or any ovarian or uterine parameters nor on embryo-fetal or
postnatal survival, growth, or development in the offspring. An immune response was
observed in female rats following administration of each vaccine candidate and these
responses were also detectable in the offspring (fetuses and pups).
14
Nonclinical Pharmacology and Pharmacokinetics

COMIRNATY was evaluated in nonclinical pharmacology studies using animal models of
mice, rats and nonhuman primates (NHP). The data from these studies indicate: (1)
strong antigen-binding IgG and high titer neutralizing antibodies in mice, rat and rhesus
macaques; (2) Th1-biased CD4+ T-cell response and IFNγ+, CD8+ T-cell response to
BNT162b2 in both mouse and NHP studies; and (3) protection of rhesus macaques from
an infectious SARS-CoV-2 challenge, with reduced detection of viral RNA in the
BNT162b2-immunized animals as compared with the control-immunized macaques.
Nonclinical pharmacokinetics (PK) evaluation included (1) biodistribution of COMIRNATY

using (b) (4) expressing RNA as a surrogate reporter in (b) (4) mice and in rats, and
(2) the biodistribution and metabolism of the two novel lipids (ALC-0315 and ALC-0159)
contained in COMIRNATY in in vitro studies and in a PK study in rats following
administration of (b) (4) expressing RNA encapsulated in LNPs made with
radiolabeled lipid markers. The study results indicate that following IM injection, the RNA
encapsulated in LNP mainly localizes to the site of injection and, to a lesser extent,
distributes to the liver. The metabolism of ALC-0315 and ALC-0159 was evaluated in
vitro using blood, liver microsomes, S9 fractions, and hepatocytes from mice, rats,
monkeys and humans and in vivo by examining the plasma, urine, feces, and liver
samples from the PK study in rats. Approximately 50% of ALC-0159 is excreted
unchanged in feces, while metabolism appears to play a role in the elimination of ALC-
0315.
5. Clinical Pharmacology
Pharmacodynamic data, comprised of humoral immune responses to COMIRNATY,

were obtained in the clinical studies. The data demonstrated that COMIRNATY induces
a humoral immune response against the SARS-CoV-2 spike protein. The exact
immunologic mechanism that confers protection against SARS-CoV-2 is unknown.
6. Clinical/Statistical
a. Clinical Program
Overview
The Applicant included data from two clinical studies in the BLA. The clinical studies
which will be discussed in this SBRA are shown in Table 6.
Table 6. Overview of Clinical Studies

Study ID C4591001 BNT162-01
NCT ID 04368728 04380701
Phase 1/2/3 1/2
Argentina, Brazil, Germany, South
Countries Germany
Africa, Turkey, U.S.
Phase 1: 30 participants
Enrollment 24
Phase 2/3: 43,847 participants
Age 16 - 85 YOA 18 - 85 YOA
Evaluate VE for prevention of
Evaluate safety and
Purpose COVID-19 (pivotal clinical endpoint
immunogenicity
study)
15
Study ID C4591001 BNT162-01

Control Saline Placebo None
Phase 2/3: 2 groups, randomized
1 group, randomized received
Groups 1:1 to receive COMIRNATY or
COMIRNATY IM
Placebo IM
Schedule D0, D21 D0, D21
Total follow-up 6 Months (follow-up ongoing) 6 Months (follow-up ongoing)
YOA: years of age; VE: vaccine efficacy; IM: intramuscular; D: day
Study C4591001
Study C4591001 is an ongoing, randomized, placebo-controlled, observer-blind Phase
1/2/3 study being conducted in the U.S., Argentina, Brazil, Germany, South Africa and
Turkey. Initially the study was designed as a Phase 1/2 study in healthy adults in the
U.S. for vaccine candidate and dosage selection, as well as evaluation of
immunogenicity and preliminary efficacy. The protocol was expanded to include a Phase
2/3 portion of the study to evaluate clinical disease efficacy endpoint in individuals 12
years of age and older in the U.S. and additional sites outside of the U.S.
The Phase 1 portion of the study was designed to identify a preferred vaccine candidate,
vaccine dose, and administration schedule for further development based on the
vaccine’s safety, tolerability, and immunogenicity. To this end, two age groups were
evaluated in separate cohorts, younger adults 18 through 55 years of age (N=45) and
older adults 65 through 85 years of age (N=45). The study population included healthy
men and women and excluded participants at high risk of SARS-CoV-2 infection or with
serological evidence of prior or current SARS-CoV-2 infection. Two different vaccine
candidates were evaluated, and younger participants received increasing dose levels
(10, 20 and 30 μg) with progression to higher dose levels in a stepwise manner.
Evaluation of increasing doses in the older age group (65 through 85 years) was based
on recommendations from an internal review committee that reviewed safety and
immunogenicity data derived from adults 18 through 55 years of age. For each vaccine
candidate and dose, participants were randomized 4:1, such that 12 participants
received the vaccine candidate and 3 participants received placebo. Review of the safety
and immunogenicity from the Phase 1 portion of Study C4591001, in combination with
data from Study BNT162-01, supported the final vaccine candidate, dose and dosing
regimen (BNT162b2 administered at 30 μg, given 3 weeks apart) to proceed to the
Phase 2/3 portion of Study C4591001.
In Phase 2/3, participants were enrolled with stratification by age (younger adults: 18
through 55 years of age; older adults: over 55 years of age) with the goal for the older
age strata to consist of 40% of the entire study population. Adolescents were added to
the protocol, based on review of safety data in younger adults enrolled in the ongoing
study; thus, the age strata were revised as follows: 16 through 55 years of age, and 56
years of age and older. The study population for Phase 2/3 includes participants at
higher risk for acquiring COVID-19 and at higher risk of severe COVID-19, such as
participants working in the healthcare field, participants with autoimmune disease, and
participants with chronic but stable medical conditions such as hypertension, asthma,
diabetes, and infection with HIV, hepatitis B or hepatitis C. Participants were randomized
1:1 to receive 2 doses of either COMIRNATY or placebo, 3 weeks apart. The Phase 2
portion of the study evaluated reactogenicity and immunogenicity of the vaccine in 360
16
participants in the early stage of Phase 2/3, and these participants also contribute to the
overall efficacy and safety data in the Phase 3 portion.
The ongoing Phase 3 portion of the study is evaluating the safety and efficacy of
COMIRNATY for the prevention of COVID-19 occurring at least 7 days after the second
dose of vaccine. Efficacy is being assessed throughout a participant’s blinded follow-up
in the study through surveillance for potential cases of COVID-19. If, at any time, a
participant develops acute respiratory illness, an illness visit occurs. Assessments for
illness visits include a nasal (mid-turbinate) swab, which is tested at a central laboratory
using a reverse transcription-polymerase chain reaction (RT-PCR) test (i.e., Cepheid;
FDA- authorized under EUA), or other sufficiently validated nucleic acid amplification-
based test (NAAT), to detect SARS-CoV-2. The central laboratory NAAT result is used
for the case definition, unless it was not possible to test the sample at the central
laboratory. In that case, the following NAAT results are acceptable: Cepheid Xpert
Xpress SARS-CoV-2, Roche cobas SARS-CoV-2 real-time RT-PCR test
(EUA200009/A001), and Abbott Molecular/RealTime SARS-CoV-2 assay
(EUA200023/A001).
The study design included a planned interim analysis of the first primary efficacy
endpoint (the efficacy of BNT162b2 against confirmed COVID-19 occurring from 7 days
after Dose 2 in participants without evidence of SARS-CoV-2 infection before
vaccination) at pre-specified numbers of COVID-19 cases (at least 62, 92, and 120
cases). All primary and secondary efficacy endpoints were analyzed in the final efficacy
analysis after at least 164 COVID-19 cases were accrued. Participants are expected to
participate for a maximum of approximately 26 months.
Per protocol, since December 14, 2020, following issuance of the emergency use
authorization for the Pfizer-BioNTech COVID-19 Vaccine, study participants 16 years of
age and older have been progressively unblinded to their treatment assignment (when
eligible per local recommendations) and offered BNT162b2 vaccination if they were
randomized to placebo.
The study was unblinded in stages as all ongoing participants were either individually
unblinded (when eligible per local recommendations) or the subject had concluded their
6-month post–Dose 2 study visit. Participants 16 years of age and older who participated
in the Phase 2/3 study were given the opportunity to receive COMIRNATY no later than
the 6-month timepoint after the second study vaccination. Participants who originally
received placebo but received COMIRNATY were moved to a new visit schedule to
receive both doses of COMIRNATY, 3 weeks apart.
The primary safety and efficacy endpoints were:
1. Primary safety endpoint (descriptive): Solicited local adverse reactions (injection

site pain, redness, swelling), solicited systemic adverse events (AE) (fever,
fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and
new or worsened joint pain), unsolicited AEs, serious adverse events (SAEs).
17
2. First primary efficacy endpoint: COVID-19 incidence per 1000 person-years of

follow-up based on laboratory-confirmed NAAT in participants with no serological
or virological evidence (up to 7 days after Dose 2) of past SARS-CoV-2 infection.
3. Second primary efficacy endpoint: COVID-19 incidence per 1000 person-years of

follow-up based on laboratory-confirmed NAAT in participants with and without
serological or virological evidence (up to 7 days after Dose 2) of past SARS-CoV-
2 infection.
The pertinent secondary endpoint was:
1. Severe COVID-19 incidence per 1000 person-years of follow-up.
Study C4591001 results

The population in the protocol-specified, event-driven final primary efficacy analysis
included all participants 12 years of age and older who had been enrolled from July 27,
2020 and followed for the development of COVID-19 through November 14, 2020. For
participants without evidence of SARS-CoV-2 infection prior to 7 days after Dose 2, VE
against confirmed COVID-19 occurring at least 7 days after Dose 2 was 95.0% (95%
credible interval: 90.0, 97.9), which met the pre-specified success criterion. The case
split was 8 COVID-19 cases in the BNT162b2 group compared to 162 COVID-19 cases
in the placebo group. This protocol-specified, event-driven final primary efficacy analysis
was the basis for issuance of the emergency use authorization for the Pfizer-BioNTech
COVID-19 Vaccine on December 11, 2020.
Therefore, the primary study objective of VE against COVID-19 was met as the point
estimate was above 50% and the lower bound of the 95% CI of the point estimate of VE
was above 30%.
The population for the updated vaccine efficacy analysis per protocol included
participants 16 years of age and older who had been enrolled from July 27, 2020, and
followed for the development of COVID-19 during blinded placebo-controlled follow-up
through March 13, 2021, representing up to ~6 months of follow-up after Dose 2. Overall,
60.8% of participants in the COMIRNATY group and 58.7% of participants in the placebo
group had ≥4 months of follow-up time after Dose 2 in the blinded placebo-controlled
follow-up period. The overall VE against COVID-19 in participants without evidence of
prior SARS-CoV-2 infection was 91.1% (95% CI: 88.8 to 93.1). The overall VE against
COVID-19 in participants with or without evidence of prior SARS-CoV-2 infection was
90.9% (95% CI: 88.5 to 92.8).
Subgroup analyses of vaccine efficacy (although limited by small numbers of cases in

some subgroups) did not suggest meaningful differences in efficacy across genders,
ethnic groups, geographies, or for participants with obesity or medical comorbidities
associated with high risk of severe COVID-19.
The updated vaccine efficacy information is presented in Tables 7a and 7b.
18
Table 7a: First COVID-19 occurrence from 7 days after Dose 2 in participants
without evidence of prior SARS-CoV-2 infection - Evaluable Efficacy (7 Days)
Population During the Placebo-Controlled Follow-up Period *
COMIRNATY Placebo
Na=19,993 Na=20,118
Cases Cases
n1b n1b
Surveillance Timec Surveillance Timec Vaccine Efficacy %
Subgroup (n2d) (n2d) (95% CIe)
77 833 91.1
All participants 6.092 (19,711) 5.857 (19,741) (88.8, 93.1)
70 709 90.5
16 through 64 years 4.859 (15,519) 4.654 (15,515) (87.9, 92.7)
7 124 94.5
65 years and older 1.233 (4192) 1.202 (4226) (88.3, 97.8)
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2
not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days
after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the
endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the
surveillance time.
Table 7b: First COVID-19 occurrence from 7 days after Dose 2 in participants with
or without* evidence of prior SARS-CoV-2 infection - Evaluable Efficacy (7 Days)
Population During the Placebo-Controlled Follow-up Period *
Placebo
COMIRNATY Na=21,210
Na=21,047 Cases
Cases n1b Vaccine Efficacy
n1b Surveillance Timec %
Subgroup Surveillance Timec (n2d) (n2d) (95% CIe)
81 854 90.9
All participants 6.340 (20,533) 6.110 (20,595) (88.5, 92.8)
74 726 90.2
16 through 64 years 5.073 (16,218) 4.879 (16,269) (87.5, 92.4)
7 128 94.7
65 years and older 1.267 (4315) 1.232 (4326) (88.7, 97.9)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and
SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were included in the analysis.
a. N = Number of participants in the specified group.
b. n1 = Number of participants meeting the endpoint definition.
c. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the
d. n2 = Number of participants at risk for the endpoint.
e. Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the
surveillance time.
19
Efficacy Against Severe COVID-19

Vaccine efficacy against severe COVID-19 for participants with or without prior SARS-
CoV-2 infection is shown in Tables 8a and 8b. The VE against severe COVID-19 in
participants with or without evidence of prior SARS-CoV-2 infection was 95.3% (95% CI:
71.0 to 99.9) using the protocol definition of severe COVID-19 and 100.0% (95% CI: 87.6
to 100.0) based on the CDC definition of severe COVID-19.
Table 8a: Vaccine Efficacy – First Severe COVID-19 Occurrence in Participants 16

Years of Age and Older With or Without* Prior SARS-CoV-2 Infection Based on
Protocol† Definition From 7 Days After Dose 2 – Evaluable Efficacy (7 Days)
Population During the Placebo-Controlled Follow-up
COMIRNATY Placebo
Cases Cases
n1a n1a Vaccine Efficacy
Surveillance Timeb Surveillance Timeb %
(n2c) (n2c) (95% CId)
7 days after Dose 2d 1 21 95.3
6.353 (20,540) 6.237 (20,629) (70.9, 99.9)
Table 8b: Vaccine Efficacy – First Severe COVID-19 Occurrence in Participants 16

Years of Age and Older With or Without* Prior SARS-CoV-2 Infection Based on
Centers for Disease Control and Prevention (CDC)‡ Definition From 7 Days After
Dose 2 – Evaluable Efficacy (7 Days) Population During the Placebo-Controlled
Follow-up
COMIRNATY Placebo
Cases Cases
n1a n1a Vaccine Efficacy
Surveillance Timeb Surveillance Timeb %
(n2c) (n2c) (95% CId)
7 days after Dose 2d 0 31 100
6.345 (20,513) 6.225 (20,593) (87.6, 100.0)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).
* Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and
SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit
prior to 7 days after Dose 2 were included in the analysis.
†
Severe illness from COVID-19 is defined in the protocol as confirmed COVID-19 and presence of at least 1 of the following:
• Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥30 breaths per minute, heart rate ≥125 beats
per minute, saturation of oxygen ≤93% on room air at sea level, or ratio of arterial oxygen partial pressure to fractional
inspired oxygen <300 mm Hg);
• Respiratory failure [defined as needing highflow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal
membrane oxygenation (ECMO)];
• Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg, or requiring vasopressors);
• Significant acute renal, hepatic, or neurologic dysfunction;
• Admission to an Intensive Care Unit;
• Death.
‡
Severe illness from COVID-19 as defined by CDC is confirmed COVID-19 and presence of at least 1 of the following:
• Hospitalization;
• Admission to the Intensive Care Unit;
• Intubation or mechanical ventilation;
• Death.
a. n1 = Number of participants meeting the endpoint definition.
b. Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the
c. n2 = Number of participants at risk for the endpoint.
20
d. Two-side confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the
surveillance time
Study BNT162-01
Study BNT162-01 is an ongoing Phase 1/2, open-label, dose-finding study to evaluate
the safety and immunogenicity of several candidate vaccines, including BNT162b2 (1, 3,
10, 20, and 30 µg), conducted in Germany in healthy and immunocompromised adults.
Only safety and immunogenicity data in individuals 16 years of age and older, the
population for the intended use and who received the final vaccine formulation (30 µg
BNT162b2) are used to support this application. The 30 µg dosage of BNT162b2 was
administered to 12 adults 18 to 55 years of age and 12 adults 56 to 85 years of age.
The primary objective was to evaluate the safety of the BNT162 candidate vaccines.
Secondary and exploratory objectives were to describe humoral and cellular immune
responses following vaccination, measured at baseline and various time points after
vaccination, specifically 7 days post Dose 2. Adverse event monitoring was the same as
the safety monitoring in study C4591001.
The study started April 23, 2020. The BLA contains safety data (reactogenicity and AE
analyses) up to 1 month after Dose 2 (data cutoff date: October 23, 2020), neutralizing
antibody data up to ~2 months after Dose 2 (data cutoff date: October 23, 2020), and T-
cell data up to ~6 months after Dose 2 (data cutoff date: March 2, 2021).
Study BNT162-01 Results

Disposition of 30 µg BNT162b2 group:
- Safety: Of a total of 24 participants, 12 participants 18 to 55 years of age and 12
participants 56 to 85 years of age completed the visit at 1- month post-Dose 2.
- Immunogenicity: Of the 12 participants, serum neutralizing antibody and T-cell
responses were available for 10 and 12 participants, respectively.
Safety: The safety profiles for adult participants 18-55 and 56-85 years of age receiving
30 µg BNT162b2 in this study were similar to age-matched participants in study
C4591001.
Immunogenicity: Dose-dependent increases were noted 42 days after Dose 2, compared

to SARS-CoV-2 neutralizing GMTs at baseline (pre-Dose 1), and most pronounced at
the 30 μg dose level. The Th1 polarization of the T-helper response was indicated by
IFNγ and IL-2 production, and only minimal IL-4 production upon antigen-specific
(SARS-CoV-2 S protein peptide pools) re-stimulation.
Review of the safety and immunogenicity from Phase 1 part of Study C4591001, in
combination with data from Study BNT162-01, supported selection of the final vaccine
candidate and dose level (BNT162b2 at 30 μg, given as two doses 3 weeks apart) to
proceed into Phase 2/3 part of Study C4591001.
Lot Consistency
Consistency of process performance qualification (PPQ) batches manufactured at both
Pfizer Puurs and Pfizer Kalamazoo was demonstrated by verifying process parameters
and in-process testing results as well as DP release testing. Data obtained from the
analytical comparability assessments on the PPQ batches manufactured at both sites
21
provide evidence of reproducible and consistent manufacture of COMIRNATY DP of

acceptable product quality across all supply nodes.
b. Bioresearch Monitoring (BIMO) – Clinical/Statistical/Pharmacovigilance

BIMO inspection assignments were issued for a total of nine (9) clinical study sites that
participated in the conduct of study Protocol C4591001. Three (3) of these inspection
assignments focused on clinical study sites that enrolled the pediatric population and six
(6) of the study sites enrolled the adult population. The inspections did not reveal
findings that impact the BLA.
c. Pediatrics
The Applicant’s Pediatric Plan was presented to the FDA Pediatric Review Committee
(PeRC) on August 3, 2021. The committee agreed with the Applicant’s request for a
deferral for studies in participants 0 to <16 years of age because the biological product is
ready for approval for use in individuals 16 years of age and older before pediatric
studies in participants 0 to <16 years of age are completed (Section 505B(a)(3)(A)(i) of
PREA).
The PREA-required studies specified in the approval letter and agreed upon with the
Applicant are as follows:
1. Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in

children 12 years through 15 years of age

children 6 months to <12 years of age

infants <6 months of age
7. Safety and Pharmacovigilance
The most commonly reported (≥10%) solicited adverse reactions in COMIRNATY

recipients 16 through 55 years of age following any dose were pain at the injection site
(88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint
pain (27.5%), fever (17.8%), and injection site swelling (10.6%). The most commonly
reported (≥10%) solicited adverse reactions in COMIRNATY recipients 56 years of age
and older following any dose were pain at the injection site (78.2%), fatigue (56.9%),
headache, (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site
swelling (11.8%), fever (11.5%), and injection site redness (10.4%).
Among participants 16 through 55 years of age who had received at least 1 dose of
COMIRNATY (N=12,995) or placebo (N=13,026), serious adverse events from Dose 1
up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%)
COMIRNATY recipients and 117 (0.9%) placebo recipients. In a similar analysis in
participants 56 years of age and older (COMIRNATY=8,931, placebo=8,895), serious
adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%)
placebo recipients who received at least 1 dose of COMIRNATY or placebo,
respectively. In these analyses, 58.2% of study participants had at least 4 months of
22
follow-up after Dose 2. There were no notable patterns between treatment groups for
specific categories of serious adverse events (including neurologic, neuro-inflammatory,
and thrombotic events) that would suggest a causal relationship to COMIRNATY.
From Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38
deaths, 21 in the COMIRNATY group and 17 in the placebo group. None of the deaths
were considered related to vaccination.
Since the issuance of the EUA (December 11, 2020), post-authorization safety data has
been reported from individuals 16 years of age and older following any dose of
COMIRNATY. Because these reactions are reported from a population of uncertain size,
it is not always possible to reliably estimate their frequency or establish a causal
relationship to vaccine exposure. Below are presented adverse reactions categorized as
important identified risks in the pharmacovigilance plan that have occurred during the
conduct of the clinical trial and have been reported following the issuance of the EUA.
Myocarditis/Pericarditis
During the time from Dose 1 to unblinding in Study C4591001, one report of pericarditis
was identified in the COMIRNATY group, occurring in a male participant ≥55 years of
age, with no medical history, 28 days after Dose 2; the event was assessed by the
investigator as not related to the study intervention and was ongoing at the time of the
data cutoff. One report of myocarditis was identified in a male participant <55 years of
age in the placebo group, occurring 5 days after his second placebo dose.
Post-EUA safety surveillance reports received by FDA and CDC identified serious risks
for myocarditis and pericarditis following administration of COMIRNATY. Reporting rates
for medical chart-confirmed myocarditis/pericarditis in VAERS have been higher among
males under 40 years of age than among females and older males and have been
highest in males 12-17 years of age (65 cases per million doses administered as per
CDC communication on August 20, 2021), particularly following the second dose, and
onset of symptoms within 7 days following vaccination. Although some cases of vaccine-
associated myocarditis/pericarditis required intensive care support, available data from
short-term follow up suggest that most individuals have had resolution of symptoms with
conservative management. Information is not yet available about potential long-term
sequelae and outcomes in affected individuals. A mechanism of action by which the
vaccine could cause myocarditis and pericarditis has not been established.
These safety findings of increased risk for myocarditis/pericarditis led to warning in

section 5.2 Warning and Precautions of the PI.
Myocarditis and pericarditis are considered important identified risks in the

pharmacovigilance plan included in the BLA. Of note, the Applicant will be required to
conduct postmarketing requirement (PMR) safety studies under Section 505(o) of the
Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of
myocarditis and pericarditis as well as an unexpected serious risk for subclinical
myocarditis (see Section 11c Recommendation for Postmarketing Activities, for study
details).
23
Moreover, since vaccine-associated myocarditis/pericarditis is the most clinically

significant identified risk, FDA undertook a quantitative benefit-risk assessment to model
the excess risk of myocarditis/pericarditis vs. the expected benefits of preventing COVID-
19 and associated hospitalizations, ICU admissions, and deaths. For estimation of risk,
the model took a conservative approach by relying on non-chart-confirmed cases from a
US healthcare claims database (OPTUM) that could provide a control group and greater
confidence in denominators for vaccine exposures. Thus, the estimates of excess risk in
this model are higher than the rates estimated from reports to VAERS (an uncontrolled
passive surveillance system), with an estimated excess risk approaching 200 cases per
million vaccinated males 16-17 years of age (the age/sex-stratified group with the
highest risk). For estimation of benefit, the model output was highly dependent on the
assumed COVID-19 incidence, as well as assumptions about vaccine efficacy and
duration of protection. The assessment therefore considered a range of scenarios
including but not limited to a “most likely” scenario associated with recent Delta variant
surge and diminished vaccine effectiveness (70% overall, 80% against COVID-19
hospitalization) compared to that observed in the clinical trial. The “worst-case” scenario
with low COVID-19 incidence reflecting the July 2021 nadir and the same somewhat
diminished vaccine effectiveness as in the “most likely” scenario.
For males and females 18 years of age and older and for females 16-17 years of age,
even before accounting for morbidity prevented from non-hospitalized COVID-19, the
model predicts that the benefits of prevented COVID-19 hospitalizations, ICU admissions
and deaths would clearly outweigh the predicted excess risk of vaccine-associated
myocarditis/pericarditis under all conditions examined. For males 16-17 years of age, the
model predicts that the benefits of prevented COVID-19 hospitalizations, ICU admissions
and deaths would clearly outweigh the predicted excess risk of vaccine-associated
myocarditis/pericarditis under the “most likely” scenario, but that predicted excess cases
of vaccine-associated myocarditis/pericarditis would exceed COVID-19 hospitalizations
and deaths under the “worst case” scenario. However, this predicted numerical
imbalance does not account for the greater severity and length of hospitalization, on
average, for COVID-19 compared with vaccine-associated myocarditis/pericarditis.
Additionally, the “worst case” scenario model predicts prevention of >13,000 cases of
non-hospitalized COVID-19 per million vaccinated males 16-17 years of age, which
would include prevention of clinically significant morbidity and/or long-term sequelae
associated with some of these cases. Finally, the model does not account for indirect
societal/public health benefits of vaccination. Considering these additional factors, FDA
concluded that even under the “worst case” scenario the benefits of vaccination
sufficiently outweigh risks to support approval of the vaccine in males 16-17 years of
age.
Mitigation of the observed risks and associated uncertainties will be accomplished

through labeling (including warning statements) and through continued safety
surveillance and postmarketing studies to further assess and understand these risks,
including an immunogenicity and safety study of lower dose levels of COMIRNATY in
individuals 12 through <30 years of age. The Applicant will be required to conduct
postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal
Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis
and pericarditis and an unexpected serious risk for subclinical myocarditis (see section
11c for study details).
24
Anaphylaxis
The risk of anaphylaxis was recognized early in the post-authorization time period and it
is included as an important identified risk in the PVP. The estimated crude reporting rate
for anaphylaxis is 6.0 cases per million doses. Therefore, the incidence of anaphylaxis
after receipt of COMIRNATY is comparable with those reported after receipt of other
vaccines.
There were no reports of anaphylaxis associated with COMIRNATY in clinical study

participants through the cutoff date of March 13, 2021.
A contraindication for individuals with known history of a severe allergic reaction (e.g.,
anaphylaxis) to any component of COMIRNATY is included in section 4 of the PI.
Additionally, a warning statement is included in section 5.1 of the PI instructing that
“appropriate medical treatment used to manage immediate allergic reactions must be
immediately available in the event an acute anaphylactic reaction occurs following
administration of COMIRNATY”
Pharmacovigilance Plan (PVP)

The Applicant’s proposed pharmacovigilance plan (version 1.1) includes the following
important risks and missing information:
• Important identified risks: Anaphylaxis; Myocarditis and Pericarditis
• Important potential risk: Vaccine-Associated Enhanced Disease (VAED), including
Vaccine-Associated Enhanced Respiratory Disease (VAERD)
• Missing information: Use in pregnancy and lactation; Vaccine effectiveness; Use
in pediatric individuals <12 years of age
In addition to routine pharmacovigilance, the Applicant will conduct the postmarketing

studies listed in Section 11c Recommendation for Postmarketing Activities.
Adverse event reporting under 21 CFR 600.80 and the postmarketing studies in Section
11c are adequate to monitor the postmarketing safety for COMIRNATY.
8. Labeling
The proprietary name, COMIRNATY, was reviewed by CBER’s Advertising and

Promotional Labeling Branch (APLB) on July 2, 2021, and found to be acceptable. CBER
communicated this decision to the Applicant on July 6, 2021. The APLB found the PI and
package/container labels to be acceptable from a promotional and comprehension
perspective. The Review Committee negotiated revisions to the PI, including modifying
the proposed proper name from “COVID-19 mRNA vaccine (nucleoside-modified)” to
“COVID-19 Vaccine, mRNA” and including a warning for an increased risk of myocarditis
and pericarditis following administration of COMIRNATY. All labeling issues regarding
the PI and the carton and container labels were acceptably resolved after exchange of
information and discussions with the Applicant.
25
9. Advisory Committee Meetings
Vaccines and Related Biological Products Committee (VRBPAC) meetings were

convened on October 22, 2020 to discuss, in general, development for EUA and
licensure of vaccines to prevent COVID-19 and on December 10, 2020, to discuss
BioNTech Manufacturing GmbH/Pfizer’s EUA request for the Pfizer-BioNTech COVID-19
Vaccine.
On October 22, 2020, the VRBPAC was presented with the following items for
discussion (no vote):
1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the
respective guidance documents.
2. Please discuss considerations for continuation of blinded Phase 3 clinical trials if

an EUA has been issued for an investigational COVID-19 vaccine.
3. Please discuss studies following licensure and/or issuance of an EUA for COVID-
19 vaccines to
a. Further evaluate safety, effectiveness and immune markers of protection
b. Evaluate the safety and effectiveness in specific populations
In general, the VRBPAC endorsed FDA’s approach and recommendations on the safety
and effectiveness data necessary to support a BLA and EUA for COVID-19 vaccines as
outlined in the respective guidance documents. VRBPAC members recommended for
the median follow-up of 2 month to be the minimum follow-up period and suggested
longer follow-up periods to evaluate, both safety and efficacy, if feasible. The VRBPAC
endorsed the importance of additional studies to further evaluate safety and
effectiveness of the vaccine after EUA issuance and/or licensure and underscored the
need to evaluate the safety and effectiveness of COVID-19 vaccines in specific
populations.
On December 10, 2020, VRBPAC discussed Pfizer- BioNTech Manufacturing GmbH’s

EUA request for their vaccine to prevent COVID-19 in individuals 16 years of age and
older. The committee discussed the safety and efficacy data derived from the clinical
disease endpoint efficacy study C4591001.
The VRPBAC voted on one question:
1. Based on the totality of scientific evidence available, do the benefits of the Pfizer-
BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of
age and older?
The results of the vote were as follows:

Yes = 17 No = 4 Abstain = 1
The VRBPAC was presented with the following items for discussion (no vote):
1. Pfizer has proposed a plan for continuation of blinded, placebo-controlled follow-

up in ongoing trials if the vaccine were made available under EUA. Please discuss
26
Pfizer’s plan, including how loss of blinded, placebo-controlled follow-up in

ongoing trials should be addressed.
2. Please discuss any gaps in plans described today and in the briefing documents
for further evaluation of vaccine safety and effectiveness in populations who
receive the Pfizer-BioNTech COVID-19 Vaccine under an EUA.
The committee discussed potential implications of loss of blinded, placebo-controlled

follow-up in ongoing trials including how this may impact availability of safety data to
support a BLA. The VRBPAC commented on the need to further assess vaccine effect
on asymptomatic infection and viral shedding, and further evaluation of safety and
effectiveness in subpopulations such as HIV-infected individuals, individuals with prior
exposure to SARS-CoV-2.
FDA did not refer this application to the VRBPAC because our review of the information
submitted to this BLA did not raise concerns or controversial issues that would have
benefited from an advisory committee discussion.
10. Other Relevant Regulatory Issues
a. Identification of BLA Lots

Upon CBER’s request inquiring about what BLA-compliant EUA-labeled lots may be
available for use upon licensure of COMIRNATY, the Applicant submitted information
listing which lots they considered to be manufactured according to the BLA. To address
the issue of these lots not bearing the vial label associated with BLA approval, CBER
worked with the Applicant to develop a Dear HCP letter to be included with lots
considered by CBER to be BLA-compliant. This letter explained that some lots labeled
for EUA use were also considered BLA-compliant and refers HCP to a website for
additional information. CBER requested and the Applicant agreed that only EUA-labeled
lots that had also undergone CBER lot release according to the BLA would be
considered BLA-compliant and listed at the website included in the Dear HCP letter.
b. Exception to the 21 CFR 610.15(a) Requirement for a Preservative

Under 21 CFR 610.15(a), a vaccine product in multiple-dose containers must (absent
certain exceptions) contain a preservative. The Applicant submitted a request for
exception to this requirement and provided a justification for the multi-dose presentation
of COMIRNATY not containing a preservative. CBER considered the Applicant’s request
for an exception to the 21 CFR 610.15(a) for COMIRNATY as a multiple dose
preservative-free presentation acceptable.
11. Recommendations and Benefit/Risk Assessment
a. Recommended Regulatory Action

Based on the review of the clinical, pre-clinical, and product-related data submitted in
the original BLA, the Review Committee recommends approval of COMIRNATY for
the labeled indication and usage.
27
b. Benefit/Risk Assessment
Considering the data submitted to support the safety and effectiveness of
COMIRNATY that have been presented and discussed in this document, as well as
the seriousness of COVID-19, the Review Committee is in agreement that the
risk/benefit balance for COMIRNATY is favorable and supports approval for use in
individuals 16 years of age and older.
c. Recommendation for Postmarketing Activities

BioNTech Manufacturing GmbH has committed to conduct the following
postmarketing activities, which will be included in the approval letter.
POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
1. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the

Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the
occurrence of myocarditis and pericarditis following administration of COMIRNATY

Monitoring Report Submission: October 31, 2022
Interim Report Submission: October 31, 2023
2. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study

Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease
2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis
following administration of COMIRNATY

Progress Report Submission: September 30, 2021
3. Study C4591021 substudy to describe the natural history of myocarditis and

pericarditis following administration of COMIRNATY

4. Study C4591036, a prospective cohort study with at least 5 years of follow-up for
potential long-term sequelae of myocarditis after vaccination (in collaboration with
Pediatric Heart Network)
28


myocarditis following administration of the second dose of COMIRNATY in a subset
of participants 5 through 15 years of age


myocarditis following administration of a third dose of COMIRNATY in a subset of
participants 16 to 30 years of age

POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS

UNDER SECTION 506B
7. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during

Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant
Outcomes in the Organization of Teratology Information Specialists
(OTIS)/MotherToBaby Pregnancy Registry”
Final Protocol Submission: July 1, 2021

8. Study C4591007 substudy to evaluate the immunogenicity and safety of lower dose
levels of COMIRNATY in individuals 12 through <30 years of age

9. Study C4591012, entitled “Post-emergency Use Authorization Active Safety

Surveillance Study Among Individuals in the Veteran’s Affairs Health System
Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine”

10. Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine

Effectiveness Study - Kaiser Permanente Southern California”
29
Final Protocol Submission: March 22, 2021

Final Report Submission: June 30, 2023
PEDIATRIC REQUIREMENTS
11. Deferred pediatric study C4591001 to evaluate the safety and effectiveness of
COMIRNATY in children 12 years through 15 years of age
Final Protocol Submission: October 7, 2020

Study Completion: May 31, 2023
COMIRNATY in children 6 months to <12 years of age
Final Protocol Submission: February 8, 2021

COMIRNATY in infants <6 months of age

Study Completion: July 31, 2024
30
Marks Decl.
Exhibit D
Contains Nonbinding Recommendations
Development and Licensure of

Vaccines to Prevent COVID-19
Guidance for Industry
U.S. Department of Health and Human Services

June 2020
Preface
Public Comment
This guidance is being issued to address the coronavirus disease 2019 (COVID-19) public health
emergency. This guidance is being implemented without prior public comment because the
Food and Drug Administration (FDA or Agency) has determined that prior public participation
for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This
guidance document is being implemented immediately, but it remains subject to comment in
accordance with the Agency’s good guidance practices.
Comments may be submitted at any time for Agency consideration. Submit written comments to
the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.
All comments should be identified with the docket FDA-2020-D-1137 and complete title of the
guidance in the request.
Additional Copies
Additional copies are available from the FDA webpage titled “COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,” available at
https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-
guidance-documents-industry-fda-staff-and-other-stakeholders, the FDA webpage titled “Search
for FDA Guidance Documents,” available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents, and the FDA webpage titled “Biologics
Guidances,” available at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-
regulatory-information-biologics/biologics-guidances. You may also send an email request to
[email protected] to receive an additional copy of the guidance. Please include the docket
number FDA-2020-D-1137 and complete title of the guidance in the request.
Questions
For questions about this document, contact the Office of Communication, Outreach, and
Development (OCOD) by email at [email protected] or at 800-835-4709 or 240-402-8010.
Table of Contents
I. INTRODUCTION..................................................................................................................... 1
II. BACKGROUND ....................................................................................................................... 2
III. CHEMISTRY, MANUFACTURING, AND CONTROLS – KEY CONSIDERATIONS . 3
A. General Considerations ..................................................................................................... 3
B. Manufacture of Drug Substance and Drug Product ....................................................... 3
C. Facilities and Inspections ................................................................................................... 5
IV. NONCLINICAL DATA – KEY CONSIDERATIONS ......................................................... 6
B. Toxicity Studies (Refs. 10-14) ............................................................................................ 6
C. Characterization of the Immune Response in Animal Models ...................................... 7
D. Studies to Address the Potential for Vaccine-associated Enhanced Respiratory
Disease ................................................................................................................................. 8
V. CLINICAL TRIALS – KEY CONSIDERATIONS .............................................................. 9
B. Trial Populations .............................................................................................................. 10
C. Trial Design....................................................................................................................... 12
D. Efficacy Considerations ................................................................................................... 13
E. Statistical Considerations ................................................................................................ 14
F. Safety Considerations ...................................................................................................... 15
VI. POST-LICENSURE SAFETY EVALUATION – KEY CONSIDERATIONS ................ 16
A. General Considerations ................................................................................................... 16
B. Pharmacovigilance Activities for COVID-19 Vaccines ................................................ 16
C. Required Postmarketing Safety Studies ......................................................................... 17
VII. DIAGNOSTIC AND SEROLOGICAL ASSAYS – KEY CONSIDERATIONS .............. 17
VIII. ADDITIONAL CONSIDERATIONS ................................................................................... 18
A. Additional Considerations in Demonstrating Vaccine Effectiveness .......................... 18
B. Emergency Use Authorization ........................................................................................ 19
IX. REFERENCES........................................................................................................................ 20
i
Development and Licensure of

Vaccines to Prevent COVID-19
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency)
on this topic. It does not establish any rights for any person and is not binding on FDA or the public.
You can use an alternative approach if it satisfies the requirements of the applicable statutes and
regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance
as listed on the title page.
I. INTRODUCTION
FDA plays a critical role in protecting the United States from threats such as emerging infectious
diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic which has been caused by
the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). FDA is committed to
providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines
for the prevention of COVID-19.
This guidance is intended to remain in effect for the duration of the public health emergency related
to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020,
effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with
section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). The
recommendations described in the guidance are expected to assist the Agency and sponsors in the
clinical development and licensure of vaccines for the prevention of COVID-19 and reflect the
Agency’s current thinking on this issue.
Given this public health emergency, and as discussed in the Notice in the Federal Register of March
25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease
2019” (85 FR 16949), available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-
06222.pdf, this guidance is being implemented without prior public comment because FDA has
determined that prior public participation for this guidance is not feasible or appropriate (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 371(h)(1)(C)),
and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it
remains subject to comment in accordance with the Agency’s good guidance practices. However,
FDA expects that the recommendations set forth in this revised guidance will continue to apply
outside the context of the current public health emergency.
1
Therefore, within 60 days following the termination of the public health emergency, FDA intends to
revise and replace this guidance with an updated guidance that incorporates any appropriate changes
based on comments received on this guidance and the Agency’s experience with implementation.
In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The
use of the word should in Agency guidance means that something is suggested or recommended, but
not required.
II. BACKGROUND
There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has
been named “SARS-CoV-2” and the disease it causes has been named “COVID-19.” On January 31,
2020, the Secretary of HHS issued a declaration of a public health emergency related to COVID-19
and mobilized the Operating Divisions of HHS. 1 In addition, on March 13, 2020, the President
0F
declared a national emergency in response to COVID-19. 2 1F
The SARS-CoV-2 pandemic presents an extraordinary challenge to global health. There are
currently no FDA-licensed vaccines to prevent COVID-19. Commercial vaccine manufacturers and
other entities are developing COVID-19 vaccine candidates using different technologies including
RNA, DNA, protein, and viral vectored vaccines.
This guidance describes FDA’s current recommendations regarding the data needed to facilitate
clinical development and licensure of vaccines to prevent COVID-19. There are currently no
accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19
vaccine. Thus, at this time, the goal of development programs should be to pursue traditional
approval via direct evidence of vaccine safety and efficacy in protecting humans from SARS-CoV-2
infection and/or clinical disease.
This guidance provides an overview of key considerations to satisfy regulatory requirements set forth
in the investigational new drug application (IND) regulations in 21 CFR Part 312 and licensing
regulations in 21 CFR Part 601 for chemistry, manufacturing, and controls (CMC), and nonclinical
and clinical data through development and licensure, and for post-licensure safety evaluation of
COVID-19 preventive vaccines. 3 FDA is committed to supporting all scientifically sound
2F
approaches to attenuating the clinical impact of COVID-19. Sponsors engaged in the development
of vaccines to prevent COVID-19 should also see the guidance for industry and investigators,
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for
COVID-19 Related Drugs and Biological Products (Ref. 1).
1
Secretary of Health and Human Services Alex M. Azar, Determination that a Public Health Emergency Exists. (Jan. 31,
2020, renewed April 21, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
2
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak
(Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-
emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
3
Novel devices used to administer COVID-19 vaccines raise additional issues which are not addressed in this guidance.
2
There are many COVID-19 vaccines currently in development and FDA recognizes that the
considerations presented here do not represent all the considerations necessary to satisfy statutory
and regulatory requirements applicable to the licensure of vaccines intended to prevent COVID-19.
The nature of a particular vaccine and its intended use may impact specific data needs. We encourage
sponsors to contact the Center for Biologics Evaluation and Research (CBER) Office of Vaccines
Research and Review (OVRR) with specific questions.
III. CHEMISTRY, MANUFACTURING, AND CONTROLS – KEY CONSIDERATIONS
A. General Considerations
• COVID-19 vaccines licensed in the United States must meet the statutory and
regulatory requirements for vaccine development and approval, including for
quality, development, manufacture, and control (section 351(a) of the Public
Health Service Act (PHS Act), (42 U.S.C. 262)). The vaccine product must be
adequately characterized and its manufacture in compliance with applicable
standards including current good manufacturing practice (cGMP) (section
501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)( B)) and 21 CFR Parts 210,
211, and 610). It is critical that vaccine production processes for each vaccine are
well defined and appropriately controlled to ensure consistency in manufacturing.
• COVID-19 vaccine development may be accelerated based on knowledge gained

from similar products manufactured with the same well-characterized platform
technology, to the extent legally and scientifically permissible. Similarly, with
appropriate justification, some aspects of manufacture and control may be based
on the vaccine platform, and in some instances, reduce the need for product-
specific data. FDA recommends that vaccine manufacturers engage in early
communications with OVRR to discuss the type and extent of chemistry,
manufacturing, and control information needed for development and licensure of
their COVID-19 vaccine.
B. Manufacture of Drug Substance and Drug Product
• Data should be provided to show that all source material used in manufacturing is
adequately controlled, including, for example, history and qualification of cell
banks, history and qualification of virus banks, and identification of all animal
derived materials used for cell culture and virus growth.
• Complete details of the manufacturing process must be provided in a Biologics

License Application (BLA) to support licensure of a COVID-19 vaccine (21 CFR
601.2). Accordingly, sponsors should submit data and information identifying
critical process parameters, critical quality attributes, batch records, defined hold
times, and the in-process testing scheme. Specifications should be established for
3
each critical parameter. Validation data from the manufacture of platform-related

products may provide useful supportive information, particularly in the
identification of critical parameters.
• In-process control tests must be established that allow quality to be monitored for
each lot for all stages of production (section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) and, as applicable, 21 CFR 211.110(a)).
• Data to support the consistency of the manufacturing process should be provided,

including process validation protocols and study reports, data from engineering
lots, and drug substance process performance qualification.
• The manufacturing process must be adequately validated (section 501(a)(2)(B) of

the FD&C Act (21 U.S.C. 351(a)(2)(B)) and, as applicable, 21 CFR 211.100(a)
and 211.110). Validation would typically include a sufficient number of
commercial-scale batches that can be manufactured routinely, meeting
predetermined in-process controls, critical process parameters, and lot release
specifications. Typically, data on the manufacture of at least three commercial-
scale batches are sufficient to support the validation of the manufacturing process
(Ref. 2).
• A quality control system should be in place for all stages of manufacturing,

including a well-defined testing program to ensure in process/intermediate product
quality and product quality throughout the formulation and filling process. This
system should also include a well-defined testing program to ensure drug
substance quality profile and drug product quality for release. Data on the
qualification/validation for all quality indicating assays should be submitted to the
BLA to support licensure.
• All quality-control release tests, including key tests for vaccine purity, identity and
potency, should be validated and shown to be suitable for the intended purpose.
Release specifications are product specific and will be discussed with the sponsor
as part of the review of a BLA.
• If adequately justified, final validation of formulation and filling operations may

be completed after product approval if the impact on product quality is not
compromised. It is important that any data that will be submitted after product
approval be agreed upon prior to licensure and be submitted as a postmarketing
commitment using the appropriate submission category.
• For vaccine licensure, the stability and expiry date of the vaccine in its final
container, when maintained at the recommended storage temperature, should be
demonstrated using final containers from at least three final lots made from
different vaccine bulks.
• Storage conditions, including container closure integrity, must be fully validated

(21 CFR 211.166).
4
• The vaccine must have been shown to maintain its potency for a period equal to
that from the date of release to the expiry date (21 CFR 601.2 and 610.10). Post
marketing commitments to provide full shelf life data may be acceptable with
appropriate justification.
• A product specific stability program should be established to verify that licensed

product maintains quality over the defined shelf life.
C. Facilities and Inspections
• Facilities must be of suitable size and construction to facilitate operations and

should be adequately designed to prevent contamination, cross-contamination and
mix-ups (section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) and, as
applicable,21 CFR 211.42(a)). All utilities (including plumbing and sanitation)
must be validated, and HVAC systems must provide adequate control over air
pressure, micro-organisms, dust, humidity, and temperature, and sufficient
protection or containment as needed (section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) and, as applicable, 21 CFR 211.46(c)) (Ref. 3). Facility and
equipment cleaning and maintenance processes must be developed and validated
(section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) and, as
applicable, 21 CFR 211.56(c) and 211.67(b)).
• Manufacturing equipment should be qualified and sterile filtration and sterilization

processes validated. Aseptic processes should be adequately validated using
media simulations and personnel should be trained and qualified for their intended
duties.
• A quality control unit must be established and must have the responsibility for
oversight of manufacturing, and review and release of components, containers and
closures, labeling, in-process material, and final products (section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B)) and, as applicable, 21 CFR 211.22). The
quality control unit must have the responsibility for approving validation
protocols, reports, investigate deviations, and institute corrective and preventive
actions.
• FDA recommends that vaccine manufacturers engage in early communication

with CBER’s Office of Compliance and Biologics Quality, Division of
Manufacturing and Product Quality to discuss facility preparation and inspection
timing.
• Pre-license inspections of manufacturing sites are considered part of the review of

a BLA and are generally conducted following the acceptance of a BLA filing (21
CFR 601.20). During the COVID-19 public health emergency, FDA is utilizing
all available tools and sources of information to support regulatory decisions on
applications that include sites impacted by FDA’s ability to inspect due to
COVID-19. During this interim period, we are using additional tools, where
available, to determine the need for an on-site inspection and to support the
5
application assessment, such as reviewing a firm’s previous compliance history,

and requesting records in advance of or in lieu of on-site inspections or voluntarily
from facilities and sites.
IV. NONCLINICAL DATA – KEY CONSIDERATIONS
• The purpose of nonclinical studies of a COVID-19 vaccine candidate is to define

its immunogenicity and safety characteristics through in vitro and in vivo testing.
Nonclinical studies in animal models 4 help identify potential vaccine related
3F
safety risks and guide the selection of dose, dosing regimen, and route of
administration to be used in clinical studies. The extent of nonclinical data
required to support proceeding to first in human (FIH) clinical trials depends on
the vaccine construct, the supportive data available for the construct and data from
closely related vaccines.
• Data from studies in animal models administered certain vaccine constructs

against other coronaviruses (SARS-CoV and MERS-CoV) have raised concerns of
a theoretical risk for COVID-19 vaccine-associated enhanced respiratory disease
(ERD). In these studies, animal models were administered vaccine constructs
against other coronaviruses and subsequently challenged with the respective wild-
type virus. These studies have shown evidence of immunopathologic lung
reactions characteristic of a Th-2 type hypersensitivity similar to ERD described
in infants and animals that were administered formalin-inactivated respiratory
syncytial virus (RSV) vaccine and that were subsequently challenged with RSV
virus due to natural exposure or in the laboratory, respectively (Refs. 4-9).
Vaccine candidates should be assessed in light of these studies as described in
section D, below.
• FDA recommends that vaccine manufacturers engage in early communications

with FDA to discuss the type and extent of nonclinical testing required for the
particular COVID-19 vaccine candidate to support proceeding to FIH clinical
trials and further clinical development.
B. Toxicity Studies (Refs. 10-14)
• For a COVID-19 vaccine candidate consisting of a novel product type and for
which no prior nonclinical and clinical data are available, nonclinical safety
studies will be required prior to proceeding to FIH clinical trials 21 CFR
312.23(a)(8).
4
The preclinical program for any investigational product should be individualized with respect to scope, complexity, and
overall design. We support the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible.
Proposals, with justification for any potential alternative approaches (e.g., in vitro or in silico testing), should be
submitted during early communication meetings with FDA (see section VI of this document). We will consider if such
an alternative method could be used in place of an animal test method.
6
• In some cases, it may not be necessary to perform nonclinical safety studies prior
to FIH clinical trials because adequate information to characterize product safety
may be available from other sources. For example, if the COVID-19 vaccine
candidate is made using a platform technology utilized to manufacture a licensed
vaccine or other previously studied investigational vaccines and is sufficiently
characterized, it may be possible to use toxicology data (e.g., data from repeat
dose toxicity studies, biodistribution studies) and clinical data accrued with other
products using the same platform to support FIH clinical trials for that COVID-19
vaccine candidate. Vaccine manufacturers should summarize the findings and
provide a rationale if considering using these data in lieu of performing
nonclinical safety studies.
• When needed to support proceeding to FIH clinical trials, nonclinical safety

assessments including toxicity and local tolerance studies must be conducted
under conditions consistent with regulations prescribing good laboratory practices
for conducting nonclincial laboratory studies (GLP) (21 CFR Part 58). Such
studies should be completed and analysed prior to initiation of FIH clinical trials.
When toxicology studies do not adequately characterize risk, additional safety
testing should be conducted as appropriate.
• Data from toxicity studies may be submitted as unaudited final draft toxicicologic
reports to accelerate proceeding to FIH clincial trials with COVID-19 vaccine
candidates. The final, fully quality-assured reports should be available to FDA
within 120 days of the start of the FIH clinical trial.
• Use of COVID-19 preventive vaccines in pregnancy and in women of

childbearing potential will be an important consideration for vaccination
programs. Therefore, FDA recommends that prior to enrolling pregnant women
and women of childbearing potential who are not actively avoiding pregnancy in
clinical trials, sponsors conduct developmental and reproductive toxicity (DART)
studies with their respective COVID-19 vaccine candidate. Alternatively,
sponsors may submit available data from DART studies with a similar product
using comparable platform technology if, after consultation with the agency, the
agency agrees those data are scientifically sufficient.
• Biodistribution studies in an animal species should be considered if the vaccine

construct is novel in nature and there are no existing biodistribution data from the
platform technology. These studies should be conducted if there is a likelihood of
altered infectivity and tissue tropism or if a novel route of administration and
formulation is to be used.
C. Characterization of the Immune Response in Animal Models
• Immunogenicity studies in animal models responsive to the selected COVID-19

vaccine antigen should be conducted to evaluate the immunologic properties of
the COVID-19 vaccine candidate and to support FIH clinical trials. The aspects of
7
immunogenicity to be measured should be appropriate for the vaccine construct

and its intended mechanism of action.
• Studies should include an evaluation of humoral, cellular, and functional immune

responses, as appropriate to each of the included COVID-19 antigens. Use of
antigen-specific enyzme linked immunosorbent assays (ELISA) should be
considered to characterize the humoral response. Evaluation of cellular reponses
should include the examination of CD8+ and CD4+ T cell responses using
sensitive and specific assays. The functional activity of immune responses should
be evaluated in vitro in neutralization assays using either wild-type virus or
pseudovirion virus. The assays used for immunogencity evaluation should be
demonstrated to be suitable for their intended purpose.
D. Studies to Address the Potential for Vaccine-associated Enhanced Respiratory

Disease
• Current knowledge and understanding of the potential risk of COVID-19 vaccine

associated ERD is limited, as is understanding of the value of available animal
models in predicting the likelihood of such occurrence in humans. Nevertheless,
studies in animal models (e.g., rodents and non-human primates) are considered
important to address the potential for vaccine-associated ERD.
• Post-vaccination animal challenge studies and the characterization of the type of

the nonclinical and clinical immune response induced by the particular COVID-19
vaccine candidate can be used to evaluate the likelihood of the vaccine to induce
vaccine-associated ERD in humans.
• To support proceeding to FIH clinical trials, sponsors should conduct studies

characterizing the vaccine-induced immune response in animal models evaluating
immune markers of potential ERD outcomes. These should include assessments
of functional immune responses (e.g., neutralizing antibody) versus total antibody
responses and Th1/Th2 balance in animals vaccinated with clinically relevant
doses of the COVID-19 vaccine candidate.
• COVID-19 vaccine candidates with immunogenicity data demonstrating high

neutralizing antibody titers and Th1-type T cell polarization may be allowed to
proceed to FIH trials without first completing postvaccination challenge studies in
appropriate animal models, provided adequate risk mitigation strategies are put in
place in the FIH trials. In these situations, postvaccination challenge studies are
expected to be conducted in parallel with FIH trials to ensure the potential for
vaccine-associated ERD is addressed prior to enrolling large numbers of human
subjects into Phase 2 and 3 clinical trials. For COVID-19 vaccine candidates for
which other data raise increased concerns about ERD, postvaccination animal
challenge data and/or animal immunopathology studies are critical to assess
protection and/or ERD prior to advancing to FIH clinical trials.
8
• The totality of data for a specific COVID-19 vaccine candidate, including data
from postvaccination challenge studies in small animal models and from FIH
clinical trials characterizing the type of immune responses induced by the vaccine
will be considered in determining whether Phase 3 studies can proceed in the
absence of postvaccination challenge data to address risk of ERD.
V. CLINICAL TRIALS – KEY CONSIDERATIONS
• Understanding of SARS-CoV-2 immunology, and specifically vaccine immune

responses that might predict protection against COVID-19, is currently limited
and evolving. Thus, while evaluation of immunogenicity is an important
component of COVID-19 vaccine development, at this time, the goal of
development programs should be to pursue traditional approval via direct evidence
of vaccine efficacy in protecting humans from SARS-CoV-2 infection and/or
disease.
• Clinical development programs for COVID-19 vaccines might be expedited by

adaptive and/or seamless clinical trial designs (described below) that allow for
selection between vaccine candidates and dosing regimens and for more rapid
progression through the usual phases of clinical development.
• Regardless of whether clinical development programs proceed in discrete phases

with separate studies or via a more seamless approach, an adequate body of data,
including data to inform the risk of vaccine-associated ERD, will be needed as
clinical development progresses to support the safety of vaccinating the proposed
study populations and number of participants and, for later stage development, to
ensure that the study design is adequate to meet its objectives.
• FDA can provide early advice, and potentially concurrence in principle, on plans
for expedited/seamless clinical development. However, sponsors should plan to
submit summaries of data available at each development milestone for FDA
review and concurrence prior to advancing to the next phase of development.
• Conducting clinical trials in the setting of a public health emergency presents

operational challenges. FDA has issued guidance to provide general
considerations to assist sponsors in assuring the safety of trial participants,
maintaining compliance with good clinical practice (GCP), and minimizing risks
to trial integrity for the duration of the COVID-19 public health emergency. It
should be noted that not all of the recommendations in that guidance may be
applicable to vaccine development, given some of the different considerations for
these products (Ref. 15).
9
B. Trial Populations
• Once acceptable pre-clinical data are available, FIH and other early phase studies
(which typically expose 10–100 participants to each vaccine candidate being
evaluated) should first enroll healthy adult participants who are at low risk of
severe COVID-19. Exclusion of participants at higher risk of severe COVID-19
from early phase studies is necessary to mitigate potential risk of vaccine-
associated ERD until additional data to inform that potential risk becomes
available through ongoing product development.
o As the understanding of COVID-19 pathogenesis continues to evolve,

exclusion criteria should reflect the current understanding of risk factors for
more severe COVID-19, such as those described by the Centers for Disease
Control and Prevention (Ref. 16).
o Older adult participants (e.g., over 55 years of age) may be enrolled in FIH
and other early phase studies so long as they do not have medical
comorbidities associated with an increased risk of severe COVID-19. Some
preliminary safety data in younger adults (e.g., 7 days after a single
vaccination) should be available prior to enrolling older adult participants,
especially for vaccine platforms without prior clinical experience.
o If possible, early clinical studies should also exclude participants at high risk
of SARS-CoV-2 exposure (e.g., healthcare workers).
• Sponsors should collect and evaluate at least preliminary clinical safety and
immunogenicity data for each dose level and age group (e.g., younger versus older
adults) to support progression of clinical development to include larger numbers
(e.g., hundreds) of participants and participants at higher risk of severe COVID-19.
o Preliminary immunogenicity data from early phase development should

include assessments of neutralizing vs. total antibody responses and Th1 vs.
Th2 polarization.
o Additional data to further inform potential risk of vaccine-associated ERD and

to support progression of clinical development, if available, may include
preliminary evaluation of COVID-19 disease outcomes from earlier clinical
development and results of non-clinical studies evaluating protection and/or
histopathological markers of vaccine-associated ERD following SARS-CoV-2
challenge.
• To generate sufficient data to meet the BLA approval standard, late phase clinical
trials to demonstrate vaccine efficacy with formal hypothesis testing will likely
need to enroll many thousands of participants, including many with medical
comorbidities for trials seeking to assess protection against severe COVID-19.
o Initiation of late phase trials should be preceded by adequate characterization

of safety and immunogenicity (e.g., in a few hundred participants for each
10
vaccine candidate, dose level, and age group to be evaluated) to support

general safety, potential for vaccine efficacy, and low risk of vaccine-
associated ERD.
o Results of non-clinical studies evaluating protection and/or histopathological

markers of vaccine-associated ERD following SARS-CoV-2 challenge and
COVID-19 disease outcomes from earlier clinical development are other
potentially important sources of information to support clinical trials with
thousands of participants.
• Although establishing vaccine safety and efficacy in SARS-CoV-2 naïve

individuals is critical, vaccine safety and COVID-19 outcomes in individuals with
prior SARS-CoV-2 infection, which might have been asymptomatic, is also
important to examine because pre-vaccination screening for prior infection is
unlikely to occur in practice with the deployment of licensed COVID-19 vaccines.
Therefore, COVID-19 vaccine trials need not screen for or exclude participants
with history or laboratory evidence of prior SARS-CoV-2 infection. However,
individuals with acute COVID-19 (or other acute infectious illness) should be
excluded from COVID-19 vaccine trials.
• FDA encourages the inclusion of diverse populations in all phases of vaccine

clinical development. This inclusion helps to ensure that vaccines are safe and
effective for everyone in the indicated populations.
o FDA strongly encourages the enrollment of populations most affected by

COVID-19, specifically racial and ethnic minorities.
o Evaluation of vaccine safety and efficacy in late phase clinical development in

adults should include adequate representation of elderly individuals and
individuals with medical comorbidities.
o FDA encourages vaccine developers to consider early in their development

programs data that might support inclusion of pregnant women and women of
childbearing potential who are not actively avoiding pregnancy in pre-
licensure clinical trials (Ref. 17).
o It is important for developers of COVID-19 vaccines to plan for pediatric

assessments of safety and effectiveness, given the nature of the COVID-19
public health emergency, and to help ensure compliance with the Pediatric
Research Equity Act (PREA) (section 505B of the FD&C Act (21 U.S.C.
355c)) (Ref. 18). The epidemiology and pathogenesis of COVID-19, and the
safety and effectiveness of COVID-19 vaccines, may be different in children
compared with adults. In order to ensure compliance with 21 CFR Part 50
Subpart D (Additional safeguards for children in clinical investigations),
considerations on the prospect of direct benefit and acceptable risk to support
initiation of pediatric studies, and the appropriate design and endpoints for
pediatric studies, should be discussed in the context of specific vaccine
development programs.
11
C. Trial Design
• Early phase trials often aim to down-select among multiple vaccine candidates
and/or dosing regimens via randomization of participants to different treatment
groups. While including a placebo control and blinding are not required for early
phase studies, doing so may assist in interpretation of preliminary safety data.
• Later phase trials, including efficacy trials, should be randomized, double-blinded,

and placebo controlled.
o An individually randomized controlled trial with 1:1 randomization between

vaccine and placebo groups is usually the most efficient study design for
demonstrating vaccine efficacy. Other types of randomization, such as cluster
randomization, may be acceptable but require careful consideration of
potential biases that are usually avoided with individual randomization.
o An efficacy trial that evaluates multiple vaccine candidates against a single

placebo group may be an acceptable approach to further increase efficiency,
provided that the trial is adequately designed with appropriate statistical
methods to evaluate efficacy.
o If the availability of a COVID-19 vaccine proven to be safe and effective

precludes ethical inclusion of a placebo control group, that vaccine could serve
as the control treatment in a study designed to evaluate efficacy with non-
inferiority hypothesis testing.
• Protocols for adaptive trials should include pre-specified criteria for adding or
removing vaccine candidates or dosing regimens, and protocols for seamless trials
should include pre-specified criteria (e.g., safety and immunogenicity data) for
advancing from one phase of the study to the next.
• Follow-up of study participants for COVID-19 outcomes (in particular, for severe
COVID-19 disease manifestations) should continue as long as feasible, ideally at
least one to two years, to assess duration of protection and potential for vaccine-
associated ERD as immune responses to the vaccine wane.
• Efficacy trials should include contingency plans for continued follow up and
analysis of safety and effectiveness outcomes in the event that a safe and effective
vaccine becomes available (e.g., as demonstrated in a planned interim analysis or
as demonstrated in another clinical trial). In that case, discussion with the agency
may be necessary to address ethical arguments to break the blind and offer vaccine
to placebo recipients.
• In cases where statistical equivalency testing of vaccine immune responses in

humans is required to support manufacturing consistency (clinical lot-to-lot
consistency trial), this testing can be incorporated into the design of an efficacy
trial and does not need to be conducted in a separate study.
12
D. Efficacy Considerations
• Either laboratory-confirmed COVID-19 or laboratory-confirmed SARS-CoV-2

infection is an acceptable primary endpoint for a COVID-19 vaccine efficacy trial.
o Acute cases of COVID-19 should be virologically confirmed (e.g., by RT-

PCR).
o SARS-CoV-2 infection, including asymptomatic infection, can be monitored

for and confirmed either by virologic methods or by serologic methods
evaluating antibodies to SARS-CoV-2 antigens not included in the vaccine.
• Standardization of efficacy endpoints across clinical trials may facilitate

comparative evaluation of vaccines for deployment programs, provided that such
comparisons are not confounded by differences in trial design or study
populations. To this end, FDA recommends that either the primary endpoint or a
secondary endpoint (with or without formal hypothesis testing) be defined as
virologically confirmed SARS-CoV-2 infection with one or more of the following
symptoms:
o Fever or chills
o Cough
o Shortness of breath or difficulty breathing
o Fatigue
o Muscle or body aches
o Headache
o New loss of taste or smell
o Sore throat
o Congestion or runny nose
o Nausea or vomiting
o Diarrhea
• As it is possible that a COVID-19 vaccine might be much more effective in

preventing severe versus mild COVID-19, sponsors should consider powering
efficacy trials for formal hypothesis testing on a severe COVID-19 endpoint.
Regardless, severe COVID-19 should be evaluated as a secondary endpoint (with
or without formal hypothesis testing) if not evaluated as a primary endpoint. FDA
recommends that severe COVID-19 be defined as virologically confirmed SARS-
CoV-2 infection with any of the following:
o Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30

per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level
or PaO2/FiO2 < 300 mm Hg)
o Respiratory failure (defined as needing high-flow oxygen, noninvasive
ventilation, mechanical ventilation or ECMO)
o Evidence of shock (SBP < 90 mm Hg, DBP < 60 mm Hg, or requiring
vasopressors)
o Significant acute renal, hepatic, or neurologic dysfunction
13
o Admission to an ICU
o Death
• SARS-CoV-2 infection (whether or not symptomatic) should be evaluated as a

secondary or exploratory endpoint, if not evaluated as a primary endpoint.
• The above diagnostic criteria may need to be modified in certain populations; for
example, in pediatric patients and those with respiratory comorbidities. Sponsors
should discuss their proposed case definitions with the Agency prior to initiating
enrollment.
E. Statistical Considerations
• To ensure that a widely deployed COVID-19 vaccine is effective, the primary

efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at
least 50%, and the statistical success criterion should be that the lower bound of
the appropriately alpha-adjusted confidence interval around the primary efficacy
endpoint point estimate is >30%.
o The same statistical success criterion should be used for any interim analysis
designed for early detection of efficacy.
o A lower bound ≤30% but >0% may be acceptable as a statistical success

criterion for a secondary efficacy endpoint, provided that secondary endpoint
hypothesis testing is dependent on success on the primary endpoint.
• For non-inferiority comparison to a COVID-19 vaccine already proven to be

effective, the statistical success criterion should be that the lower bound of the
appropriately alpha-adjusted confidence interval around the primary relative
efficacy point estimate is >-10%.
• For each vaccine candidate, appropriate statistical methods should be used to

control type 1 error for hypothesis testing on multiple endpoints and/or interim
efficacy analyses.
• Late phase studies should include interim analyses to assess risk of vaccine-
associated ERD (see section F) and futility.
• Study sample sizes and timing of interim analyses should be based on the
statistical success criteria for primary and secondary (if applicable) efficacy
analyses and realistic, data-driven estimates of vaccine efficacy and incidence of
COVID-19 (or SARS-CoV-2 infection) for the populations and locales in which
the trial will be conducted.
14
F. Safety Considerations
• The general safety evaluation of COVID-19 vaccines, including the size of the
safety database to support vaccine licensure, should be no different than for other
preventive vaccines for infectious diseases. Safety assessments throughout
clinical development should include:
o Solicited local and systemic adverse events for at least 7 days after each study
vaccination in an adequate number of study participants to characterize
reactogenicity (including at least a subset of participants in late phase efficacy
trials).
o Unsolicited adverse events in all study participants for at least 21–28 days
after each study vaccination.
o Serious and other medically attended adverse events in all study participants
for at least 6 months after completion of all study vaccinations. Longer safety
monitoring may be warranted for certain vaccine platforms (e.g., those that
include novel adjuvants).
o All pregnancies in study participants for which the date of conception is prior
to vaccination or within 30 days after vaccination should be followed for
pregnancy outcomes, including pregnancy loss, stillbirth, and congenital
anomalies.
• The pre-licensure safety database for preventive vaccines for infectious diseases
typically consists of at least 3,000 study participants vaccinated with the dosing
regimen intended for licensure. FDA anticipates that adequately powered efficacy
trials for COVID-19 vaccines will be of sufficient size to provide an acceptable
safety database for each of younger adult and elderly populations, provided that no
significant safety concerns arise during clinical development that would warrant
further pre-licensure evaluation.
• COVID-19 vaccine trials should periodically monitor for unfavorable imbalances

between vaccine and control groups in COVID-19 disease outcomes, in particular
for cases of severe COVID-19 that may be a signal for vaccine-associated ERD.
o Studies should include pre-specified criteria for halting based on signals of

potential vaccine-associated ERD.
o FDA recommends use of an independent data safety monitoring board

(DSMB) (Ref. 18) for vaccine-associated ERD and other safety signal
monitoring, especially during later stage development.
15
VI. POST-LICENSURE SAFETY EVALUATION – KEY CONSIDERATIONS
• As with all licensed vaccines, there can be limitations in the safety database accrued
from the pre-licensure clinical studies of a COVID-19 vaccine. For example:
o The number of subjects receiving a COVID-19 vaccine in pre-licensure
clinical studies may not be adequate to detect some adverse reactions that may
occur infrequently.
o Pre-licensure safety data in some subpopulations likely to receive a COVID-19
vaccine (e.g., pregnant individuals, or individuals with medical comorbidities)
may be limited at the time of licensure.
o For some COVID-19 vaccines, the safety follow-up period to monitor for
possible vaccine-associated ERD and other adverse reactions may not have
been completed for all subjects enrolled in pre-licensure clinical studies before
the vaccine is licensed.
• For COVID-19 vaccines, it is likely that during the early postmarketing period, a
large population might be vaccinated in a relatively short timeframe. Thus, FDA
recommends early planning of pharmacovigilance activities before licensure.
• To facilitate accurate recording and identification of vaccines in health records,

manufacturers should consider establishment of individual Current Procedural
Terminology (CPT) codes and the use of bar codes to label the immediate
container.
B. Pharmacovigilance Activities for COVID-19 Vaccines
• Routine pharmacovigilance for licensed biological products includes expedited

reporting of serious and unexpected adverse events as well as periodic safety
reports in accordance with 21 CFR 600.80 (Postmarketing reporting of adverse
experiences).
• FDA recommends that at the time of a BLA submission for a COVID-19 vaccine,
applicants submit a Pharmacovigilance Plan (PVP) as described in the FDA
Guidance for Industry; E2E Pharmacovigilance Planning (Ref. 20). The contents
of a PVP for a COVID-19 vaccine will depend on its safety profile and will be
based on data, which includes the pre-licensure clinical safety database, preclinical
data, and available safety information for related vaccines, among other
considerations.
• The PVP should include actions designed to address all important identified risks,
important potential risks or important missing information.
Pharmacoepidemiologic studies or other actions to evaluate notable potential risks,
such as vaccine-associated ERD, should be considered. FDA may recommend
one or more of the following as components of a PVP for a COVID-19 vaccine:
16
o Submission of reports of specific adverse events of interest in an expedited

manner beyond routine required reporting;
o Submission of adverse event report summaries at more frequent intervals than
specified for routine required reporting;
o Ongoing and/or extended safety follow-up (under an IND) for vaccine-
associated ERD of subjects enrolled in pre-licensure clinical studies;
o A pharmacoepidemiologic study to further evaluate (an) important identified
or potential risk(s) from the clinical development program, such as vaccine-
associated ERD or other uncommon or delayed-onset adverse events of special
interest;
o A pregnancy exposure registry that actively collects information on
vaccination during pregnancy and associated pregnancy and infant outcomes
(Ref. 21).
C. Required Postmarketing Safety Studies
• Section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)) authorizes FDA to
require certain postmarketing studies or clinical trials for prescription drugs
approved under section 505(b) of the FD&C Act (21 U.S.C. 355(b)) and
biological products approved under section 351 of the PHS Act (42 U.S.C. 262)
(Ref. 22). Under section 505(o)(3), FDA can require such studies or trials at the
time of approval to assess a known serious risk related to the use of the drug, to
assess signals of serious risk related to the use of the drug, or to identify an
unexpected serious risk when available data indicate the potential for a serious
risk. Under section 505(o)(3), FDA can also require such studies or trials after
approval if FDA becomes aware of new safety information, which is defined at
section 505-1(b)(3) of the FD&C Act (21 U.S.C. 355-1(b)(3)).
• For COVID-19 vaccines, FDA may require postmarketing studies or trials to

assess known or potential serious risks when such studies or trials are warranted.
VII. DIAGNOSTIC AND SEROLOGICAL ASSAYS – KEY CONSIDERATIONS
• Diagnostic assays used to support the pivotal efficacy analysis (e.g., RT-PCR)
should be sensitive and accurate for the purpose of confirming infection and
should be validated before use.
• Assays used for immunogenicity evaluation should be suitable for their intended
purpose of assessing relevant immune responses to vaccination and be validated
before use in pivotal clinical trials.
17
VIII. ADDITIONAL CONSIDERATIONS
A. Additional Considerations in Demonstrating Vaccine Effectiveness
• Given the current state of knowledge about COVID-19, the most direct approach
to demonstrate effectiveness for a COVID-19 vaccine candidate is based on
clinical endpoint efficacy trials showing protection against disease (see section V.
D. above).
• Once additional understanding of SARS-CoV-2 immunology, and specifically

vaccine immune responses that might be reasonably likely to predict protection
against COVID-19, is acquired, accelerated approval of a COVID-19 vaccine
pursuant to section 506 of the FD&C Act (21 U.S.C. 356) and 21 CFR 601.40
may be considered if an applicant provides sufficient data and information to meet
the applicable legal requirements. For a COVID-19 vaccine, it may be possible to
approve a product under these provisions based on adequate and well-controlled
clinical trials establishing an effect of the product on a surrogate endpoint (e.g.,
immune response) that is reasonably likely to predict clinical benefit.
• A potential surrogate endpoint likely would depend on the characteristics of the

vaccine, such as antigen structure, mode of delivery, and antigen processing and
presentation in the individual vaccinated. For example, an immune marker
established for an adenovirus-based vaccine cannot be presumed applicable to a
VSV-based vaccine, given that the two vaccines present antigen in different ways
and engender different types of protective immune responses.
• Since SARS-CoV-2 represents a novel pathogen, a surrogate endpoint reasonably

likely to predict protection from COVID-19 should ideally be derived from human
efficacy studies examining clinical disease endpoints. If the surrogate endpoint is
derived from other data sources, sponsors should consult the FDA to reach
agreement on the use of the surrogate endpoint.
• An adequate dataset evaluating the safety of the vaccine in humans would need to
be provided for consideration of licensure.
• For drugs granted accelerated approval, postmarketing confirmatory trials have

been required to verify and describe the predicted effect on clinical benefit. These
studies should usually be underway at the time of the accelerated approval, 21
CFR Part 601, Subpart E, and must be completed with due diligence (section
506(c)(3)(A) of the FD&C Act (21 U.S.C. 356(c)(3)(A)) and 21 CFR 601.41).
• If it is no longer possible to demonstrate vaccine effectiveness by way of

conducting clinical disease endpoint efficacy studies, the use of a controlled
human infection model to obtain evidence to support vaccine efficacy may be
considered. However, many issues, including logistical, human subject protection,
ethical, and scientific issues, would need to be satisfactorily addressed. At this
18
time no controlled human infection models for SARS-CoV-2 have been

established or characterized.
B. Emergency Use Authorization
• An Emergency Use Authorization (EUA) may be issued only after several

statutory requirements are met (section 564 of the FD&C Act (21 U.S.C. 360bbb-
2)) (Ref. 23). Among these requirements is a determination by FDA that the
known and potential benefits of a product, when used to diagnose, prevent, or treat
serious or life-threatening diseases, outweigh the known and potential risks of the
product.
• Issuance of an EUA (Ref. 23) may be appropriate for a COVID-19 vaccine

provided the standard for issuing an EUA is met. Issuance of an EUA for a
COVID-19 vaccine prior to the completion of large randomized clinical efficacy
trials could reduce the ability to demonstrate effectiveness of the investigational
vaccine in a clinical disease endpoint efficacy trial to support licensure, and such
clinical disease endpoint efficacy trials may be needed to investigate the potential
for vaccine-associated ERD. Thus, for a vaccine for which there is adequate
manufacturing information, issuance of an EUA may be appropriate once studies
have demonstrated the safety and effectiveness of the vaccine but before the
manufacturer has submitted and/or FDA has completed its formal review of the
biologics license application.
• In the case of investigational vaccines being developed for the prevention of

COVID-19, any assessment regarding an EUA would be made on a case by case
basis considering the target population, the characteristics of the product, the
preclinical and human clinical study data on the product, and the totality of the
available scientific evidence relevant to the product.
19
IX. REFERENCES
1. COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests
for COVID-19 Related Drugs and Biological Products; Guidance for Industry, May 2020,
2. Guidance for Industry: Process Validation: General Principles and Practices, January 2011,
3. Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls
Information and Establishment Description Information for a Vaccine or Related Product,
January 1999, https://www.fda.gov/media/73614/download.
4. Perlman S and Dandekar AA, 2005, Immunopathogenesis of Coronavirus Infections:

Implications for SARS, Nat Rev Immunol 5: 917-927, https://doi.org/10.1038/nri1732.
5. Haagmans BL, Boudet F, Kuiken T, deLang A, et al., 2005, Protective immunity induced by
the inactivated SARS coronavirus vaccine, Abstract S 12-1 Presented at the X International
Nidovirus Symposium, Colorado, Springs, CO.
6. Tseng C-T, Sbrana E, Iwata-Yoshikawa N, Newman P, et al., 2012, Immunization with SARS
Coronavirus Vaccines Leads to Pulmonary Immunopathology on Challenge with the SARS
Virus, PloS One, 7(4): e35421,
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0035421.
7. Yasui F, Kai C, Kitabatake M, Inoue S, et al., 2008, Prior Immunization With Severe Acute
Respiratory Syndrome (SARS) – associated Coronavirus (SARS-CoV) Nucleocapsid Protein
Causes Severe Pneumonia in Mice Infected with SARS-CoV, J Immunol, 181(9): 6337-6348,
https://www.jimmunol.org/content/181/9/6337.long.
8. Bolles M, Deming D, Long K, Agnihothram S, et al., 2011, A Double-Inactivated Severe

Acute Respiratory Syndrome Coronavirus Vaccine Provides Incomplete Protection In Mice
And Induces Increased Eosinophilic Proinflammatory Pulmonary Response Upon Challenge,
J Virol 85(23) 12201-12215, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3209347/.
9. Agrawal AS, Tao X, Algaissi A, Garron T, et al., 2016, Immunization With Inactivated
Middle East Respiratory Syndrome Coronavirus Vaccine Leads To Lung Immunopathology
On Challenge With Live Virus, Hum Vaccin Immunother, 12(9): 2351-2356,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5027702/.
10. Guidance for Industry: Considerations For Plasmid DNA Vaccines For Infectious Disease
Indications, November 2007, https://www.fda.gov/media/73667/download.
11. [Intentionally left blank.]
12. Guidance for Industry: Considerations For Developmental Toxicity Studies For Preventive
And Therapeutic Vaccines For Infectious Disease Indications, February 2006,
20
13. World Health Organization, WHO Guidelines On Nonclinical Evaluation Of Vaccines,

Annex 1, WHO Technical Report Series, 2005; 927:31-63,
https://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANN
EX%201Nonclinical.P31-63.pdf?ua=1.
14. World Health Organization, Guidelines On The Nonclinical Evaluation Of Vaccine

Adjuvants And Adjuvanted Vaccines, Annex 2, WHO Technical Report Series, TRS 987:59-
100, https://www.who.int/biologicals/areas/vaccines/TRS_987_Annex2.pdf?ua=1.
15. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public
Health Emergency; Guidance for Industry, Investigators, and Institutional Review Boards,
March 2020 and updated June 2020, https://www.fda.gov/media/136238/download.
16. Centers for Disease Control and Prevention, Coronavirus Disease 2019 (COVID-19) At Risk
for Severe Illness, last reviewed May 14, 2020, https://www.cdc.gov/coronavirus/2019-
ncov/need-extra-precautions/groups-at-higher-risk.html.
17. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft
Guidance for Industry, April 2018, https://www.fda.gov/media/112195/download.*
18. Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act,
September 2005, https://www.fda.gov/media/72274/download.*
19. Guidance for Industry: Establishment and Operation of Clinical Trial Data Monitoring
Committees, March 2006, https://www.fda.gov/media/75398/download.
20. Guidance for Industry: E2E Pharmacovigilance Planning, April 2005,

21. Postapproval Pregnancy Safety Studies; Draft Guidance for Industry, May 2019,
https://www.fda.gov/media/124746/download.*
22. Guidance for Industry: Postmarketing Studies and Clinical Trials — Implementation of
Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, April 2011,
23. Emergency Use Authorization of Medical Products and Related Authorities; Guidance for
Industry and Other Stakeholders, January 2017, https://www.fda.gov/media/97321/download.
* When finalized, this guidance will represent FDA’s current thinking on this topic.
21
Marks Decl.
Exhibit E
August 23, 2021
Meryl Nass, M.D.

Robert F. Kennedy, Jr.
Children’s Health Defense
1227 North Peachtree Parkway
Suite 202
Peachtree City, GA 30269
Re: Citizen Petition (Docket Number FDA-2021-P-0460)
Dear Dr. Nass and Mr. Kennedy,
This letter responds to the citizen petition dated May 16, 2021 that you submitted to the Food
and Drug Administration (FDA, the Agency, we) on behalf of Children’s Health Defense
(Petitioner) relating to: clinical trials, Emergency Use Authorization, licensure, and advertising
and promotion of vaccines to prevent Coronavirus Disease 2019 (COVID-19) caused by severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (the Petition).
In the Petition, Petitioner requests that FDA:
1. “revoke all EUAs and refrain from approving any future EUA, NDA, or BLA for any
COVID vaccine for all demographic groups”;
2. “immediately refrain from allowing minors to participate in COVID vaccine trials, refrain
from amending EUAs to include children, and immediately revoke all EUAs that permit
vaccination of children under 16 for the Pfizer vaccine and under 18 for other COVID
vaccines”;
3. “immediately revoke tacit approval that pregnant women may receive any EUA or licensed
COVID vaccines and immediately issue public guidance to that effect”;
4. “immediately amend [FDA’s] existing guidance for the use of the chloroquine drugs,
ivermectin, and any other drugs demonstrated to be safe and effective against COVID…and
immediately issue notifications to all stakeholders”;
5. “issue guidance to the Secretary of the Defense [sic] and the President not to grant an
unprecedented Presidential waiver of prior consent regarding COVID vaccines for
Servicemembers [sic]”;
6. “issue guidance…to affirm that all citizens have the option to accept or refuse
administration of investigational COVID vaccines without adverse work, educational or other
non-health related consequences”; and
U.S. Food and Drug Administration

www.fda.gov
7. “[p]ending revocation of COVID vaccine EUAs, FDA should issue guidance that all
marketing and promotion of COVID vaccines must refrain from labeling them ‘safe and
effective.’”
Petition at 1-2.
In this letter, we discuss the safety of licensed and authorized vaccines. We then turn to the
requests contained in the Petition. We consider each of your requests in light of the legal
standards for FDA action, and provide our conclusions based on the facts, the science, and the
law.
This letter responds to the Petition in full. FDA has carefully reviewed the Petition and other
relevant information available to the Agency. Based on our review of these materials and for the
reasons described below, we conclude that the Petition does not contain facts demonstrating any
reasonable grounds for the requested action. In accordance with 21 CFR § 10.30(e)(3), and for
the reasons stated below, FDA is denying the Petition.
Here is an outline of our response:
I. Background
II. Vaccines That Are FDA-Licensed or Receive an Emergency Use Authorization
Meet Relevant Statutory Requirements
a. Vaccines that are FDA-Licensed are Safe
i. Vaccines that are FDA-Licensed are Shown to Be Safe at the Time
of Licensure
ii. Vaccine Safety Continues to Be Monitored Post-Licensure
b. An Emergency Use Authorization for a COVID-19 Preventative Vaccine
Is Issued Only If the Relevant Statutory Standards Are Met
III. Discussion
a. Investigational New Drugs
b. The Citizen Petition
i. Petitioner’s Request to Revoke all Emergency Use Authorizations
for COVID-19 Vaccines and Refrain from Issuing any Future EUA
or Approving any Future NDA, or BLA for any COVID-19
Vaccine for all Demographic Groups because the Current Risks of
Serious Adverse Events or Deaths Outweigh the Benefits, and
Because Existing, Approved Drugs Provide Highly Effective
Prophylaxis and Treatment against COVID-19, Mooting the EUAs
1. Petitioner’s Request to Revoke all Emergency Use
Authorizations for COVID-19 Vaccines
2. Petitioner’s Request to Refrain from Granting any Future
EUA for a COVID-19 Vaccine for any Population
3. Petitioner’s Request to Refrain from Approving any Future
NDA for any COVID-19 Vaccine for any Population
2
4. Petitioner’s Request to Refrain from Licensing any Future

BLA for any COVID-19 Vaccine for any Population
ii. Petitioner’s Request Regarding COVID-19 Vaccines in Children
1. Request to Immediately Refrain from Allowing COVID-19
Vaccine Trials to Include Pediatric Subjects
2. Request that FDA Refrain from Issuing EUA Amendments
for Authorized COVID-19 Vaccines to Include Indications
for Pediatric Populations
3. Request that FDA Immediately Revoke all EUAs for
COVID-19 Vaccines with Pediatric Indications
iii. Petitioner’s Request that FDA Immediately Revoke Tacit
Approval that Pregnant Women may Receive any EUA or
Licensed COVID-19 Vaccines and Immediately Issue Public
Guidance
1. Covid-19 in Pregnancy
2. Certain Content and Format Requirements for Prescription
Drug Labeling for Products Approved Under NDAs or
BLAs
3. Inclusion of Contraindications and Pregnancy Information
in the Labeling for the Authorized COVID-19 Vaccines
4. Inclusion of Contraindications and Pregnancy Information
in the Labeling for Licensed COVID-19 Vaccines
iv. Petitioner’s Request that FDA Immediately Amend its Guidance
regarding Certain Approved Drugs [chloroquine drugs, ivermectin,
“and any other drugs demonstrated to be safe and effective against
COVID”]
v. Petitioner’s Request that FDA Issue Guidance to the Secretary of
Defense and the President
vi. Petitioner’s Request that FDA Issue Guidance to Stakeholders
Regarding the Option to Refuse or Accept Administration of
Investigational COVID-19 Vaccines
vii. Petitioner’s Request that FDA Issue Guidance Regarding
Marketing and Promotion of COVID-19 Vaccines
c. Conclusion
Appendix I: Aspects of Vaccine Development and Process for Licensure
I. Background
There is currently a pandemic of respiratory disease, COVID-19, caused by a novel coronavirus,
SARS-CoV-2. The COVID-19 pandemic presents an extraordinary challenge to global health.
On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration
3
of a public health emergency related to COVID-19. 1On February 4, 2020, pursuant to section
564 of the FD&C Act (21 U.S.C. § 360bbb-3), the Secretary of HHS determined that there is a
public health emergency that has a significant potential to affect national security or the health
and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19. 2
On the basis of such determination, on March 27, 2020, the Secretary then declared that
circumstances exist justifying the authorization of emergency use of drugs and biological
products during the COVID-19 pandemic (“COVID-19 EUA Declaration”), pursuant to section
564(b)(1) of the FD&C Act. 3 In addition, on March 13, 2020, the President declared a national
emergency in response to COVID-19. 4
Commercial vaccine manufacturers and other entities are developing COVID-19 vaccine
candidates, and clinical studies of these vaccines are underway and/or have been
completed. Between December 11, 2020 and February 27, 2021, FDA issued emergency use
authorizations for three vaccines to prevent COVID-19, including vaccines sponsored by Pfizer
Inc. (Pfizer); ModernaTX, Inc. (Moderna); and Janssen Biotech, Inc. (Janssen), a pharmaceutical
company of Johnson & Johnson. FDA received a Biologics License Application (BLA) for the
COVID-19 vaccine, BNT162b2, intended to prevent COVID-19 in individuals 16 years of age
and older. As announced by FDA on August 23, 2021, the Agency is issuing a biologics license
for this COVID-19 vaccine (COVID-19 Vaccine, mRNA; Comirnaty) to BioNTech
Manufacturing GmbH. 5
II. Vaccines That Are FDA-Licensed or Receive an Emergency Use Authorization Meet
Relevant Statutory Requirements
a. Vaccines that are FDA-Licensed are Safe
i. Vaccines that are FDA-Licensed Are Shown to Be Safe at the Time of
Licensure
FDA has a stringent regulatory process for licensing vaccines. 6,7 The Public Health Service
Act (PHS Act) authorizes FDA to license biological products, including vaccines, if they have
1
Secretary of Health and Human Services Alex M. Azar, Determination that a Public Health Emergency Exists.
(Originally issued on Jan. 31, 2020, and subsequently renewed),
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
2
HHS, Determination of Public Health Emergency, 85 FR 7316, February 7, 2020,
https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency.
3
HHS, Emergency Use Authorization Declaration, 85 FR 18250, April 1, 2020,
https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration.
4
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)
Outbreak, issued March 13, 2020, https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-
declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/ .
5
BioNTech Manufacturing GmbH is the biologics license holder for this vaccine, which is manufactured by Pfizer
Inc. for BioNTech Manufacturing GmbH (hereinafter “BioNTech”). The basis for FDA's licensure decision is set
forth in FDA's Summary Basis for Regulatory Action (SBRA) for the BioNTech application. This memorandum
will be posted on fda.gov. We incorporate by reference the SBRA for the BLA.
6
CDC, Ensuring the Safety of Vaccines in the United States, February 2013,
https://www.cdc.gov/vaccines/hcp/patient-ed/conversations/downloads/vacsafe-ensuring-bw-office.pdf.
7
FDA, Vaccine Safety Questions and Answers, last updated March 2018, https://www.fda.gov/vaccines-blood-
biologics/safety-availability-biologics/vaccine-safety-questions-and-answers.
4
been demonstrated to be “safe, pure, and potent.” 8 Prior to approval by FDA, vaccines are
extensively tested in non-clinical studies and in humans. FDA’s regulations describe some of the
extensive data and information that each sponsor of a vaccine must submit to FDA in order to
demonstrate the product’s safety before FDA will consider licensing the vaccine. FDA requires
that the sponsor’s biologics license application (BLA) include, among other things, data derived
from nonclinical and clinical studies showing the product’s safety, purity, and potency; a full
description of manufacturing methods for the product; data establishing the product’s stability
through the dating period; and a representative sample of the product and summaries of results of
tests performed on the lot(s) represented by the sample. 9
As is evident from the language of the PHS Act and FDA’s regulations, the licensure process for
a vaccine requires the sponsor to establish, through carefully controlled laboratory and clinical
studies, as well as through other data, that the product is safe and effective for its approved
indication(s) and use. FDA’s multidisciplinary review teams then rigorously evaluate the
sponsor’s laboratory and clinical data, as well as other information, to help assess whether the
safety, purity, and potency of a vaccine has been demonstrated. 10 Only when FDA’s standards
are met is a vaccine licensed.
FDA regulations explicitly state that “[a]pproval of a biologics license application or issuance of
a biologics license shall constitute a determination that the establishment(s) and the product meet
applicable requirements to ensure the continued safety, purity, and potency of such products.” 11
Therefore, the manufacturers of vaccines that have been licensed in the U.S. have necessarily
demonstrated the safety of the vaccines within the meaning of the applicable statutory and
regulatory provisions before the vaccines were licensed and allowed to be marketed.
For more information on FDA’s thorough process for evaluating the safety of vaccines, see
Appendix I of this letter, Aspects of Vaccine Development and Process for Licensure.
ii. Vaccine Safety Continues to Be Monitored Post-Licensure
FDA’s oversight of vaccine safety continues after licensure of the product. Once the licensed
vaccine is on the market, post-marketing surveillance of vaccine safety is conducted in order to
detect any rare, serious, or unexpected adverse events, as well as to monitor vaccine lots. FDA
employs multiple surveillance systems and databases to continue to evaluate the safety of these
vaccines. In certain cases, FDA may require the manufacturer to conduct post-marketing studies
to further assess known or potential serious risks.
b. An Emergency Use Authorization for a COVID-19 Preventative Vaccine Is Issued
Only If the Relevant Statutory Standards Are Met
Congress established the Emergency Use Authorization (EUA) pathway to ensure that, during
public health emergencies, potentially lifesaving medical products could be made available
before being approved. The EUA process allows the Secretary of HHS, in appropriate
circumstances, to declare that EUAs are justified for products to respond to certain types of
8
42 U.S.C. § 262(a)(2)(C)(i)(I).
9
21 CFR § 601.2(a).
10
FDA, Vaccines, last updated January 2021, https://www.fda.gov/vaccines-blood-biologics/vaccines.
11
21 CFR § 601.2(d) (emphasis added).
5
threats. When such a declaration is made, FDA may issue an EUA, which is different from the
regulatory process for vaccine licensure.
Section 564 of the Food Drug & Cosmetic Act (FD&C Act) (21 U.S.C. § 360bbb-3) authorizes
FDA to, under certain circumstances, issue an EUA to allow unapproved medical products or
unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by chemical, biological,
radiological, or nuclear threat agents when there are no adequate, approved, and available
alternatives.
On February 4, 2020, pursuant to section 564(b)(1)(C) of the FD&C Act (21 U.S.C. § 360bbb-
3(b)(1)(C)), the Secretary of HHS determined that there is a public health emergency that has a
significant potential to affect national security or the health and security of United States (U.S.)
citizens living abroad, and that involves the virus that causes COVID-19. 12 On the basis of such
determination, on March 27, 2020, the Secretary then declared that circumstances exist justifying
the authorization of emergency use of drugs and biological products during the COVID-19
pandemic, pursuant to section 564(b)(1) of the FD&C Act (21 U.S.C. § 360bbb-3(b)(1)). 13
Based on this declaration and determination, under section 564(c) of the FD&C Act (21 U.S.C. §
360bbb-3(c)), FDA may issue an EUA during the COVID-19 pandemic after FDA concludes
that the following statutory requirements are met:
• The agent referred to in the March 27, 2020 EUA declaration by the Secretary (SARS-
CoV-2) can cause a serious or life-threatening disease or condition.
• Based on the totality of scientific evidence available, including data from adequate and
well-controlled trials, if available, it is reasonable to believe that the product may be
effective in diagnosing, treating, or preventing such serious or life-threatening disease or
condition that can be caused by SARS-CoV-2.
• The known and potential benefits of the product, when used to diagnose, prevent, or treat
the identified serious or life-threatening disease or condition, outweigh the known and
potential risks of the product.
• There is no adequate, approved, and available alternative to the product for diagnosing,
preventing, or treating the disease or condition.
Although EUAs are governed under a different statutory framework than BLAs, FDA has made
clear that issuance of an EUA for a COVID-19 vaccine would require that the vaccine
demonstrated clear and compelling safety and efficacy in a large, well-designed Phase 3 clinical
trial. In the guidance document Emergency Use Authorization for Vaccines to Prevent COVID-
19 (October 2020 Guidance), FDA has provided recommendations that describe key information
12
13
6
that would support issuance of an EUA for a vaccine to prevent COVID-19. 14 In the October
2020 Guidance, FDA explained that, in the case of such investigational vaccines, any assessment
regarding an EUA will be made on a case-by-case basis considering the target population, the
characteristics of the product, the preclinical and human clinical study data on the product, and
the totality of the available scientific evidence relevant to the product. 15 FDA has also stated, in
this guidance, that for a COVID-19 vaccine for which there is adequate manufacturing
information to ensure its quality and consistency, issuance of an EUA would require a
determination by FDA that the vaccine’s benefits outweigh its risks based on data from at least
one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a
clear and compelling manner. 16
A Phase 3 trial of a vaccine is generally a large clinical trial in which a large number of people
are assigned to receive the investigational vaccine or a control. In general, in Phase 3 trials that
are designed to show whether a vaccine is effective, neither people receiving the vaccine nor
those assessing the outcome know who received the vaccine or the comparator.
In a Phase 3 study of a COVID-19 vaccine, the efficacy of the investigational vaccine to prevent
disease will be assessed by comparing the number of cases of disease in each study group. For
Phase 3 trials, FDA has recommended to manufacturers in guidance that the vaccine should be at
least 50% more effective than the comparator, and that the outcome be reliable enough so that it
is not likely to have happened by chance. 17 During the entire study, subjects will be monitored
for safety events. If the evidence from the clinical trial meets the pre-specified criteria for
success for efficacy and the safety profile is acceptable, the results from the trial can potentially
be submitted to FDA in support of an EUA request.
Investigational COVID-19 vaccines continue to be studied in Phase 2 or Phase 3 trials.
Following clinical trials, manufacturers analyze data prior to submitting to FDA a BLA to
request approval from FDA to market the vaccine. A BLA for a new vaccine includes
information and data regarding the safety, effectiveness, chemistry, manufacturing and controls,
and other details regarding the product. During the current public health emergency,
manufacturers may, with the requisite data and taking into consideration input from FDA, choose
to submit a request for an EUA.
Importantly, FDA has made clear that any vaccine that meets FDA’s standards for effectiveness
is also expected to meet the Agency’s safety standards. FDA has stated that the duration of
safety follow-up for a vaccine authorized under an EUA may be shorter than with a BLA (which
the Agency expects will ultimately be submitted by manufacturers of vaccines that are
authorized under an EUA). Specifically, FDA’s guidance to manufacturers recommends that
data from Phase 3 studies to support an EUA include a median follow-up duration of at least 2
months after completion of the full vaccination regimen. 18 Furthermore, robust safety
monitoring is conducted after a vaccine is made available. The monitoring systems include the
14
Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry, October 2020 (October
2020 Guidance), https://www.fda.gov/media/142749/download.
15
Id. at 3.
16
Id. at 4.
17
Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry, June 2020,
18
October 2020 Guidance at 10-11.
7
Vaccine Adverse Event Reporting System (VAERS), FDA’s Biologics Effectiveness and Safety
(BEST) System, and the Centers for Disease Control and Prevention’s (CDC) Vaccine Safety
Datalink. In addition, FDA has a partnership with the Centers for Medicare & Medicaid
Services (CMS) to study vaccine safety. Other tools to monitor vaccine safety are under
development. Collectively, these programs will help detect any new, unusual and rare side
effects after vaccination that might not have been observed during clinical trials, as well as
monitor for increases in any known side effects.
It is FDA’s expectation that, following submission of an EUA request and issuance of an EUA, a
sponsor would continue to evaluate the vaccine and would also work towards submission of a
BLA as soon as possible.
III. Discussion
The Petition makes a request regarding clinical trials of COVID-19 vaccines that include or
propose to include children. FDA’s investigational new drug process applies to the development
of new drugs and biological products, including vaccines. 19
a. Investigational New Drugs

Before a vaccine is licensed (approved) by FDA for use by the public, FDA requires that it
undergo a rigorous and extensive development program to determine the vaccine’s safety and
effectiveness. This development program encompasses preclinical research (laboratory research,
animal studies 20) and clinical studies. At the preclinical stage, the sponsor focuses on collecting
the data and information necessary to establish that the product will not expose humans to
unreasonable risks when used in limited, early-stage clinical studies. Clinical studies, in humans,
are conducted under well-defined conditions and with careful safety monitoring through all the
phases of the investigational new drug process. FDA’s regulations governing the conduct of
clinical investigations are set out at 21 CFR Part 312.
Before conducting a clinical investigation in the U.S. in which a new drug or biological product
is administered to humans, a sponsor must submit an investigational new drug application (IND)
to FDA. 21 The IND describes the proposed clinical study in detail and, among other things,
helps protect the safety and rights of human subjects. 22 In addition to other information, an IND
must contain information on clinical protocols and clinical investigators. Detailed protocols for
proposed clinical studies permit FDA to assess whether the initial-phase trials will expose
subjects to unnecessary risks. Information on the qualifications of clinical investigators
(professionals, generally physicians, who oversee the administration of the experimental drug)
permits FDA to assess whether they are qualified to fulfill their clinical trial duties. The IND
19
See 21 CFR § 312.2 (explaining that the IND regulations apply to clinical investigations of both drugs and
biologics).
20
We support the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible. We
encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable,
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency
to an animal test method.
21
See 21 CFR § 312.20(a).
22
For additional information regarding the IND review process and general responsibilities of sponsor-investigators
related to clinical investigations see Investigational New Drug Applications Prepared and Submitted by Sponsor-
Investigators; Draft Guidance for Industry, May 2015, https://www.fda.gov/media/92604/download.
8
includes commitments to obtain informed consent from the research subjects, to obtain review of
the study by an institutional review board (IRB), 23 and to adhere to the investigational new drug
regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical
trials, unless FDA informs the sponsor that the trial may begin earlier. During this time,
FDA reviews the IND. FDA’s primary objectives in reviewing an IND are, in all phases of the
investigation, to assure the safety and rights of subjects, and, in Phase 2 and Phase 3, to help
assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of
the drug’s effectiveness and safety. 24
FDA’s regulations provide that, once an IND is in effect, the sponsor may conduct a clinical
investigation of the product, with the investigation generally being divided into three phases.
With respect to vaccines, the initial human studies, referred to as Phase 1 studies, are generally
safety and immunogenicity studies performed in a small number of closely monitored subjects.
Phase 2 studies may include up to several hundred individuals and are designed to provide
information regarding the incidence of common short-term side effects such as redness and
swelling at the injection site or fever and to further describe the immune response to the
investigational vaccine. If an investigational new vaccine progresses past Phase 1 and Phase 2
studies, it may progress to Phase 3 studies. For Phase 3 studies, the sample size is often
determined by the number of subjects required to establish the effectiveness of the new vaccine,
which may be in the thousands or tens of thousands of subjects. Phase 3 studies provide the
critical documentation of effectiveness and important additional safety data required for
licensing.
Additionally, FDA regulations require that an IRB must review clinical investigations involving
children as subjects covered by 21 CFR 50, subpart D and only approve those clinical
investigations involving children as subjects that satisfy the criteria in 21 CFR 50, subpart D,
Additional Safeguards for Children in Clinical Investigations. As explained in the preamble to
the final rule, “[t]hese safeguards are intended to ensure that the rights and welfare of children
who participate in clinical investigations are adequately protected.” 25
At any stage of development, if data raise significant concerns about either safety or
effectiveness, FDA may request additional information or studies; FDA may also halt ongoing
clinical studies. The FD&C Act provides a specific mechanism, called a “clinical hold,” for
prohibiting sponsors of clinical investigations from conducting the investigation (section
23
The IRB is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical
research. IRBs approve clinical study protocols, which describe the type of people who may participate in the
clinical study; the schedule of tests and procedures; the medications and dosages to be studied; the length of the
study; the study's objectives; and other details. IRBs make sure that the study is acceptable, that participants have
given consent and are fully informed of the risks, and that researchers take appropriate steps to protect patients from
harm. See The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective web page, last updated
November 2017, https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-ensuring-drugs-
are-safe-and-effective.
24
21 CFR § 312.22(a).
25
Preamble to final rule, “Additional Safeguards for Children in Clinical Investigations of Food and Drug
Administration-Regulated Products” (78 FR 12937 at 12938, February 26, 2013),
https://www.federalregister.gov/documents/2013/02/26/2013-04387/additional-safeguards-for-children-in-clinical-
investigations-of-food-and-drug.
9
505(i)(3) of the FD&C Act; 21 U.S.C. § 355(i)(3)), and FDA’s IND regulations in 21 CFR §
312.42 identify the circumstances that may justify a clinical hold. Generally, a clinical hold is an
order issued by FDA to the sponsor of an IND to delay a proposed clinical investigation or to
suspend an ongoing investigation. 26
b. The Citizen Petition
i. Petitioner’s Request to Revoke all Emergency Use Authorizations for

COVID-19 Vaccines and Refrain from Issuing any Future EUA or
Approving any Future NDA, or BLA for any COVID-19 Vaccine for all
Demographic Groups because the Current Risks of Serious Adverse
Events or Deaths Outweigh the Benefits, and Because Existing,
Approved Drugs Provide Highly Effective Prophylaxis and Treatment
against COVID-19, Mooting the EUAs
Petitioner makes several requests regarding COVID-19 vaccines in the Petition and, in support of
these requests, argues that (1) the rates of serious adverse events or deaths outweigh the benefits
of these vaccines and (2) approved drugs provide highly effective prophylaxis/treatment against
COVID, thereby “mooting” the EUAs. We interpret this as an argument that the authorizations
of COVID-19 vaccines to date did not meet the relevant legal standard. Below, we address each
of Petitioner’s requests and the information provided by Petitioner in support of these requests.
1. Petitioner’s Request to Revoke all Emergency Use

Authorizations for COVID-19 Vaccines
In this section, we address Petitioner’s request that FDA “revoke all EUAs . . . for any COVID
vaccine for all demographic groups because the current risks of serious adverse events or deaths
outweigh the benefits, and because existing, approved drugs provide highly effective prophylaxis
and treatment against COVID, mooting the EUAs.” Petition at 1.
a. EUAs for COVID-19 Vaccines

As noted above in Section II above, FDA may issue an EUA during the COVID-19 public health
emergency after FDA concludes that the statutory requirements provided in section 564 of the
FD&C Act are met. In an attempt to prevent the spread of disease and to control the pandemic,
numerous COVID-19 vaccine candidates have been developed. COVID-19 vaccines that have
been developed or are currently in development are based on various platforms and include
mRNA, DNA, viral vectored, subunit, inactivated, and live-attenuated vaccines. Most COVID-
19 candidate vaccines express the spike protein or parts of the spike protein, i.e., the receptor
binding domain, as the immunogenic determinant.
To date, FDA has issued EUAs for three COVID-19 vaccines (“the Authorized COVID-19
Vaccines”), as described in the Scope of Authorization for these COVID-19 vaccines, pursuant
26
21 CFR § 312.42(a).
10
to section 564 of the FD&C Act. Additionally, FDA has expanded the authorized age range for
one COVID-19 vaccine.
• On December 11, 2020, FDA issued an EUA for emergency use of Pfizer-BioNTech
COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and
older.
o On May 10, 2021, FDA authorized the emergency use of Pfizer-BioNTech
COVID-19 Vaccine to include individuals 12 through 15 years of age.
• On December 18, 2020, FDA issued an EUA for emergency use of Moderna COVID-19
Vaccine for the prevention of COVID-19 in individuals 18 years of age and older.
• On February 27, 2021, FDA issued an EUA for emergency use of Janssen COVID-19
Vaccine for the prevention of COVID-19 in individuals 18 years of age and older.
The Agency issued these EUAs after a thorough evaluation of scientific data regarding the
safety, effectiveness, and manufacturing information (which helps ensure product quality and
consistency) of these COVID-19 vaccines and after reaching a determination that these vaccines
meet the statutory requirements under section 564 of the FD&C Act. This letter incorporates by
reference the EUA Review Memoranda for the Authorized COVID-19 Vaccines, 27 which discuss
this determination, and the data upon which it was based, in detail as well as the Summary Basis
of Regulatory Action for the BioNTech COVID-19 vaccine (COVID-19 Vaccine, mRNA;
Comirnaty). 28
Petitioner argues that the authorizations for these vaccines should be revoked, and that future
COVID vaccines should not be authorized or licensed, because (1) “the current risks of serious
adverse events or deaths outweigh the benefits,” and (2) “existing, approved drugs provide
highly effective prophylaxis and treatment against COVID, mooting the EUAs.” We address
each of Petitioner’s arguments, and data submitted in the Petition in support of these arguments,
below.
FDA disagrees with Petitioner’s position that the Authorized COVID-19 Vaccines did not meet
the statutory standard at the time of authorization, and finds no basis in the information
submitted in the Petition, or in any postmarket data regarding these vaccines, to support a
revocation of any of these authorizations. FDA is not aware of any information indicating that
the known and potential benefits of the Authorized COVID-19 Vaccines are outweighed by their
known and potential risks, nor has Petitioner provided any such information in the Petition. The
27
FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Decision Memorandum (Dec. 11, 2020),
https://www.fda.gov/media/144416/download; FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Amendment
Decision Memorandum for Authorization in Individuals 12-15 Years of Age (May 10, 2021),
Decision Memorandum for Authorization of an Additional Dose in Certain Immunocompromised Individuals
(August 12, 2021) https://www.fda.gov/media/151613/download; FDA, Moderna COVID-19 Vaccine EUA
Decision Memorandum (Dec. 18, 2020), https://www.fda.gov/media/144673/download; FDA, Moderna COVID-19
Vaccine EUA Amendment Decision Memorandum for Authorization of an Additional Dose in Certain
Immunocompromised Individuals (August 12, 2021) https://www.fda.gov/media/151611/download; FDA, Janssen
COVID-19 Vaccine EUA Decision Memorandum (Feb. 27, 2021), https://www.fda.gov/media/146338/download.
28
This letter incorporates by reference FDA's Summary Basis for Regulatory Action (SBRA) for the BioNTech
BLA. This memorandum will be posted on www.fda.gov.
11
known and potential benefits of the Authorized COVID-19 Vaccines continue to outweigh their
known and potential risks, given the risk of COVID-19 and related, potentially severe,
complications. Furthermore, as explained below, there is no adequate, approved, and available
alternative to the Authorized COVID-19 Vaccines for preventing COVID-19. Accordingly, this
request is denied.
b. Standard for Revocation of EUAs is not Met for the

Authorized COVID-19 Vaccines
Section 564(g)(2) of the FD&C Act provides the standard for revocation of an EUA. Under this
statutory authority, FDA may revise or revoke an EUA if:
(A) the circumstances described under [section 564(b)(1) of the FD&C Act] no longer
exist;
(B) the criteria under [section 564(c) of the FD&C Act] for issuance of such authorization
are no longer met; or
(C) other circumstances make such revision or revocation appropriate to protect the
public health or safety.
FDA’s guidance entitled Emergency Use Authorization of Medical Products and Related
Authorities (“EUA Guidance”), 29 notes that once an EUA is issued for a product, in general, that
EUA will remain in effect for the duration of the EUA declaration under which it was issued,
“unless the EUA is revoked because the criteria for issuance . . . are no longer met or revocation
is appropriate to protect public health or safety (section 564(f),(g) [of the FD&C Act]).” 30
Regarding the circumstances that would make a revision or revocation appropriate to protect the
public health or safety, FDA explains in the EUA guidance that
Such circumstances may include significant adverse inspectional

findings (e.g., when an inspection of the manufacturing site and
processes has raised significant questions regarding the purity,
potency, or safety of the EUA product that materially affect the
risk/benefit assessment upon which the EUA was based); reports
of adverse events (number or severity) linked to, or suspected of
being caused by, the EUA product; product failure; product
ineffectiveness (such as newly emerging data that may contribute
to revision of the FDA's initial conclusion that the product "may be
effective" against a particular CBRN agent); a request from the
sponsor to revoke the EUA; a material change in the risk/benefit
assessment based on evolving understanding of the disease or
condition and/or availability of authorized MCMs; or as provided
in section 564(b)(2), a change in the approval status of the product
may make an EUA unnecessary.
29
Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other
Stakeholders, January 2017 (EUA Guidance), https://www.fda.gov/media/97321/download.
30
Id. at 28.
12
EUA guidance at 29.
Thus, in addressing Petitioner’s request for FDA to revoke the Authorized COVID-19 Vaccines,
we assess whether any of the statutory conditions under which FDA may revoke an EUA are
met, namely: (1) whether the circumstances justifying their issuance under section 564(b)(1) of
the FD&C Act no longer exist, (2) whether the criteria for their issuance under section 564(c) of
the FD&C Act are no longer met, and (3) whether other circumstances make a revision or
revocation appropriate to protect the public health or safety.
i. Circumstances Continue to Justify the Issuance of

the EUAs for the Authorized COVID-19 Vaccines
As explained above in section II.b., on February 4, 2020, pursuant to section 564(b)(1)(C) of the
FD&C Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of HHS determined that there is a
public health emergency that has a significant potential to affect national security or the health
and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19. 31
On the basis of such determination, on March 27, 2020, the Secretary then declared that
circumstances exist justifying the authorization of emergency use of drugs and biological
products during the COVID-19 pandemic (“COVID-19 EUA Declaration”), pursuant to section
564(b)(1) of the FD&C Act (21 U.S.C. § 360bbb-3(b)(1)). 32
Based on this declaration and determination, under section 564(c) of the FD&C Act (21 U.S.C. §
360bbb-3(c)), FDA may issue an EUA during the COVID-19 pandemic after FDA concludes
that the statutory requirements provided in section 564(c) are met. Section 564(b)(2) sets forth
the statutory standard for termination of an EUA declaration. An EUA declaration remains in
place until the earlier of: (1) a determination by the HHS Secretary that the circumstances that
precipitated the declaration have ceased (after consultation as appropriate with the Secretary of
Defense) or (2) a change in the approval status of the product such that the authorized use(s) of
the product are no longer unapproved. Neither of those statutory criteria is satisfied with respect
to the Authorized COVID-19 Vaccines.
Thus, the circumstances described under section 564(b)(1) of the FD&C Act continue to exist.
FDA therefore is not revoking the EUAs for the Authorized COVID-19 Vaccines under the
authority in section 564(g)(2)(A) of the FD&C Act.
ii. The Criteria for The Issuance of the Authorized

COVID-19 Vaccines Continue to Be Met
This section describes in detail why the criteria under section 564(c) of the FD&C Act continue
to be met with respect to the Authorized COVID-19 Vaccines and why, therefore, FDA is not
revoking the EUAs for the Authorized COVID-19 Vaccines under the authority in section
564(g)(2)(B) of the FD&C Act.
31
32
13
1. Serious or life-threatening disease or

condition.
Section 564(c)(1) of the FD&C Act requires that, for an EUA to be issued for a medical product,
FDA must conclude “the agent(s) referred to in [the HHS Secretary’s EUA declaration] can
cause a serious or life-threatening disease or condition.” FDA has concluded that SARS-CoV-2,
which is the subject of the EUA declaration, meets this standard.
The SARS-CoV-2 pandemic continues to present an extraordinary challenge to global health

and, as of August 3, 2021, has caused more than 199 million cases of COVID-19 and claimed the
lives of more than 4.2 million people worldwide. 33 In the United States, more than 34 million
cases and over 611,000 deaths have been reported to the CDC. 34 On January 31, 2020, the U.S.
Secretary of Health and Human Services (HHS) declared a public health emergency related to
COVID-19 and mobilized the Operating Divisions of HHS, and the U.S. President declared a
national emergency in response to COVID-19 on March 13, 2020.
FDA is not aware of science indicating that there is any change in the ability of the SARS-CoV-2
virus to cause a serious or life-threatening disease or condition, namely COVID-19, nor has
Petitioner provided any information about such a change. Therefore, the criterion under section
564(c)(1) continues to be met with respect to the Authorized COVID-19 Vaccines.
2. Evidence of Effectiveness
Section 564(c)(2)(A) of the FD&C Act requires that, for an EUA to be issued for a medical
product, FDA must conclude “based on the totality of scientific evidence available to the
Secretary, including data from adequate and well-controlled trials, if available, it is reasonable to
believe that the product may be effective to prevent, diagnose, or treat such serious or life-
threatening disease or condition that can be caused by SARS-CoV-2.”
FDA issued EUAs for the Authorized COVID-19 Vaccines after determining that, among other
things, these products were demonstrated in clinical trials to prevent symptomatic and severe
COVID-19 in vaccinated clinical trial subjects. 35 FDA is not aware of any data that changes this
conclusion, nor has Petitioner provided any such data in the Petition. This section addresses
Petitioner’s arguments regarding the effectiveness of the Authorized COVID-19 vaccines and
explains why the information submitted by Petitioner does not change FDA’s analysis regarding
the effectiveness of these vaccines.
After FDA approves a vaccine or authorizes a vaccine for emergency use, the vaccine continues
to be studied to determine how well it works under real-world conditions. FDA, CDC, and other
federal partners have been assessing, and will continue to assess, COVID-19 vaccine
33
Johns Hopkins University School of Medicine, Coronavirus Resource Center,
https://coronavirus.jhu.edu/map.html.
34
CDC, COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.
35
FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Decision Memorandum (Dec. 11, 2020), at 23,
https://www.fda.gov/media/144416/download; FDA, Moderna COVID-19 Vaccine EUA Decision Memorandum
(Dec. 18, 2020), at 24, https://www.fda.gov/media/144673/download; FDA, Janssen COVID-19 Vaccine EUA
Decision Memorandum (Feb. 27, 2021), at 25, https://www.fda.gov/media/146338/download.
14
effectiveness under real-world conditions. Such evaluations will help us understand if vaccines
are performing as expected outside the more controlled setting of a clinical trial.
Petitioner raises concerns regarding the post-market effectiveness of the Authorized COVID-19
Vaccines (Petition at 6). Petitioner points to CDC-reported “breakthrough cases” to suggest that
the Authorized COVID-19 Vaccines are not effective and argues that the EUAs for the
Authorized COVID-19 Vaccines should therefore be revoked because the current risks of these
vaccines outweigh their benefits. This perspective fails to recognize several important points
regarding the concept of breakthrough cases and regarding the CDC publication cited in the
Petition.
First, we note that the Letters of Authorization for the Authorized COVID-19 Vaccines require
EUA-holders to report to VAERS “cases of COVID-19 that result in hospitalization or death,
that are reported to [the EUA holder].” 36 Thus, the possibility that individuals who received one
of the Authorized COVID-19 Vaccines could develop breakthrough COVID-19 cases was
recognized by FDA when the Agency evaluated the EUA requests for these vaccines and
determined that their known and potential benefits outweigh their known and potential and risks.
Second, the Authorized COVID-19 Vaccines are indicated to prevent symptomatic COVID-19, 37
not to prevent SARS-CoV-2 infection. Over 353 million doses of COVID-19 vaccines have
been administered in the United States 38 and FDA’s ongoing post authorization monitoring
informs us that the known and potential benefits continue to outweigh the known and potential
risks. Additionally, CDC’s post-authorization data regarding the Authorized COVID-19
Vaccines continues to support FDA’s conclusion that these vaccines prevent symptomatic
COVID-19. 39
Third, a vaccine does not need to be 100% effective in preventing the target disease in order to
meet the licensure or EUA standard. It is expected that some vaccinated individuals will contract
the target disease despite having been vaccinated against it. No FDA licensed or authorized
vaccine is 100% effective, but scientific data has nevertheless demonstrated that vaccinations
have been a very effective approach to protecting the public's health in the United States. 40
36
Section 8, Requirements and Instructions for Reporting Adverse Events and Vaccine Administration Errors,
Pfizer-BioNTech COVID-19 Fact Sheet for Healthcare Providers Administering Vaccine,
https://www.fda.gov/media/144413/download; Section 8, Requirements and Instructions for Reporting Adverse
Events and Vaccine Administration Errors, Moderna COVID-19 Fact Sheet for Healthcare Providers Administering
Vaccine, https://www.fda.gov/media/144637/download; Section 8, Requirements and Instructions for Reporting
Adverse Events and Vaccine Administration Errors, Janssen COVID-19 Fact Sheet for Healthcare Providers
Administering Vaccine, https://www.fda.gov/media/146304/download.
37
FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Decision Memorandum (Dec. 11, 2020), at 23,
38
CDC, COVID Data Tracker Weekly Review, Interpretive Summary for August 13, 2021,
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html
39
CDC, COVID-19 Vaccine Effectiveness Research, https://www.cdc.gov/vaccines/covid-19/effectiveness-
research/protocols.html.
40
Vaccine Safety Questions and Answers, last updated March 2018, https://www.fda.gov/vaccines-blood-
15
Similarly, a COVID-19 vaccine need not be 100% effective in preventing symptomatic COVID-
19, or even close to 100% effective in doing so, in order to have a significant effect in altering
the course of the COVID-19 pandemic. As FDA noted in its June 2020 Guidance for Industry,
Development and Licensure of Vaccines to Prevent COVID-19, (“The Vaccine Development
and Licensure Guidance”) “[t]o ensure that a widely deployed COVID-19 vaccine is effective,
the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at
least 50%, and the statistical success criterion should be that the lower bound of the appropriately
alpha-adjusted confidence interval around the primary efficacy endpoint point estimate is
>30%.” 41 This statistical consideration provided in the Vaccine Development and Licensure
Guidance reflects FDA’s assessment that a vaccine with at least 50 percent efficacy would have
a significant impact on disease, both at the individual and societal level.
Finally, we note that Petitioner refers to “CDC-reported” breakthrough cases in support of its
argument that there are effectiveness concerns with the Authorized COVID-19 Vaccines but fails
to acknowledge that CDC reported a set of breakthrough cases that includes a large proportion of
asymptomatic individuals who tested positive for SARS-CoV-2. Petitioner thus applies a
narrower definition of the term “breakthrough case” to a set of cases than CDC has in its
COVID-19 Vaccine Breakthrough Case Investigation. 42 Petitioner refers to breakthrough cases
in which vaccinated individuals “fall ill and potentially transmit the virus” (Petition at 6) and
states that “CDC reported over 9,000 ‘breakthrough cases’ and 132 COVID-caused deaths
among vaccinated people.” Petition at 6.
CDC’s objective in the COVID-19 Vaccine Breakthrough Case Investigation is to 43 ensure the
COVID-19 vaccines are working as expected and to “identify patterns or trends” in:
• Patients’ characteristics, such as age or underlying medical conditions

• The specific vaccine that patients received
• Whether a specific SARS-CoV-2 variant caused the infections” 44
The objective of this investigation is not simply to count symptomatic COVID-19 cases.
Currently, COVID-19 cases are increasing again in nearly all states. The highest rate of COVID-
19 case spread is in areas with low vaccination rates. 45
Petitioner’s submitted data regarding CDC-reported “breakthrough cases” therefore does not
present new data or information that the Agency has not previously considered regarding the
effectiveness of the Authorized COVID-19 Vaccines. Available data regarding effectiveness of
41
Development and Licensure of Vaccines to Prevent COVID-19, Guidance for Industry, June 2020, at 14,
42
CDC, COVID-19 Vaccine Breakthrough Case Investigations and Reporting, https://www.cdc.gov/vaccines/covid-
19/health-departments/breakthrough-cases.html.
43
44
45
“As of July 22 [2021], 35% of U.S. counties are experiencing high levels of community transmission. COVID-19
cases are on the rise in nearly 90% of U.S. jurisdictions, and we are seeing outbreaks in parts of the country that
have low vaccination coverage.” CDC, COVID Data Tracker Weekly Review, Interpretive Summary for July 23,
2021, available at https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html.
16
the Authorized COVID-19 Vaccines continues to support the conclusion that these vaccines may
be effective in preventing COVID-19. FDA is not aware of any data that changes this
conclusion, nor has Petitioner provided any such data in the Petition. Therefore, the criterion
under section 564(c)(2)(A) continues to be met with respect to the Authorized COVID-19
Vaccines.
3. Benefit-Risk Analysis
Section 564(c)(2)(B) of the FD&C Act requires that, for an EUA to be issued for a medical
product, FDA must conclude “the known and potential benefits of the product, when used to
diagnose, prevent, or treat [the identified serious or life-threatening disease or condition],
outweigh the known and potential risks of the product . . . .” Petitioner argues that the current
risks of serious adverse events or deaths associated with the Authorized COVID-19 Vaccines
outweigh the benefits of COVID-19 vaccines. This section addresses Petitioner’s arguments
regarding the safety of COVID-19 vaccines and explains why the information submitted by
Petitioner does not change FDA’s analysis regarding the benefits and risks of the Authorized
COVID-19 Vaccines.
FDA issued EUAs for the Authorized COVID-19 Vaccines after reaching a determination
regarding each of these vaccines that, among other things, the known and potential benefits of
the vaccine, when used to prevent COVID-19, outweigh its known and potential risks. 46 FDA is
not aware of any data that changes this determination, nor has Petitioner provided any such data
in the Petition. The known and potential benefits of the Authorized COVID-19 Vaccines, when
used to prevent COVID-19, continue to outweigh their known and potential risks, given the risk
of COVID-19 and related, potentially severe, complications.
Petitioner raises numerous concerns regarding safety of the Authorized COVID-19 Vaccines
(Petition at 2-6) and asserts that the EUAs for the Authorized COVID-19 Vaccines should be
revoked due in part to these safety concerns. For reasons explained below, FDA disagrees with
Petitioner’s assertions regarding the safety of the Authorized COVID-19 Vaccines.
As an initial matter, we note that the Petition discusses several assertions made by CDC and
requests that have been directed to CDC. For requests intended for CDC, you should contact
CDC directly.
a. Petitioner’s Claims Regarding

VAERS Data
46
For an extensive discussion of FDA’s analysis of the clinical trial data regarding the risks and benefits of each of
the authorized COVID-19 Vaccines, see FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Decision Memorandum
(Dec. 11, 2020), at 49, https://www.fda.gov/media/144416/download; FDA, Moderna COVID-19 Vaccine EUA
Decision Memorandum (Dec. 18, 2020), at 55, https://www.fda.gov/media/144673/download; FDA, Janssen
COVID-19 Vaccine EUA Decision Memorandum (Feb. 27, 2021), at 59,
https://www.fda.gov/media/146338/download. See also, FDA, Pfizer-BioNTech COVID-19 Vaccine EUA
Amendment Decision Memorandum for Authorization in Individuals 12-15 Years of Age (May 10, 2021), at 38,
17
In arguing that the Authorized COVID-19 Vaccines should be revoked due, in part, to safety
concerns, Petitioners assert that “Vaccine Adverse Event Reporting System (VAERS) data reveal
unprecedented levels of deaths and other adverse events since the FDA issued Emergency Use
Authorizations (EUAs) for three COVID vaccines. As of May 10, 2021, VAERS reported 4,434
deaths of people who received at least one COVID vaccination.” As an initial matter, we note
that VAERS is a national passive surveillance vaccine safety database that receives unconfirmed
reports of possible adverse events following the use of a vaccine licensed or authorized in the
United States. VAERS is not designed to assess whether a reported adverse event was caused by
a vaccine. This section explains vaccine safety surveillance, including VAERS, in greater detail
below.
Regarding the number of VAERS reports submitted for the Authorized COVID-19 Vaccines,
this figure can be attributed to multiple factors. First, we note that a large number of COVID-19
vaccine doses have been administered in the United States and that certain adverse event
reporting by vaccination providers is required for the Authorized COVID-19 Vaccines. As of
August 13, 2021, over 353,000,000 doses of the Authorized COVID-19 Vaccines have been
administered. 47 We note that the crude number of VAERS reports of death is extremely small
compared to the to the large number of people who have been vaccinated. The VAERS
reporting rate for deaths (which is the number of VAERS death reports received out of the
number of individuals vaccinated) for the Authorized COVID-19 Vaccines is actually very low
(6,490 reports of death out of 346 million doses administered (0.0019%) as of August 2, 2021). 48
Petitioner’s assertion fails to account for this fact.
For licensed vaccines, healthcare providers are legally required under 42 USC 300aa-25 to report
to VAERS two categories of adverse events: “[a]ny adverse event listed in the VAERS Table of
Reportable Events Following Vaccination that occurs within the specified time period after
vaccination [and] [a]n adverse event listed by the vaccine manufacturer as a contraindication to
further doses of the vaccine” 49 Vaccine manufacturers are also required to report to VAERS all
adverse events that come to their attention. 50
Under the EUAs for the Authorized COVID-19 Vaccines, however, vaccination providers are
required to report to VAERS serious adverse events following vaccination with the Authorized
COVID-19 Vaccines, “irrespective of attribution to vaccination” and without a specified time
period after vaccination. 51 Another contributing factor is the v-safe system, 52 which is a new
CDC smartphone-based active-surveillance system in which participants who have been
47
CDC, COVID Data Tracker, COVID-19 Vaccinations in the United States, https://covid.cdc.gov/covid-data-
tracker/#vaccinations_vacc-total-admin-rate-total.
48
CDC, Selected Adverse Events Reported after COVID-19 Vaccination, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/safety/adverse-events.html.
49
VAERS, Frequently Asked Questions, https://vaers.hhs.gov/faq.html (emphasis added).
50
21 CFR 600.80. See also VAERS, Frequently Asked Questions, https://vaers.hhs.gov/faq.html.
51
Section 8, Requirements and Instructions for Reporting Adverse Events and Vaccine Administration Errors,
Pfizer-BioNTech COVID-19 Fact Sheet for Healthcare Providers Administering Vaccine,
https://www.fda.gov/media/144413/download; Section 8, Requirements and Instructions for Reporting Adverse
Events and Vaccine Administration Errors, Moderna COVID-19 Fact Sheet for Healthcare Providers Administering
Vaccine, https://www.fda.gov/media/144637/download; Section 8, Requirements and Instructions for Reporting
Adverse Events and Vaccine Administration Errors, Janssen COVID-19 Fact Sheet for Healthcare Providers
Administering Vaccine, https://www.fda.gov/media/146304/download.
52
CDC, v-safe Overview, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html.
18
vaccinated may voluntarily enroll. This system was developed for the COVID-19 vaccination
program. V-safe sends text messages and web surveys to participants who can report side effects
following receipt of a COVID-19 vaccine. If a participant indicates through the v-safe surveys
that he or she required medical care at any time, CDC calls the participant to complete a report
through VAERS. This system is unique to COVID-19 vaccines and may be contributing to the
number of VAERS reports submitted for the Authorized COVID-19 Vaccines.
Finally, another potential factor is the concept of “stimulated reporting.” 53 Because of extensive
media coverage and awareness of the public health emergency – and of the Authorized COVID-
19 Vaccines and their reported side effects –vaccine recipients, health care providers, and others
are more likely to report adverse events for the Authorized COVID-19 Vaccines than for other
vaccines that have been widely available for longer periods of time. Additionally, one of the
articles submitted by Petitioner in support of their argument actually provides support for this
explanation for the number of VAERS reports submitted for the Authorized COVID-19
Vaccines. The article notes “[t]he relatively rapid increase in numbers of reports to VAERS
following the introduction and initial uptake of a new vaccine, an expected occurrence, has been
misinterpreted as actual increases in incidence of adverse events and vaccine related risk.” 54
Petitioner’s argument regarding VAERS data for the Authorized COVID-19 Vaccines is
unavailing because it fails to account for the factors outlined above.
In addressing Petitioner’s assertion regarding VAERS claims, this section addresses the
extensive vaccine safety surveillance efforts, in addition to VAERS, that are in place for the
Authorized COVID-19 Vaccines. 55 FDA is monitoring the safety of the Authorized COVID-19
Vaccines through both passive and active safety surveillance systems. FDA is doing so in
collaboration with the Centers for Disease Control and Prevention (CDC), the Centers for
Medicare and Medicaid Services (CMS), the Department of Veterans Affairs (VA), and other
academic and large non-government healthcare data systems.
In addition, FDA participates actively in ongoing international pharmacovigilance efforts,

including those organized by the International Coalition of Medicines Regulatory Authorities
53
We note that an article submitted by Petitioner in support of their arguments regarding VAERS acknowledges this
concept: “Like all spontaneous public health reporting systems, VAERS has limitations. VAERS is subject to
reporting bias, including underreporting of adverse events – especially common, mild ones– and stimulated
reporting, which is elevated reporting that might occur in response to intense media attention and increased public
awareness, such as during the 2009 H1N1 pandemic influenza vaccination program” Shimabukuro et al., Safety
monitoring in the Vaccine Adverse Event Reporting System (VAERS), Vaccine (Nov. 4, 2015),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/. See also “The number of reports and reporting rate
following 2009-H1N1 vaccination were higher than following 2009–2010 seasonal influenza vaccines for all age
groups. These findings, however, should be interpreted in light of the publicity around the 2009-H1N1 vaccine and
efforts to increase reporting to VAERS. Heightened public awareness and stimulated reporting likely enhanced
reporting to VAERS. Furthermore, although 2009-H1N1 was licensed similarly to seasonal influenza vaccines, it
was likely perceived as a ‘new’ vaccine by the public and susceptible to the known tendency (i.e., the Weber effect)
for adverse events to be reported more frequently following newly licensed products.” Vellozzi, et al., Adverse
events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting
System, United States, October 1, 2009–January 31, 2010, Vaccine (Oct. 21, 2010),
https://www.sciencedirect.com/science/article/pii/S0264410X10013319.
54
Shimabukuro et al., Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS), Vaccine (Nov.
4, 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/ (emphasis added).
55
FDA, COVID-19 Vaccine Safety Surveillance, https://www.fda.gov/vaccines-blood-biologics/safety-availability-
biologics/covid-19-vaccine-safety-surveillance.
19
(ICMRA) and the World Health Organization (WHO). These efforts are in addition to the
pharmacovigilance efforts being undertaken by the individual manufacturers for authorized
vaccines. A coordinated and overlapping approach using state-of the art technologies has been
implemented. As part of our efforts to be transparent about our COVID-19 vaccine safety
monitoring activities, FDA is posting summaries of the key safety monitoring findings on the
FDA website. 56
i. Vaccine Safety Surveillance

Passive Surveillance
VAERS is a national passive surveillance vaccine safety database that receives unconfirmed
United States. Passive surveillance is defined as unsolicited reports of adverse events that are
sent to a central database or health authority. In the United States, these are received and entered
into VAERS, which is co-managed by FDA and CDC. In the current pandemic, these reports are
being used to monitor the occurrence of both known and unknown adverse events, as providers
of COVID-19 vaccines are required to report serious adverse events to VAERS.
As part of FDA and CDC's multi-system approach to post-licensure and post-authorization
vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns
of adverse events, also known as “safety signals.” VAERS reports generally cannot be used to
determine if a vaccine caused or contributed to an adverse event or illness. If the VAERS data
suggest a possible link between an adverse event and vaccination, the relationship may be further
studied in a controlled fashion. 57
Anyone can make a report to VAERS, including vaccine manufacturers, private practitioners,
state and local public health clinics, vaccine recipients, and their parents or caregivers.
Surveillance programs like VAERS perform a critical function by generating signals of potential
problems that may warrant further investigation.
VAERS is not designed to assess causality. It is often difficult to determine with certainty if a
vaccine caused an adverse event reported to VAERS. Many events that occur after vaccination
can happen by chance alone. Some adverse events are so rare that their association with a
vaccine is difficult to evaluate. In addition, we often receive reports where there is no clear
clinical diagnosis. FDA draws upon multiple sources of data and medical and scientific
expertise to assess the potential strength of association between a vaccine, including COVID-19
vaccines, and a possible adverse event.
If VAERS monitoring suggests that a vaccine might be causing a health problem, additional
scientifically rigorous studies or investigations can be performed by FDA and CDC. Monitoring
and analysis of VAERS reports typically includes daily in-depth medical review of all serious
reports, statistical data mining techniques, and epidemiological analysis. We look for patterns
and similarities in the onset timing and clinical description. We review published literature to
56
FDA, COVID-19 Vaccine Safety Surveillance, https://www.fda.gov/vaccines-blood-biologics/safety-availability-
biologics/covid-19-vaccine-safety-surveillance
57
FDA, VAERS Overview, https://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaers-overview.
20
understand possible biologic hypotheses that could plausibly link the reported adverse event to
the vaccine. We review the pre-licensure or pre-authorization data and any other post-marketing
studies that have been conducted. We also consider “background rate,” meaning the rate at
which a type of adverse event occurs in the unvaccinated general population. When necessary,
we discuss the potential adverse event with our federal and international safety surveillance
partners. We also carefully evaluate unusual or unexpected reports, as well as reports of
“positive re-challenges” (adverse events that occur in the same patient after each dose received).
When there is sufficient evidence for a potential safety concern, we may proceed to conduct
large studies, and we may coordinate with our federal, academic, and private partners to further
assess the potential risk after vaccination. In addition, when potential safety issues arise, they are
often presented to various U.S. government advisory committees, including the Vaccines and
Related Biological Products Advisory Committee, the Advisory Committee on Immunization
Practices (ACIP), and the Advisory Committee on Childhood Vaccines, and are often discussed
with experts from other countries and from the World Health Organization. Federal agencies
that assist in population-based vaccines safety studies include the CDC, Centers for Medicaid
and Medicare (CMS), the Department of Defense (DoD), and the Indian Health Services (IHS).
In addition, we generally communicate and work with international regulatory authorities and
international partners to conduct studies in vaccine safety.
Active Surveillance
Active surveillance involves proactively obtaining and rapidly analyzing information related to
millions of individuals and recorded in large healthcare data systems to verify safety signals
identified through passive surveillance or to detect additional safety signals that may not have
been reported as adverse events to passive surveillance systems. FDA is conducting active
surveillance using the Sentinel BEST (Biologics Effectiveness and Safety) System and the CMS
system, and is also collaborating with other federal and non-federal partners.
BEST
To elaborate further, the BEST system, 58 which is part of the Sentinel initiative, 59 comprises
large-scale claims data, electronic health records (EHR), and linked claims-EHR databases with
a data lag of approximately three months. The system makes use of multiple data sources and
enables rapid queries to detect or evaluate adverse events as well as studies to answer specific
safety questions for vaccines. The linked claims-EHR database makes it possible to study the
safety of vaccines in sub-populations with pre-existing conditions or in pregnant women. The
major partners for BEST currently are Acumen, IBM Federal HealthCare, IQVIA, and Columbia
University and many affiliated partners such as MedStar Health, BlueCross BlueShield of
58
CBER Biologics Effectiveness and Safety (BEST) System, https://www.fda.gov/vaccines-blood-biologics/safety-
availability-biologics/cber-biologics-effectiveness-and-safety-best-system.
59
FDA’s Sentinel Initiative, https://www.fda.gov/safety/fdas-sentinel-initiative.
21
America, the Observational Health Data Sciences and Informatics (OHDSI), OneFlorida,
University of California and several others. 60
Using BEST, CBER plans to monitor about 15 adverse events 61 that have been seen with the
deployment of previous vaccines but have yet to be associated with a safety concern for an
authorized COVID-19 vaccine at this time. CBER further plans to use the BEST system to
conduct more in-depth analyses should a safety concern be identified from sources such as
VAERS.
CMS
FDA has worked over the past several years with CMS to develop capabilities for routine and
time-sensitive assessments of the safety of vaccines for people 65 years of age and older using
the Medicare Claims database. 62 Because it was already in place, this system was immediately
put into use for COVID-19 vaccine surveillance to monitor for adverse events. 63
During the current pandemic, FDA, CMS, and CDC have already used the Medicare data to
publish a study showing that frailty, comorbidities, and race/ethnicity were strong risk factors of
COVID-19 hospitalization and death among the U.S. elderly. 64
VSD
In addition, the Vaccine Safety Datalink (VSD) is a collaborative project between CDC’s
Immunization Safety Office and nine health care organizations. As noted on the CDC’s
60
To confirm the utility of the BEST system for situations such as COVID-19 vaccine surveillance, a test case was
conducted. This study aimed to replicate a previous study by the CDC’s Vaccine Safety Datalink (VSD) (Klein et al.
Pediatrics 2010) that examined the databases and analytic capabilities of the new system. The objective of this study
was to test the new system’s ability to reproduce the increased risk of febrile seizures in children receiving the first
dose of measles-mumps-rubella-varicella (MMRV) vaccine, compared to that of MMR and varicella vaccines
separately but on the same day. The results of the study met the objectives and demonstrated the ability of the BEST
Initiative data network to run a complex study protocol at multiple sites using a distributed data network and the
Observational Medical Outcomes Partnership Common Data Model (organizing disparate data sources into the same
database design using a common format).
61
Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring, Draft
Protocol (December 31, 2020), https://www.bestinitiative.org/wp-content/uploads/2021/01/C19-Vaccine-Safety-
AESI-Background-Rate-Protocol-2020.pdf.
62
CMS, Standard Analytical Files (Medicare Claims) – LDS, https://www.cms.gov/Research-Statistics-Data-and-
Systems/Files-for-Order/LimitedDataSets/StandardAnalyticalFiles.
63
As one example of the capabilities of this system, FDA, CMS, and CDC evaluated the risk of Guillain-Barré
syndrome (GBS) following influenza vaccination after CDC’s Vaccine Safety Datalink, identified safety signals
suggesting an increased risk of GBS following high-dose influenza vaccinations and Shingrix vaccinations during
the 2018-2019 influenza season. CBER, CDC, and CMS formed working groups in February 2019 to refine these
safety signals in the CMS data.
64
Hector S Izurieta, David J Graham, Yixin Jiao, Mao Hu, Yun Lu, Yue Wu, Yoganand Chillarige, Michael
Wernecke, Mikhail Menis, Douglas Pratt, Jeffrey Kelman, Richard Forshee, Natural History of Coronavirus Disease
2019: Risk Factors for Hospitalizations and Deaths Among >26 Million US Medicare Beneficiaries, The Journal of
Infectious Diseases, Volume 223, Issue 6, 15 March 2021, Pages 945–956, https://doi.org/10.1093/infdis/jiaa767
https://academic.oup.com/jid/article/223/6/945/6039057.
22
webpage, the VSD started in 1990 and continues today in order to monitor safety of vaccines and
conduct studies about rare and serious adverse events following immunization.
The VSD uses electronic health data from each participating site. This includes information on
vaccines: the kind of vaccine given to each patient, date of vaccination, and other vaccinations
given on the same day. The VSD also uses information on medical illnesses that have been
diagnosed at doctors’ offices, urgent care visits, emergency department visits, and hospital stays.
The VSD conducts vaccine safety studies based on questions or concerns raised from the medical
literature and reports to the Vaccine Adverse Event Reporting System (VAERS). When there are
new vaccines that have been recommended for use in the United States or if there are changes in
how a vaccine is recommended, the VSD will monitor the safety of these vaccines.
The VSD has a long history of monitoring and evaluating the safety of vaccines. Since 1990,
investigators from the VSD have published many studies to address vaccine safety concerns. 65
In summary, in collaboration and coordination with several different partners, FDA has
assembled passive surveillance systems - including VAERS - and active surveillance systems
that can detect and refine safety findings with the Authorized COVID-19 Vaccines in a relatively
rapid manner. These systems can also potentially be leveraged to assess safety in specific
subpopulations and to assess vaccine effectiveness.
ii. Articles Submitted in Petition

Regarding Vaccine Surveillance
We note at the outset that Petitioner raises concerns regarding the methodology by which CDC
calculated rates of anaphylactic adverse events post-vaccination. Such concerns are best directed
to CDC and are outside the scope of FDA’s Petition response.
Regarding Petitioner’s contention that a low percentage of adverse events have been reported to
VAERS and that therefore “the safety of COVID vaccines is considerably worse than it currently
appears” (Petition at 4), as explained in detail above in this section, VAERS is only one part of a
multi-tiered vaccine safety surveillance system, so the information derived from VAERS reports
does not represent the full extent of vaccine safety information being monitored by FDA and its
federal partners.
Specifically, Petitioner cites to three studies in support of the argument that “[g]iven that only 1
to 13% of adverse reactions have been reported to the FDA and CDC via the VAERS passive
reporting system, according to Lazarus et al., the high number of adverse events and deaths
following COVID vaccines is alarming.” Petition at 5. The articles cited by Petitioner in support
of this contention do not support Petitioner’s position that, due to underreporting of adverse
events, the rate of reported adverse events associated with COVID-19 vaccination is low in
comparison to the actual rate of adverse events. As discussed above in this section, there are
several factors unique to the surveillance of the Authorized COVID-19 Vaccines that have
65
See, e.g., CDC, White Paper on the Safety of the Childhood Immunization Schedule, Vaccine Safety Datalink,
available at https://www.cdc.gov/vaccinesafety/pdf/WhitePaperSafety_WEB.pdf.
23
contributed to the number of VAERS reports submitted for these vaccines. Petitioner’s argument
that adverse events associated with the Authorized COVID-19 Vaccines are underreported
because of the figures presented in the articles cited fail to account for any of those factors that
are unique to the Authorized COVID-19 Vaccines.
Petitioner cites to a publication from the Agency for Healthcare Research and Quality (Lazarus
et al.) in support of the argument that deaths and adverse events associated with the Authorized
COVID-19 Vaccines are underreported because “only 1 to 13% of adverse reactions have been
reported to the FDA and CDC via the VAERS passive reporting system” (Petition at 5), and
therefore the actual rate of COVID-19 Vaccine adverse events is significantly higher than
reported. 66 As an initial matter, we note that the language cited from the Lazarus article is
referring to adverse event reporting for drugs and vaccines, not just vaccine adverse events
reported to VAERS. 67 Furthermore, as explained in detail above, several factors have
contributed to the number of VAERS reports submitted for the Authorized COVID-19 Vaccines.
The issues raised in this article regarding underreporting of drug adverse event reporting are not
directly relevant to the claims Petitioner makes regarding adverse event reporting for the
Authorized COVID-19 Vaccines. The article was published in 2010 and does not consider the
numerous factors outlined above regarding reporting of adverse events following COVID-19
vaccination.
Petitioner cites to a journal article in the publication Vaccine 68 regarding VAERS safety
monitoring in support of their argument that adverse event reports for the Authorized COVID-19
Vaccines are underreported. This article generally discusses the limitations of VAERS and
passive surveillance, which are well-understood by the FDA and which are discussed in this
letter. Additionally, this article notes “[p]erhaps the two most common misconceptions about
VAERS are that temporally associated reports represent true adverse reactions caused by
vaccination, and that VAERS reports equate to rates of adverse events or indicate risk of adverse
events associated with vaccination.” 69 This statement from the article demonstrates the flaws
underlying Petitioner’s claims that the Authorized COVID-19 Vaccines are unsafe due to the
number of serious adverse events reported to VAERS following administration of these vaccines.
Additionally, the article notes “[t]he relatively rapid increase in numbers of reports to VAERS
following the introduction and initial uptake of a new vaccine, an expected occurrence, has been
misinterpreted as actual increases in incidence of adverse events and vaccine related risk.” 70
Thus, the article cited by Petitioner directly contradicts Petitioner’s claims regarding the safety of
the Authorized COVID-19 Vaccines based on the number of VAERS adverse event reports
associated with these vaccines.
66
Lazarus et al., Electronic Support for Public Health-Vaccine Adverse Event Reporting System, Agency for
Healthcare Research and Quality, HHS (Sept. 30, 2010), https://digital.ahrq.gov/ahrq-funded-projects/electronic-
support-public-health-vaccine-adverse-event-reporting-system.
67
Id. at 6.
68
Shimabukuro et al., Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS), Vaccine (Nov.
4, 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/.
69
Id. at 9.
70
Id.
24
Finally, Petitioner also cites to a journal article in the American Journal of Public Health. 71 This
article does not raise issues that have not already been addressed in this letter’s discussion of
safety surveillance. For instance, the article notes that passive surveillance has several
limitations, specifically, passive surveillance may involve underreporting of adverse events, and
passive surveillance data is not adequate to determine causation. Additionally, this article notes
that passive surveillance can provide valuable information, “[n]evertheless, if reporting is
reasonably consistent, it may be possible to detect changes in trends of known common adverse
events.” 72
Therefore, the articles submitted by Petitioner do not present data or information regarding the
Authorized COVID-19 Vaccines that change the Agency’s analysis regarding the benefits and
risks of the Authorized COVID-19 Vaccines.
Petitioner further asserts that extensive safety information regarding vaccines is inaccessible to
the public (“the VAERS database is the only safety database to which the public has access. The
government withholds extensive safety information from the public despite having at least ten
additional data sources and expert consultants to analyze these data . . . .” Petition at 2.). This
contention represents a misunderstanding by Petitioner of the sources of data analyzed by FDA
and its federal partners, and of the types of information available to the public.
As noted above, Petitioner's questions regarding databases operated by other federal partners,
such as DOD, CMS, CDC, VA, should be directed to those federal entities. Regarding FDA’s
BEST system, Petitioner erroneously claims that the public does not have access to the
information on this system. As noted above, the BEST system, 73 which is part of the Sentinel
initiative, 74 comprises large-scale claims data, electronic health records (EHR), and linked
claims-EHR databases with a data lag of approximately three months. The system makes use of
multiple data sources and enables rapid queries to detect or evaluate adverse events as well as
studies to answer specific safety questions for vaccines. The system is not intended to be a
source of raw EHR data. Instead, as explained on FDA’s webpage describing the BEST system,
the purpose of the BEST system is to: (1) build data, analytics, infrastructure for an active, large-
scale, efficient surveillance system for biologic products; and (2) develop innovative methods to
utilize electronic health records (EHR) effectively and establish automated adverse events
reporting, utilizing natural language processing and artificial intelligence. 75 BEST does not have
access to the raw, identifiable data. BEST data partners analyze the raw data per publicly posted
protocols and send the results in aggregated form to BEST for review. The information is
summarized in either final reports, manuscripts or public presentations. BEST publicly posts
study protocols of surveillance activities on the BEST site with open public comments regarding
the protocols, final reports and manuscripts as well as communication on CBER safety site and
public meetings, e.g., VRBPAC, where appropriate. These protocols delineate the scientific
approach to analyzing the raw data, where in the raw form is of limited utility to the public, to
71
S. Rosenthal and R. Chen, The reporting sensitivities of two passive surveillance systems for vaccine adverse
events, American Journal of Public Health (Dec. 1995), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1615747/.
72
Id.
73
74
FDA’s Sentinel Initiative, https://www.fda.gov/safety/fdas-sentinel-initiative.
75
25
generate information on vaccine safety. The final reports and manuscripts summarize the
information and conclusions inferred from well-conducted surveillance studies.
iii. FDA Has Responded to Safety

Signals Related to the Authorized
COVID-19 Vaccines by Extensively
Reviewing Data, Updating the
Authorized Labeling, and
Communicating to the Public
Petitioner further asserts that “FDA and CDC have not responded to these data by issuing any
warnings or restricting the use of these vaccines.” Petition at 2. This assertion is inaccurate. As
explained in detail above, FDA and its federal partners, including CDC, have closely monitored
post-market safety data regarding the Authorized COVID-19 Vaccines. FDA has worked to
identify and investigate serious adverse events occurring in people after receiving the Authorized
COVID-19 Vaccines, and to communicate these risks to the public and revise the authorized
labeling to reflect these risks in a timely fashion. 76 The surveillance systems that are in place to
monitor the safety of COVID-19 vaccines authorized for emergency use are working, as
demonstrated by FDA’s and CDC’s work to identify and investigate these serious adverse events
in a timely manner.
Adverse events reported to VAERS following administration of one of the authorized COVID-19
vaccines are reviewed to assess possible safety concerns. Such review of VAERS data regarding
the authorized COVID-19 vaccines has been conducted since these vaccines were authorized.
Such review has prompted the Agency to take action with respect to the currently authorized
COVID-19 vaccines:
• On April 13, 2021, FDA and CDC recommended a pause in the use of the Janssen
COVID-19 vaccine following six VAERS reports in the U.S. of thrombosis with
thrombocytopenia. 77 The FDA and CDC thoroughly reviewed VAERS and other post-
authorization information and data related to the Janssen COVID-19 vaccine during the
recommended pause. This review included two meetings of ACIP. Following a
thorough safety review, FDA determined that the available data show that the Janssen
COVID-19 vaccine’s known and potential benefits outweigh its known and potential
76
Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers),
Sections 5.2 and 5.3 Warnings and Precautions Regarding Thrombosis with Thrombocytopenia and GBS,
https://www.fda.gov/media/146304/download; Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers), Section 5.2, Warning and Precautions Regarding
Myocarditis and Pericarditis, https://www.fda.gov/media/144413/download; Moderna COVID-19 Vaccine Fact
Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Section 5.2, Warning and
Precautions Regarding Myocarditis and Pericarditis, https://www.fda.gov/media/144637/download.
77
We note that Petitioner mentions that Denmark, among other nations, has “banned” the Janssen COVID-19
vaccine. To the extent Petitioner relies on this ban as support for Petitioner’s request that FDA revoke the EUA for
this vaccine, we note that Denmark and other nations’ actions with respect to the use of this vaccine are outside
purview of FDA’s work, so we cannot comment on decisions they make under their public health regulatory
framework.
26
risks in individuals 18 years of age and older. As a result of this review, the Fact Sheet
for Healthcare Providers Administering Vaccine (Vaccination Providers) was updated to
include a Warning pertaining to the risk of thrombosis with thrombocytopenia. The Fact
Sheet for Recipients and Caregivers was also updated to include information about these
serious adverse events. The FDA and CDC conducted extensive outreach to providers
and clinicians to ensure they were made aware of the potential for these adverse events
and could properly recognize and manage thrombosis with thrombocytopenia in
individuals who receive the Janssen COVID-19 Vaccine.
• On June 25, 2021, following review of VAERS reports, FDA required revisions to the
authorized labeling for the Pfizer-BioNTech COVID-19 vaccine and the Moderna
COVID-19 vaccine to add a warning regarding the suggested increased risks of
myocarditis and pericarditis. This update to the authorized labeling for these vaccines
followed an extensive review of information and the discussion by CDC’s ACIP meeting
on June 23, 2021. As of July 26, 2021, the FDA and the Centers for Disease Control and
Prevention (CDC) have received 1,194 reports of myocarditis or pericarditis occurring
among people ages 30 and younger who received either Moderna or Pfizer-BioNTech
COVID-19 vaccines, particularly following the second dose. 78 Through follow-up,
including medical record reviews, the FDA and CDC had confirmed 699 cases of
myocarditis or pericarditis. 79
• On July 13, 2021, FDA required revisions to the vaccine recipient and vaccination
provider fact sheets for the Janssen COVID-19 Vaccine to include information pertaining
to a suggested increased risk of Guillain-Barré Syndrome (GBS) during the 42 days
following vaccination. Based on an analysis of Vaccine Adverse Event Reporting
(VAERS) data, at that time, there had been 100 reports of presumptive GBS following
vaccination with the Janssen vaccine after approximately 12.5 million doses
administered. Of these reports, 95 of them were serious and required hospitalization.
There was one reported death. As noted in the Janssen Fact Sheet for Healthcare
Providers Administering Vaccine, because these reactions are reported voluntarily, it is
not always possible to reliably estimate their frequency or establish a causal relationship
to vaccine exposure. Each year in the United States, an estimated 3,000 to 6,000 people
develop GBS. Most people fully recover from the disorder. FDA publicly presented this
issue, and information regarding these 100 reports of presumptive GBS, to the ACIP on
July 22, 2021. 80
During each of these post-authorization reviews and labeling changes, the FDA has evaluated the
available post-authorization information for the authorized COVID-19 Vaccines and continues to
find the known and potential benefits clearly outweigh the known and potential risks.
78
CDC, COVID-19 Reported Adverse Events, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/safety/adverse-events.html.
79
Id.
80
FDA, CDC ACIP Meeting Presentation, Guillain-Barré Syndrome (GBS) after Janssen COVID-19 Vaccine:
Vaccine Adverse Event Reporting System (VAERS), July 22, 2021,
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/02-COVID-Alimchandani-508.pdf.
27
iv. Petitioner’s Claims Regarding

Anaphylaxis
Petitioner cites to a study of acute allergic reactions to mRNA COVID-19 vaccines in support of
their argument that adverse event rates for COVID-19 vaccines have been miscalculated by
CDC. 81 As stated above, questions relating to CDC are best directed to that Agency. We note,
however, that this journal article states, immediately after the sentence quoted by Petitioner,
“[h]owever, the overall risk of anaphylaxis to an mRNA COVID-19 vaccine remains extremely
low and largely comparable to other common health care exposures. Although cases were
clinically compatible with anaphylaxis, the mechanism of these reactions is unknown.” The
paper further states, in describing the limitations of the study, that “[a] northeastern US cohort
may not be generalizable.” Thus, Petitioner is inappropriately generalizing the results of this
study in an attempt to compare the results to the CDC’s reported data and conclude that the
safety of COVID vaccines is “considerably worse than it currently appears.” Petition at 4.
Additionally, we note that the authorized labeling for all the Authorized COVID-19 vaccines
already contain warnings regarding the risk of anaphylaxis as a potential adverse event. Thus,
the risk of anaphylaxis is a potential safety issue FDA is already aware of, and Petitioner’s
argument, and the article submitted in support of this argument, does not change FDA’s
conclusions regarding the safety of the Authorized COVID-19 vaccines.
v. Animal Toxicology and

Pharmacokinetic Studies of COVID-
19 Vaccines
Petitioner raises concerns regarding FDA’s vaccine safety assessment. Specifically, Petitioner
states that other “problems with vaccine safety assessment may exist because of inadequate
animal toxicology and pharmacokinetic studies of COVID vaccines.” Petition at 5; emphasis
added. As an initial matter, we note that Petitioner’s concerns regarding the vaccine safety
assessment for COVID-19 vaccines involves speculation regarding whether problems actually
exist (“problems with vaccine safety assessment may exist . . .”), and Petitioner fails to point to
any specific problems that result or may result from the allegedly inadequate studies.
Regarding Petitioner’s claims, in general, when evaluating the safety data regarding a vaccine,
FDA considers data from animal studies (if such pre-clinical studies were performed) as one part
of the full body of evidence regarding the vaccine. In addition to data from animal studies, if
available, FDA evaluates data from in vitro studies and conducts a safety assessment of data
from clinical studies.
Thus, although Petitioner raises several concerns and cites to several articles regarding risks of
COVID-19 vaccination, FDA is not aware of any information indicating that the known and
potential benefits of the Authorized COVID-19 Vaccines are outweighed by their known and
potential risks, nor has Petitioner provided any such information in the Petition. Therefore, the
81
Blumenthal KG, Robinson LB, Camargo CA, et al., Acute Allergic Reactions to mRNA COVID-19 Vaccines,
JAMA. 2021;325(15):1562–1565. doi:10.1001/jama.2021.3976,
https://jamanetwork.com/journals/jama/fullarticle/2777417.
28
criterion under section 564(c)(2)(B) continues to be met with respect to the Authorized COVID-
19 Vaccines.
4. No Alternatives
As noted above, Petitioner requests that “FDA should revoke all EUAs and refrain from
approving any future EUA . . . for any COVID vaccine for all demographic groups because the
current risks of serious adverse events or deaths outweigh the benefits, and because existing,
approved drugs provide highly effective prophylaxis and treatment against COVID, mooting the
EUAs.” Petition at 1. Section 564(c)(3) of the FD&C Act provides one of the required statutory
factors that must be met in order for a product to be granted an EUA. This statutory provision
requires that “there is no adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating [the serious or life-threatening disease or condition].” 82 To
the extent Petitioner’s contention can be interpreted as an argument that there are adequate,
approved, available drugs indicated for the prevention of COVID-19 (and that therefore the
requirement in section 564(c)(3) of the FD&C Act that there is no “adequate, approved, and
available alternative to the Authorized COVID-19 Vaccines for preventing COVID-19 is not
met), this argument is erroneous.
As explained in the Decision Review Memoranda for the Authorized COVID-19 Vaccines, at the
time each COVID-19 vaccine EUA was issued, there were no FDA-approved drugs or biological
products indicated to prevent COVID-19 in any population because no vaccine or other medical
product was the subject of an approved marketing application for prevention of COVID-19. 83
This is still true today, with the exception of the BLA for BioNTech’s COVID-19 vaccine
(COVID-19 Vaccine, mRNA; Comirnaty), which is now approved for the prevention of
coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) in individuals 16 years of age and older. The EUA for Pfizer-BioNTech
COVID-19 Vaccine remains in effect. This EUA will continue to cover individuals 12 through
15 years of age, to cover the administration of a third dose to certain immunocompromised
individuals 12 years of age and older, and to cover individuals 16 years of age and older until
sufficient approved vaccine can be manufactured and distributed. Similarly, the EUA for the
Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine remain in effect for
individuals 18 years of age and older. Although FDA has approved one new drug application
(NDA) for remdesivir for use in adult and pediatric patients 12 years of age and older and
weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalization, this
drug is not for prevention of COVID-19. Several other therapies are currently available under
EUA, but not FDA approved, for treatment of COVID-19, and one is available under EUA, but
not FDA approved, for post-exposure prophylaxis in a limited population. These products that
are available under EUA are not considered “approved” products for purposes of section
82
The term “approved,” for purposes of section 564(c) of the FD&C Act, means a product is approved, licensed, or
cleared by FDA under section 505, 510(k), or 515 of the FD&C Act or section 351 of the PHS Act, as applicable,
and this term is indication-specific. See, section 564(a)(2) of the FD&C Act. See also, EUA guidance at 3.
83
FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Decision Memorandum (Dec. 11, 2020), at 8-9,
29
564(c)(3) because they are not the subject of an approved marketing application (i.e., they are not
approved under an NDA or BLA).
Thus, Petitioner’s assertion that the EUAs for the Authorized COVID-19 Vaccines are “mooted”
by the existence of drugs approved to prevent COVID-19 is incorrect.
5. No Other Circumstances Make A Revision or

Revocation Appropriate to Protect the Public
Health or Safety
As noted above, section 564(g)(2)(C) of the FD&C Act provides that FDA may revise or revoke
an EUA if circumstances justifying its issuance (under section 564(b)(1)) no longer exist, the
criteria for its issuance are no longer met, or other circumstances make a revision or revocation
appropriate to protect the public health or safety. The EUA guidance explains that such other
circumstances may include:
significant adverse inspectional findings (e.g., when an inspection

of the manufacturing site and processes has raised significant
questions regarding the purity, potency, or safety of the EUA
product that materially affect the risk/benefit assessment upon
which the EUA was based); reports of adverse events (number or
severity) linked to, or suspected of being caused by, the EUA
product; product failure; product ineffectiveness (such as newly
emerging data that may contribute to revision of the FDA's initial
conclusion that the product "may be effective" against a particular
CBRN agent); a request from the sponsor to revoke the EUA; a
material change in the risk/benefit assessment based on evolving
understanding of the disease or condition and/or availability of
authorized MCMs; or as provided in section 564(b)(2), a change in
the approval status of the product may make an EUA
unnecessary. 84
As of the date of this writing, FDA has not identified any such circumstances that would make
revocation of any of the Authorized COVID-19 Vaccines appropriate to protect the public health
or safety. As stated previously in this response, FDA determined the EUA standard is met for
the three authorized COVID-19 vaccines because data submitted by the sponsors demonstrated
in a clear and compelling manner that the known and potential benefits of these products, when
used to prevent COVID-19, outweigh the known and potential risks of these products, and that
there is no adequate, approved, and available alternative to the product for diagnosing,
preventing, or treating COVID-19.
As described in detail in section III.b.i.1.b above, FDA has identified circumstances that have
made revision of the EUAs for the Authorized COVID-19 Vaccines appropriate, and,
84
EUA Guidance at 29.
30
accordingly, has required changes to the authorized labeling for the Authorized COVID-19
Vaccines. 85
Additionally, as explained above, FDA finds no basis in the information submitted in the
Petition, or in any postmarket data regarding the Authorized COVID-19 Vaccines, to support a
revocation of any of these EUAs, nor has Petitioner provided any such information in the
Petition. FDA is not aware of any information indicating that the known and potential benefits
of the Authorized COVID-19 Vaccines are outweighed by their known and potential risks, nor
has Petitioner provided any such information in the Petition. Furthermore, there are no other
circumstances that make a revision or revocation appropriate to protect the public health or
safety, nor has Petitioner provided any information about such circumstances.
FDA therefore sees no justifiable basis upon which to take any action based on Petitioner’s
request with respect to the any of the Authorized COVID-19 Vaccines. Accordingly, as noted
above, we deny Petitioner’s request for FDA to “revoke all EUAs . . . for any COVID vaccine
for all demographic groups because existing, approved drugs provide highly effective
prophylaxis and treatment against COVID, mooting the EUAs.”
2. Petitioner’s Request to Refrain from Granting any Future

EUA for a COVID-19 Vaccine for any Population Because
Approved Drugs Exist for COVID-19 Prevention
Petitioner also requests in the Petition that FDA “refrain from approving any future EUA . . . for
any COVID vaccine for all demographic groups because the current risks of serious adverse
events or deaths outweigh the benefits, and because existing, approved drugs provide highly
effective prophylaxis and treatment against COVID, mooting the EUAs.” 86 Petition at 1.
Petitioner has provided no evidence that would provide a basis for FDA to conclude that no
future COVID-19 vaccine candidate could meet the EUA standard. Indeed, FDA is not aware of
any information indicating that the known and potential benefits of the Authorized COVID-19
Vaccines are outweighed by their known and potential risks, nor has Petitioner provided any
such information in the Petition.
Additionally, as explained above in section III.b.i.1.b. of this letter, to the extent Petitioner’s
contention can be interpreted as an argument that there are FDA-approved drugs indicated for the
prevention of COVID-19 (and that therefore the requirement in section 564(c)(3) of the FD&C
Act that there is no “adequate, approved, and available alternative” could not be met), this
85
FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Amendment Decision Memorandum for Authorization in
Individuals 12 -15 Years of Age (May 10, 2021), Section 4.6, EUA Prescribing Information and Fact Sheets,
Decision Memorandum for Authorization of an Additional Dose in Certain Immunocompromised Individuals
(August 12, 2021), https://www.fda.gov/media/151613/download; FDA, Moderna COVID-19 Vaccine EUA
Amendment Decision Memorandum for Authorization of an Additional Dose in Certain Immunocompromised
Individuals (August 12, 2021), https://www.fda.gov/media/151611/download.
86
FDA authorization of an EUA request is not FDA approval. FDA does not “approve” an EUA request. Rather,
FDA authorizes the emergency use of a product following review of data and information submitted in an EUA
request.
31
argument fails. Should FDA receive future requests for EUAs for COVID-19 vaccine
candidates, FDA would consider such requests on a case-by-case basis. 87 Accordingly,
Petitioner’s request is denied.
3. Petitioner’s Request to Refrain from Approving any Future

NDA for any COVID-19 Vaccine for any Population
Petitioner’s request regarding “any future…NDA … for any COVID Vaccine for all
demographic groups” is moot because vaccines are biological products subject to licensure under
the PHS Act and are not subject to approval under section 505 of the FD&C Act.
4. Petitioner’s Request to Refrain from Licensing any Future

BLA for any COVID-19 Vaccine for any Population
Petitioner requests that FDA “refrain from approving any future . . . BLA for any COVID
vaccine for all demographic groups because the current risks of serious adverse events or deaths
outweigh the benefits, and because existing, approved drugs provide highly effective prophylaxis
and treatment against COVID, mooting the EUAs.” Petition at 1. To the extent this request can
be interpreted as asserting that the risks of serious adverse events or deaths associated with any
COVID-19 vaccine would necessarily outweigh the benefits of any COVID-19 vaccine and
therefore FDA should refrain from approving any BLA for any COVID-19 vaccine, this section
explains why this argument is unavailing and why we are denying Petitioner’s request.
To the extent this request can be interpreted as also asserting, in addition to the assertion above,
that, because approved drugs provide effective prophylaxis and treatment of COVID-19, the
approval of a BLA for a COVID-19 vaccine would be “moot,” this section explains why such a
position is flawed and why FDA is not granting this request.
a. Petitioner’s Request that FDA Refrain from Approving

any BLA for any COVID-19 Vaccine because the
Current Risks Outweigh the Benefits
Petitioner requests that FDA “refrain from approving any future BLA . . . for any COVID
vaccine for all demographic groups” because the risks of serious adverse events or deaths
associated with any COVID-19 vaccine outweigh the benefits of any COVID-19 vaccine.
Petitioner has provided no evidence that would provide a basis for FDA to conclude that no
COVID-19 vaccine could meet the BLA approval standard, however. Indeed, FDA has now
approved a BLA for BioNTech’s COVID-19 vaccine (COVID-19 Vaccine, mRNA; Comirnaty)
because, among other things, the data and information in the application demonstrated the safety
and effectiveness of the vaccine. 88 Thus, Petitioner’s request that FDA refrain from approving
any BLAs for COVID-19 vaccines is denied.
87
FDA has issued guidance describing factors the Agency intends to use in determining how to prioritize EUA
requests for COVID-19 vaccine candidates. See October 2020 Guidance at 5 (citing EUA Guidance at 18-20).
88
See FDA's Summary Basis for Regulatory Action (SBRA) for the BioNTech BLA. This memorandum will be
posted on www.fda.gov.
32
In Appendix I to this letter, we have provided additional background information about FDA’s
regulatory framework for the review of vaccine BLAs.
b. Petitioner’s Request that FDA Refrain from Approving

any BLA for any COVID-19 Vaccine because the
Current Risks Outweigh the Benefits and because
Currently-Approved Drugs are Effective in Preventing
COVID-19
To the extent Petitioner is arguing that FDA should also refrain from approving a BLA for any
COVID-19 vaccine because of the existence of FDA-approved drugs that are effective in
preventing COVID-19, this argument is unavailing. As described above in section III.b.i.1, there
are no FDA-approved drugs that are effective in preventing COVID-19 (other than
BioNTech’sCOVID-19 vaccine [COVID-19 Vaccine, mRNA; Comirnaty], which is now
approved for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of
age and older.).
For the reasons outlined in this section, FDA denies Petitioner’s requests to refrain from
licensing any BLAs for a COVID-19 vaccine.
ii. Petitioner’s Requests Regarding COVID-19 Vaccines in Children
1. Request to Immediately Refrain from Allowing COVID-19

Vaccine Trials to Include Pediatric Subjects
In the Petition, Petitioner requests that FDA “immediately refrain from allowing minors to
participate in COVID vaccine trials . . . .” Petition at 1. To the extent that the Petition can be
interpreted to request that FDA suspend any COVID-19 vaccine clinical trial that includes
pediatric subjects, this section explains why FDA is not at this time ordering that these clinical
trials be suspended.
As explained above in section III.a., with certain exceptions, clinical investigations in which a
drug is administered to human subjects must be conducted under an IND submitted to FDA by
the sponsor. FDA’s review of an IND includes a review of the study protocol which describes,
among other things, the design of the clinical study, including the identified endpoints and
methods for assessing the safety and effectiveness of the investigational product. The Petition
requests that FDA adopt a universal approach toward all clinical trials of COVID-19 vaccines.
Under FDA’s regulations, however, the Agency examines each Investigational New Drug (IND)
Application individually and considers the IND in the context of the standards in the regulation.
The FD&C Act provides a specific mechanism, called a “clinical hold,” for prohibiting sponsors
of clinical investigations from conducting the investigation (section 505(i)(3) of the FD&C Act;
21 U.S.C. 355(i)(3)). FDA’s implementing regulations in 21 CFR 312.42 identify the
circumstances that may justify a clinical hold. In this section of this letter, we explain why, at
this time, FDA has not granted Petitioner’s request to place all proposed or ongoing studies of
COVID-19 vaccines enrolling pediatric subjects on clinical hold under 21 CFR 312.42(b).
33
The grounds for placing a proposed or ongoing study, including an ongoing Phase 3 study, on
clinical hold are provided in 21 CFR 312.42(b). Specifically, 21 CFR 312.42(b)(1)(i) through
(b)(1)(v) provides grounds for imposition of a clinical hold of a Phase 1 study. Additionally, as
stated in 21 CFR 312.42(b)(2), FDA may place a proposed or ongoing Phase 2 or 3 investigation
on clinical hold if it finds that: (i) any of the conditions in 21 CFR 312.42(b)(1)(i) through
(b)(1)(v) apply; or (ii) the plan or protocol for the investigation is clearly deficient in design to
meet its stated objectives. As indicated in more detail below, at this time, FDA has not granted
Petitioner’s request to place all proposed or ongoing studies of COVID-19 vaccines enrolling
pediatric subjects on clinical hold under 21 CFR 312.42(b).
• 21 CFR 312.42(b)(1)(i): Human subjects are or would be exposed to an unreasonable

and significant risk of illness or injury.
FDA continues to evaluate all available information and, based on this evaluation
thus far, does not believe that human subjects in any COVID-19 vaccine study
that includes pediatric subjects are or would be exposed to an unreasonable and
significant risk of illness or injury. The Agency reviews the protocols for
COVID-19 vaccine clinical trials proposing to enroll pediatric subjects when they
are submitted to the IND, in addition to any subsequent protocol amendments. For
those clinical trials that have proceeded to studying COVID-19 vaccines in
pediatric populations, FDA has determined that, based on all information
currently available to FDA, the studies do not expose subjects to unreasonable
risks.
• 21 CFR 312.42(b)(1)(ii): The clinical investigators named in the IND are not
qualified by reason of their scientific training and experience to conduct the
investigation described in the IND.
The Petitioner has not provided evidence and FDA is currently aware of no other
information indicating that clinical investigators named in the IND for any
COVID-19 vaccine clinical trial including pediatric subjects are not qualified by
reason of their scientific training and experience to conduct the investigation
described in the INDs.
• 21 CFR 312.42(b)(1)(iii): The investigator brochure is misleading, erroneous, or

materially incomplete.
information indicating that the investigator brochures for any ongoing COVID-19
vaccine investigation which includes or proposes to include pediatric subjects are
misleading, erroneous, or materially incomplete.
• 21 CFR 312.42(b)(1)(iv): The IND does not contain sufficient information required
under 312.23 to assess the risks to subjects of the proposed studies.
information indicating that the IND for any ongoing COVID-19 vaccine in which
34
pediatric subjects are enrolled contains insufficient information required under 21

CFR 312.23 to assess the risks to pediatric subjects participating in the studies.
• 21 CFR 312.42(b)(1)(v) [provides, in part, that]: The IND is for the study of an
investigational drug intended to treat a life-threatening disease or condition that
affects both genders, and men or women with reproductive potential who have the
disease or condition being studied are excluded from eligibility because of a risk or
potential risk from use of the investigational drug of reproductive toxicity (i.e.,
affecting reproductive organs) or developmental toxicity (i.e., affecting potential
offspring)….
information indicating that any COVID-19 vaccine studies enrolling pediatric
subjects are excluding from eligibility men or women – including male and
female adolescents and teenagers - with reproductive potential.
• 21 CFR 312.42(b)(2)(ii): The plan or protocol for the Phase 2 or Phase 3 investigation
is clearly deficient in design to meet its stated objectives.
The Agency reviewed the protocols for the COVID-19 vaccine investigations
involving pediatric subjects at the time they were submitted to the INDs, as well
as any subsequent amendments as they were submitted, and has determined that
the study designs meets their stated objectives.
At this time, the Agency is aware of no information to indicate that the protocols
for any ongoing clinical investigations of COVID-19 vaccines involving pediatric
subjects are clearly deficient in design to meet their stated objectives.
FDA has reviewed the issues raised in the Petition relating to the request to “immediately refrain
from allowing minors to participate in COVID vaccine trials.” Petition at 1. For the reasons
outlined above, and in light of information currently available to FDA, FDA has determined that
grounds do not exist to grant Petitioner’s request to place all COVID-19 vaccine clinical
investigations involving pediatric subjects on clinical hold pursuant to 21 CFR 312.42.
2. Request that FDA Refrain from Issuing EUA Amendments for

Authorized COVID-19 Vaccines to Include Indications for
Pediatric Populations
The Petition requests, among other things, that “[g]iven the extremely low risk of COVID illness
in children, FDA should . . . immediately refrain from amending EUAs to include children. . . .”
Petition at 1. To the extent that the Petition requests that FDA refrain from issuing EUA
amendments for any of the Authorized COVID-19 Vaccines to include an indication for use in
pediatric populations, this section explains why FDA is not granting this request.
In determining whether to issue an EUA for a product, including an amendment to an EUA in
order to include additional populations within the indication, the FDA evaluates the available
evidence and assesses, among other things, any known or potential risks and any known or
potential benefits. Once a manufacturer submits an EUA request for a COVID-19 vaccine, the
FDA then evaluates the request and determines whether the relevant statutory criteria are met,
35
taking into account the totality of the scientific evidence about the vaccine that is available to the
agency.
As noted in Section II.b. above, in the October 2020 Guidance, FDA provided recommendations
that describe key information that would support issuance of an EUA for a vaccine to prevent
COVID-19. 89 In this guidance, FDA explained that, in the case of such vaccines, any assessment
regarding an EUA will be made on a case-by-case basis considering the target population, the
characteristics of the product, the preclinical and human clinical study data on the product, and
the totality of the available scientific evidence relevant to the product. 90 FDA has also stated, in
this guidance, that for a COVID-19 vaccine for which there is adequate manufacturing
information to ensure its quality and consistency, issuance of an EUA would require a
determination by FDA that the vaccine’s benefits outweigh its risks based on data from at least
one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a
clear and compelling manner. 91
a. Information Submitted by Petitioner Regarding the Safety

of COVID-19 Vaccines in Pediatric Populations
Petitioner argues that, for children, the risks of COVID-19 vaccines outweigh the benefits
because the risk of severe COVID in children is “extremely low.” Petition at 1. Petitioner cites
to several sources of information in support of this argument (Petition at 12-13), which FDA has
reviewed and considered.
Petitioner cites to CDC data 92 regarding death rates of children in the United States due to
COVID-19 and compares the number of children who have died involving COVID-19 to the
number of Americans of all ages who have died of COVID-19. Petitioner’s approach of simply
comparing raw numbers of deaths involving COVID-19 in the U.S. pediatric population against
the raw numbers of deaths involving COVID-19 in the overall U.S. population (all sexes and all
ages), does not provide a sufficient scientific basis upon which to conclude, as Petitioner
contends, that the “relative risk for children due to COVID is very low.” Petition at 12.
Additionally, as discussed in further detail below, based on available data and information, we
have concluded that COVID-19 is a serious or life-threatening disease or condition in the 12-17
age group.
As a preliminary matter, we note that petitioner’s claim that “the death rate following either
vaccination in this age group, assuming these children were trial enrollees, is approximately 2 in
2,000 or 0.1%.” (Petition at 13) is erroneous. Our review of the submitted clinical trial data
associated with the Pfizer-BioNTech COVID-19 Vaccine has not identified any deaths among
adolescent or young adult vaccinees. 93 Additionally, as described in a NEJM article regarding
89
October 2020 Guidance at 6-7.
90
Id. at 3.
91
Id. at 4.
92
CDC, National Center for Health Statistics, Weekly Updates by Select Demographic and Geographic
Characteristics, https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#SexAndAge.
93
https://www.fda.gov/media/144416/download (stating that there were two deaths in vaccine recipients, both >55
years of age). FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Amendment Decision Memorandum for
36
the Moderna COVID-19 vaccine, no deaths were reported among vaccine recipients enrolled in
the clinical trial of Moderna COVID-19 Vaccine. 94 Investigational New Drug (IND) application
sponsors are required to notify FDA in a written safety report of any adverse experience
associated with the use of the drug that is both serious and unexpected. 95 Any death that occurs
in a vaccine clinical trial therefore must be reported to FDA and is then thoroughly evaluated by
FDA to determine the cause and whether or not the death is plausibly related to the vaccine.
Additionally, we note that Petitioner raised concerns regarding VAERS reports in arguing that
COVID-19 vaccines should not be authorized for pediatric populations because, Petitioner
argues, “[a]vailable evidence strongly suggests that the vaccine is much more dangerous to
children than the disease.” Petition at 12. VAERS data reviewed to date has not identified risks
related to vaccination that would cause the Agency to change its view that the benefits of
vaccination with the Pfizer-BioNTech COVID-19 vaccine outweigh the risks of vaccination in
individuals 12-17 years of age. VAERS data is evaluated thoroughly, and as described in greater
detail above, FDA acts on safety signals. VAERS reports, however, are not used in isolation to
draw an association between a vaccine and a possible adverse event.
Finally, we note that petitioner cites to an opinion piece published in the British Medical Journal,
which presents the authors’ opinion that the benefits of COVD-19 vaccination are outweighed by
its risks in pediatric populations. 96 FDA has reviewed this article and determined it does not
present evidence that the EUA standard could not be met for pediatric populations. Indeed, as
explained in the FDA Decision Memorandum for the Pfizer-BioNTech COVID-19 Vaccine
EUA, based on FDA’s review of all available data regarding the benefits and risks of the use of
the Pfizer-BioNTech COVID-19 vaccine in individuals 12 through 17 years of age, we have
determined that this EUA meets the statutory criteria for individuals in this age range. 97
Petitioner has failed to present data demonstrating that, for children, the risks of COVID-19
vaccines outweigh their benefits because the risk of severe COVID in children is “extremely
low.” Petition at 1. As explained in this section, the information submitted by Petitioner does
not support this contention. As explained in further detail below, data reviewed by the Agency
demonstrates that the Pfizer-BioNTech COVID-19 Vaccine, which is authorized for use in
individuals 12 years of age and older, continues to demonstrate that the known and potential
benefits of this vaccine outweigh its known and potential risks in this population. Any other
EUA requests for COVID-19 vaccine candidates for use in pediatric populations will be
reviewed on a case-by-case basis under the applicable statutory standards. Therefore, we deny
Authorization in Individuals 12-15 Years of Age (May 10, 2021), https://www.fda.gov/media/148542/download

(stating that there were no deaths among vaccine recipients 12-15 years of age during the follow-up period).
94
K. Ali, et al., Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents, NEJM (Aug. 11, 2021), DOI:
10.1056/NEJMoa2109522, https://www.nejm.org/doi/10.1056/NEJMoa2109522.
95
21 CFR § 312.32(c)(1)(i).
96
W. Pegden, V. Prasad, S. Baral, Covid vaccines for children should not get emergency use authorization, BMJ
(May 7, 2021), https://blogs.bmj.com/bmj/2021/05/07/covid-vaccines-for-children-should-not-get-emergency-use-
authorization/.
97
37
Petitioner’s request to refrain from amending any EUA for a COVID-19 vaccine to include a
pediatric indication.
3. Request that FDA Immediately Revoke all EUAs for COVID-
19 Vaccines with Pediatric Indications
Petitioner requests that FDA “immediately revoke all EUAs that permit vaccination of children
under 16 for the Pfizer vaccine and under 18 for other COVID vaccines.” Petition at 1.
Currently, only the Pfizer-BioNTech COVID-19 vaccine is indicated for the prevention of
COVID-19 in pediatric populations. This vaccine is indicated for individuals 12 years of age and
older. As explained in section III.B.i.1.b above, in addressing this request, it is necessary to
consider the EUA revocation standard provided in section 564(g)(2) of the FD&C Act. In this
section, we assess whether any of these statutory conditions under which FDA may revoke an
EUA are met with respect to the pediatric indication for the Pfizer-BioNTech COVID-19
Vaccine EUA and explain why the EUA revocation standard is not met for this vaccine.
a. Standard for Revocation of EUAs is not Met for the

Authorized COVID-19 Vaccines with Pediatric Indications
As explained above in section III.b.i.1.b of this letter, Section 564(g)(2) of the FD&C Act
provides the standard for revocation of an EUA. Under this statutory authority, FDA may revise
or revoke an EUA if:
(A) the circumstances described under [section 564(b)(1) of the FD&C Act] no longer
exist;
(B) the criteria under [section 564(c) of the FD&C Act] for issuance of such authorization
are no longer met; or
(C) other circumstances make such revision or revocation appropriate to protect the
public health or safety.
As explained above in section II.b., the EUA Guidance notes that once an EUA is issued for a
product, in general, that EUA will remain in effect for the duration of the EUA declaration under
which it was issued, “unless the EUA is revoked because the criteria for issuance . . . are no
longer met or revocation is appropriate to protect public health or safety (section 564(f),(g) [of
the FD&C Act]).” 98
i. Circumstances Continue to Justify the Issuance

of the EUAs for the Authorized COVID-19
Vaccine with Pediatric Indications
As explained in detail above in section III.b.i.1.b., section 564(b)(2) of the FD&C Act sets forth
the statutory standard for termination of an EUA declaration. This provision provides that an
EUA declaration remains in place until the earlier of: (1) a determination by the HHS Secretary,
in consultation with the Secretary of Defense, that the circumstances that precipitated the
declaration have ceased or (2) a change in the approval status of the product such that the
authorized use(s) of the product are no longer unapproved. Neither of those statutory criteria is
98
EUA Guidance at 28.
38
satisfied with respect to the Authorized COVID-19 Vaccine with a pediatric indication. Thus,
the circumstances described under section 564(b)(1) of the FD&C Act continue to exist. FDA
therefore is not revoking the EUA for the Authorized COVID-19 vaccine with a pediatric
indication under the authority in section 564(g)(2)(A) of the FD&C Act.
1. The Criteria for The Issuance of the

Authorized COVID-19 Vaccine with
Pediatric Indications Continues to Be Met
This section describes in detail why the criteria under section 564(c) of the FD&C Act continue
to be met with respect to the pediatric indication for the Pfizer-BioNTech COVID-19 Vaccine
EUA and why, therefore, FDA may not revoke this EUA under the authority in section
564(g)(2)(B) of the FD&C Act.
a. Serious or life-threatening disease

or condition.
As explained above in section III.b.i.1 of this letter, section 564(c)(1) of the FD&C Act requires
that, for an EUA to be issued for a medical product, “the agent(s) referred to in [the HHS
Secretary’s EUA declaration] can cause a serious or life-threatening disease or condition.” FDA
has concluded that SARS-CoV-2, which is the subject of the EUA declaration, meets this
standard. FDA is not aware of science indicating that there is any change in the ability of the
SARS-CoV-2 virus to cause a serious or life-threatening disease or condition, namely COVID-
19, nor has Petitioner provided any information about such a change.
The SARS-CoV-2 pandemic continues to present an extraordinary challenge to global health

and, as of August 3, 2021, has caused more than 199 million cases of COVID-19 and claimed the
lives of more than 4.2 million people worldwide. 99 In the United States, more than 34 million
cases and over 611,000 deaths have been reported to the CDC. 100 On January 31, 2020, the U.S.
Secretary of Health and Human Services (HHS) declared a public health emergency related to
COVID-19 and mobilized the Operating Divisions of HHS, and the U.S. President declared a
national emergency in response to COVID-19 on March 13, 2020. Additional background
information on the SARS-CoV-2 virus and COVID-19 pandemic may be found in FDA Decision
Memoranda for the Authorized COVID-19 Vaccines. 101
Since March 1, 2020, approximately 1.7 million COVID-19 cases in individuals 12 to 17 years
of age have been reported to the Centers for Disease Control and Prevention (CDC). Among
these cases approximately 11,700 resulted in hospitalization, with more than 691 ICU admissions
99
Johns Hopkins University School of Medicine, Coronavirus Resource Center,
https://coronavirus.jhu.edu/map.html.
100
CDC, COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.
101
(Dec. 18, 2020), https://www.fda.gov/media/144673/download; FDA, Janssen COVID-19 Vaccine EUA Decision
Memorandum (Feb. 27, 2021), https://www.fda.gov/media/146338/download.
39
and more than 100 deaths. It is difficult to estimate the incidence of COVID-19 among children
and adolescents because they are frequently asymptomatic and infrequently tested. Children and
adolescents appear less susceptible to SARS-CoV-2 infection and have a milder COVID-19
disease course as compared with adults. However, as with adults, children and adolescents with
underlying conditions such as asthma, chronic lung disease, and cancer are at higher risk than
their heathier counterparts for COVID-19-related hospitalization and death. Of the children who
have developed severe illness from COVID-19, most have had underlying medical conditions.
Multisystem inflammatory syndrome in children (MIS-C) is a rare but serious COVID-19-
associated condition that can present with persistent fever, laboratory markers of inflammation
and heart damage, and, in severe cases, hypotension and shock. As of June 28, 2021, the CDC
received reports of 4196 cases and 37 deaths that met the definition for MIS-C.
Both FDA and CDC have convened advisory committee meetings to discuss the use of COVID-
19 vaccines in pediatric populations. Overall, these advisory committees agreed that there is a
serious risk of severe COVID-19 in the pediatric population. In particular, the June 23, 2021
ACIP meeting discussed the benefits and risks of the use of COVID-19 mRNA vaccines in
adolescents and young adults. 102 This discussion raised the point that adolescents and young
adults have the highest COVID-19 incidence rates, and that these populations are an increasing
proportion of COVID-19 cases reported. COVID-19-associated deaths continue to occur in these
populations; since April 2021, 316 deaths have been reported among persons aged 12-29 years.
Additionally, post-COVID conditions -- such as Multisystem Inflammatory Syndrome in
Children (MIS-C) and Multisystem Inflammatory Syndrome in Adults (MIS-A) -- can occur in
these populations following COVID-19.
Therefore, the criterion under section 564(c)(1) continues to be met with respect to the
Authorized COVID-19 Vaccines with Pediatric Indications.
b. Evidence of Effectiveness
As explained above in section III.b.i.1.b of this letter, Section 564(c)(2)(A) of the FD&C Act
requires that, for an EUA to be issued for a medical product, FDA must conclude “based on the
totality of scientific evidence available to the Secretary, including data from adequate and well-
controlled trials, if available, it is reasonable to believe that the product may be effective to
prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused
by SARS-CoV-2.” FDA has determined that based on the totality of scientific evidence
available, including data from adequate and well-controlled trials, it is reasonable to believe that
the Pfizer-BioNTech COVID-19 vaccine may be effective to prevent, diagnose, or treat such
serious or life-threatening disease or condition in the 12 through 17 years of age population. 103
The basis for this determination is explained in detail in FDA’s decision memoranda regarding
102
CDC, Megan Wallace and Sara Oliver, CDC ACIP Meeting Presentation, COVID-19 mRNA Vaccines in
Adolescents and Young Adults: Benefit-Risk Discussion, (June 23, 2021),
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/05-COVID-Wallace-508.pdf; CDC, ACIP
Meeting Slides, (June 23, 2021), https://www.cdc.gov/vaccines/acip/meetings/slides-2021-06.html.
103
40
the Pfizer BioNTech COVID-19 Vaccine EUA. 104 Section III.b.ii of this letter explains why
Petitioner’s arguments regarding the effectiveness of the Authorized COVID-19 Vaccines, and
the information submitted by Petitioner in support of this argument, does not change FDA’s
analysis regarding the effectiveness of the Pfizer-BioNTech COVID-19 vaccine in individuals 12
through 17 years of age.
Therefore, the criterion under section 564(c)(2)(A) continues to be met with respect to the
Authorized COVID-19 Vaccines.
c. Benefit-Risk Analysis
Section 564(c)(2)(B) of the FD&C Act requires that, for an EUA to be issued for a medical
product, FDA must conclude “the known and potential benefits of the product, when used to
diagnose, prevent, or treat [the identified serious or life-threatening disease or condition],
outweigh the known and potential risks of the product . . . .” Petitioner argues that the current
risks of serious adverse events or deaths associated with the authorized COVID-19 vaccines
outweigh the benefits of COVID-19 vaccines in the pediatric population. Section III.b.i.1.b.ii
above addresses these arguments insofar as they apply to the Authorized COVID-19 Vaccines
generally and explains why they are unavailing. Section III.b.ii above addresses Petitioner’s
arguments regarding the safety of COVID-19 vaccines in the pediatric population, and explains
why the information submitted by Petitioner does not change FDA’s analysis regarding the
benefits and risks of the authorized COVID-19 vaccines in the pediatric population.
d. No Alternatives
Section 564(c)(3) of the FD&C Act provides one of the required statutory factors that must be
met in order for a product to be granted an EUA. This statutory provision requires that “there is
no adequate, approved, and available alternative to the product for diagnosing, preventing, or
treating [the serious or life-threatening disease or condition].” To the extent Petitioner’s
contention can be interpreted as an argument that there are FDA-approved drugs indicated for the
prevention of COVID-19 in pediatric populations (and that therefore the requirement in section
564(c)(3) of the FD&C Act is not met with respect to the Authorized COVID-19 Vaccine with a
pediatric indication), this argument is erroneous.
As described above in section III.b.i.1.b, there are no FDA-approved drugs or biological products
indicated to prevent COVID-19 in any population, other than the newly-approved BioNTech
COVID-19 vaccine (COVID-19 Vaccine, mRNA; Comirnaty). That vaccine is approved for the
prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. 105
The EUA for Pfizer-BioNTech COVID-19 Vaccine remains in effect to cover those 12 through
104
105
FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Decision Memorandum (Dec. 11, 2020), at 8-9,
41
15 years of age, the administration of a third dose to certain immunocompromised individuals 12

years of age and older, and until sufficient approved vaccine can be manufactured and distributed
for use in those 16 years of age and older. Similarly, the EUA for the Moderna COVID-19
Vaccine and the Janssen COVID-19 Vaccine remain in effect for individuals 18 years of age and
older. Therefore, there is no adequate, approved, and available alternative to the Authorized
COVID-19 Vaccines for preventing COVID-19.
ii. No Other Circumstances Make A Revision or

Revocation Appropriate to Protect the Public
Health or Safety
As noted above in section III.b.i.1.b of this letter, section 564(g)(2)(C) of the FD&C Act
provides that FDA may revise or revoke an EUA if circumstances justifying its issuance (under
section 564(b)(1)) no longer exist, the criteria for its issuance are no longer met, or other
circumstances make a revision or revocation appropriate to protect the public health or safety.
The EUA guidance explains that such other circumstances may include:
significant adverse inspectional findings (e.g., when an inspection

of the manufacturing site and processes has raised significant
questions regarding the purity, potency, or safety of the EUA
product that materially affect the risk/benefit assessment upon
which the EUA was based); reports of adverse events (number or
severity) linked to, or suspected of being caused by, the EUA
product; product failure; product ineffectiveness (such as newly
emerging data that may contribute to revision of the FDA's initial
conclusion that the product "may be effective" against a particular
CBRN agent); a request from the sponsor to revoke the EUA; a
material change in the risk/benefit assessment based on evolving
understanding of the disease or condition and/or availability of
authorized MCMs; or as provided in section 564(b)(2), a change in
the approval status of the product may make an EUA
unnecessary. 106
As of the date of this writing, FDA has not identified any such circumstances that would make
revocation of the pediatric indication for the Pfizer-BioNTech COVID-19 Vaccine EUA
appropriate to protect the public health or safety. As stated previously in this response, FDA
determined the EUA standard is met for the Pfizer-BioNTech COVID-19 Vaccine in individuals
12 through 17 years of age because data submitted by the sponsors demonstrated in a clear and
compelling manner that the known and potential benefits of this vaccine, when used to prevent
COVID-19, outweigh the known and potential risks of this vaccine in individuals 12 through 17
years of age, and that there is no adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating COVID-19 in this population.
As described in detail in section III.b.i.1 above, FDA has identified circumstances that have
made revision of the EUAs for the Authorized COVID-19 Vaccines appropriate, and,
106
EUA Guidance at 29.
42
accordingly, has required changes to the authorized labeling for the Authorized COVID-19
Vaccines. 107
Additionally, as explained above, FDA finds no basis in the information submitted in the
Petition, or in any postmarket data regarding the Pfizer-BioNTech COVID-19 Vaccine, to
support a revocation of the pediatric indication for the Pfizer-BioNTech COVID-19 Vaccine
EUA, nor has Petitioner provided any such information in the Petition. FDA is not aware of any
information indicating that the known and potential benefits of Pfizer-BioNTech COVID-19
Vaccine in the 12-17 years of age population are outweighed by their known and potential risks,
nor has Petitioner provided any such information in the Petition. Furthermore, there are no other
circumstances that make a revision or revocation of the pediatric indication for the Pfizer-
BioNTech COVID-19 Vaccine EUA appropriate to protect the public health or safety, nor has
Petitioner provided any information about such circumstances. FDA therefore sees no justifiable
basis upon which to take any action based on Petitioner’s request with respect to the pediatric
indication for the Pfizer-BioNTech COVID-19 Vaccine EUA. Accordingly, as noted above, we
deny Petitioner’s request that FDA “immediately revoke all EUAs that permit vaccination of
children under 16 for the Pfizer vaccine and under 18 for other COVID vaccines.” Petition at 1.
iii. Petitioner’s Request that FDA Immediately Revoke Tacit Approval that
Pregnant Women may Receive any EUA or Licensed COVID-19
Vaccines and Immediately Issue Public Guidance
Petitioner requests that FDA “immediately revoke tacit approval that pregnant women may
receive any EUA or licensed COVID vaccines and immediately issue public guidance to that
effect.” Petition at 1. Because “tacit approval,” or revocation thereof, is not a concept that exists
in applicable statutes or regulations governing FDA-regulated products, FDA interprets this as a
request that the labeling for the Authorized COVID-19 Vaccines, and any COVID-19 vaccine
that may be licensed in the future, contain a contraindication for use during pregnancy.
In addressing Petitioner’s request for a contraindication, we first discuss the risks posed to
pregnant women by COVID-19. We then provide an explanation of the regulatory framework
for prescription drug labeling for approved and licensed products, including the standard for
inclusion of contraindications in such labeling to inform health care providers of information
such as known hazards in the use of a particular drug as well as the requirements for pregnancy
and lactation information in such labeling. We then discuss labeling for products made available
under an EUA and explain why a contraindication for use in pregnant women was not included
in the labeling for the Authorized COVID-19 Vaccines. This section concludes with an
explanation for why Petitioner’s requests for a contraindication for use during pregnancy in the
labeling for the Authorized COVID-19 Vaccines – and BioNTech’s COVID-19 vaccine
(COVID-19 Vaccine, mRNA; Comirnaty) - is denied.
107
FDA, Pfizer-BioNTech COVID-19 Vaccine EUA Amendment Decision Memorandum for Authorization in
Individuals 12-15 Years of Age (May 10, 2021), https://www.fda.gov/media/148542/download; FDA, Pfizer-
BioNTech COVID-19 Vaccine EUA Amendment Decision Memorandum for Authorization of an Additional Dose
in Certain Immunocompromised Individuals (August 12, 2021), https://www.fda.gov/media/151613/download;
FDA, Moderna COVID-19 Vaccine EUA Amendment Decision Memorandum for Authorization of an Additional
Dose in Certain Immunocompromised Individuals (August 12, 2021),
https://www.fda.gov/media/151611/download; FDA, Janssen COVID-19 Vaccine EUA Decision Memorandum
(Feb. 27, 2021), https://www.fda.gov/media/146338/download.
43
1. COVID-19 in Pregnancy
As a preliminary matter, we note that COVID-19 poses significant risks to pregnant women.
CDC explains that “observational data regarding COVID-19 during pregnancy demonstrate that
pregnant people with COVID-19 have an increased risk of severe illness, including illness
resulting in intensive care admission, mechanical ventilation, extracorporeal membrane
oxygenation, or death, though the absolute risk for these outcomes is low. Additionally, they are
at increased risk of preterm birth and might be at an increased risk of adverse pregnancy
complications and outcomes, such as preeclampsia, coagulopathy, and stillbirth.” 108
2. Certain Content and Format Requirements for Prescription

Drug Labeling for Products Approved Under NDAs or BLAs
As FDA explains in the draft guidance for industry, Pregnancy, Lactation, and Reproductive
Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format,
(“Pregnancy and Lactation Guidance”) “[p]rescription drug labeling is a communication tool. Its
principal objective is to make available to health care providers the detailed prescribing
information necessary for the safe and effective use of a drug, in a manner that is clear and useful
to providers when prescribing for and counseling patients.” 109 In order to achieve this objective,
prescription labeling must be based on scientific data, and it must not be inaccurate, false, or
misleading. 110
FDA regulations govern the content and format of prescription drug labeling for approved drugs
and biological products (see, e.g., §§ 201.56 and 201.57 (21 CFR 201.57); see also 21 CFR
201.100(c)). The regulations are intended to organize labeling information to more effectively
communicate to health care professionals the “information necessary for the safe and effective
use of prescription drugs.” 111 FDA regulations require that the labeling of most prescription drug
products include Highlights of Prescribing Information, which are intended to summarize the
information that is most important for prescribing the drug safely and effectively and to facilitate
access to the more detailed information within product labeling (see § 201.57(a)). FDA
regulations further require that the labeling for most prescription drugs include, among other
information, the following sections: Contraindications; Warnings and Precautions; Adverse
108
CDC, Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States,
Vaccination of Pregnant or Lactating People, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-
19-vaccines-us.html?CDC_AA_refVal=https%3A%2F%2F1.800.gay%3A443%2Fhttps%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-
product%2Fclinical-considerations.html#pregnant.
109
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological
Products - Content and Format Guidance for Industry, Draft Guidance, July 2020, at 2,
110
21 CFR § 201.56(a)(2) “The labeling must be informative and accurate and neither promotional in tone nor false
or misleading in any particular. In accordance with §§ 314.70 and 601.12 of this chapter, the labeling must be
updated when new information becomes available that causes the labeling to become inaccurate, false, or
misleading.”
111
Preamble to final rule, “Requirements on Content and Format of Labeling for Human Prescription Drug and
Biological Products” (71 FR 3922 at 3928, January 24, 2006) (Physician Labeling Rule). For the content and format
requirements for the labeling of older prescription drug products that are not subject to the labeling requirements in
§ 201.57, see § 201.80 (21 CFR 201.80). The specific labeling requirements for older drug products differ in certain
respects, and generally are not referenced in this response.
44
Reactions; and Use in Specific Populations, which includes a subsection on Pregnancy (see §
201.57(c)(1), (5), (6), (7), and (9)(i)).
a. Contraindications
The Contraindications section must describe any situations in which the drug should not be used
because the risk of use “clearly outweighs any possible therapeutic benefit” (§ 201.57(c)(5)).
This section should include observed and anticipated risks, but not theoretical risks. 112 This
could include, for example, a situation where animal data raise substantial concern about the
potential for occurrence of the adverse reaction in humans (e.g., animal data demonstrate that the
drug has teratogenic effects) and those risks do not outweigh any potential benefit of the drug to
any patient. 113
b. Pregnancy
The Pregnancy subsection is located under the Use in Specific Populations section (see §
201.57(c)(9)(i)). On December 4, 2014, FDA issued a final rule amending the regulations on the
requirements for pregnancy and lactation information in prescription drug and biological product
labeling (Pregnancy and Lactation Labeling Rule (PLLR)). 114 The PLLR revisions to the
regulations were intended “to create a consistent format for providing information about the
effects of a drug on pregnancy and lactation that would be useful for decision making by health
care providers and their patients.” 115 The labeling content and format requirements in §
201.57(c)(9)(i), as revised by the PLLR, took effect on June 30, 2015, with a phased
implementation schedule for drugs (including biological products) that are the subject of NDAs,
BLAs, and efficacy supplements that had been approved on or after June 30, 2001. 116 The PLLR
also requires for all human prescription drug and biological products, including those for which
an application was approved before June 30, 2001, that the Pregnancy subsection of labeling be
revised to remove the pregnancy letter categories A, B, C, D, and X. 117
Information in the Pregnancy subsection of labeling may present, in greater detail, a topic that is
briefly summarized in another section of labeling (e.g., Warnings and Precautions). 118 FDA has
explained that when a topic is discussed in more than one section of labeling, the section
containing the most important information relevant to prescribing should typically include a
succinct description and should cross-reference sections that contain additional detail. 119
112
See § 201.57(c)(5); see also FDA guidance for industry, Warnings and Precautions, Contraindications, and
Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format;
Guidance for Industry, October 2011 (Warnings Guidance), at 8, https://www.fda.gov/media/71866/download.
113
See Warnings Guidance at 8.
114
Final rule, “Content and Format of Labeling for Human Prescription Drug and Biological Products;
Requirements for Pregnancy and Lactation Labeling” (PLLR) (79 FR 72064, December 4, 2014),
https://www.federalregister.gov/documents/2014/12/04/2014-28241/content-and-format-of-labeling-for-human-
prescription-drug-and-biological-products-requirements-for.
115
Id. at 72066.
116
See §§ 201.56(b) and 201.57(c)(9)(i).
117
§§ 201.57(c)(9) and 201.80; see also 79 FR 72064 at 72095 (December 4, 2014).
118
PLLR, 79 FR 72064 at 72085 (December 4, 2014).
119
See FDA guidance for industry, Labeling for Human Prescription Drug and Biological Products - Implementing
the PLR Content and Format Requirements; Guidance for Industry, February 2013,
45
Under current labeling requirements, information in the Pregnancy subsection of labeling is

presented under the following subheadings: Pregnancy Exposure Registry; Risk Summary;
Clinical Considerations; and Data. 120 The labeling for the Authorized COVID-19 Vaccines
includes the Pregnancy Exposure Registry and the Risk Summary subheadings. We briefly
describe these subheadings below.
i. Pregnancy Exposure Registry

If there is a scientifically acceptable pregnancy exposure registry for the drug, the labeling must
state that fact and provide contact information needed for enrolling in or obtaining information
about the registry.
ii. Risk Summary

The Risk Summary subheading is required under the Pregnancy subsection because certain
statements must be included even when no product-specific data are available, given that all
pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 121 The Risk
Summary must contain risk statement(s) that describe for the drug the risk of adverse
developmental outcomes based on all relevant human data, animal data, and/or the drug’s
pharmacology. 122 When multiple data sources are available, the risk statements are required to be
presented in the following order: human, animal, and pharmacologic. 123
When human data are available that establish the presence or absence of any adverse
developmental outcome(s) associated with maternal use of the drug, a risk statement based on
human data must summarize the specific developmental outcome(s) and include its incidence
and the effects of dose, duration of exposure, and gestational timing of exposure. 124 If human
data indicate that there is an increased risk for a specific adverse developmental outcome in
infants born to women exposed to the drug during pregnancy, the risk summary must contain a
quantitative comparison of that risk to the risk for the same outcome in infants born to women
who were not exposed to the drug, but who have the disease or condition for which the drug is
indicated to be used. 125 When risk information is not available for women with the disease or
condition(s) for which the drug is indicated, the risk summary must contain a comparison of the
specific outcome in women exposed to the drug during pregnancy against the rate at which the
outcome occurs in the general population. 126
When animal data are available, the risk statement based on such data must describe the potential
risk for adverse developmental outcomes in humans and summarize the available data. 127 This
statement must include: the number and type(s) of species affected; timing of exposure; animal
doses expressed in terms of human dose or exposure equivalents; and outcomes for pregnant
animals and offspring. 128
120
§ 201.57(c)(9)(i).
121
§ 201.57(c)(9)(i)(B).
122
Id.
123
Id.
124
§ 201.57(c)(9)(i)(B)(1).
125
Id.
126
Id.
127
§ 201.57(c)(9)(i)(B)(2).
128
Id.
46
With respect to pharmacology, when the drug has a well-understood pharmacologic mechanism
of action that may result in adverse developmental outcomes, the Risk Summary must explain
the mechanism of action and the potential associated risks. 129
3. Inclusion of Contraindications and Pregnancy Information in

the Labeling for the Authorized COVID-19 Vaccines
For the emergency use of an unapproved product, section 564(e)(1)(A)(i) of the FD&C Act
requires that FDA must—to the extent practicable given the applicable circumstances of the
emergency, and as FDA finds necessary and appropriate to protect the public health—establish
appropriate conditions designed to ensure that health care professionals administering the
authorized product are informed:
• That FDA has authorized the emergency use of the product (including the product name
and an explanation of its intended use);
• Of the significant known and potential benefits and risks of the emergency use of the
product, and the extent to which such benefits and risks are unknown; and
• Of available alternatives and their benefits and risks.
Therefore, as explained in the EUA Guidance, FDA recommends that “a request for an EUA
include a ‘Fact Sheet’ for health care professionals or authorized dispensers that includes
essential information about the product. In addition to the required information, Fact Sheets
should include . . . any contraindications or warnings.” 130 The EUA guidance also recommends
that, for unapproved drugs that do not have “FDA-approved labeling for any indication . . . in
addition to the brief summary information found in a Fact Sheet, the sponsor also develop more
detailed information similar to what health care professionals are accustomed to finding in FDA-
approved package inserts.” 131
The sponsors for all the Authorized COVID-19 Vaccines submitted such prescribing information
in the EUA requests, and FDA reviewed and authorized this labeling. The Fact Sheets for
Healthcare Providers Administering Vaccine for all of the Authorized COVID-19 Vaccines
contain Contraindications and Warnings and Precautions sections because FDA determined that
sufficient data existed for inclusion of such information in the authorized labeling for these
vaccines. 132
FDA did not, however, require inclusion of a contraindication for pregnancy in the authorized
labeling. The authorized COVID-19 vaccines are authorized for use in an age range that includes
women of childbearing age and are not contraindicated for use in pregnant women because FDA
129
§ 201.57(c)(9)(i)(B)(3).
130
EUA Guidance at 22.
131
EUA Guidance at 23.
132
Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers),
Sections 5.2 and 5.3 Warnings and Precautions Regarding Thrombosis with Thrombocytopenia and GBS,
https://www.fda.gov/media/146304/download; Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers), Section 5.2, Warning and Precautions Regarding
Myocarditis and Pericarditis, https://www.fda.gov/media/144413/download Moderna COVID-19 Vaccine Fact
Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Section 5.2, Warning and
Precautions Regarding Myocarditis and Pericarditis, https://www.fda.gov/media/144637/download.
47
is not aware of any evidence that suggests the risk of use of the Authorized COVID-19 Vaccines
in pregnant women would clearly outweigh any possible therapeutic benefit. 133 Nor has the
Petitioner presented any such evidence in the Petition. Accordingly, this request is denied.
4. Inclusion of Contraindications and Pregnancy Information in

the Labeling for Licensed COVID-19 Vaccines
With respect to Petitioner’s request that FDA “immediately revoke tacit approval that pregnant
women may receive any EUA or licensed COVID vaccines and immediately issue public
guidance to that effect” (Petition at 1; emphasis added), as explained above in this section, FDA
regulations require the Contraindications section of the labeling for an approved drug or
biological product to describe any situations in which the drug or biological product should not
be used because the risk of use “clearly outweighs any possible therapeutic benefit” (§
201.57(c)(5)). This section should include observed and anticipated risks, but not theoretical
risks. 134 The approved COVID-19 vaccine (COVID-19 Vaccine, mRNA; Comirnaty) is indicated
for use in an age range that includes women of childbearing age and is not contraindicated for
use in pregnant women because FDA is not aware of any evidence that suggests the risk of use of
BioNTech’s COVID-19 vaccine in pregnant women would clearly outweigh any possible
therapeutic benefit, 135 nor has the Petitioner presented any such evidence in the Petition.
In its review of a BLA for any future COVID-19 vaccine candidate, FDA will apply the
regulatory standards outlined above in determining, on a case-by-case basis, whether to include a
contraindication in pregnancy, or any other contraindications, in the approved labeling for such a
vaccine. Accordingly, Petitioner’s request is denied.
iv. Petitioner’s Request that FDA Immediately Amend its Guidance

regarding Certain Approved Drugs [chloroquine drugs, ivermectin,
“and any other drugs demonstrated to be safe and effective against
COVID”]
Petitioner requests that the Agency “immediately amend its existing guidance for the use of the
chloroquine drugs, ivermectin, and any other drugs demonstrated to be safe and effective against
COVID, to comport with current scientific evidence of safety and efficacy at currently used
doses and immediately issue notifications to all stakeholders of this change.” Petition at 2. FDA
has not issued “guidance for the use of chloroquine drugs, ivermectin, and other drugs
133
FDA’s decision memoranda for the Authorized COVID-19 Vaccines discuss FDA’s analysis of all available data
regarding the use of the Authorized COVID-19 Vaccines in pregnancy. See, FDA, Pfizer-BioNTech COVID-19
Vaccine EUA Decision Memorandum (Dec. 11, 2020), https://www.fda.gov/media/144416/download; FDA,
Moderna COVID-19 Vaccine EUA Decision Memorandum (Dec. 18, 2020),
https://www.fda.gov/media/144673/download; FDA, Janssen COVID-19 Vaccine EUA Decision Memorandum
(Feb. 27, 2021), https://www.fda.gov/media/146338/download.
134
See § 201.57(c)(5); see also Warnings Guidance at 8.
135
See FDA's Summary Basis for Regulatory Action (SBRA) for the BioNTech BLA. This memorandum will be
posted on www.fda.gov.
48
demonstrated to be safe and effective against COVID.” 136 FDA has, however, analyzed adverse
event information and made publicly available safety issues regarding the use of
hydroxychloroquine and chloroquine to treat patients with COVID-19. 137 FDA has also informed
the public that it has received multiple reports of patients who have required medical support and
been hospitalized after self-medicating with ivermectin intended for horses, that taking large
doses of ivermectin can cause serious harm, that ivermectin is not authorized or approved by
FDA to treat COVID-19, and that using any treatment for COVID-19 that is not approved or
authorized by the FDA, unless part of a clinical trial, can cause serious harm. 138 You have not
provided any evidence to suggest that the safety information in these communications is
inaccurate. Thus, to the extent you are requesting that FDA withdraw or revise these previous
safety communications, that request is denied.
v. Petitioner’s Request that FDA Issue Guidance to the Secretary of

Defense and the President
Petitioner requests that FDA “issue guidance to the Secretary of the Defense and the President
not to grant an unprecedented Presidential waiver of prior consent regarding COVID vaccines
for Servicemembers under 10 U.S.C. § 1107(f) or 10 U.S.C. § 1107a.” Petition at 2.
FDA denies this request because FDA, an agency within the U.S. Department of Health and
Human Services, does not issue guidance of the type requested to the President of the United
States or to other Departments in the executive branch of the U.S. federal government.
136
Under FDA’s good guidance practices regulations, a “guidance document” is defined as “documents prepared for
FDA staff, applicants/sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory
issue.” 21 CFR 10.115(a)(b)(1). The regulation provides further that “[g]uidance documents include, but are not
limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of
regulated products; the processing, content, and evaluation or approval of submissions; and inspection and
enforcement policies.” Importantly, the provision at 21 CFR 10.115(b)(3), excludes from the definition of “guidance
document” general information documents provided to consumers or health professionals, such as those
communications that have been provided to the public regarding the use of hydroxychloroquine, chloroquine, and
ivermectin to treat patients with COVID-19. 21 CFR 10.115(b)(3) states: “[g]uidance documents do not include:
Documents relating to internal FDA procedures, agency reports, general information documents provided to
consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials,
warning letters, memoranda of understanding, or other communications directed to individual persons or firms.”
(Emphasis added.)
137
FDA Drug Safety Communication, FDA cautions against use of hydroxychloroquine or chloroquine for COVID-
19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems, April 24, 2020, updated
June 15, 2020 and July 1, 2020, https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-
hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or; FDA, CDER Office of Surveillance and
Epidemiology Pharmacovigilance Memorandum, May 19, 2020,
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/OSE%20Review_Hydroxychloroquine-
Cholorquine%20-%2019May2020_Redacted.pdf.
138
FDA Consumer Update, Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, March 5, 2021,
https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-
19; FDA Letter to Stakeholders, Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in
Humans, April 10, 2020, https://www.fda.gov/animal-veterinary/product-safety-information/fda-letter-stakeholders-
do-not-use-ivermectin-intended-animals-treatment-covid-19-humans.
49
vi. Petitioner’s Request that FDA Issue Guidance to Stakeholders

Regarding the Option to Refuse or Accept Administration of
Investigational COVID-19 Vaccines
Petitioner requests that FDA “issue guidance to all stakeholders in digital and written formats to
affirm that all citizens have the option to accept or refuse administration of investigational
COVID vaccines without adverse work, educational or other non-health related consequences,
under 21 U.S.C. § 360bbb-3(e)(1)(a)(ii)(III) 1 and the informed consent requirements of the
Nuremberg Code.” 139 We interpret this request to relate to the Authorized COVID-19 Vaccines
and third parties’ decisions with respect to unvaccinated individuals’ participation in certain
activities. Such decisions by third parties with respect to employment, education, and other non-
FDA-regulated activities would not be within FDA’s purview. Accordingly, FDA denies
Petitioner’s request.
vii. Petitioner’s Request that FDA Issue Guidance Regarding Marketing

and Promotion of COVID-19 Vaccines
FDA notes that your Petition discusses statements made by CDC. For requests intended for
CDC, you should contact CDC directly.
As explained above in section III.b.i.1.b of this response, the EUA revocation standard in section
564(g)(2) of the FD&C Act is not met for any of the Authorized COVID-19 Vaccines. With
respect to Petitioner’s request to issue guidance pending revocation of the EUAs for the
Authorized COVID-19 Vaccines, we note that the EUA Guidance contains a section regarding
advertising for EUA products. As explained in the EUA guidance, FDA may, under section
564(e)(1)(B) of the FD&C Act, on a case-by-case basis and to the extent feasible given the
circumstances of a particular public health emergency, establish certain additional conditions that
FDA finds to be necessary or appropriate to protect the public health. 140 The EUA guidance
explains that, under section 564(e)(4) of the FD&C Act, FDA may place conditions on
“advertisements and other promotional descriptive printed matter (e.g., press releases issued by
the EUA sponsor) relating to the use of an EUA product, such as requirements applicable to
prescription drugs under section 502(n) . . . .” 141 FDA’s authority under section 564(e)(4)
ordinarily does not extend to statements by third parties who have no direct connection with the
EUA sponsor.
For the Authorized COVID-19 Vaccines, FDA has determined that such conditions are necessary
to protect the public health. Accordingly, the Letter of Authorization for each of the Authorized
COVID-19 Vaccines contains conditions related to printed matter, advertising, and promotion. 142
Given the current public health emergency, FDA does not see a need to expend the resources
139
Concerns about potential State vaccine requirements are better directed to the States. FDA does not mandate use
of vaccines.
140
EUA Guidance at 26.
141
Id. at 27.
142
FDA, Pfizer-BioNTech COVID-19 Vaccine Letter of Authorization (Aug. 12, 2021),
https://www.fda.gov/media/150386/download; FDA, Moderna COVID-19 Vaccine Letter of Authorization (Aug.
12, 2021), https://www.fda.gov/media/144636/download; FDA, Janssen COVID-19 Vaccine Letter of
Authorization (June 10, 2021), https://www.fda.gov/media/146303/download.
50
necessary to develop and issue additional guidance on this topic. Thus, because FDA has already
issued guidance addressing advertising and promotion of EUA products, and because FDA has
established conditions related to printed matter, advertising, and promotion for all of the
Authorized COVID-19 Vaccines, FDA denies Petitioner’s request to issue additional guidance
on this issue.
c. Conclusion
FDA has considered Petitioner’s requests as they relate to the Authorized COVID-19 Vaccines
and the approved COVID-19 Vaccine. For the reasons given in this letter, FDA denies the
requests in Petitioner’s citizen petition. Therefore, we deny the Petition in its entirety.
Sincerely,
Peter Marks, MD, PhD

Director
cc: Dockets Management Staff
51
A. Vaccines are Biologics and Drugs

Vaccines are both biological products under the Public Health Service Act (PHS Act) (42 U.S.C.
§ 262) and drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. §
321). The PHS Act defines a “biological product” as including a “vaccine…or analogous
product…applicable to the prevention, treatment, or cure of a disease or condition of human
beings.” 42 U.S.C. § 262(i)(1). The FD&C Act defines drug to include “articles intended for
use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.” 21 U.S.C. §
321(g)(1)(B).
Under the PHS Act, a biological product may not be introduced or delivered for introduction into
interstate commerce unless a biologics license is in effect for the product. 42 U.S.C. §
262(a)(1)(A).
B. Clinical Investigations of Vaccines
Before a vaccine is licensed (approved) by FDA and can be used by the public, FDA requires
that it undergo a rigorous and extensive development program that includes laboratory research,
animal studies, and human clinical studies to determine the vaccine’s safety and effectiveness.
The PHS Act and the FD&C Act provide FDA with the authority to promulgate regulations that
provide a pathway for the study of unapproved new drugs and biologics. 42 U.S.C. §
262(a)(2)(A) and 21 U.S.C. § 355(i). The regulations on clinical investigations require the
submission of an Investigational New Drug application (IND), which describes the protocol, and,
among other things, assures the safety and rights of human subjects. These regulations are set
out at 21 CFR Part 312. See 21 CFR § 312.2 (explaining that the IND regulations apply to
clinical investigations of both drugs and biologics).
The regulations provide that, once an IND is in effect, the sponsor may conduct a clinical
With respect to vaccines, Phase 1 studies typically enroll fewer than 100 participants and are
designed to look for very common side effects and preliminary evidence of an immune response
to the candidate vaccine. Phase 2 studies may include up to several hundred individuals and are
designed to provide information regarding the incidence of common short-term side effects, such
as redness and swelling at the injection site or fever, and to further describe the immune response
to the investigational vaccine. If an investigational new vaccine progresses past Phase 1 and
Phase 2 studies, it may progress to Phase 3 studies. For Phase 3 studies, the sample size is often
which may be in the thousands or tens of thousands of subjects. Phase 3 studies are usually of
sufficient size to detect less common adverse events.
If product development is successful and the clinical data are supportive of the proposed
indication, the completion of all three phases of clinical development can be followed by
submission of a Biologics License Application (BLA) pursuant to the PHS Act (42 U.S.C. §
262(a)), as specified in 21 CFR § 601.2.
52
C. Biologics License Applications

A BLA must include data demonstrating that the product is safe, pure, and potent and that the
facility in which the product is manufactured “meets standards designed to assure that the
biological product continues to be safe, pure, and potent.” 42 U.S.C. § 262(a)(2)(C)(i). FDA
does not consider an application to be filed until FDA determines that all pertinent information
and data have been received. 21 CFR § 601.2. FDA’s filing of an application indicates that the
application is complete and ready for review but is not an approval of the application.
Under § 601.2(a), FDA may approve a manufacturer’s application for a biologics license only
after the manufacturer submits an application accompanied by, among other things, “data derived
from nonclinical laboratory and clinical studies which demonstrate that the manufactured
product meets prescribed requirements of safety, purity, and potency.” The BLA must provide
the multidisciplinary FDA reviewer team (medical officers, microbiologists, chemists,
biostatisticians, etc.) with the Chemistry, Manufacturing, and Controls (CMC) 143 and clinical
information necessary to make a benefit-risk assessment, and to determine whether “the
establishment(s) and the product meet the applicable requirements established in [FDA’s
regulations].” 21 CFR § 601.4(a).
FDA generally conducts a pre-license inspection of the proposed manufacturing facility, during
which production of the vaccine is examined in detail. 42 U.S.C. § 262(c). In addition, FDA
carefully reviews information on the manufacturing process of new vaccines, including the
results of testing performed on individual vaccine lots.
FDA scientists and physicians evaluate all the information contained in a BLA, including the
safety and effectiveness data and the manufacturing information, to determine whether the
application meets the statutory and regulatory requirements. FDA may also convene a meeting
of its advisory committee to seek input from outside, independent, technical experts from various
scientific and public health disciplines that provide input on scientific data and its public health
significance.
As part of FDA’s evaluation of a vaccine as a whole, FDA takes all of a vaccine’s ingredients
into account (including preservatives and adjuvants). FDA licenses a vaccine only after the
Agency has determined that the vaccine is safe and effective for its intended use, in that its
benefits outweigh its potential risks.
143
Also referred to as Pharmaceutical Quality/CMC.
53
Marks Decl.
Exhibit F
July 23, 2021
Electronic Submission
Division of Dockets Management

Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852
CITIZEN PETITION
This petition for administrative action is submitted on behalf of CAALM, the Coalition
Advocating for Adequately Licensed Medicines (“Petitioner”) pursuant to 21 C.F.R. § 10.30 and
related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health
Service Act to request that the Commissioner of Food and Drugs (the “Commissioner”) require
that the vaccine manufacturers provide the FDA with the data outlined in the “Actions
Requested” section below before approval of any COVID-19 vaccine.
The Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) to
three COVID-19 vaccines, enabling rapid, and widespread vaccine rollout across the United
States. These EUAs do not have any built-in expiration date, and therefore vaccines can
continue to be lawfully distributed under EUA even after a future date when a public health
emergency no longer exists.
Approximately seven months have passed since the first EUAs were granted, and two vaccine
manufacturers now seek licensure (approval) and have submitted Biologics License Applications
(BLAs). Other manufacturers have indicated similar intentions, as well as intentions for EUAs for
additional pediatric populations.
We believe the FDA should not prematurely grant a license to any COVID-19 vaccine until all
necessary efficacy and safety studies are completed and substantial evidence demonstrates the
benefits of an individual COVID-19 vaccine product outweigh the harms for the indicated,
recipient population. We are concerned that the premature licensure of a COVID-19 vaccine
can seriously undermine public confidence in regulatory authorities, particularly if long-term
safety issues were to emerge following licensure.
In this petition, we outline efficacy and safety measures that must be met before serious
consideration is given to granting a BLA of any COVID-19 vaccine. These measures include:
1. Completing at least 2 years of follow-up of participants originally enrolled in pivotal

clinical trials, even if the trials were unblinded and now lack a placebo control. All
vaccine manufacturer phase 3 trials were already designed with this planned duration.
2. Ensuring, prior to including in the list of populations for which a vaccine is approved,
that there is substantial evidence of clinical effectiveness that outweighs harms in
special populations such as: infants, children, and adolescents; those with past SARS-
CoV-2 infection; immunocompromised; pregnant women; nursing women; frail older
adults; and individuals with cancer, autoimmune disorders, and hematological
conditions.
3. Requiring thorough safety assessment of spike proteins being produced in-situ by the
body tissues following vaccine administration, and spike proteins’ full biodistribution,
pharmacokinetics, and tissue specific toxicity.
4. Completion of vaccine biodistribution studies from administration site and safety
implications of mRNA translation in distant tissues.
5. Thorough investigation of all severe adverse reactions reported following COVID-19
vaccination, such as deaths, reported in the United States and global pharmacovigilance
systems.
6. Assessment of safety in individuals receiving more than two doses.
7. Inclusion of gene delivery and therapy experts in the Vaccines and Related Biological
Products Advisory Committee (VRBPAC), in recognition of the fact that the novel COVID
vaccines work on the premise of gene delivery, in contrast to conventional vaccines.
8. Enforcing stringent conflict of interest requirements to ensure individuals involved in
data analysis and BLA-related decision making processes have no conflict of interests
with vaccine manufacturers.
A COVID-19 vaccine BLA should be approved when—and only when—substantial evidence

demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient
population.
This means that the following are invalid reasons to approve a COVID-19 vaccine:
● To ensure vaccines are accessible after the public health emergency has ended. COVID-
19 vaccines granted an emergency use authorization (EUA) can be lawfully used after
the expiry of the SARS-CoV-2 public health emergency declaration. (This is made clear
by the many products for Ebola and Zika viruses which still have active EUAs. 1)
● To ensure adequate access to vaccines across the population. A BLA is not necessary to
assure access to COVID-19 vaccines. Unlike normal licensing, in which widespread use
of a drug or vaccine follows approval, EUAs for COVID-19 vaccines have enabled, and
continue to enable, their widespread use. Ensuring access to vaccines is irrelevant to
the considerations for issuance of a BLA because broad access to COVID-19 vaccines has
already been accomplished.
● To enable vaccine mandates. Consideration of vaccine mandates is outside of FDA’s

purview. Furthermore, a mandate should only be considered once the evidentiary
conditions are met for a BLA (demonstrating that benefits outweigh harms).
● To bolster public confidence. Like mandates, approving a medical product in order to

bolster public confidence is backward logic and is outside the FDA’s purview. Approving
before substantial evidence that population-based evidence of clinical effectiveness is
superior to harms may contribute to public wariness and hesitancy, not only about
COVID-19 vaccines, but other vaccines and public health authorities more broadly. An
approval may bolster public confidence, but it is not a valid reason to approve.
Regardless of any legitimacy of each of the above reasons, none provides grounds to approve a
COVID-19 vaccine.
The widespread use of a COVID-19 vaccine under EUA, particularly for a limited amount of time,
also is not a valid reason to approve a product. Even if vaccine recipients are followed up within
observational studies, such studies may have important design biases and flaws, and their
conclusions, especially concerning clinical effectiveness outcomes, may not be reliable.
Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety
of US residents, with global ramifications considering the international importance of FDA
decisions. It also could set a precedent of lowered standards for future vaccine approvals. For
these reasons and due to the compelling need to ensure the safety and efficacy of any COVID-
19 vaccine licensed by the FDA and to allow Petitioner the opportunity to seek emergency
judicial relief should the instant Petition be denied, it is respectfully requested that FDA act on
the instant Amended Petition by July 30, 2021.
I. ACTIONS REQUESTED
Petitioner request that the FDA, prior to granting any license for a COVID-19 vaccine:
1. Confirm, in revised Guidance, that the FDA expects a minimum of 2 years of follow-up of
participants enrolled in pivotal clinical trials, even if trials are unblinded and lack a
placebo control.
2. Require data demonstrating substantial evidence of clinical effectiveness that outweighs

harms, in all special populations, as a condition of consideration of including these
populations among the indicated populations. Special populations include: infants,
children, and adolescents; those with past SARS-CoV-2 infection; immunosuppressed
individuals; those with history of or current cancer; individuals with hematological
disorders or autoimmune diseases; pregnant or nursing women; and frail older adults.
3. Require data on the safety and pharmacokinetic profiles of the spike protein.
4. Require data from biodistribution studies investigating the actual COVID-19 vaccines.
5. Require data from pharmacovigilance systems in the US and globally documenting a

thorough investigation of serious adverse events, carried out by independent, impartial
individuals.
6. Clarify in revised Guidance that safety data from individuals receiving more than 2
vaccine doses must be submitted.
7. Ensure the inclusion of experts in gene therapy in the VRBPAC.
8. Ensure that the analysis of data and decisions regarding any COVID-19 vaccine BLA
application are informed by experts with no financial or research relationships with any
vaccine manufacturers within the last 36 months, both within FDA and amongst the
composition of the VRBPAC.
II. STATEMENT OF GROUNDS
Here, in the order as above, we set out the rationale for each requested action.
1. Confirm, in revised Guidance, that the FDA expects a minimum of 2 years of follow-up
of participants enrolled in pivotal clinical trials, even if trials are unblinded and lack a
placebo control. Rationale:
a. Requiring at least 2 years is consistent with the 2 year follow-up duration
prospectively proposed by the manufacturers when they registered their
ongoing phase 3 trials of COVID-19 vaccines (Moderna: NCT04470427, Pfizer:
NCT04368728, Janssen: NCT04505722) and consistent with the June 2020 FDA
guidance on COVID-19 vaccines which stated participants should be followed for
COVID-19 outcomes for “as long as feasible, ideally at least one to two years.” 2
b. Important adverse event signals can be detected in clinical trials. This is true
despite enrolling tens of thousands of participants, which is still too few to
assess rare adverse events. For example, a serious blood clot occurring in the
phase 3 Janssen clinical trial led to an initial trial pause in October 2020.3
c. Two year follow-up from trials allows the detection of commonly experienced
longer-term adverse effects that may not manifest until many months following
vaccination.
d. Two year follow-up from trials would also allow for more detailed assessment of
infection, re-infection, infectiousness, and the monitoring of immune response
over time, among all vaccinated participants.
e. The quality of data collection in clinical trials can be expected to be superior to
passive data collection systems like the Vaccine Adverse Event Reporting System
(VAERS). Therefore, trials of at least 2 years duration provide a valuable chance
to develop a more complete understanding of the adverse event profile in the
general population as well as in specific groups, such as individuals of
reproductive age, immunocompromised individuals, and different age groups,

including adolescents and young children.
f. The quality of data on adverse events during an ongoing trial can be improved
while the trial is ongoing (e.g., improving the range of types of adverse events
that are systematically assessed), as and when evidence from other data sources
(e.g., pre-clinical or pharmacovigilance) show any trends or indicate specific
types of adverse events of special interest.
g. Finally, the expectation of at least 2 years of follow-up prior to BLA also carries
the advantage of longer-term data collection from other available sources (e.g.,
MedWatch/VAERS, V-safe, Vaccine Safety Datalink, FDA-CMS, BEST & PRISM, VA
Electronic Health Records & data warehouse, Department of Defense DMSS, and
Genesis HealthCare (Brown University & NIH-National Institute of Aging), as well
as other medical claims databases).
2. Require data demonstrating substantial evidence of clinical effectiveness that

outweighs harms, in all special populations, as a condition of consideration of
including these populations among the indicated populations. Special populations
include: infants, children, and adolescents; those with past SARS-CoV-2 infection;
immunosuppressed individuals; those with history of or current cancer; individuals
with hematological disorders or autoimmune diseases; pregnant or nursing women;
and frail older adults. Rationale:
a. The efficacy and safety of medicines often differs amongst populations such as
healthy young adults vs. older adults, men vs. women, or SARS-CoV-2 survivors
vs. never-exposed individuals.
b. For example, the relative risks of SARS-CoV-2 infection, hospitalization, and
death are considerably lower in infants, children, and adolescents in comparison
to adults.4,5
c. For example, individuals who experienced past SARS-CoV-2 infection (which are
now believed to be a significant minority of many subpopulations6) are likely to
have immunity to subsequent infections for as long or longer than immunity
conferred by vaccine,7–10 and may also be at heightened risk for adverse
effects.11–14
d. The ongoing phase 3 trials of COVID-19 vaccines (Moderna: NCT04470427,
Pfizer: NCT04368728, Janssen: NCT04505722) largely (or wholly) excluded the
following important populations in which there is reason to believe the effects of
the product may differ from the populations enrolled in the trial:
i. Infants, children, and adolescents
ii. Those with past SARS-CoV-2 infection
iii. Those who are immunosuppressed
iv. Those with history of or current cancer
v. Those with hematological disorders
vi. Those with autoimmune diseases
vii. Those who are pregnant or nursing
viii. Frail older adults (including those living in nursing homes)
e. The question is not simply whether there is efficacy, but how much efficacy
exists in these populations, what kind of efficacy (e.g. reduction in risk of
symptomatic COVID-19 vs. reduction in risk of hospitalization or death), and do
efficacy advantages outweigh potential harms in these populations.
f. Before these special populations can be considered for inclusion amongst the
approved indicated populations, data demonstrating substantial evidence of
clinical effectiveness that outweighs harms in these specific populations, are
needed.
3. Require data on the safety and pharmacokinetic profiles of the spike protein.
Rationale:
a. In-situ production of SARS-CoV-2 spike protein is the target mechanism of action
of all COVID-19 vaccines with an EUA at present. Therefore, the safety profile of
spike protein itself (i.e., in the absence of virus) must be thoroughly understood
in the range of populations on the indications list.
b. Recently, evidence of systemic circulation of spike protein or its components in
subjects post-immunization was reported.15 All studies we are aware of to date
raise concerns about the safety of spike protein,16–28 and the concentration of
circulatory spikes was correlated to the disease severity in COVID-19 patients.29
c. Required studies must, at a minimum, address these concerns:
i. Coagulopathy issues, including blood clots, hemorrhage,
thrombocytopenia, heart attack, and strokes. According to the VAERS, as
of May 21, 2021, there have been a total of 1,222 reports of
thrombocytopenia/low platelets; and 6,494 (112 in 0-24 year-olds)
reports of blood clots/strokes.
ii. Reproductive issues, including menstrual irregularities, reduced fertility,
miscarriages, and preterm births. According to VAERS, as of May 21,
2021, there were 511 reports of miscarriage and 522 reports of uterine
hemorrhage (including 88 in women older than 50 years). The vaccines
induce the generation of antibodies to attack spike protein, which are
genetically similar to proteins produced by the placenta.30 To date, no
vaccine sponsors have conducted immunologic studies of spike protein
involvement with proteins involved in placental development.
iii. Carcinogenesis. There is preliminary and theoretical evidence that the
spike protein may promote cancer.31,32 Considering the potential for
annual booster vaccinations, COVID-19 vaccines should be treated
similarly to medication taken for chronic conditions on a long term basis.
Carcinogenic potential is important to characterize.
iv. Transmission of spike protein (or its fragments) from vaccinated
individuals, such as through breast milk and associated risk in neonates
and infants. According to the UK Medicines & Healthcare products
Regulatory Agency, there are 921 reports of exposure via breast milk
following AstraZeneca’s vaccine and 215 reports following Pfizer’s
vaccine.
v. Neurological disorders, including Guillain-Barré syndrome, acute

disseminated encephalomyelitis, transverse myelitis, encephalitis,
myelitis, encephalomyelitis, meningoencephalitis, meningitis,
encephalopathy, demyelinating diseases, and multiple sclerosis.
vi. Cardiac issues, including myocardial infarction, myocarditis and
pericarditis, among others. According to the VAERS, as of May 21, 2021,
there have been a total of 1,598 reports of heart attacks (24 reported in
0-24 year-olds; 501 resulted in death).
vii. Autoimmune diseases, including thyroiditis and diabetes mellitus,
immune thrombocytopenia, autoimmune hepatitis, primary biliary
cholangitis, systemic sclerosis, autoimmune disease for skeletal muscles
(myasthenia gravis, myositis such as polymyositis, dermatomyositis, or
other inflammatory myopathies)
viii. Studies should be conducted in individuals of both sexes 33 and all ages.
We cannot assume that the effects of spike protein are the same across
populations of all ages, sex, and across pre-existing conditions.
4. Require data from biodistribution studies investigating the actual COVID-19 vaccines.
Rationale:
a. Data from the biodistribution studies submitted by Moderna and Pfizer suggests
that the vaccines distribute widely in the body, including to the liver, brain,
heart, lung, adrenals, ovaries, and testes, among many other tissues. 34,35 (See
Tables 1a, 1b, and 2 below for studies R-[?]-0072 and 185350 submitted by
Pfizer and study 5002121 submitted by Moderna.)
b. However these were not studies of the currently authorized products: Pfizer’s
BNT162b2, Moderna’s mRNA-1273, or Janssen’s Ad26.COV2.S.34–36
c. Instead of presenting novel biodistribution studies of the COVID-19 vaccine
formulations, sponsors presented substitute studies to FDA for an EUA during
the pandemic.34–36
d. Therefore, novel biodistribution studies investigating the actual COVID-19
vaccines are necessary.
e. Biodistribution studies would be required for any small molecule pharmaceutical
drug submitted for approval (i.e. New Drug Application), and should be
conducted on the COVID-19 vaccines as well as these novel vaccines which work
on the premise of gene delivery--very different to conventional vaccines.
f. Biodistribution studies help inform an understanding of vaccine transfection to
various tissues (away from injection site) spurring various distant tissues to
produce spike proteins and consequent autoimmune response against the
body’s cells. These studies will therefore help enhance our understanding of the
nature of potential short and long term adverse events. At this point in time, in
which other data sources exist to characterize short term harms of COVID-19
vaccines with an EUA, the utility of biodistribution studies to characterize long
term adverse effects and better understand potential mechanism(s) of action of
short and long term harms, remains critically important.
g. Necessary studies must, at a minimum, address these concerns related to

biodistribution, as well as the effects of vaccines in the body:
i. The need to know basic pharmacokinetic parameters, including
absorption, distribution, metabolism, and excretion (ADME).
ii. Effects of multiple doses. ADME may change depending on dose and
cumulative dose and should be investigated. This is more important
than usual as the whole purpose of all COVID-19 vaccines with an EUA
at present is to change the body’s way of processing spike protein, and
therefore repeated injections should result in different rates of
clearance of spike protein from the blood, and different rates of
immune attack on spike protein producing cells.
iii. The impact of body mass index (size of deltoid muscle) and vaccine
distribution away from injection site, implications for dose estimation
for lean or younger age groups or frail older adults.
iv. The duration of the studies must be sufficient to fully understand the
complete distribution and elimination of the injected vaccine and its
carrier and other constituents. For example, data from the substitute
study submitted for Pfizer’s vaccine (see Tables 1a, 1b, and 2 below for
studies R-[?]-0072 and 185350 submitted by Pfizer and study 5002121
submitted by Moderna) showed levels of drug product increasing at
the 48 hour mark, but it is unknown what occurred after 48 hours as
this was apparently the study cut off.37
v. Potential side effects (safety review) in those organs/tissues with a
detectable proportion of injected vaccine (antigen or novel excipients)
from the circulatory system.
5. Require data from pharmacovigilance systems in the US and globally documenting a

thorough investigation of serious adverse events, carried out by independent,
impartial individuals. Rationale:
a. A major testament to the overall short-term safety of a medical product is the
absence of serious adverse events (SAEs) when administered to millions. COVID-
19 vaccines have now been administered to hundreds of millions of individuals,
and it is vital that all reports of SAEs are thoroughly investigated to determine
whether the vaccine played any role in the SAE.
b. The most serious of all SAEs is death, and a CDC webpage on VAERS discusses
4,863 reports of death after COVID-19 vaccination reported between December
14, 2020 and May 24, 2021. 38 CDC states that:
i. “CDC follows up on any report of death to request additional
information to learn more about what occurred and to determine
whether the death was a result of the vaccine or was unrelated.”
ii. “CDC and FDA physicians review each case report of death as soon as
notified and CDC requests medical records to further assess reports.”
iii. “A review of available clinical information, including death certificates,

autopsy, and medical records has not established a causal link to
COVID-19 vaccines.”38
c. However, the FDA has stated that VAERS staff do not contact family members to
learn more about the deaths. It stated: “Because the VAERS system is not
designed to determine causality of adverse events, there is not a mechanism to
follow-up with families for additional details. The determination of the cause of
death is done by the certifying official who completes the death certificate or the
pathologist who conducts the autopsy.”39
d. Regulators in other countries have conducted detailed case investigations (e.g.
Norway’s investigation of 100 deaths amongst frail elderly following COVID-19
vaccination40,41).
e. FDA must require evidence of a thorough investigation into deaths and other
SAEs—investigations that include contacting families to obtain a full medical
history and personal accounts (in the case of deaths) and those who experienced
the adverse event (in the case of other SAEs). Event adjudication, as done on
data safety monitoring boards, must be in place in order to carry out detailed
case investigations, and must be carried out by independent, impartial
individuals.
6. Clarify in revised Guidance that safety data from individuals receiving more than 2
vaccine doses must be submitted by vaccine manufacturers. Rationale:
a. There is wide speculation that COVID-19 vaccines may become offered as annual
vaccines, much like influenza vaccines, and regulators have already released
guidance to this effect.42
b. Some manufacturers, such as Pfizer and Moderna, have indicated that a third
dose may be necessary within the first 12 months. Other manufacturers may
present similar claims in the future.43
c. The safety profile of multiple doses, possibly more than 70 doses across an
average lifetime, must be considered at the time of licensure. Phase 3 trial data
make clear that the safety profile differs by dose (e.g. dose 2 of the Pfizer and
Moderna vaccines induce more severe systemic adverse events than dose 1). 44,45
d. Information on the types and severity of adverse events that emerge following
the administration of additional doses is necessary to better characterize long
term safety.
7. Ensure the inclusion of experts in gene therapy in the VRBPAC. Rationale:

a. The COVID-19 vaccines produced by Pfizer, Moderna, and Janssen (as well as
AstraZeneca, CanSinoBio (China) and Gamaleya Research Institute (Russia)) are
gene based vaccines. Their mechanism of action differs substantially from all
other vaccines that have been used on populations globally, as these novel
vaccines work on the premise of gene delivery, and may therefore be considered
a type of gene therapy. These gene based vaccines involve entering the cell,
where the overwhelming majority of critical body activities occur, and utilizing
the host’s cells to produce spike protein. This is an entirely different mechanism
than that utilized by traditional vaccines such as inactivated, attenuated, subunit
or protein-based (that are not intended to invade cells). Therefore, there is a
need to consider safety with the informed perspectives of those with expertise
in gene therapies.
8. Ensure that the analysis of data and decisions regarding any COVID-19 vaccine BLA
application are informed by experts with no financial or research relationships with
any vaccine manufacturers within the last 36 months, both within FDA and amongst
the composition of the VRBPAC. Rationale:
a. The public interest weighs strongly in favor of the evaluation of data and all
decision making to be performed by competent individuals with independence
from vaccine manufacturers (institutions that stand to gain or lose from a BLA
decision on a COVID-19 vaccine). Disclosure requirements should be at least as
stringent, if not more, than what is expected for writing a manuscript in a
medical journal—namely, disclosure of relationships within the last 36 months,
as requested by the International Committee of Medical Journal Editors (ICMJE).
Insisting on this level of disclosure, and transparency of the disclosures, can
publicly demonstrate the independence of the FDA’s decision making process. 46
Table 1a. Pfizer study report R-[?]-0072, biodistribution study submitted by Pfizer to Japanese
regulator (PMDA).
Source: Japan PMDA (PDF page 15).37

Table 1b. Pfizer study report 185350, biodistribution study submitted by Pfizer to Japanese
regulator (PMDA).

Table 2. Modern study report 5002121, biodistribution study submitted by Moderna to

Japanese regulator (PMDA).
III. ENVIRONMENT IMPACT

The petitioner hereby states that the relief requested in this petition will have no
environmental impact and therefore an environmental assessment is not required under 21
C.F.R. Sections 25.30 and 25.31.
IV. ECONOMIC IMPACT

Economic impact information will be submitted upon request of the commissioner.
V. CERTIFICATION
The undersigned certifies that, to the best knowledge and belief of the undersigned, this
petition includes all information and views on which the petition relies, and that it includes
representative data and information known to the petitioner which are unfavorable to the
petition.
Respectfully submitted,
Linda Wastila, BSPharm, MSPH, PhD

Representative
Coalition Advocating for Adequately Licensed Medicines (CAALM)
Coalition Advocating for Adequately Licensed Medicines (CAALM), current members as of July
23, 2021:
Peter Aaby, MSc, DMSc† Anthony J Brookes, PhD† Juan Erviti, PharmD, PhD†
Head of Bandim Health Project, Professor of Genetics Unit of Innovation and
Guinea-Bissau University of Leicester Organization
University of Southern Leicester, United Kingdom Navarre Health Service, Spain
† Dr. Brookes’s organizational
Denmark Pamplona, Spain
† Dr. Erviti’s organizational
Copenhagen, Denmark affiliation is included for
† Dr. Aaby’s organizational identification purposes only. affiliation is included for
affiliation is included for identification purposes only.
identification purposes only. Byram W. Bridle, PhD†
Associate Professor of Viral Peter C. Gøtzsche, Professor,
Christine Stabell Benn, MD, Immunology DrMedSci, MD, MSc
PhD, DMSc† University of Guelph Director
Professor of Global Health Ontario, Canada Institute for Scientific Freedom
† Dr. Bridle’s organizational
University of Southern Copenhagen, Denmark
Denmark affiliation is included for
Copenhagen, Denmark identification purposes only. Janice E. Graham, PhD, FCAHS,
† Dr. Benn’s organizational FRSC†
affiliation is included for Peter Collignon AM, MB, University Research Professor
identification purposes only. BS(Hons), BSc(Med), FRACP, Dalhousie University
FRCPA, FASM† Halifax, Canada
Aditi Bhargava, PhD† Professor † Dr. Graham’s organizational
Professor Australian National University affiliation is included for

University of California, San Medical School identification purposes only
Francisco Canberra, Australia
† Dr. Collignon’s organizational
San Francisco, California, U.S.A. David Healy, MD FRCPsych†
† Dr. Bhargava’s organizational affiliation is included for Professor of Psychiatry
affiliation is included for identification purposes only. McMaster University
identification purposes only. Ontario, Canada
Peter Doshi, PhD† † Dr. Healy’s organizational
Dick Bijl, PhD, MD, MSc† Associate Prof., Pharmaceutical affiliation is included for
Pharmacoepidemiologist, Health Services Research identification purposes only.
former GP University of Maryland School
Utrecht, the Netherlands of Pharmacy Iona Heath, CBE FRCGP†
† President, International Baltimore, Maryland, U.S.A. Past president of the Royal
Society of Drug Bulletins † Dr. Doshi’s organizational College of General Practitioners
affiliation is included for London, United Kingdom
† Dr. Heath’s former affiliation
Florence T. Bourgeois MD, identification purposes only.
MPH† is included for identification
Associate Professor of purposes only.
Pediatrics
Harvard Medical School
Boston, Massachusetts, U.S.A.
†
Dr. Bourgeois’s organizational
affiliation is included for
identification purposes only.
Matthew Herder, JSM LLM† Joseph A. Ladapo, MD, PhD† Hamid A. Merchant, BPharm,
Director, Health Law Institute Associate Prof. of Medicine MPharm, PhD, RPh, CQP,
Dalhousie University David Geffen School of PGCertHE, FHEA, SRPharmS†
Nova Scotia, Canada Medicine at UCLA Subject Leader in Pharmacy
† Prof. Herder’s organizational Los Angeles, California, U.S.A. University of Huddersfield
† Dr. Ladapo’s organizational
affiliation is included for Huddersfield, United Kingdom
† Dr. Merchant’s organizational
identification purposes only. affiliation is included for
identification purposes only. affiliation is included for
Tom Jefferson, MD MRCGP identification purposes only.
FFPHM† Trudo Lemmens, LicJur, LLM
Senior Associate Tutor bioethics, DCL† Barbara Mintzes, BA, MSc,
University of Oxford Professor and Scholl Chair in PhD†
† Dr. Jefferson’s organizational Health Law and Policy Associate Professor, School of
affiliation is included for University of Toronto Pharmacy
identification purposes only. Toronto, Canada The University of Sydney
† Dr. Lemmens' organizational Sydney, Australia
† Dr. Mintzes’ organizational
Mark Jones, PhD† identification purposes only affiliation is included for
Associate Professor of identification purposes only.
Biostatistics Tianjing Li, MD, MHS, PhD†
Bond University Associate Professor
Gold Coast, Queensland, University of Colorado Huseyin Naci, MHS, PhD†
Australia Anschutz Medical Campus Associate Professor of Health
† Dr. Jones’s organizational Aurora, Colorado, U.S.A. Policy
† Dr. Li’s organizational
affiliation is included for London School of Economics
identification purposes only. affiliation is included for and Political Science
identification purposes only. London, United Kingdom
Robert M. Kaplan, PhD† † Dr. Naci’s organizational
Distinguished Research Donald W. Light, PhD† affiliation is included for

Professor Professor of Comparative identification purposes only.
UCLA Fielding School of Public Health Policy and Psychiatry
Health Rowan University School of Allyson M Pollock, MBChB,
Los Angeles, California, U.S.A. Osteopathic Medicine FRCPH, FRCP (Ed) FRCGP†
† Dr. Kaplan’s organizational Glassboro, New Jersey, U.S.A. Clinical Professor of Public
affiliation is included for † Dr. Light’s organizational Health
identification purposes only. affiliation is included for Institute of Health and Society,
identification purposes only. Newcastle University
Ulrich Keil, MD, PhD, FRCP Newcastle upon Tyne, United
(London)† Peter A. McCullough, MD, Kingdom
Professor Emeritus MPH† † Dr. Pollock’s organizational
University of Muenster Professor of Medicine affiliation is included for

Muenster, Germany Texas A & M College of identification purposes only.
† Dr. Keil’s organizational Medicine
affiliation is included for Dallas, Texas, U.S.A.
†
identification purposes only. Dr. McCullough’s
organizational affiliation is
included for identification
purposes only.
Angela Spelsberg, MD, SM† Linda Wastila, BSPharm, Patrick Whelan, MD PhD†
Comprehensive Cancer Center MSPH, PhD*† Associate Clinical Professor of
Aachen Professor, Pharmaceutical Pediatrics
Aachen, Germany Health Services Research David Geffen School of
† Dr. Spelsberg’s organizational University of Maryland School Medicine at UCLA
affiliation is included for of Pharmacy Los Angeles, California, U.S.A.
† Dr. Whelan’s organizational
identification purposes only. 220 Arch Street, Baltimore,
Maryland 21201, U.S.A. affiliation is included for
Erick Turner, MD† * Dr. Wastila is serving as the identification purposes only.
Associate Professor of Representative of CAALM
† Dr. Wastila’s organizational
Psychiatry Kim Witczak
Oregon Health & Science affiliation is included for President/Co-Founder
University identification purposes only. Woodymatters
Portland, Oregon, U.S.A. Minneapolis, Minnesota, U.S.A.
†
Dr. Turner’s organizational
identification purposes only.
References
1. Zuckerman DM. Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for
COVID-19 and Public Health. Am J Public Health [Internet]. 2021 Jun;111(6):1065–9. Available from:
http://dx.doi.org/10.2105/AJPH.2021.306273
2. Food and Drug Administration. Development and Licensure of Vaccines to Prevent COVID-19:
Guidance for Industry [Internet]. 2020 [cited 2020 Oct 6]. Available from:
https://www.fda.gov/media/139638/download
3. Food and Drug Administration. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the
Prevention of COVID-19 [Internet]. 2021 [cited 2021 May 28]. Available from:
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23. Rhea EM, Logsdon AF, Hansen KM, Williams LM, Reed MJ, Baumann KK, et al. The S1 protein of
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25. Lei Y, Zhang J, Schiavon CR, He M, Chen L, Shen H, et al. SARS-CoV-2 Spike Protein Impairs
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27. Suzuki YJ, Nikolaienko SI, Dibrova VA, Dibrova YV, Vasylyk VM, Novikov MY, et al. SARS-CoV-2 spike
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ge=7
Marks Decl.
Exhibit G

August 23, 2021
Linda Wastila, BSPharm, MSPH, PhD

Representative
Coalition Advocating for Adequately Licensed Medicines (CAALM)
Re: Citizen Petition (Docket Number FDA-2021-P-0786)
Dear Petitioner,
This letter responds to the citizen petition that the Coalition Advocating for Adequately Licensed
Medicines (CAALM) (the Petitioner, you) submitted to the Food and Drug Administration
(FDA, the Agency, we) relating to licensure of vaccines to prevent Coronavirus Disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (the
CP).
In the CP, Petitioner requests that FDA:
1. “Confirm, in revised Guidance, that the FDA expects a minimum of 2 years of follow-up of
participants enrolled in pivotal clinical trials, even if trials are unblinded and lack a placebo
control”;
2. “Require data demonstrating substantial evidence of clinical effectiveness that outweighs
harms, in all special populations, as a condition of consideration of including these
populations among the indicated populations” including the special populations “infants,
children, and adolescents; those with past SARS-CoV-2 infection; immunosuppressed
individuals; those with history of or current cancer; individuals with hematological disorders
or autoimmune diseases; pregnant or nursing women; and frail older adults”;
3. “Require data on the safety and pharmacokinetic profiles of the spike protein”;
4. “Require data from biodistribution studies investigating the actual COVID-19 vaccines”;
5. “Require data from pharmacovigilance systems in the US and globally documenting a
thorough investigation of serious adverse events, carried out by independent, impartial
individuals”;
6. “Clarify in revised Guidance that safety data from individuals receiving more than 2
vaccine doses must be submitted”;
7. “Ensure the inclusion of experts in gene therapy in the VRBPAC”; and
8. “Ensure that the analysis of data and decisions regarding any COVID-19 vaccine BLA
application are informed by experts with no financial or research relationships with any
vaccine manufacturers within the last 36 months, both within FDA and amongst the
composition of the VRBPAC.”
CP at 3-4.

U.S. Food and Drug Administration
www.fda.gov

This letter responds to the CP in full. FDA has carefully reviewed the CP and other relevant
information available to the Agency. Based on our review of these materials and for the reasons
described below, we conclude that the CP does not contain facts demonstrating any reasonable
grounds for the requested action. In accordance with 21 CFR § 10.30(e)(3), and for the reasons
stated below, FDA is denying the CP.
In this letter, we discuss the requirements for licensed vaccines. We then turn to the requests
contained in the CP. We consider each of your requests in light of the legal standards for FDA
action, and provide our conclusions based on the facts, the science, and the law.
I. Background
There is currently a pandemic of respiratory disease, COVID-19, caused by a novel coronavirus,
SARS-CoV-2. The COVID-19 pandemic presents an extraordinary challenge to global health.
On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration
of a public health emergency related to COVID-19.1 On February 4, 2020, pursuant to section
564 of the FD&C Act, the Secretary of HHS determined that there is a public health emergency
that has a significant potential to affect national security or the health and security of U.S.
citizens living abroad, and that involves the virus that causes COVID-19.2 On the basis of such
determination, on March 27, 2020, the Secretary then declared that circumstances exist justifying
the authorization of emergency use of drugs and biological products during the COVID-19
pandemic (“COVID-19 EUA Declaration”), pursuant to section 564(b)(1) of the FD&C Act.3 In
addition, on March 13, 2020, the Presidential declared a national emergency in response to
COVID-19.4
Commercial vaccine manufacturers and other entities are developing COVID-19 vaccine
candidates, and clinical studies of these vaccines are underway and/or have been
completed. Between December 11, 2020 and February 27, 2021, FDA issued emergency use
authorizations for three vaccines to prevent COVID-19, including vaccines sponsored by Pfizer
Inc. (Pfizer); ModernaTX, Inc. (Moderna); and Janssen Biotech, Inc. (Janssen), a pharmaceutical
company of Johnson & Johnson. FDA received a Biologics License Application (BLA) for the
COVID-19 vaccine, BNT162b2, intended to prevent COVID-19 in individuals 16 years of age
and older. As announced by FDA on August 23, 2021, the Agency is issuing a biologics license

1
Secretary of Health and Human Services Alex M. Azar, Determination that a Public Health Emergency Exists
(Originally issued Jan. 31, 2020, and subsequently
renewed), https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
2
3
4
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)
Outbreak, issued March 13, 2020, https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-
declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
2
for this COVID-19 vaccine (COVID-19 Vaccine, mRNA; Comirnaty) to BioNTech

Manufacturing GmbH.5,6
II. Vaccines That Are FDA-Licensed Meet Relevant Statutory Requirements
1. Vaccines Are Shown to Be Safe, Pure, and Potent at the Time of Licensure
FDA has a stringent regulatory process for licensing vaccines.7,8 The Public Health Service
Act (PHS Act) authorizes FDA to license biological products, including vaccines, if they have
been demonstrated to be “safe, pure, and potent.”9 Prior to approval by FDA, vaccines are
extensively tested in non-clinical studies and in humans. FDA’s regulations describe some of the
extensive data and information that each sponsor of a vaccine must submit to FDA in order to
demonstrate the product’s safety before FDA will consider licensing the vaccine. FDA requires
that the sponsor’s BLA include, among other things, data derived from nonclinical and clinical
studies showing the product’s safety, purity, and potency; a full description of manufacturing
methods for the product; data establishing the product’s stability through the dating period; and a
representative sample of the product and summaries of results of tests performed on the lot(s)
represented by the sample.10
As is evident from the language of the PHS Act and FDA’s regulations, the licensure process for
a vaccine requires the sponsor to establish, through carefully controlled laboratory and clinical
studies, as well as through other data, that the product is safe and effective for its approved
indication(s) and use. FDA’s multidisciplinary review teams then rigorously evaluate the
sponsor’s laboratory and clinical data, as well as other information, to help assess whether the
safety, purity, and potency of a vaccine has been demonstrated.11 Only when FDA’s standards
are met is a vaccine licensed.
FDA regulations explicitly state that “[a]pproval of a biologics license application or issuance of
a biologics license shall constitute a determination that the establishment(s) and the product meet
applicable requirements to ensure the continued safety, purity, and potency of such products.”12
Therefore, the manufacturers of vaccines that have been licensed in the U.S. have necessarily
demonstrated the safety of the vaccines within the meaning of the applicable statutory and
regulatory provisions before the vaccines were licensed and allowed to be marketed.
For more information on FDA’s thorough process for evaluating the safety of vaccines, see
Appendix I of this letter, Aspects of Vaccine Development and Process for Licensure.

5
BioNTech Manufacturing GmbH is the biologics license holder for this vaccine, which is manufactured by Pfizer
Inc. for BioNTech Manufacturing GmbH (hereinafter “BioNTech”).
6
The basis for FDA's licensure decision is set forth in FDA's Summary Basis for Regulatory Action for the
BioNTech application. This memorandum will be posted on fda.gov. We incorporate by reference the SBRA for the
BLA.
7
CDC, Ensuring the Safety of Vaccines in the United States, February 2013,
https://www.cdc.gov/vaccines/hcp/patient-ed/conversations/downloads/vacsafe-ensuring-bw-office.pdf.
8
Vaccine Safety Questions and Answers, last updated March 2018, https://www.fda.gov/vaccines-blood-
9
42 U.S.C. § 262(a)(2)(C)(i)(I).
10
21 CFR § 601.2(a).
11
Vaccines, last updated January 2021, https://www.fda.gov/vaccines-blood-biologics/vaccines.
12
21 CFR § 601.2(d) (emphasis added).
3
2. Vaccine Safety Continues to Be Monitored Post-Licensure

FDA’s oversight of vaccine safety continues after licensure of the product. Once the licensed
vaccine is on the market, post-marketing surveillance of vaccine safety is conducted in order to
detect any rare, serious, or unexpected adverse events, as well as to monitor vaccine lots. FDA
employs multiple surveillance systems and databases to continue to evaluate the safety of these
vaccines. In certain cases, FDA may require the manufacturer to conduct post-marketing studies
to further assess known or potential serious risks.
For more information on post-licensure safety monitoring of vaccines, see Appendix II of this
letter, Aspects of Vaccine Postmarketing Safety Monitoring.
III. Discussion
The CP makes a series of requests regarding the data to be submitted in support of licensure of
vaccines to prevent COVID-19. Much of the key data supporting licensure applications is
developed during the clinical trial process, which is subject to FDA’s investigational new drug
process.13
A. Investigational New Drugs
Before a vaccine is licensed (approved) by FDA for use by the public, FDA requires that it
undergo a rigorous and extensive development program to determine the vaccine’s safety and
effectiveness. This development program encompasses preclinical research (laboratory research,
animal studies14) and clinical studies. At the preclinical stage, the sponsor focuses on collecting
the data and information necessary to establish that the product will not expose humans to
unreasonable risks when used in limited, early-stage clinical studies. Clinical studies, in humans,
are conducted under well-defined conditions and with careful safety monitoring through all the
phases of the investigational new drug process. FDA’s regulations governing the conduct of
clinical investigations are set out at 21 CFR Part 312.
Before conducting a clinical investigation in the U.S. in which a new drug or biological product
is administered to humans, a sponsor must submit an investigational new drug application (IND)
to FDA.15 The IND describes the proposed clinical study in detail and, among other things,
helps protect the safety and rights of human subjects.16 In addition to other information, an IND
must contain information on clinical protocols and clinical investigators. Detailed protocols for
proposed clinical studies permit FDA to assess whether the initial-phase trials will expose
subjects to unnecessary risks. Information on the qualifications of clinical investigators
(professionals, generally physicians, who oversee the administration of the experimental drug)
permits FDA to assess whether they are qualified to fulfill their clinical trial duties. The IND

13
See 21 CFR § 312.2 (explaining that the IND regulations apply to clinical investigations of both drugs and
biologics).
14
We support the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible. We
encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable,
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency
to an animal test method.
15
See 21 CFR § 312.20(a).
16
For additional information regarding the IND review process and general responsibilities of sponsor-investigators
related to clinical investigations see Investigational New Drug Applications Prepared and Submitted by Sponsor-
Investigators; Draft Guidance for Industry, May 2015, https://www.fda.gov/media/92604/download.
4
includes commitments to obtain informed consent from the research subjects, to obtain review of
the study by an institutional review board (IRB),17 and to adhere to the investigational new drug
regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical
trials, unless FDA informs the sponsor that the trial may begin earlier. During this time,
FDA reviews the IND. FDA’s primary objectives in reviewing an IND are, in all phases of the
investigation, to assure the safety and rights of subjects, and, in Phase 2 and Phase 3, to help
assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of
the drug’s effectiveness and safety.18
FDA’s regulations provide that, once an IND is in effect, the sponsor may conduct a clinical
With respect to vaccines, the initial human studies, referred to as Phase 1 studies, are generally
safety and immunogenicity studies performed in a small number of closely monitored subjects.
Phase 2 studies may include up to several hundred individuals and are designed to provide
information regarding the incidence of common short-term side effects such as redness and
swelling at the injection site or fever and to further describe the immune response to the
investigational vaccine. If an investigational new vaccine progresses past Phase 1 and Phase 2
studies, it may progress to Phase 3 studies. For Phase 3 studies, the sample size is often
which may be in the thousands or tens of thousands of subjects. Phase 3 studies provide the
critical documentation of effectiveness and important additional safety data required for
licensing.
At any stage of development, if data raise significant concerns about either safety or
effectiveness, FDA may request additional information or studies; FDA may also halt ongoing
clinical studies. The FD&C Act provides a specific mechanism, called a “clinical hold,” for
prohibiting sponsors of clinical investigations from conducting the investigation (section
505(i)(3) of the FD&C Act; 21 U.S.C. § 355(i)(3)), and FDA’s IND regulations in 21 CFR §
312.42 identify the circumstances that may justify a clinical hold. Generally, a clinical hold is an
order issued by FDA to the sponsor of an IND to delay a proposed clinical investigation or to
suspend an ongoing investigation.19
B. The Citizen Petition
In the CP, Petitioner requests that before FDA licenses any vaccine20 for COVID-19, the agency
require certain data be submitted. Because much of the relevant data is the kind that would be

17
The IRB is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical
research. IRBs approve clinical study protocols, which describe the type of people who may participate in the
clinical study; the schedule of tests and procedures; the medications and dosages to be studied; the length of the
study; the study's objectives; and other details. IRBs make sure that the study is acceptable, that participants have
given consent and are fully informed of the risks, and that researchers take appropriate steps to protect patients from
harm. See The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective web page, last updated
November 2017, https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-ensuring-drugs-
are-safe-and-effective.
18
21 CFR § 312.22(a).
19
21 CFR § 312.42(a).
20
The CP refers to “granting” a license. See, e.g., CP at 1. FDA generally refers to issuing licenses, or approving a
BLA. See 21 CFR § 601.2(d); 21 CFR § 601.4(a).
5
gathered during clinical trials, we interpret the CP as asking that FDA require the sponsors to
make the requested changes to their investigations, as well as, in some cases, to submit certain
other data. As explained above, with certain exceptions, clinical investigations in which a drug
is administered to human subjects must be conducted under an IND submitted to FDA by the
sponsor. FDA’s review of an IND includes a review of the study protocol which describes,
among other things, the design of the clinical study, including the identified endpoints and
methods for assessing the safety and effectiveness of the investigational product.
Below, we discuss the requested changes to the study design and other data submissions.
1. Petitioner’s request to require data demonstrating “substantial
evidence of clinical effectiveness that outweighs harms” in all
“special populations”
Petitioner asks that, prior to issuing a license for a COVID-19 vaccine, FDA require certain types
of clinical data, specifically:
data demonstrating substantial evidence of clinical effectiveness that outweighs harms, in all
special populations, as a condition of consideration of including these populations among the
indicated populations. Special populations include: infants, children, and adolescents; those with
past SARS-CoV-2 infection; immunosuppressed individuals; those with history of or current
cancer; individuals with hematological disorders or autoimmune diseases; pregnant or nursing
women; and frail older adults.
CP at 3.
Petitioner refers to the ongoing phase 3 trials of COVID-19 vaccines for the Moderna, Pfizer,
and Janssen products, and states that the trials “largely (or wholly) excluded” certain identified
populations. CP at 5. Petitioner states that there should be information about “what kind of
efficacy” exists for these populations, and refers to “reduction in risk of symptomatic COVID-19
vs. reduction in risk of hospitalization or death.” CP at 6.
Thus, Petitioner appears to request that FDA require evidence derived from clinical trials to
provide evidence of effectiveness for each of the identified populations, and also that clinical
trials be designed and conducted in each population to assess the effectiveness of these vaccines
to prevent COVID-19 disease of varying severity in the specified populations.
In support of Petitioner’s request, Petitioner asserts that “efficacy and safety of medicines often
differs amongst populations” and that the risks of SARS-CoV-2 infection are “considerably
lower in infants, children, and adolescents in comparison to adults.” CP at 5.
FDA addressed trial populations in the guidance.21 In the June 2020 guidance, FDA noted that
while certain exclusions were recommended, for example “[e]xclusion of participants at higher
risk of severe COVID-19 from early phase studies” in order “to mitigate potential risk of vaccine
associated [enhanced respiratory disease] until additional data to inform that potential risk
becomes available through ongoing product development,”22 FDA in general “encourages the

21
Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry, June 2020 (June 2020
Guidance), https://www.fda.gov/media/139638/download.
22
June 2020 Guidance at 10.
6
inclusion of diverse populations in all phases of vaccine clinical development.”23 FDA also
noted in the June 2020 Guidance that “vaccine safety and COVID-19 outcomes in individuals
with prior SARS-CoV-2 infection, which might have been asymptomatic, is also important to
examine because pre-vaccination screening for prior infection is unlikely to occur in practice
with the deployment of licensed COVID-19 vaccines.”24
With respect to the pediatric population, the June 2020 Guidance acknowledged that “the safety
and effectiveness of COVID-19 vaccines, may be different in children compared with adults”25
and recommended that “considerations on the prospect of direct benefit and acceptable risk to
support initiation of pediatric studies, and the appropriate design and endpoints for pediatric
studies, should be discussed in the context of specific vaccine development programs.”26
Although the June 2020 Guidance includes various recommendations, ultimately FDA licensure
decisions are based on an evaluation of the entirety of the data contained in a BLA and a finding
that a vaccine’s benefits outweigh its potential risks.
In assessing benefits and risks, FDA takes into account a number of factors including, but not
limited to, the evidence for benefit, the requested indication, severity of the disease or condition,
treatment alternatives, and the type and severity of adverse events. In general, the evidence for
benefit is based on the results of clinical trials. In some cases, vaccine clinical trials assess
clinical disease endpoints. In other cases, it may be scientifically acceptable to utilize
immunogenicity endpoints.
In assessing benefits for particular populations, FDA is not limited to considering evidence of
effectiveness based on clinical trial studies with disease endpoints. In some cases, FDA may
conclude that pediatric effectiveness can be extrapolated from adequate and well-controlled
studies in adults.27 Furthermore, a study may not be needed in each pediatric age group if data
from one age group can be extrapolated to another age group.28 There are times where it is
scientifically appropriate to demonstrate effectiveness using scientifically accepted immune
marker(s) of protection or to infer effectiveness for a population through immunobridging.
In assessing risks, FDA takes into account the type, frequency, and severity of any adverse
events.
The benefit-risk assessment will be informed by the body of evidence about the vaccine’s safety
and effectiveness submitted by an applicant in the BLA, the severity of the target disease, and the
target population. Thus, in approving or authorizing a vaccine for use in a particular population
(such as children), FDA will take into account the severity of the disease in the population as
well as the benefits of the vaccine.

23
Id. at 11.
24
Id.
25
Id.
26
Id.
27
See section 505B(a)(2)(B)(i) of the FD&C Act (21 U.S.C. 355c(a)(2)(B)(i)) (providing that “[i]f the course of the
disease and the effects of the drug are sufficiently similar in adults and pediatric patients, the Secretary may
conclude that pediatric effectiveness can be extrapolated from adequate and well-controlled studies in adults, usually
supplemented with other information obtained in pediatric patients, such as pharmacokinetic studies”).
28
See section 505B(a)(2)(B)(ii) of the FD&C Act (21 U.S.C. 355c(a)(2)(B)(ii)) (providing that “[a] study may not
be needed in each pediatric age group if data from one age group can be extrapolated to another age group”).
7
To require the Petitioner’s proposed across-the-board approach—i.e., of requiring effectiveness

data from clinical trials specific to each population group and specifically designed to evaluate
disease endpoints of varying severity (e.g., hospitalization and death) in all of the specified
populations—would not reflect the scientifically valid methods of assessing safety and
effectiveness described above. Petitioner has not provided a scientific justification for why such
tools as immunobridging or extrapolation across population groups cannot be used. Therefore,
we deny Petitioner’s request29 to require effectiveness data from clinical trials specifically
designed to assess disease endpoints of varying severity (e.g., hospitalization and death) for each
of the identified populations as a condition of licensing a COVID-19 vaccine.30,31

29
In denying Petitioner’s request, we do not dispute Petitioner’s statement that the risks of SARS-CoV-2 infection
can differ across population groups. That has been a feature of the pandemic’s effects thus far, with children and
adolescents generally experiencing a milder disease course compared to older adults. But as with adults, children
and adolescents with underlying conditions such as asthma, chronic lung disease, and cancer are at higher risk than
their healthier counterparts for COVID-19-related hospitalization and death. See generally Emergency Use
Authorization (EUA) Amendment for an Unapproved Product Review Memorandum (pertaining to FDA’s
authorization of the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years and older),
https://www.fda.gov/media/148542/download. These are features of COVID-19 that FDA may consider in weighing
the risks and benefits of COVID-19 vaccines for different populations.
30
With respect to Petitioner’s statement that it is important to consider “how much efficacy exists” (CP at 6) for
different populations, with the example of reduction of risk of hospitalization or death vs. reduction of risk of
symptomatic COVID-19, we agree that severity of disease experienced by different groups is an important
consideration that may be accounted for in a risk-benefit analysis. What we disagree with is Petitioner’s apparent
request that FDA only accept the results of clinical trials that have different endpoints for different populations (e.g.,
hospitalization or death for a younger population and symptomatic COVID-19 for older populations). A clinical
trial endpoint of symptomatic disease for all populations included in the trial may provide sufficient information for
FDA to adequately assess the risks and benefits of the vaccine, and FDA may evaluate the effectiveness of the
vaccine in different populations by considering subgroup analyses of the data including analyses of vaccine
effectiveness against disease of varying severity using pre-specified case definitions.
31
With respect to Petitioner’s statement that individuals with past SARS-CoV-2 infection “are likely to have
immunity to subsequent infections for as long or longer than immunity conferred by vaccine,” and that they “may
also be at heightened risk for adverse effects,” (CP at 5) we note that there is scientific uncertainty about the
duration of protection provided by previous natural infection, but that the scientific community believes that
vaccines may provide a longer duration of protection than that provided by natural infection. See CDC, COVID-19
Frequently Asked Questions, last updated August 2021, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/faq.html; Boyton, R. and D Altmann, 2021, Risk of SARS-CoV-2 reinfection after natural infection,
Lancet, 397(10280):1161-1163, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00662-
0/fulltext
In addition, you state that individuals with previous infection “may also be at heightened risk for adverse effects.”
CP at 5. The sources that you cite for this proposition are unavailing. First, the Krammer et al. publication
(http://medrxiv.org/lookup/doi/10.1101/2021.01.29.21250653) does not assert safety problems with this population
receiving COVID-19 vaccines; rather, the publication asserts that these individuals could receive only one dose of
vaccine without negatively impacting their antibody titers and sparing them from unnecessary local and systemic
adverse reactions (e.g., pain, swelling, fatigue, headache, chills, fever, muscle or joint pains) while also freeing up
many urgently needed vaccine doses. The Samanovic et al. publication
(http://dx.doi.org/10.1101/2021.02.07.21251311) similarly does not identify safety concerns, but rather concludes
that prior history of COVID-19 affects adaptive immune responses to mRNA vaccination. The Camara et al.
publication (https://www.biorxiv.org/content/10.1101/2021.03.22.436441v1) asserts only that the second dose may
not be necessary in individuals with prior infection and that a second dose may cause a “possible contraction of their
spike-specific memory T cell immunity,” while also noting that “[o]ur study has clear limitations” and that “more
detailed analysis of the phenotype of the spike-specific T cells induced by COVID-19 vaccines both in naïve and

8
2. Petitioner’s request to require data on the safety and

pharmacokinetic profiles of the spike protein
Petitioner asks FDA to “[r]equire data on the safety and pharmacokinetic profiles of the spike
protein” prior to licensing any COVID-19 vaccine. CP at 6. In support of this request, Petitioner
states that “[i]n-situ production of SARS-CoV-2 spike protein is the target mechanism of action
of all COVID-19 vaccines with an EUA at present. Therefore, the safety profile of the spike
protein itself (i.e., in the absence of virus) must be thoroughly understood in the range of
populations on the indications list.” CP at 6.
This request relates to the technology used to make the COVID-19 vaccines that have been
authorized by FDA for emergency use. The Pfizer-BioNTech and Moderna vaccines contain a
piece of mRNA that instructs cells in the body to make the distinctive “spike” protein of the
SARS-COV-2 virus. The Janssen COVID-19 vaccine is manufactured using a specific type of
virus called adenovirus type 26 (Ad26) that delivers a piece of the DNA that is used to make the
distinctive “spike” protein of the SARS-CoV-2 virus.
Your request appears to be premised on the notion that licensure should be contingent on
sponsors’ conducting safety studies of a specific protein produced by the COVID-19 vaccines
that is designed to elicit an immune response. Contrary to the assumption underlying your
request, it is not scientifically necessary to require toxicological or pharmacokinetic studies in
individuals to evaluate specific features of a vaccine outside the context of evaluating the vaccine
as a whole. In making a licensure decision, FDA determines whether the data and information
provided by a manufacturer have demonstrated that a vaccine is safe, pure, and potent. In
making a determination about the safety of a vaccine, the agency evaluates the complete
manufacturing process and whether specific features of a vaccine are such that the finished
product itself, when used at the recommended dose, is safe for the recipient. FDA applies its

recovered individuals are needed to answer these questions.” Petitioner also references a preprint by Levi et al.
(https://www.medrxiv.org/content/10.1101/2021.02.01.21250923v2). In the published version of that study, the
authors conclude that “[o]ne vaccine dose is sufficient in symptomatic SARS-CoV-2-exposed subjects to reach a
high titer of antibodies, suggesting no need for a second dose, particularly in light of current [sic] vaccine shortage.”
Levi et al. One Dose of SARS-CoV-2 Vaccine Exponentially Increases Antibodies in Individuals Who Have
Recovered from Symptomatic COVID-19, J Clin Invest. 2021;131(12):e149154:
https://www.jci.org/articles/view/149154). Levi et al. does not identify safety concerns with COVID-19 vaccines.
We note that history of infection prior to vaccination is not usually known in adverse event reports (either because it
wasn’t reported, or because it could have been asymptomatic and the patient never knew they had
infection). Likewise, there could be a reporting bias for a reporting system like VAERS, which relies on vaccine
recipients, healthcare providers, or others to initiate reports to the system, because individuals who were infected
previously might be more likely to report adverse events. However, FDA, together with CDC, has not become
aware of data from VAERS to suggest an increased frequency of adverse events in vaccinees who were infected
with SARS-CoV-2 prior to vaccination. FDA and CDC Medical Officers conduct on-going review of certain,
serious adverse events of special interest for the COVID vaccines. These reviews often include examination of the
narrative and other fields which would contain information about past infection, if provided. Additionally, CDC and
the VAERS Program contractor collect follow-up medical records for certain serious reports. Teams of physicians,
nurses, and other reviewers abstract key clinical details, including medical history, from these records. The
reviewers conducting these on-going surveillance efforts have not identified patterns of adverse events associated
with prior infection.
9
sound scientific judgment in evaluating vaccines and other biological products, and ensures that
vaccines licensed by the agency are safe within the meaning of the PHSA, the FD&C Act, and
implementing regulations.
With respect to the spike protein feature of vaccines for COVID-19, while there have been
numerous claims on social media suggesting that the spike protein is toxic,32 there are in fact no
reliable scientific data to indicate that the spike protein is toxic or that it lingers at any toxic level
in the body after vaccination. Below, we list the publications you cite in footnotes 15-28 of your
petition in support of what you describe as “safety concerns” with the spike protein feature of
authorized vaccines.33 The left column identifies the relevant footnote in your petition and the
accompanying citation, and the right column describes FDA’s analysis of the publication. The
information in the right column explains why you have not in fact presented data showing safety
problems with the spike protein feature of vaccines that would cause the vaccines to be unsafe.
Publication cited by Petitioner in support of “safety FDA analysis

concerns” regarding spike protein
Footnote 15: Ogata AF, Cheng C-A, Desjardins M, This work conducted in a small number of
Senussi Y, Sherman AC, Powell M, et al. Circulating individuals (n=13) documents that shortly following
SARS-CoV-2 Vaccine Antigen Detected in the Plasma of administration of the mRNA-1273 COVID-19
mRNA-1273 Vaccine Recipients. Clin Infect Dis vaccine, SAR-CoV-2 spike protein was detectible in
[Internet]. 2021 May 20; Available from: the plasma of 11 of the 13. Clearance of the protein
http://dx.doi.org/10.1093/cid/ciab465 from the circulation was associated with the
development of IgG and IgA antibodies. The authors
suggest a mechanism that might have led to the
findings, based on the immune response to the
vaccine. This paper documents the appearance of
spike protein in plasma and its clearance with
development of an immune response. This
publication does not provide evidence that
authorized COVID-19 vaccines are unsafe.
Footnote 16: Kuba K, Imai Y, Rao S, Gao H, Guo F, This article relates to SARS-CoV, the causative
Guan B, et al. A crucial role of angiotensin converting agent of SARS, an atypical pneumonia that occurred
enzyme 2 in several countries in 2002-2003. It was published
(ACE2) in SARS coronavirus-induced lung injury. Nat in 2005 before the discovery of SARS-CoV-2 and
Med [Internet]. 2005 Aug;11(8):875–9. the development of vaccines to prevent COVID-19.
Available from: http://dx.doi.org/10.1038/nm1267 Therefore, the reports in this publication do not
present safety concerns about the use of the spike
protein in vaccines.
Footnote 17: Chen I-Y, Chang SC, Wu H-Y, Yu T-C, This 2010 publication describes in vitro studies with
Wei W-C, Lin S, et al. Upregulation of the chemokine SARS-CoV. It was published in 2010 before the
(C-C discovery of SARS-CoV-2 and the development of
motif) ligand 2 via a severe acute respiratory syndrome vaccines to prevent COVID-19. The publication
coronavirus spike-ACE2 signaling pathway. J therefore does not present any evidence of safety

32
See, e.g., FactCheck.org, COVID-19 Vaccine-Generated Spike Protein is Safe, Contrary to Viral Claims,
https://www.factcheck.org/2021/07/scicheck-covid-19-vaccine-generated-spike-protein-is-safe-contrary-to-viral-
claims/ (describing spread of social media claims about the spike protein); Lin, R., 2021, Busted: 3 dangerous
social-media myths about COVID-19 vaccines, LA Times, https://www.latimes.com/california/story/2021-06-
03/covid-19-vaccine-myths-busted (same); Dupuy, B., 2021, Spike protein produced by vaccine not toxic, AP,
https://apnews.com/article/fact-checking-377989296609 (same).
33
See Sec. 3(b) of the CP, which refers to footnotes 15-28 as support for asserted safety concerns with the spike
protein.
10
Virol [Internet]. 2010 Aug;84(15):7703–12. Available concerns related to the formulation of COVID-19
from: http://dx.doi.org/10.1128/JVI.02560-09 vaccines.
Footnote 18: Patra T, Meyer K, Geerling L, Isbell TS, This publication pertains to SARS-CoV-2 infection
Hoft DF, Brien J, et al. SARS-CoV-2 spike protein and disease progression, but does not relate to
promotes IL6 trans-signaling by activation of angiotensin vaccines to prevent COVID-19. The publication
II receptor signaling in epithelial cells. PLoS Pathog therefore does not present any evidence of safety
[Internet]. 2020 Dec;16(12):e1009128. Available from: concerns related to the formulation of COVID-19
http://dx.doi.org/10.1371/journal.ppat.1009128 vaccines.
Footnote 19: Zhang S, Liu Y, Wang X, Yang L, Li H, This publication pertains to SARS-CoV-2 infection
Wang Y, et al. SARS-CoV-2 binds platelet ACE2 to and disease progression, but does not relate to
enhance thrombosis in COVID-19. J Hematol Oncol vaccines to prevent COVID-19. The publication
[Internet]. 2020 Sep 4;13(1):120. Available from: therefore does not present any evidence of safety
http://dx.doi.org/10.1186/s13045-020-00954-7 concerns related to the formulation of COVID-19
vaccines.
Footnote 20: Suresh SJ, Suzuki YJ. SARS-CoV-2 Spike This publication states that “it is critical to
Protein and Lung Vascular Cells. Journal of Respiration understand the biological effects of this [spike]
[Internet]. 2020 Dec 31 [cited 2021 May 25];1(1):40–8. protein on human cells to ensure that it does not
Available from: https://www.mdpi.com/2673-527X/1/1/4 promote long-term adverse health consequences”
and that “[f]urther work is needed to understand the
effects of various SARS-CoV-2 spike protein
segments” used in vaccines. But the publication
does not in fact report any adverse effects of
authorized vaccines. Nor does it conclude that use of
spike protein in authorized vaccines causes the
vaccines to be unsafe.
Footnote 21: Angeli F, Spanevello A, Reboldi G, Visca This article summarizes the features of several
D, Verdecchia P. SARS-CoV-2 vaccines: Lights and COVID-19 vaccines and discusses potential
shadows. Eur J Intern Med [Internet]. 2021 Apr 30; interactions between the spike protein of vaccines
Available from: with the cardiovascular system. The article notes
http://dx.doi.org/10.1016/j.ejim.2021.04.019 “[t]he basic mechanisms …require further
research…” and that newer vaccines might be
developed; however, it does not state that the spike
protein itself should be studied in people.
Footnote 22: Han M, Pandey D. ZMPSTE24 Regulates This publication pertains to COVID-19 disease, but
SARS-CoV-2 Spike Protein-enhanced Expression of does not relate to vaccines to prevent COVID-19.
Endothelial Plasminogen Activator Inhibitor-1. Am J The publication therefore does not present any
Respir Cell Mol Biol [Internet]. 2021 May 18; Available evidence of safety concerns related to the
from: http://dx.doi.org/10.1165/rcmb.2020-0544OC formulation of COVID-19 vaccines.
Footnote 23: Rhea EM, Logsdon AF, Hansen KM, This publication pertains to COVID-19 disease, but
Williams LM, Reed MJ, Baumann KK, et al. The S1 does not relate to vaccines to prevent COVID-19.
protein of SARS-CoV-2 crosses the blood-brain barrier in The publication therefore does not present any
mice. Nat Neurosci [Internet]. 2021 Mar;24(3):368– 78. evidence of safety concerns related to the
Available from: http://dx.doi.org/10.1038/s41593-020- formulation of COVID-19 vaccines.
00771-8
Footnote 24: Idrees D, Kumar V. SARS-CoV-2 spike This publication pertains to COVID-19, but does not
protein interactions with amyloidogenic proteins: relate to vaccines to prevent COVID-19. The
Potential clues to neurodegeneration. Biochem Biophys publication therefore does not present any evidence
Res Commun [Internet]. 2021 May 21;554:94–8. of safety concerns related to the formulation of
Available from: COVID-19 vaccines.
http://dx.doi.org/10.1016/j.bbrc.2021.03.100
Footnote 25: Lei Y, Zhang J, Schiavon CR, He M, Chen This publication pertains to the S protein, but does
L, Shen H, et al. SARS-CoV-2 Spike Protein Impairs not relate to vaccines to prevent COVID-19. The
Endothelial Function via Downregulation of ACE 2. Circ publication therefore does not present any evidence
Res [Internet]. 2021 Apr 30;128(9):1323–6. Available of safety concerns related to the formulation of
COVID-19 vaccines. In fact, the publication
11
from: concludes by stating: “vaccination-generated

http://dx.doi.org/10.1161/CIRCRESAHA.121.318902 antibody and/or exogenous antibody against S
protein not only protects the host from SARS-CoV-2
infectivity but also inhibits S protein-imposed
endothelial injury.”
Footnote 26: Zhang L, Richards A, Barrasa MI, Hughes This publication pertains to SARS-CoV-2 infection,
SH, Young RA, Jaenisch R. Reverse-transcribed SARS- but does not relate to vaccines to prevent COVID-19.
CoV-2 RNA can integrate into the genome of cultured The publication therefore does not present any
human cells and can be expressed in patientderived evidence of safety concerns related to the
tissues. Proc Natl Acad Sci U S A [Internet]. 2021 May formulation of COVID-19 vaccines.
25;118(21). Available from:
http://dx.doi.org/10.1073/pnas.2105968118
Footnote 27: Suzuki YJ, Nikolaienko SI, Dibrova VA, This publication pertains to SARS-CoV-2 infection,
Dibrova YV, Vasylyk VM, Novikov MY, et al. SARS- but does not relate to vaccines to prevent COVID-19.
CoV-2 spike protein-mediated cell signaling in lung The publication therefore does not present any
vascular cells. Vascul Pharmacol [Internet]. 2021 evidence of safety concerns related to the
Apr;137:106823. Available from: formulation of COVID-19 vaccines.
http://dx.doi.org/10.1016/j.vph.2020.106823
Footnote 28: Suzuki YJ, Gychka SG. SARS-CoV-2 Spike This publication states that “it is important to
Protein Elicits Cell Signaling in Human Host Cells: consider the possibility that the SARS-CoV-2 spike
Implications for Possible Consequences of COVID-19 protein produced by the new COVID-19 vaccines
Vaccines. Vaccines (Basel) [Internet]. 2021 Jan 11;9(1). triggers cell signaling events that promote
Available from: [pulmonary arterial hypertension],” and that it
http://doi.org/10.3390/vaccines901003 important to monitor vaccinees for long-term
consequences. While the publication advocates
experimental animal studies, it does not provide any
data suggesting that the vaccines cause any harm.

In sum, you have not demonstrated why FDA is scientifically or legally obligated to require
“data on the safety and pharmacokinetic profiles of the spike protein.” In other words, you have
not demonstrated why it is scientifically or legally faulty for FDA to make licensure
determinations without requiring the specific requested safety data on the isolated spike protein
in individuals. Therefore, we deny your request.34
3. Petitioner’s request to require data from biodistribution studies
Petitioner asks FDA to require “data from biodistribution studies investigating the actual
COVID-19 vaccines.” CP at 7. Petitioner asserts that data submitted thus far by Moderna and
Pfizer “suggests that the vaccines distribute widely in the body, including to the liver, brain,
heart, lung, adrenals, ovaries, and testes, among many other tissues.” CP at 7. Petitioner further
states that “instead of presenting novel biodistribution studies of the COVID-19 vaccine
formulations, sponsors presented substitute studies to FDA for an EUA during the pandemic.”
CP at 7. Therefore, according to Petitioner, “novel biodistribution studies investigating the

34
We note that in addition to generally requesting “data on the safety and pharmacokinetic profiles of the spike
protein,” you request that studies investigate the spike protein’s link to certain identified health outcomes (e.g.,
related to coagulopathy, reproduction, etc.). See Sec. 3(c) of the CP. Because we conclude that you have not
supported the need for the requested type of data that is specific to the isolated spike protein, we deny your requests
that FDA require that the studies producing such data examine the identified health outcomes. It is worth pausing to
acknowledge that you premise some of the health outcome data requests on information that you attribute to
VAERS. While VAERS is a critical part of FDA’s post-market safety monitoring system for vaccines, reports to
VAERS are not confirmed to be associated with vaccination.
12
actual COVID-19 vaccines are necessary.” CP at 7. Petitioner further states that the studies are
important “to characterize long term adverse effects and better understand potential
mechanism(s) of action of short and long term harms. . . ” CP at 7.
FDA addressed biodistribution studies in the June 2020 Guidance in the section regarding
toxicity studies. FDA recommended biodistribution studies “if the vaccine
construct is novel in nature and there are no existing biodistribution data from the
platform technology.”35 FDA specified that biodistribution studies may not be necessary in
certain situations “if the COVID-19 vaccine candidate is made using a platform technology
utilized to manufacture a licensed vaccine or other previously studied investigational vaccines
and is sufficiently characterized.”36
Petitioner has not demonstrated the need for biodistribution studies of “the actual COVID-19
vaccines.” For example, it is not scientifically inappropriate to support a BLA with
biodistribution data for a surrogate protein produced using the platform technology, for example
if imaging on such protein can be performed to visualize the location of the protein expression.
Because Petitioner has not explained why such alternative approaches cannot be used, we deny
Petitioner’s request.
4. Petitioner’s Request to Require Data from Pharmacovigilance
Systems Documenting an Investigation into Serious Adverse Events
Petitioner asks FDA to require “data from pharmacovigilance systems in the US and globally
documenting a thorough investigation serious adverse events, carried out by independent,
impartial individuals.” CP at 8. Petitioner states that “COVID-19 vaccines have now been
administered to hundreds of millions of individuals, and it is vital that all reports of SAEs
[significant adverse events] are thoroughly investigated to determine whether the vaccine played
any role in the SAE.” CP at 8. Petitioner also states that the investigation “must be carried out
by independent, impartial individuals.” CP at 9. Thus, Petitioner appears to be asking for
“thorough investigation” into serious adverse events.
It is unclear whether Petitioner is requesting that individual manufacturers perform the
pharmacovigilance, or if Petitioner asks that FDA do so. Given that post-marketing surveillance
systems are conducted both by sponsors and FDA, we interpret the request as asking that FDA
ensure that both the agency and sponsors conduct the requested investigations.
Petitioner has not demonstrated any failures to conduct “thorough investigations” into post-
marketing serious adverse events, so it is unclear what additional action FDA could take in
response to the CP. Therefore, we deny this request.
FDA agrees that post-marketing surveillance plays an important role. FDA is monitoring the
safety of the Authorized COVID-19 Vaccines through both passive and active safety surveillance
systems. FDA is doing so in collaboration with the Centers for Disease Control and Prevention
(CDC), the Centers for Medicare and Medicaid Services (CMS), the Department of Veterans
Affairs (VA), and other academic and large non-government healthcare data systems.

35
June 2020 Guidance, at 7.
36
Id.
13
In addition, FDA participates actively in ongoing international pharmacovigilance efforts,

including those organized by the International Coalition of Medicines Regulatory Authorities
(ICMRA) and the World Health Organization (WHO). These efforts are in addition to the
pharmacovigilance efforts being undertaken by the individual manufacturers for authorized
vaccines. A coordinated and overlapping approach using state-of the art technologies has been
implemented. As part of our efforts to be transparent about our COVID-19 vaccine safety
monitoring activities, FDA is posting summaries of the key safety monitoring findings on the
FDA website.37
Passive Surveillance
VAERS is a national passive surveillance vaccine safety database that receives unconfirmed
United States. Passive surveillance is defined as unsolicited reports of adverse events that are
sent to a central database or health authority. In the United States, these are received and entered
into VAERS, which is co-managed by FDA and CDC. In the current pandemic, these reports are
being used to monitor the occurrence of both known and unknown adverse events, as providers
of COVID-19 vaccines are required to report serious adverse events to VAERS.
As part of FDA and CDC's multi-system approach to post-licensure and post-authorization

vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns
of adverse events, also known as “safety signals.” VAERS reports generally cannot be used to
determine if a vaccine caused or contributed to an adverse event or illness. If the VAERS data
suggest a possible link between an adverse event and vaccination, the relationship may be further
studied in a controlled fashion.38
Anyone can make a report to VAERS, including vaccine manufacturers, private practitioners,
state and local public health clinics, vaccine recipients, and their parents or caregivers.
Surveillance programs like VAERS perform a critical function by generating signals of potential
problems that may warrant further investigation.
Active Surveillance
Active surveillance involves proactively obtaining and rapidly analyzing information related to
millions of individuals and recorded in large healthcare data systems to verify safety signals
identified through passive surveillance or to detect additional safety signals that may not have
been reported as adverse events to passive surveillance systems. FDA is conducting active
surveillance using the Sentinel BEST (Biologics Effectiveness and Safety) System and the CMS
system, and is also collaborating with other federal and non-federal partners.
BEST

37
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-
vaccines?
38
FDA, VAERS Overview, available at https://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-
events/vaers-overview
14
To elaborate further, the BEST system,39 which is part of the Sentinel initiative,40 comprises
large-scale claims data, electronic health records (EHR), and linked claims-EHR databases with
a data lag of approximately three months. The system makes use of multiple data sources and
enables rapid queries to detect or evaluate adverse events as well as studies to answer specific
safety questions for vaccines. The linked claims-EHR database makes it possible to study the
safety of vaccines in sub-populations with pre-existing conditions or in pregnant women. The
major partners for BEST currently are Acumen, IBM Federal HealthCare, IQVIA, and Columbia
University and many affiliated partners such as MedStar Health, BlueCross BlueShield of
America, the Observational Health Data Sciences and Informatics (OHDSI), OneFlorida,
University of California and several others.41
Using BEST, CBER plans to monitor about 15 adverse events42 that have been seen with the
deployment of previous vaccines but have yet to be associated with a safety concern for an
authorized COVID-19 vaccine at this time. CBER further plans to use the BEST system to
conduct more in-depth analyses should a safety concern be identified from sources such as
VAERS.
CMS
FDA has worked over the past several years with CMS to develop capabilities for routine and
time-sensitive assessments of the safety of vaccines for people 65 years of age and older using
the Medicare Claims database.43 Because it was already in place, this system was immediately
put into use for COVID-19 vaccine surveillance to monitor for adverse events.44

39
Biologics Effectiveness and Safety (BEST) System, https://www.fda.gov/vaccines-blood-biologics/safety-
availability-biologics/cber-biologics-effectiveness-and-safety-best-system
40
FDA’s Sentinel Initiative, https://www.fda.gov/safety/fdas-sentinel-initiative
41
To confirm the utility of the BEST system for situations such as COVID-19 vaccine surveillance, a test case was
conducted. This study aimed to replicate a previous study by the CDC’s Vaccine Safety Datalink (VSD) (Klein et al.
Pediatrics 2010) that examined the databases and analytic capabilities of the new system. The objective of this study
was to test the new system’s ability to reproduce the increased risk of febrile seizures in children receiving the first
dose of measles-mumps-rubella-varicella (MMRV) vaccine, compared to that of MMR and varicella vaccines
separately but on the same day. The results of the study met the objectives and demonstrated the ability of the BEST
Initiative data network to run a complex study protocol at multiple sites using a distributed data network and the
Observational Medical Outcomes Partnership Common Data Model (organizing disparate data sources into the same
database design using a common format).
42
CBER, Background Rates of Adverse Events of Special Interest for COVID-19 Vaccine Safety Monitoring, Draft
Protocol (December 31, 2020), https://www.bestinitiative.org/wp-content/uploads/2021/01/C19-Vaccine-Safety-
AESI-Background-Rate-Protocol-2020.pdf
43
CMS, Standard Analytical Files (Medicare Claims) – LDS, https://www.cms.gov/Research-Statistics-Data-and-
Systems/Files-for-Order/LimitedDataSets/StandardAnalyticalFiles
44
As one example of the capabilities of this system, FDA, CMS, and CDC evaluated the risk of Guillain-Barré
syndrome (GBS) following influenza vaccination after CDC’s Vaccine Safety Datalink, identified safety signals
suggesting an increased risk of GBS following high-dose influenza vaccinations and Shingrix vaccinations during
the 2018-2019 influenza season. CBER, CDC, and CMS formed working groups in February 2019 to refine these
safety signals in the CMS data.
15
During the current pandemic, FDA, CMS, and CDC have already used the Medicare data to
publish a study showing that frailty, comorbidities, and race/ethnicity were strong risk factors of
COVID-19 hospitalization and death among the U.S. elderly.45
In summary, in collaboration and coordination with several different partners, FDA has
assembled passive surveillance systems – including VAERS – and active surveillance systems
that can detect and refine safety findings with the Authorized COVID-19 Vaccines in a relatively
rapid manner. These systems can also potentially be leveraged to assess safety in specific
subpopulations and to assess vaccine effectiveness.
Petitioner points to a CDC webpage on COVID-19 vaccines that discusses 4,863 reports to
VAERS of death after COVID-19 vaccination that describes the monitoring that is conducted in
connection with such reports.46 Petitioner suggests that this is inadequate because of an FDA
response to a question posed by one of the CP signatories on the proportion of VAERS death
reports for which FDA/CDC staff had reached out to families to collect follow-up information.
In that response, FDA stated that “the VAERS system is not designed to determine causality of
adverse events” and thus “there is not a mechanism to follow-up with families for additional
details.”47 However, there are indeed procedures in place to conduct continuous monitoring of
VAERS data, including deaths (though the procedures do not involve following up with
families). When FDA and CDC receive reports of deaths in VAERS, there is a mechanism for
requesting and evaluating other types of follow-up information, including associated health
records, such as hospital discharge summaries, and medical and laboratory results, death
certificates, and autopsy reports.48
5. Petitioner’s Request to Include Gene Therapy Experts on the
Vaccines and Related Biological Products Advisory Committee
(VRBPAC)
Petitioner requests that FDA ensure the inclusion of gene therapy experts on the VRBPAC
because “there is a need to consider safety with the informed perspectives of those with expertise
in gene therapies.” CP at 9-10. In support of this request, Petitioner states that the vaccines
produced by several manufacturers are gene based and that “[t]heir mechanism of action differs
substantially from all other vaccines that have been used on populations globally, as these novel

45
Hector S Izurieta, David J Graham, Yixin Jiao, Mao Hu, Yun Lu, Yue Wu, Yoganand Chillarige, Michael
Wernecke, Mikhail Menis, Douglas Pratt, Jeffrey Kelman, Richard Forshee, Natural History of Coronavirus Disease
2019: Risk Factors for Hospitalizations and Deaths Among >26 Million US Medicare Beneficiaries, The Journal of
Infectious Diseases, 223: 6: 945–956 (2021), https://doi.org/10.1093/infdis/jiaa767
https://academic.oup.com/jid/article/223/6/945/6039057
46
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html.
47
Petitioner refers to a Letter to the Editor authored by one of the CP signatories that includes questions the
signatory posed to FDA, and FDA’s responses. See https://www.bmj.com/content/372/bmj.n149/rr-25.
48
See Shimabukuro et al., Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/ (stating that “For reports classified as serious, the
VAERS contractor requests associated health records, including hospital discharge summaries, medical and
laboratory results, and death certificates and autopsy reports for deaths. Additional MedDRA terms might be added
based on information obtained through follow-up. Also, for serious reports where the patient has not recovered from
the adverse event by the time the report was filed or recovery status was unknown, a follow-up letter is sent to the
reporter at one year requesting information on recovery status if that information is still not known”).
16
vaccines work on the premise of gene delivery, and may therefore be considered a type of gene
therapy.” CP at 9.
The VRBPAC’s members are selected “among authorities knowledgeable in the fields of
immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics,
vaccine policy, vaccine safety science, federal immunization activities, vaccine development
including translational and clinical evaluation programs, allergy, preventive medicine, infectious
diseases, pediatrics, microbiology, and biochemistry.”49 Additionally, an advisory committee
may consult with experts.50 FDA may also add temporary voting members to the VRBPAC, for
example to provide relevant expertise.51 The VRBPAC’s role is to advise FDA. The VRBPAC
does not make regulatory decisions.
The premise of the CP is that certain actions need to be taken “before serious consideration is
given to granting a BLA of any COVID-19 vaccine.” CP at 1. But it is FDA, not VRBPAC, that
is authorized to determine whether to approve a BLA. Indeed, the Public Health Service Act
confers this authority to the Secretary of the Department of Health and Human Services, and this
authority has been delegated to the Commissioner of FDA. Because FDA is authorized to
approve a BLA, we do not agree that the composition of an advisory committee is determinative
of whether to approve or seriously consider approving a BLA. Accordingly, we deny your
request.
6. Petitioner’s Request that FDA Ensure That Experts Within FDA
and Amongst VRBPAC Have No Financial or Research
Relationships With Any Vaccine Manufacturer’s Within 36 Months
Petitioner requests that FDA “[e]nsure that the analysis of data and decisions regarding any
COVID-19 vaccine BLA application are informed by experts with no financial or research
relationships52 with any vaccine manufacturers within the last 36 months, both within FDA and
amongst the composition of the VRBPAC.”53 CP at 10. In support of this request, Petitioner
states disclosure and transparency would demonstrate the independence of FDA decision making
and that an evaluation of data by “competent individuals with independence from vaccine
manufacturers” would be in the public interest.54 CP at 10.

49
See FDA’s Website on Vaccines and Related Biological Products Advisory Committee,
https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-
products-advisory-committee.
50
21 CFR § 14.31.
51
See https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-
committee/charter-vaccines-and-related-biological-products-advisory-committee.
52
You do not describe what you mean for there to be a conflict related to “research relationships.” You refer only to
disclosure requirements established by the International Committee of Medical Journal Editors (ICMJE)
(presumably that organization’s document related to providing readers of manuscripts with information about
interests that could influence how they receive scientific work), but an online form we found for ICMJE does not
use or define the term “research relationship.” See https://cdn-
links.lww.com/permalink/jbjs/d/jbjs_2017_03_30_tashjian_e15_sdc1.pdf. That form does describe financial
conflicts of interests, see id., and given the CP’s statement that decisions should be made by individuals with
“independence” we assume you refer to financial or employment-type conflicts.
53
CP at 10.
54
CP at 10.
17
FDA acknowledges the value in maintaining a positive public perception of how FDA conducts
its activities and ensuring that the decisions FDA employees make, and actions they take, neither
are, nor appear to be, tainted by any conflict of interest. Ethical requirements for both advisory
committee and staff are described in statute and regulation.55
FDA has addressed the evaluation of financial interests by special Government employees
(SGEs) and FDA employees in the 2014 Guidance for the Public, FDA Advisory
Committee Members, and FDA Staff: Public Availability of Advisory Committee Members’
Financial Interest Information and Waivers56 (Financial Issues Guidance) and has addressed the
evaluation of appearance issues in the 2016 draft Guidance for the Public, FDA Advisory
Committee Members, and FDA Staff: Procedures for Evaluating Appearance Issues and
Granting Authorizations for Participation in FDA Advisory Committees (Appearance Issues
Draft Guidance).57 The 2016 draft guidance, when finalized, will represent the current thinking
of the Food and Drug Administration (FDA or Agency) on this topic. As described in the
Appearance Issues Draft Guidance, “[t]o protect the credibility and integrity of advisory
committee advice, FDA screens advisory committee members carefully for two categories of
potentially disqualifying interests or relationships: (1) current financial interests that may create a
recusal obligation under Federal conflict of interest laws; and (2) other interests and relationships
that do not create a recusal obligation under Federal conflict of interest laws but that may create
the appearance that a member lacks impartiality, known as ‘appearance issues.’” The
Appearance Issues Guidance explicitly contemplates that a Research Relationship might raise an
appearance issue.58
FDA employees also are subject to strict ethical requirements.59 FDA employees, as well as
their spouses and minor children, are prohibited from holding financial interests, like stock, in
certain businesses regulated by FDA. This includes many companies working in the drug,
biologic, medical device, food, and tobacco industries, among others.60 In addition, certain
restrictions apply to FDA employees working on particular matters involving parties with whom
the employee has served as officer, director, trustee, general partner, agent, attorney, consultant,
contractor or employee.61
Although both the VRBPAC members and FDA employees are subject to ethical requirements,
the requirements do not involve a 36-month prohibition. For example, FDA is authorized by
statute to grant waivers to allow individuals with potentially conflicting financial interests to
participate in meetings where it concludes, after close scrutiny, that certain criteria are met.62
In addition, the restrictions that apply to FDA employees working on particular matters involving
parties with whom the employee has served as officer, director, trustee, general partner, agent,

55
See, e.g., 18 U.S.C. § 208; See also the description of Ethics Laws and Regulations on FDA’s website, available
at: https://www.fda.gov/about-fda/ethics/ethics-laws-and-regulations
56
https://www.fda.gov/media/83188/download. “Most FDA advisory committee members are appointed as SGEs.”
Financial Issues Guidance at 3.
57
58
See Appearance Issues Draft Guidance at 14-15.
59
For a summary of relevant requirements, see the description of Ethics Laws and Regulations on FDA’s website
https://www.fda.gov/about-fda/ethics/ethics-laws-and-regulations.
60
See Prohibited Financial Interests for FDA Employees, https://www.fda.gov/about-fda/ethics/prohibited-financial-
interests-fda-employees.
61
5 CFR § 2635.502.
62
See 18 U.S.C. § 208(b)(1) and (b)(3).
18
attorney, consultant, contractor or employee apply when the employee has served within the last
year--but not longer.
In evaluating your request, we are guided by these laws and regulations, which do not contain a
36-month prohibition. We also note that you have not demonstrated that any FDA employees or
members of the VRBPAC have been improperly involved in the agency’s review of COVID-19
vaccines. We are also guided by our consideration of one of the purposes served by an FDA
advisory committee, which is that it permits the agency access to a range of perspectives from
experts with the most current knowledge. We believe that applying our existing standards for
conflict of interest will address the perception concern that the CP articulates, while
appropriately balancing the agency’s need for current outside expertise. Accordingly, we deny
your request.
7. Petitioner’s Request to Revise the 2020 Guidance to Require 2
Years of Follow-Up
Petitioner requests that FDA “[c]onfirm, in revised Guidance, that the FDA expects a minimum
of 2 years of follow-up of participants enrolled in pivotal clinical trials, even if trials are
unblinded and lack a placebo control.” CP at 4. You state that “two year follow-up from trials
allows the detection of commonly experienced longer-term adverse effects that may not manifest
until many months following vaccination” and would add to the data collection in clinical trials
in certain ways that you identify. CP at 4.
FDA’s June 2020 Guidance describes FDA’s expectations for follow-up of participants enrolled
in clinical trials.63 FDA does not at this time see a need to revise its guidance documents,
because FDA may communicate to individual sponsors whether there is a need to support a BLA
with a particular duration of follow-up for a clinical trial. While guidance documents allow the
agency to articulate its interpretation of or policy on a regulatory matter (21 CFR § 10.115(b)),
there are also times where FDA’s advice would be specific to an individual manufacturer.
In addition, we note that there are many reasons why it may be appropriate to license some
vaccines based on follow-up of participants for less than two years. For example, if a clinical
trial enrolls subjects rapidly and the primary endpoint is the incidence of a disease such as
COVID-19 which occurs frequently, cases may accumulate quickly and may allow FDA to
assess the benefit-risk profile of the vaccine based on a shorter clinical trial duration and
participant follow-up. By contrast, if a clinical trial enrolls subjects more slowly and assesses a
disease with lower incidence, more time may be needed to accumulate a database that allows
statistically meaningful comparisons to be drawn between the vaccine and control groups.
FDA’s benefit-risk analysis may reasonably take into account the historical experience with
vaccines, and the fact that most adverse events that are plausibly linked to vaccination occur
within two months of vaccination.64 Furthermore, vaccine trials involve different types of
endpoints, with some trials focusing on immunogenicity endpoints and some focusing on disease
endpoints. All of these features impact the type and duration of data needed to evaluate the
benefits and risks of a vaccine.

63
See, e.g., June 2020 Guidance at 12.
64
Table VI. National Vaccine Injury Compensation Program. Rockville, MD: Health Resources and Services
Administration, 2017 (https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/vaccine-injury-table.pdf.
opens in new tab).
19
For all of these reasons, we deny Petitioner’s request.

8. Petitioner’s Request that FDA Revise its Guidance Document to
Address Safety Data from Individuals Receiving more than 2 Doses
Petitioner states that FDA should “[c]larify in revised Guidance that safety data from individuals
receiving more than 2 vaccine doses must be submitted by vaccine manufacturers.” CP at 9.
Petitioner states that the safety profile of multiple doses must be considered. CP at 9.
FDA does not at this time see a need to revise its guidance documents, because FDA may
communicate to individual sponsors whether there is a need to provide the agency with data to
support the possible use of more than 2 vaccine doses. While guidance documents allow the
agency to articulate its interpretation of or policy on a regulatory matter (21 CFR § 10.115(b)),
there are also times where FDA’s advice would be specific to an individual manufacturer.
Accordingly, we deny Petitioner’s request.
a. Conclusion
FDA has considered Petitioner’s requests. For the reasons given in this letter, FDA denies the
requests in Petitioner’s citizen petition. Therefore, we deny the CP in its entirety.
Sincerely,
Peter Marks, MD, PhD

Director
cc: Dockets Management Staff
20
A. Vaccines are Biologics and Drugs

Vaccines are both biological products under the Public Health Service Act (PHS Act) (42 U.S.C.
§ 262) and drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. §
321). The PHS Act defines a “biological product” as including a “vaccine…or analogous
product…applicable to the prevention, treatment, or cure of a disease or condition of human
beings.” 42 U.S.C. § 262(i)(1). The FD&C Act defines drug to include “articles intended for
use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.” 21 U.S.C. §
321(g)(1)(B).
Under the PHS Act, a biological product may not be introduced or delivered for introduction into
interstate commerce unless a biologics license is in effect for the product. 42 U.S.C. §
262(a)(1)(A).
B. Clinical Investigations of Vaccines
Before a vaccine is licensed (approved) by FDA and can be used by the public, FDA requires
that it undergo a rigorous and extensive development program that includes laboratory research,
animal studies, and human clinical studies to determine the vaccine’s safety and effectiveness.
The PHS Act and the FD&C Act provide FDA with the authority to promulgate regulations that
provide a pathway for the study of unapproved new drugs and biologics. 42 U.S.C. §
262(a)(2)(A) and 21 U.S.C. § 355(i). The regulations on clinical investigations require the
submission of an Investigational New Drug application (IND), which describes the protocol, and,
among other things, assures the safety and rights of human subjects. These regulations are set
out at 21 CFR Part 312. See 21 CFR § 312.2 (explaining that the IND regulations apply to
clinical investigations of both drugs and biologics).
The regulations provide that, once an IND is in effect, the sponsor may conduct a clinical
With respect to vaccines, Phase 1 studies typically enroll fewer than 100 participants and are
designed to look for very common side effects and preliminary evidence of an immune response
to the candidate vaccine. Phase 2 studies may include up to several hundred individuals and are
designed to provide information regarding the incidence of common short-term side effects, such
as redness and swelling at the injection site or fever, and to further describe the immune response
to the investigational vaccine. If an investigational new vaccine progresses past Phase 1 and
Phase 2 studies, it may progress to Phase 3 studies. For Phase 3 studies, the sample size is often
which may be in the thousands or tens of thousands of subjects. Phase 3 studies are usually of
sufficient size to detect less common adverse events.
If product development is successful and the clinical data are supportive of the proposed
indication, the completion of all three phases of clinical development can be followed by
submission of a Biologics License Application (BLA) pursuant to the PHS Act (42 U.S.C. §
262(a)), as specified in 21 CFR § 601.2.

21

C. Biologics License Applications
A BLA must include data demonstrating that the product is safe, pure, and potent and that the
facility in which the product is manufactured “meets standards designed to assure that the
biological product continues to be safe, pure, and potent.” 42 U.S.C. § 262(a)(2)(C)(i). FDA
does not consider an application to be filed until FDA determines that all pertinent information
and data have been received. 21 CFR § 601.2. FDA’s filing of an application indicates that the
application is complete and ready for review but is not an approval of the application.
Under § 601.2(a), FDA may approve a manufacturer’s application for a biologics license only
after the manufacturer submits an application accompanied by, among other things, “data derived
from nonclinical laboratory and clinical studies which demonstrate that the manufactured
product meets prescribed requirements of safety, purity, and potency.” The BLA must provide
the multidisciplinary FDA reviewer team (medical officers, microbiologists, chemists,
biostatisticians, etc.) with the Chemistry, Manufacturing, and Controls (CMC)65 and clinical
information necessary to make a benefit-risk assessment, and to determine whether “the
establishment(s) and the product meet the applicable requirements established in [FDA’s
regulations].” 21 CFR § 601.4(a).
FDA generally conducts a pre-license inspection of the proposed manufacturing facility, during
which production of the vaccine is examined in detail. 42 U.S.C. § 262(c). In addition, FDA
carefully reviews information on the manufacturing process of new vaccines, including the
results of testing performed on individual vaccine lots.
FDA scientists and physicians evaluate all the information contained in a BLA, including the
safety and effectiveness data and the manufacturing information, to determine whether the
application meets the statutory and regulatory requirements. FDA may also convene a meeting
of its advisory committee to seek input from outside, independent, technical experts from various
scientific and public health disciplines that provide input on scientific data and its public health
significance.
As part of FDA’s evaluation of a vaccine as a whole, FDA takes all of a vaccine’s ingredients
into account (including preservatives and adjuvants). FDA licenses a vaccine only after the
Agency has determined that the vaccine is safe and effective for its intended use, in that its
benefits outweigh its potential risks.

65
Also referred to as Pharmaceutical Quality/CMC.
22
Appendix II: Aspects of Vaccine Postmarketing Safety Monitoring

Post-marketing surveillance of vaccine safety is crucial to detect any rare, serious, or unexpected
adverse events, as well as to monitor vaccine lots. Manufacturers often conduct post-marketing
observational studies. However, FDA also uses multiple tools and databases to evaluate the
safety of vaccines after they have been licensed and used in the general population.
The Vaccine Adverse Event Reporting System (VAERS) is a national passive surveillance
vaccine safety database that receives unconfirmed reports of possible adverse events following
the use of a vaccine licensed in the United States. VAERS is co-administered by FDA and the
Centers for Disease Control and Prevention (CDC). Anyone can make a report to VAERS,
including vaccine manufacturers, private practitioners, State and local public health clinics,
vaccine recipients, and their parents or caregivers. Surveillance programs like VAERS perform
a critical function by generating signals of potential problems that may warrant further
investigation.
It is often difficult to determine with certainty if a vaccine caused an adverse event reported to
VAERS. Many events that occur after vaccination can happen by chance alone. Some adverse
events are so rare that their association with a vaccine is difficult to evaluate. In addition,
VAERS often receives reports where there is no clear clinical diagnosis. FDA draws upon
multiple sources of data and medical and scientific expertise to assess the potential strength of
association between a vaccine and a possible adverse event.
Monitoring and analysis of VAERS reports typically includes daily in-depth medical review of
all serious reports, statistical data mining techniques, and epidemiological analysis. We look for
patterns and similarities in the onset timing and clinical description. We review published
literature to understand possible biologic hypotheses that could plausibly link the reported
adverse event to the vaccine. We review the pre-licensure data and any other post-marketing
studies that have been conducted. We also consider “background rate,” meaning the rate at
which a type of adverse event occurs in the unvaccinated general population. When necessary,
we discuss the potential adverse event with our federal and international safety surveillance
partners. We also carefully evaluate unusual or unexpected reports, as well as reports of
“positive re-challenges” (adverse events that occur in the same patient after each dose received).
When there is sufficient evidence for a potential safety concern we may proceed to conduct large
studies, and we may coordinate with our federal, academic and private partners to further assess
the potential risk after vaccination. In addition, when potential safety issues arise, they are often
presented to various U.S. government advisory committees, including the Vaccines and Related
Biological Products Advisory Committee, the Advisory Committee on Immunization Practices,
the Vaccines Advisory Committee, and the Advisory Committee on Childhood Vaccines, and are
often discussed with experts from other countries and from the World Health Organization
(WHO). Federal agencies that assist in population-based vaccines safety studies include the
Centers for Medicaid and Medicare (CMS), the Department of Defense (DoD), and the Indian
Health Services (IHS). In addition, we generally communicate and work with international
regulatory authorities and international partners to conduct studies in vaccine safety.
The Vaccine Safety Datalink (VSD) project has actively monitored vaccine safety in more than
9.1 million people nationwide, over 3% of the US population. The VSD can monitor vaccine
safety with near real-time surveillance systems, which is particularly important for new vaccines.
If there is a vaccine safety signal in the VSD, chart reviews and case series analyses are done
23
when assessing the possible association between a vaccine and an adverse event. If needed,
VSD is able to use its large health care database to further evaluate specific vaccine safety
concerns.
The Clinical Immunization Safety Assessment (CISA) is a national network of six medical
research centers with expertise conducting clinical research related to vaccine safety. The goals
of CISA are: to study the pathophysiologic basis of adverse events following immunization using
hypothesis-driven protocols; to study risk factors associated with developing an adverse event
following immunization using hypothesis-driven protocols, including genetic host-risk factors; to
provide clinicians with evidence-based guidelines when evaluating adverse events following
immunization; to provide clinicians with evidence-based vaccination or revaccination guidelines;
and to serve as a regional referral center to address complex vaccine safety inquiries. Advances
in genetics and immunology continue to help us further assess the safety of vaccines, and FDA
has established a genomics evaluation team for vaccine safety.
Finally, the Sentinel Initiative is a national electronic system that will continue to improve
FDA’s ability to track the safety of medical products, including vaccines. Launched in May
2008 by FDA, the Sentinel System will enable FDA to actively query diverse automated
healthcare data holders – like electronic health record systems, administrative and insurance
claims databases, and registries – to evaluate possible safety issues quickly and securely. The
Sentinel Initiative will cover 100 million people in the U.S. It is also anticipated that Sentinel
will facilitate the development of active surveillance methodologies related to signal detection,
strengthening, and validation.
24
EXHIBIT B

GALVESTON DIVISION
v.
DR. ANTHONY FAUCI, in his official

capacity, et al.,
Defendants.
DECLARATION OF JOHN T. BROOKS, M.D.
I, John T. Brooks, M.D., state and declare as follows:
1. I am a physician with over twenty years of experience. I have devoted the majority
of my career to public health, with a focus on infectious diseases. In 1994, I obtained my medical
degree from Harvard Medical School. In 1995, I completed my internship in Internal Medicine at
Brigham and Women’s Hospital in Boston, Massachusetts. I was the Chief Medical Resident at
West Roxbury Veteran’s Hospital in West Roxbury, Massachusetts in October through December
1996. I was an AIDS Fellow at Brigham and Women’s Hospital in March through June 1997, and
an Infectious Disease Fellow in the Harvard Combined Program from July 1997 through June
1998. I served as an Epidemic Intelligence Service Officer for the Centers for Disease Control and
Prevention (“CDC”) from July 1998 through June 2000. In 1997, I received the American Board
of Internal Medicine certification, and in 2002, I received an Infectious Diseases subspecialty
certification. I have been continuously licensed to practice medicine in Massachusetts since 1996.
2. Since January 2020, I have served as the Chief Medical Officer for the
COVID-19 Emergency Response at CDC. My duties for this role include, but are not
limited to, serving as a subject matter expert to leadership within CDC. Accordingly, I stay
current on the emerging treatment and prevention science related to SARS-CoV-2
infection. In my regular role outside of the emergency response, I serve as the Chief
Medical Officer for the Division of HIV/AIDS Prevention at CDC, and I have held this
position since October 2015. I have been a Clinical Assistant Professor at Emory
University School of Medicine since November 2001.
3. I have held numerous roles within CDC since 1998, including medical
epidemiologist, team leader, task force leader, and incident manager. I have been involved
in CDC’s responses to crises including the Anthrax Response in 2001, SARS Response in
2003, Hurricane Katrina Response in 2005, Ebola Response in 2014 and 2015, and Zika
Response in 2016 and 2017. My curriculum vitae provides additional information
regarding my positions with CDC, as well as my education and training, certifications and
licensures, employment, committee and professional memberships, honors and awards,
and my work in peer-reviewed journals and publications. A true and accurate copy of my
curriculum vitae is attached to this declaration as Exhibit 1.
4. I have reviewed the complaint and motion for temporary restraining order in this
case, including the declarations attached to those filings. Based on my education, knowledge, and
experience, I opine as follows, to a reasonable degree of medical certainty.
5. CDC’s Science Brief, SARS-CoV-2 Infection-induced and Vaccine-induced
immunity, https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/vaccine-induced-
immunity.html (updated Oct. 29, 2021) (“Immunity Science Brief” or “Imm. Sci. Br.”), provides
2
an overview of the current scientific evidence that is informing our evolving understanding of the
protection against SARS-CoV-2 that is offered by vaccination versus previous infection.1 The
Immunity Science Brief considered over 90 peer-reviewed and pre-print publications, as well as
unpublished CDC data.
6. Population-based studies have shown that at a population level, higher antibody
concentrations in the blood are associated with decreased risk of SARS-CoV-2 infection. Imm.
Sci. Br. at 3, n.43, n.46-48. Vaccines, which safely and effectively prevent SARS-CoV-2 infection
and have been received by hundreds of millions of Americans, and which are readily available in
the United States at no cost,2 produce a more consistent and on average a stronger and more
predictable level of antibodies than infection with SARS-CoV-2 (the virus that causes the disease
COVID-19); SARS-CoV-2 infection produces antibody levels that vary more greatly, generally
according to the severity of the illness: antibody levels are higher after severe disease than after
mild or asymptomatic infection. Imm. Sci. Br. at 2, 3, 4, n.6, n.9-10, n.14-16, n.24, n.26-29, n.51.
7. With respect to assessing protection in individuals, scientists do not know the
antibody threshold needed for continued protection from a SARS-CoV-2 infection. Per the U.S.
Food and Drug Administration (“FDA”), “Currently authorized SARS-CoV-2 antibody tests are
not validated to evaluate specific immunity or protection from SARS-CoV-2 infection.”3 In other
words, there is no FDA-authorized or approved antibody test that can determine if an individual
person is protected against SARS-CoV-2 infection. This fact is important with respect to persons
1
The page numbers for the two Science Briefs cited in this declaration can be obtained by using the Print
function on the website and saving the documents as pdfs.
2
See CDC, COVID-19 Vaccinations in the United States, https://covid.cdc.gov/covid-data-
tracker/#vaccinations_vacc-total-admin-rate-total (updated daily).
3
FDA, Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19
Vaccination, https://www.fda.gov/medical-devices/safety-communications/antibody-testing-not-currently-
recommended-assess-immunity-after-covid-19-vaccination-fda-safety (issued May 19, 2021).
3
who were previously infected with SARS-CoV-2 for whom, as noted above, the immune response
is more variable than the immune response to vaccination; scientists do not know the antibody
threshold needed for continued protection from a SARS-CoV-2 infection in individuals. Imm. Sci.
Br. at 3. At the individual level, it is impossible to accurately test and verify whether any single
person has infection-induced immunity comparable to the immunity provided by current
vaccination, Imm. Sci. Br. at 3, which as noted, and in contrast to infection, produces a more
predictable immune response.
8. The data on infection-induced immunity are less robust than the data on vaccine-
induced immunity and thus more limited in their generalizability. In contrast to the data on vaccine-
induced protection against infection, which come from large randomized controlled trials as well
as prospective cohort studies, the data on infection-induced protection are derived mostly from
observational studies, many of which are retrospective. Imm. Sci. Br. at 1. Further, among the
seven large published and peer-reviewed studies of infection-induced immunity, the severity of
prior illness was fully characterized in only one. Imm. Sci. Br. at 8-11, n.54-58, n.95-96. The
remaining studies have a probable bias towards including persons who had symptomatic or
medically attended illness. Persons who have had mild or asymptomatic illness—who represent
up to one-third of infections4 and are estimated to account for more than 50 percent of new
infections5—are likely underrepresented in these other studies. At this time, this additional
4
Oran DP, Topol EJ. The Proportion of SARS-CoV-2 Infections That Are Asymptomatic: A Systematic
Review. Ann Intern Med. 2021 May;174(5):655-662. doi: 10.7326/M20-6976. Epub 2021 Jan 22. PMID:
33481642; PMCID: PMC7839426.
5
Johansson MA, Quandelacy TM, Kada S, Prasad PV, Steele M, Brooks JT, Slayton RB, Biggerstaff M,
Butler JC. SARS-CoV-2 Transmission From People Without COVID-19 Symptoms. JAMA Netw Open.
2021 Jan 4;4(1):e2035057. doi: 10.1001/jamanetworkopen.2020.35057. Erratum in: JAMA Netw Open.
2021 Feb 1;4(2):e211383. PMID: 33410879; PMCID: PMC7791354.
4
limitation to our understanding of infection-induced immunity also limits confident extension of
any protective benefit resulting from prior infection to the large fraction of people for whom that
illness was mild or asymptomatic.
9. Rigorous randomized controlled trials have demonstrated that COVID-19
vaccination provides strong protection against COVID-19 illness, including against severe disease,
hospitalization, and death. See CDC, Science Brief: COVID-19 Vaccines and Vaccination,
https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html
(updated Sept. 15, 2021) (Vaccine Sci. Br.). Additional studies have shown that COVID-19
vaccines are highly effective against hospitalization and death from infections caused by the
variants of the virus, including currently circulating variants of concern Alpha, Beta, Gamma and
Delta. Id. A growing body of evidence also suggests that COVID-19 vaccines reduce
asymptomatic infection and transmission. Id. at 3. Substantial reductions in SARS-CoV-2
infections (both symptomatic and asymptomatic) will reduce overall levels of disease and the
transmission of SARS-CoV-2 in the United States and thereby improve the safety of high-density
indoor environments such as schools, workplaces, entertainment venues, and places of worship,
among others. Id.
10. Studies also show that vaccination after infection safely strengthens the immune
response by significantly increasing antibody levels, including neutralizing antibodies that work
against the SARS-CoV-2 variants. Imm. Sci. Br. at 6, n.236, n.82-907.
6
Now published as Sokal A, Barba-Spaeth G, Fernández I, et al. mRNA vaccination of naive and COVID-
19-recovered individuals elicits potent memory B cells that recognize SARS-CoV-2 variants. Immunity.
2021 Sep 21:S1074-7613(21)00396-4. doi: 10.1016/j.immuni.2021.09.011. Epub ahead of print. PMID:
34614412; PMCID: PMC8452492.
7
n.82 now published as Appelman B, van der Straten K, Lavell AHA et al., Time since SARS-CoV-2
infection and humoral immune response following BNT162b2 mRNA vaccination. EBioMedicine. 2021
Oct;72:103589. doi: 10.1016/j.ebiom.2021.103589. Epub 2021 Sep 24. PMID: 34571363; PMCID:
PMC8461365. n.83 now published as Blain H, Tuaillon E, Gamon L, et al. Response after one and two
5
11. Multiple studies have shown that vaccination after infection also protects
better against reinfection than infection without subsequent vaccination, so that vaccination
of previously infected persons further reduces overall risk of further community
transmission. Id. at 5-7, n.79, n.92-94. For example, a case-control study of 738 residents
in Kentucky who had laboratory-confirmed COVID-19 found that among previously
infected persons, those who had remained unvaccinated were 2.3 times more likely to be
subsequently reinfected than those previously infected persons who were vaccinated after
they had recovered. Imm. Sci. Bri. at 6, n.92. Additional evidence includes results drawn
from studies of over 700,000 health system users in Israel, over 11,000 healthcare workers
in India, as well as a meta-analysis, which is a form of study that takes data from multiple
studies and weighs the evidence they contain as group to reach an overall conclusion. Imm.
Sci. Bri. at 6, n.93-94. In other words, available evidence from a growing body of research
supports the conclusion that vaccination after recovery from COVID-19 significantly
reduces the likelihood that a previously infected person will become infected again, which
thereby better protects them against another potentially serious illness and also decreases
the number of persons at risk for reinfection who could pose a threat of transmitting
infection to others.
jabs of the BNT162b2 vaccine in nursing home residents: The CONsort-19 study. Allergy. 2021 Jul
19:10.1111/all.15007. doi: 10.1111/all.15007. Epub ahead of print. PMID: 34286856; PMCID:
PMC8441741. n.84 now published as Lozano-Ojalvo D, Camara C, Lopez-Granados E, et al. Differential
effects of the second SARS-CoV-2 mRNA vaccine dose on T cell immunity in naive and COVID-19
recovered individuals. Cell Rep. 2021 Aug 24;36(8):109570. doi: 10.1016/j.celrep.2021.109570. Epub
2021 Aug 4. PMID: 34390647; PMCID: PMC8332924. n.85 now published as Carbonare LD, Valenti MT,
Bisoffi Z, et.al. Serology study after BTN162b2 vaccination in participants previously infected with SARS-
CoV-2 in two different waves versus naïve. Commun Med. 2021 Oct 13; published ahead of print.
https://doi.org/10.1038/s43856-021-00039-7.
6
12. Based on the review of the evidence in the Immunity Science Brief and additional
peer-reviewed scientific publications, the CDC recommends that even people who have already
had COVID-19 and have fully recovered should be vaccinated. COVID-19 vaccination not only
protects the individual but importantly also protects the greater public health, including those in
the workplace. The best way to stop COVID-19, including the emergence of variants, is with
widespread COVID-19 vaccination, and with disease prevention actions such as mask wearing,
physical distancing, frequent handwashing, and staying home when sick.
Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury that the above statements
are true and correct.
Executed on this 22nd day of November, 2021
__________________________
John T. Brooks, M.D.
7
EXHIBIT 1
John T. Brooks, MD
CURRICULUM VITAE
JOHN T. BROOKS, M.D. November 2021
EDUCATION
Harvard Medical School, Boston MA M.D. degree 1990-1994
University of Heidelberg, Heidelberg, Germany 1985-1986
Fellow at the Institute for Sediment Research, member Soils Research Group.
Wesleyan University, Middletown CT B.A. degree with Honors in Earth Science and German 1980-1985
Thesis: “Distribution and Geochemistry of Heavy Metals in Sediments of the Connecticut River Estuary”
PROFESSIONAL TRAINING
Clinical Assistant Professor, Emory University School of Medicine, Atlanta, GA 11/01- present
Epidemic Intelligence Service (EIS) Officer, Centers for Disease Control (CDC), Atlanta, GA 7/98-6/00
Infectious Disease Fellow, Harvard Combined Program, Boston, MA 7/97-6/98
AIDS Fellow, Brigham and Women’s Hospital, Boston, MA 3/97-6/97
Chief Medical Resident, West Roxbury Veteran’s Hospital, West Roxbury, MA 10/96-12/96
Resident, Internal Medicine, Brigham and Women’s Hospital, Boston, MA 7/95-6/97
Intern, Internal Medicine, Brigham and Women’s Hospital, Boston MA 6/94-6/95
LICENSES AND BOARDS

Massachusetts Medical License #150591, expires 01/31/2023
United States Medical Licensing Examination, Part I 1993, Part II 1994, Part III 1995
American Board of Internal Medicine Certification, 1997
Infectious Diseases Subspecialty Certification, 2002
EMPLOYMENT
Chief Medical Officer, CDC COVID-19 Emergency Response 01/20-present
1600 Clifton Road NE, 30329
Served as subject matter expert assisting response leadership remain current on the emerging treatment and
prevention science related to SARS-CoV-2 infection.
Chief Medical Officer, Division of HIV/AIDS Prevention, CDC, Atlanta GA 10/15-present

Responsible for advising Division leadership on all medical aspects of HIV infection, including the planning
and execution of the 2019 Presidential initiative “Ending the HIV Epidemic” – A Plan for America”
Team Leader, CDC Zika Response Unit (temporary duty), Atlanta GA 02/16-03/17
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John T. Brooks, MD

Supervised Zika Sexual Transmission Team in assessment of case of sexual transmission, responding to public
inquiries, and drafting guidelines for the prevention of sexual transmission of Zika virus.
Team Leader and Medical Epidemiologist, Division of HIV/AIDS Prevention, CDC, Atlanta GA 11/02-10/15
Team Leader of the Epidemiology Research Team, Division of HIV/AIDS Prevention, National Center for
HIV, TB, and STD Prevention. Supervise a team (7 full-time employees) that investigates and synthesizes
behavioral, clinical and social outcomes data to characterize U.S. HIV epidemic and its drivers to improve
prevention and treatment services. Lead the HIV Outpatient Study (HOPS), a 21-year multicenter prospective
cohort study of the natural history of HIV disease in North America. Provide technical assistance across the
Agency and Division as well as other federal partners (e.g., NIH, HRSA, VA, Department of Justice) for issues
related to HIV prevention, care, and treatment. Editor or writing member of multiple HIV-related guidelines.
Mentor EIS officers and other trainees.
Incident Manager, CDC 2015 Indiana HIV/HCV Outbreak Response (temporary duty), Atlanta GA 4/15-7/15
Led CDC collaboration with Indiana State Health Department in response to this event. Duties included
managing all aspects of epidemiologic and laboratory investigation, interventions to prevent new infections,
studies to fully characterize risk factors for HIV and HCV infection, and national estimation of other U.S.
communities vulnerable to rapid dissemination of HIV infection due to unsafe injection practices.
Task Force Leader, CDC Ebola Response Unit (temporary duty), Atlanta GA 8/14-10/14 and 3/15-4/15
Supervised Medical Care Task Force, later renamed Domestic Task Force, which grew from 40 to >150 persons
during this phase of the response. Responsibilities included managing all clinical are and infection control
aspects of the response during the time the epidemic was accelerating in West Africa and the first cases were
diagnosed in the United States.
Team Leader, CDC Hurricane Katrina Response Unit (temporary duty), Baton Rouge, LA 10/05-11/05
Supervised active surveillance for infectious diseases with outbreak potential (e.g., influenza-like illness, bloody
diarrhea, tuberculosis, bacterial meningitis) at > 300 evacuee centers throughout Louisiana on behalf of the
Louisiana Department of Health and Hospitals, Office of Public Health.
Team Leader, CDC SARS Response Unit (temporary duty), Atlanta GA 3/03-4/03
Supervised domestic surveillance for severe acute respiratory syndrome (SARS) with co-team leaders.
Managed a 35-member team of epidemiologists responsible for collecting surveillance data and producing daily
reports. Coordinated activities and communication between states and CDC. Assisted staff with briefings to
US Congress and with preparation of weekly summaries in Morbidity and Mortality Weekly Report.
Medical Epidemiologist, Division of HIV/AIDS Prevention, CDC, Atlanta GA 7/01-10/02

Supervised a variety of enhanced surveillance projects related to HIV disease, clinical outcomes, and quality of
care provided to HIV-infected persons. Supervised investigations of HIV infections of potential public health
significance including infections with non-clade B HIV-1, HIV-2, Group O HIV-1, HIV infection clusters, and
potential new modes of transmission.
Team Leader, CDC Anthrax Response Unit (temporary duty), Washington DC 11/01
Following initial investigation of anthrax bioterrorist events in Washington DC, supervised 25-member team
conducting follow-up activities, including interpretation of environmental testing results and clinical monitoring
of persons placed on antibiotic prophylaxis (e.g., adherence, side effects). Acted as CDC’s local liaison in these
Page 2 of 25
John T. Brooks, MD
focus areas with U.S. Congress, State Department, Central Intelligence Agency and other federal and local
governmental agencies.
Medical Epidemiologist, Foodborne and Diarrheal Disease Branch, CDC, Atlanta GA 7/00-6/01
Supervised the investigation of outbreaks of cholera (Micronesia, Marshall Islands) and E. coli O157 (multistate
USA), development of a web-based electronic foodborne outbreak reporting system, and on-going field
research in rural western Kenya that included a case-control study of risk factors for bloody diarrhea. Initiated
research project to study etiologies of diarrhea in HIV-infected adults in western Kenya. Served as the CDC
representative to the Partnership for Food Safety Education and to the Interstate Shellfish Sanitation
Conference. Responded to public and press inquiries.
Epidemic Intelligence Service Officer, CDC, Atlanta GA 7/98-6/00

Assigned to Foodborne and Diarrheal Diseases Branch. Principal duties included investigating domestic
outbreaks of foodborne and diarrheal disease, and developing epidemiologic and statistical skills. Other duties
included researching etiology and microbiology of bacterial enteric disease in rural western Kenya as well as
efficacy and acceptability of interventions to provide clean water. Managed domestic surveillance for botulism.
Consultant, World Health Organization, South Pacific Regional Office, Fiji 1/97-4/97
YWCA Building, Suva, FIJI
Instituted active national surveillance program to confirm regional polio eradication.
Research Assistant, Neutra Laboratory, Children’s Hospital, Boston MA 6/91-8/91
Evaluated the protective effect of experimental oral cholera vaccine in mice.
Feature Writer, Gannett News Service, Arlington VA 9/90-8/92

Wrote feature articles on a variety of science subjects in medicine and geology.
Science Consultant, Akin, Gump, Strauss, Hauer, and Feld, Washington DC 11/87-7/90
1333 New Hampshire Ave. NW, 20036
Researched issues relating to firm’s practice in personal injury claims, scientific fraud, and legislative
lobbying. Topics ranged from medicine and toxicology to geology and engineering. Advised clients on
interpretation of occupational health and environmental regulations.
NATIONAL COMMITTEE MEMBERSHIPS

AIDS Clinical Trials Group, Co-Infection and Malignancy Work Group 2013-present
DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents, member 2010-present
NIH-CDC-IDSA/HIVMA Treatment and Prevention of Opportunistic Infections Guidelines, coeditor 2007-present
Partnership for Food Safety and Education 1998-2001
Interstate Shellfish Sanitation Commission 1998-2001
HONORS AND AWARDS
United States Public Health Service, Commissioned Corps

Outstanding Unit Commendation awarded 2007
In recognition of vision, professional leadership, teamwork, and dedication in responding
to the President’s Emergency Plan for AIDS Relief
In recognition of protecting public health of citizens of Louisiana, Texas, Florida, and
Mississippi after hurricanes Katrina, Rita, and Wilma
Page 3 of 25
John T. Brooks, MD
Crisis Response Service Award awarded 2006

For contributions to the federal response to Hurricanes Katrina and Rita
Unit Commendation awarded 2005
For enhancing the collaboration across CDC of human papillomavirus activities
For exemplary teamwork and scientific excellence in the public health response to SARS
Public Health Service Citation awarded 2004
For noteworthy contributions to improving clinical care of HIV-infected Americans
Crisis Response Service Award awarded 2002
For contributions in the bioterrorism and anthrax activities of 2001
For service in responding to national terrorist attacks
For response to cholera outbreaks in two southern Pacific nations
Unit Commendation awarded 2002
For response to an outbreak of E. coli O111:H8 in Texas
Achievement Medal awarded 2001
For surveillance work for bacterial enteric infections in rural western Kenya
Foreign Duty Service Awards awarded 1999-2004
Other Awards
Charles C. Shepard Science Award for Data Methods and Study Design awarded 2018
For scientific excellence in peer-reviewed publication
Charles C. Shepard Science Award for Prevention and Control awarded 2017
For scientific excellence in peer-reviewed publication
Secretary of Health and Human Services Award for Distinguished Service awarded 2007
For exceptional commitment and teamwork responding to the destruction caused
by hurricanes Katrina, Rita and Wilma during 2005.
Nakano Citation awarded 2005
For outstanding scientific paper published in 2004 regarding SARS surveillance
Secretary of Health and Human Services Award for Distinguished Service awarded 2005
For extraordinary teamwork, productivity, and scientific excellence to control
the spread of SARS and monkeypox
Secretary of Health and Human Services Distinguished Service Medal awarded 2002
For exemplary teamwork, productivity, organization and scientific excellence
demonstrated during the public health emergency response to the World Trade
Center and Pentagon terrorist attacks and the anthrax investigation
Langmuir Prize awarded 2001
For best manuscript written while an EIS Officer, CDC
FDA Group Recognition Award awarded 2000
For work related to an outbreak of Salmonella
Soma Weiss Teaching Award awarded 1998
For outstanding performance as a Clinical Fellow
German Academic Exchange Service (D.A.A.D.) Fellowship awarded 1985
Sigma Xi elected 1985
Phi Beta Kappa elected 1985
PROFESSIONAL MEMBERSHIPS
member American College of Physicians
member Infectious Diseases Society of America and HIV Medicine Association
Page 4 of 25
John T. Brooks, MD
member International AIDS Society

member American Society of Tropical Medicine and Hygiene
member Massachusetts Medical Society
OTHER PROFESSIONAL DUTIES
Chair, Tuberculosis Clinical Trials Consortium Data Safety Monitoring Board 03/17-present
SPECIAL SKILLS
fluent in German, conversant in French

experienced using multiple statistical and graphics software packages (e.g. EpiInfo, SAS, Excel, PowerPoint)
Page 5 of 25
John T. Brooks, MD
MANUSCRIPTS
1. Brooks JT, Beezhold DH, Noti JD, Coyle JP, Derk RC, Blachere FM, Lindsley WG. Maximizing Fit for Cloth and
Medical Procedure Masks to Improve Performance and Reduce SARS-CoV-2 Transmission and Exposure, 2021.
Morbidity Mortality Weekly Report, 70(7):254-257, 2021. doi: 10.15585/mmwr.mm7007e1. PMID: 33600386;
PMCID: PMC7891692.
2. Brooks JT, Butler JC. Effectiveness of Mask Wearing to Control Community Spread of SARS-CoV-2. JAMA,
9;325(10):998-999,2021. doi: 10.1001/jama.2021.1505. PMID: 33566056.
3. Honein MA, Barrios LC, Brooks JT. Data and Policy to Guide Opening Schools Safely to Limit the Spread of
SARS-CoV-2 Infection. JAMA. 325(9):823-824, 2021. doi: 10.1001/jama.2021.0374. PMID: 33497433.
4. Christie A, Brooks JT, Hicks LA, Sauber-Schatz EK, Yoder JS, Honein MA; CDC COVID-19 Response Team.
Guidance for Implementing COVID-19 Prevention Strategies in the Context of Varying Community Transmission
Levels and Vaccination Coverage. Morbidity Mortality Weekly Report. 70(30):1044-1047, 2021. doi:
10.15585/mmwr.mm7030e2.
5. Lindsley WG, Derk RC, Coyle JP, Martin SB, Mead, KR, , Blachere FM, Beezhold DH, Brooks JT, Boots T, Noti
JD. Efficacy of Portable Air Cleaners and Masking for Reducing Indoor Exposure to Simulated Exhaled SARS-
CoV-2 Aerosols — United States, 2021Morbidity Mortality Weekly Report, 70 Early Release, July 2, 2021.
6. Patel MR, Carroll D, Ussery E, Whitham H, Elkins CA, Noble-Wang J, Rasheed JK, Lu X, Lindstrom S, Bowen V,
Waller J, Armstrong G, Gerber S, Brooks JT. Performance of Oropharyngeal Swab Testing Compared With
Nasopharyngeal Swab Testing for Diagnosis of Coronavirus Disease 2019-United States, January 2020-February
2020. Clinical Infectious Diseases. 72(3):403-410, 2021. doi: 10.1093/cid/ciaa759. PMID: 33527126.
7. Johansson MA, Quandelacy TM, Kada S, Prasad PV, Steele M, Brooks JT, Slayton RB, Biggerstaff M, Butler JC.
SARS-CoV-2 Transmission from People Without COVID-19 Symptoms. JAMA Network Open, 4(1):e2035057,
2021. doi: 10.1001/jamanetworkopen.2020.35057. Erratum in: JAMA Network Open, 4(2):e211383, 2021. PMID:
33410879; PMCID: PMC7791354.
8. Galloway SE, Paul P, MacCannell DR, Johansson MA, Brooks JT, MacNeil A, Slayton RB, Tong S, Silk BJ,
Armstrong GL, Biggerstaff M, Dugan VG. Emergence of SARS-CoV-2 B.1.1.7 Lineage - United States, December
29, 2020-January 12, 2021. Morbidity Mortality Weekly Report, 20(3):95-99, 2021. doi:
10.15585/mmwr.mm7003e2. PMID: 33476315; PMCID: PMC7821772.
9. Bull-Otterson L, Gray EB, Budnitz DS, Strosnider HM, Schieber LZ, Courtney J, García MC, Brooks JT, Mac
Kenzie WR, Gundlapalli AV. Hydroxychloroquine and Chloroquine Prescribing Patterns by Provider Specialty
Following Initial Reports of Potential Benefit for COVID-19 Treatment - United States, January-June 2020.
Morbidity Mortality Weekly Report, 69(35):1210-1215, 2020. doi: 10.15585/mmwr.mm6935a4. PMID: 32881845;
PMCID: PMC7470458.
10. Honein MA, Christie A, Rose DA, Brooks JT, Meaney-Delman D, Cohn A, Sauber-Schatz EK, Walker A,
McDonald LC, Liburd LC, Hall JE, Fry AM, Hall AJ, Gupta N, Kuhnert WL, Yoon PW, Gundlapalli AV, Beach
MJ, Walke HT; CDC COVID-19 Response Team. Summary of Guidance for Public Health Strategies to Address
High Levels of Community Transmission of SARS-CoV-2 and Related Deaths, December 2020. Morbidity
Mortality Weekly Report, 69(49):1860-1867, 2020. doi: 10.15585/mmwr.mm6949e2. PMID: 33301434; PMCID:
PMC7737690.
11. Brooks JT, Butler JC, Redfield RR. Universal Masking to Prevent SARS-CoV-2 Transmission-The Time Is Now.
JAMA,2020. doi: 10.1001/jama.2020.13107. Epub ahead of print. PMID: 32663243.
Page 6 of 25
John T. Brooks, MD
12. Gundlapalli AV, Salerno RM, Brooks JT, Averhoff F, Petersen LR, McDonald LC, Iademarco MF; CDC COVID-
19 Response. SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response.
Open Forum for Infectious Diseases, 8(1):ofaa555, 2020. doi: 10.1093/ofid/ofaa555. PMID: 33442555; PMCID:
PMC7717402.
13. Kirkcaldy R, King BA, Brooks JT, “COVID-19 and Postinfection Immunity Limited Evidence, Many Remaining
Questions “, JAMA, 323(22):2245-2246, 2020. doi: 10.1001/jama.2020.7869.
14. Furukawa NW, Brooks JT, Sobel J, “Evidence supporting transmission of severe acute respiratory syndrome
coronavirus 2 while presymptomatic or asymptomatic”, Emerging Infectious Diseases, 26(7):e201595, 2020. doi:
10.3201/eid2607.201595.
15. Jones JM, Kracalik I, Levi M, Bowman, J, Berger J, Bixler D, Buchacz K, Moorman A, Brooks JT, Basavaraju
SV, “PHS Guideline for Solid Organ Donor Assessment for Human Immunodeficiency Virus, Hepatitis B Virus,
and Hepatitis C Virus Infection and Transplant Recipient Monitoring”, Morbidity Mortality Weekly Report,
26;69(4):1-16, 2010. doi: 10.15585/mmwr.rr6904a1.
16. Oster AM, France AM, McClung RP, Buchacz K, Lyss SB, Peters PJ, Weidle PJ, Switzer WM, Phillip SA
Jr, Brooks JT, Hernandez AL. The CDC HIV Outbreak Coordination Unit: Developing a Standardized,
Collaborative Approach to HIV Outbreak Assessment and Response. Public Health Reports. 2021 May
28:333549211018678. doi: 10.1177/00333549211018678.
17. Peruski AH, Wesolowski LG, Delaney KP, Chavez P, Owen SM, Granade TC, Sullivan V, Switzer WM, Dong X,
Brooks, JT, Joyce MP, “Trends in HIV-2 Diagnoses and Use of the HIV-1/HIV-2 Differentiation Test — National
HIV Surveillance System, United States and Six Dependent Areas, 2010–2017”, Morbidity Mortality Weekly
Report, 69(3):63-66, 2020.
18. Hall HI, Brooks JT, Mermin J, “Can the United States Achieve 90-90-90?”, Current Opinion in HIV/AIDS,
14(6):464-470, 2019.
19. Henny KD, Duke CC, Buchacz K, Brooks JT, Samandari T, Sutton MY, “HIV prescriptions on the frontlines:
Primary care providers' use of antiretrovirals for prevention in the Southeast United States, 2017”, Prevention
Medicine, doi: 10.1016/j.ypmed.2019.105875. [Epub 2019 Oct 31].
20. Vu QM, Shouse RL, Brady K, Brooks JT, Weiser J, “Changes in HIV antiretroviral prescribing practices in the
United States”, International Journal of STDs and AIDS, doi.org/10.1177/0956462419880127.[Epub ahead of
print].
21. Klos B, Patel P, Rose C, Bush T, Conley L, Kojic EM, Henry K, Brooks JT, Hammer J; SUN study investigators,
“Lower serum adiponectin level is associated with lipodystrophy among HIV-infected men in the Study
to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN) study”, HIV Medicine,
2019 May 31. doi: 10.1111/hiv.12754, Epub ahead of print.
22. Pitasi MA, Delaney KP, Brooks JT, DiNenno EA, Johnson SD, Prejean J. “HIV Testing in 50 Local Jurisdictions
Accounting for the Majority of New HIV Diagnoses and Seven States with Disproportionate Occurrence of HIV in
Rural Areas, 2016-2017”, Morbidity Mortality Weekly Report, 68(25):561-567, 2019 doi:
10.15585/mmwr.mm6825a2.
23. Hartnett KP, Jackson KA, Felsen C, McDonald R, Bardossy AC, Gokhale RH, Kracalik I, Lucas T, McGovern O,
Van Beneden CA, Michael Mendoza M, Bohm M, Brooks JT, Asher AK, Magill SS, Fiore A, Blog D, Dufort EM,
See I, Dumyati G, “Bacterial and Fungal Infections in Persons Who Inject Drugs — Western New York, 2017”,
Morbidity Mortality Weekly Report, 68(26):583-586, 2019.
Page 7 of 25
John T. Brooks, MD
24. Patel P, Bush T, Conley L, Unger ER, Darragh TM, Henry K, Escota G, Brooks JT, Erna Milunka Kojic EM,
Prevalence, Incidence, and Clearance of Human Papillomavirus (HPV) Types Covered by Current Vaccines in
Men with HIV in the SUN Study”, Journal of Infectious Diseases, doi: 10.1093/infdis/jiz425. [Epub ahead of print]
25. Jones JM, Gurbaxani BM, Asher A, Sansom S, Annambhotla P, Moorman AC, Brooks JT, Basavaraju SV,
“Quantifying the Risk of Undetected HIV, Hepatitis B Virus, or Hepatitis C Virus Infection in Public Health
Service Increased Risk Donors”, American Journal of Transplantation, 2019 Apr 13. doi: 10.1111/ajt.15393. [Epub
ahead of print].
26. Bosh KA, Brooks JT, Hall HI, “HIV Epidemic Control in the United States-Assessment of Proposed UNAIDS
Metrics, 2010-2015”, Clinical Infectious Diseases, Epub 2019 February 26.
27. Abara WE, Collier MG, Moorman A, Bixler D, Jones J, Annambhotla P, Bowman J, Levi ME, Brooks JT,
Basavaraju SV, “Characteristics of Deceased Solid Organ Donors and Screening Results for Hepatitis B, C, and
Human Immunodeficiency Viruses — United States, 2010–2017”, Morbidity Mortality Weekly Report,68(3):61-
66, 2019. DOI: 10.15585/mmwr.mm6803a2 and American Journal of Transplantation, 19(3):939-947, 2019. doi:
10.1111/ajt.15284.
28. Escota G, Baker J, Bush T, Conley L, Brooks JT, Patel P, Powderly W, Presti R, Overton ET; CDC (Centers for
Disease Control and Prevention)-SUN (Study to Understand the Natural History of HIV/AIDS in the Era of
Effective Therapy) Investigators, “Brief report: Aging attenuates the association between coronary artery
calcification and bone loss among HIV-infected persons”, Journal of the Acquired Immunodeficiency Syndrome,
82(1):46-50, 2019.
29. Hernández-Ramírez RU, Qin L, Lin H, Leyden W, Neugebauer RS, Althoff KN, Hessol NA, Achenbach CJ,
Brooks JT, Gill MJ, Grover S, Horberg MA, Li J, Mathews WC, Mayor AM, Patel P, Rabkin CS, Rachlis A,
Justice AC, Moore RD, Engels EA, Silverberg MJ, Dubrow R; North American AIDS Cohort Collaboration on
Research and Design of the International Epidemiologic Databases to Evaluate AIDS. “Association of
immunosuppression and HIV viremia with anal cancer risk in persons living with HIV in the United States and
Canada”, Clinical Infectious Diseases, 2019 doi: 10.1093/cid/ciz329. [Epub ahead of print].
30. Bradley H, Althoff KN, Buchacz K, Brooks JT, Gill MJ, Horberg MA, Kitahata MM, Marconi V, Mayer KH,
Mayor A, Moore R, Mugavero M, Napravnik S, Paz-Bailey G, Prejean J, Rebeiro PF, Rentsch CT, Shouse RL,
Silverberg MJ, Sullivan PS, Thorne JE, Yehia B, Rosenberg ES, “Viral suppression among persons in HIV care in
the United States during 2009-2013: sampling bias in Medical Monitoring Project surveillance estimates”, Annals
of Epidemiology, 2019 Mar;31:3-7. doi: 10.1016/j.annepidem.2018.11.005. Epub 2018 Nov 22.
31. Polen KD, Gilboa SM, Hills S, Oduyebo T, Kohl KS, Brooks JT, Adamski A, Simeone RM, Walker AT, Kissin
DM, Petersen LR, Honein MA, Meaney-Delman D, “Update: Interim Guidance for Preconception Counseling and
Prevention of Sexual Transmission of Zika Virus for Men with Possible Zika Virus Exposure - United States,
August 2018”, Morbidity Mortality Weekly Report, 67:868-871, 2018. DOI: 10.15585/mmwr.mm6731e2.
32. Smith DM, Switzer WM, Peters P, Delaney KP, Granade TC, Masciotra S, Shouse L, Brooks, JT,“A Strategy for
PrEP Clinicians to Manage Ambiguous HIV Test Results during Follow-up Visits”, Open Forum for Infectious
Diseases, 5(8): ofy180, 2018. DOI: 10.1093/ofid/ofy180
33. Pitasi MA, Delaney KP, Oraka E, Bradley H, DiNenno EA, Brooks JT, Prejean J, “Interval Since Last HIV Test
for Men and Women with Recent Risk for HIV Infection — United States, 2006–2016”, Morbidity Mortality
Weekly Report, 67(24):677-681, 2018.
34. Kojic EM, Conley L, Bush T, Cu-Uvin S, Unger ER, Henry K, Hammer J, Escota G, Darragh TM, Palefsky JM,
Brooks JT, Patel P, “Prevalence and Incidence of Anal and Cervical High-Risk Human Papillomavirus Types
covered by Current HPV Vaccines among HIV-Infected Women in the Study to Understand the Natural History of
HIV/AIDS in the Era of Effective Therapy (The SUN Study)”, Journal of Infectious Diseases, 217(10:1544-1552,
2018. doi: 10.1093/infdis/jiy087.
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John T. Brooks, MD
35. Campbell EM, Jia H, Shankar A, Hanson D, Luo W, Masciotra S, Owen SM, Oster AM, Galang RR, Spiller MW,
Blosser SJ, Chapman E, Roseberry JC, Gentry J, Pontones P, Duwve J, Peyrani P, Kagan RM, Whitcomb JM,
Peters PJ, Heneine W, Brooks JT, Switzer WM, “Detailed Transmission Network Analysis of a Large Opiate-
Driven Outbreak of HIV Infection in the United States”, Journal of Infectious Diseases, 216(9):1053-1062, 2017.
published ahead of print October 5, 2017, doi: 10.1093/infdis/jix307
36. Jackson KA, Bohm MK, Brooks JT, Asher A, Nadle J, Bamberg W, Petit S, Ray SM, Harrison LH, Lynfield R,
Dumyati G, Schaffner W, Townes JM, Se I, “Invasive Methicillin-Resistant Staphylococcus aureus Infections
Among Persons Who Inject Drugs — Six Sites, 2005–2016’, Morbidity Mortality Weekly Report ,67:625–628,
2018. DOI: 10.15585/mmwr.mm6722a2
37. Mead PS, Duggal NK, PhD, Hook SA, Delorey M, Fischer M, McGuire DO, Becksted H, Max RJ, Anishchenko M,
Schwartz AM, Tzeng W, Nelson C, McDonald EM, Brooks JT, Brault AC, Hinckley AF, “Zika Virus Shedding in
Semen and Urine of Symptomatically Infected Men”, New England Journal of Medicine, 378(15):1377-1385, 2018.
38. Patel P, Bush T, Kojic EM, Conley L, Unger ER, Darragh TM, Henry K, Hammer J, Escota G, Palefsky JM,
Brooks JT, “Prevalence, incidence, and clearance of anal high-risk human papillomavirus (HPV) infection among
HIV-infected men in the SUN Study”, Journal of Infectious Diseases, 217(6):953-963, 2018. published ahead of
print December 4, 2017, doi: 10.1093/infdis/jix607.
39. Frazier EL, Sutton MY, Brooks JT, Shouse RL, Weiser J, “Trends in cigarette smoking among adults with HIV
compared with the general adult population, United States - 2009-2014”, Preventive Medicine, 111:231-234, 2018.
doi: 10.1093/infdis/jiy087.
40. Altekruse SF, Shiels MS, Modur SP, Land SR, Crothers KA, Kitahata MM, Thorne JE, Mathews WC, Fernández-
Santos DM, Mayor AM, Gill JM, Horberg MA, Brooks JT, Moore RD, Silverberg MJ, Althoff KN, Engels EA,
“Cancer burden attributable to cigarette smoking among HIV-infected people in North America”, AIDS, 32(4):513-
321, 2018. doi: 10.1097/QAD.0000000000001721.
41. Patel MR, Combs B, Hall P, Hough J, Chapman E, Perez A, Brooks JT, Peters PJ, Broz D, “Reduction in Injection
Risk Behaviors Following Emergency Implementation of a Syringe Services Program During an HIV Outbreak”,
Journal of the Acquired Immunodeficiency Syndrome, 77(4): 373-382, 2018. doi:
10.1097/QAI.0000000000001615.
42. Rosenberg ES, Bradley H, Buchacz K, McKenney J, Paz-Bailey G, Prejean J, Brooks JT, Shouse L, Sullivan PS,
”Improving Estimation of HIV Viral Suppression in the United States: A Method to Adjust HIV Surveillance
Estimates From the Medical Monitoring Project Using Cohort Data”, American Journal of Epidemiology, Apr 4.
doi: 10.1093/aje/kwy039. [Epub ahead of print], 2018.
43. Gregory CJ, Oduyebo T, Brault AC, Brooks JT, Chung KW, Hills S, Kuehnert MJ, Mead P, Meaney-Delman D,
Rabe I, Staples E, Petersen LR., “Modes of Zika Transmission”, Journal of Infectious Diseases, 215(S10):S875-
S883, 2017.
44. DeGroote NP, Mattson CL, Tie Y, Brooks JT, Garg S, Weiser S, “Hepatitis A Virus Immunity and Vaccination
Among At-risk Persons Receiving HIV Medical Care”, Preventive Medicine Reports, 11:139-144, 2018.
45. Yanik EL, Hernández-Ramírez RU, Qin L, Lin H, Leyden W, Neugebauer RS, Horberg MA, Moore RD, Mathews
WC, Justice AC, Hessol NA, Mayor AM, Gill MJ, Brooks JT, Sun J, Althoff KN, Engels EA, Silverberg MJ,
Dubrow R, “Brief Report: Cutaneous Melanoma Risk Among People With HIV in the United States and Canada”,
Journal of the Acquired Immunodeficiency Syndrome, 78(5):499-504, 2018. doi:
10.1097/QAI.0000000000001719.
Page 9 of 25
John T. Brooks, MD
46. Bosh KA, Coyle JR Hansen V, Kim EM, Speers S, Comer M, Maddox LM, Khuwaja S, Zhou W, Jatta A, Mayer
R, Brantley AD, Muriithi NW Bhattacharjee R, Flynn C Bouton L, John B, Keusch J, Barber CA, Sweet K,
Ramaswamy C, Westheimer EF, Vanderbusch L, Nishimura A, Vu A, Hoffman-Arriaga L, Rowlinson E, Carter
AO, Yerkes LE, Li W, Reuer JR, Stockman LJ, Tang T, Brooks JT, Teshale EH, Hall, IH, “HIV and viral hepatitis
coinfection analysis using surveillance data from 15 US states and two cities”, Epidemiology and Infection,
146(7):920-930, 2018. doi: 10.1017/S0950268818000766.
47. Mead PS, Hills SL, Brooks JT, “Zika as a Sexually Transmitted Pathogen”, Current Opinion in Infectious
Diseases, published ahead of print November 4, 2017. doi: 10.1097/QCO.0000000000000414.
48. Sullivan-Chang L, Saraiya M, Dunne EF, Brooks JT, “More testing, more questions: Screening tests for oral
human papillomavirus infection”, Journal of the American Dental Association, 148(11):781-783, 2017.
49. Engels EA, Yanik EL, Wheeler W, Gill MJ, Shiels MS, Dubrow R, Althoff KN, Silverberg MJ, Brooks JT,
Kitahata MM, Goedert JJ, Grover S, Mayor AM, Moore RD, Park LS, Rachlis A, Sigel K, Sterling TR, Thorne JE,
Pfeiffer RM; North American AIDS Cohort Collaboration on Research and Design of the International
Epidemiologic Databases to Evaluate AIDS; North American AIDS Cohort Collaboration on Research and Design
of the International Epidemiologic Databases to Evaluate AIDS, “Cancer-Attributable Mortality Among People
With Treated Human Immunodeficiency Virus Infection in North America”, Clinical Infectious Diseases,
65(4):636-643, 2018. doi: 10.1093/cid/cix392.
50. Weiser J, Beer L, Brooks JT, Irwin K, West BT, Duke CC, Gremel GW, Skarbinski J,” Delivery of HIV
Antiretroviral Therapy Adherence Support Services by HIV Care Providers in the United States, 2013 to 2014”,
Journal of the International Association of Providers of AIDS Care, 16(6):624-631, 2017.
51. Patel MR, Brooks JT, Tie Y, Garg S, Bradley H, “Prevalence of Gonorrhea and Chlamydia Testing by Anatomical
Site Among Men Who Have Sex With Men in HIV Medical Care, United States, 2013-2014”, Sexually
Transmitted Diseases, 45(1):25-27, 2017. doi: 10.1097/OLQ.0000000000000691.
52. Brooks JT, Kawwass JF, Smith DK, Kissin DM, Lampe M, Haddad LB, Boulet SL, Jamieson DJ, “Effects of
Antiretroviral Therapy to Prevent HIV Transmission to Women in Couples Attempting Conception When the Man
Has HIV Infection - United States, 2017”, Morbidity Mortality Weekly Report, 66(32):859-860, doi:
10.15585/mmwr.mm6632e1.
53. Samandari T, Tedaldi E, Armon C, Hart R, Chmiel JS, Brooks JT, Buchacz K, and the HIV Outpatient Study
Investigators, “Incidence of Hepatitis C Virus Infection in the Human Immunodeficiency Virus Outpatient Study
Cohort, 2000-2013”, Open Forum for Infectious Diseases, 4(2):ofx076, 2017. doi: 10.1093/ofid/ofx076.
54. McCree DH, Purcell DW, Cleveland JC, Brooks JT, “Increasing Availability of Prevention to Communities
Disproportionately Affected by HIV”, American Journal of Public Health, 107(7):1027-1028, 2017. doi:
10.2105/AJPH.2017.303764
55. Dean BB, Scott M, Hart R, Battalora L, Novak RM, Durham MD, Brooks JT, Buchacz K; HIV Outpatient Study
(HOPS) Investigators, “Sexually Transmitted Disease Testing of Human Immunodeficiency Virus-Infected Men
Who Have Sex With Men: Room for Improvement”, Sexually Transmitted Diseases, 44(11):678-684, 2017. doi:
10.1097/OLQ.0000000000000664.
56. Drozd DR, Kitahata MM, Althoff KN, Zhang J, Gange SJ, Napravnik S, Burkholder GA, Mathews WC, Silverberg
MJ, Sterling TR, Heckbert SR, Budoff MJ, Van Rompaey S, Delaney JAC, Wong C, Tong W, Palella FJ, Elion
RA, Martin JN, Brooks JT, Jacobson LP, Eron JJ, Justice AC, Freiberg MS, Klein DB, Post WS, Saag MS, Moore
RD, Crane HM, “Increased Risk of Myocardial Infarction in HIV-Infected Individuals in North America Compared
to the General Population”, Journal of the Acquired Immunodeficiency Syndrome, published ahead of print May
17, 2017.
Page 10 of 25
John T. Brooks, MD
57. Manion M, Hullsiek KH, Wilson EMP, Rhame F, Kojic E, Gibson D, Hammer J, Patel P, Brooks JT, Baker JV,
Sereti I; Study to Understand the Natural History of HIV/AIDS in the Era of Effective Antiretroviral Therapy (the
‘SUN Study’) Investigators, “Vitamin D deficiency is associated with IL-6 levels and monocyte activation in HIV-
infected persons, PLoS One, 12(5):e0175517, 2017.
58. Weiser J, Brooks JT, Skarbinski J, West BT, Duke CC, Gremel GW, Beer L. Barriers to Universal Prescribing of
Antiretroviral Therapy by HIV Care Providers in the United States, 2013-2014. Journal of the Acquired
Immunodeficiency Syndrome, 74(5):479-487, 2017.
59. Peters PJ, Pontones P, Hoover KW, Patel MR, Galang RR, Shields J, Blosser SJ, Spiller MW, Combs B, Switzer
WM, Conrad C, Gentry J, Khudyakov Y, Waterhouse D, Owen SM, Chapman E, Roseberry JC, McCants V, Weidle
PJ, Broz D, Samandari T, Mermin J, Walthall J, Brooks JT, and Duwve J for the Indiana HIV Outbreak
Investigation Team, “An Outbreak of HIV Infection Linked to Injection Drug Use of Oxymorphone — Indiana,
2014 – 2015”, New England Journal of Medicine, 375(3):229-239, 2016.
60. Van Handel MM, Brooks JT, “Understanding local context is necessary for HIV and HCV prevention planning”,
Journal of the Acquired Immunodeficiency Syndrome, 74(3):e84-e85, 2016.
61. Russell K, Hills SL, Oster AM, Porse CC, Danyluk G, Cone M, Brooks R, Scotland S, Schiffman E, Fredette C,
White JL, Ellingson K, Hubbard A, Cohn A, Fischer M, Mead P, Powers AM, Brooks JT, ”Male-to-Female
Sexual Transmission of Zika Virus-United States, January-April 2016“ Clinical Infectious Diseases, published
ahead of print Oct 19 2016. pii: ciw692
62. Deckard DT, Chung WM, Brooks JT, Smith JC, Woldai S, Hennessey M, Kwit N, Mead P, “Male-to-Male Sexual
Transmission of Zika Virus - Texas, January 2016”, Morbidity Mortality Weekly Report, 65(14):372-4. doi:
10.15585/mmwr.mm6514a3, 2016.
63. Willis LA, Kachur R, Castellanos TJ, Spikes P, Gaul ZJ, Gamayo AC, Durham M, Jones S, Nichols K, Han
Barthelemy S, LaPlace L, Staatz C, Hogben M, Robinson S, Brooks JT, Sutton MY. Developing a Motion Comic
for HIV/STD Prevention for Young People Ages 15-24, Part 1: Listening to Your Target Audience. Health
Communications, 33(2):212-221, 2018.
64. Brooks JT, Friedman A, Kachur RE, LaFlam M, Peters PJ, Jamieson DJ, “Update: Interim Guidance for
Prevention of Sexual Transmission of Zika Virus - United States, July 2016”. Morbidity Mortality Weekly Report,
65(29):745-7, 2016.
65. Oster AM, Russell K, Stryker JE, Friedman A, Kachur RE, Petersen EE, Jamieson DJ, Cohn AC, Brooks JT,
“Update: Interim Guidance for Prevention of Sexual Transmission of Zika Virus - United States, 2016”, Morbidity
Mortality Weekly Report, 65(12):323-5, doi: 10.15585/mmwr.mm6505e1, 2016.
66. Petersen EE, Polen KN, Meaney-Delman D, Ellington SR, Oduyebo T, Cohn A, Oster AM, Russell K, Kawwass
JF, Karwowski MP, Powers AM, Bertolli J, Brooks JT, Kissin D, Villanueva J, Muñoz-Jordan J, Kuehnert M,
Olson CK, Honein MA, Rivera M, Jamieson DJ, Rasmussen SA. Update: Interim Guidance for Health Care
Providers Caring for Women of Reproductive Age with Possible Zika Virus Exposure - United States, 2016.
Morbidity Mortality Weekly Report, 65(12):315-22. doi: 10.15585/mmwr.mm6512e2, 2016.
67. Gokhale, RH, Galang RR, Pitman JP, John T. Brooks JT, “A Tale of Two HIV Outbreaks Caused by Unsafe
Injections in Cambodia and United States 2014-2015”, American Journal of Infection Control, 1;45(2):106-107,
2017.
68. Van Handel M, Rose CE, Hallisey EJ, Kolling JL, Zibbell JE, Lewis B, Bohm MK, Jones CM, Flannigan BE,
Siddiqi AEA, Iqbal K, Dent A, Mermin JH, McCray E, Ward JW, Brooks JT, “County-level Vulnerability
Assessment for Rapid Dissemination of HIV or HCV Infections among Persons who Inject Drugs, United States”,
Journal of the Acquired Immunodeficiency Syndrome, 73(3):323-331, 2016.
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John T. Brooks, MD
69. Gokhale RH, Galang RR, Pitman JP, Brooks JT, “A tale of 2 HIV outbreaks caused by unsafe injections in
Cambodia and the United States, 2014-2015”, American Journal of Infection Control. pii: S0196-6553(16)30967-1,
DOI: 10.1016/j.ajic.2016.10.014, 2016
70. Thompson-Paul AM, Lichtenstein KA, Armon C, Buchacz K, Skarbinski J, Hart R, Chmiel JS, Palella FJ, Wei SC,
Loustalot F, Brooks JT, “Cardiovascular disease risk prediction in the HIV Outpatient Study”, Clinical Infectious
Diseases, 63(11):1508-1516, 2016.
71. Buchacz K, Lau B, Jing Y, Bosch R, Abraham A, Silverberg MJ, Sterling T, Gill J, Brukholder G. Samji H, Althoff
KN, Patel P, Mayor A, Henry K, Rachlis A, Moore R, Gange SJ, Brooks JT, “Incidence of AIDS-defining
opportunistic infections in a multicohort analysis of HIV-infected persons in the United States and Canada, 2000-
2010”, Journal of Infectious Diseases, 214(6):862-872, 2016.
72. Durham MD, Hart R, Buchacz K, Young B, Hammer J, Yangco B, Wood K, Yang D, Brooks JT, “ Frequency and
correlates of antiretroviral non-adherence in the HIV Outpatient Study (HOPS), USA, 2007 – 2014”, in peer
review.
73. Conley LJ, Bush TJ, Darragh TM, Palefsky JM, Unger ER, Patel P, Steinau M, Kojic EM, Martin H, Overton ET,
Cu-Uvin S, Hammer J, Henry K, Wood K, Brooks JT and the SUN Study Investigators, “Incidence and Predictors
For Development of Abnormal Anal Cytology Among HIV-infected Adults Receiving Contemporary
Antiretroviral Therapy”, in peer review.
74. Rhea S, Moorman A, Pace R, Mobley V, MacFarquhar J, Robinson E, Hayden T, Thai H, Drobeniuc J, Brooks JT,
Moore Z, Patel PR, “Hepatitis B Reactivation and Hemodialysis-Related Transmission, North Carolina, 2013”,
American Journal of Kidney Disease, 68(2):292-5. doi: 10.1053/j.ajkd.2016.03.424, 2016
75. Patel P, Bush T, Kojic EM, Overton ET, Henry K, Önen N, Rhame F, Conley L, Brooks JT, Fry A, “Duration of
influenza shedding among HIV-infected adults in the cART Era, 2010-2011”, AIDS Research and Human
Retroviruses, 32(12):1180-1186, 2016.
76. Palella FJ, Armon C, Chmiel JS, Brooks JT, Hart R, Lichtenstein K, Novak R, Yangco B, Wood K, Durham M,
Buchacz K, and the HOPS Investigators, “CD4 Cell Count at Initiation of Antiretroviral Therapy Predicts Long-
term Likelihood of Achieving CD4 >750 cells./mm3 and Mortality Risk”, Journal of Antimicrobial Chemotherapy,
71(9):2654-2662, doi:10.1093/jac/dkw196, 2016.
77. Kahler CW, Liu T, Cioe PA, Bryant V, Pinkston MM, Kojic EM, Onen N, Baker JV, Hammer J, Brooks JT, Patel
P, “ Direct and indirect effects of heavy alcohol use on clinical outcomes in a longitudinal study of HIV patients on
ART”, AIDS and Behavior. doi:10.1007/s10461-016-1474-y, 2016
78. Young B, Hart RLD, Buchacz K, Scott M, Palella F, Brooks JT, for the HIV Outpatient Study (HOPS), “HIV viral
load monitoring frequency and risk of treatment failure among immunologically stable HIV-infected patients
prescribed combination antiretroviral therapy”, International Journal of Physicians In AIDS Care, 14(6):536-543,
2016.
79. Sheth AN, Ofotokun I, Buchacz K, Armon C, Chmiel JS, Hart RL, Baker R, Brooks JT, Palella FJ Jr.
Antiretroviral Regimen Durability and Success in Treatment-Naive and Treatment-Experienced Patients by Year of
Treatment Initiation, United States, 1996-2011. Journal of the Acquired Immunodeficiency Syndrome, 71(1):47-
56, 2016.
Page 12 of 25
John T. Brooks, MD
80. Silverberg MJ, Lau B, Achenbach CJ, Jing Y, Althoff KN, D’Souza G, EA Engels, Hessol N, Brooks JT, Burchell
AN, Gill MJ, Goedert JJ, Hogg R, Horberg MA, Kirk GD, Kitahata MM, Korthuis PT, Mathews WC, Mayor A,
Modur SP, Napravnik S, Novak RM, Patel P, Rachlis AR, Sterling TR, Willig JH, Justice AC, Moore RD, and
Dubrow R for the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of IeDEA,
“Cumulative Incidence of Cancer among HIV-infected Individuals in North America”, Annals of Internal
Medicine, 163(7):507-518, 2015.
81. Conley L, Bush T, Rupert AW, Sereti I, Patel P, Brooks JT, and Baker JV for the SUN (Study to Understand the
Natural History of HIV/AIDS in the Era of Effective Therapy) Investigators, “Obesity is Associated with Greater
Inflammation and Monocyte Activation Among HIV-infected Adults Receiving Contemporary Antiretroviral
Therapy”, AIDS, 29(16):2201-2207, 2015.
82. Fitzpatrick M, Brooks JT, Kaplan JE, “Epidemiology of HIV-Associated Lung Disease in the United States”,
Seminars in Respiratory and Critical Care Medicine, 37(2):181-198, doi: 10.1055/s-0036-1572556, 2016.
83. Kwan CK, Rose CE, Brooks JT, Marks G, Sionean C, “HIV Testing Among Men at Risk for Acquiring HIV
Infection Before and After the 2006 CDC Recommendations”, Public Health Reports, 131(2):311-319, doi: 2016.
84. Oster AM, Brooks JT, Stryker JE, Kachur RE, Mead P, Pesik NT, Petersen LR, “Interim Guidelines for
Prevention of Sexual Transmission of Zika Virus — United States, 2016”, Morbidity and Mortality Weekly Report,
65(5):1-2, 2016.
85. Rebeiro PF, Althoff KN, Lau B, Gill J, Abraham AG, Horberg MA, Kitahata MM, Yehia BR, Samji H, Brooks
JT, Buchacz K, Napravnik S, Silverberg MJ, Rachlis A, Gebo KA, Sterling TR, Moore RD, Gange SJ, “Laboratory
Measures as Proxies for Primary Care Encounters: Implications for Quantifying Clinical Retention Among HIV-
Infected Adults in North America”, American Journal of Epidemiology, 182(11):952-950, 2016
86. Escota GV, Mondy K, Bush T, Conley L, Brooks JT, Önen N, Patel P, Kojic EM, Henry K, Hammer J7, Wood
KC, Lichtenstein KA, Overton ET, “High Prevalence of Low Bone Mineral Density and Substantial Bone Loss
over 4 Years Among HIV-Infected Persons in the Era of Modern Antiretroviral Therapy”, AIDS Research and
Human Retroviruses, 32(1):59-67, 2016
87. Ruone S, Paxton L, McLaurin T, Taylor A, Hanson D, Heneine W, Brooks JT, Garcia-Lerma JG, “HIV-1
evolution in breakthrough infections in a human trial of oral pre-exposure prophylaxis with emtricitabine and
tenofovir disoproxil fumarate”, Journal of the Acquired Immunodeficiency Syndrome, 72(2):129-32. doi:
10.1097/QAI.0000000000000921, 2016
88. Buchacz K, Frazier EL, Irene, HI Hall, Hart R, Huang P, Franklin D, Hu X, Palella FJ, Chmiel JS, Novak RM,
Wood K, Yangco B, Armon C, Brooks JT, Skarbinski J, “A Matter of Perspective: Comparison of the
Characteristics of Persons with HIV Infection in the United States from the HIV Outpatient Study, Medical
Monitoring Project, and National HIV Surveillance System.:. The Open AIDS Journal, 9:123-133, 2015.
89. Mdodo R, Frazier EL, Dube SR, Mattson CL, Sutton MY, Brooks JT, Skarbinski J, “Cigarette Smoking
Prevalence among HIV-infected Adults, United States, 2009”, Annals of Internal Medicine, 162(5):335-344, 2015.
90. Djawe K, Buchacz K, Hsu L, Chen MJ, Selik RM, Rose C, Williams T, Brooks JT, Schwarcz S., “Mortality Risk
After AIDS-Defining Opportunistic Illness Among HIV-Infected Persons-San Francisco, 1981-2012”, Clinical
Infectious Diseases, June 3, 2015 published ahead of print PMID: 26044289.
91. Buchacz K, Young B, Palella FJ Jr, Armon C, Brooks JT and the HIV Outpatient Study (HOPS) investigators;
HIV Outpatient Study HOPS investigators, “Trends in use of genotypic resistance testing and frequency of major
drug resistance among antiretroviral-naive persons in the HIV Outpatient Study, 1999-2011”, Journal of
Antimicrobial Chemotherapy, 70(8):2337-2346, 2015.
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92. Novak RM, Hart RL, Chmiel JS, Brooks JT, Buchacz K and the HIV Outpatient Study (HOPS) Investigators,
“Disparities in initiation of combination antiretroviral treatment and in virologic suppression among patients in the
HIV Outpatient Study (HOPS), 2000-2013”, Journal of the Acquired Immunodeficiency Syndrome, 70(1):23-32,
2015.
93. Kojic EM, Cu-Uvin S, Conley L, Bush T, Onyekwuluje J, Swan DC, Unger ER, Henry K, Hammer J, Overton ET,
Darragh TM, Palefsky JM, Vellozzi C, Patel P, Brooks JT, “Human papillomavirus infection and cytologic
abnormalities of the anus and cervix among HIV-infected women in the Study to Understand the Natural History of
HIV/AIDS in the Era of Effective Therapy (the SUN Study)”, Sexually Transmitted Diseases, 38(4):253-9, 2011.
doi: 10.1097/OLQ.0b013e3181f70253
94. Joyce MP, Kuhar D, Brooks JT, “Notes from the Field: Occupationally Acquired HIV Infection Among Health
Care Workers - United States, 1985-2013.”, Morbidity and Mortality Weekly Report, 63(53):1245-6, 2015.
95. Dean BB, Hart RL, Buchacz K, Bozzette SA, Wood K, Brooks JT, and the HOPS Investigators, “HIV Laboratory
Monitoring Reliably Identifies Persons Engaged in Care”, Journal of the Acquired Immune Deficiency Syndromes,
68(2):133-9, 2015.
96. Buchacz K, Wiegand R, Armon C, Chmiel JS, Wood K, Brooks JT, Palella FJ Jr., “Long-term immunologic and
virologic responses on raltegravir-containing regimens among ART-experienced participants in the HIV Outpatient
Study”, HIV Clinical Trials, July 1, 2015 published ahead of print PMID: 26126549
97. Durham MD, Buchacz K, Armon C, Patel P, Wood K, Brooks JT; for the HIV Outpatient Study (HOPS)
Investigators, “Seasonal Influenza Vaccination Rates in the HIV Outpatient Study-United States, 1999-2013”,
Clinical Infectious Diseases, 60(6):976-977, 2015.
98. Escota GV, Patel P, Brooks JT, Bush T, Conley L, Baker J, Kojic EM, Hammer J, Önen NF, ”The Veterans Aging
Cohort Study Index Is an Effective Tool to Assess Baseline Frailty Status in a Contemporary Cohort of HIV-
Infected Persons.”, AIDS Research and Human Retroviruses, 31(3):313-317, 2015.
99. Patel P, Armon C, Chmiel JS, Brooks JT, Buchacz K, Wood K, Novak RM, “Factors Associated with Cancer
Incidence and with All-Cause Mortality after Cancer Diagnosis among HIV-infected Persons during the cART
Era”, Open Forum for Infectious Diseases, May 27, 2014 published ahead of print PMID: 25734086.
100. Willis LA, Kachur R, Castellanos TJ, Spikes P, Gaul ZJ, Gamayo AC, Durham M, Nichols K, Barthelemy SH,
Hogben M, Sutton MS, Robinson S and Brooks JT, “Developing a Motion Comic for HIV/STD Prevention for
Young People Ages 15-24: Listening to Your Target Audience”, submitted.
101. Wilson EM, Singh A, Hullsiek KH, Gibson D, Henry WK, Lichtenstein K, Önen NF, Kojic E, Patel P, Brooks JT,
Sereti I, Baker JV; Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN
Study) Investigators. “Monocyte-activation phenotypes are associated with biomarkers of inflammation and
coagulation in chronic HIV infection.” Journal of Infectious Diseases, 210(9):1396-1406, 2014.
102. Rebeiro PF, Horberg MA, Gange SJ, Gebo KA, Yehia BR, Brooks JT, Buchacz K, Silverberg MJ, Gill J, Moore
RD, Althoff KN; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), “Strong
agreement of nationally recommended retention measures from the Institute of Medicine and Department of Health
and Human Services.”, PLoS ONE, 9(11):e111772, 2014.
103. Patel P, Borkowf CB, Brooks JT, Lasry A, Lansky A, Mermin J, “Estimating per-act HIV transmission risk: a
systematic review”, AIDS, 28(10): 1509-1519, 2014.
104. Palella FJ, Armon C, Buchacz K, Chmiel JS, Novak RM, D’Aquila RT, Brooks JT, the HOPS Investigators,
“Factors associated with mortality among persistently viremic triple-antiretroviral-class-experienced patients
receiving antiretroviral therapy in the HIV Outpatient Study (HOPS)”, Journal of Antimicrobial Chemotherapy,
69(10): 2826-34, 2014
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105. Yangco BG, Buchacz K, Baker R, Palella FJ, Armon C, Brooks JT, and the HIV Outpatient Study Investigators,
“Is primary mycobacterium avium complex prophylaxis necessary in patients with CD4 <50 cells/μL who are
virologically suppressed on cART?”, AIDS Patient Care and STDS, 28(6):280-3, 2014.
106. Althoff KN, Rebeiro P, Brooks JT, Buchacz K, Gebo K, Martin J, Hogg R, Thorne JE, Klein M, Gill MJ, Sterling
TJ, Yehia B, Silverberg MJ, Crane H, Justice AC, Gange SJ, Moore R, Kitahata MM, Horberg MA, for the North
American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), ”Disparities in the quality of HIV
care when using Department of Health and Human Services indicators”, Clinical Infectious Diseases, 58(8):1185-9,
2014.
107. Tedaldi EM, Richardson JT, Debes R, Young B, Chmiel JS, Durham MD, Brooks JT and the HOPS Investigators,
“Retention in care within 1 year of initial HIV care visit in a multisite cohort: who’s in and who’s out?”, Journal of
the International Association of Providers of AIDS Care, 13(3):232-41, 2014.
108. Heiman KE, Karlsson G, Grass J, Howie B, Kirkcaldy R, Mahon B, Brooks JT, Bowen A, “Notes from the field:
Shigella with decreased susceptibility to azithromycin among men who have sex with men – United States, 2002-
2013”, MMWR, 63(6): 132-133, 2014.
109. Baker JV, Hullsiek KH, Singh A, Wilson E, Henry K, Lichtenstein K, Onen N, Kojic E, Patel P, Brooks JT, Hodis
HN, Budoff M, Sereti I; for the CDC SUN Study, “Immunologic predictors of coronary artery calcium progression
in a contemporary HIV cohort”, AIDS, 28(6):831-40, 2014.
110. Chirwa LI, Johnson JA, Niska RW, Segolodi TM, Henderson FL, Rose CE, Li JF, Thigpen MC, Matlhaba O,
Paxton LA, Brooks JT.” CD4+ cell count, viral load, and drug resistance patterns among heterosexual
breakthrough HIV infections in a study of oral preexposure prophylaxis”, AIDS, 28(2):223-6, 2014.
111. Holtzman C, Armon C, Tedaldi E, Chmiel JS, Buchacz K, Wood K, Brooks JT, and the HOPS Investigators,
“Polypharmacy and risk of antiretroviral drug interactions among the aging HIV-infected population”, Journal of
General Internal Medicine, 28(10): 1302-1310, 2013. doi: 10.1007/s11606-013-2449-6.
112. Iuliano AD, Weidle PJ, Brooks JT, Masaba R, Girde S, Ndivo R, Ogindo P, Omolo P, Zeh C, Thomas TK,
“Neutropenia in HIV-Infected Kenyan Women Receiving Triple Antiretroviral Prophylaxis to Prevent Mother-to-
Child HIV Transmission Is Not Associated with Serious Clinical Sequelae, Journal of the International Association
of Physicians in AIDS Care, September 30 2013 published ahead of print. doi: 10.1177/2325957413502543
113. Abraham AG, Strickler HD, Jing Y, Gange SJ, Sterling TR, Silverberg M, Saag M, Rourke S, Rachlis A,
Napravnik S, Moore RD, Klein M, Kitahata M, Kirk G, Hogg R, Hessol NA, Goedert JJ, Gill MJ, Gebo K, Eron JJ,
Engels EA, Dubrow R, Crane HM, Brooks JT, Bosch R, D'Souza G; for the North American AIDS Cohort
Collaboration on Research and Design (NA-ACCORD) of IeDEA, “Invasive cervical cancer risk among HIV-
infected women: A North American multi-cohort collaboration prospective study” Journal of the Acquired Immune
Deficiency Syndromes, 62(4): 405-413, 2013. doi: 10.1097/QAI.0b013e31828177d7
114. Farnham PG, Gopalappa C, Sansom SL, Hutchinson AB, Brooks JT, Weidle PJ, Marconi VC, Rimland D,
“Updates of Lifetime HIV Treatment Costs and Quality of Life Measures in the United States: Early Versus Late
Diagnosis and Entry into Care“, Journal of the Acquired Immune Deficiency Syndromes, 64(2): 183-198, 2013.
doi: 10.1097/QAI.0b013e3182973966
115. Rebeiro P, Althoff KN, Buchacz K, Gill J, Horberg M, Krentz H, Moore R, Sterling TR, Brooks JT, Gebo KA,
Hogg R, Klein M, Martin J, Mugavero M, Rourke S, Silverberg MJ, Thorne J, Gange SJ; North American AIDS
Cohort Collaboration on Research and Design, “Retention among North American HIV-infected persons in clinical
care, 2000-2008”, Journal of the Acquired Immune Deficiency Syndromes, 62(3):356-62, 2013. doi:
10.1097/QAI.0b013e31827f578a
116. Durham MD, Buchacz K, Richardson J, DerShung Y, Wood K, Yangco B, Brooks JT, and the HOPS
Investigators, “Sexual Risk Behavior and Viremia Among Men Who Have Sex With Men in the HIV Outpatient
Study, United States, 2007–2010”, Journal of Acquired Immune Deficiency Syndromes, 63(3):372-378, 2013.
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117. Peters PJ, Brooks JT, McAllister SK, Limbago B, Lowery HK, Fosheim G, Guest JL, Gorwitz RJ, Bethea M,
Hageman J, Mindley R, McDougal LK, Rimland D, “Methicillin-Resistant Staphylococcus aureus Colonization of
the Groin and Risk for Clinical Infection among HIV-infected Adults”, Emerging Infectious Diseases 19(4), 2013.
http://dx.doi.org/10.3201/eid1904.121353, doi: 10.3201/eid1904.121353
118. Justice AC, Modur S, Tate JP, Althoff KN, Jacobson LP, Gebo K, Kitahata M, Horberg M, Brooks JT, Buchacz K,
Rourke S, Rachlis A, Napravnik S, Eron J, Saag MS, Moore R, Kirk GD, Bosch R, Rodriguez B, Hogg R, Thorne J,
Goedert J, Klein MB, Gill MJ, Deeks S, Sterling TR, Anastos K, and Gange SJ for the NA-ACCORD and VACS
Project Teams, “The VACS Index Accurately Predicts Mortality among 15,901 HIV-Infected Individuals in North
America on Antiretroviral Therapy”, Journal of the Acquired Immune Deficiency Syndromes, 62(2):149-63, 2013.
doi: 10.1097/QAI.0b013e31827df36c.
119. Rebeiro P, Althoff KN, Buchacz K, Gill MJ, Horberg M, Krentz H, Moore R, Sterling TR, Gebo KA, Hogg R,
Klein M, Martin J, Mugavero M, Rourke S, Thorne J, Brooks JT, Gange SJ, for the North American AIDS Cohort
Collaboration on Research and Design (NA-ACCORD), “Retention Among North American HIV–infected Persons
in Clinical Care, 2000-2008”, Journal of Acquired Immune Deficiency Syndromes, December 13 2012 published
ahead of print]. doi: 10.1097/QAI.0b013e31827f578a
120. Lichtenstein KA, Armon C, Buchacz K, Chmiel JS, Buckner K, Tedaldi E, Wood K, Holmberg SD, Brooks, JT,
“Provider Compliance with U.S. NCEP ATP III-based IDSA/AACTG Cardiovascular Risk Management
Guidelines in the HIV Outpatient Study (HOPS)”, Preventing Chronic Disease, January 19 2013 published ahead
of print. doi: 10.5888/pcd10.120083.
121. Althoff KN, Buchacz K, Hall I, Zhang J, Hanna DB, Rebeiro P, Gange SJ, Moore RD, Kitahata MM, Gebo KA,
Martin J, Justice AC, Horberg M, Hogg RS, Sterling TR, Cescon A, Klein MB, Thorne J, Crane H, Mugavero1 MJ,
Napravnik S, Rodriguez B, Kirk GD, Anastos K, Jacobson LP, and Brooks JT for The North American AIDS
Cohort Collaboration on Research and Design, “Trends in antiretroviral therapy use, HIV RNA plasma viral loads
and CD4 T-lymphocyte counts among human immunodeficiency virus (HIV)-infected persons in care in the United
States, 2000-2008”, Annals of Internal Medicine, 157(5):325-335, 2012.
122. Buchacz K, Baker R, Ward DJ, Palella FJ, Chmiel J, Young B, Yangco BG, Novak RM, Brooks JT , “Trends in
Decline of Antiretroviral Resistance among ARV-experienced Patients in the HIV Outpatient Study: 1999-2008”,
AIDS Research and Treatment, epub March 12 2012. doi:10.1155/2012/230290.
123. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Segolodi TM, Soud FA, Henderson FL, Pathak SR, Rose
CE, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T,
Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, and Brooks JT for the TDF2 Study Group, “Safety
and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young
Adults in Botswana: the TDF2 Study”, New England Journal of Medicine, 367:423-434, 2012.
124. Tedaldi EM, van den Berg-Wolf M, Richardson J, Patel P, Durham M, Hammer J, Henry K, Metzler S, Onen N,
Conley L, Wood K, Brooks JT, Buchacz K, “Sadness in the SUN: Using Computerized Screening to Analyze
Correlates of Depression and Adherence in HIV-Infected Adults in the United States”, AIDS Patient Care and
STDs 26(12): 718-729, 2012.
125. Kwan CK, Al-Samarrai T, Smith LC, Sabharwal CJ, Valente KA, Torian LV, McMurdo LM, Shepard CW, Brooks
JT, Kuehnert MJ . “HIV Screening Practices for Living Organ Donors, New York State, 2010: Need for Standard
Policies”, Clinical Infectious Diseases, 55(7): 990-995, 2012.
126. Brooks JT, Buchacz K, Gebo K, and Mermin J, “Aging and HIV Infection: The Public Health Perspective”,
American Journal of Public Health, 102(8): 1516-1526, 2012.
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127. Patel P, Bush T, Mayer KH, Milam J, Richardson J, Hammer J, Henry K, ET Overton, Conley L, Brooks JT, SUN
Study Investigators, “Routine Brief Risk-Reduction Counseling With Biannual STD Testing Reduces STD
Incidence Among HIV-Infected Men Who Have Sex With Men in Care”, Sexually Transmitted Diseases, 39(6):
470-474, 2012.
128. Novak R, Richardson JT, Buchacz K, Chmiel JS, Durham MD, Palella FJ, Wendrow A, Wood K, Young B,
Brooks JT, and the HOPS Investigators, “Immune reconstitution inflammatory syndrome: incidence and
implications for mortality”, AIDS, 26(6): 721-730, 2012.
129. Mayer KH, Bush T, Henry K, Overton ET, Hammer J, Richardson J, Wood K, Conley L, Papp J, Caliendo AM,
Patel P, Brooks, JT, “Ongoing Sexually Transmitted Disease Acquisition and Risk taking Behavior among U.S.
HIV-infected Patients in Primary Care: Implications for Prevention Interventions”, Sexually Transmitted Diseases,
39(1): 1-7, 2012
130. Patel P, Bush T, Mayer K, Desai S, Henry K, Overton ET, Conley L, Hammer J, Brooks JT and the SUN Study
Investigators, “Prevalence and risk factors associated with herpes simplex virus-2 infection in a contemporary
cohort of HIV-infected persons in the United States”, Sexually Transmitted Diseases, 39(2): 154-160, 2012.
131. Buchacz K, Baker RK, Palella FJ Jr, Shaw L, Patel P, Lichtenstein KA, Chmiel JS, Vellozzi C, Debes R, Henry K,
Overton ET, Bush TJ, Tedaldi E, Carpenter C, Mayer KH, Brooks JT; the HIV Outpatient Study Investigators.
Disparities in prevalence of key chronic diseases by gender and race/ethnicity among antiretroviral-treated HIV-
infected adults in the US. Antiviral Therapy. 2012 Oct 30. doi: 10.3851/IMP2450. [Epub ahead of print]
132. Sullivan PS, Hanson DL, Richardson JT, Brooks JT, “Trends in the treatment of anemia using recombinant human
erythropoietin in patients with HIV infection”, Open AIDS Journal, 5: 113-118, 2011.
133. Patel P, Bush T, Overton ET, Baker JV, Hammer J, Kojic EM, Conley L, Henry K, Brooks JT, on behalf of the
SUN Study Investigators, “Effect of Abacavir on Acute Changes in Biomarkers Associated with Cardiovascular
Dysfunction”, Antiviral Therapy,17(4):755-761, 2011.
134. Buchacz K, Armon C, Palella FJ, Baker RS, Tedaldi E, Durham MS, Brooks JT, and the HOPS Investigators.
“CD4 cell counts at HIV diagnosis among HIV Outpatient Study (HOPS) participants, 2000-2007”, AIDS
Research and Treatment, Epub 2011 September 20, doi: 10.1155/2012/869841
135. Brooks JT, Matyas BA, Fontana J, DeGroot MA, Beuchat LR, Hoekstra M, Friedman, CR, “An Outbreak of
Salmonella serotype Typhimurium Infections with an Unusually Long Incubation Period”, Foodborne Pathogens
and Disease, 9(2): 1-4, 2012.
136. Silverberg MJ, Lau B, Justice AC, Engels E, Gill MJ, Goedert JJ, Kirk GD, D’Souza G, Bosch RJ, Brooks JT,
Napravnik S, Hessol NA, Jacobson LA, Kitahata MM, Klein MB, Moore RD, Rodriguez B, Rourke SB, Saag MS,
Sterling TR, Gebo KA, Press N, Martin JN, and Dubrow R for the North American AIDS Cohort Collaboration on
Research and Design (NA-ACCORD) of IeDEA, “Risk of Anal Cancer in HIV-Infected and HIV-uninfected
Individuals in North America”, Clinical Infectious Diseases, 54(7): 1026-1-34, 2012.
137. Sorensen SW, Samson SL, Brooks JT, Marks G, Begier EM, Buchacz K, DiNenno EA, Mermin JH, “A
Mathematical Model of Comprehensive Test-and-Treat Services and HIV Incidence among Men Who Have Sex
With Men in the United States”, PLoS ONE, 7(2): e29098. doi:10.1371/journal.pone.0029098.
138. Overton ET, Kauwe K, Paul R, Carpenter C, Brooks JT, Clifford DB, “Performances on the CogState and
standard neuropsychological batteries among HIV-infected adults without dementia”, AIDS Research and Human
Retroviruses, 15(8): 1902-1909, 2011.
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139. Baker JV, Henry WK, Patel P, Bush TJ, Conley LJ, Mack WJ, Overton ET, Budoff M, Hammer J, Carpenter CC,
Hodis HN, Brooks JT; for the Study to Understand the Natural History of HIV/AIDS in the Era of Effective
Therapy Investigators, “Progression of Carotid Intima-Media Thickness in a Contemporary HIV Cohort”, Clinical
Infectious Diseases, 53(8):826-835, 2011
140. Kelley CF, Haaland RE, Patel P, Evans-Strickfaden T, Farshy C, Hanson D, Mayer K, Lennox JL, Brooks JT,
Hart CE, “HIV-1 RNA Rectal Shedding Is Reduced in Men With Low Plasma HIV-1 RNA Viral Loads and Is Not
Enhanced by Sexually Transmitted Bacterial Infections of the Rectum”, Journal of Infectious Diseases, 204(5):
761-7, 2011.
141. Sterling TR, Lau B, Zhang J, Freeman A, Bosch RJ, Brooks JT, Deeks SG, French A, Gange S, Gebo KA, Gill
MJ, Horberg MA, Jacobson LP, Kirk GD, Kitahata MM, Klein MB, Martin JN, Rodriguez B, Silverberg MJ,
Willig JH, Eron JJ, Goedert JJ, Hogg RS, Justice AC, McKaig RG, Napravnik S, Thorne J, Moore RD, for the
North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of the International
Epidemiologic Databases to Evaluate AIDS (IeDEA) “Risk Factors for Tuberculosis After Highly Active
Antiretroviral Therapy Initiation in the United States and Canada: Implications for Tuberculosis Screening”,
Journal of Infectious Diseases, 204(6): 893-901, 2011.
142. Durham MD, Buchacz K, Armon C, Patel P, Wood K, Brooks JT, and the HOPS Investigators, “Seasonal
Influenza Vaccination Rates in the HIV Outpatient Study, 1999 – 2008, Preventive Medicine, 53: 89-94, 2011.
143. Palella FJ, Baker RK, Buchacz K, Chmiel JS, Tedaldi EM, Novak RM, Durham MD, Brooks JT, and the HOPS
Investigators, “Increased mortality among publicly insured patients in the HIV Outpatient Study (HOPS) despite
HAART treatment”, AIDS, 25(15): 1865-1876, 2011 .
144. Prabhu VS, Farnham PG, Hutchinson, Soorapanth S, Heffelfinger JD, Golden MR, Brooks JT, Rimland D,
Sansom SL, “Cost-effectiveness of Diagnosing HIV Infection in Different Settings: A Model-based Comparison of
Diagnostic Testing in Inpatient Units and Screening in Emergency Departments and STD Clinics”, PLoS ONE,
6(5), manuscript e19936, 2011 .
145. Young B, Dao C, Buchacz K, Baker RK, Brooks JT, “Increased rates of bone fracture among HIV-infected
persons in the HIV Outpatient Study (HOPS) compared with the U.S. general population, 2000-2008, Clinical
Infectious Diseases, 52 (8): 1061-1068, 2011.
146. Koeppe J, Lichtenstein K, Armon C, Chmiel JS, Buchacz K, Wood K, Brooks JT. “Factors Associated With
Initiation of Prolonged Analgesic Use Among Patients in the HIV Outpatient Study (HOPS)”, Clinical Journal of
Pain, 27(8): 699-706, 2011.
147. Mosoko JJ, Akam W, Weidle PJ, Brooks JT, Aweh AJ, Kinge TN, Pals S, Raghunathan PL. “Retention in an
antiretroviral therapy program during an era of decreasing drug cost in Limbe, Cameroon”, Journal of the
International AIDS Society 14: 32, 2011.
148. From the Centers for Diseases Control and Prevention, “HIV Transmitted from a Living Organ Donor — New
York City, 2009”, MMWR, 60 (10): 297-301, 2011.
149. From the Centers for Diseases Control and Prevention, “HIV Transmission through Blood Transfusion — Missouri
and Colorado, 2008”, MMWR, 59 (41): 1335-1339, 2010.
150. Althoff KN, Gebo KA, Gange SJ, Klein MB, Brooks JT, Hogg RS, Bosch RJ, Horberg MA, Saag MS, Kitahata
MM, Eron JJ, Napravnik S, Rourke SB, Gill MJ, Rodriguez B, Sterling TR, Deeks SG, Martin JN, Jacobson LP,
Kirk GD, Collier AC, Benson CA, Silverberg MJ, Goedert JJ, McKaig RG, Thorne J, Rachlis A, Moore RD,
Justice AC. “CD4 count at presentation for HIV care in the United States and Canada: Are those over 50 years
more likely to have a delayed presentation?”, AIDS Research and Therapy, (7)1: 45, 2010.
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151. Kyser M, Buchacz K, Bush TJ, Conley LJ, Hammer J, Henry K, Kojic ME, Milam J, Overton ET, Wood KC,
Brooks JT, “Factors associated with non-adherence to antiretroviral therapy in the SUN Study”, AIDS Care,
February 2: 1-11, 2011.
152. Peters PJ, Stringer J, McConnell MS, Kiarie J, Ratanusawan W, Intalapaporn, Potter D, Mutsotso W, Zulu I,
Borkowf CB, Bolu O, Brooks JT, and Weidle PJ. “Nevirapine-associated hepatotoxicity occurs but is not
predicted by CD4 cell count > 250 cells/µL among women initiating antiretroviral therapy in Zambia, Thailand,
and Kenya”. HIV Medicine, 11(10):650-660, 2010.
153. Conley L, Bush T, Darragh TM, Palefsky JM, Unger ER, Patel P, Kojic EM, Cu-Uvin , Martin H, Overton ET,
Hammer J, Henry K, Vellozzi C, Wood K, Brooks JT, and the SUN Investigators, “Factors associated with
prevalent abnormal anal cytology in a large cohort of HIV-infected U.S. adults”, Journal of Infectious Diseases,
202(10): 1567-1576, 2010.
154. Vellozzi C, Buchacz K, Baker R, Spradling PR, Richardson JT, Moorman AC, Tedaldi E, Durham M, Ward J,
Brooks JT, “Treatment of hepatitis C (HCV) infection in patients coinfected with HIV in the HIV Outpatient
Study (HOPS), 1997-2007”, Journal of Viral Hepatitis, 18(5): 316-324, 2011.
155. Buchacz K, Baker RS, Young B, Durham MD, and Brooks JT. “Changes in the utilization of HIV-1 antiretroviral
resistance testing in a large cohort of U.S. patients, 1999-2006”, Journal of Acquired Immune Deficiency
Syndromes, 53(5): 625-632, 2010.
156. Peters PJ, Brooks JT, Limbago B, Lowery HK, McAllister SK, Mindley R, Fosheim G, Gorwitz RJ, Guest JL,
Hageman J, Fridge J, Rimland D, “Methicillin-resistant Staphylococcus aureus colonization in HIV-infected
outpatients is common and detection is enhanced by groin culture”, Epidemiology and Infection; 139(): 998-1008,
2011.
157. Sheth AN, Althoff KA, Brooks JT, “Influenza susceptibility, severity and shedding in HIV-infected adults:
review of the literature”, Clinical Infectious Diseases, 52(2): 219-227, 2011.
158. Dao C, Patel P, Overton ET, Rhame F, Pals SL, Johnson C, Bush T, Brooks JT, and the SUN Investigators,
“Prevalence and risk factors for vitamin D insufficiency in a cohort of HIV-infected adults and comparison with
prevalence of vitamin D insufficiency among adults in the U.S. general population”, Clinical Infectious Diseases,
52(3): 396-405, 2011,
159. Mondy KE, Gottdiener J, Overton ET, Henry K, Bush T, Conley L, Hammer J, Carpenter CC, Kojic E, Patel P,
Brooks JT, and the SUN Study Investigators, High Prevalence of Echocardiographic Abnormalities among HIV-
infected Persons in the Era of Highly Active Antiretroviral Therapy”, Clinical Infectious Diseases, 52(3): 378-386,
2011.
160. Spradling PR, Richardson JT, Buchacz K, Moorman AC, Brooks JT, “Prevalence of chronic hepatitis B (HBV)
infection among patients in the HIV Outpatient Study, 1996-2007”, Journal of Viral Hepatitis, 17(12): 879-886,
2010.
161. Peters P, Skarbinski J, Louie JK, Jain S, the New York City Department of Health Swine Flu Investigations Team,
Roland M, Jani SG, Finelli L, Brooks JT, “HIV-infected hospitalized patients with 2009 influenza A (H1N1) –
United States, spring and summer, 2009”, Clinical Infectious Diseases, 52 (Supp1): S183-S188, 2010.
162. Deeks SG, Gange SJ, Kitahata MM, Saag MS, Justice AC, Hogg RS, Eron JJ, Brooks JT, Rourke SB, Gill MJ,
Bosch RJ, Benson CA, Collier AC, Martin JN, Klein MB, Jacobson LP, Rodriguez B, Sterling TR, Kirk GD,
Napravnik S, Rachlis AR, Calzavara LM, Horberg MA, Silverberg MJ, Gebo KA, Kushel MB, Goedert JJ, McKaig
RG, Moore RD. “Trends in multidrug treatment failure and subsequent mortality among antiretroviral therapy-
experienced patients with HIV infection in North America” Clinical Infectious Diseases, 49(10): 1582-1590, 2010.
163. Lansky A, Brooks JT, DiNenno E, Heffelfinger J, Hall, HI, Mermin J, “Epidemiology of HIV in the United
States”, Journal of Acquired Immune Deficiency Syndromes, 55(Supp 2): S64-S68, 2010.
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164. Hoover KW, Butler M, Workowski K, Carpio F, Follansbee S, Gratzer B, Hare B, Johnston B, Theodore JL,
Wohlfeiler M, Tao G, Brooks JT, Chorba T, Irwin K, Kent CK, and the Evaluation Group for Adherence to STD
and Hepatitis Screening. “Screening for sexually transmitted diseases in HIV-infected men who have sex with
men”, Sexually Transmitted Diseases; 37(12):771-776, 2010.
165. Lichtenstein KA, Armon C, Buchacz K, Chmiel JS, Buckner K, Tedaldi EM, Wood K, Holmberg SD, and Brooks
JT, for the HIV Outpatient Study (HOPS) Investigators, “Low CD4+ T Cell Count Is a Risk Factor for
Cardiovascular Disease Events in the HIV Outpatient Study”, Clinical Infectious Diseases; 51(4):435–447, 2010.
166. Buchacz K, Baker RS, Palella FJ, Chmiel JS, Lichtenstein KA, Durham MS, Wood KC, Brooks JT, and the HOPS
Investigators. “AIDS-defining opportunistic illnesses in a large cohort of U.S. patients”, AIDS; 24(10):1549-1559,
2010.
167. Brooks JT, “The importance of a complete sexual history for HIV-infected adults: reducing risk and improving
health”, Clinical Issues in HIV Medicine; v-vi, 2009. Available at:
https://www.hivma.org/uploadedFiles/HIVMA/Publications/Annual_Compendia_of_CID_Articles_on_HIV/2009/
PDFs/v.pdf
168. Steinau M, Swan DC, Onyekwuluje JM, Brooks JT, Vellozzi C, Unger ER, and the SUN Study Investigators.
“Differences and changes of HPV16 variant status in HIV-positive adults are not uncommon”, Journal of General
Virology, 91: 2068-2072, 2010
169. Althoff KN, Gange SJ, Klein MB, Brooks JT, Hogg RS, Bosch RJ, Horberg MA, Saag MS, Kitahata MM, Justice
AC, Gebo KA, Eron JJ, Rourke SB, Gill MJ, Rodriguez B, Sterling TR, Calzavara LM, Deeks SG, Martin JN,
Rachlis AR, Napravnik S, Jacobson LP, Kirk GD, Collier AC, Benson CA, Silverberg MJ, Kushel M, Goedert JJ,
McKaig RG, Van Rompaey SE, Zhang J, Moore RD. “Late presentation for human immunodeficiency virus care in
the United States and Canada.” Clinical Infectious Diseases, 50(11): 1512-1520, 2010.
170. Spradling PR, Richardson JT, Buchacz K, Moorman AC, Finelli L, Bell BP, Brooks JT and the HOPS
investigators, “Prevalence of chronic hepatitis C virus (HCV) infection among patients in the HIV Outpatient
Study, 1996-2005”, Journal of Acquired Immune Deficiency Syndromes, 53(3): 388-396, 2010.
171. van Eijk AM, Brooks JT, Adcock PM, Garrett V, Eberhard M, Rosen DH, Ayisi JG, Ochieng JB, Kumar L,
Gentsh JR, Nahlen BL, Mintz ED, Slutsker L, “Diarrhea in children less than two years of age known HIV status
Kisumu, Kenya”, International Journal of Infectious Diseases, 14: e220-e225, 2010.
172. Beatty ME, Ochieng JB, Chege W, Kumar L, Okoth G, Shapiro RL, Wells JG, Parson M, Bopp C, Chiller T,
Vulule J, Mintz E., Slutsker L, Brooks JT, “Comparison of bacterial etiology and antibiotic resistance patters of
sporadic pediatric diarrheal illness in urban and rural sites in western Kenya”, East African Medical Journal, 86(8):
387-398, 2009.
173. Heffelfinger JD, Patel P, Brooks JT, Calvet H, Daley CL, Dean HD, Edlin BR, Gensheimer KF, Jereb J, Kent CK,
Lennox JL, Louie JK, Lynfield R, Peters PJ, Pickney L, Spradling P, Voetsch AC, and Fiore A. “Pandemic
Influenza: Implications for Programs Controlling for HIV Infection, Tuberculosis, and Chronic Viral Hepatitis”,
American Journal of Public Health, 99(S2): S333-S338, 2009.
174. Young B, Buchacz K, Moorman A, Wood KS, Brooks JT, “Renal function in patients with pre-existing renal
disease receiving tenofovir-containing HAART in the HIV Outpatient Study”, AIDS Patient Care and STDs, 23(8):
589-592, 2009.
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John T. Brooks, MD
175. Kitahata MM, Gange SJ, Abraham AG, Merriman B, Saag MS, Justice AC, Hogg RS, Deeks SG, Eron JJ, Brooks
JT, Rourke SB, Gill MJ, Bosch RJ, Martin JN, Klein MB, Jacobson LP, Rodriguez B, Sterling TR, Kirk GD,
Napravnik S, Rachlis AR, Calzavara LM, Horberg MA, Silverberg MJ, Gebo KA, Goedert JJ, Benson CA, Collier
AC, Rompaey SE, Crane HM, McKaig RG, Lau B, Freeman AM, Moore RD, for The North American AIDS
Cohort Collaboration on Research and Design. “Initiating rather than deferring HAART at a CD4+ count between
351-500 cells/mm3 and >500 cells/mm3 is associated with improved survival. North American AIDS Cohort
Collaboration on Research and Design (NA-ACCORD) of the International Epidemiological Databases to Evaluate
AIDS (IeDEA) project”, New England Journal of Medicine, 360(18): 1815-1826, 2009.
176. Brooks JT, Kaplan JE, Holmes KK, Benson C, Pau A, Masur H, “HIV-associated opportunistic infections: going,
going but not gone. The continued need for prevention and treatment guidelines”, Clinical Infectious Diseases,
48(5):609-11, 2009.
177. CDC, Centers for Disease Control and Prevention. Kaplan JE, Benson C, Holmes KK, Brooks JT, Pau A, Masur
H. “Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents
Recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the
Infectious Diseases Society of America”, MMWR Recommendations and Reports, 58 (RR-4), April 10, 2009:1-
207.
178. Brooks JT, Kaplan JE, Masur H. “What’s new in the 2009 U.S. guidelines for prevention and treatment of
opportunistic infections among adults and adolescents?” Topics in HIV Medicine, 17(3): 109-114, 2009.
179. Palella FJ, Armon C, Chmiel , Buchacz K, Novak R, Wood KC, Moorman AC, Brooks JT, and the HOPS
investigators, “Enhanced survival associated with the use of HIV susceptibility testing among patients in the HIV
Outpatient Study”, Annals of Internal Medicine, 151(2): 73-84, 2009.
180. Gaur AH, Dominguez KL, Kalish ML, Rivera-Hernandez D, Donohoe M, Brooks JT, Mitchell CD, “Practice of
feeding premasticated food to infants – a potential risk factor for HIV transmission”, Pediatrics, 124(2): 658-666,
2009.
181. Uy J, Armon C, Buchacz K, Brooks JT, and the HOPS investigators, “Initiation of HAART at higher CD4 cell
counts in associated with a lower prevalence of antiretroviral drug resistance mutations at virologic failure”,
Journal of Acquired Immune Deficiency Syndromes, 51(4): 450-453, 2009.
182. Vellozzi C, Brooks JT, Bush TJ, Conley LJ, Henry K, Carpenter Ch, Overton ET, Hammer J, Wood K, Holmberg
SD, and the SUN Study Investigators, “The Study to Understand the Natural History of HIV and AIDS in the era of
Effective Therapy (SUN Study)”, American Journal of Epidemiology, 169(5): 643-652, 2009.
183. Chiller TM, Polyak C, Brooks JT, Williamson J, Ochieng B, Ouma P, Greene C, Hamel M, Vulule J, Bopp C,
Slutsker L, Mintz E, “The effect of daily trimethoprim-sulfamethoxazole prophylaxis on intestinal carriage of
Escherichia coli and Salmonella in HIV-infected adults in Kenya”, Journal of the International Association of
Physicians in AIDS Care, 8(3): 165-169, 2009.
184. Forna F, Moore D, Mermin J, Brooks JT, Were W, Buchacz K, Downing R, Borkowf CB, Weidle PJ,
“Hematologic changes associated with zidovudine following single-drug substitution from stavudine in a home-
based AIDS care program in rural Uganda”, Journal of the International Association of Physicians in AIDS Care,
8(2):128-138, 2009.
185. Buchacz K, Rangel M, Blacher R, Brooks JT, “Changes in the clinical epidemiology of HIV infection in the
United States: Implications for the Clinician”, Current Infectious Disease Reports, 11(11): 75-83, 2008.
186. Buchacz K, Moorman AC, Richardson JT, Baker RK, Wood KC, Holmberg SD, Brooks JT, and the HOPS
investigators “Rates of hospitalizations and associated diagnoses in a large multisite cohort of HIV patients in the
United States, 1994-2005”, AIDS, 22(11): 1345-1356, 2008.
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John T. Brooks, MD
187. Weidle PJ, Moore D, Mermin J, Buchacz K, Were W, Downing R, Kigozi A, Ndazima V, Peters P, Brooks JT,
“Liver function enzymes improve over 24 months among adults on first-line non-nucleoside reverse transcriptase
inhibitor-based antiretroviral therapy in the Home-Based AIDS Care (HBAC) Program in rural Uganda”, AIDS
Patient Care and STDs, 22(10): 1-9, 2008.
188. Patel P, Hanson D, Novak RM, Moorman AC, Tong T, Holmberg SD, Sullivan P, Brooks JT, “Incidence of
cancers among HIV-infected persons in the United States 1992-2003”, Annals of Internal Medicine, 148(10): 728-
736, 2008.
189. Peters P, Moore D, Mermin J, Brooks JT, Downing R, Were W, Kigozi A, Buchacz K, Weidle PJ, “Renal
function improves among HIV-infected Ugandans receiving antiretroviral therapy”, Kidney International, 74(7):
699-710, 2008.
190. Hamel M, Greene C, Chiller T, Ouma P, Polyak C, Otieno K, Williamson J, Shi YP, Feikin DF, Marston B,
Brooks JT, Poe A, Zhou Z, Ochieng B, Bopp C, Facklam D, Mintz E, Vulule J, Escalante A, Udhayakumar V,
Slutsker L, “Does cotrimoxazole prophylaxis for the prevention of HIV-associated opportunistic infections select
for resistant pathogens in Kenya adults?”, American Journal of Tropical Medicine and Hygiene, 79(3): 320-330,
2008.
191. Buchacz K, Weidle PJ, Moore D, Were W, Mermin J, Downing R, Kigozi A, Borkowf C, Ndazima V, Brooks JT,
“Changes in lipid profile over 24 months among adults on first-line HAART in the Home-Based AIDS Care
(HBAC) Program in rural Uganda”, Journal of Acquired Immune Deficiency Syndromes, 47(3): 304-311, 2008.
192. Lichtenstein KA, Armon C, Buchacz K, Chmiel J, Moorman A, Wood KC, Holmberg SD, Brooks JT, “Initiation
of antiretroviral therapy at CD4 cell counts > 350 cells/mm3 does not increase incidence or risk of peripheral
neuropathy, anemia, and renal insufficiency”, Journal of Acquired Immune Deficiency Syndromes, 47(1): 27-35,
2008.
193. Buchacz K, Klausner JD, Kerndt PR, Shouse LR, Onorato I, McElroy PD, Schwendemann J, Tambe PB, Allen M,
Coye F, Kent CK, Hawkins K, Samoff E, Brooks JT, “HIV incidence among men diagnosed with primary or
secondary syphilis in Atlanta, San Francisco, and Los Angeles, 2004-2005”, Journal of Acquired Immune
Deficiency Syndromes, 47(2): 234-240, 2008.
194. Uy J, Brooks JT, Baker R, Hoffman M, Moorman A, Novak R, and the HOPS Investigators, “HIV genotype
resistance testing to optimize antiretroviral prescribing: is there room for improvement?”, Antiviral Therapy,
12:957-92, 2007.
195. Forna F, Liechty CA, Solberg P, Asiimwe F, Were W, Mermin J, Behumbiize P, Tong T, Brooks JT, Weidle PJ,
“Early clinical toxicity to highly active antiretroviral therapy in a home-based AIDS care program in rural
Uganda”, Journal of Acquired Immune Deficiency Syndromes, 44(4): 456-462, 2007.
196. Teshale EH, Hanson DL, Wolfe MI, Brooks JT, Kaplan JE, Bort Z, Sullivan PS, “Reasons for lack of appropriate
receipt of primary PCP prophylaxis in a large cohort of HIV-infected persons in care in the US, 1994-2003”,
Clinical Infectious Diseases, 44(6): 879-883, 2007
197. Gange SJ, Kitahata MM, Saag MS, Bangsberg DR, Bosch RJ, Brooks JT, Calzavara L, Deeks SG, Eron JJ, Gebo
KA, Gill MJ, Hass DW, Hogg RS, Horberg MA, Jacobson LP, Justice AC, Kirk GD, Klein MB, Martin JN,
McKaig RG, Rodriguez B, Rourke SB, Sterling TR, Freeman AM, Moore RD, “Cohort Profile: The North
American AIDS Cohort Collaboration on Research and Design (NA-ACCORD)”, International Journal of
Epidemiology 36(2):294-301, 2007.
198. Taylor MM, Rotblatt H, Brooks JT, Montoya J, Aynalem G, Smith L, Kenney K, Laubacher L, Bustamante T,
Kim-Farley R, Fielding J, Bernard B, Daar E, Kerndt PR, “Epidemiologic investigation of a cluster of workplace
HIV infections in the adult film industry, Los Angeles 2004”, Clinical Infectious Diseases 44(2): 301-305, 2007.
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John T. Brooks, MD
199. Young B, Buchacz K, Baker RK, Moorman A, Chmiel JS, Wood KS, Brooks JT, “Renal function in tenofovir–
exposed and unexposed patients receiving highly active antiretroviral therapy (HAART) in the HIV Outpatient
Study (HOPS) cohort”, Journal of the International Association of Physicians in AIDS Care 6(3):178-187, 2007.
200. Buchacz K, Young B, Baker RK, Moorman A, Chmiel JS, Wood KS, Brooks JT, “Creatinine clearance in
patients receiving tenofovir with ritonavir/lopinavir or ritonavir/atazanavir in the HOPS cohort”, Journal of
Acquired Immune Deficiency Syndromes, 43(5): 626-628, 2006.
201. Forna F, Fitzpatrick L, Adimora AA, McLellan-Lemal E, Leone P, Brooks JT, Marks G, Greenberg A, “HIV
transmission among black women in North Carolina, 2004”, Journal of the National Medical Association, 98(11):
1798-1804, 2006.
202. Buchacz K, Brooks JT, Tong T, Moorman AC, Baker RK, Holmberg SD, Greenberg A, ”Evaluation of
hypophosphatemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV outpatients receiving
highly active antiretroviral therapy”, HIV Medicine, 7: 451-456, 2006.
203. Palella FJ, Baker RK, Moorman AC, Chmiel JS, Wood KS, Brooks JT, Holmberg SD, “Mortality in the HAART
era: changing causes of death and disease in the HIV Outpatient Study (HOPS)”, Journal of Acquired Immune
Deficiency Syndromes, 43(1):27-34.
204. Tedaldi EM, Brooks JT, Weidle PJ, Richardson JT, Baker RK, Buchacz K, Moorman AC, Wood KC, Holmberg
SD, “Increased body mass index does not alter response to initial highly active antiretroviral therapy (HAART) in
HIV-1 infected patients”, Journal of Acquired Immune Deficiency Syndromes, 43(1): 35-41.
205. Brooks JT, Ochieng JB, Kumar L, Okoth G, Shapiro RL, Wells, JG, Bird M, Bopp C, Chege W, Beatty ME,
Chiller T, Vulule JM, Mintz E, Slutsker L, ”Surveillance for bacterial diarrhea and antimicrobial resistance in rural
western Kenya, 1997-2003”, Clinical Infectious Diseases, 43(4): 393-401, 2006.
206. Forna F, McConnell M, Kitabire FN, Homsy J, Brooks JT, Mermin J, Weidle PJ, “Review of the safety of
trimethoprim-sulfamethoxazole for prophylaxis in HIV-infected pregnant women: implications for resource-limited
settings”, AIDS Reviews, 8(1): 24-36, 2006.
207. Sullivan PS, Hanson DL, Teshale EH, Wotring LL, Brooks JT, “The effect of hepatitis C infection on progression
of HIV disease and response to antiretroviral therapy in patients with HIV infection”, AIDS, 20(8): 1171-1179,
2006.
208. Brooks JT, Robbins KS, Youngpairoj AS, Rotblatt H, Kerndt PR, Taylor MM, Daar ES, Kalish ML, “Molecular
analysis of HIV strains from a cluster of worker infections in the adult film industry, Los Angeles 2004”, AIDS,
20(6), 923-928, 2006.
209. From the Centers for Diseases Control and Prevention, “Surveillance in hurricane evacuation centers – Louisiana,
September-October 2005”, MMWR, 55(2), 32-5, 2006.
210. Sanchez TH, Brooks JT, Sullivan PS, Juhasz M, Mintz E, Dworkin MS, Jones JL, and the Adult/Adolescent
Spectrum of HIV Disease Study Group, “Bacterial diarrhea in persons with HIV infection, United States, 1992
through 2002, Clinical Infectious Diseases, 41(11): 1621-7, 2005.
211. From the Centers for Diseases Control and Prevention, “HIV transmission in the adult film industry – Los Angeles,
California, 2004”, MMWR, 54 (37), 923-6, 2005.
212. From the Centers for Diseases Control and Prevention, “Shigella flexneri serotype 3 infections among men who
have sex with men – Chicago, Illinois, 2003-2004”, MMWR, 54(33), 820-2, 2005.
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John T. Brooks, MD
213. Brooks JT, Sowers EG, Wells JG, Greene KD, Griffin PM, Hoekstra RM, Strockbine NA, “Non-O157 Shiga
toxin-producing Escherichia coli infections in the United States, 1983-2002”, Journal of Infectious Diseases,
192(8): 1422-9, 2005.
214. Brooks JT, Song R, Hanson DL, Wolfe M, Swerdlow DL, “Discontinuation of primary prophylaxis against
Mycobacterium avium complex (MAC) infections in HIV- infected persons receiving antiretroviral therapy:
observations from a large national cohort, United States 1992-2002”, Clinical Infectious Diseases, 41(4): 549-53,
2005.
215. From the Centers for Diseases Control and Prevention, “HIV transmission among black women – North Carolina,
2004”, MMWR, 54(4), 89-94, 2005.
216. Gupta A, Hunter SB, Bidol SA, Dietrich S, Kincaid J, Salehi E, Nicholson L, Genese CA, Todd-Weinstein S,
Marengo L, Kimura AC, Brooks JT, “Escherichia coli O157 cluster evaluation”, Emerging Infectious Diseases
10(10): 1856-8, 2004. http://www.cdc.gov/ncidod/EID/vol10no10/04-0374.htm.
217. Schrag SJ, Brooks JT, Van Beneden C, Parashar UD, Griffin PM, Anderson LJ, Bellini WJ, Benson RJ, Erdman
DD, Klimov A, Ksiazek TG, Peret TCT, Talkington DF, Thacker WL, Tondella ML, Hightower AW, Nordenberg
DF, Plikaytis BD, Khan AS, Rosenstein NS, Treadwell TA, Whitney CG, Fiore AE, Durant TM, Perz JF, Wasley
A, Feikin D, Herndon JL, Bower WA, Kilbourn BW, Levy DA, Coronado VG, Buffington J, Dykewicz CA,
Khabbaz RF, Chamberland ME, “SARS Surveillance in the United States during the emergency public health
response, March-July, 2003”, Emerging Infectious Diseases 10(2): 185-94, 2004.
http://www.cdc.gov/ncidod/EID/vol10no2/03-0752.htm.
218. Brooks, JT, “Antiretroviral Rounds - MRSA: not just for inpatients anymore”, AIDS Clinical Care 16(10): 82-3,
2004.
219. Brooks JT, Bergmire-Sweat D, Kennedy M, Hendricks K, Garcia M, Marengo L, Wells JG, Ying M, Griffin PM,
Hoekstra RM, Friedman CR, “Outbreak of Shiga toxin-producing Escherichia coli O111:H8 infections among
attendees of a high school cheerleading camp”, Clinical Infectious Diseases 38(2): 190-8, 2004.
220. Beatty ME, Sivapalasingam S, Jack T, Yao S, Paul I, Milne T, Greene KD, Bopp C, Hoekstra R, Mintz ED,
Brooks JT, “An outbreak of Vibrio cholerae O1 infections on Ebeye Island, Republic of the Marshall Islands,
associated with use of an adequately chlorinated water source”, Clinical Infectious Diseases 38(1):1-9, 2004.
221. Brooks, JT, Shapiro RL, Kumar L, Wells JG, Phillips-Howard P, Vulule J, Hoekstra RM, Mintz E, Slutsker L,
“Epidemiology of sporadic bloody diarrhea in rural western Kenya”, accepted American Journal of Tropical
Medicine and Hygiene, 68(6):671-7, 2003. http://www.cdc.gov/ncidod/EID/vol10no2/03-0752.htm.
222. Brooks, JT, Rowe SY, Shillam P, Heltzel DM, Hunter SB, Slutsker L, Hoekstra RM, Luby SP, “Salmonella
Typhimurium infections transmitted by chlorine-pretreated clover sprout seeds”, American Journal of
Epidemiology, 154 (11), 2001.
223. Cummings K, Barrett E, Mohle-Boetani J, Brooks JT, Farrar J, Hunt T, Fiore A, Komatsu K, Werner SB, Slutsker
L, “A multistate outbreak of Salmonella Baildon associated with domestic tomatoes”, Emerging Infectious
Diseases, 7(6): 1046-8, 2001. http://www.cdc.gov/ncidod/eid/vol7no6/cummings.htm.
224. Shapiro R, Kumar L, Phillips-Howard P, Wells JG, Adcock P, Brooks JT, Ackers ML, Ochieng JB, Bopp CA,
Nahlen B, Hawley W, Mintz E, Waiyaki P, Slutsker L, Antimicrobial-resistant bacterial diarrhea in rural western
Kenya”, Journal of Infectious Diseases 183:1701-4, 2001.
225. From the Centers for Diseases Control and Prevention, “Shigella sonnei outbreak among men who have sex with
men - San Francisco, California, 2000-2001”, MMWR, 50(42), 922, 2001.
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John T. Brooks, MD
226. From the Centers for Diseases Control and Prevention, “Outbreak of Escherichia coli O111:H8 infections among
teenage campers - Texas, 1999”, MMWR, 49(15), 321, 2000.
227. From the Centers for Diseases Control and Prevention, “Foodborne botulism from eating home-pickled eggs -
Illinois, 1997”, MMWR, 49(34), 778, 2000.
228. Brooks JT, Wheat J, “Histoplasmosis, Update 1998”, AIDS Clinical Care, January 1998.
229. Brooks JT, “Protease Inhibitors and Anticonvulsants”, AIDS Clinical Care, November 1997.
BOOK CHAPTERS
1. Peters OJ, Marston BJ, Weidle PJ, Brooks JT, “Human Immunodeficiency Virus Infection”, in Hunter’s
Tropical Medicine, 9th Edition, ed. Ryan E, W.B. Saunders, 2013.
2. Brooks JT and Chen M, “The HIV Epidemic in the USA: Current Trends, 2010”, in HIV and Liver Disease,
ed. Sherman KE, Springer, 2011.
3. Brooks JT, “HIV Infection and Acquired Immune Deficiency Syndrome (AIDS)”, in Chapter 3 – Infectious
Diseases Related to Travel, CDC Health Information for International Travel 2012, eds. G. Brunette, PE
Kozarsky, AJ Magill, DR Shlim and AD Whatley, Elsevier Mosby, Philadelphia PA, 2012.
4. Palella F, Moorman AC, Brooks JT, “The HIV Outpatient Study (HOPS)”, in A Decade of HAART: Historical
Perspectives and Future Directions, ed. J Bartlett, Oxford University Press, New York NY, 2008
5. Brooks JT, Leung G, Shannon M, “Inhalants”, Chapter 16 in Source Book of Substance Abuse and Addiction,
eds. L. Friedman et al., Williams and Wilkins, Baltimore MD, 1996.
Page 25 of 25
EXHIBIT C
EXHIBIT D

GALVESTON DIVISION
v.
DECLARATION OF JOHN
DR. ANTHONY FAUCI, in his official CUNNINGHAM
capacity, et al.,
Defendants.
I, JOHN CUNNINGHAM, hereby declare as follows:
1. I am the Deputy Chief Human Capital Officer, Strategy & Services, within the
Office of Human Capital (“OHC”) at the U.S. Immigration and Customs Enforcement
(“ICE”). In this position, I am responsible for directing ICE’s Employee Relations, Labor
Relations, Medical Affairs, Executive Services, Employee Resilience, and Strategic Initiatives
programs within OHC in consultation with the ICE Chief Human Capital Officer and the
U.S. Department of Homeland Security (DHS) Office of the Chief Human Capital Officer
(OCHCO). The statements in this Declaration are based on my personal knowledge and
information provided to me in my official capacity.
2. Consistent with Executive Order No. 14043, ICE is requiring its employees to
be vaccinated against COVID-19, subject to such exceptions as required by law. ICE plans
to use a phased process known as progressive discipline for enforcing the COVID-19
vaccination requirement against employees who have not timely provided proof of vaccination
and do not have a pending exception request. The goal of this process is to help employees
understand and accept the benefit of becoming fully vaccinated.
3. ICE’s enforcement process is intended to provide unvaccinated employees with
every opportunity to become vaccinated. If an unvaccinated employee takes steps toward
becoming vaccinated, the enforcement process would be put on hold to give him or her time
to become fully vaccinated. In addition, if an unvaccinated employee requests an exception at
any time during the enforcement process, the enforcement process would be put on hold until
the exception request has been adjudicated by ICE.
4. For unvaccinated employees with no pending exception request, ICE’s
enforcement process will begin with a brief period of education and counseling about the
benefits of vaccination and ways to obtain the vaccine. After this counseling period concludes,
unvaccinated employees who have not submitted exception requests may be subject to
progressive discipline, to include a proposed suspension followed by, where appropriate,
proposed removal from employment. 1 0F
5. Plaintiff Gabriel Escoto is an employee of ICE and has served as a Deportation
Officer for 13 years. He is employed in a bargaining unit represented by the American
Federation of Government Employees National ICE Council 118 (hereafter Council 118) and
is covered by a collective bargaining agreement (“CBA” or “Agreement 2000”), attached
hereto as Exhibit A.
1When an employee joins ICE, the employee is generally subject to a probationary or trial
period. Competitive Service positions have a one-year probationary period. Excepted Service
positions have a two-year trial period. Employees who have not yet completed this
probationary or trial period may be removed after counseling, without first being suspended.
2
6. Plaintiff Roy Kenneth Egbert, II is an employee of ICE and has served as a
Deportation Officer for 13 years. He is employed in a bargaining unit represented by Council
118 and is covered by a collective bargaining agreement (“CBA” or “Agreement 2000”),
attached hereto as Exhibit A.
7. Plaintiff Carole LeAnn Mezzacapo is an employee of ICE and has served as an
Enforcement and Removal Assistant with ICE since 2008. She is employed in a bargaining
unit represented by Council 118 and is covered by a collective bargaining agreement (“CBA”
or “Agreement 2000”), attached hereto as Exhibit A.
8. CBA or Agreement 2000 includes contractual provisions for disciplinary and
adverse actions, negotiated grievance procedures, and arbitration procedures. Ex. A, at art.
31, Disciplinary and Adverse Actions; art. 47, Grievance Procedures; art. 48, Arbitration. This
CBA also includes reference to Plaintiffs Mezzacapo, Escoto, and Egbert’s statutory rights of
appeal, which include the right to appeal before the Merit Systems Protection Board (“MSPB”)
or to initiate an Equal Employment Opportunity (“EEO”) complaint with ICE. Id. at art. 31,
Disciplinary and Adverse Actions, I.(2). Plaintiffs Mezzacapo, Escoto, and Egbert would all
be provided ample process under this CBA and in accordance with any statutory rights they
have under the law.
9. Plaintiff James Rodden is an employee of ICE and serves as an Assistant Chief
Counsel (attorney). He has been an ICE employee since March 1, 2020. He is employed in a
bargaining unit represented by the American Federation of Government Employees Local 511
and is covered by another CBA (“Professional Employees Agreement 2019”), attached hereto
as Exhibit B. This CBA also includes contractual provisions for disciplinary and adverse
3
actions and negotiated grievance and arbitration procedures. Ex. B at art. 26, Disciplinary and
Adverse Actions; art. 22, Grievance and Arbitration Procedures. These grievance procedures
would apply to the suspension of an employee who is still within the trial/probationary period,
see supra page 2 n.1, but not to the removal of such an employee.
10. As of November 22, 2021, ICE has a record of pending requests within the
Accessibility Compliance Management System (“ACMS”) from Plaintiffs Escoto, Egbert, and
Rodden for exception to the requirement that ICE employees be vaccinated against COVID-
19 pursuant to Executive Order 14,043.
11. As of November 22, 2021, ICE does not have a record within ACMS of any
pending exception request from Plaintiff Mezzacapo. However, if such a request were to be
submitted, regardless of the method of submission (i.e., verbal, written, formal), ICE would
consider the request.
12. Pursuant to ICE policy, ICE will not take disciplinary action against an
employee who has an exception request pending. Currently this includes Plaintiffs Escoto,
Egbert, and Rodden. If ICE denies the exception request for any one of these three Plaintiffs,
that Plaintiff would be given a new deadline by which to provide proof that he has become
fully vaccinated against COVID-19. This new deadline will give that Plaintiff at least two
weeks to initiate the process of becoming vaccinated against COVID-19, during which time
he would not be disciplined for being unvaccinated. In addition, he would be afforded the
opportunity to seek reconsideration from a designated senior ICE official of any denial and
would not be disciplined pending the outcome of that reconsideration. If Plaintiffs Escoto,
4
Egbert, and Rodden’s exception request is denied, and any one of these Plaintiffs fails to meet
the new vaccination deadline, ICE would expect to initiate the enforcement process outline in
paragraphs 2-4, above.
13. The exception requests from Plaintiffs Escoto, Egbert, and Rodden have been
received within the ACMS, and each request remains pending, as stated in paragraph 10 above.
ICE has not yet begun adjudicating requests from any employees. ICE will not begin
adjudicating requests until they are fully processed and prepared for presentation to the
appropriate decision-making body under procedures established by ICE. These procedures
have not been fully established or operationalized as of November 22, 2021.
14. Plaintiff Mezzacapo has not yet been counseled or disciplined for not being
vaccinated against COVID-19. She will not be fully vaccinated by the November 22, 2021
deadline, so she could begin to receive counseling at any point. Because the counseling period
lasts five days, the earliest she could receive a letter of reprimand (if counseling began today,
November 22, 2021) would be November 29, 2021. If she were to receive a letter of
reprimand, she would have 10 days within which to submit for ICE’s consideration a statement
of disagreement with the letter of reprimand. See CBA, Agreement 2000, art. 31, Disciplinary
and Adverse Actions, H.(2).
15. If Plaintiff Mezzacapo does not request an exception or take steps to become
vaccinated, she could receive a proposed suspension. A proposed suspension would take at
least 30 days to effectuate. Plaintiff Mezzacapo would have at least 10 days—or more if she
requests an extension—to submit a reply for ICE’s consideration. The proposed suspension
5
would then need to be adjudicated by a neutral decision maker (“Deciding Official”) within
ICE. And if ICE issued a final decision to suspend her for 14 days or less, she would have
the right to file a grievance to try to reverse that decision. See CBA, Agreement 2000, art. 31,
Disciplinary and Adverse Actions, I.(1).
16. Given the possibility of obtaining an exception to the vaccination requirement,
and the multi-step administrative process for addressing employment disputes described
above, it is uncertain whether and when Ms. Mezzacapo may face workplace discipline for
being unvaccinated. If these processes resulted in a proposal to remove Plaintiff Mezzacapo
from employment, she would have the statutory right to be issued a notice of proposed action,
the right to respond orally and/or in writing, the right to be represented during any removal
proceedings, and the right to have a decision issued by a neutral Deciding Official within ICE.
This Deciding Official would then have to consider all evidence relied upon to issue the notice
of proposed action, additional information the employee submitted during the reply period,
and an analysis of the applicable factors set forth in Douglas vs. Veterans Administration, 5
M.S.P.R. 280 (1981), when determining whether to sustain the charge(s) and whether to
maintain or mitigate any proposed penalty.
17. If Plaintiff Mezzacapo were ultimately removed, she would have various
options for challenging her removal, including her statutory rights of appeal before the MSPB,
or to initiate an EEO complaint with ICE, or to file a grievance (which would begin at the
arbitration step, as per the CBA). See CBA, Agreement 2000, art. 31, Disciplinary and Adverse
Actions, I.(2) and J.(2); see also CBA, Agreement 2000, art. 48, Arbitration.
6
18. Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury that the above
statements are true and correct.
Dated: November 22, 2021 Respectfully submitted,
John D. Cunningham
Deputy Chief Human Capital Officer,
Strategy & Services
ICE Office of Human Capital
7
EXHIBIT A
U.S. Department of Justice

Immigration and Naturalization Service
Agreement 2000
Between
U.S. Immigration and

Naturalization Service
and
National Immigration
and Naturalization
Service Council
American Federation of Government Employees, AFL-CIO

M-203 (Rev. 06/08/2000) N
TABLE OF ARTICLES PAGE

ARTICLE 1 - Recognition ......................................................................................4
ARTICLE 2 - Effect of Law and Regulation ..........................................................4
ARTICLE 3 - Employee Rights ...............................................................................5
ARTICLE 4 - Management Rights ..........................................................................6
ARTICLE 5 - Union Rights .....................................................................................7
ARTICLE 6 - Status of Employee Representatives ..................................................8
ARTICLE 7 - Use of Official Time ..........................................................................9
ARTICLE 8 - Facilities and Services......................................................................14
ARTICLE 9 - Impact Bargaining and Mid-Term Bargaining.................................18
ARTICLE 10 - Partnership and Labor-Management Relations...............................23
ARTICLE 11 - Protecting Against Prohibited Personnel Practices.........................25
ARTICLE 12 - Notice to Employees .......................................................................29
ARTICLE 13 - Outside Employment .....................................................................30
ARTICLE 14 - Retirement.......................................................................................31
ARTICLE 15 - Development and Training .............................................................32
ARTICLE 16 - Classification ..................................................................................33
ARTICLE 17 - Safety and Health ............................................................................34
ARTICLE 18 - Injury Compensation.......................................................................38
ARTICLE 19 - Fitness for Duty Examination .........................................................40
ARTICLE 20 - Disabled Employees........................................................................40
ARTICLE 21 - Personnel Records...........................................................................40
ARTICLE 22 - Performance Appraisal....................................................................41
ARTICLE 23 - Reduction-in-Force, Transfer of Function and Reorganization ......42
ARTICLE 24 - Firearms and other Weapons ..........................................................44
ARTICLE 25 - Uniforms and Appearance ..............................................................45
ARTICLE 26 - Travel ..............................................................................................48
ARTICLE 27 - Overtime - (Other than Uncontrollable Overtime and LEA) ..........52
ARTICLE 28 - Details and Temporary Duty Stations .............................................53
ARTICLE 29 - Hours of Work ................................................................................55
ARTICLE 30 - Formal Meetings and Investigative Interviews ...............................58
INS/NINSC AGREEMENT 2000 PAGE 1

(ARTICLE 2 - Effect of Law and Regulation)
ARTICLE 31 - Disciplinary and Adverse Actions ..................................................59

ARTICLE 32 - Actions Based Upon Unacceptable Performance ...........................62
ARTICLE 33 - Career Ladder Promotions and Within Grade Increases.................64
ARTICLE 34 - Quality Step Increase ......................................................................66
ARTICLE 35 - Annual Leave ..................................................................................66
ARTICLE 36 - Sick Leave.......................................................................................69
ARTICLE 37 - Administrative Leave......................................................................72
ARTICLE 38 - Home Leave ....................................................................................73
ARTICLE 39 - Leave Without Pay..........................................................................73
ARTICLE 40 - Leave for Family Responsibilities ..................................................75
ARTICLE 41 - Counseling for Performance and Conduct ......................................77
ARTICLE 42 - Holidays and Religious Observances..............................................78
ARTICLE 43 - Probationary Employees .................................................................80
ARTICLE 44 - Equal Employment Opportunity .....................................................81
ARTICLE 45 - EEO Advisory Committees.............................................................85
ARTICLE 46 - Sexual Harassment..........................................................................86
ARTICLE 47 - Grievance Procedure .......................................................................90
ARTICLE 48 - Arbitration.......................................................................................97
ARTICLE 49 - Effective Date and Duration .........................................................100
ARTICLE 50 - Negotiation of Supplemental Agreements ....................................101
ARTICLE 51 - Impasses in Supplemental Negotiations, Impact Bargaining, and Mid-
Term Negotiations. .................................................................................................103
ARTICLE 52 - Total Quality Management ...........................................................103
ARTICLE 53 - Employee Assistance Program.....................................................104
ARTICLE 54 - Contracting....................................................................................105
Signature Page…………………………………………………………………….106

TABLE OF APPENDICES
APPENDIX 1 - Merit Promotion Plan I ................................................................107
APPENDIX 2 - Dues Withholding ........................................................................108
APPENDIX 3 - Side Letter on Intent of Article 7.C.(2): Official Time ................113
APPENDIX 4 - TQM Memorandum of Understanding ........................................114
APPENDIX 5 - Side letter on Intent of Article 53:Employee Assistance Program116
APPENDIX 6 - Side Letter on Web Gear Equipment ...........................................117
APPENDIX 7 - Memorandum of Understanding on Ethics ..................................118
OUTLINE INDEX
An outline of the contact is provided at the end for easy reference.
The outline can be used as a tool to quickly look through the contract to find the
articles and paragraphs relevant to issues in the workplace, or for training.
The outline headings throughout the contract are for reference only.
---------------- Notes ----------------
Note: Organizational titles frequently change. The titles referenced in this agreement
are those that existed when the agreement was negotiated.

ARTICLE 1 - Recognition
BARGAINING UNIT. The Service recognizes the American Federation of Government

Employees (National Immigration and Naturalization Service Council) as the
bargaining agent for all personnel of the Immigration and Naturalization Service,
except professionals, those assigned to Border Patrol Sectors and those excluded from
coverage by the Civil Service Reform Act.
GENDER LANGUAGE. All references to members in this Agreement designate both
sexes, and whenever the male gender is used, it shall be construed to include male and
female members as appropriate.
ARTICLE 2 - Effect of Law and Regulation

A. EXISTING OR FUTURE LAWS. In the administration of all matters covered by this
Agreement, the parties are governed by existing or future laws; and government wide
rules or regulations in effect upon the effective date of this Agreement. In the
administration of this Agreement, should any conflict arise between the terms of this
Agreement and any present or future laws, provisions of such laws shall supersede
conflicting provisions of this Agreement.
B. GOVERNMENT WIDE RULE OR REGULATION. Should any conflict arise in the

administration of this Agreement between the terms of this Agreement and any
government wide rule or regulation such as the Code of Federal Regulations or
Department of Justice Orders, Policy Letters, Manuals (other than a rule or regulation
implementing 5 U.S.C. 2302), issued after the effective date of this Agreement, the
terms of this Agreement will supersede and govern.
C. SERVICE POLICY. In any conflict between the terms of this Agreement and any
provision of Service Orders, Policy Letters, Manuals, etc., regardless of date of
issuance, the terms of the Agreement will govern.
D. EFFECT OF INVALIDATION. Should any part of this Agreement or any provision or

provisions contained herein be rendered or declared invalid by reason of any of the
contingencies referred to in this Article, such invalidation of such provision or
provisions of this Agreement shall not invalidate those unaffected parts or provisions
contained in this Agreement and they shall remain in full force and effect.
E. SCOPE. The requirements of this Article shall apply to all supplemental,

implementing, subsidiary or informal agreements between the parties.
F. INTENT OF RESTATEMENT. In a number of the provisions of this agreement, statutes

or regulations are restated for the convenience of the parties and the employees
covered by the agreement. In restating the provisions of such statutes and regulations,
some minor changes to the statutory and regulatory language have been made for

larity or to place that language in context. These wording changes are not intended to
change the meaning of the language in question. However, should there be any
conflict between the language of this agreement and the language of applicable
statutes, or regulations in effect at the time the agreement became effective, the
language of the statutes and regulations is controlling.
ARTICLE 3 - Employee Rights

A. RIGHT TO JOIN AND PARTICIPATE.
(1) Employee Participation. Employees covered by this Agreement shall have the
right to form, join, or assist any labor organization, or to refrain from any such
activity, freely and without fear of penalty or reprisal, and each employee shall be
protected in the exercise of such right. Except as otherwise provided in the Civil
Service Reform Act of 1978, such rights include the right -
(a) Representation. To act for a labor organization in the capacity of a

representative and the right, in that capacity to present the views of the labor
organization to heads of agencies and other officials of the Executive Branch
of the government, the Congress or other appropriate authorities; and
(b) Collective Bargaining. To engage in collective bargaining with respect to

conditions of employment through the Union as provided by law and this
Agreement.
(2) Management Non-participation. Nothing in this section, or this Agreement,

authorizes participation in the management of a labor organization by a
management official, a supervisor, or a confidential employee, except as
specifically provided in the Civil Service Reform Act of 1978, or by an employee
if the participation or activity would result in a conflict or apparent conflict of
interest or would otherwise be incompatible with law or with the official duties of
the employee.
B. PRIVATE COUNSELING. Any discussions with individual employees concerning

counseling, evaluations, workload review, or disciplinary actions will be conducted so
as to insure the privacy of the employee
C. CONTRIBUTIONS / GIFTS..
(1) Voluntary. The Employer agrees that participation in the Combined Federal
Campaign, United States Bond Drives, Blood Donor Drives, and other worthy
programs will be on a voluntary basis.
(2) Gifts. Contributions for gifts for supervisors, management officials or fellow
employees will be strictly voluntary.

(ARTICLE 3 - Employee Rights)
D. RIGHT TO COMMUNICATE. An employee has the right to communicate

with the appropriate member of the following offices concerning individual
personnel matters:
(1) The servicing Human Resources Office(s) including District, Center, Office,
Regional and Headquarters Human Resources Offices;
(2) The EEO Office or the EEO Officer;
(3) A Supervisor or Management Official of a higher rank than the employee’s

immediate supervisor;
(4) EEO Counselors;
(5) The appropriate official in the Safety and Health Office.

Employees are encouraged (but not required) to initiate such individual personnel
matters with first-line supervisors and to follow the chain of command where
appropriate.
ARTICLE 4 - Management Rights

A. NEGOTIATING. Nothing in this Contract shall preclude the Service and the Union
from negotiating:
(1) Permissive Subjects. At the election of the Service, on the numbers, types and
grades of employees or positions assigned to any organizational subdivision, work
projects, or tour of duty, or on the technology, methods and means of performing
work.
(2) Procedures. Procedures which management officials of the Service will observe
in exercising any authority under this Article; or
(3) Appropriate Arrangements. Appropriate arrangements for employees adversely

affected by the exercise of any authority under this Article by Service officials.
B. AUTHORITY OF SERVICE OFFICIALS. Nothing in this Contract shall affect the

authority of any Service official:
(1) To determine the mission, budget, organization, number of employees and internal
security practices of the service; and
(2) In accordance with applicable laws:

(ARTICLE 4 - Management Rights)
(a) To hire, assign, direct, lay off and retain employees in the Service, or to
suspend, remove, reduce in grade or pay, or take other disciplinary action against
such employees:
(b) To assign work, to make determination with respect to contracting out and to
determine the personnel by which Service operations shall be conducted;
(c) With respect to filling positions, to make selections for appointment from:
(i) Among properly ranked and certified candidates for promotion; or
(ii) Any other appropriate source; and
(d) To take whatever action may be necessary to carry out the Service Mission
during emergencies.
ARTICLE 5 - Union Rights

A. EXCLUSIVE REPRESENTATIVE. The Union is the exclusive representative of the
employees in the unit and is entitled to act for, and represent the interests of all
employees in the unit. Where appropriate, for the purposes of this agreement, when
the term District Office is used it is understood that it will include Service Centers,
Asylum Offices, Administrative Centers, Regional Offices, and Headquarters.
B REPRESENTATION AT FORMAL DISCUSSIONS.
(1) Formal Discussions. The Union shall be given the opportunity to be represented
at any formal discussion between one or more representatives of the Employer and
one or more employees in the unit or their representatives concerning any
grievance or any personnel policy or practice or other general condition of
employment.
(2) Notice. The Union representative will receive reasonable advance notice of such
formal discussions. The Union will receive copies of documents supplied to
employees at the time of the discussion. Except in circumstances in which an
urgent operational need to act quickly requires a shorter period or a shorter period
is mutually agreed to by the parties, reasonable notice will mean not less than 24
hours.
C. REPRESENTATION AT INVESTIGATORY INTERVIEWS. The Union shall be given the

opportunity to represent employees in investigative interviews as provided in Article
30, Section B of this Agreement.
D. RIGHT TO PRESENT VIEWS. The Union shall have the right to present its views, either
orally or in writing, to the Employer on any matters of concern regarding personnel
policies and practices and matters affecting working conditions.

(ARTICLE 5 - Union Rights)
E. EXISTING AGREEMENTS. This Agreement is not intended to abolish, solely by

exclusion here from, any national, local or regional understandings or agreements
which have been mutually acceptable at the national, local or regional level. It is
understood that any such understandings and agreements are valid only to the extent
they are not inconsistent with the provisions of this agreement or controlling
regulations as described in Article two.
ARTICLE 6 - Status of Employee Representatives

A. NO RESTRAINT. The Service shall not impose any restraint (except as may be
otherwise provided in this Agreement), interference, coercion, or discrimination
against employees in the exercise of their rights to organize and designate
representatives of their own choosing for the purposes of collective bargaining, the
presentation of grievances, appeals from adverse actions, Labor-Management
Relations, or upon duly designated employee representatives acting on behalf of an
employee or group of employees within the bargaining unit.
B. DESIGNATION OF STEWARDS. A reasonable number of stewards may be designated

by the Union or its affiliated Locals and shall be recognized as employee
representatives for employees in the District, or other service facility in which they are
designated to be stewards. The Union will supply the Service with their names,
which may be posted on appropriate bulletin boards. It shall be the duty of the Union
to notify Management of any changes in the roster of stewards.
C. AUTHORIZATION FOR REPRESENTATIONAL DUTIES. Upon request and approval in

advance, Union officials are authorized to perform and discharge the duties and
responsibilities which may be properly assigned to them under the terms of the Civil
Service Reform Act of 1978 by the Union in accordance with this Agreement and any
supplemental agreement or agreements hereunder. The Service agrees that there shall
be no restraint, interference, coercion, or discrimination against a union official
because of the performance of these duties while they are serving as Union officials.
Union officials shall be relieved from official duties during the period they are serving
as union officials. This does not preclude employees being called back to their
official duties when there is an immediate need for their services. Nothing shall
require a Union official to take official time at an agency location unless required by
the representational duties performed and/or required by the official duties from
which the employee is relieved.
D. STEWARD AND OFFICER LISTS / MANAGEMENT DIRECTORIES. It is incumbent upon

the Union to furnish Management written notice of the names of the Union Officials
and to advise Management of any changes in its list of designated Union
representatives. In turn, Management will provide the Union, at the National,
Regional and Local level, the appropriate Service telephone Directories and updates
as printed. Management will advise new unit employees or employees transferring

(ARTICLE 6 - Status of Employee Representatives)
between stations, upon entering on duty, of the name of the Local President in
writing.
ARTICLE 7 - Use of Official Time

A. AUTHORIZED USES. Upon request, and approval, Union officials may use official
time to conduct representational functions where such is authorized pursuant to, and
consistent with, applicable statutes, regulations, and executive orders relating to
complaints, grievances, appeals and other matters involving dealings with Service
officials. Official time for representational functions performed by Union officers and
stewards will be authorized for:
(1) Representation. Representation in grievances, discrimination complaints and

appeals.
(2) Grievances. To prepare and present grievances under the NGP, including
allegations of discrimination, the Local representative may be authorized up to a
maximum of sixteen (16) hours of official time but may not use more than eight
(8) hours at any step of the grievance procedure. After arbitration has been
invoked in accordance with Article 48, if a Local representative is designated to
present the grievant’s case, he or she will be authorized twenty-four (24) hours to
prepare for arbitration. Should the hearing be continued, the designated
representative will be granted eight (8) hours preparation time for each additional
scheduled hearing day. The Local representative may be authorized up to a
maximum of four (4) hours to prepare a ULP charge. Prior to filing an unfair
labor practice charge with the Federal Labor Relations Authority, Union
Representatives will, in an effort to resolve the issue, discuss the complaint with
local managers. Union officials shall not knowingly file a grievance or a ULP
charge concerning the implementation of a policy or procedure agreed to by the
Council President and Management at the national level.
(3) Labor-Management Meetings. For representation of the Union in Labor-

Management meetings with the Employer pursuant to Article 10. Local presidents
shall be authorized up to three (3) hours for preparation prior to each meeting.
(4) Arbitrations & Appeals. For representation at arbitrations and statutory appeal
hearings.
(5) Adjustment of Grievances. Representation at adjustment of grievances, adverse

actions and any EEO matters that affect bargaining unit employees.
(6) Committee Meetings. Attendance at committee meetings as the designated Union

representative.

(ARTICLE 7 - Use of Official Time)
(7) Respond to Management. Review of and response to memoranda, letters,

and requests from the Employer, as well as proposed new instructions, manuals,
notices, etc., which affect personnel policies, practices or working conditions.
(8) Technical Representative. To act as a technical advisor or assistant employee

representative in hearings. The technical advisor or assistant employee
representative will be granted up to 8 hours official time to prepare for the
hearing. There shall be a limit of one representative so designated at a
proceeding.
(9) Observer. To attend hearings or meetings in the capacity of an observer where

bargaining unit employees have elected to pursue a grievance without Union
representation.
(10) Respond to Congress. To respond to requests for information from members of

Congress and/or testify before Congress.
(11) Partnership. To participate in Labor-Management Partnership Council

proceedings and endeavors. Official time used under this subsection will not be
counted against the negotiated block time of any local union official.
(12) Treasurer. The treasurer of each local and the Council will be authorized four
(4) hours per month to complete reports required by other federal agencies.
(13) EEO Briefings. To participate in status briefings of the Service’s EEO program.
(14) Other Functions. To perform those functions stated elsewhere in this agreement
for which official time has been expressly provided.
Approval of official time for appropriate Union representational activities other than
those specified above will be subject to review at the regional level.
B. BLOCK TIME. Official time for the performance of functions described in Article
7(A) as well as labor-management partnership activities will be granted during regular
duty hours to Union officials as follows:
(1) Council President -(100%)
(2) Executive Vice President (100%)
(3) Seven Vice Presidents (100%)
(4) Fair Practices Coordinator - (100%)
(5) Two Staff Assistants to the President - (100%)

(6) Except as specifically provided, Local Union Officers shall be authorized

reasonable official time to perform functions outlined in this agreement. The
parties agree that use of blocks of official time for local union officials is an
appropriate subject for bargaining in local supplemental negotiations.
C. REQUIRED PROCEDURES:
(1) Advance Notice. All Union officials (except those listed in Section B 1 thru 5
above) will make every effort to schedule use of time and give advance written
notice to Management in accordance with C(2) below. Requesting Union officials
will inform the immediate supervisor by way of a completely filled out Form G-
826, including among other matters, the nature of the duties to be performed and
will indicate on the form the estimated amount of time to be used and the object
class code to which the time is to be charged.
(2) Form G-826 Procedures. The Employer will furnish a form G-826 (pre-printed
memorandum) which shall be used by all Union officers (except those listed In
Section B 1 through 5 above) to request official time pursuant to this Article. The
Union officer will prepare the form completely pursuant to this Article and submit
the form to the appropriate supervisor in duplicate. The supervisor will endorse
the form indicating approval or denial, retain one copy and return one copy to the
requester. If the request is approved, the Union officer, upon completion of the
authorized activity and at the time of his or her return to duty; will advise his or
her supervisor, either orally or in writing, as to the date and time of his or her
return to duty and total number of hours used. The supervisor will then note on
his or her copy of the original request to reflect the total time (hours/dates) used
and insure that such time is appropriately recorded on the Union officer’s time and
attendance report. The supervisor will also, at that time, forward a copy of the to
the appropriate servicing Human Resources (LMR) Office. The Union official
shall not be required to identify a possible grievant at the informal stage of the
NGP until such time as the grievance is officially filed, but shall be required to
identify the specific issue being considered and the Union official must identify
his or her place of contact or telephone number at all times pursuant to Article 6C.
Requests for official time will be acted upon in a timely manner. Adjudication of
the request in a timely manner will mean 24 hours or less on consecutive
weekdays, excluding weekends or holidays from the time that a properly
completed request is submitted to an appropriate management official. Managers
will take into consideration the time constraints the Union official may be
operating under. Should an occasion arise when a request must be denied, in
whole or in part, the Service will cite the reason for the denial on the official time
request form.

(3) Supervisory Approval. The Union officer and/or employee involved shall
also obtain approval of the employee’s supervisor for any meeting during the
employee’s duty time.
(4) No Internal Union Business. In no case will internal Union business such as
solicitation of dues, maintenance of the dues check-off agreement, or solicitation
of membership be conducted on official time.
D. RESTRICTION ON BLOCK TIME. The 2080 hours of official time authorized for use by
Council Officers listed in Section B 1 thru 5 above is intended and shall be interpreted
as authorizing those Council Officers 100% official time for all representational
duties performed during their normal duty hours. However, it does not authorize
official time during normal duty hours for the following activities:
(1) Internal Union Business. Conduct of internal Union business for which Council
Officers shall charge their time to annual leave or leave without pay.
(2) Leave. Activities for which the employee would normally be required to charge
his or her time to annual, sick or other appropriate leave if he or she were not a
Union officer (e.g. annual leave for a vacation or sick leave for an illness).
Recall to Duty. Not-withstanding the provision of this Section, the Council Officers
may be assigned official duties (and appropriately compensated) in situations of
emergency.
E. TRAVEL TIME. A Local President or designee may be granted reasonable and

necessary travel time for the purpose of traveling to assist in representing a grievant
within his or her district at a sub-office or remote location which does not have a local
Union steward, or for any other meetings scheduled by management.
F. COUNCIL REPRESENTATIVES. National Council representatives are authorized

official time to attend the following meetings:
(1) Labor-Management Meetings. National and Regional Annual Labor-

Management Meetings respectively;
(2) Safety and Health Committee Meetings. National and Regional Safety and
Health Committee Meetings; or
(3) Other Meetings with Management. Any other meeting scheduled by

Management with the intent of meeting with the Union as general representative
of the bargaining unit for the purpose of obtaining the Union’s views or offering
Management’s views on the operation of a policy or program (excluding
grievance representation, complaints, appeals, negotiations, etc.) will be
authorized travel expenses and per diem. Necessary time for travel will be
allowed.

G. ADMINISTRATIVE TIME FOR TRAINING.
(1) Limits. The Service agrees that official leave may be administratively authorized
for Union representatives to attend training approved by Management which is
designed to advise representatives on matters within the scope of CSRA and Title
7, which are of mutual concern to the Service and the Union. Administrative
excusal for this purpose will not exceed:
(a) Offices of Less than 50. Fifteen (15) training days per calendar year for each
District, Office or Center, with less than fifty (50) employees,
(b) Offices of 50 to 299. Thirty (30) training days for each District, Office or
Center with 50-299 employees,
(c) Offices of 300 to 500. Forty (40) training days for each District, Office or
Center with three hundred (300) to five hundred (500) or more employees,
(d) Offices of More than 500. Sixty (60) training days for each District, Office or
Center with more than five hundred (500) employees.
(e) Council. Thirty (30) training days per year for the Council. Council officers as
identified in B who present such training may use the authorized official time
for this presentation.
(2) Procedures. Requests for such leave to attend training shall be submitted to the
appropriate District, Service Center, or Asylum Office, and a copy as well to the
appropriate Administrative Center Director together with an agenda that includes
the actual hours that training will be conducted. Requests shall be received in
writing from the Union at least fifteen (15) working days in advance of the date
the training is scheduled to commence. Management shall notify the Union of its
decision no later than ten (10) working days after receipt of the request.
H. ARBITRATION TRAVEL AND PER DIEM. The Service will pay travel and per diem
expenses for Council Officers identified in Section B 3 when they act as
representatives in arbitration cases for disciplinary actions of ten (10) calendar days or
more, within their area.
I. COUNCIL TRIPS. The Council President and Executive Vice-President or Council

Officers designated by the Council President will be authorized up to a combined
total of twenty-two (22) trips, for the purpose of improving the labor management
relationship within the Service, to assist local unions in 9A bargaining; to present the
Union’s case in arbitration of suspensions of 20 days or more; or cases involving
demotions in grade. The trips will be authorized and coordinated with the Labor
Management Relations Office in Washington, D.C.

J. TRAVEL AND PER DIEM FOR UNION REPRESENTATIVES. Union representative

official time and travel and per diem provisions of this agreement shall normally
apply only to designated union representatives. However, it is also understood that the
Union at the local level may from time to time designate other employees to represent
its interests and to participate in activities including rating panels, labor management
meetings, partnership activities, or any other meetings called by management. Such
employees shall be authorized official time, travel and per diem as necessary for
participation in such activities consistent with the needs of the Service. The union
shall make every practicable effort to rely on employees who are locally available for
participation in such activities.
ARTICLE 8 - Facilities and Services

A. UNION USE OF SERVICE FACILITIES.
(1) Meeting Space. Upon reasonable advance request by the Union, the Employer
will provide meeting space, if available, in areas occupied by the Employer for
meetings during non-duty hours. The Union will comply with all security, safety
and housekeeping rules in effect at that time and place.
(2) Non-duty Hours. Employees attending meetings under Subsection (1) will do so
only during non-duty hours or while they are in a leave status.
(3) Elections. Upon reasonable advance request, mutually agreed upon space will be
provided, if available, by the Employer to be used in conjunction with elections
governed by Local by-laws. The Union acknowledges that no responsibility for
the safety or security of the ballot boxes is assumed by the Employer.
(4) Membership Drives & Materials. Upon reasonable advance request,

management agrees to provide space for the purpose of membership drives and
distributing Union issued materials. These activities will be conducted during
break, lunch periods and non-duty hours and shall not interfere with the mission
of the Service. Specific arrangements will be negotiated locally.
B. FACILITIES FOR REPRESENTATION.
(1) Meeting Space. Upon reasonable advance request by the Union, the Employer
will provide confidential meeting space, if available, during official hours of
business, in areas occupied by the Employer, for the following purposes:
(a) Grievances / Appeals. Preparing or discussing a grievance or appeal;
(b) Caucusing. Caucusing immediately before, after, and during scheduled

meetings with the Employer;

(ARTICLE 8 - Facilities and Services)
(c) Agreement Administration. Discussing matters directly related to the

administration of this Agreement.
(2) No Internal Union Business. Nothing in this section shall be construed as

permitting meetings or the use of management supplied equipment for the purpose
of conducting internal union business.
C. BULLETIN BOARDS
(1) Prominent and Accessible. Each Employer installation will provide bulletin
board space in a place of prominence and reasonably accessible for posting
material published by the Union or its affiliated Locals.
(2) Exclusive Use. In each District Office the Employer will provide to the Union for
its exclusive use one locked bulletin board (of approximately three feet by four
feet). The bulletin board will be permanently attached to the walls where building
regulations permit such permanent installations. The Union may, subject to
availability of suitable space, install at its own expense bulletin boards of up to
three (3) by five (5) feet in addition to the bulletin board supplied by management.
(3) Restrictions. Material which does not violate any law, contain libelous material
or personal attacks may be posted on union bulletin boards.
D. ACCESS TO EMPLOYEES.
(1) Employee Lists. Upon request, but no more than annually, the Service will
furnish to the Union, at the Regional level, for its internal use only, a list which
will contain the names, grades, position title, and posts of duty of all employees in
the local bargaining unit. The Regional Vice President will be supplied, on a
monthly basis, a listing of bargaining unit personnel accessions and separations
from each District, Service Centers, Asylum Office, Regional Office,
Administrative Centers, or Headquarters. The parties recognize that errors may
occur from time-to-time in regard to input and coding of data, and that the listings
will not be construed as action by the Employer to unilaterally deny bargaining
unit status to any employee, or to confer it.
(2) Employee Orientation. Each new employee, including transfers, as part of his or
her orientation, will be given a presentation not to exceed twenty-five (25)
minutes by the local Union representative. The Union representative will be
invited to attend and will be in a duty status, and the orientation will cover only
the labor relations law, the provisions of the Contract and Union/Management
Agreements. No recruiting or other internal Union business may be conducted
during the orientation

E. REFERENCE MATERIALS.
(1) Employee Use of CFR and AM. The Service agrees to continue to provide in
each District a copy of the Code of Federal Regulations and the Administrative
Manual (AM) for use of employees and the Union, and will keep such material
up-to-date.
(2) CFR and AM. The Service will provide a copy of Title 5 of the Code of Federal
Regulations and the AM to those installations where there are more than one
hundred (100) bargaining unit employees.
(3) Council Copy of AM. The Service will provide a copy of the AM and subsequent
changes to the National Council President, the Executive Vice-President and to
the Regional Vice-Presidents of the Council.
F. LOCKER ROOMS. To the extent that local conditions warrant and space and resources
are available, the Service agrees to provide suitable space for changing uniforms and
lockers for storage of employee uniforms. Whenever Service facilities are redesigned,
renovated or when a new facility is contracted, the Service will, to the maximum
extent possible, provide adequate locker space for all uniformed employees.
G. CONTRACT COPIES.
(1) Employee Copy. A copy of this Agreement will be printed and given to each
employee in the unit.
(2) Printing. The Service agrees to reproduce and distribute (8 ½” by 11”) copies of
this Agreement, legibly printed, with blue cover including bold letters “Agreement
2000” to all employees currently assigned to the bargaining unit and those
subsequently hired into the unit. It is further understood that proof copies of the
agreement will be reviewed and approved by Service and Union prior to final
printing of the agreement.
(3) Council and Local Copies. The Service agrees to provide six hundred (600)
copies of the printed Agreement to the President of the Council and fifty (50)
copies to AFGE and each Local Union in the Council.
H. UNION REPRESENTATIVES PERMITTED ON GOVERNMENT PROPERTY. National

representatives of the Union and Council officers shall normally be permitted upon all
Service installations. It is understood that such Union representatives shall request
permission to visit in advance to the supervisor in charge of the installation. If the
supervisor cannot approve the visit for valid operational reasons the supervisor will
make an alternative arrangement for the official. Upon arrival, the official shall advise
the supervisor of his or her presence. Such representatives shall not interfere with the
work of employees of the installation during duty hours. Subject to the above

estrictions, national representatives of the Union shall be permitted to participate in

meetings between Local representatives and the Service.
I. TELEPHONES. Telephones will be made available on a reasonable basis to Union

officers to conduct Union representational activities as authorized under the
provisions of Article 7 of this agreement.
J. SPACE & EQUIPMENT. The parties agree that providing Local Union office space and
reasonable access to government equipment is in the best interest of the parties and of
their partnership endeavors. The Service will provide office space and reasonable
access to government office equipment to each local union.
K. ELECTRONIC MAIL. Union officials are authorized the use the Service’s e-mail
system. The Union may use the e-mail system to communicate informally with
employees and the Service but not for strictly internal union business. The parties
agree that internal union business is prohibited when using government-provided
access to the Internet. The parties should be mindful of the fact that electronic mail
messages are considered government records which may be accessed whenever a
legitimate governmental purpose exists for doing so. Correspondence submitted
through the e-mail system does not satisfy official notice requirements under this
agreement.
L. INSERTS. The Service shall provide and update the Service’s CD-ROM titled
“INSERTS” to all Local Presidents and all Council Officers. The Union shall provide
the Headquarters Labor and Employee Relations Policy Section with a list of those
officials (including addresses) of all officials who are to receive “INSERTS”.
M. TELEPHONE CARDS. The Service shall provide all Council Officers, including staff
assistants, with a telephone credit card which may be used for all calls except for
internal union business or personal business.
N. COPY MACHINES. Copy machines will be made available to union officials, with
management approval. There will be no use of copiers for internal union business.
The Union will supply the paper for any copies made.
O. FAX MACHINES. Union officials, in the performance of their representational

responsibilities, may make reasonable use of the Service’s fax machines to
communicate with management officials, grievants and other Union officials,
provided that the Union official concerned has sought and secured the permission of
management. It is understood that documents pertaining to internal Union business
are not to be transmitted over the Service’s fax machines. It is also understood that
bargaining notices and demands are not to be served by fax communiqués unless the
receiving party expressly consented to such means of service in regard to the
particular matter at issue.

ARTICLE 9 - Impact Bargaining and Mid-Term Bargaining
A. NOTICE OF PROPOSED CHANGE. The parties recognize that from time-to-time during
the life of the Agreement, the need will arise for Management to change existing
Service regulations covering personnel policies, practices, and/or working conditions
not covered by this Agreement. The parties are encouraged to engage in pre-
decisional involvement prior to the agency’s formal presentation of proposals for
working conditions under this article. If the parties are unable to reach an agreement
through pre-decisional involvement or if pre-decisional involvement is not used, the
Service shall present the changes and explanation of the changes, including the reason
for the change(s) it wishes to make to existing rules, regulations, and, existing
practices to the Union in writing. The Service recognizes that this obligation exists at
the National, Regional and District level depending upon the level at which such
changes originate. If the Service proposes a change in working conditions in locals in
more than one region, such as for Telephone Centers or Service Centers, it shall serve
the requisite notice on the Council at the national level. If the Union intends to
exercise its bargaining rights regarding the proposed change, it must submit a timely
bargaining demand including proposals, in accordance with the procedures and time
frames specified below.
B. BARGAINING PROCEDURES. As applicable, mid-term bargaining shall be conducted

in accordance with the following procedures and time frames:
(1) National Level Bargaining:
(a) Notice of Proposed Change. When bargaining is appropriate at the National

Level, Management shall serve its notice of the proposed change upon the
President of the Council or his or her designee.
(b) Demand to Bargain / Information. Within twenty-two (22) workdays after

being served with the notice of the proposed change, the President of the
Council, or his or her designee, may request any additional information
necessary to clarify or determine the impact of the proposed change. At the
same time they shall serve any bargaining demand in writing upon the Chief,
Labor and Employee Relations Policy Section, INS Headquarters, or such
other person as may have been identified for this purpose in the Service’s
notice to the Union.
(c) Union Proposals. The Union will submit bargaining proposals with its demand
to bargain. If the Union has requested additional information from
management related to the proposal from management, amendments to the
proposals may be made within fifteen (15) workdays of receipt of the
information.

d) Negotiations. If, following any informal discussions, the Parties are unable to
reach agreement on the proposed change, they shall commence negotiations
on a mutually agreeable date and site. Absent mutual agreement on a date for
bargaining, such negotiations shall commence at 9:00 a.m. on the fifteenth
workday following the date the Union’s proposals were first received by
Management.
(e) Delays / Breaks. Once negotiations have commenced the parties recognize the
obligation exists to bargain in good faith and will therefore avoid unnecessary
delays. If a break in negotiations is necessary the parties will agree on a time
and date to resume bargaining prior to any recess, whenever practicable.
(f) Bargaining Teams. Each Party will inform the other of the names of its
bargaining team members at least five (5) workdays before the start of any
negotiations. The Union’s bargaining team members will be accorded official
time for all time spent in bargaining, including necessary travel time and
impasse proceedings, provided that the number of such Union team members
is not greater than Management’s bargaining team. The Service will also pay
the travel and per diem expenses for such members of the Union’s bargaining
team. To accommodate the bargaining process, Management will make such
shift adjustments as may be necessary for those on the Union’s team who are
entitled to official time for bargaining purposes.
(g) Additional Team Members. The parties agree that the Union team may have
members in excess of those on Management’s team, not to exceed two (2),
who will be on official time if an employee of the Service. Any necessary
travel and per diem for such additional team members will be borne by the
Union.
(h) Travel & Per Diem. The Service will pay the travel and per diem expenses for
those members of the Union’s bargaining team who are entitled to official
time as specified above.
(i) Equipment. Management will provide the Union bargaining team with access
to office equipment as may reasonably be needed by the Union team in its
negotiations with Management.
(2) Regional Level Bargaining: Except as modified below, the provisions applicable
to National Level mid-term bargaining shall apply to Regional Level mid-term
bargaining.
(a) Notice of Proposed Change. When bargaining is appropriate at the Regional

Level, Regional Management shall serve its notice of a proposed change upon
the appropriate Regional Vice President of the Council.

(b) Demand to Bargain / Information. Within ten (10) workdays after being
served with the Region’s notice, the Regional Vice President or designee, may
request any additional information necessary to clarify or determine the impact
of the proposed change. At the same time the Union shall serve any
bargaining demand in writing on the Head of the appropriate Administrative
Center Human Resources Office or such other person as may have been
identified for such purpose.
to bargain, if the Union has requested additional information from
proposals may be made within fifteen (15) workdays of receipt of the
information.
(d) Negotiations. If, following any informal discussions, the Parties are unable to
reach agreement on the proposed change, they shall commence negotiations
on a mutually agreeable date at a site within the Region as provided by
Management. Absent mutual agreement on a date for bargaining, such
negotiations shall commence on the fifteenth workday following the date the
Union’s proposals were first received by Management.
(e) Consistent with Master. Agreements reached pursuant to Regional Level mid-
term bargaining may not be inconsistent with the provisions of this Master
Labor Agreement.
(f) Delays / Breaks. Once negotiations have commenced the parties recognize the
obligation exists to bargain in good faith and will, therefore, avoid
unnecessary delays. If a break in negotiations is necessary the parties will
agree on a time and date to resume bargaining prior to any recess, wherever
practicable.
(g) Travel & Per Diem. The Service will pay the travel and per diem expenses for
members of the Union’s bargaining team not to exceed the number on
management’s team but not less than two (2), which may include Council
Officers as provided for in Article 7, or local officials. Any additional Union
team members will have their travel and per diem costs borne by the Union.
Team members for whom the Union is paying travel and per diem will also be
on official time.
(3) Local Level Bargaining: Except as modified below, the provisions applicable to
National Level mid-term bargaining shall apply to Local Level mid-term
bargaining.
(a) Notice of Proposed Change. Local Management shall serve its notice of a
proposed change upon the President of the appropriate Local affiliate.

(b) Demand to Bargain / Information. Within ten (10) workdays after being
served with the notice of a proposed change, the Local President or designee
may request any additional information necessary to clarify or determine the
impact of the proposed change. At the same time they shall serve any
bargaining demand in writing upon the District Director or such other person
as may have been identified for this purpose.
to bargain, if the Union has requested additional information from
proposals may be made within ten (10) workdays of receipt of the information.
(d) Negotiations. If, following any informal discussions, the local Parties are
unable to reach agreement on the proposed change, they shall commence
negotiations on a mutually agreeable date at a site within the District as
provided by Management. Absent mutual agreement on a date for bargaining,
negotiations shall commence not later than the tenth workday following the
date the Local’s proposals were first received by Management.
(e) Bargaining Team. The local parties shall inform each other of their bargaining
team members at least two (2) workdays before the start of any negotiations.
Union bargaining team members equal in number to those on management’s
bargaining team, but not less than two (2), will be granted official time for all
time spent in bargaining including impasse proceedings.
(f) Travel & Per Diem. Management will pay the necessary travel and per diem
expenses for no more than two members of the Union’s bargaining team,
which may include Council Officers as provided for in Article 7, or local
officials.
(g) Consistent with Master. Agreements reached pursuant to Local Level mid-
term bargaining may not be inconsistent with the terms of this Master Labor
Agreement.
C. SERVICE OF NOTICES AND DEMANDS. Service of all notices, requests, demands or

documents provided for under this Article shall be accomplished either by personal
delivery or by U.S. Mail-Return Receipt Requested. Applicable time limits shall
begin to run from the date of receipt of the document that triggers the particular time
limit. Service will be deemed timely if the required document is either personally
delivered or deposited in the U.S. mail within the specified time limit. The parties
agree that they will act in good faith in receipting for documents and will not attempt
to evade the service of documents upon them.

D. GOOD FAITH. The duties of the parties to negotiate in good faith under this
Article shall include the obligation:
(1) Resolve to Reach Agreement. To approach the negotiations with sincere resolve
to reach agreement;
(2) Duly Represented. To be represented by duly authorized representatives prepared

to discuss and negotiate on the subjects authorized by this Article;
(3) Reasonable Times. To meet at reasonable times as frequently as may be

necessary, and to avoid unnecessary delays.
E. IMPASSES. Impasses in impact and mid-term bargaining negotiations at the local

level will be resolved in accord with Article 51 of this contract.
F. POST IMPLEMENTATION BARGAINING. The parties agree that effective management

of the Service and its resources is a mutual concern. The parties also agree that on
certain occasions there is a need for expedited implementation of new policies or
practices affecting conditions of employment. The provisions of this article apply to
such situations. It is understood, however, that nothing in this Article precludes the
Service and the Union from engaging in post implementation bargaining if mutually
agreeable.
G. “COVERED BY THE AGREEMENT”. Mid-term agreements may be negotiated at the

level of recognition covering subjects or matters not specifically covered in this
agreement. The parties agree that, notwithstanding the Federal Labor Relations
Authority’s “covered by the agreement” rule, the Employer is required to provide the
Union with notice and an opportunity to negotiate pursuant to this article with regard
to management-initiated changes concerning the following matters:
(1) Tours of Duty. Implementation of new tours of duty and/or shifts including re-
implementation of shifts not used in the previous twelve (12) months
(2) Work Sites. Establishment of new or substantially expanded work sites
(3) Discipline Regulations. Implementation of revised Department of Justice or INS

regulations governing the administration of discipline
(4) Overtime. Changes in:
(a) Eligible Employees. The classes of employees eligible for overtime and
(b) Distribution Procedures / Caps. Procedures for distribution of overtime

(including procedures for assuring compliance with statutory overtime caps
and procedures providing for assignment of overtime to volunteers before
making mandatory assignments).

ARTICLE 10 - Partnership and Labor-Management Relations
A. INFORMATION AND QUESTIONS. The Employer and the Union recognize that
providing Union representatives the opportunity to obtain information and ask
questions about Employer programs and other matters of interest may contribute to
the effectiveness of the labor-management relationship. Therefore, the Employer
shall provide the Union with briefings and the opportunity to ask questions about
matters of interest and concern at the national, regional, and local levels.
B. NATIONAL CONSULTATIONS. Representatives of the Employer and the Union shall

meet at the national level annually or at such other times as may be mutually agreed.
These meetings shall be conducted immediately following National Labor
Management Partnership Council Meetings held in Washington, D.C. The purpose of
these meetings shall be to provide information to the Union’s representatives and to
permit the Union representatives to ask questions about matters of concern. An
agenda covering the items to be discussed must be forwarded, in writing, to the
Assistant Commissioner for Human Resources and Development at least thirty (30)
calendar days prior to the scheduled meeting. Up to ten (10) additional agenda items
may be submitted on the first (1st) day of the meeting. Issues of concern about which
information is provided may be appropriate subjects for resolution through National
Labor-Management Partnership Council meetings or as subjects of negotiation at the
time of renegotiation of this Agreement or pursuant to a notice of proposed change in
conditions of employment, such as personnel policies, rules, regulations and/or
working conditions in accordance with Article 9.
Union representatives, not to exceed five (5), will be in official time status while
attending such meetings. The cost of travel, including per diem or actual subsistence,
will be borne by the Employer. These national consultations shall be held for two (2)
days, with travel being accomplished on official time. Any additional representatives
the Union feels are required (not to exceed four (4)) for the meetings may attend on
official time at Union expense.
C. REGIONAL CONSULTATIONS. Regional officials and Union representatives, not to

exceed five (5), will meet annually or at such other times as may be mutually agreed
and the representatives will be in official status while attending such meetings. These
meetings shall be conducted immediately following Regional Labor Management
Partnership Council Meetings. Such regional consultations meetings will not exceed
two (2) days, with travel being accomplished on official time, provided it occurs
during the regular workweek. The cost of travel and per diem will be borne by the
Service. Any additional representatives the Union feels are required (not to exceed
four (4)) for the meeting may attend, on official time, at Union expense. The purpose
of Regional meetings will be to provide information to the Union’s representatives
and to permit the Union representatives to ask questions about matters of concern.
Agenda items to be discussed must be forwarded in writing to the appropriate
Regional Director at least thirty (30) calendar days prior to the scheduled meetings.

uch notice must be acknowledged promptly. Up to ten (10) additional agenda items
may be submitted on the first (1st) day of the meeting.
D. LOCAL CONSULTATIONS. Representatives of the Employer and the Union at the

District level shall have the opportunity to meet quarterly or at such other times as
may be mutually agreed for the exchange of views and information, the informal
resolution of problems, and for the improvement of communications, understanding,
and cooperation. between the Service and the Union. Where the Local President is
located away from the District Office, the Employer shall pay travel and per diem for
the Local President, when travel is required, to attend any quarterly meetings under
this Section and for meetings called by management. The local parties may, by
mutual agreement, substitute meetings of a local labor-management partnership
council for the meetings specified in this paragraph.
E. LABOR MANAGEMENT PARTNERSHIPS
(1) Cooperative Relationship. The parties recognize the importance of working

closely together for the purpose of promoting and improving a cooperative
relationship by developing meaningful solutions to workplace issues.
(2) Partnership Councils .The parties have established joint Labor-Management

Partnership initiatives and encouraged the establishment of Partnership Councils
at all appropriate levels. Partnership Councils are the forum in which the parties
can review, discuss, consider, and make recommendations to the Employer on
matters relating to or affecting working conditions, employee morale, and
efficiency of the agency’s operations.
(3) Duty Status. If otherwise in a duty status, Union representatives will be accorded
reasonable official time for the performance of duties or endeavors undertaken at
the direction of an established partnership council. Such official time must be
requested and approved as provided in Article 7.
(4) Status of Partnership Agreements. When an agreement or an understanding has

been reached by appropriate Management and Union representatives in regard to a
particular matter pursuant to the endeavors of an established partnership council,
the Parties recognize and agree that such understanding or agreement can be
implemented within the Jurisdiction of the particular partnership council without
following the procedures in Article 9.
F. JOINT MASTER AGREEMENT TRAINING. The parties will jointly provide Master
Agreement training for each local union and Service office. The Service will pay the
cost of the Master Agreement joint training. Any training document for the joint
training will be prepared jointly. Training will be done jointly; however, this does not
preclude additional or independent training by each party nor does it prohibit either
party from developing training material for its own training programs.

ARTICLE 11 - Protecting Against Prohibited Personnel Practices
A. DEFINITIONS.
(1) Prohibited Personnel Practice. For the purpose of this Article, “prohibited
personnel practice” means any action described in Section B.
(2) Personnel Action. For the purpose of this Article, “personnel action” means:
(a) An appointment;
(b) A promotion;
(c) An adverse action, disciplinary action or other corrective action;
(d) A detail, transfer, or reassignment;
(e) A reinstatement;
(f) A restoration;
(g) A reemployment;
(h) A performance evaluation under Chapter 43 of Title 5 of the United States

Code;
(i) A decision concerning pay, benefits, or awards, or concerning education or

training if the education or training may reasonably be expected to lead to an
appointment, promotion, performance evaluation, or other action described in
this subsection; and
(j) Any other significant change in duties or responsibilities which is inconsistent

with the employee’s salary or grade level.
B. PROHIBITED ACTIONS. Any employee of the Service who has authority to take, direct
others to take, recommend, or approve any personnel action, shall not, with respect to
such authority:
(1) Discrimination. Discriminate for or against any employee or applicant for

employment -
(a) On the basis of race, color, religion, sex, or national origin, as prohibited
under Section 717 of the Civil Rights Act of 1964;
(b) On the basis of age, as prohibited under Sections 12 and 15 of the Age
Discrimination in Employment Act of 1967;

(c) On the basis of sex, as prohibited under Section 6(d) of the Fair Labor
Standards Act of 1938;
(d) On the basis of handicapping condition, as prohibited under Section 501 of the
Rehabilitation Act of 1973, as amended; or
(e) On the basis of marital status or political affiliation, as prohibited under any
law, rule, or regulation.
(2) Non-merit Considerations. Solicit or consider any recommendation or statement,

oral or written, with respect to any individual who requests or is under
consideration for any personnel action unless such recommendation or statement
is based on the personal knowledge or records of the person furnishing it and
consists of—
(a) An evaluation of the work performance, ability, aptitude or general

qualifications of such individual; or
(b) An evaluation of the character, loyalty, or suitability of such individual.
(3) Political Activity. Coerce the political activity of any person (including the
providing of any political contribution or service), or take any action against any
employee or applicant for employment as a reprisal for the refusal of any person to
engage in such political activity.
(4) Obstruct Competition. Deceive or willfully obstruct any person with respect to
such person’s right to compete for employment.
(5) Influence Withdrawals. Influence any person to withdraw from competition for
any position for the purpose of improving or injuring the prospects of any other
person for employment.
(6) Unauthorized Preference. Grant any preference or advantage not authorized by

law, rule, or regulation to any employee or applicant for employment (including
defining the scope or manner of competition or the requirements for any position)
for the purpose of improving or injuring the prospects of any particular person for
employment.
(7) Relatives. Appoint, employ, promote, advance, or advocate for appointment,

employment, promotion, or advancement, in or to a civilian position any
individual who is a relative (as defined in Title 5 of the United States Code) of
such employee if such position is in the agency in which such employee is serving
as a public official (as defined in Title 5 of the United States Code) or over which
such employee exercises jurisdiction or control as such an official.

(8) Whistleblower Reprisal. Take or fail to take personnel action with

respect to any employee or applicant for employment as reprisal for—
(a) Disclosures. A disclosure of information by an employee or applicant which

the employee or applicant reasonably believes evidences—
(i) A violation of any law, rule, or regulation; or
(ii) Mismanagement, a gross waste of funds, an abuse of authority, or a
substantial and specific danger to public health or safety, if such disclosure
is not specifically prohibited by law and if such information is not
specifically required by Executive Order to be kept secret in the interest of
national defense or the conduct of foreign affairs; or
(b) Special Counsel / Inspector General. A disclosure to the Special Counsel or to

the Inspector General of an agency or another employee designated by the
head of the agency to receive such disclosures, of information which the
employee or applicant reasonably believes evidences—
(i) A violation of any law, rule, or regulation; or
(ii) Mismanagement, a gross waste of funds, an abuse of authority, or a
substantial and specific danger to public health or safety.
(9) Appeal Reprisal. Take or fail to take any personnel action against any employee
or applicant for employment as a reprisal for the exercise of any appeal right
granted by any law, rule, or regulation.
(10) Outside Conduct. Discriminate for or against an employee or applicant for

employment on the basis of conduct which does not adversely affect the
performance of the employee or applicant or the performance of others, except
that nothing in this subsection shall prohibit an agency from taking into account in
determining suitability or fitness any conviction of the employee or applicant for
any crime under the laws of any State, of the District of Columbia, or of the
United States.
(11) Violation of Merit System Principles. Take or fail to take any other personnel
action if the taking of or failure to take such action violates any law, rule, or
regulation implementing, or directly concerning the merit system principles
contained in the Civil Service Reform Act of 1978.
C. INFORMATION TO CONGRESS. Nothing in Section B above shall be construed to

authorize the withholding of information from the Congress or the taking of any
personnel action against an employee who discloses information to the Congress.
D. EEO AFFIRMATIVE ACTION. Nothing in Section B above, shall be construed to

extinguish or lessen any effort to achieve equal employment opportunity through

ffirmative action or any right or remedy available to any employee or applicant for
employment in the civil service under—
(1) Section 717 of the Civil Rights Act of 1964 prohibiting discrimination on the
basis of race, color, religion, sex, or national origin;
(2) Sections 12 and 15 of the Age Discrimination in Employment Act of 1967,

prohibiting discrimination on the basis of age;
(3) Under Section 6(d) of the Fair Labor Standards Act of 1938, prohibiting
discrimination on the basis of sex;
(4) Section 501 of the Rehabilitation Act of 1973, prohibiting discrimination on the
basis of handicapping condition; or
(5) The provisions of any law, rule, or regulation prohibiting discrimination on the
basis of marital status or political affiliation.
E. REDRESS PROCEDURES.
(1) Elect Statute or Grievance. An employee aggrieved under Section B(l), above,
may raise the matter under a statutory procedure or the grievance and arbitration
procedure provided in this Agreement, but not under both.
(2) Effect of Election. An employee shall be deemed to have exercised his or her
option under this section at such time as the employee timely initiates an action
under the applicable statutory procedure or timely files a written grievance under
the provisions of this Agreement, whichever occurs first.
(3) MSPB Appeal of Grievance. The selection of the negotiated grievance

procedures contained in this Agreement to process a complaint of discrimination
shall in no manner prejudice the right of an aggrieved employee to request the
Merit Systems Protection Board (MSPB) to review the final decision in the case
of any personnel action that could have been appealed to the Board or where
applicable to request the Equal Employment Opportunity Commission to review a
final decision in any other matter involving a complaint of discrimination of the
type prohibited by any law administered by the Commission. Appeals to the
Merit Systems Protection Board or the Equal Employment Opportunity
Commission shall be filed pursuant to such regulations as the Board or the
Commission may prescribe.
F. EXCLUSIVE GRIEVANCE PROCEDURE. Except as provided in Section E, above, an

employee may only file his or her complaint under the grievance and arbitration
provisions contained in this Agreement.

ARTICLE 12 - Notice to Employees
A. COPY FOR UNION REPRESENTATIVE. An employee who receives a personally

addressed notice, proposal or correspondence from the Employer concerning:
(1) An adverse action;
(2) A disciplinary action;
(3) A reduction-in-force;
(4) Denial of a within-grade salary increase;
(5) A fitness for duty examination; or
(6) An involuntary reassignment or transfer;

shall receive an additional copy which states at the top of the first page “The copy
may at your option be furnished to your Union representative.”
B. NEW EMPLOYEES.
(1) Union Information. All new bargaining unit employees will be informed by the
Employer that the Union is the exclusive representative of employees in the unit.
(2) Right to Join. The Employer will also inform each new bargaining unit employee
that he or she has the right, freely and without fear of penalty or reprisal, to form,
join and assist a labor organization or refrain therefrom.
(3) Contract. Each new bargaining unit employee shall receive from the Employer a
copy of this Agreement.
C. LEAVE AND EARNINGS STATEMENTS. Each employee will be furnished, on a

biweekly basis, a NFC payroll earnings statement showing the employee’s total
cumulative earnings and total cumulative deductions from the first yearly pay period
in each standard category. The notice shall also contain annual leave and sick leave
balances.
D. WORKPLACE INJURIES. The Employer agrees to provide an employee who is injured

while in a duty status with a copy of the brochure entitled “When Injured at Work,”
within a reasonable time after the filing of an official accident or injury report, with
no more than two (2) copies to be sent to an individual in one year.

ARTICLE 13 - Outside Employment
A. PERMISSION. Employees may engage in outside employment, including self

employment, only with the written permission of the Employer. Such employment
must not result in, or create the appearance of a conflict of interest with official duties
or with official business of the Service; or tend to impair the employee’s mental or
physical capacity to perform official duties and responsibilities.
B. REQUEST. Employees desiring to accept or undertake outside employment, including

self-employment, shall request permission in writing, (on Form G-843, if available)
and obtain written authorization from the Employer prior to commencement thereof.
The request must include the following information:
(1) Identity of proposed Employer;
(2) Nature of work to be performed;
(3) Approximate remuneration involved;
(4) Anticipated maximum number of hours to be worked, and anticipated work

schedule.
Voluntary Work. Employees can engage in voluntary work, except that an employee
must obtain written approval before engaging in voluntary work involving:
(1) The practice of law, or
(2) A subject matter, policy or program that is in the area of responsibility of the
Immigration and Naturalization Service.
C. TIMEFRAMES. An employee’s request must be submitted to the Employer at least

fourteen (14) calendar days, prior to proposed commencement of outside employment
or business activity. This time period is three (3) days in those cases where an
employee has received a furlough notice.
D. APPROVAL. The Employer will respond to the employee, approving or denying the
request, as soon as possible but not later than ten (10) calendar days, after receipt of
the request. If there is no response within ten (10) calendar days from receipt, the
employee may assume there is no objection and begin in the outside employment or
self employment. However, employees who have received less than ten (10) days
advance notice of a furlough without pay may assume their requests have been
approved if they have not received a response within three (3) calendar days from
management’s receipt of their request. When the Employer denies a request, the
employee will be advised of the reason therefor. The parties recognize that any
approval (whether express or implied) to engage in outside employment may be
withdrawn at anytime, provided the Service has a valid basis, as described above, for

rdering the employee to cease his or her outside employment. The approval of outside
employment for an employee earning AUO or LEA does not modify the eligibility
requirements for AUO or LEA.
E. APPLICABLE LAW. The Employer agrees to follow all applicable laws and regulations
regarding outside employment. The Employer shall not take actions regarding an
employee’s outside employment which are arbitrary or capricious.
F. PRACTICE OF LAW. Except for employees specifically exempted under the provisions
of the Memorandum of Understanding between the parties found in Appendix 7,
employees will not engage in the practice of law.
ARTICLE 14 - Retirement
A. RETIREMENT COUNSELING. The Employer will provide a retirement counseling
program describing benefits and eligibility, to be made available on an as-needed
basis, in which all employees in the unit nearing eligibility for retirement may
voluntarily participate. Employees nearing eligibility for retirement who have
questions concerning retirement benefits will, upon request, receive an oral or written
response.
B. DISABILITY / DEFERRED ANNUITY. Each employee who separates voluntarily or

involuntarily (except by retirement) will be informed by the Employer of the
possibility of applying for a discontinued service annuity and eligibility for deferred
annuity at sixty-two (62), provided he or she has at least five (5) years of civilian
service and leaves his or her money on deposit with the Office of Personnel
Management. Upon request, the Employer will inform an employee of his or her right
to file an application for disability retirement provided the employee meets the length
of service required for disability retirement (5 years for those under the CSRS and 18
months for those under the FERS system).
C. WITHDRAWAL. An employee may withdraw a retirement application at any time prior

to its effective date unless a commitment has been made to fill the vacancy created by
the retirement or the position is scheduled to be abolished. However, if a vacancy
exists within the duty station at the same grade and series, management will allow the
employee to withdraw his/her retirement application.
D. LEO RETIREMENT. The Employer agrees that employees who have questions
concerning their eligibility for the special retirement benefits available to law
enforcement officers, will, upon request, receive any and all Service, Department of
Justice and Office of Personnel Management regulations relating thereto. Such
requests may be made annually within five (5) years of retirement eligibility.

(ARTICLE 14 - Retirement)
ARTICLE 15 - Development and Training
A. EMPLOYEE DEVELOPMENT. The Service and the Union agree that the training and
development of employees within the unit is a matter of primary importance to the
parties. The Service agrees to develop and maintain forward-looking effective
policies and programs designed to achieve this purpose, consistent with its needs.
Through the procedures established in Article 10 of the agreement, the parties shall
discuss training and development of employees.
B. EMPLOYEE INITIATIVE. The Service and the Union recognize that each employee is
responsible for applying reasonable effort, time and initiative in increasing his or her
potential value to the Service through self-development and training. Employees are
encouraged to take advantage of training and educational opportunities which will add
to the skills and qualifications needed to increase their efficiency in the performance
of their duties and for possible advancement in the Service.
C. FAIR AND EQUITABLE / SERVICE NEEDS. The nomination of employees to participate

in training and career development programs and courses shall be based on Service
needs and will be fair, equitable and free of personal favoritism.
D. SCHEDULE VARIATIONS. Employees may be granted variations within the normal

workweek, including leave without pay, for educational purposes consistent with
Service needs.
E. INDIVIDUAL DEVELOPMENT PLAN. The Service encourages the individual employee

to develop a personal plan for career self-development. In developing this plan, the
employees may seek counseling and advice from the supervisor. (See Article 3,
Section D, for rights of employees to contact Human Resources Office or higher-level
supervisor for advice). The Service agrees to provide lists and catalogs on available
Service training.
F. ELIMINATED POSITIONS. The Employer agrees that, when an employee is reassigned

due to the position previously held having been eliminated, sufficient training as
determined by the Employer will be given to the employee to enable him or her to
perform the duties of the new position.
G. OUT-SERVICE TRAINING. The Employer will pay authorized expenses for out-service
training at a facility, approved by the Employer when the following conditions have
been met:
(1) The training has been applied for and approved in advance;
(2) Such training will enable the employee to increase his or her proficiency in the
current position (i.e., the training is job-related);

(ARTICLE 14 - Retirement)
(3) Existing training programs within the Service will not adequately meet the
training need;
(4) It is not feasible to establish a new training program to meet the need effectively;
(5) Reasonable inquiry has failed to disclose the availability of a suitable and
adequate program elsewhere in government;
(6) Funds are available to pay for the training program;
(7) The course is not being taken solely for the purpose of obtaining a degree; and
(8) The approval of such training will not create undue interference with operational
requirements or an imbalance in staffing patterns.
H. TRAINING RECORDS. The Service will maintain records for all employees who
receive Service training. The Service will assign training for trainee level positions
consistent with applicable policy and the needs of the Service.
I. UNION RECOMMENDATIONS. The Service encourages the Union to submit

recommendations to the Commissioner or the Regional Administrators concerning
employee training needs and programs. When establishing or modifying the content
or structure of its training courses or programs, the Service will give careful and due
consideration to any recommendations received from the Union.
J. FAIR AND EQUITABLE SELECTION. The parties recognize that it is the Service’s right
to assign duties in accordance with Part 7106 of Title VII of the Civil Service Reform
Act of 1978 and that the types of duties assigned to employees may contribute to
employee development. Therefore, supervisors will make assignments based on
Service needs but will make reasonable efforts to be fair and equitable in this regard.
ARTICLE 16 - Classification
A. UNION PARTICIPATION. The Service encourages the Union to make known to the
Service its views on the adequacy or inadequacy of occupational classification
standards. The Service agrees to consider the Union’s oral or written views
concerning the occupational classification standards when making recommendations
to the Office of Personnel Management and will notify the Union, in like manner, of
any action taken.
B. NEW CLASSIFICATIONS. Classification decisions rendered by the Service or the

Office of Personnel Management having the effect of establishing a grade level within
an occupation hitherto nonexistent in that occupation, will be forwarded by the region
in which the action is taken to the Headquarters Office for circulation of that decision
and the basis for that decision to all regions. This information will be considered

(ARTICLE 16 - Classification)
here appropriate in the subsequent classification of similar positions within the

occupation throughout the Service.
C. UNION REPRESENTATION. When the employee designates the Union as the

employee’s representative in a classification appeal, the representative may discuss
the classification appeal with the classifier prior to the beginning of a desk audit.
Sufficient time shall be allowed prior to the beginning of the desk audit for the
designated representative and the classifier to arrange a mutually agreeable meeting
date to discuss the classification appeal. The classifier will summarize his or her
findings for the appellant and the Union representative.
D. DESK AUDITS. Headquarters and Regional Classifiers may continue to make visits or
telephone calls to field position locations to conduct desk audits of the different
Service positions. Notice of the visit of the classifier will be posted as far in advance
as possible on the bulletin board of the station he or she intends to visit.
E. POSITION DESCRIPTIONS. The Service will provide every employee of the Service
with an accurate description of his or her duties which may govern his or her grade.
The employee will be encouraged to discuss any changes or inaccuracies with the
supervisor who will also maintain a continuing review of duties.
F. REQUEST FOR DESK AUDIT. If an employee has a question concerning his or her
classification or position description, he or she is entitled to discuss his or her position
description with his or her supervisor. Upon request of the employee, a Union
representative may be present during this discussion. If the employee wishes to
further pursue the question, he or she may forward a written request to the servicing
Human Resources Office. The servicing Human Resources Office will either answer
or acknowledge receipt of the request in writing within thirty (30) days, providing an
estimate of the additional time needed to reply.
G. EFFECT OF LOWER GRADED DUTIES.. The parties agree that where lower graded
duties not addressed in the employee’s position description are assigned to an
employee on a continuing basis to meet the needs of the agency, this will not
adversely affect the employee’s salary or classification and the devotion of time to
such duties will be recognized through an appropriate adjustment in assigned
performance standards.
ARTICLE 17 - Safety and Health

A. SAFE AND HEALTHFUL WORKING CONDITIONS. The Service agrees to provide safe
and healthful working conditions, taking into account the mission of the Service and
the inherent hazards of the job performed. The parties shall be governed by the Safety
and Health Regulations contained in the I&NS Administrative Manual (AM)

(ARTICLE 17 - Safety and Health)
nd this Agreement. Safety and Health Committees consisting of union and agency
representatives will meet at the national and regional level as provided in the AM.
B. SAFETY AND HEALTH COMMITTEES. Safety and health committees are an important
part of the Service Safety and Health Program as they form a chain of communication
between employees and Management. They are in an excellent position to give
program advice to appropriate levels of Management. With respect to Safety and
Health Committees, the term District will include Regional Processing and Service
Centers, Regional Offices, Asylum Offices, Headquarters Office, FLETC/Glynco,
GA., and FLETC/Artesia, New Mexico, when a local representative is available at the
facility. Where such Districts, Offices or Centers are co-located, the formation of a
unified committee is appropriate if mutually agreeable to the union local and each
activity head.
Where the term District Director is used in this article it is understood that certain
Service facilities are under the control of officials other than District Directors. At
those facilities the appropriate official shall be responsible for matters under this
Article.
(1) Membership. Each Safety and Health Committee shall be composed of at least
one representative of Management and at least one representative of the Union per
local. The Management representative shall be designated by the Service. The
Union representative shall be selected by the Union.
(2) Meetings. The Safety and Health Committee will meet as often as necessary
upon the request of either party, but as a minimum, the committee will meet once
every year to inspect facilities. The annual inspection will include a review of
ergonomic conditions in the workplace. Copies of the minutes of the meeting and
inspection reports will be submitted to the Director for correction of
unsafe/unhealthful working conditions or practices observed or reported. A copy
of the minutes/inspection report and the written response will be furnished in a
timely fashion from the Director to the committee and will be posted on the
District bulletin board for the information of all employees. Copies of the minutes
will be forwarded to the Regional Administrators, Regional Safety and Health
Specialist and Regional Program Manager.
(3) Purpose of Meeting. Committees will meet to discuss methods for protecting the
safety and health of employees, promoting safety and health education, promoting
and implementing the Service and Regional Safety and Health Programs, the
development and implementation of a Safety and Health Program as it applies to
the District, conduct annual inspections of facilities and the recommendation of
deserving employees for safety awards in accordance with the AM.
C. UNION PARTICIPATION. The Union agrees to participate on the Committee and will
endeavor to have its members observe all safety rules and use all equipment and

afeguards provided. Members of the Committee, upon request and with the approval
of the Director, shall be allowed to leave their work, for the purpose of performing
their duties as outlined in this Article, without loss of pay or charge to leave.
D. DUTY TO REPORT UNSAFE CONDITIONS. In the course of performing their normally

assigned work, employees will be alert to observe unsafe practices and conditions. If
an unsafe condition is observed, the employee should report it, in writing, to a
member of the Safety and Health Committee.
(1) Review and Report Unsafe Conditions. The Committee shall meet within five
(5) workdays of notification that a question has arisen and shall issue its
recommendations, in writing, to the Director no later than ten (10) workdays after
their meeting, In the event that the members of the Committee do not agree on the
recommendations, any of the members shall have the right to express a written
minority view.
(2) Director Decision. The written decision or an interim response of the Director
shall be rendered within ten (10) workdays after receipt of the Committee’s
recommendations.
(3) Grievance. In the event that the decision of the Director does not satisfactorily
resolve the problem, the employee or the Union may file a grievance pursuant to
Article 47 of this Agreement, except that all such grievances shall be presented
within ten (10) workdays at Step III of the grievance procedure, and insofar as the
subject matter would be negotiable under the Civil Service Reform Act of 1978.
(4) Identical Grievances. When the parties become aware of identical grievances on
safety issues arising under this section, involving two or more Districts, subject to
the consent of the Union, one grievance shall be selected by the Union for
processing. All decisions for that grievance will be binding on the other safety
grievances.
(5) Injury Logs. Copies of the OSHA 200 log maintained by each office will be
provided to the Safety and Health Committee for investigation of related unsafe
conditions. The parties agree that any confidential or private information
contained in the OSHA 200 Log may be redacted prior to submission to the
committee.
E. VEHICLE SAFETY. Service policy prohibits the use of vehicles not in safe operating
condition. The Service will continue to require periodic inspection of all vehicles in
order to insure a safe operating condition at all times. It is clearly the responsibility of
any vehicle operator to report, in writing, all vehicle malfunctions or deficiencies to
the person responsible no later than the end of the tour of duty; who, in turn, will be
responsible to take immediate action to see that needed repairs are made.

egligence in reporting vehicle damages may be grounds for disciplinary action being
taken against the responsible operator.
F. SERVICE HANDBOOK. The Service agrees to amend the appropriate Service handbook
to incorporate changes relating to Service safety procedures which both the Union and
the Service agree are necessary.
G. SPECIAL HAZARDS / IMMINENT RISK. When duties involving special hazards must be
performed, the Service will provide reasonable training or indoctrination to the
employees involved concerning the hazards and the proper work methods to be used.
When an employee or the Union believes that the employee is being required to work
under conditions which are unsafe or unhealthy beyond normal hazards inherent in the
operation in question, he or she shall refer the matter to his or her supervisor. This
may include situations where staffing levels are not in keeping with the demonstrated
levels of risk. The supervisor will make an evaluation of the working conditions and
direct that the work either be continued or stopped. If the supervisor directs that the
work continue, the employee (or Union official) may, if time permits, immediately
escalate the request for review of the matter to the second line supervisor. However,
if time does not permit such an escalation, the employee must obey the order of the
supervisor unless the employee reasonably believes that obeying the order would
expose the employee to a health or safety hazard presenting an imminent risk of death
or serious bodily harm.
H. WEATHER SHELTER. Immigration Inspectors shall not be prohibited from using

inspection booths or other available shelter during inclement weather conditions while
not actually engaged in the inspection.
I. MEAL BREAKS / LUNCH ROOMS. Employees assigned to District and to Regional

Offices and to the Headquarters Office should be accorded an uninterrupted lunch
period between the third (3rd) and fifth (5th) hours of duty where lunch periods are
customarily taken to the maximum extent possible. Lunch periods may fall outside the
3rd and 5th hours of duties in offices where alternative work schedule arrangements are
in place. The Service shall provide clean and healthful lunch rooms for the
consumption of food, to the maximum extent possible, for all Service employees.
Arrangements within Districts for lunch periods will be subject to supplemental
negotiations.
J. DAY CARE / HOUSING. The Service agrees to cooperate with other local and Federal
agencies whose function it is to provide assistance to locating day-care centers and
low-cost housing.
K. GSA FACILITIES. The Service, following the recommendations of the Safety and
Health Committees, as provided in Article 17, Section B, will contact the General
Services Administration or Management of the responsible facility to correct
problems relating to safety and health that are their responsibility to correct.

L. IMMUNIZATIONS. Subject to the availability of funds, the Service will provide

appropriate immunizations in accordance with established procedures for employees
who have reached their fortieth (40th) birthday and have five (5) continuous years of
service in the Service, at no expense to the employee.
M. UNSAFE CONDITION MOVE. In the event of a relocation of an office that involves the
safety or health of employees, the Union will be notified (in accordance with Article
9A of this agreement) in advance of such a move.
N. SAFE STAFFING. The safety and health of all employees is a foremost concern of the
Service, and will be considered when employees are required to work after hours or
overtime. Ensuring adequate staffing is an essential part of maintaining a safe and
healthy workplace. When overtime assignments are required to ensure safety, such
assignments shall be made in a fashion consistent with applicable agreements
regarding overtime distribution.
O. EMPLOYEE RESPONSIBILITY FOR SAFETY. The Union will endeavor to have its
members observe all safety rules and use all equipment and safeguards provided. In
the course of performing their normally assigned work, employees will be alert to
observe unsafe practices and conditions. If an unsafe condition is observed, the
employee should report it to his or her supervisor or a member of the Union-
Management Safety and Health Committee in accordance with the AM.
P. ASSISTANCE FOR HANDICAPPED EMPLOYEES. The Employer agrees to develop

procedures to assure that all handicapped employees are provided appropriate
assistance to evacuate buildings in case of emergencies.
Q. FEDERAL EMPLOYEE HEALTH BENEFITS (FEHB). The Employer agrees to furnish

each employee, on a timely basis, a copy of each of the following:
(1) Open Season Instructions;
(2) Information to consider in choosing a health plan; and
(3) Biweekly Health Benefits Rates.

Such distribution shall be made by the Employer to the extent such brochures are
available to it from the normal sources of supply.
R. TB SCREENING. Subject to fund availability, the Service will conduct a voluntary

screening program for Tuberculosis.
ARTICLE 18 - Injury Compensation

A. WORKPLACE ILLNESS / INJURY. When employees or their representatives report an
illness or injury has occurred in the performance of official duties, the employees at

(ARTICLE 18 - Injury Compensation)
heir request will be promptly counseled by trained personnel as to their right to file
for compensation benefits and the benefits payable. The employees also shall be
advised as soon as possible that compensation benefits can be used in lieu of sick or
annual leave. The Service will give appropriate assistance to the employee in filing a
compensation claim.
B. CONTINUATION OF PAY / LEAVE. The Service and Union understand that injury
compensation cannot be paid for any period when an employee is on paid leave. If at
the time disability begins the injured employee has sick or annual leave to his or her
credit, he or she may decide whether to use all or part of it before applying for injury
compensation benefits. An employee who suffers a traumatic injury, may obtain
continuation of pay for absences caused by the traumatic injury in accordance with 5
U.S.C. 8118. If the employee should be charged for sick or annual leave (or if he or
she is so charged because he or she was not informed of the possibility of injury
compensation benefits) he or she may repay, in a lump sum or by any other plan
acceptable to his or her payroll office, the amount collected while on annual or sick
leave. This repayment would permit him or her to qualify for injury compensation
provided all other conditions are met.
C. “PAMPHLETS AND FORMS
(1) “When Injured at Work”. The Employer agrees to provide an employee who is
injured while in a duty status with a copy of the brochure entitled “When Injured
at Work,” within a reasonable time after the filing of an official accident or injury
report, with no more than two (2) copies to be sent to an individual in one year.
(2) “Authorization for Examination and/or Treatment” (CA-16). If the employee

requires medical treatment because of a work-related traumatic injury, the
supervisor should complete the front of Form CA-16 “Authorization for
Examination and/or Treatment” within 4 hours of the request. In an emergency,
where there is not time to complete the form, the Employer may authorize medical
treatment by telephone and then forward Form CA-16 to the medical facility
within 48 hours. Form CA-16 may not be used to authorize treatment for
occupational disease or illness except if OWCP authorizes such use in an
individual case.
D. DOCUMENT REVIEW. Employees will be permitted to review documents relating to

their claim which the Office of Workers’ Compensation Programs has authorized the
appropriate Regional Human Resources Office to make available. Employees may be
accompanied by their designated representative if they so desire.

ARTICLE 19 - Fitness for Duty Examination
A. FITNESS FOR DUTY EXAMINATION. In directing employees to undergo a fitness for

duty examination, the Service will observe applicable rules and regulations.
B. RIGHT TO UNION REPRESENTATION. Employees will be advised of their rights to

have a Union representative at any time allowed, or not prohibited, by Civil Service
procedures. Employees may also be represented by an attorney or any other person of
their choice.
ARTICLE 20 - Disabled Employees

A. LIGHT DUTY. If the treating physician of an incapacitated or injured employee (or a
physician of the Service) certifies that the employee is capable of performing light
duty work, the employee will be assigned such light duty work on a temporary basis
as may be available and which the employee is capable of performing. The Parties
understand that this provision does not obligate Management to create light duty work
or light duty overtime work but only to temporarily assign it to qualified employees to
the extent that it is available and necessary.
B. RESTORED TO DUTY. An employee who suffers a compensable illness or injury and

later, within one year after commencement of benefits, recovers from such injury or
illness and meets the physical requirements of the position to which he or she is being
assigned will be restored to duty in the former or an equivalent position in accordance
with 5 U.S.C. 8151 and 5 CFR 353.307 et. seq.
ARTICLE 21 - Personnel Records

A. OFFICIAL PERSONNEL FOLDERS. Official Personnel Folders (OPF) will be
maintained in accordance with applicable laws and regulations. Only information
authorized by law or regulation will be maintained in the OPF.
B. COPY OF DOCUMENTS AND RIGHT TO RESPOND. Each employee or his or her

personal representative designated in writing will, upon request, and in accordance
with the provisions of the Freedom of Information Act and/or the Privacy Act, be
given a copy of any document contained in his or her OPF or Employee Performance
Folder (EPF) with the exception of records restricted by law or regulation. The
employee shall have the right to prepare and file on the temporary side of the OPF a
concise statement of disagreement (no more than two pages) with any letter of
reprimand, suspension, or demotion within ten (10) days of the effective date of the
action. If the employee elects to file such a statement, a copy of the proposal (if
applicable) and decision letter on which the action is based will be placed on
temporary side of the OPF. When the document for which the employee files a
statement of disagreement is removed from the OPF, the statement of disagreement

(ARTICLE 20 - Disabled Employees)
ill also be removed. Nothing in this Article shall negate an employee’s right to grieve
any matter.
C. UNAUTHORIZED DISCLOSURE. No record, file or document filed in the OPF or EPF

which is not available to the employee or his or her representative for inspection will
be made available to any unauthorized person for inspection or photocopy. Such
information will be made available to any authorized person only for official use.
D. PROCEDURES TO REVIEW. Requests for access to OPF or EPF shall be made in

writing through channels to the appropriate Headquarters or Regional Human
Resources Office. The review of the OPF or EPF will normally take place at the
requesting employee’s place of assignment. Where this is not feasible it will take
place at a site mutually agreed upon by the employee and/or Union representative and
the Employer.
E. DEROGATORY MATERIAL. No derogatory material of any nature which might reflect

adversely upon the employee’s character or Service career will be placed in his or her
OPF without his or her knowledge.
In the interest of strengthening supervisor-employee relationships, supervisors will
discuss employee work performance or work deficiencies with involved employee on
a timely basis.
F. RESULTS OF INVESTIGATION. When a formal investigation of an employee’s alleged

misconduct is conducted under the auspices of the Service’s Office of Internal Audit
(or successor), and or the investigative report of the Inspector General or Office of
Professional Responsibility is reviewed by the Service and the Service determines that
misconduct did not occur, the Service will notify the employee in writing. Such
notification shall be provided unless prohibited by law or applicable regulation. The
Union acknowledges that the Service may not be authorized under law to release or
reference specific investigations conducted by an agency external to itself.
ARTICLE 22 - Performance Appraisal

A. AUTHORITY OF ARBITRATOR. Pursuant to the provisions of the Civil Service Reform
Act of 1978, and regulations prescribed by the Office of Personnel Management, the
Parties recognize that an arbitrator has jurisdiction to hold management to carry out
the provisions of Administrative Manual on Performance Appraisals, which provides
the performance appraisal system for bargaining unit employees, including periodic
appraisals of the job performance of employees, encouraging employee participation
in establishing performance standards, and use of the results as a basis for training,
rewarding, reassigning, promoting, reducing in grade, retaining, and removing
employees.

(ARTICLE 22 - Performance Appraisal)
B. REVISED AMS. In recognition of the fact that provisions of AM Chapter on

Performance Appraisals are in the process of being revised, the Parties further agree
as follows:
(1) when the revisions have been completed and approved by both Parties, the
provisions of this Article will apply to AM Chapter on Performance Appraisals as
revised; and
(2) as revised, AM Chapter on Performance Appraisals will be incorporated into this

agreement as an appendix.
ARTICLE 23 - Reduction-in-Force, Transfer of Function and Reorganization

A. WORKFORCE ADJUSTMENTS. The Service and the Union jointly recognize that
occasions may arise where adjustments of the work force may be necessary either by
reduction-in-force, transfer of function, or reorganization.
B. DEFINITIONS.
(1) Reduction-in-Force. A reduction-in-force means the release of employees from

their competitive level by separation, demotion, furlough for more than thirty (30)
days, or reassignment requiring displacement; when lack of work or shortage of
funds, reorganization, insufficient personnel ceiling, reclassification due to change
in duties, or the need to replace a person exercising reemployment or restoration
rights requires the Service to release the employee.
(2) Transfer of Function. Transfer of function means the transfer of the performance
of a continuing function from one competitive area and its addition to one or more
other competitive areas, except when the function is virtually identical to
functions already being performed in the other competitive areas affected; or the
movement of the competitive area in which the function is performed to another
commuting area.
(3) Reorganization. For the purpose of this article, “Reorganization” means the
planned elimination, addition, or redistribution of functions or duties in an
organization that result in an employee’s release from a competitive level by
separation, furlough for more than thirty (30) days, demotion or reassignment.
C. EMPLOYEE / UNION NOTIFICATION. Except in the case of furloughs due to

unforeseeable circumstances beyond the control of the Service, prior to official
notification of employees, the Union will receive ten (10) days advance notice of any
pending reduction-in-force or transfer of function or reorganization. This notice, in
writing, will include the reasons for the reduction-in-force, transfer of function or
reorganization, the approximate number and types of positions affected, the
approximate date of the action, and an invitation to the Union to a meeting conducted

(ARTICLE 23 - Reduction-in-Force, Transfer of Function and Reorganization)
y the Service to explain the reduction-in-force, transfer of function or reorganization

procedures, and answer relevant questions.
D. MINIMIZE ADVERSE IMPACT. The Service will attempt to minimize actions that
adversely affect employees which often follow reduction-in-force by using, to the
extent feasible, attrition to accomplish reductions. All reductions-in-force will
comply with applicable laws and regulations.
E. ADVANCE NOTICE. Except in the case of furloughs due to unforeseeable

circumstances beyond the control of the Service, the Service agrees to provide
affected employees as much advance notice of reduction-in-force as is
administratively possible but in no case will such notice be less than sixty (60)
calendar days. All such notices shall contain the information required by Office of
Personnel Management regulations.
F. APPLICABLE LAWS. All reductions-in-force, transfer of function and reorganizations

will be carried out in compliance with applicable laws, and any alleged failure to
comply with such laws and regulations will be processed in accordance with the
grievance procedure set forth in Article 47, of this agreement, or for cases appealable
to the MSPB, in accordance with their rules.
G. RETENTION REGISTERS. Employees receiving a reduction-in-force notice have the

right to review retention lists pertaining to all positions for which they are qualified.
This includes the retention register for their competitive level and those for other
positions for which they are qualified, down to and including those in the same or
equivalent grade as the position offered by the Service. If separation occurs, this
includes all positions equal to or below the grade level of their current positions.
Affected employees shall have the right to the assistance of the Union when
reviewing such lists of records.
H. OFFERS OF EMPLOYMENT. Affected employees shall have a minimum of five (5)

calendar days in which to accept or reject, in writing, an offer of another position.
Failure of employees to respond, in writing, to the offer within the time limits will be
considered a rejection of the offer.
I. MANAGEMENT RESPONSIBILITIES. The Service will:
(1) Inform Employees. Inform employees of plans for the transfer of function and
the governing regulation after a decision has been made;
(2) Written Notification. Notify the employee of the proposed plan, in writing, so
that the employee will be able to consider the action and give a reasonable answer.
Where the transfer of function is to another commuting area, the employee shall
have no less than thirty (30) calendar days to accept or reject the position offered;

(ARTICLE 23 - Reduction-in-Force, Transfer of Function and Reorganization)
(3) Placement Assistance. Assist and counsel affected employees in seeking

placement opportunities with other Federal agencies or elsewhere in the
community; and,
(4) Retirement and Severance. Counsel employees on individual rights relating to

such matters as retirement and severance pay.
J. MINIMIZE ADVERSE IMPACT. The Service will attempt to minimize actions that
adversely affect employees which often follow a reduction-in-force by using, to the
extent possible, attrition to accomplish reductions.
In the event career or career-conditional employees are separated by reduction-in-
force the Service will refer these names to the Department of Justice for inclusion on
the appropriate reemployment priority list in accordance with governing regulations.
Employees will be given preference for reemployment consistent with governing
regulations.
The Service will provide affected employees information regarding employment
possibilities with other government agencies, retirement, severance pay and other
benefits available to them.
K. AUTOMATION AND TECHNOLOGY CHANGES. The parties agree that technological

changes such as automation and re-engineering are desirable for the efficient
operation of the Service. However, decisions and actions concerning the impact of
these changes should be made with a full awareness of employee morale. In light of
this, when changes affect the classification, or status of positions covered by this
Agreement, the Service will meet with the Union to discuss these changes. The
Service will attempt to minimize the adverse impact of these changes by using
attrition and reassignment.
L. TRANSFER OF FUNCTION TO OTHER AGENCY. In the event of a transfer of function

of Service activity to another government entity, the Service will solicit the
cooperation of the gaining agency in explaining the ramifications of such a change to
the Union.
M. ELIMINATED POSITIONS. The Service agrees that, when an employee is reassigned

due to the position previously held having been eliminated, sufficient training as
determined by the Employer will be given to the employee to enable him or her to
perform the duties of the new position.
ARTICLE 24 - Firearms and other Weapons

A. AUTHORIZATION TO CARRY.
(1) Management Right. Determinations as to when, where, under what

circumstances, and which employees shall be authorized or required to carry

(ARTICLE 24 - Firearms and other Weapons)
irearms and/or other weapons are reserved to the Employer. The Employer shall
make determinations concerning firearms consistent with the requirements of the
firearms policy.
(2) Specific Authorization. Those employees not specifically authorized by the

Employer to carry firearms or other weapons are prohibited from carrying
weapons in connection with their employment.
B. EMPLOYEE RESPONSIBILITY.
(1) Laws, Regulations and Policy. All employees authorized to carry firearms and/or
other weapons shall adhere to established laws, regulations, and policies
governing the use and control of such weapons.
(2) Policy Training. All employees authorized to carry firearms shall be informed of
the Justice Department policy concerning Department representation in Federal,
State, Civil or criminal proceedings with respect to employment-related matters.
C. QUARTERLY QUALIFYING. Employees who are required and/or authorized to carry

firearms must qualify quarterly, shall be provided ammunition, official time, and
supervision/instruction consistent with outstanding policy of the Service.
D. EFFECT ON INSPECTIONAL OVERTIME. The qualifications requirements of the

Inspections firearms policy are not intended and should not be used to provide a basis
for denying inspectional overtime to any eligible employee solely by reason of his or
her occupation group, as provided in the applicable memorandum of understanding of
October 5, 1989. The parties understand that this does not require the Employer to
permit employees to carry firearms if they are not qualified to do so.
ARTICLE 25 - Uniforms and Appearance

A. EMPLOYEE SUGGESTIONS.. The Service agrees to notify the Council President within
twenty-two (22) workdays of receipt in the Headquarters of all employees’
suggestions regarding uniforms.
B. UNION NOTIFICATION. The Service will notify and discuss with the Union all
proposed uniform changes, additions and deletions, prior to circulation to the field.
C. UNIFORM ALLOWANCE. Uniformed employees covered by this agreement shall

receive a uniform allowance of not less than five-hundred dollars ($500.00), per
annum effective FY 2002 and said allowance shall increase at a rate of twenty-five
dollars ($25.00) per annum each year thereafter. These increases are contingent on
continued Legislative authorization.

(ARTICLE 25 - Uniforms and Appearance)
D. UNIFORM SELECTION.
(1) Short or Long Sleeve / Neckties. An officer may choose to wear either the short
sleeve or long sleeve uniform shirt in order to adapt to various climatic or
environmental conditions. Neckties will be worn with the long sleeved uniform
shirts or with dress uniform coats.
(2) Rough Duty Uniform. The decision as to when to wear a rough duty uniform is a
matter appropriate for local supplemental negotiations under Article 50.
(3) Leather / Synthetic Equipment. All leather goods for uniform wear shall be
made of high quality, black, untooled leather or a similar synthetic material when
the employee wears the rough duty uniform. Such synthetic material gear will be
purchased from the uniform catalogue. Leather equipment shall be kept dyed and
shined, and shall be replaced when it is cracked or worn out. All leather goods for
plainclothes wear shall be well made of high quality leather and maintained in
good serviceable condition. In all cases, the style and design of holsters and other
leather goods will meet the specifications contained in Service regulations.
E. UNIFORM INSPECTION. Bringing all uniform items to formal inspections shall not be
necessary after all required uniform items have been purchased and inspected by the
appropriate supervisory officer. Thereafter, officers may be required to appear for
formal inspection semiannually, once in winter dress uniform and once in summer
dress uniform.
F. UNIFORMED OFFICERS
(1) Groomed Appearance. Uniformed immigration officers need to maintain a

professional and neatly groomed appearance. Accordingly, the following
standards shall apply to all uniformed personnel.
(a) Hair Grooming. Head and facial hair, including sideburns and moustaches
shall be neatly trimmed and clean, and shall neither interfere with the wearing
of the required uniform nor constitute a safety hazard or an impediment to the
employee’s ability to properly perform his or her assigned duties.
(b) Hair Length. Hair shall not be worn below the bottom of the outer shirt collar
(as measured when the officer is standing), nor cover any portion of the
eyebrows.
(2) Facial Hair.
(a) Beards. Beards shall not be permitted, except for religious and/or documented
medical reasons.

(b) Sideburns. Sideburns may not extend below the bottom of the earlobe, and
may not be more than ¾” wider than at their narrowest point.
(c) Moustaches. Moustaches may not extend more than ¾” sideways from the
corner of the mouth and/or more than ½” down from the corner of the mouth.
Moustaches may not touch the lower lip when the mouth is closed. Handlebar
moustaches are not permitted.
(3) Jewelry. Necklaces (other than a small portion of the chain) shall not be visible.
“Choker” chains are not permitted.
(4) Tattoos.
(a) Obscene / Offensive. Obscene, racially/ethnically derogatory and/or criminal

gang tattoos shall not be visible.
(b) Grievance Procedures. Any disputes concerning whether a tattoo falls within
the foregoing parameters may be grieved and referred to expedited arbitration
in accordance with Article 48. Pending the outcome of the arbitration, such
tattoos shall not be visible.
G. FATIGUE CLOTHING. Management will provide special agents and deportation

officers fatigue clothing suitable for the protection of civilian clothing when working
in environments which warrant such protection. Fatigue clothing will be stored at the
official duty stations.
H. FEMALE UNIFORMS. Female Immigration Inspectors and female information officers

shall be allowed the option of wearing either the authorized uniform skirt or uniform
slacks. The color of women’s hose will be the natural flesh tones of the wearer.
I. RAID JACKETS / VESTS. An adequate supply of raid jackets and bulletproof vests will
be maintained at the work site consistent with the Service’s soft body armor policy.
J. NON-UNIFORMED BEARDS. Non-uniformed employees will be allowed to have a

neatly trimmed beard of such a length as to not present a safety hazard.
K. NON-UNIFORMED APPEARANCE. Non-uniformed employees will maintain a

professional appearance, consistent with norms prevailing in the local community.
Employees shall be attired in a manner appropriate for their position and the duties
being performed, such as office duty, court duty, field duty, rough duty or undercover
assignments. The parties recognize and agree that this provision shall not preclude
employees from participating in casual dress days such as “dress down Fridays”
where such practices now exist or are subsequently established through local
supplemental bargaining.

L. NAMETAGS. The parties recognize that officer safety is matter of critical

importance. When management becomes aware that an employee, as a result of the
performance of official duties, has been subjected to threats, harassment or other
conduct leading to a reasonable fear on the part of the employee for the safety of the
employee and/or his or her family, the Employer shall take action as follows.
(1) Numbered Name Plate. The Employer will promptly discuss the matter with the
employee and shall authorize the use of a numbered badge or numbered name
plate in lieu of a regular nametag for a period of not less than 120 days while the
incident is reviewed.
(2) Extensions. At the end of 120 days, management may extend the authorization to
use the numbered identification in lieu of the nametag in 60 day increments
pending the outcome of the review.
(3) Other Actions. The agency may also take such other action as may be
appropriate, including, but not limited to, reimbursing the employee for the cost of
an unlisted telephone number, contacting local and Federal law enforcement
authorities and/or relocating the employee if the employee and Service agree that
such action is necessary.
(4) Written Statement. As soon as practical, the employee will provide management
with a written statement outlining the threat, which will be used by management
as the basis for conducting a review.
ARTICLE 26 - Travel
A. REIMBURSEMENT.
(1) Federal Travel Regulations. Employees shall be reimbursed for travel on official
business in accordance with law and the Federal Travel Regulations and
interpretations thereof by the Comptroller General of the United States and or
interpretations of the Administrator, General Services Administration and in
accordance with this Agreement.
(2) Changed Rates. The parties agree that any change in rates or reimbursements to
Federal employees by law or regulation during the life of this Agreement will be
adopted on the effective dates of the changes.
B. DEFINITIONS.
(1) “Regular duty station” is defined as: (1) the work location (such as station
headquarters office, border crossing, airport) to which an employee is assigned
permanently or, (2) if 50 miles or less from the employee’s official duty station,

(ARTICLE 26 - Travel)
ny work location to which the employee is assigned as part of a predetermined

rotational schedule.
(2) “Temporary duty station” is defined as any job site which is not the employee’s
regular duty station. The parties agree that the definition of temporary duty
station is applicable for determinations of mileage and other related travel
expenses subject to reimbursement.
(3) “Official duty station” is defined as the area, or, in the case of large reservations,
the established subdivision thereof having definite boundaries within the
corporate limit of the city or town in which the employee is stationed, but if not
stationed in an incorporated city or town, the official duty station is the
reservations, station or established area within which the regular duty station is
located. A regular duty station and a temporary duty station may both be located
within the official duty station.
C. TRAVEL STATUS.
(1) Regularly Scheduled Workweek. To the maximum extent practicable, the

employer shall schedule the time to be spent by an employee in a travel status
away from his or her official duty, station within the regularly scheduled
workweek of the employee.
(2) Compensable Hours. Time spent in a travel status away from the official duty
station of any employee is not hours of employment unless it satisfies the criteria
specified in governing law and regulations.
D. REGULAR COMMUTE. It is the responsibility of employees to place themselves at

their regular duty station and return therefrom at their own expense.
E. LOCAL TRAVEL / TEMPORARY DUTY STATION.
(1) Local Mileage. After an employee places himself or herself at his or her regular
duty station, the cost to the employee of any local travel required for official
purposes during regular hours of work or on overtime shall be reimbursed by the
employer. In this regard, once an employee arrives at his or her regular duty
station, he or she will receive mileage reimbursement for authorized use of a
privately-owned vehicle in subsequent travel to any temporary duty station. For
purposes of this article, “mileage” includes road and bridge tolls, ferry/fares, and
parking fees, as well as the authorized mileage rate for the distance traveled.
(2) Home to Temporary Station. When an employee travels by privately-owned

vehicle from his or her home to a temporary duty station and/or from a temporary,
duty station to his or her home, the employee will be reimbursed for any, mileage

n excess of his or her normal round trip from his or her home to his or her regular
duty station.
(3) POV Examples. Examples of the rules set forth in subsections (1) and (2), above,
for travel by privately-owned vehicle, include:
(a) Residence to Temporary Duty Station. When an employee travels from his or
her residence to a temporary duty station and then returns home, the employee
shall be reimbursed for actual mileage in excess of the normal round trip
distance between his or her residence and his or her regular duty station.
(b) Regular Duty Station to Temporary Duty Station. When an employee travels
from his or her residence to his or her regular duty station; then travels from
his or her regular duty station to a temporary duty station back to his or her
home, the employee shall be reimbursed for all distance traveled after
departing from his or her regular duty station which exceeds the distance
between his or her regular duty station and his or her home.
(4) Established Rotational Assignments Excepted. Subsections (1) and (2), above,
do not apply to or cover established rotational assignments through different duty
stations within fifty (50) miles of the employee’s official duty station. The site of
each rotational duty assignment shall be the employee’s regular duty station for
the duration of the employee’s rotational assignment at that specific job site.
Work- locations of more than fifty (50) miles from the official duty station shall
be considered temporary duty stations for the purpose of entitlement to
reimbursement of travel expenses.
(5) Overtime Assignments. The local travel reimbursement policies set forth in
subsections, (1) and (2), above, apply to travel to overtime assignments during
regular hours of work.
F. PER DIEM.
(1) Eligibility. Employees shall be eligible for per diem or actual subsistence
allowance only when they travel to an assignment located outside their “official
duty station” as defined in Section B (3).
(2) Partial Per Diem. In accordance with subsection (1) above, employees
performing travel outside the city limits of their regular duty station for a period of
less than twenty-four (24) hours but at least twelve (12) hours without incurring
lodging costs are entitled to partial per diem.

G. TRAVEL ADVANCES.
(1) Sufficient Notice. Travel or any extension thereof will, to the maximum extent
possible, be authorized or ordered in advance in sufficient time for the employee
to have in his or her possession a travel advance prior to starting such travel.
(2) Government Credit Card Advance. Those employees who have a valid
government credit card for travel purposes are to use such credit cards to obtain
necessary and appropriate cash advances.
(3) Imprest Fund. In cases where travel is not authorized or ordered in sufficient
time for the employee to obtain a travel advance, the Service will attempt to
accommodate the employee from the Imprest Fund. When an employee is
authorized or ordered to travel without sufficient time to request and receive a
travel advance, and funds cannot be advanced from the Imprest Fund at his or her
duty station, he or she will be accommodated, if possible, from the Imprest Fund
at the location to which he or she is detailed.
H. NECESSITY TRAVEL. When the nature and location of the work at a temporary duty
station are such that suitable meals cannot be obtained there, the expense of daily
travel required to obtain meals at the nearest available place may be approved as
necessary transportation, not part of per diem or actual expense reimbursement. A
statement of the necessity for such daily travel shall accompany the travel voucher.
I. ACCOMMODATE HANDICAPPED EMPLOYEES. Although handicapped employees may

be directed to perform official travel, there are situations in which the assistance of an
attendant or escort must be provided if the travel is to be accomplished. Under such
circumstances, the transportation and per diem expenses of an attendant will be
allowed as necessary expenses for travel.
J. ORDERED OVERTIME TRAVEL. An employee may be reimbursed for taxi cab fares,
plus tip, for transportation between office and home incident to officially ordered
overtime provided all of the following conditions are met:
(1) Concurrent Authorization. Reimbursement is authorized concurrently, with the

ordering of overtime work;
(2) Official Business. The employee performed overtime duty incident to the conduct
of official business at the designated post of duty;
(3) Dependent on Public Transport. The employee is dependent on public

transportation incident to the officially ordered overtime.
(4) Infrequent Public Transport / Darkness. The travel is performed during hours
of infrequently scheduled public transportation or darkness.

K. GOVERNMENT OWNED VEHICLES. It is understood by all employees that

in the use of government-owned or government-leased automobiles, there must be
no intermingling of private and public interest. Failure to utilize government-
owned or government-leased vehicles for purposes which are in the interest of the
government or for its benefit, subjects employees to penalties.
ARTICLE 27 - Overtime - (Other than Uncontrollable Overtime and LEA)

A. FAIR AND EQUITABLE ROTATION. Overtime assignments will be distributed and
rotated fairly and equitably among eligible and qualified employees. Supervisors
shall not assign overtime work to employees as a reward or a penalty, but solely in
accordance with the Service’s need. Complaints or disagreements on distribution of
overtime shall be processed in accordance with the negotiated grievance procedure.
B. PERFORMANCE OF DUTIES. All employees in an overtime status will perform the

duties of the position to which assigned. They will wear the necessary uniform and
identification that the duties of the position require.
C. MAINTAIN RECORDS. Necessary records to comply with this provision will be

maintained at each duty station and made available to all employees upon request.
D. LAWS, REGULATIONS, AND POLICIES. The Service agrees to continue to comply with
applicable regulations, laws and policies in the payment of overtime to employees.
E. EFFECT ON PERFORMANCE APPRAISAL. The participation or non-participation of an

employee in overtime work, where such work is voluntary, shall not in any manner
reflect adversely on his or her appraisal.
F. REOPENER FOR INSPECTION OVERTIME. Should any higher authority alter, amend,
or change Immigration Inspection Overtime laws, this part may be reopened during
the life of this Agreement.
G. OVERTIME CAP. Where the local parties do not have either an agreement or practice
capping overtime earnings, management may restrict full participation in overtime
assignments for the remainder of the overtime year by any employee whose projected
overtime earnings as indicated on the Overtime Watch List Report (OT-732) at or
after September 15th are within $500.00 of the statutory cap. Procedures for restricting
full participation in overtime shall be bargained locally.
H. OVERTIME HOURS LIMIT. No employee shall be required to work more than 8 hours
of inspectional overtime (including rollback) on a regular work day or more than 12
hours of overtime (excluding rollback) on a Sunday, Holiday, or other day on which
the employee is not regularly scheduled to work when there are other qualified and
eligible employees who are available and willing to work.

(ARTICLE 27 - Overtime - (Other than Uncontrollable Overtime and LEA))
I. BREAK IN OVERTIME HOURS.. Breaks in working hours of more than one (1)
hour shall not be scheduled or assigned in any overtime day absent the agreement of
the affected employee.
J. LIGHT DUTY. An employee on light duty is not precluded from participating in

overtime if there is a need for those light duties to be performed on an overtime basis.
K. OVERTIME ASSIGNMENT PROCEDURES. The Parties recognize and agree that

procedures, such as overtime wheels, for equitably distributing overtime assignments
among eligible employees are matters appropriate for local bargaining.
ARTICLE 28 - Details and Temporary Duty Stations

A. PROCEDURES TO ASSIGN.
(1) Management Right. The Employer retains the right to detail employees.
(2) Limits. The Employer shall exercise this authority:
(a) Law, Regulation, and Contract. In accordance with applicable law,

appropriate regulations, and this Agreement;
(b) Advance Notice. By giving as much advance notice as possible to employees

selected for detail.
(c) Utilize Volunteers. Absent a particularized need for specific skills or

qualifications the Service shall utilize volunteers before requiring employees
to participate on details involuntarily unless management determines that there
is a need for a specific volunteer to continue to perform his regular duties.
B. DEFINITIONS. For the purposes of this Article, the following definitions apply:
(1) Temporary Assignment: The change of an employee from one position, work
location, or post of duty for a fixed or limited duration of time, upon the
expiration of which the employee is expected to return to the original position,
work location or post of duty. A temporary assignment may be in the form of
either a temporary promotion or a detail.
(2) Detail: Temporary assignment of an employee to a different position, work

location, or post of duty without change of pay regardless of grade, for a specified
period, with the employee returning to his or her assigned position at the end of
the detail.

(ARTICLE 28 - Details and Temporary Duty Stations)
(3) Rotation: The recurring assignment of employees to different work locations,

work shifts and/or tours of duty within the confines of the employee’s work
location or other locations to which the employees are regularly assigned.
C. TEMPORARY PROMOTIONS. Temporary Promotions and details to higher graded

positions will be handled in accordance with the Merit Promotion and Reassignment
Plan.
D. RECORD OF DETAIL / PERSONAL FAVORITISM. The parties recognize that details to

other positions and activities are necessary and integral part of mission
accomplishment. Details to other activities or to higher graded positions for fifteen
(15) consecutive workdays or more will be documented by memorandum to the
employee with a copy to his or her Official Personnel Folder. Details will not be
made on the basis of personal favoritism. Should the requirements of the Service
necessitate an employee’s being detailed to a lower position, this will in no way
adversely affect the employee’s salary, classification or job standing. If an employee
alleges that a detail violates governing regulations or this Agreement, he or she may
file a grievance under the negotiated grievance procedure.
E. VOLUNTEER LISTS. Employees who are interested in participating in details at other

than their regular duty station should make their interest known to local supervisors.
The Employer will maintain and refer to employee requests for voluntary details.
Absent a particularized need for a specific skill or qualification, employee volunteers
will be considered as the primary source for selecting employees for details.
F. UNDERCOVER EMPLOYEES. Management will ensure that employees involved in

undercover operations will not be assigned to activities that are likely to compromise
their identity.
G. TIME LIMIT. Except for training courses, and details outside the 50 States, details
away from the normal duty station will not exceed 45 calendar days, unless the
employee volunteers for a longer period or management determines that there is a
valid operational need for a specific employee to continue on the detail.
H. UNION REPRESENTATIVES. Management will make every effort to avoid placing a

Union representative on a detail that would prevent that official from performing his
or her representational functions, unless the employee volunteers for the detail.
I. SELECTION PROCEDURES. The following procedures shall apply when the service
offers temporary assignments, noncompetitive details or rotations, of forty-five (45)
consecutive workdays or more to members of the bargaining unit:
(1) Volunteers. The Service will canvass the qualified employees for volunteers.
(2) Selection. Selection will be made from qualified volunteers.

(ARTICLE 28 - Details and Temporary Duty Stations)
(3) Local Bargaining. Procedures for selecting from qualified volunteers are
a matter appropriate for bargaining as part of a local supplemental agreement.
ARTICLE 29 - Hours of Work

A. DETERMINATION OF WORK HOURS. It is agreed that except in cases of emergency, or
where otherwise authorized by law or applicable government-wide rule or regulation,
or where the Service determines that it would be seriously handicapped in carrying
out its functions or that the cost would be substantially increased, it will provide the
following, consistent with 5 CFR 610.121:
(1) Basic Workweek. The administrative workweek shall be seven (7) consecutive
days, Sunday through Saturday. The basic workweek shall be scheduled on five
(5) days, Monday through Friday, where possible and the two (2) days outside the
basic workweek shall be consecutive.
(2) Inspections Workweek. The basic workweek for Inspectors shall be scheduled
on five days, Monday through Saturday, including Holidays, in accordance with
the AM.
(3) Basic Workday. The basic non-overtime workdays shall not exceed eight (8)
hours, excluding any non-paid meal period.
(4) Effect of Holidays. The occurrence of holidays shall not affect the designation of
the basic workweek.
(5) Posted Schedules / Individual Changes. Assignments to tours of duty shall be

posted 5 days in advance in the appropriate work area covering a 4 week period.
Individual changes in the tours of duty schedule or assigned shifts shall be posted
in the work area no later than one (1) week prior to the beginning of the workday
affected. Exceptions to this provision may be made where there is mutual
agreement between the employees and supervisors involved. Individuals involved
in a change of tour shall be notified of the reasons, including the circumstances of
the change.
(6) Break Between Shifts. The Service agrees to make every effort to schedule at
least 16 hours between changes in shifts, unless the parties agree locally to a lesser
period.
(7) Voluntary Schedule Adjustments. Employees who have been required to work
greater than sixteen (16) consecutive hours may request a schedule adjustment to
allow for rest and recuperation. Consistent with operational requirements,
Management shall make every effort to accommodate such requests. It is
understood that accommodation of such requests and such schedule adjustments
may result in an apparent loss of overtime.

(ARTICLE 29 - Hours of Work)
(8) Break in Work Hours. Breaks in working hours of more than one (1)
hour shall not be scheduled in any basic workday.
(9) Shift Trades. Where mutually agreeable to all employees affected, employees
may trade shifts or tours of duty out of the normal rotation, consistent with the
needs of the Service. Supervisors will not disapprove such mutually agreeable
shift trade requests except for valid operational reasons.
(10) Meal Breaks / Lunch Rooms. Employees assigned to District and to Regional
Offices and to the Headquarters Office should be accorded an uninterrupted lunch
period between the third (3rd) and fifth (5th) hours of duty where lunch periods are
customarily taken to the maximum extent possible. Lunch periods may fall
outside the 3rd and 5th hours of duty in offices where alternative work schedule
arrangements are in place. The Service shall provide clean and healthful lunch
rooms for the consumption of food, to the maximum extent possible, for all
Service employees. Arrangements within Districts for lunch periods will be
subject to supplemental negotiations.
(11) Duty Rosters. Establishment of duty rosters for employees who may be called
back to duty is an appropriate subject for local bargaining.
B. DEFINITIONS. For the purposes of this Article, the parties understand that:
(1) Tours of Duty. Tours of duty refers to an employee’s basic workweek, i.e., the
days and hours within which the employee is expected to be on duty, e.g., day
shift Monday through Friday; and
(2) Shifts. Shifts refer to the particular hours which define an employee’s daily work
schedule, e.g., the evening shift which starts at 2 p.m. and ends at 10 p.m.
C. ALTERNATIVE WORK SCHEDULES
(4) Establishment of Alternative Work Schedules. As an exception to other

provisions of the contract relating to the establishment of work hours, Directors
who have determined that the establishment of an alternative work schedule for
any work unit has the potential of improving productivity and providing greater
service to the public in accordance with 5 U.S.C. Section 6120, may establish
alternative work schedules consistent with this Article. Management is
responsible for obtaining any necessary higher agency approval for the
establishment of such a schedule. The terms and conditions of employee
participation (e.g., whether mandatory or voluntary) in alternative work schedules
are to be determined through local consultations and negotiations as provided
below and as consistent with Article 50.

(2) Concepts.
(a) Definitions:
Alternative Work Schedule (AWS) means both flexible work schedules and
compressed work schedules.
Compressed Work Schedule means a schedule in which a full-time employee
completes the 80-hour bi-weekly basic work requirement in less than ten
workdays or a part-time employee completes a basic bi-weekly work
requirement of less than 80 hours in less than ten workdays. For purposes of
this contract, the compressed work schedule is commonly one in which full-
time employees are scheduled to work four ten hour workdays each week,
scheduled on four of the workdays, or a part-time employee with a fixed
schedule is scheduled to complete that schedule over four of the workdays, or
the commonly practiced 5-4-9 system, or other compressed work schedules.
Flexible Work Schedule means a schedule in which employees are allowed to
determine their starting and ending time within the limits set by the Service in
accordance with Article 50.
(b) Legal Restrictions. The parties recognize that the law provides that the
Service may not establish such a schedule or continue such a schedule if the
schedule would result in:
(i) A reduction in the productivity of the agency;
(ii) A diminished level of services furnished to the public by the agency; or
(iii) An increase in the cost of agency operations (other than a reasonable
administrative cost relating to the process of establishing an alternative
work schedule).
(c) Inspections Limitations. Because of the statutory restrictions, the parties

recognize the following requirements for scheduling:
(i) The establishment of the hours of the workday in an alternative work
schedule for inspectors must be consistent with the actual inspectional
requirements of the unit or port of entry. For example, if most arrivals
occur between three and seven p.m., the required workday should
encompass these normally required inspections without the payment of
overtime.
(ii) The schedules of inspectors over the administrative workweek should to
the maximum extent be allocated over the available workdays to ensure
that inspections on Monday through Saturday during the basic workday do
not require the payment of overtime.

(3) Overtime. It is understood by the parties that, under law, none of

the hours that constitute an alternative work schedule may be compensated
with, or be credited for purposes of premium pay, including
administratively uncontrollable overtime, inspectional overtime and Fair
Labor Standards Act compensation. In accordance with applicable law,
inspectional overtime remains the basis for compensation of inspectors
conducting appropriate inspectional operations on Sundays and holidays.
(4) Consultations. Where local management or the Local Union believes that
productivity and services to the public will be promoted by the establishment of
an alternative work schedule, they shall informally consult with the other party
about proposed arrangements after providing written notice. Assuming the parties
find the arrangements acceptable, such a schedule may be established without the
necessity of negotiating an agreement.
(5) Negotiations. If, after consultations, the Local Union objects to the establishment
or termination of an alternative work schedule, management may propose the
establishment or termination of such a schedule in accordance with Article 9A. If
management objects to the establishment of such a schedule, the Local Union may
propose negotiations over such a schedule in accordance with Article 50
Supplemental Negotiations. In any negotiations over the establishment of an
alternative work schedule, the parties shall be governed by the provision of
subsection B of this Article and all requirements of applicable regulations and the
law.
ARTICLE 30 - Formal Meetings and Investigative Interviews

A. FORMAL DISCUSSIONS. The Union shall be given the opportunity to be represented at
any formal discussion between one or more representatives of the Service and one or
more employees in the unit or their representatives concerning any grievance or any
personnel policy or practices or other general conditions of employment.
B. INVESTIGATORY INTERVIEWS
(1) Weingarten Rights. The Service will provide the Union the opportunity to be
represented at any examination of an employee in the unit by a representative of
the Service in connection with an investigation if:
(a) Reasonable Belief. The employee reasonably believes that the examination
may result in disciplinary action against the employee; and
(b) Employee Request. The employee requests representation.
(2) Annual Notice. The Employer will advise employees in the unit of this right
annually.

(ARTICLE 30 - Formal Meetings and Investigative Interviews)
C. WRITTEN MEMORANDUM. In some circumstances, a written

memorandum may be used as a substitute for an oral examination in connection
with an investigation. In such cases, where the criteria of paragraph B (1) of this
article are met, the employee is entitled to the opportunity to consult with a Union
representative prior to completing the memorandum.
D. WRITTEN NOTICE / WITNESSES.
(1) Office of Internal Audit. In conducting investigations under the auspices of the
Office of Internal Audit (or successor), the Service in taking a sworn statement
from employees based on allegations which could result in disciplinary action
against the employee, will provide sufficient advance written notice to the subject
of the interview to allow them time to secure Union representation if they so
desire. The failure to obtain representation, or adequately confer with the
representative, will not delay the interrogation by more than 48 hours from the
time the employee receives such notice. The Union will promptly designate its
representative and make reasonable efforts to minimize delay. Upon request, a
reasonable extension of time will be granted when the representative cannot be
present.
(2) Witness. An employee who is requested to give testimony against another

employee and who refuses to do so voluntarily will be entitled to representation
prior to the time the Service initiates proceedings to compel such testimony or
institutes charges of insubordination.
E. SCHEDULING OF INTERVIEW. Interviews in connection with misconduct

investigations may be conducted at any reasonable hour. However, where an
employee is directed to appear for an interview, all hours spent in the interview shall
be compensated at the appropriate rate.
F. TRAVEL FOR INTERVIEW. When an employee is required to travel for the purpose of
participation in an investigative interview or any hearing appeal process, the Service
will pay the travel and per diem for the employee.
ARTICLE 31 - Disciplinary and Adverse Actions

A. DISCIPLINE DEFINITION. The disciplinary actions covered by the provisions of this
Article are written reprimands and suspensions of fourteen (14) days or less.
B. ADVERSE ACTION DEFINITION. Adverse actions covered by the provisions of this

Article are removals, suspensions for more than fourteen (14) days, reductions in pay,
reductions in grade, and furloughs of thirty (30) days or less.

(ARTICLE 31 - Disciplinary and Adverse Actions)
C. ORAL ADMONISHMENT. An oral admonishment will not normally be used as a

first step in progressive discipline, unless it is confirmed in writing and a copy
furnished to the employee.
D. UNION REPRESENTATIVE / INFORMATION. When the Union is designated as the

representative in a disciplinary or adverse action, the employee will furnish to the
Service, in writing, the name and address of the person to whom a copy of all
correspondence addressed to the employee relating to the case shall be mailed or
delivered. A copy of correspondence addressed to the employee will be furnished to
the designated person by mail to the address provided or by personal delivery. The
employee will be provided a complete copy of the disciplinary file on which the
proposed action is based at the time the proposal is served. It is understood that all
witnesses’ personal information will be redacted.
E. ADDRESSEE. If the employee elects not to be represented by the Union,

correspondence will be addressed to the employee and it will remain his or her
prerogative as to whether he or she wishes to furnish the Union with copies of such
correspondence.
F. UNFOUNDED COMPLAINTS. No record of a complaint, determined to be unfounded or

not investigated, will be placed in the employee’s Official Personnel Folder. Such
complaint may, in the interest of the employee and the Service, be maintained in a
subject file but will not under any circumstances be considered as a factor in
connection with any disciplinary action, promotion, etc. Such subject file will be
maintained in accordance with the Service records retirement program. An employee
will be advised of such a complaint when it is maintained in a subject file by local
management unless the release of such information is prohibited by law or relates to a
pending or ongoing investigation.
G. FINANCIAL OBLIGATIONS. It is recognized that all employees are expected to pay

promptly all just financial obligations. A just obligation is one which the employee
acknowledges as being just, one issued by law such as state and local taxes, or one
which has been reduced to a judgment by court means. In the event of a dispute as to
the validity of a debt between an employee and any private individual or firm, the
Service will take no action (other than to comply with a valid court order) until the
dispute has been resolved. This would not apply in those cases where it is shown the
employee has been involved in fraud or deceptive practices.
H. DISCIPLINE / ADVERSE ACTION PROCEDURES.
(1) Just Cause. The parties agree that letters of reprimand, suspensions of less than
fifteen (15) days, and adverse actions will be taken only for appropriate cause as
provided in applicable law. Such cause, in the case of actions which are not based
on unacceptable performance, shall be just and sufficient and only for reasons as
will promote the efficiency of the Service.

(2) Letter of Reprimand. When a letter of reprimand is issued, the employee

shall have the right, within ten (10) days, to prepare and submit a concise
statement (no more than two pages) of disagreement. The Employer will consider
the statement, and if appropriate modify, or withdraw the letter of reprimand. If
the letter of reprimand is not withdrawn the statement of disagreement will be
filed with the letter of reprimand on the temporary side of the OPF.
(3) Notice of Proposed Action. An original and one (1) copy of all proposed notices
of disciplinary actions, including adverse actions, shall be furnished to employees.
(4) Timeliness. The Employer shall furnish employees with notices of proposed
disciplinary actions at the earliest practicable date after the alleged offense has
been committed and made known to the Employer. The parties recognize that
certain investigations are beyond the administrative control of the Employer.
Where investigations have been unduly prolonged, regardless of whether they are
within the administrative control of the Employer, a reasonable extension of the
response period to the proposed disciplinary action will be granted by the
Employer, upon the request of the employee or his or her representative.
I. APPEAL. If employees believe that they have been unfairly disciplined, they may:
(1) Reprimands and Short Suspensions. With regard to written reprimands and
suspensions of 14 days or less: file a grievance as stated below.
(2) Adverse Actions. With regard to adverse actions: file either a grievance as stated
below or file a statutory appeal. Once an employee (or the Union on behalf of the
employee) has filed a written grievance or a timely statutory appeal, he or she may
not pursue the other procedure.
J. GRIEVANCE. If an employee wishes to pursue a grievance concerning a written

reprimand or the final decision regarding a suspension or an adverse action, the
Parties recognize and agree that:
(1) Reprimands. In the case of an official reprimand, the grievance process shall
begin with Step III of Article 47E of this Agreement and continue through the
successive steps.
(2) Suspension or Adverse Action. In the case of a suspension or adverse action, the
grievance process shall begin at the arbitration step in accordance with the
procedures set forth at Article 48 provided that the Union invokes arbitration after
being so requested by the employee (if the Union declines to invoke arbitration,
the employee has no further grievance rights under the negotiated grievance
procedure). However, where the Union declines to invoke arbitration, the
employee still retains whatever statutory appeal rights they might otherwise

ossess. The Service Notice of Decision shall represent the Service’s final decision
referred to in Section A of Article 48.
(3) Appeal Arbitrator. An employee may seek review of an arbitrator’s award in an

appealable adverse action to the Merit Systems Protection Board according to the
rules and regulations of the Board pursuant to 5 U.S.C. 7121(d).
(4) Appeal Performance Based Action. In arbitration over adverse actions for
performance or efficiency under 5 U.S.C. Sections 4303 and 7512 (Civil Service
Reform Act of 1978), an arbitrator shall be governed by Section 7701(c) of Title
5. That provision provides that an action shall be affirmed if for unacceptable
performance, if supported by substantial evidence; and affirmed if for efficiency,
if supported by the preponderance of the evidence.
K. UNWARRANTED DISCIPLINE. Any disciplinary or adverse actions and all copies

thereof which are later found to have been unwarranted shall be removed from the
official file of the employee and destroyed and the employee so notified in writing.
F. INVESTIGATIVE INTERVIEW TRAVEL. When an employee is required to travel for the

purpose of participation in an investigative interview or any hearing appeal process,
the Service will pay the travel and per diem for the employee.
ARTICLE 32 - Actions Based Upon Unacceptable Performance

A. PERFORMANCE BASED ACTIONS. The actions covered by the provisions of this
Article are: reduction in grade and removal for unacceptable performance pursuant to
5 U.S.C. 4303, for employees in bargaining unit positions at the time the action was
initiated.
B. PERFORMANCE IMPROVEMENT PLAN. Before a performance based action is taken

against an employee, the employee will be given an opportunity to improve his or her
performance through the issuance of a written Performance Improvement Plan (PIP).
The PIP will include the following:
(1) Identify Problems. Identification of each critical element which is being

performed at an unacceptable level.
(2) Explain Standards. An explanation of what the employee must do to bring his or
her performance in the critical elements so identified up to an acceptable level.
(3) Allow Improvement. A reasonable period of time commensurate with the

employee’s duties and responsibilities in which to improve performance, but not
less than forty-five (45) days. And

(ARTICLE 32 - Actions Based Upon Unacceptable Performance)
(4) Provide Assistance. Where appropriate, the types of assistance that will
be provided to the employee in improving his or her performance.
C. ADVANCE WRITTEN NOTICE. An employee whose reduction in grade or removal

under this Article is proposed shall be provided with at least a thirty (30) day advance
written notice which identifies:
(1) Identify Unacceptable Performance. Specific instances of unacceptable

performance;
(2) Identify Critical Elements. The critical elements of the employee’s position
involved in each instance of unacceptable performance;
(3) Time to Review and Respond. That the employee will be provided a reasonable
amount of official time to review material on which the action is based and to
prepare an answer orally and in writing;
(4) Right to Representation. That the employee will be given the right to be
represented by the Union or an attorney or other person of his or her choosing in
responding to the proposed action; and
(5) Written Decision That the Service will provide a written decision with specific
reasons for the action taken within thirty (30) days after the expiration date of the
notice period.
D. ESTABLISHED PERFORMANCE STANDARDS. No bargaining unit employee will be

subject to removal or reduction in grade based on unacceptable performance unless
that employee’s performance fails to meet established performance standards in one
or more critical elements of his or her position.
E. RIGHT TO REVIEW DOCUMENTS. Where an action is proposed under this Article, the
employee or his or her representative will be provided, upon written request, with a
copy of those portions of written documents which contain information and evidence
on which the action is based. The Employer will also supply the employee or his or
her representative, upon written request, with a copy of those portions of written
documents favorable to the employee which are directly related to the specific
instances on which the unacceptable performance is based.
F. PERFORMANCE BASED ACTION PROCEDURE.
(1) Notice, Information and Response. An employee against whom an action is

proposed under this Article shall be provided with ten (10) days, from receipt of
notice of the proposed action and all information as set forth in Section E above,
to review material relied upon by the Employer and answer the proposed action
orally and/or in writing. Any request for data must be submitted within 10 days

f receipt of the proposal. The employee may submit affidavits and/or other
documentary evidence in support of the answer.
(2) Decision. An official who sustains the proposed reasons against an employee in
an action based on unacceptable performance will set forth his or her reasons for
the decision.
G. ONE YEAR LIMIT. The final decision in the case of a proposed action to either
remove or downgrade an employee based on unacceptable performance will be based
on those instances of unacceptable performance by the employee which occurred
during the one (1) year period ending on the date of the advance notice letter.
H. RECORD RETENTION. If, because of performance improvement by the employee

during the notice period, the employee is not reduced in grade or removed, and the
employee’s performance continues to be acceptable for three (3) years from the date
of the advance written notice letter, any entry or other notation of the unacceptable
performance for which the action was proposed shall be removed from any record
relating to the employee.
I. FINAL DECISION. The final decision regarding a proposed action based on

unacceptable performance will be concurred in by an official in a higher position than
the official who proposed the action. The final decision letter shall set forth the basis
of the decision.
J. APPEAL. If the Employer’s decision is to effect an action based upon unacceptable

performance, the employee may appeal the decision to the Merit Systems Protection
Board in accordance with the applicable law or under the grievance/arbitration
procedures as provided in this Agreement. Under no circumstances may an employee
appeal an action under this Article to both MSPB and the grievance/arbitration
procedures in this Agreement.
ARTICLE 33 - Career Ladder Promotions and Within Grade Increases

A. PROMOTIONS. Career ladder promotions shall be processed in a timely manner once
an employee has meet the time-in–grade and qualification requirements and the
supervisor has determined the employee has acquired the knowledge, skills and
abilities to work at the next higher level. Once these criteria are met, the promotions
will be made effective at the beginning of the following pay period. If the
determination is delayed, and that determination is that the employee possessed the
necessary knowledge, skills and abilities on the date of eligibility, the promotion will
be retroactive. Promotions will be processed retroactively if a delay occurs after the
supervisor’s determination.

(ARTICLE 33 - Career Ladder Promotions and Within Grade Increases)
B. GRADE INCREASES. A within-grade increase shall be effective on the first day of

the first pay period following the completion of the required waiting period. There
are two exceptions:
(1) Not Acceptable Level of Competence. When there has been a determination that
the employee is not performing at an acceptable level of competence (ALOC); or
(2) Delayed Determination. When the employee’s ALOC is delayed because the
employee
(a) 90 Day Review. Has not served 90 days under performance standards; or
(b) New Position. The employee was reduced in grade because of poor
performance and has not served 90 days under performance standards in the
new position.
However, an employee’s within-grade-increase will not be delayed under (2)
(a) solely because the Service has made changes to an employee’s
performance standard. If a within grade is delayed under (2) and the employee
is subsequently found to be performing at the ALOC, the increase will be
granted retroactively to the beginning of the pay period following the
completion of the waiting period.
C. PERFORMANCE ASSISTANCE. When the Service’s evaluation leads to a conclusion

that the employee’s work is not at an acceptable level of competence for a within
grade increase, the Employer will be required to take the following actions:
(1) Identify Problems. Explain each aspect of performance in which the employee’s
performance falls below an acceptable level and relate deficiencies to specific job
elements and performance standards.
(2) Explain Requirements. Explain what is required to meet the acceptable level and
what the employee must do to elevate his or her performance to that level,
(3) Warn of Consequences. Warn the employee that if performance does not
improve to the acceptable level, the within grade increase, for which the employee
otherwise would be eligible, will be denied.
(4) Provide Assistance. Provide assistance in improving performance rated below the
fully successful level. Such assistance may include formal training, on-the-job
training, counseling, or closer supervision. Within-grade increase determinations
will be made in accordance with regulations, to include providing the employee
with a written notification, when a negative determination is made, stating the
reason(s) for the determination and what the employee must do to improve
performance to an acceptable level.

ARTICLE 34 - Quality Step Increase
A. DEFINITION. “Quality Step Increase” means an increase in an employee’s rate of

basic pay from one step of the grade of his or her position to the next higher step of
the grade in accordance with Section 5336 of Title 5, United States Code. The term
“quality step increase” is used in Section 5336 of Title 5, United States Code.
B. PURPOSE. The purpose of quality step increases is to recognize outstanding

performance by granting faster than normal step increases.
C. CONSIDERATION. To be considered for a quality step increase, an employee’s current

rating of record must be outstanding and the employee must not have received a
quality step increase within the preceding 52 consecutive calendar weeks.
D. DETERMINATION. A determination to grant a quality step increase should be made as

soon as practicable after a rating of record is approved.
E. EFFECTIVE DATE. A quality step increase shall be effective on the first (1st) day of
the first (1st) pay period following the approval date.
F. UNION CONSULTATIONS. The Union may raise questions and concerns with regard to
the performance rating system at Regional consultations pursuant to Article 10 of the
contract.
ARTICLE 35 - Annual Leave

A. RIGHT TO USE. Use of accrued annual leave is a right of the employee and not a
privilege.
B. EARN AND ACCRUE. Annual leave will be earned and accrued in accordance with
applicable laws and regulations.
C. REQUEST PROCEDURES. All requests for annual leave in excess of five (5) days will
be requested in advance and in writing (on Standard Form 71), where possible. Leave
use will be recorded on the Time and Attendance Report and will be documented in
writing on the SF-71, the Attendance Record Sheet or other document established by
past practice or under Article 9 or Article 50.
D. TIMELY LEAVE APPROVAL. Consistent with the needs of the Service, annual leave
which is requested in advance will be approved in a timely manner.
E. PROCEDURE TO SCHEDULE IN ADVANCE. Each employee shall be responsible for

planning and making timely requests for his or her annual leave in accordance with
his or her personal desires. Leave preferences shall be submitted in order that leave
schedules can be established and posted in a conspicuous place in the facility no later

(ARTICLE 35 - Annual Leave)
han February 15 of each calendar year. Employees who do not request leave by
February 15 will be allowed to take leave at a later date, provided it does not interfere
with the annual leave schedule. Requests for annual leave of five (5) days or less
need not have been included in the annual leave schedule provided all five (5) days
are within one (1) administrative workweek.
F. PRIORITY APPROVAL. When all requests for annual leave for a given period cannot
be granted, the supervisor shall give consideration to the following factors:
(1) Accrued Leave. Amount of leave to the employee’s credit.
(2) Seniority: (For the purpose of the Article, seniority is defined as the length of
I&NS service commencing with the first (1st) day of employment.)
(3) Children’s Vacation. Whether employees have children of school age and cannot
benefit from vacations taken when their children are in school.
(4) Previous Requests. Whether employees were able to take leave at desired time
during a previous scheduling period.
G. THREE CONSECUTIVE WEEKS. The Employer agrees to grant annual leave in a

manner which permits each employee, if he or she wishes, to take at least three (3)
consecutive weeks of annual leave each year.
H. NO SEASONAL EXCLUSION. In no case will any particular time of the year or season
be excluded from consideration for the granting of annual leave only because it is a
particular time or season of the year.
I. RELIGIOUS HOLIDAY. An employee may be granted a request for annual leave for an
established religious holiday of his or her faith which occurs on a regularly scheduled
workday of the employee’s basic workweek, in accordance with provisions set forth
in Section D of this Article.
J. REASON FOR LEAVE. Employees are not required to specify the reason for a request
of annual leave when such reasons are of a personal nature unless the employee is
requesting leave under the emergency procedures of Section L below. Such leave will
be granted in accordance with provisions of Section D of this Article.
K. CANCELED / CHANGED LEAVE
(1) Employee Initiated Change. Any employee initiated change in approved

vacation schedule cannot be made without the concurrence of all employees
whose vacation schedule would be affected by the change.
(2) Operational Need. Approved annual leave requests for sixteen (16) hours or
more, once approved, will be canceled only for valid operational reasons which

equire the employee not to take leave. Valid operational reasons include such
matters as illness or death of another employee, directed details by authority
outside the Service, special mission requirements which do not lend themselves to
normal scheduling, and other events which create an actual necessity for personnel
and not reasons which may make canceling leave merely desirable.
(3) Restoration of Canceled Leave. Annual leave that has been canceled for valid
operational reasons may be restored in accord with the provisions of the governing
regulations.
L. EMERGENCIES
(1) Procedure. Where unforeseen emergencies arise requiring the use of leave, at the
earliest opportunity, the employee shall notify the Employer of the nature of the
emergency, the anticipated extent of his or her absence, and seek the Employer’s
approval for annual leave or leave without pay.
(2) Extension. If the emergency extends beyond the period for which leave was
originally requested, the employee must again notify the Employer and request
additional leave.
M. HABITUAL TARDINESS. Habitual tardiness will not be excused and may be corrected
through the initiation of disciplinary action. Tardiness of less than sixty (60) minutes,
regardless of cause, at the discretion of the supervisor may be excused for adequate
reasons. Depending on the circumstances the time may be charged to annual leave,
compensatory leave, leave without pay or AWOL. If a charge against annual leave is
made, it must be in multiples of fifteen (15) minutes, and the employee cannot be
required to perform work for the period of leave charged against his or her account.
N. ADVANCE ANNUAL LEAVE. Annual leave may be granted and used in advance of
accrual, not to exceed the amount that is expected to accrue during the remainder of
the same leave year.
O. BEREAVEMENT LEAVE. An employee may be granted a reasonable amount of

appropriate leave in the event of a death in his or her immediate family. “Immediate
family” means the following:
(1) Spouse, and parents thereof;
(2) Children, including adopted children, and spouses thereof;
(3) Parents;
(4) Brothers and sisters, and spouses thereof;
(5) Grandparents and Grandchildren.

(6) Any individual related by blood or affinity whose close association with the
employee is the equivalent of a family member.
P. LEAVE BANK. Employees are encouraged, but not required, to contribute to the
Department of Justice Voluntary Leave Bank and the INS Voluntary Leave Transfer
Program.
ARTICLE 36 - Sick Leave

A. EARN AND ACCRUE. Sick leave will be earned, accrued, and approved in accordance
with applicable laws, regulations, and this Agreement.
B. PURPOSES FOR SICK LEAVE. When requested and approved as provided in this
Article, employees may use sick leave for the following purposes:
(1) Medical Appointments. To receive medical, dental, or optical examination or

treatment;
(2) Incapacity. When incapacitated for duty by physical or mental illness, injury,
pregnancy, or childbirth;
(3) Family Care. To provide care for a family member (as defined at 5 CFR 630.201
or its successor) as a result of physical or mental illness, injury, pregnancy,
childbirth, or medical, dental or optical examination or treatment, provided,
however, that a full-time employee may not use more than 104 hours of sick leave
(or for part-time employees the amount of sick leave the employee normally
accrues in a leave year) for these purposes within any leave year except as may
otherwise be permitted by the Code of Federal Regulations;
(4) Family Death. To make arrangements in connection with the death of a family
member or attend the funeral of a family member (as defined above), to the extent
leave for these purposes does not exceed the limitations as described in (3) above;
(5) Communicable Disease. When, as determined by health authorities having

jurisdiction or by a health care provider, the employee’s presence on the job
would jeopardize the health of others as consequence of the employee’s exposure
to a communicable disease;
(6) Adoption. When the employee must be absent from duty for purposes relating to
the adoption of a child, including appointments with adoption agencies, social
workers, attorneys, court proceedings, and required related travel.
(7) FEFFLA Employees shall not be charged for leave taken under the Federal
Employee Family Friendly Leave Act unless they specifically request sick leave
for the care of a family member.

(ARTICLE 36 - Sick Leave)
C. SICK LEAVE REQUEST PROCEDURES.
(1) Anticipated Sick Leave. When an employee knows in advance that sick leave
will be required, he or she shall request sick leave at the time the necessity for the
leave is determined.
Employees assigned to duty stations which have more than one 8-hour shift will
provide notification at least one hour prior to beginning of the assigned shift.
(2) Unanticipated Sick Leave. When the need for sick leave is unanticipated and
sickness or injury prevents the employee from reporting to work, the employee
shall notify the Employer as soon as possible. In no event shall the employee
provide such notification to his or her supervisor later than one (1) hour after the
normal time for reporting to work. When employees are assigned to a duty station
which has an evening and/or midnight shift, the employee will provide
notification at least one hour prior to the beginning of the assigned shift. If the
degree of the employee’s illness or injury prohibits compliance with the
notification requirements provided above, the employee shall provide such
notification as soon as possible. Acceptable evidence of such circumstances may
be required.
D. EVIDENCE OF ILLNESS. Employees may be required to furnish acceptable evidence

and Form 71 to substantiate a request for sick leave if the sick leave exceeds three (3)
consecutive workdays. Leave use will be recorded on the Time and Attendance
Report and will be documented in writing on the SF-71, the Attendance Record Sheet
or other document established by past practice or under Article 9 or Article 50.
Furthermore, supervisors may require medical certificates for absences of three (3)
workdays or less when a pattern of abuse is reasonably suggested by an employee’s
chronic use of short periods of sick leave or when there is reasonable doubt as to the
validity of the claim to such sick leave. When requiring medical certificates under
such circumstances, the employee will be counseled by the supervisor that continued
abuse of sick leave may result in a requirement to furnish a medical certificate for
each subsequent absence or sick leave regardless of duration. After an employee has
been placed on leave restriction, the leave restriction will continue for a period of one
year, unless the supervisor determines earlier that the leave abuse has ceased. The
employee will be notified, in writing, at the end of the one-year of the reasons if the
leave restriction is to continue beyond one year. If the leave restriction is not
continued, the employee will be notified of the cancellation of the leave restriction,
and the employee’s record will be made clean.
E. ANNUAL LEAVE FOR ILLNESS. Upon request by the employee, an approved absence
which would otherwise be chargeable to sick leave may be charged to annual leave if
the request is made at the time the request for approval of the leave is submitted.

F. ADVANCED SICK LEAVE
(1) Requirements. When an employee’s sick leave balance has been exhausted, the
Employer will approve requests for advance sick leave in cases of serious
disability or ailment if:
(a) Medical Certificate The application is supported by a medical certificate;
(b) Repayment. Repayment may be reasonably expected;
(c) Maximum Advance. The amount advanced to a full-time employee may not
exceed thirty (30) days. Part-time employees, working under a regular tour of
duty, may be advanced sick leave on a pro rata basis.
(d) Minimum Absence. The absence on account of illness must be for a period of
five (5) or more consecutive workdays, but the actual advance may be for any
part of the total absence;
(2) Conditions for Advanced Sick Leave.
(a) Charged to Employee. The total sick leave advanced must be charged against
sick leave subsequently earned. In case of separation of any employee who is
indebted for advanced sick leave (except in case of death, disability supported
by an acceptable medical certificate, retirement for disability, or for active
military service with restoration rights) recovery must be made for salary paid
by:
(i) deduction from any salary due the employee;
(ii) refund from the employees;
(iii) a claim filed against his or her retirement account; or
(iv) referral to General Accounting Office for collection.
(b) Temporary Employees. Temporary employees may not be advanced sick leave
in excess of the amount which they will earn during the period of temporary
employment.
(c) Retiring Employees. Employees approaching mandatory retirement may not

be advanced sick leave in excess of the amount which they will earn prior to
date of retirement.
G. INCREMENT CHARGED. Sick leave may be charged in fifteen (15) minute increments.

ARTICLE 37 - Administrative Leave
A. DEFINITION. Administrative leave is an excused absence from duty administratively

authorized without loss of pay and without charge to an employee’s accrued leave.
B. VOTING IN CIVIL ELECTION.
(1) General Rule. As a general rule, where the polls are not open at least three (3)
hours either before or after an employee’s regular hours of work, he or she may be
granted an amount of excused leave to vote in a civil election which will permit
him or her to report for work three (3) hours after the polls open or leave work
three (3) hours before the polls close, whichever requires the lesser amount of
time off.
(2) Additional Time. Depending upon exceptional circumstance in an individual

case, an employee may be excused for such additional time as may be needed to
enable him or her to vote, depending upon the particular circumstances in his or
her individual case, but not to exceed a full day.
(3) Travel Time. If an employee’s voting place is beyond normal commuting

distance and vote by absentee ballot is not permitted, the employee may be
granted the time necessary to make the trip to the voting place to cast his or her
ballot. Time off in excess of one (1) day shall be charged to annual leave or if
annual leave is exhausted, then to leave without pay.
(4) In-person Registration. For employees who vote in jurisdictions which require
registration in person, time off to register may be granted on the same basis as for
voting, except that no time shall be granted if registration can be accomplished on
a non-workday and the place of registration is within reasonable one (1) day round
trip travel distance of the employee’s place of residence,
(5) Costs. All costs incurred for travel in cases described in Sections B(l), (2), (3) and
(4) will be borne by the employee.
C. BLOOD DRIVE. An employee donating blood at an officially authorized blood bank or

in emergencies to individuals, will be granted administrative leave for the time
necessary to make the blood donation and necessary time for travel and recuperation.
The time authorized under this section shall be limited to four (4) hours on the day the
blood is donated.
D. CHANGE OF DUTY STATION. Employees effecting changes in a residence in

connection with a change in duty station within the Service will be granted
administrative leave of five (5) workdays. The first two (2) days will be provided by
the losing activity and the remaining three (3) days will be provided by the gaining
activity. The purpose of this leave is to make all arrangements, preparations, and

ctions relating to preparing for and actually effecting the changes in station. An
additional one (1) workday of administrative leave will be granted by the gaining
activity when the changes in station will not be at government expense.
E. COURT LEAVE. Employees will be granted court leave to serve as a juror, or as a

witness on behalf of a state or local government when officially required to appear.
F. SERVICE INTERVIEWS. Employees being interviewed for positions within the Service
or taking examinations for positions within the Service will be granted administrative
leave.
ARTICLE 38 - Home Leave

A. ACCRUAL. Home leave shall accrue, be credited, and be granted in accordance with
applicable laws and regulations and this Agreement.
B. GRANTING. Home leave will be granted to an employee who has completed an initial
tour of overseas duty of twenty-four (24) months and who has been approved for an
additional assignment overseas.
C. LIMITED USE. Home leave may be used only in the United States, the
Commonwealth of Puerto Rico, or a territory or possession of the United States, or at
other locations, in accordance with regulations.
D. COMBINED WITH ANNUAL LEAVE. Home leave may be taken in combination with
annual leave.
E. MANAGEMENT DISCRETION. The discretion to approve an employee’s home leave

request will rest with the Headquarters, Human Resources Branch. Home leave will
be approved in a fair and objective manner devoid of personal favoritism.
ARTICLE 39 - Leave Without Pay

A. DEFINITION. Leave without Pay (LWOP) is a temporary non-pay status and absence
from duty which has been requested and approved in advance by the Employer.
B. MATTER OF RIGHT. The following employees are entitled, as a matter of right, to

take leave without pay for the following purposes:
(1) Disabled Veteran. A disabled veteran for medical treatment when he or she
presents an official statement from a duly constituted medical authority that
medical treatment is required. The disabled veteran must give prior notice of the
period during which his or her absence for treatment will occur.

(ARTICLE 38 - Home Leave)
(2) Military Reservist. A military reservist or national guardsman for the

period he or she is required to perform active duty training if he or she has
exhausted his or her military leave or he or she is not entitled to military leave.
(3) Family Necessity. An employee presenting acceptable documentation of need and

who so requests in writing will be granted up to 12 weeks of leave without pay
during any 12 month period as necessary to manage one or more of the following
circumstances: the birth, adoption, or foster care of a child; a serious health
condition of the employee that renders the employee unable to perform the
essential functions of his or her position; to care for a spouse, son, daughter, or
parent of the employee when that person has a serious health condition. It is
understood that the definitions as set forth at 5 CFR Part 630, Subpart L, shall
apply to the terms of this subsection to the extent such terms are so defined.
C. NATIONAL UNION OFFICE. The Employer may approve leave without pay in the
following circumstances: For three (3) years to any employee elected a National
Officer of AFGE. Such leave may be extended in three (3) year increments and will
be terminated when the employee leaves office.
D. ADMINISTRATIVE DISCRETION. Recognizing that LWOP is a matter of administrative

discretion and may not be demanded as a right, the Employer may approve requests
for LWOP in the following circumstances:
(1) Education. When requested at least sixty (60) days in advance (a response will
issue within thirty (30) days of receipt thereof), an employee may be granted up to
one (1) year to participate in full-time study at an accredited institution of higher
learning when the following conditions are met:
(a) Related to Position. The proposed course of study is directly related to the
employee’s position with the Service and the employee has completed a
minimum of five (5) years of service with INS.
(b) Acceptable Performance / Expected Return. The employee has demonstrated

an acceptable level of competence through past performance and it can
reasonably be expected that the employee will return to work with the Service
upon completion of the study period. Such LWOP will be automatically
terminated without further notice when the employee withdraws or is
terminated from the study program.
(2) Injury / Illness. For up to six (6) calendar months when an employee has an
illness or injury, that would otherwise be covered with sick leave when the
employee’s annual and sick leave have been exhausted and there is reasonable
assurance that the employee can and will return to work with the Service at the
end of the leave period.

(ARTICLE 39 - Leave Without Pay)
E. NINSC CONVENTION. Local Officers, duly elected delegates, and

National Officers at their option may substitute LWOP for annual leave for the
purpose of attending the regularly scheduled INS Council Convention.
F. SUBSTITUTE FOR ANNUAL LEAVE. An employee at his or her option may substitute
leave without pay for annual leave in the following situation:
(1) Family Death. For leave granted in conjunction with death in the immediate
family,
(2) Religious Holiday. For leave on an established religious holiday which occurs on
a regularly scheduled workday of the employee.
G. UNION REPRESENTATIVES. Upon request of the National President of AFGE,

employees who are selected to serve in the capacity of AFGE Union representative or
officer, which requires absence from the job, may be granted annual and/or leave
without pay for a period of up to three (3) years. Extension for an additional year may
be considered. For short absences, not exceeding two (2) weeks of annual leave or
LWOP, upon request of the Local President or the Council President, Executive Vice
President, or Regional Vice President, the Local District Director may approve such
absences for a reasonable number of employees consistent with workload
requirements.
ARTICLE 40 - Leave for Family Responsibilities

A. FAMILY CONSIDERATIONS. The Parties recognize that, consistent with Department of
Justice and government-wide policies concerning family-friendly working conditions,
the Employer encourages its managers, to the maximum extent consistent with
efficient and effective mission accomplishment to grant leave requested by its
employees in connection with employee family responsibilities. Such family
responsibilities include childbirth, adoption, caring for an ill or disabled family
member, attending physician or dental appointments with a family member, and
making arrangements necessitated by the death of a family member and attending
funerals of family members. The Employer shall approve or disapprove such requests
for leave consistent with law and applicable regulations.
B. FAMILY MEMBER DEFINITION. For the purposes of granting annual leave, sick leave
under the Federal Employee Family Friendly Leave Act, and participation in
voluntary leave transfer program and leave bank programs, a family member is
defined as:
(1) A spouse or parents thereof;
(2) Children, including adopted children, and spouses thereof;

(ARTICLE 40 - Leave for Family Responsibilities)
(3) Parents;
(4) Brothers and sisters, and spouses thereof; and
(5) Any individual related by blood or affinity whose close association with the
employee is the equivalent of a family relationship.
A more limited definition applies to employees requesting leave without pay under
the Family and Medical Leave Act (FAMLA). The FAMLA definitions are found in
5 Code of Federal Regulations 630.1202.
C. MATERNITY LEAVE.
(1) Request Procedure. Employees may initially request leave for the purpose of
childbirth for a period of up to five (5) months. If circumstances require it,
additional requests for leave may be submitted. An employee may use sick leave
to cover physical examinations, medical treatment, and the period during which
the employee is physically incapacitated for the performance of duties by
pregnancy and confinement. In addition, sick leave may be used for care of the
child as provided in Article 36 B (3). Any additional period of time may be
charged to accrued annual leave and/or leave without pay. To obtain leave
without pay in excess of 12 weeks in a leave year, the employee must intend to
return to duty. All requests for maternity leave will be accompanied by a medical
certificate. The certificate shall specify the date the doctor recommends the
employee be placed on sick leave and the expected date of confinement.
(2) Advanced Sick Leave for Maternity. Sick leave for maternity reasons can be
advanced to any employee on the same basis and under the same conditions that
sick leave is normally advanced.
(3) Advanced Annual Leave for Maternity. Annual leave for maternity reasons can
be advanced to an employee on the same basis and under the same conditions that
annual leave is normally advanced.
D. ACCOMMODATION OF PREGNANCY. Where working conditions are more strenuous or

hazardous than normal office conditions, a pregnant employee, after consultation with
her physician, may request temporary reassignment to other available work for which
she is qualified, to protect her health and that of her unborn child. Where such light
duty is requested, based on medical certification, the Employer will make a
reasonable effort to accommodate the employee’s request, including participation or
non-participation in available overtime as provided in Article 20. A pregnant
employee shall not be involuntarily reassigned to other duties solely because of
pregnancy, absent a medical determination that she is incapable of performing some
or all of the duties of her position.

(ARTICLE 40 - Leave for Family Responsibilities)
E. CONTINUATION OF EMPLOYMENT. The Employer assures the continued

employment of an employee who has been absent for maternity reasons. She will be
continued in her current position or a position of like seniority, status, and pay unless
termination of employment is otherwise required by expiration of appointment, by
reduction in force, for cause, or for similar reasons unrelated to the absence.
F. PATERNITY AND ADOPTION LEAVE. Fathers of newborns and employees who are
adopting a child, may use sick leave in accordance with the provisions in Article 36
(B) (3) and (6). Annual leave and Leave without Pay (including LWOP under the
Family and Medical Leave Act - FAMLA) may also be used for the purpose of caring
for the new child. Employees may initially request leave for these purposes for a
period of up to five (5) months. If circumstances require it, additional requests for
leave may be submitted.
G. CARE FOR FAMILY MEMBERS. Employees may take sick leave as described in
Articles 36 (B) (3) and (5) to care for a family member who is incapacitated as the
result of physical or mental illness, or injury. Annual Leave and Leave without Pay
(including LWOP under the Family Medial Leave Act) may also be used for the
purpose of caring for a family member. Employees may initially request leave for
these purposes for a period of up to five (5) months. If circumstances require it,
additional requests may be submitted. Employees may also request leave to attend
medical, dental, or optical appointments with a family member.
H. LEAVE FOR THE DEATH OF FAMILY MEMBERS. Employees may use sick leave under
Article 36 (B) (4) to make arrangements necessitated by the death of a family member
or to attend the funeral of a family member. Annual Leave or Leave without Pay may
also be requested for such purposes.
I. LEAVE FOR OTHER FAMILY PURPOSES. Employees may be granted annual leave in
accordance with Article 35 for the purposes of participating in events with family
members that do not meet the criteria described elsewhere in this article. This
includes such activities as participation in school activities, weddings, sports and
cultural events.
J. VOLUNTARY LEAVE TRANSFER PROGRAM AND LEAVE BANK PROGRAM. An

employee who has no leave balance may apply for the Voluntary Leave Transfer
Program for the purpose of caring for a family member in a medical emergency.
Participants in the Leave Bank Program may also apply to be a leave recipient for this
reason.
ARTICLE 41 - Counseling for Performance and Conduct

A. REASONABLE AND FAIR. Counseling shall be reasonable, fair, and used to encourage
an employee’s improvement in areas of conduct and performance.

(ARTICLE 41 - Counseling for Performance and Conduct)
B. PRIVACY AND NOTICE. Oral counseling will be conducted during a private

interview with the employee. The supervisor will notify the employee in advance if
more than one Management official is to attend the counseling session.
C. UNION REPRESENTATIVE. The employee may request Union representation when the
meeting involves an examination as described in Article 30 (B).
D. WRITTEN RECORD. Not all counseling will necessitate a written record. However, if
a counseling is reduced to writing, the employee will be given two copies of the
written record. The written counseling will include, if appropriate, any references to
prior related oral counseling.
E. MISCONDUCT RECORD. A record of counseling for misconduct will be retained for a

period of up to on year.
F. PERFORMANCE RECORD. A record of counseling for performance will be retained

during the rating period for which it was issued. If the performance appraisal for that
year incorporates information in the narrative sections from the counseling record or
the counseling is incorporated into a performance improvement plan notice, it may be
retained for a longer period.
ARTICLE 42 - Holidays and Religious Observances

A. HOLIDAYS. The following days are treated as holidays for the purpose of pay and
leave of Service employees:
(1) New Year’s Day - January 1;
(2) Martin Luther King’s Birthday - 3rd Monday in January;
(3) Washington’s Birthday - 3rd Monday in February;
(4) Memorial Day - Last Monday in May;
(5) Independence Day - July 4;
(6) Labor Day - 1st Monday in September;
(7) Columbus Day - 2nd Monday in October;
(8) Veterans Day - November 11;
(9) Thanksgiving Day - 4th Thursday in November;
(10) Christmas Day - December 25;

(ARTICLE 42 - Holidays and Religious Observances)
(11) Inauguration Day - January 20 quadrennially (in the Washington, D.C.

metropolitan area only);
(12) Any other day designated as a holiday by Federal Statute or Executive Order.
B. IN LIEU OF HOLIDAY OBSERVANCE
(1) Federal Statute. For employees working a Monday through Friday workweek,
holidays falling on a weekend will be celebrated as defined by Federal Statute.
(2) Sunday. When a holiday falls on a Sunday or an employee’s day off in lieu of
Sunday, the employee is excused from work on the next workday of his or her
basic workweek. Holiday pay is authorized for the next workday if the employee
is not excused on that day.
(3) Saturday. When a holiday falls on Saturday or an employee’s day off in lieu of
Saturday, the employee is excused from work on the previous day of his or her
basic workweek. Holiday pay is authorized for the previous workday if the
employee is not excused from duty on that day.
(4) Staffing Needs. The parties recognize that Service staffing needs on holidays are
the same or greater than normal workday for some operations. However, where a
holiday falls on a scheduled workday of an employee, every effort should be made
to excuse the employee on the holiday consistent with the needs of the Service.
C. RELIGIOUS HOLIDAYS. Employees who wish to attend or participate in the

observance of the established religious holidays of their faith (e.g., Good Friday, Yom
Kippur) may be granted annual leave in accordance with provisions set forth in
Section D of this Article.
D. ACCOMMODATION OF RELIGIOUS BELIEFS.
(1) Religious Observance. The Service will make every effort to accommodate the
practice of religious beliefs by individual employees as consistent with the needs
of the Service. Employees who are required to be absent for some period of the
workday because of religious observance or belief, may elect to work
compensatory overtime as a substitute for time off, or take appropriate leave.
(2) Compensatory Time. The Employer shall grant compensatory time off to an
employee requesting such time off, and shall in each instance afford the employee
the opportunity to work compensatory overtime in order to repay the
compensatory time off. A request may be disapproved, however, if the requested
change in work schedule would interfere with the ability of an organization to
efficiently accomplish its mission. In such circumstances, there is no obligation to
approve requests for time off for religious observances.

(ARTICLE 42 - Holidays and Religious Observances)
(3) Leave Procedures.. Where an employee is granted leave for religious

observance, the employee may perform compensatory overtime work before or
after the compensatory time off. Time off taken in advance must be repaid by an
equal amount of compensatory overtime work within six (6) pay periods
following the pay period in which the employee was absent; otherwise, the time
off will be charged to annual leave or leave without pay, as appropriate. When
compensatory overtime work is performed in advance, the time off for religious
observance must be taken within six (6) pay periods of the pay period in which it
was earned; otherwise, it will be forfeited.
(4) Premium Pay Excluded. The premium pay provisions for overtime work do not
apply to compensatory overtime work performed under this section.
(5) Unavailable Overtime. If no productive overtime is available to be worked by

the employee at such time as he or she may initially request such work, alternative
times will be arranged by the Employer for the performance of the compensatory
overtime work within the time frames stated in Section D (3).
E. STATE AND LOCAL HOLIDAYS. State and local holidays will normally be treated as
regular workdays if they fall within an employee’s basic workweek. However, the
Employer may release employees on administrative leave for a state or local holiday
when the employees of the Service office, installation, or post of duty are actually
prevented from working by one of the following circumstances:
(1) Building Closures. The building or office in which the employees work is
physically closed; or building services essential to proper performance of work are
not operating.
(2) Local Transportation. Local transportation services are discontinued or

interrupted to the point where employees are prevented from reporting to their
work location.
(3) Related Duties. The duties of the employees consist largely or entirely of dealing
directly with employees or industrial establishments or local government offices,
and all such establishments are closed in observance of the holiday, and there are
no other duties (consistent with their normal duties) to which the employees can
be assigned on the holiday.
ARTICLE 43 - Probationary Employees

A. PERFORMANCE STANDARDS AND REVIEW. Probationary employees will be advised
in writing of the applicable critical elements and performance standard at the
beginning of the probationary period. The supervisor will explain the requirements of
each probationer’s position and answer any questions the employee may have. The
supervisor will review the performance of the probationary employee and provide

(ARTICLE 43 - Probationary Employees)
ounseling regarding any performance deficiencies. If the employee is not performing

satisfactorily, he will be so advised by the supervisor. The supervisor will inform the
employee how to correct his performance. The parties understand that a probationary
employee may be terminated whether or not the supervisor has followed these
procedures.
B. NON-RETENTION AND NOTICE. Although termination of a probationary or a

temporary employee is not an adverse action, the Service agrees that when it deems
advance notice of termination to be in the best interests of the operations of the
Service, the affected employee will be given two (2) weeks advance notice prior to
the effective date of such action. When an employee is selected for an Officer Corps
position, prior experience in an Officer Corps position within the INS qualifies
towards the probationary period to the extent consistent with applicable law and
regulation.
ARTICLE 44 - Equal Employment Opportunity

A. DEFINITION. The Employer will provide equal opportunity in employment for all
qualified persons and will prohibit discrimination in employment because of race,
color, religion, sex, national origin, age, or disability, except where required by statute
or pursuant to bona fide occupational qualifications.
B. BARGAINING OBLIGATIONS. Where the development and implementation of the

Employer’s Equal Employment Opportunity Plans and Programs involve changes in
personnel policies, practices, or working conditions, the Employer will fulfill its
bargaining obligations with the Union under Chapter 71 -- Labor-Management
Relations—of Title 5, United States Code.
C. DISCRIMINATION CLAIM PROCEDURES.
(1) Claims. Any employee who believes that he or she has been discriminated against
on the grounds set forth in Section A, above, may file any one of the following:
(a) Grievance. A grievance pursuant to the provisions of Article 47 of this

Agreement;
(b) EEO Pre-complaint Counseling. A complaint of discrimination with the

Service subsequent to required EEO pre-complaint counseling; or
(c) MSPB. An appeal to the Merit Systems Protection Board (MSPB) where an
action is otherwise appealable to the Board and the employee alleges that the
basis for the action was discrimination prohibited by Section A.

(ARTICLE 44 - Equal Employment Opportunity)
(2) Elected Procedure. An employee shall be deemed to have exercised his

or her option under this section at such time as the employee timely files either
a formal complaint of discrimination, an MSPB appeal, or a grievance in
writing in accordance with the provisions of this Agreement.
(3) Grievance Appeal. The selection of the negotiated grievance procedure contained
in this Agreement to process a complaint of discrimination shall in no manner
prejudice the right of an aggrieved employee to request the Merit Systems
Protection Board to review the final decision in the case of any personnel action
that could have been appealed to the Board, or, where applicable, to request the
Equal Employment Opportunity Commission to review a final decision in any
other matter involving a complaint of discrimination of the type prohibited by any
law administered by the Commission. Appeals to the Merit Systems Protection
Board or the Equal Employment Opportunity Commission shall be filed pursuant
to such regulations as the Board or the Commission may prescribe.
D. GRIEVANCE FILING DEADLINES.. An employee may file a grievance pursuant to this

Article within fifteen (15) days following:
(1) Incident. The date of the alleged discriminatory incident; or
(2) Awareness. The date upon which the aggrieved became aware of the alleged
discriminatory incident or situation; or
(3) Final Interview. The date of the employee’s final interview with the Equal
Employment Opportunity Counselor.
E. USE OF EEO COUNSELORS.
(1) Consultation. Employees are encouraged but not required to consult with an
Equal Employment Opportunity Counselor prior to filing a grievance under this
Article. Such consultation shall take place within forty-five (45) days of the
alleged discriminatory incident.
(2) Counselor Lists. The names, offices, and telephone numbers of local Equal
Employment Opportunity (EEO) Counselors serving the duty station shall be
posted on official bulletin boards.
(3) EEO Counselor Duties. The EEO Counselor shall:
(a) Counsel. Counsel the aggrieved employee concerning the issues in the matter;
(b) Inquire. Make whatever inquiry into the matter that he or she believes
necessary;
(c) Resolve. Seek a solution of the matter on an informal basis;

(d) Document. Keep a record of his or her counseling activities; and
(e) Written Report. Submit a written report to the Equal Employment Opportunity
Officer, with a copy to the aggrieved employee, summarizing his/her actions
concerning the allegations of discrimination.
(f) Inform of Right to Representative. Advise the aggrieved employee that he or

she has the right to have a union representative or other representative of their
own choosing present, throughout all stages of the EEO complaint process.
(4) Final Interview. The EEO Counselor shall, insofar as is practicable, conduct a
final interview with the aggrieved employee within thirty (30) calendar days after
the date on which the matter was called to the attention of the EEO Counselor by
the aggrieved employee.
(5) Right to File Complaint. If the final interview is not concluded within thirty (30)
calendar days and the matter has not been previously resolved to the satisfaction
of the employee, the Counselor shall at that time inform the aggrieved employee
of his or her right to immediately file a complaint of discrimination by exercising
one of the options in Section C(l).
(6) Neutrality of EEO Counselor. The EEO Counselor shall not in any way attempt
to restrain an employee from filing an EEO complaint, nor may an EEO
Counselor encourage an employee to file an EEO complaint.
(7) Confidentiality. The EEO Counselor shall not reveal the identity of an aggrieved
employee who has come to him or her for counseling, except when authorized to
do so by the aggrieved employee, until a written EEO complaint has been filed.
(8) Independence of EEO Counselor. Equal Employment Opportunity Counselors

shall be free from restraint, interference, coercion, discrimination, or reprisal in
connection with the performance of their duties.
(9) Right to Representation. At any stage in the processing of an EEO complaint the
employee shall have the right to be accompanied, represented, and advised by a
representative of his/her choosing.
(10) Right to Represent Self. The employee shall also have the right to present the
EEO complaint without representation.
F. UNION RIGHT TO BE PRESENT. If the employee elects to pursue the complaint under
the grievance procedures of this Agreement and he or she elects to process the
grievance without representation, the Union shall have the right to be present at any
meeting between Management and the employee concerning the grievance.

G. UNION NOTIFICATION OF CHANGE. If at any stage of the complaint process under

procedures covered by this article, the Employer determines to make changes to
resolve the complaint with respect to personnel policies and practices or matters
affecting the general working conditions of unit employees, the Union will be
afforded reasonable notification.
H. CONFLICT WITH CONTRACT.
(1) Notice and Opportunity to Bargain. Where the corrective or remedial action to
be taken as a result of statutory adjudicatory procedures would conflict with or
appear to conflict with, the provisions of this Agreement, the Employer shall
afford the Union reasonable notification and opportunity to negotiate the impact
of the Employer’s action effectuating the decision.
(2) Priority of Appellate Decisions. The provisions of this Agreement may not serve
to prevent implementation of statutory equal employment opportunity decisions
(of, i.e., the Merit Systems Protection Board, the Equal Employment Opportunity
Commission or the Federal courts) where the provisions:
(a) Violate applicable law, order, or regulations in effect at the time this
Agreement was approved; or
(b) Are themselves discriminatory in their impact on employees; or
(c) Leave no reasonable alternative for taking required action.
I. PROCEDURES FOR SELECTING EEO COUNSELORS.
(1) Employer Responsibility. The selection of Equal Employment Opportunity

Counselors is solely the responsibility of the Employer.
(2) Volunteers. Any employee who is interested in serving as an Equal Employment

Opportunity Counselor shall notify the appropriate Regional Director, Director of
Administrative Center or Equal Employment Opportunity Officer, in writing.
Such notification shall include a statement of the employee’s qualifications and
the reasons for his or her desire to serve in such capacity.
(3) Conflict of Interest. In order to avoid conflict of interest, or apparent conflict of

interest, Union stewards or Union officials may not serve as Equal Employment
Opportunity Counselors.
(4) Nominations. Nominations for prospective Counselors may be submitted by the

Union, employees, or other interested persons or organizations. Union
membership, or lack thereof, shall not provide a basis for nomination or failure to
nominate an employee.

(5) Selection. Equal Employment Opportunity Counselors shall be selected by

the Employer without regard to race, color, sex, religion, national origin, age,
marital status, political affiliation, physical or mental disability or Union
membership.
J. EEO PLANS. The Union recognizes that the Employer is responsible for the
development of the Equal Employment Opportunity Plans at both the National and
Regional levels which must be submitted to the Equal Employment Opportunity
Commission for approval.
(1) Assessment. The first stage of Equal Employment Opportunity Plan development
is the assessment stage in which information is gathered on the existing status of
Equal Employment Opportunity within the Service. During this stage, the Union
may present, in writing, its views, opinions, and other information on the status of
the Equal Employment Opportunity program to the Employer’s officials. The
assessment views of the Union shall be submitted through the Regional and
National Labor Relations Offices of the Employer.
(2) Union Comment. After the Employer has formulated its Equal Employment
Opportunity plans, draft copies of the plans will be submitted to the Union for
comment. The Union’s views and comments shall be given due consideration in
the preparation of the final plan to be submitted to the Equal Employment
Opportunity Commission. Copies of the final plans submitted to the Commission
will be provided to the Union.
(3) Opportunity to Bargain. If implementation of the Employer’s Equal

Employment Opportunity Plans involves changes in personnel policies, practices,
or matters affecting working conditions, the Union will be given reasonable
opportunity to exercise its bargaining rights pursuant to Chapter 71 of Title 5,
United States Code prior to implementation.
ARTICLE 45 - EEO Advisory Committees

A. EEO COMMITTEES.
(1) Purpose. The Employer and Union reaffirm their commitment to the principles of
EEO, and to that end agree to support a positive program which has as its
objective the realization of that commitment.
(2) Membership. An EEO Committee will be established in each District. The

Committee will be composed of Management representatives, at least one Union
representative per local, and the Special Emphasis Program Managers. For the
purposes of this Article, the SEPMs are neither Service nor Union representatives.

(ARTICLE 45 - EEO Advisory Committees)
(3) Headquarters Committee. An EEO Committee will be established at the

Headquarters Office to represent HQ employees. The Union may appoint up to
three (3) Union representatives to attend the EEO Committee meetings. The
Union representatives will be employees in the Headquarters Office.
(4) Meetings. The District and Headquarters Office Committees shall meet quarterly.
(5) Duty Hours. All Committee meetings will be during regular duty hours and the
Employer will, to the maximum extent possible, make shift changes to
accommodate attendance by Union representatives.
(6) Time, Travel and Per Diem. Because EEO Committees are established as
Management Advisory Committees, all Union representatives shall receive
official time while attending such meetings. The cost of travel and per diem for a
Union representative to attend District EEO meetings will be borne by the
Service. Any travel required by a Union representative will be on official time.
B. COMMITTEE RESPONSIBILITIES. Advisory Committees established under this Article

are to be only advisory and consultative in nature. Specifically, they exist to serve the
EEO interests of the local work force by functioning as a continuing link of
communication on matters of an EEO nature. Operations and functions of EEO
Advisory Committees will consist of:
(1) Identify Issues. Identifying and bringing to the attention of local management any
personnel policy, practice or procedure which denies equality of opportunity to
any group or individual on the basis of race, color, religion, sex, national origin,
age or disability.
(2) Exchange Ideas / Proposals. Acting as a forum for an exchange of ideas and
action proposals on sensitive issues, and matters of concern of an EEO nature.
C. EEO STATISTICS. The Service agrees to furnish semiannually to the Council

President two (2) legible copies of raw statistical EEO reports.
D. SUMMARY OF COMPLAINTS. The Service agrees to furnish the Council President an

annual summary of the number and types of discrimination complaints received.
ARTICLE 46 - Sexual Harassment

A. WORKPLACE ATMOSPHERE. The Employer agrees to provide all bargaining unit
employees a work atmosphere free from sexual harassment.
B. UNWELCOME ADVANCES. Unwelcome sexual advances, request for sexual favors,

and other verbal or physical conduct of a sexual nature constitute sexual harassment
when:

(ARTICLE 46 - Sexual Harassment)
(1) Condition of Employment. Submission to such conduct is made explicitly or

implicitly a term or condition of an individual’s employment;
(2) Employment Decisions. Submission to or rejection of such conduct by an

individual is used as the basis for employment decisions affecting such individual;
or
(3) Hostile Work Environment. Such conduct has the purpose or effect of
unreasonably interfering with an individual’s work performance or creating an
intimidating, hostile, or offensive working environment.
C. EMPLOYER’S RESPONSIBILITY.
(1) Managers and Supervisors. The Employer recognizes its responsibility for its
acts and those of its managers and supervisors with respect to sexual harassment
to the extent of and in accordance with applicable law.
(2) Fellow Employees. With respect to conduct between fellow employees, the
Employer may also be responsible for acts of sexual harassment in the work place,
where the Employer knows or should have known of the conduct, unless it can be
shown that the Employer took immediate and appropriate corrective action.
(3) Lost Opportunity. Where employment opportunities or benefits are granted

because of an individual’s submission to the Employer’s sexual advances or
requests for sexual favors, an employee who was qualified for but denied that
employment opportunity or benefit has the right to exercise one of the options in
Section E (1) below.
D. COMPLAINT PROCEDURES
(1) Investigation. Where an allegation of sexual harassment is brought to the

attention of Management, the Employer will promptly and seriously investigate
said allegations.
(2) Substantiation. In substantiating an allegation of sexual harassment, an employee

need not demonstrate resistance to the harassment or that resistance of the
harassment caused loss or denial of tangible job benefits.
(3) Confidentiality. Where an employee has brought an allegation of sexual

harassment to the attention of Management, the Employer shall treat such
allegations as confidential and shall reveal no more information concerning such
an allegation than is necessary to conduct a full, prompt, and serious investigation.
E. FILING A COMPLAINT. Any employee who believes that he or she has been
discriminated against on any of the grounds set forth in this Article may file one of the
following:

(1) Grievance. A grievance pursuant to the provisions of Article 47 of this

agreement.
(2) EEO Complaint. A complaint of discrimination with the Service, subsequent to

required EEO pre-complaint counseling pursuant to applicable law and regulation
prescribed by EEOC; or
(3) MSPB Appeal. An appeal to the Merit Systems Protection Board (MSPB) where
an action is otherwise appealable to the Board and the employee alleges that the
basis of the action was discrimination prohibited by Section A, pursuant to
applicable law and regulation prescribed by MSPB.
F. GRIEVANCE DEADLINES. An employee may file a grievance pursuant to this Article

within fifteen (15) days following:
(1) Incident. The date of the alleged discriminatory incident; or
(2) Awareness. The date upon which the aggrieved became aware of the alleged
discriminatory or situation; or
(3) Final Interview. The date of the employee’s final interview with the Equal
Employment Opportunity Counselor.
G. EEO COUNSELORS.
(1) Optional Consultation. Employees are encouraged but not required to consult an
Equal Employment Opportunity Counselor prior to filing a grievance under this
Article. Such consultation shall take place within forty-five (45) days of the
alleged discriminatory incident.
(2) List of Counselors. The names, offices, and telephone numbers of local Equal
Employment Opportunity (EEO) Counselors serving the duty station shall be
posted on official bulletin boards.
(3) Counselor Duties. The EEO Counselor shall:
(a) Counsel. Counsel the aggrieved employee concerning the issues in the matter;
(b) Inquire. Make whatever inquiry into the matter that he or she believes
necessary;
(c) Resolve. Seek a solution of the matter on an informal basis;
(d) Document. Keep a record of his or her counseling activities; and

(e) Written Report. Submit a written report to the Equal Employment

Opportunity Officer, with a copy to the aggrieved employee summarizing his
or her actions concerning the allegations of discrimination.
(4) Final Interview. The EEO Counselor shall, insofar as is practicable, conduct a
final interview with the aggrieved employee within thirty (30) calendar days after
the date on which the matter was called to the attention of the EEO Counselor by
the aggrieved employee.
(5) Right to File Complaint. If the final interview is not concluded within thirty (30)
calendar days and the matter has not been previously resolved to the satisfaction
of the employee, the EEO Counselor shall at that time inform the aggrieved
employee of his or her right to immediately exercise one of the options set out in
Section E (1).
(6) Neutrality of EEO Counselor. The EEO Counselor shall not in any way attempt
to restrain an employee from filing an EEO complaint, nor may an EEO
Counselor encourage an employee to file an EEO complaint.
(7) Confidentiality. The EEO Counselor shall not reveal the identity of an aggrieved
employee who has come to him or her for counseling except when authorized to
do so by the aggrieved employee, until a written EEO complaint has been filed.
(8) Independence of EEO Counselor. Equal Employment Opportunity Counselors

shall be free from restraint, interference, coercion, discrimination, or reprisal in
connection with the performance of their duties.
(9) Right to Representation. At any stage in the processing of an EEO complaint,

the employee shall have the right to be accompanied, represented, and advised by
a representative of his/her choosing.
(10) Right to Represent Self. The employee shall also have the right to present the
EEO complaint without representation.
H. UNION RIGHT TO BE PRESENT. If the employee elects to pursue the complaint under
the grievance procedures for this Agreement and he or she elects to process the
grievance without representation, the Union shall have the right to be present at any
meeting between Management and the employee concerning the grievance.
I. GRIEVANCE CONSIDERATIONS.
(1) Elevated Step. Where an employee chooses to use the grievance and arbitration
procedures provided in this Agreement to process a complaint of sexual
harassment, and the person against whom such an allegation is made is designated

o provide a response in the grievance procedure, the grievance may be filed

directly at the next higher step.
(2) Closed Hearing. Where a grievance under this Article is advanced to arbitration,
the arbitration hearing - at the option and request of the grievant - shall be
conducted as a closed hearing.
J. ANNUAL ANNOUNCEMENT. The Employer shall annually incorporate the provisions

of this Article into an information announcement on the topic of sexual harassment,
and said information announcement shall be distributed to all managers, supervisors
and employees.
ARTICLE 47 - Grievance Procedure

A. PURPOSE. The purpose of this Article is to provide a fair, simple and expeditious
means of processing grievances. This negotiated procedure shall be the exclusive
procedure available to the Union and employees in the unit for resolving grievances
which come within its coverage, except as specifically provided in B below.
However, any employee or group of employees in the unit may present such
grievances to the Service and have them adjusted, without the intervention of the
exclusive representative, as long as the adjustment is not inconsistent with the terms
of the Agreement and the exclusive representative has been given an opportunity to be
present during the processing.
The initiation or presentation of a grievance by employees will not cause any
reflection on their standing with or their loyalty to the Service.
B. DEFINITION: A grievance means a complaint either by a unit employee concerning

his or her conditions of employment, by the Union in its own behalf concerning
conditions of employment of any employee, or alleged contractual violations by the
Service, or by the Service concerning alleged contractual violations by the Union.
Unless excluded below, such a complaint may concern the adverse impact of:
(1) Violation of Agreements. The effect of interpretation, or claim of breach of this

master Agreement, or other written agreement between the parties; or
(2) Violation of Law, Rule, or Regulation. Any claimed violation,

misinterpretation, or misapplication of any law, rule, or regulation affecting
conditions of employment.
EXCLUSION: This procedure does not cover grievances concerning:
(1) Beyond Authority. Matters which are not subject to control by Management of
this Service; Matters which are not subject to control by the Union;

(ARTICLE 47 - Grievance Procedure)
(2) Political Activities. Any claimed violation of Subchapter III of Chapter 73

of Title 5 U.S. C. (relating to prohibited political activities);
(3) Benefits. Retirement, life insurance, or health insurance;
(4) National Security. A suspension or removal under Section 7532 of Title 5 U.S.C.
for reasons of national security;
(5) Hiring Authority. Any examination, certification, or appointment;
(6) Classification. The classification of any position which does not result in a
reduction in grade or pay of any employee;
(7) Statutory Discrimination Appeal. A complaint of discrimination which is listed

in 5 U.S.C. Section 2302(b)(1) if the employee has elected to use the statutory
appeal procedure;
(8) Statutory Adverse Action Appeal. An appeal of an adverse action based on

performance under 5 U.S.C. 4302 or for efficiency under 5 U.S. C. 7512 if the
employee elects the statutory appeal procedure provided under 5 U.S.C. 7701;
(9) Union Appeal of Non-represented Statutory Process. A Union appeal of an

adverse action or an allegation of discrimination against any employee if the
Union is not expressly designated by the employee as his or her representative on
the matter.
(10) Already Filed. Issues which can be raised under the grievance procedure or as an
unfair labor practice may, in the discretion of the aggrieved party, be raised under
either procedure but not under both procedures.
(11) Probation. The removal of a probationary employee during his or her

probationary period.
(12) Temporary Appointments. The termination of a temporary appointment.
(13) Proposed Actions. Notices of proposed disciplinary/adverse actions, furloughs,

or removals. Issues relating to such proposal notices may, however, be raised in
connection with any grievance over the final decision on the proposed action.
C. IDENTICAL GRIEVANCES. In the case of an identical grievance involving a group of

employees one employee’s grievance may be selected by the Union for processing.
All decisions for that grievance will be binding on the other grievance(s). The Parties
agree that for the purposes of this section identical grievances are ones arising from a
common set of circumstances which adversely affect the grievants in the same manner
where all of the witnesses would be testifying to the same or substantially similar
facts. The term “substantially similar” means facts which are sufficiently

like so that a reasonable person would conclude that application of the same rules to
the facts in each grievance would result in the same conclusions with regard to the
outcome of those grievances.
D. RESOLVE AT LOWEST POSSIBLE LEVEL. The Service and the Union agree that every
effort will be made by Management and the aggrieved party(s) to settle grievances at
the lowest possible level. It is agreed that the employee and his or her representative
will be given a reasonable amount of time to present the grievance.
E. PROCEDURES FOR GRIEVANCES FILED BY EMPLOYEES:
(1) First Step

Informal grievance must be filed within 22 workdays after the incident occurs.
This time limit will not apply where it is established that the employee had no way
of being aware of the incident. The grievance shall first be taken orally by the
concerned employee with the first level of supervision in an attempt to settle the
matter. If the first level supervisor is also the official designated as a Step II
official, the grievance will be filed with that official. The grievant may, if he or
she desires, be assisted in the presentation by a Union representative.
The Union representative must be present if the employee so desires. If the
employee presents a grievance directly to Service Management for adjustment
consistent with the terms of this Agreement, the Union shall be given the
opportunity to have an observer present, on official time, at the time of
adjustment. Within five (5) workdays after receiving the employee’s grievance,
the immediate supervisor (or designee) shall complete such inquiry as he or she
deems necessary and render his or her decision to the grieving employee. After
receiving the decision of the immediate supervisor, the employee may, at his or
her option, pursue his or her informal grievance to the next higher level of
supervision, if that level is not one of the Management officials cited in Step II.
All aforementioned procedures for Step I shall apply at this level for informal
resolution of the employee’s grievance. The employee may, at his or her option,
reduce the grievance to writing
(2) Second Step

If the employee is dissatisfied with the decision of the immediate supervisor and
desires to proceed to Step II, the employee (or the employee’s union
representative acting on behalf of the employee) must submit a written grievance,
to the appropriate official as specified below, within ten (10) workdays after
receiving the immediate supervisor’s decision on the grievance.
Submission of Step II Grievances:
District Office employees: to the District Director

Telephone Service Center and Service Center employees: to the Center

Director
Asylum Office employees: to the Asylum Office Director
Foreign Office employees other than Foreign Districts: To the Officer in
Charge
Administrative Center employees: to the appropriate Assistant Center Director
Regional Office employees: to the Deputy Regional Director
Regional Counsel employees: to the Regional Counsel
HQ Non-Operational employees: to the appropriate Associate Commissioner
or Director
HQ Operational employees: as appropriate, to the Associate Commissioner for
Enforcement or the Associate Commissioner for Examinations
The employee shall set forth in precise terms exactly what his or her grievance is;
all the facts relating thereto, including the names of any individuals against whom
the grievance is made; the Article and Section of the Agreement which is in
dispute; the reason for his or her dissatisfaction, and the corrective action desired.
The Grievant will also include documents and evidence related to the grievance.
When the Union is designated as the representative of an employee in a grievance,
the employee will also furnish the name and address of the representative to the
Service in writing. The employee will also furnish the name and address of any
witnesses.
Within fifteen (15) workdays after receiving the grievance, the Deciding Official
(or designee) shall hold such meetings and complete such inquiry as he or she
deems necessary and shall render his or her written decision on the grievance.
The written decision shall set forth, in precise terms, the basis of the decision.
No letter from an employee designating the Union as his or her representative in
pursuing a grievance will be required in those cases where the Union is presenting
a grievance concerning the Union’s rights under the contract or law, or in those
cases where the Union files a grievance on behalf of an employee and the election
of the grievance procedure does not represent a choice between the grievance
procedure and other administrative or judicial procedures that may be available to
the employee.
(3) Third Step

If the employee is dissatisfied with the decision at Step II and desires to proceed to
Step III, the employee (or the employee’s union representative acting on behalf of
the employee) must submit a written grievance, to the appropriate official as
specified below, within ten (10) workdays after receiving the Step II decision.

Submission of Step III Grievances

District and Region Office employees: to the Regional Director (or his/her
designee who is an official above the Step II official)
Administrative Center employees: to the Administrative Center Director
Telephone Service Center and Service Center employees: to the Assistant
Commissioner, Service Center Operations
Regional Counsel employees: to the General Counsel
Asylum Office employees: to the Deputy Asylum Director Headquarters
Foreign District and Office employees: Director, Office of International
Affairs
Headquarters employees: to the appropriate Executive Associate
Commissioner
The written grievance must include the information specified at Step II above,
including also a copy of the Step II decision and an explanation as to why that
decision was not acceptable to the employee. Within twenty (20) workdays after
receiving the grievance, the Deciding Official (or designee) shall complete such
inquiry as he or she deems necessary and render a written decision on the
grievance. Such written decision shall set forth, in precise terms, the basis for the
decision. If the employee is dissatisfied with this decision, he or she may submit
the grievance to the appropriate Local for a decision by the Union as to whether to
process the case through arbitration as provided in Article 48.
If a dispositive issue in the grievance involves interpretation of this agreement,
either the Step III Official or the Union may refer the grievance to the national
parties for an interpretation of the contract within thirty (30) days of the Step III
decision. A joint response from the national parties will be binding on the
local/regional parties, absent which the matter shall proceed to arbitration.
F. REQUESTED RELIEF GRANTED. In no case in which the precise relief requested is

granted, will the grievance be continued on to the next Step, including the invoking of
arbitration.
G. EXCEPTIONS TO STEP I. Except as otherwise specified below, all employee

grievances are to be initiated at Step I of the grievance procedure within the time
frame as stated at Step I:
(1) Policy of Director. Grievances that are based on the written decision or policy of
the District Director are to be initiated at Step II of the grievance procedure within
the time frame specified at Step I.
(2) Reprimands. Grievances concerning written reprimands are to be initiated at Step

III of the grievance procedure within the time frame specified at Step I.

(3) Suspensions and Adverse Actions. Grievances concerning suspensions

and adverse actions are to be initiated at the arbitration stage of the grievance
procedure as provided at Article 31.
(4) MP&RP Violations. Employee grievances concerning alleged violations of the

Merit Promotion and Reassignment Plan (MP&RP) are to be filed and processed
as follows:
(a) Step A. Such grievances are to be filed in writing with the Head of the Human
Resources Office that serviced the particular promotion/vacancy action at
issue within 22 work days. The Head of the servicing Human Resources
Office shall conduct whatever inquiry or review he or she deems appropriate
and render a written decision on the grievance within 15 work days after
receipt of the grievance.
(b) Step B. If the grievant is not satisfied with the decision of the Head of the
servicing Human Resources Office, he or she may pursue the grievance further
by filing a Step III appeal with the appropriate Administrative Center Director
(or the INS Director of Human Resources for grievances in which the
position/vacancy at issue is serviced by the INS Headquarters Human
Resources Office) within 10 work days after receipt of the decision of the head
of the servicing Human Resources Office. Such appeal must include a copy of
the decision received from the Head of the servicing Human Resources office.
H. GRIEVABILITY / ARBITRABILITY. When the Service or the Union has reason to

believe that a grievance is not grievable or arbitrable, it will endeavor to so inform the
other party as soon as possible. If the Union or the Service elects to proceed to
arbitration of the grievance, such grievability/arbitrability questions are to be decided
as a threshold issue by the arbitrator who decides the merits of the grievance. The
final written decision of the arbitrator in such a case shall consist of two parts. In the
first part, the arbitrator shall decide the grievability/arbitrability issue in the case. In
the second part, he or she will pass upon the merits of the grievance. If the arbitrator
should determine that the grievance is either not grievable or not arbitrable, however,
the decision shall consist of one part, the determination on grievability/arbitrability,
and no consideration of the merits of the grievance shall be provided.
If either party raises an arbitrability question later than fourteen (14) calendar days
prior to the date scheduled for a hearing, the other party shall have the right to
postpone the hearing, if it deems postponement necessary. Any additional costs by
the arbitrator for cancellation required by the late notification as to the arbitrability
issue shall be borne by the party raising the question.

I. PROCEDURES FOR GRIEVANCES FILED BY THE UNION OR THE SERVICE:
(1) District Level Disputes:
(a) Step A. If a dispute arises between a Local of the Council and a District,
Service Center, Telephone Service Center, Asylum Office, or Administrative
Center, either the President of the Local or the Head of the particular
organizational component (or their respective designees) may file a written
grievance with the other party, provided such grievance is filed within twenty-
two (22) workdays after the event giving rise to the grievance. This time limit
will not apply where it is established that the grieving party had no way of
being aware of the incident. Any such grievance must include the relevant
facts, the provisions of any law, rule, or contract allegedly violated, and the
relief being sought. The party against whom the grievance was filed shall
render a written decision on the grievance within fifteen (15) workdays after
receipt of the grievance.
(b) Step B. If the decision on the grievance is unacceptable, the matter may be
escalated to the appropriate Council Vice-President or the appropriate
Regional Director for reconsideration within 15 workdays of receipt of the
Step I decision. A copy of the original grievance and response shall be
included in the grievance when it is escalated to the next step. The Council
Vice-President or Regional Director (or their respective designees) shall
render a written decision on the grievance within 15 workdays of receipt. If
the grievance is not resolved to the mutual satisfaction of the parties, either
party to the grievance may refer the matter to arbitration within the time frame
as described at Article 48.
(2) Regional Level Disputes. If a dispute arises between one or more Locals and a
Region, either the appropriate Council Vice President or the Regional Director (or
their respective designees) may file a written grievance with the other party within
22 workdays after the event giving rise to the grievance. This time limit will not
apply where it is established that the grieving party had no way of being aware of
the incident. The party against whom the grievance was filed shall render a
written decision on the grievance within 15 workdays after receipt of the
grievance. If the grievance is not resolved to the mutual satisfaction of the parties,
either party to the grievance may refer the matter to arbitration within the time
frame as described at Article 48.
(3) National Level Disputes. If a dispute arises between the Council and
Headquarters, either the Council President or the Associate Commissioner for
Human Resources and Development (or their respective designees) may file a
written grievance with the other party within 22 workdays after the event giving
rise to the grievance. This time limit will not apply where it is established that the
grieving party had no way of being aware of the incident. The party against

hom the grievance was filed shall render a written decision on the grievance
within 15 workdays after receipt of the grievance. If the grievance is not resolved
to the mutual satisfaction of the parties, either party to the grievance may refer the
matter to arbitration within the time frame as described at Article 48.
J. TIME LIMITS.
(1) Extensions. All time limits herein may be extended by mutual agreement of the
parties involved. If a grievant should fail to meet an applicable time limit for
moving a grievance forward, the grievance shall be deemed to have been
withdrawn. If a deciding official fails to meet the time limit for rendering a
decision on the grievance, such failure shall entitle the grievant to advance the
grievance to the next step (including arbitration, if appropriate) within the
applicable time frame for such action as measured from the date the deciding
official should have rendered his or her decision.
(2) Service of Process. All time limits of this grievance procedure, including
arbitration, shall be controlling. Service of grievances and the decisions thereon,
including arbitration notices, shall be accomplished either by personal delivery or
by U.S. Mail-Return Receipt Requested. As applicable, time limits shall begin to
run from the date of receipt of the document that triggers the particular time limit.
Service will be deemed timely if the required document is either personally
delivered or postmarked within the specified time limit. The parties agree that
they will act in good faith in receipting for documents and will not attempt to
evade the service of documents upon them.
ARTICLE 48 - Arbitration
A. INVOKING ARBITRATION. If the Service and the Union fail to settle any grievance
processed under the negotiated grievance procedures, such grievance, upon written
request by the Union or the Service, may be submitted to arbitration within fifteen
(15) workdays from the date the Service or the Union’s final decision is received. In
cases involving suspensions of less than fifteen (15) days or adverse actions, requests
for arbitration must be filed after receipt of the Notice of Decision, but not later than
fifteen (15) workdays after the effective date of the action. Requests for arbitration
filed by the Union will be submitted to the Servicing Labor Relations Officer. Issues
involving Service wide interpretation or application of this agreement will be filed
with the Chief Labor Employee Relations Policy Section at Headquarters.
B. SELECTION OF PANELS. The parties agree to the establishment of three Regional

panels to handle arbitrations under this Article. Each Regional panel shall consist of
ten (10) arbitrators. The Regional representatives of the parties will nominate ten (10)
arbitrators. If both sides nominate the same arbitrator, he/she will automatically

(ARTICLE 48 - Arbitration)
ecome a member of the panel. Otherwise, the parties will alternate strikes until ten
(10) arbitrators are chosen.
(1) Replacements. Should any arbitrator ask to be removed from the panel, the
parties will each nominate three new arbitrators. If one or more names are on
both lists, they will be selected and added to the list. Otherwise, the parties will
alternate strikes until the arbitrator is chosen.
(2) Removal. During the life of the agreement, either party at the national level may
unilaterally remove three (3) arbitrators from the panels by providing the other
party with written notice. Such removal shall not be effective until thirty days
after receipt of the written notice by the other party. Any additional removals
must be done by mutual agreement. Selection for a replacement will be done by
the procedures outlined above.
(3) Rotation. Arbitrators will be used alphabetically on a rotational basis. If an

arbitrator is not available within a mutually agreeable time, the parties may agree
to select the next arbitrator on the list.
(5) Headquarters Arbitrations. For arbitrations involving Headquarters, the parties

will request the name of the next arbitrator on each Regional list and select the
arbitrator using alternate strikes.
C. THRESHOLD ISSUES. In cases where there is a threshold issue, such as jurisdiction, the
parties may agree that an initial decision be requested on the threshold issue.
(1) Arbitrators Decision. The parties may agree to use stipulations and / or briefs to
obtain the arbitrator’s decision on the threshold issue. If there is no agreement
and either party elects to proceed to arbitration of the grievance, such grievability /
arbitrability questions are to be decided as a threshold issue by the arbitrator. If
the arbitrator should determine that the grievance is either not grievable or not
arbitrable, the decision shall consist of one part and no consideration of the merits
of the grievance shall be provided.
(2) Postponement. If either party raises an arbitrability question later than fourteen
(14) calendar days prior to the date scheduled for a hearing, the other party shall
have the right to postpone the hearing, if it deems postponement necessary. Any
additional costs by the arbitrator for cancellation required by the late notification,
as to the arbitrability issue, shall be borne by the party raising the question.
D. TRANSCRIPTS. Each party will inform the other no later than fourteen (14) calendar
days prior to the start of the arbitration hearing whether it desires a transcript of the
hearing. If the parties mutually agree upon the need for a transcript, they shall equally
share the cost of the transcript and management will make the arrangements for
securing a transcript. If they do not agree on the need for a transcript, the party

esiring a transcript will arrange for the transcript and will bear the full cost. However,
should the other party change its mind prior to the close of the arbitration hearing and
indicate its desire for a copy, it shall then be responsible for half of the costs.
E. PROCEEDINGS. The arbitrator will be requested to render his or her decision as

quickly as possible but, in any event, no later than twenty-two (22) workdays after the
conclusion of the hearing unless the parties mutually agree to extend the time limit.
Each party has the obligation to cooperate promptly with the designated arbitrator in
setting a date for a hearing. Failure of either party to proceed with due diligence in
responding to an offer of dates may serve as a basis for establishment of a hearing
date by the arbitrator or dismissal of the grievance. At the request of either party, the
Service or the Union shall be provided a complete list of the other’s known witnesses
no later than five (5) days prior to the hearing, along with a brief synopsis of the
anticipated testimony.
F. DOCKET REVIEW. Discussion of any cases where arbitration has been requested and
pending in the Region will be conducted upon advance request. Such discussions
may include possible settlements in pending cases or in pending grievance matters.
G. EXPEDITED PROCEDURE. The parties recognize the importance of promptly handling

demotions, indefinite suspensions, suspensions of 30 days or more and removal cases.
These timelines may be used in other cases where it is mutually agreeable. For such
cases, the parties have agreed to ask the arbitrator to adhere to the following time
lines:
(1) Hearing. Arbitrators are to conduct a hearing within fifteen (15) working days of
selection.
(2) Briefs. Post hearing briefs will be submitted within fifteen (15) workdays after
completion of hearing or receipt of transcript unless the parties agree to an
extension.
(3) Decision. Arbitrators are to render a decision within fifteen (15) workdays of
closing of the record. The record will be considered closed upon receipt of briefs,
receipt of transcript, or completion of hearing whichever is later.
H. COSTS. The arbitrator’s fee and the expenses of the arbitration, if any, shall be borne
equally by the Service and the Union. Fees to be paid by the Service will be governed
by existing regulations.
I. CANCELLATION. The parties will share cancellation costs equally when notice is
provided at least 96 hours prior to the scheduled hearing date. The party seeking the
cancellation will pay arbitration costs incurred for canceling less than 96 hours prior
to any hearing.

J. LOCATION. The arbitration hearing will be held, if possible, on the Service’s

premises during the regular day shift of the basic workweek. The arbitration will
normally be held within the commuting area of the grievant unless the grievant has
transferred from the site of the dispute; and in such cases the hearing will be held at
the site of the dispute unless both parties agree to hold it in another location.
K. PARTICIPANTS.
(1) Duty Status. All participants in the hearing shall be on administrative leave, if
they would otherwise be in a duty status. If a hearing is scheduled on what would
otherwise be a participant’s day off, the Service will adjust the employee’s
schedule so that the employee would be in a duty status.
(2) Travel and Per Diem. Where the grievant or relevant witnesses are not within the
commuting area of the hearing site, the Service will pay travel and per diem.
Should there be a disagreement as to the relevance of a witness where travel and
per diem is required, the Union will pay travel expenses and the issue will be
presented to the arbitrator who will decide on the relevancy of the testimony. If
the arbitrator decides that the witness is relevant, the arbitrator will so state in the
decision and the agency will pay travel and per diem at a rate no greater than that
authorized by government travel regulations.
L. BINDING AWARDS. The arbitrator’s award shall be binding on the parties unless either
party files exceptions with the Federal Labor Relations Authority, under the
regulations prescribed by the Authority. However, any adverse action appeals shall be
presented to the appropriate appellate jurisdiction.
ARTICLE 49 - Effective Date and Duration

A. EFFECT. This Agreement supersedes the 1997 Collective Bargaining Agreement.
This new Agreement shall take effect on the date that it is signed by the
Commissioner and the President of the American Federation of Government
Employees (or their respective designees) and shall remain in effect for three (3) years
from that date. If either party subsequently desires to renegotiate this contract, it will
furnish written notice to the other party containing the proposed changes not less than
one hundred and eighty (180) days but not more than two hundred and ten (210) days
prior to the termination of this Contract. If neither party desires to renegotiate the
Agreement, the parties shall execute new signatures and dates, and the Agreement
shall be renewed for a one (1) year period.
B. RENEGOTIATION. In the event notice is given by either party, renegotiations shall

begin within sixty (60) days from the date of receipt of notice of the proposed
changes.

(ARTICLE 49 - Effective Date and Duration)
Ground rules shall be negotiated one hundred and fifty (150) days prior to the
expiration date of the Agreement. Any matters remaining in dispute at the expiration
of the contract shall be forwarded to the appropriate third (3rd) party for resolution.
ARTICLE 50 - Negotiation of Supplemental Agreements

A. SUPPLEMENTAL PROCEDURES. AFGE Locals designated by the Union shall be
allowed to negotiate a Supplemental Agreement covering all eligible employees in the
District, provided that the Local shall have initiated its request for bargaining over a
Local Supplemental Agreement no later than eighteen (18) months after the effective
date of this Master Agreement. It is understood there will be only one Supplemental
Agreement per District. For the purpose of this Article, the Headquarters Office,
Service Centers, Asylum Offices, Administrative Centers, and Regional Offices will
each be treated as a District and may negotiate a Supplemental Agreement covering
all bargaining unit employees assigned to those locations. All Supplemental
Agreements are to be immediately forwarded to the Council President and the Labor
Relations Office at the Service’s headquarters for review and approval following their
execution by the Local Parties. Supplemental Agreements automatically go into
effect 90 days after submission if there have been no revisions requested by either
party.
B. MASTER AGREEMENT CONTROLLING .It is understood by the parties to this

Agreement that this is the Master Agreement and that only a Supplemental Agreement
may be negotiated at the local level. The Master Agreement is governing and
controlling and nothing may be included in the local Supplemental Agreement which
is in conflict with this Agreement. Where provisions of a Supplemental Agreement
are in conflict with the terms of this Master Agreement, the terms of the Master
Agreement shall govern. It is further understood that local Supplemental Agreements
shall not repeat or paraphrase any provisions of this Master Agreement. Where a local
union represents employees in more than one District, the negotiation of a single local
Supplemental Agreement is appropriate if mutually agreeable to the local union and
each activity head.
C. SUBJECT MATTER. Matters appropriate for local supplemental bargaining shall be

limited to the following matters:
(1) physical working conditions such as safety, sanitation, heat, ventilation, smoking
policy, parking, lockers, eating facilities, work clothing where applicable, etc.;
(2) opportunities for job related training;
(3) leave scheduling;
(4) break periods for work shifts;

(ARTICLE 50 - Negotiation of Supplemental Agreements)
(5) procedures for equitably assigning overtime work;
(6) flexible tours of duty;
(7) alternative work schedules as specified in this agreement;
(8) official time provisions (such as banks of official time) for Local officers and
stewards to the extent such provisions more precisely define the reasonable-time
limitation which the master agreement imposes;
(9) the circumstances under which rough duty attire/uniforms may be worn;
(10) casual dress days;
(11) procedures for enforcing pay caps on overtime earnings on other than a yearly
basis (e.g., a monthly, quarterly or other short-term basis);
(12) office space for Local Unions, including furniture, equipment, and E-mail access
for the Local Union;
(13) local training committees; and
(14) up to fifteen additional matters of local concern as may be identified by each

party to the particular local supplemental negotiations.
Any matters in addition to the foregoing may be negotiated only with the approval of
the Parties at the national level. Requests for approval to negotiate such additional
matters are to be jointly submitted to the President of the Council and to the Chief of
the Labor and Employee Relations Policy Section at the Service’s headquarters.
D. NEGOTIABILITY DISPUTES. If a negotiability dispute involves a question solely as to

whether a proposal conflicts, repeats, or paraphrases provisions of the master
Agreement, it may be referred by either party to both the Headquarters Office and the
National President of the National INS Council. The parties will discuss such a
referral within ten (10) working days to attempt to resolve the issue. If the issue is not
resolved, it may be presented as a Council or national-level Service grievance over the
interpretation and application of the Master Agreement.
E. EXPIRATION AND RENEGOTIATION. Supplemental Agreements predating this Master

Labor Agreement will remain in force, as qualified below, until they either expire
according to their terms or they are superseded by a new Supplemental Agreement.
Any Supplemental Agreement negotiated under the provisions of this Article shall
have a term of three (3) years from its effective date. Except for the subject matter
limitations set forth in section C above, the Parties understand and agree that the
provisions of a Supplemental Agreement predating this Master Labor Agreement may

(ARTICLE 50 - Negotiation of Supplemental Agreements)
e carried over to new Supplemental Agreements as long as they do not conflict with
the terms of this Master Labor Agreement.
ARTICLE 51 - Impasses in Supplemental Negotiations, Impact Bargaining, and

Mid-Term Negotiations.
A. IMPASSES DURING NEGOTIATION. During Supplemental Negotiations, Impact
Bargaining or Mid-Term Negotiations, when it has been determined that an impasse
has been reached, the item shall be set aside. After all negotiable items on which
agreement can be reached have been disposed of, the parties shall once more attempt
to resolve any existing impasse item.
B. MEDIATION. If such consideration does not result in the resolution of the impasse, the
assistance of the Federal Mediation and Conciliation Service may be requested by
either of these parties.
C. REFERRAL TO NATIONAL PARTIES AND IMPASSES PANEL. Any impasse which

remains unresolved following mediation may be submitted to the Associate
Commissioner Human Resources and Development, and the National President of the
National INS Council for consideration prior to referral to the Federal Service
Impasses Panel. Referral to the Panel will be in accordance with existing Department
of Justice instructions and rules established by the Panel.
D. AGREEMENTS ALLOWED. The procedure described above shall not preclude the
parties from agreeing on any issues or from entering into complete agreement with the
assistance of the Mediator or the Panel.
ARTICLE 52 - Total Quality Management

A. TQM PHILOSOPHY. Total Quality Management (TQM) is both a philosophy and a
way of doing business that emphasizes continuous improvement in the quality of
service and work performed by employees, and the quality of work life of employees.
The Service and the Union agree that it is in the interest of the service and employees
to jointly pursue TQM initiatives. Such initiatives may entail review and analysis of
Service policies and practices and changes to same when required in the interest of
improved quality. TQM is also based in the belief that employees are a valuable
resource and possess the knowledge and ability to solve work problems and improve
work processes.
B. PRINCIPLES. The Service and the Union recognize that it is mutually advantageous
for them to work together in the interest of improved quality. The parties also
recognize that a TQM effort should provide for:
(1) A firm Management and Union commitment at all levels, especially at the top;

(ARTICLE 51 - Impasses in Supplemental Negotiations, Impact Bargaining, and Mid-Term Negotiations.)
(2) An emphasis on the accomplishment of the Service mission through open

communication and understanding and meeting the needs and requirements of
our “customers”;
(3) Fostering and promoting open communications among the Union, management
and employees;
(4) A mechanism for ensuring employee awareness of quality initiatives and TQM
principles;
(5) A mechanism to ensure that employees have the appropriate skills to implement
the quality initiatives adopted;
(6) Direct management, employee, and Union involvement and participation through
Process Action Teams (PATs); and
(7) Utilization of bargaining unit volunteers whenever possible.
(8) Participation on a Process Action Team will be considered in evaluating an

individuals annual performance rating, and elements or rating factors will be
adjusted to account for time spent participating on a PAT.
C. RESERVATION OF RIGHTS. Nothing in this Article is intended to interfere with or

waive any right of the Union or the Service under this negotiated agreement or under
applicable statutes and regulations.
D. MEMORANDUM OF UNDERSTANDING. The parties’ memorandum of understanding

dated October 21, 1992 is attached as Appendix 4 to this contract.
ARTICLE 53 - Employee Assistance Program

A. ASSIST EMPLOYEES. Under the Employee Assistance Program (EAP) the Employer
agrees to continue efforts to identify, counsel and assist in rehabilitating employees
with alcohol, drug related, or personal problems which may adversely affect job
performance. The union agrees to cooperate fully with the Employer in this program,
while complying with the provisions for confidentiality in safeguarding client
information.
B. INFORMATION TO UNION. The Employer agrees to provide an orientation for union

officials concerning EAP policies, referral procedures and program resources.
C. REHABILITATION. The Employer recognizes its responsibility to identify and make

reasonable effort at rehabilitation of employees with alcohol or drug problems at an
early stage. Employees undergoing a prescribed program of treatment will be granted

(ARTICLE 53 - Employee Assistance Program)
ick leave for this purpose on the same basis as any other illness which requires
absence from work.
D. DISCIPLINE. The Employer and the Union jointly agree that employees entering the
EAP are not immune from disciplinary action. However, the fact that an employee is
actively pursuing, or indicates a commitment to enter an established program of
rehabilitation will be given weight in considering appropriate disciplinary action.
E. ANNUAL REVIEW. The EAP authorities will meet annually with designated union
representatives in reviewing the agencies yearly statistical report and general program
effectiveness.
F. CHILD CARE / ELDER CARE. The Service will continue to provide and or support
various activities in order to meet the ongoing child and elder care needs of
employees. These may include, but are not limited to, such things as child/elder care
and parenting information, child/elder care resource and referral information,
workshops, and counseling as available through the Employees Assistance Program.
It is agreed that the responsible officials will grant emergency annual leave requests
and consider emergency requests for leave without pay brought about by unexpected
changes in child care or elder care arrangements, consistent with Service needs.
Consistent with Service needs, the Service agrees to utilize programs that may assist
employee with child care or elder care needs; for example, part-time employment, job
sharing, leave, flextime, etc. The Service recognizes that it may be necessary for
employees to contact child care and elder care providers during duty hours.
ARTICLE 54 - Contracting
A. BRIEFINGS. Management will brief Council representatives concerning any decisions
to contract out work currently performed by bargaining unit employees of the Service.
The briefings are to provide information about contracting out studies under OMB
Circular A-76.
B. SITE VISITS. The Service will notify the Union if a site visit is going to be conducted
for potential bidders seeking contracts for work performed by bargaining unit
employees. A Union representative may attend such a site visit.
C. UNION NOTIFICATION. When the Service determines that unit work will be
contracted out, the Service will notify the Union to provide them an opportunity to
request to negotiate as appropriate.

(ARTICLE 54 - Contracting)
APPROVED
In witness whereof the parties hereto have caused this collective bargaining agreement to
be signed on this 8th day of June, 2000.
For the Service: For the Union:
Commissioner President
US Immigration and National INS Council American Federation of
Naturalization Service
Den& ASmith
Execu&i! Vice President E&r-n Region VP
National INS Council National INS Council
Secretary-Treasurer
Vice President At Large Staff Assistant

APPENDIX 1 - Merit Promotion Plan I

The Merit Promotion Plan presently in negotiation will become part of this
Agreement as Appendix I when approved by both parties.

(APPENDIX 1 - Merit Promotion Plan I)
APPENDIX 2 - Dues Withholding

Section I
Definitions
A. DUES: The regular, periodic amount determined by the Union to be required of the
member to maintain good standing in the Union. This amount is certified by the
Union on the SF-1187 form and excludes special assessments, back dues, fines, and
similar items not considered to be dues. A multi-level dues structure may be utilized.
B. SF-1187: “Request and Authorization for Voluntary Allotment of Compensation for

Payment of Employee Organization Dues.”
C. SF-1188: “Revocation of Voluntary Authorization for Allotment of Compensation

for Payment of Employee Organization Dues.”
D. PAYROLL OFFICE: National Finance Center, Department of Agriculture.
E. SERVICING HUMAN RESOURCES OFFICE: Regional Human Resources Office for

Regional employees and Operating Services Branch of the Human Resources Office
for Headquarters Office employees.
Section II
Eligible Employees
To be eligible to make a voluntary allotment for the payment of Union dues, an
employee must:
A. BARGAINING UNIT EMPLOYEE. Be in the Unit covered by this Agreement;
B. MEMBER IN GOOD STANDING. Be a member in good standing with the Union;
C. REGULAR SALARY. Have a regular net salary, after other legal and required
deductions, sufficient to cover the amount of the authorized allotment for dues; and
D. REQUEST. Request the allotment on the prescribed form (SF-1187) which has been
certified by the authorized Union official.
Section III
Responsibilities of the Union
The Union shall:
A. VOLUNTARY NATURE. Inform and educate its members on the voluntary nature of the
dues allotment program, including conditions governing revocation of allotments;

(APPENDIX 2 - Dues Withholding)
B. PROVIDE SF-1187. Purchase and distribute the SF-1187 Form to its members;
C. CERTIFY SF-1187. Certify on the SF-1187 Form the amount of dues to be withheld
each biweekly pay period, and identify the Local to receive the dues deductions;
D. FORWARD SF-1187. Promptly forward completed SF-1187 forms to the appropriate

servicing Human Resources Office;
E. LIST OF AUTHORIZED SIGNATURES. Furnish written notification to the servicing

Human Resources Office concerning the names and titles of Local Union officials
authorized to certify the SF-1187 form; and
F. WRITTEN NOTIFICATION. Provide the appropriate servicing Human Resources Office

with written notification concerning:
(1) Changes. Changes in the amount of Union dues;
(2) Terminations. The name of any employee who has been expelled or ceases to be
a member in good standing in the Union within ten (10) days of such
determination; and
(3) Transfers. The name of any employee on check off who transfers from one Local
to another; any change in the Local who receives dues deducted from check; and
any change in the amount to be deducted occasioned by the transfer to a new
Local.
G. MULTIPLE LOCALS. In Districts where there is more than one Local, each Local in a
District shall have the right to process SF-1187’s.
Section IV
Responsibilities of the Employer
The Employer shall:
A. SCREEN SF- 1187. Screen each Form SF-1187 to ensure that only eligible employees
are on the dues withholding listing. The servicing Human Resources Office will also
screen each promotion action to remove employees who are promoted or transferred
out of the unit.
B. CERTIFY SF-1187. Receive in the appropriate servicing Human Resources Office the
SF-1187 form from the Union; certify on the SF-1187 form that the employee is a
member of the bargaining unit; stipulate the bargaining group the employee is a
member of by certifying the appropriate group in the upper right-hand corner of the
SF-1187; and promptly forward the SF-1187 Form to the Payroll Office for
processing.

C. REINSTATE FROM TEMPORARY ASSIGNMENTS. Automatically reinstate the dues

withholding of a bargaining unit employee returning to a bargaining unit position
from a temporary reassignment or a temporary promotion to a position outside the
bargaining unit.
D. REINSTATES FROM NON-PAY STATUS. Automatically reinstate the dues withholding

of a bargaining unit employee returning to pay status from a non-pay status (for
example, leave without pay).
Section V
Procedures
It is agreed that the following procedures will govern the voluntary allotment of dues:
A. WITHHOLDING OF DUES.
(1) Arrange Withholding. Upon receipt of a properly completed SF-1187 form from
the servicing Human Resources Office, the Payroll Office shall arrange to
withhold the Union dues in accordance with existing pay periods (26 biweekly
periods) and procedures under which employees are regularly compensated.
(2) Effective Date. The dues deduction will be effective as soon as possible, but in no
case will be later than two (2) full pay periods following receipt of the SF-1187
form by the Payroll Office.
(3) Existing Withholdings. Employees who meet the eligibility requirements for
dues withholding (stated in Section II) and who have a current dues withholding
agreement in effect on the date this Agreement is approved, need not execute a
new SF-1187 form to come under the provision of this Agreement; PROVIDED,
that this Agreement does not necessitate any change being made to their current
allotment.
B. CHANGES IN DUES.
(1) Union Certification Required. The amount of dues certified on the original
allotment form (SF-1187) will remain unchanged until an authorized Union
official provides written certification to the servicing Human Resources Office
that the amount of dues has changed. New SF-1187 forms will not be required.
(2) Once per Year. Changes in the amount of the allotment due to changes in the
amount of Union dues will not be made more than once every twelve (12) months.
(3) Effective Date. Changes in the amount deducted for Union dues will be effective
as soon as possible, but in no case will it be later than two (2) full pay periods
following receipt by the Payroll Office of the Union’s certification of changes in
its dues.

C. TERMINATION OF ALLOTMENTS.
(1) Automatically:
(a) Loss of Recognition. Upon loss of exclusive recognition by the Union,

effective at the beginning of the first full pay period after such loss of
recognition;
(b) Termination of Agreement. When the dues withholding agreement is

terminated;
(c) No longer Eligible. When an employee ceases to be eligible for inclusion in

the Union in good standing, effective with the first complete pay period after
receipt by the Payroll Office of written notice from the authorized Union
official.
(2) Voluntarily:
(a) Employee Revocation. An employee may submit a written request, SF-1188,

for the revocation of an allotment at anytime. He or she may submit the
request, in duplicate, to the servicing Human Resources Office. Revocations
will be effective the first full pay period following March 1, if the request is
received in the servicing Human Resources Office by March 1.
(b) Procedures. Revocations by employees shall be in duplicate, preferably on the

SF-1188 form, and shall be forwarded by the employee to the servicing
Human Resources Office. The servicing Human Resources Office Payroll
Unit will process the SF-1188 and retain a copy for the payroll records. A
copy shall be returned to the employee at the address provided on the SF-
1188. The servicing Human Resources Office shall provide the names and
local numbers of voluntary terminations to the Council Secretary Treasurer.
D. REMITTANCES OF DUES.
(1) Composite Checks. All non-Border Patrol Locals which indicate composite
participation will neither receive checks nor employee listings. However, if the
Union code in the employee’s master record does not indicate composite
participation, the Local will continue to receive a check and listing. A maximum
of three (3) composite checks (one from each payroll computation cycle) with
supporting summary listings will be forwarded to NST AFGE, 80 F Street, N.W.,
Washington, D.C. 20001.
(2) Magnetic Tape. A magnetic tape for the non-Border Patrol Locals will be made
available to AFGE. This tape will contain detailed information to support all
deductions and charges reflected on the three (3) composite checks, as well as

hose employees in the composite Locals who did not have sufficient funds to
allow a deduction. The magnetic tape will also contain a code indicating the
employee’s current pay status, and a code indicating whether the deduction
resulted from the processing of a Time and Attendance Report or as a result of a
payroll adjustment.
(3) Code Combinations. The expected code combinations to be recorded on the SF-
1187 for proper processing are as follows:
11 - NINSC Council, to be included in composite check to AFGE.
01 - NINSC Council, to be included in check to Local.
Section VI
Cost of Withholding
The service of withholding the Union dues shall be provided at no cost to the Union
by the Employer.
Section VII
Under Payments and Over Payments
REJECTIONS. The Immigration and Naturalization Service does not assume
responsibility for the maintenance in good standing in the Union of the employee.
Any SF-1187 submitted to the servicing Human Resources Office that Management
does not process will be returned to the Union with the reasons why this was not
accepted. The Union reserves the right to discuss the exclusions with Management
personnel.
ADMINISTRATIVE ERRORS. Administrative errors in remittance will be corrected by
reductions and corrections in subsequent remittance checks. If the employee
organization is not scheduled to receive a remittance check after discovery of the
error, the employee organization agrees to promptly refund the amount of erroneous
remittance.

APPENDIX 3 - Side Letter on Intent of Article 7.C.(2): Official Time

In regard to the Form “Request for Official Time for Union Activities” agreed to in
this Article, the parties understand that the entry by the Union representative under
“Place of Contact/Phone # “ does not require that such activity be conducted at that
particular location. The entry is intended to provide Management with a means of
recalling the employee in accordance with Article 6C. Further, any reasonable
explanation for deviating from the indicated location will be considered on its merits
and the representative will not be considered to be abusing the official time solely
because of such a deviation.

(APPENDIX 3 - Side Letter on Intent of Article 7.C.(2): Official Time)
APPENDIX 4 - TQM Memorandum of Understanding

This is a memorandum of understanding between the Immigration and Naturalization
Service (INS) and the National Immigration and Naturalization Service Council
(Council), American Federation of Government Employees, regarding Total Quality
Management (TQM) in INS. This memorandum of understanding is intended to
clarify the role of the Union, employees and Management in the TQM process, and is
effective immediately. This memorandum does not absolve managers of meeting their
responsibilities under the labor relations law, and is intended to serve as our joint
commitment to the successful implementation of the TQM process
The parties agree that TQM training shall be provided to Council officers and officers
of its locals to promote understanding of the TQM process, and to facilitate the
participation of employees and the Union in same. A one day joint training session
will be conducted by Headquarters and a National Union representative in
approximately 10 locations for managers, employees, and union officers. Additional
training will be provided for up to three National Council Officers at a contractor
location. Where training on TQM is provided by the District, Service Center, or
Regional Office, Local Union representatives will be invited to attend. When TQM
training is scheduled, the Service will notify the local president who will provide
management with the names of two union officials not previously trained in the TQM
matters to be covered in the training. The individuals on that list will be invited to
attend.
The parties agree that the Union shall be represented on each process action team
(PAT) involving bargaining unit employees, that official time for such purposes shall
be authorized, along with travel and per diem for participation in training or PATS, as
may be necessary. Union representatives shall participate in PATS as
observer\contributors, and will normally not be voting members of the team. When
TQM meetings involving bargaining unit employees are to be conducted, and no
union representative is designated, the Local President or his or her designee will be
invited to attend. It is understood that union representatives for process action teams
at the District level shall be from that District. Any official time required for union
representatives to participate in TQM related activities shall be approved without
reference to the blocks of hours authorized under the negotiated agreement.
Employees shall be provided an informational notice, the terms of which should be
negotiated between the parties, explaining TQM and the roles of employees, the
Union and managers or supervisors in the TQM process.
The Headquarters LMR office shall provide the Council President with briefings
during consultations as to the status of the TQM program and any process action team
groups meeting at the headquarters which do not involve bargaining unit employees.
Similar briefings shall be provided at the District and Regional level Consultations,
for Local Presidents and the Council’s Regional Vice Presidents.

(APPENDIX 4 - TQM Memorandum of Understanding)
Nothing in this memorandum of understanding is intended to interfere with or waive

any right of the Union or the Service under the negotiated agreement or applicable
statutes and regulations.

(APPENDIX 4 - TQM Memorandum of Understanding)
APPENDIX 5 - Side letter on Intent of Article 53:Employee Assistance Program

The parties have agreed to the following understand relating to the provisions of
Article 53 – Employee Assistance Program:
A. The wording of Article 53 is without prejudice to the following two positions of the
Service:
1. That law enforcement officers are subject to a higher standard of conduct than
other personnel in the bargaining unit; and
2. That law enforcement officers whose drug related problems arise from the use of
illicit drugs may not be entitled to the same consideration for employee assistance
as personnel with different problems.
B. The parties recognize that the Union retains the right to challenge these
determinations of management in any appropriate forum.

(APPENDIX 5 - Side letter on Intent of Article 53:Employee Assistance Program)
APPENDIX 6 - Side Letter on Web Gear Equipment

Service Requirements have resulted in the necessity for uniformed officers to carry
additional equipment. The parties recognize that this may create safety and health
problems. The parties agree to establish a working group to develop a policy
addressing this issue. Said working group shall be established within 180 days of the
effective date of this agreement and charged to report and recommend a policy within
270 days of the effective date of this agreement.

(APPENDIX 6 - Side Letter on Web Gear Equipment)
APPENDIX 7 - Memorandum of Understanding on Ethics

This memorandum memorializes the agreements of the parties concerning
implementation of the Department of Justice Supplemental Standards of Ethical
Conduct, 5 CFR §§ 3801, et seq.
The parties agree that, consistent with the collective bargaining agreement between
the Immigration and Naturalization Service (INS) and the National INS Council, the
INS has discharged its duty to negotiate concerning the implementation and impact of
the supplemental standards of ethical conduct referenced in the foregoing paragraph.
Nothing in this agreement is intended to conflict with, contradict, or waive any right
of the parties or employees under the collective bargaining agreement between the
Immigration and Naturalization Service and the National INS Council.
The parties further agree that, as a one-time exception to the policy set forth in section
38Ol.106(b)(1)(i) of the Supplemental Standards of Ethical Conduct, the INS will
allow employees, who are engaged in the off-duty practice of law consistent with
Article 13, Sections A and D, of the collective bargaining agreement and who are
identified on the attached list, to continue such practice as long as the conditions of
their practice remain consistent with Article 13, Section A1. Section A of Article 13
prohibits outside employment by INS employees when such employment would
“result in, or create the appearance of a conflict of interest with official duties or with
official business of the Service; or tend to impair that employee's mental or physical
capacity to perform official duties and responsibilities." In addition, before
undertaking any new matter, the INS employees authorized to continue their off-duty
practice law under this agreement must seek a conflict-of-interest check with their
supervisors and an INS ethics official as required of other Department employees
engaged in unpaid outside practice.
Any bargaining unit employee included on the list submitted to the agency on January
29, 1999 who is denied authorization for continued outside employment in the
practice of law may pursue the matter through the negotiated grievance procedure.
Further where restrictions on an employee's outside employment in the practice of law
would cause undue personal or family hardship, and or unduly prohibit the employee
from completing a professional obligation entered into prior to entering government
service, employees may request and receive authorization for such outside
employment pursuant to the terms of the cited standards of ethical conduct.
Signed 6/9/1999 by: Charles J. Murphy for the Union
Edwin S. Campbell Jr. for the Service
1
Specifically, employees engaged in the outside practice of law consistent with Article 13, Sections A and
D, are those employees whose off-duty practice was approved consistent with Article 13, section D, or
whose requests to engage in the off-duty practice of law were not answered within the time limit set forth in
Article 13, Section D, provided that the specific natures of the practices for which approval was requested
were consistent with Article 13, Section A.

(APPENDIX 7 - Memorandum of Understanding on Ethics)

(APPENDIX 7 - Memorandum of Understanding on Ethics)
Outline of Contract
OUTLINE OF CONTRACT
ARTICLE 1 - Recognition
Bargaining Unit
Gender Language.
ARTICLE 2 - Effect of Law and Regulation

A. EXISTING OR FUTURE LAWS.
B. GOVERNMENT WIDE RULE OR REGULATION.
C. SERVICE POLICY.
D. EFFECT OF INVALIDATION.
E. SCOPE.
F. INTENT OF RESTATEMENT.
ARTICLE 3 - Employee Rights

A. RIGHT TO JOIN AND PARTICIPATE.
(1) Employee Participation.
(a) Representation.
(b) Collective Bargaining.
(2) Management Non-participation.
B. PRIVATE COUNSELING.
C. CONTRIBUTIONS / GIFTS..
(1) Voluntary.
(2) Gifts.
D. RIGHT TO COMMUNICATE.
(1) Human Resources Office
(2) EEO Office
(3) Supervisor / Management
(4) EEO Counselors;
(5) Safety and Health Office.
ARTICLE 4 - Management Rights

A. NEGOTIATING.
(1) Permissive Subjects.
(2) Procedures.
(3) Appropriate Arrangements.
B. AUTHORITY OF SERVICE OFFICIALS.
(1) Mission, Budget, Organization
(2) According to Law:
(a) Hiring and Discipline.
(b) Assign Work / Contracting.
(c) Selections

(ARTICLE 1 - Recognition)
Outline of Contract
(d) Emergencies.
ARTICLE 5 - Union Rights

A. EXCLUSIVE REPRESENTATIVE.
B REPRESENTATION AT FORMAL DISCUSSIONS.
(1) Formal Discussions.
(2) Notice.
C. REPRESENTATION AT INVESTIGATORY INTERVIEWS.
D. RIGHT TO PRESENT VIEWS.
E. EXISTING AGREEMENTS.
ARTICLE 6 - Status of Employee Representatives

A. NO RESTRAINT.
B. DESIGNATION OF STEWARDS.
C. AUTHORIZATION FOR REPRESENTATIONAL DUTIES.
D. STEWARD AND OFFICER LISTS / MANAGEMENT DIRECTORIES.
ARTICLE 7 - Use of Official Time

A. AUTHORIZED USES.
(1) Representation.
(2) Grievances.
(3) Labor-Management Meetings.
(4) Arbitrations & Appeals.
(5) Adjustment of Grievances.
(6) Committee Meetings.
(7) Respond to Management.
(8) Technical Representative.
(9) Observer.
(10) Respond to Congress.
(11) Partnership.
(12) Treasurer.
(13) EEO Briefings.
(14) Other Functions.
B. BLOCK TIME.
(1) Council President
(2) Executive Vice President
(3) Vice Presidents
(4) Fair Practices Coordinator
(5) Staff Assistants
(6) Local Union Officers
C. REQUIRED PROCEDURES:
(1) Advance Notice.
(2) Form G-826 Procedures.

(ARTICLE 5 - Union Rights)
Outline of Contract
(3) Supervisory Approval.

(4) No Internal Union Business.
D. RESTRICTION ON BLOCK TIME.
(1) Internal Union Business.
(2) Leave.
Presumptive Rating.
Recall to Duty.
E. TRAVEL TIME.
F. COUNCIL REPRESENTATIVES.
(1) Labor-Management Meetings.
(2) Safety and Health Committee Meetings.
(3) Other Meetings with Management.
G. ADMINISTRATIVE TIME FOR TRAINING.
(1) Limits.
(a) Offices of Less than 50 - Fifteen days
(b) Offices of 50 to 299 - Thirty days
(c) Offices of 300 to 500 - Forty days
(d) Offices of More than 500 - Sixty days
(e) Council - Thirty days
(2) Procedures.
H. ARBITRATION TRAVEL AND PER DIEM.
I. COUNCIL TRIPS.
J. TRAVEL AND PER DIEM FOR UNION REPRESENTATIVES.
ARTICLE 8 - Facilities and Services

A. UNION USE OF SERVICE FACILITIES.
(1) Meeting Space.
(2) Non-duty Hours.
(3) Elections.
(4) Membership Drives & Materials.
B. FACILITIES FOR REPRESENTATION.
(1) Meeting Space.
(a) Grievances / Appeals.
(b) Caucusing.
(c) Agreement Administration.
(2) No Internal Union Business.
C. BULLETIN BOARDS
(1) Prominent and Accessible.
(2) Exclusive Use.
(3) Restrictions.
D. ACCESS TO EMPLOYEES.
(1) Employee Lists.
(2) Employee Orientation.
E. REFERENCE MATERIALS.

Outline of Contract
(1) Employee Use of CFR and AM.

(2) CFR and AM.
(3) Council Copy of AM.
F. LOCKER ROOMS.
G. CONTRACT COPIES.
(1) Employee Copy.
(2) Printing.
(3) Council and Local Copies.
H. UNION REPRESENTATIVES PERMITTED ON GOVERNMENT PROPERTY.
I. TELEPHONES.
J. SPACE & EQUIPMENT.
K. ELECTRONIC MAIL.
L. INSERTS.
M. TELEPHONE CARDS.
N. COPY MACHINES.
O. FAX MACHINES.
ARTICLE 9 - Impact Bargaining and Mid-Term Bargaining

A. NOTICE OF PROPOSED CHANGE.
B. BARGAINING PROCEDURES.
(1) National Level Bargaining:
(a) Notice of Proposed Change.
(b) Demand to Bargain / Information.
(c) Union Proposals.
(d) Negotiations.
(e) Delays / Breaks.
(f) Bargaining Teams.
(g) Additional Team Members.
(h) Travel & Per Diem.
(i) Equipment.
(2) Regional Level Bargaining:
(d) Negotiations.
(e) Consistent with Master.
(f) Delays / Breaks.
(g) Travel & Per Diem.
(3) Local Level Bargaining:
(d) Negotiations.
(e) Bargaining Team.

(ARTICLE 9 - Impact Bargaining and Mid-Term Bargaining)
Outline of Contract
(f) Travel & Per Diem.

(g) Consistent with Master.
C. SERVICE OF NOTICES AND DEMANDS.
D. GOOD FAITH.
(1) Resolve to Reach Agreement.
(2) Duly Represented.
(3) Reasonable Times.
E. IMPASSES.
F. POST IMPLEMENTATION BARGAINING.
G. “COVERED BY THE AGREEMENT”.
(1) Tours of Duty.
(2) Work Sites.
(3) Discipline Regulations.
(4) Overtime.
(a) Eligible Employees.
(b) Distribution Procedures / Caps.
ARTICLE 10 - Partnership and Labor-Management Relations

A. INFORMATION AND QUESTIONS.
B. NATIONAL CONSULTATIONS.
C. REGIONAL CONSULTATIONS.
D. LOCAL CONSULTATIONS.
E. LABOR MANAGEMENT PARTNERSHIPS
(1) Cooperative Relationship.
(2) Partnership Councils.
(3) Duty Status.
(4) Avert Traditional Bargain.
F. STATUS OF PARTNERSHIP AGREEMENTS.
ARTICLE 11 - Protecting Against Prohibited Personnel Practices

A. DEFINITIONS.
(1) Prohibited Personnel Practice.
(2) Personnel Action.
(a) Appointment.
(b) Promotion.
(c) Adverse / Discipline / Corrective Actions.
(d) Detail / Transfer / Reassignment.
(e) Reinstatement.
(f) Restoration.
(g) Reemployment.
(h) Performance Evaluation.
(i) Pay / Benefits / Awards / Training.
(j) Change in Duties.
B. PROHIBITED ACTIONS.

(ARTICLE 10 - Partnership and Labor-Management Relations)
Outline of Contract
(1) Discrimination.
(a) Race / Color / Religion / Sex / National Origin.
(b) Age.
(c) Sex.
(d) Handicapping Condition.
(e) Marital Status / Political Affiliation
(2) Non-merit Considerations.
(a) Job Evaluations.
(b) Character / Suitability.
(3) Political Activity.
(4) Obstruct Competition.
(5) Influence Withdrawals.
(6) Unauthorized Preference.
(7) Relatives.
(8) Whistleblower Reprisal.
(a) Disclosures.
(i) Violation of Law / Rule / Regulation
(ii) Mismanagement / Waste / Abuse
(b) Special Counsel / Inspector General.
(i) Violation of Law / Rule / Regulation
(ii) Mismanagement / Waste / Abuse
(9)Appeal Reprisal.
(10) Outside Conduct.
(11) Violation of Merit System Principles.
C. INFORMATION TO CONGRESS.
D. EEO AFFIRMATIVE ACTION.
(a) Race / Color / Religion / Sex / National Origin.
(b) Age.
(c) Sex.
(d) Handicapping Condition.
(e) Marital Status / Political Affiliation
E. REDRESS PROCEDURES.
(1) Elect Statute or Grievance.
(2) Effect of Election.
(3) MSPB Appeal of Grievance.
F. EXCLUSIVE GRIEVANCE PROCEDURE.
ARTICLE 12 - Notice to Employees

A. COPY FOR UNION REPRESENTATIVE.
(1) Adverse Action.
(2) Disciplinary Action.
(3) Reduction-in-Force.
(4) Denial of WIGI.
(5) Fitness for Duty Exam.

(ARTICLE 12 - Notice to Employees)
Outline of Contract
(6) Involuntary Reassignment / Transfer.

“The copy may at your option be furnished to your Union representative.”
B. NEW EMPLOYEES.
(1) Union Information.
(2) Right to Join.
(3) Contract.
C. LEAVE AND EARNINGS STATEMENTS.
D. WORKPLACE INJURIES.
ARTICLE 13 - Outside Employment

A. PERMISSION.
B. REQUEST.
(1) Identity Employer.
(2) Nature of Work.
(3) Pay.
(4) Hours / Schedule.
Voluntary Work.
(1) Pro Bono Practice of Law
(2) Other Volunteer Work.
C. TIMEFRAMES.
D. APPROVAL.
E. APPLICABLE LAW.
F. PRACTICE OF LAW.
ARTICLE 14 - Retirement
A. RETIREMENT COUNSELING.
B. DISABILITY / DEFERRED ANNUITY.
C. WITHDRAWAL.
D. LEO RETIREMENT.
ARTICLE 15 - Development and Training

A. EMPLOYEE DEVELOPMENT.
B. EMPLOYEE INITIATIVE.
C. FAIR AND EQUITABLE / SERVICE NEEDS.
D. SCHEDULE VARIATIONS.
E. INDIVIDUAL DEVELOPMENT PLAN.
F. ELIMINATED POSITIONS.
G. OUT-SERVICE TRAINING.
(1) In Advance.
(2) Job-Related.
(3) Not Available within Service.
(4) New Program Unavailable.
(5) Reasonable Inquiry.

(ARTICLE 13 - Outside Employment)
Outline of Contract
(6) Funds Available.

(7) Not for Degree.
(8) Operational Needs.
H. TRAINING RECORDS.
I. UNION RECOMMENDATIONS.
J. FAIR AND EQUITABLE SELECTION.
ARTICLE 16 - Classification
A. UNION PARTICIPATION.
B. NEW CLASSIFICATIONS.
C. UNION REPRESENTATION.
D. DESK AUDITS.
E. POSITION DESCRIPTIONS.
F. REQUEST FOR DESK AUDIT.
G. EFFECT OF LOWER GRADED DUTIES..
ARTICLE 17 - Safety and Health

A. SAFE AND HEALTHFUL WORKING CONDITIONS.
B. SAFETY AND HEALTH COMMITTEES.
(1) Membership.
(2) Meetings.
(3) Purpose of Meeting.
C. UNION PARTICIPATION.
D. DUTY TO REPORT UNSAFE CONDITIONS.
(1) Review and Report Unsafe Conditions.
(2) Director Decision.
(3) Grievance.
(4) Identical Grievances.
(5) Injury Logs.
E. VEHICLE SAFETY.
F. SERVICE HANDBOOK.
G. SPECIAL HAZARDS / IMMINENT RISK.
H. WEATHER SHELTER.
I. MEAL BREAKS / LUNCH ROOMS.
J. DAY CARE / HOUSING.
K. GSA FACILITIES.
L. IMMUNIZATIONS.
M. UNSAFE CONDITION MOVE.
N. SAFE STAFFING.
O. EMPLOYEE RESPONSIBILITY FOR SAFETY.
P. ASSISTANCE FOR HANDICAPPED EMPLOYEES.
Q. FEDERAL EMPLOYEE HEALTH BENEFITS (FEHB).
(1) Open Season.

(ARTICLE 16 - Classification)
Outline of Contract
(2) Health Plans.

(3) Biweekly Health Benefits Rates.
R. TB SCREENING.
ARTICLE 18 - Injury Compensation

A. WORKPLACE ILLNESS / INJURY.
B. CONTINUATION OF PAY / LEAVE.
C. C. PAMPHLETS AND FORMS.
(1) “When Injured at Work”.
(2) “Authorization for Examination and/or Treatment” (CA-16).
D. DOCUMENT REVIEW.
ARTICLE 19 - Fitness for Duty Examination

A. FITNESS FOR DUTY EXAMINATION.
B. RIGHT TO UNION REPRESENTATION.
ARTICLE 20 - Disabled Employees

A. LIGHT DUTY.
B. RESTORED TO DUTY.
ARTICLE 21 - Personnel Records

A. OFFICIAL PERSONNEL FOLDERS.
B. COPY OF DOCUMENTS AND RIGHT TO RESPOND.
C. UNAUTHORIZED DISCLOSURE.
D. PROCEDURES TO REVIEW.
E. DEROGATORY MATERIAL.
F. RESULTS OF INVESTIGATION.
ARTICLE 22 - Performance Appraisal

A. AUTHORITY OF ARBITRATOR.
B. REVISED AMS.
ARTICLE 23 - Reduction-in-Force, Transfer of Function and Reorganization

A. WORKFORCE ADJUSTMENTS.
B. DEFINITIONS.
(1) Reduction-in-Force.
(2) Transfer of Function.
(3) Reorganization.
C. EMPLOYEE / UNION NOTIFICATION.
D. MINIMIZE ADVERSE IMPACT.
E. ADVANCE NOTICE.
F. APPLICABLE LAWS.

Outline of Contract
G. RETENTION REGISTERS.
H. OFFERS OF EMPLOYMENT.
I. MANAGEMENT RESPONSIBILITIES.
(1) Inform Employees.
(2) Written Notification.
(3) Placement Assistance.
(4) Retirement and Severance.
J. MINIMIZE ADVERSE IMPACT.
K. AUTOMATION AND TECHNOLOGY CHANGES.
L. TRANSFER OF FUNCTION TO OTHER AGENCY.
M. ELIMINATED POSITIONS.
ARTICLE 24 - Firearms and other Weapons

A. AUTHORIZATION TO CARRY.
(1) Management Right.
(2) Specific Authorization.
B. EMPLOYEE RESPONSIBILITY.
(1) Laws, Regulations and Policy.
(2) Policy Training.
C. QUARTERLY QUALIFYING.
D. EFFECT ON INSPECTIONAL OVERTIME.
ARTICLE 25 - Uniforms and Appearance

A. EMPLOYEE SUGGESTIONS..
B. UNION NOTIFICATION.
C. UNIFORM ALLOWANCE.
D. UNIFORM SELECTION.
(1) Short or Long Sleeve / Neckties.
(2) Rough Duty Uniform.
(3) Leather / Synthetic Equipment.
E. UNIFORM INSPECTION.
F. UNIFORMED OFFICERS
(1) Groomed Appearance.
(a) Hair Grooming.
(b) Hair Length.
(2) Facial Hair.
(a) Beards.
(b) Sideburns.
(c) Moustaches.
(3) Jewelry.
(4) Tattoos.
(a) Obscene / Offensive.
(b) Grievance Procedures.

(ARTICLE 24 - Firearms and other Weapons)
Outline of Contract
G. FATIGUE CLOTHING.
H. FEMALE UNIFORMS.
I. RAID JACKETS / VESTS.
J. NON-UNIFORMED BEARDS.
K. NON-UNIFORMED APPEARANCE.
L. NAMETAGS.
(1) Numbered Name Plate.
(2) Extensions.
(3) Other Actions.
(4) Written Statement.
ARTICLE 26 - Travel
A. REIMBURSEMENT.
(1) Federal Travel Regulations.
(2) Changed Rates.
B. DEFINITIONS.
(1) “Regular duty station”
(2) “Temporary duty station”
(3) “Official duty station”
C. TRAVEL STATUS.
(1) Regularly Scheduled Workweek.
(2) Compensable Hours.
D. REGULAR COMMUTE.
E. LOCAL TRAVEL / TEMPORARY DUTY STATION.
(1) Local Mileage.
(2) Home to Temporary Station.
(3) POV Examples.
(a) Residence to Temporary Duty Station.
(b) Regular Duty Station to Temporary Duty Station.
(4) Established Rotational Assignments Excepted.
(5) Overtime Assignments.
F. PER DIEM.
(1) Eligibility.
(2) Partial Per Diem.
G. TRAVEL ADVANCES.
(1) Sufficient Notice.
(2) Government Credit Card Advance.
(3) Imprest Fund.
H. NECESSITY TRAVEL.
I. ACCOMMODATE HANDICAPPED EMPLOYEES.
J. ORDERED OVERTIME TRAVEL.
(1) Concurrent Authorization.
(2) Official Business.
(3) Dependent on Public Transport.

Outline of Contract
(4) Infrequent Public Transport / Darkness.

K. GOVERNMENT OWNED VEHICLES.
ARTICLE 27 - Overtime - (Other than Uncontrollable Overtime and LEA)

A. FAIR AND EQUITABLE ROTATION.
B. PERFORMANCE OF DUTIES.
C. MAINTAIN RECORDS.
D. LAWS, REGULATIONS, AND POLICIES.
E. EFFECT ON PERFORMANCE APPRAISAL.
F. REOPENER FOR INSPECTION OVERTIME.
G. OVERTIME CAP.
H. OVERTIME HOURS LIMIT.
I. BREAK IN OVERTIME HOURS.
J. LIGHT DUTY.
K. OVERTIME ASSIGNMENT PROCEDURES.
ARTICLE 28 - Details and Temporary Duty Stations

A. PROCEDURES TO ASSIGN.
(1) Management Right.
(2) Limits.
(a) Law, Regulation, and Contract.
(b) Advance Notice.
(c) Utilize Volunteers.
B. DEFINITIONS.
(1) Temporary Assignment.
(2) Detail.
(3) Rotation.
C. TEMPORARY PROMOTIONS.
D. RECORD OF DETAIL / PERSONAL FAVORITISM.
E. VOLUNTEER LISTS.
F. UNDERCOVER EMPLOYEES.
G. TIME LIMIT.
H. UNION REPRESENTATIVES.
I. SELECTION PROCEDURES.
(1) Volunteers.
(2) Selection.
(3) Local Bargaining.
ARTICLE 29 - Hours of Work

A. DETERMINATION OF WORK HOURS.
(1) Basic Workweek.
(2) Inspections Workweek.
(3) Basic Workday.

(ARTICLE 27 - Overtime - (Other than Uncontrollable Overtime and LEA))
Outline of Contract
(4) Effect of Holidays.

(5) Posted Schedules / Individual Changes.
(6) Break Between Shifts.
(7) Voluntary Schedule Adjustments.
(8) Break in Work Hours.
(9) Shift Trades.
(10) Meal Breaks / Lunch Rooms.
(11) Duty Rosters.
B. DEFINITIONS.
(1) Tours of Duty.
(2) Shifts.
C. ALTERNATIVE WORK SCHEDULES
(6) Establishment of Alternative Work Schedules.
(2) Concepts.
(a) Definitions:
Alternative Work Schedule (AWS)
Compressed Work Schedule
Flexible Work Schedule
(b) Legal Restrictions.
(i) Reduced Productivity.
(ii) Diminished Service.
(iii) Increased Cost
(c) Inspections Limitations.
(i) Inspectional Requirements.
(ii) Overtime.
(3) Overtime.
(4) Consultations.
(5) Negotiations.
ARTICLE 30 - Formal Meetings and Investigative Interviews

A. FORMAL DISCUSSIONS.
B. INVESTIGATORY INTERVIEWS.
(1) Weingarten Rights.
(a) Reasonable Belief.
(b) Employee Request.
(2) Annual Notice.
C. WRITTEN MEMORANDUM.
D. WRITTEN NOTICE / WITNESSES.
(1) Office of Internal Audit.
(2) Witness.
E. SCHEDULING OF INTERVIEW.
F. TRAVEL FOR INTERVIEW.
ARTICLE 31 - Disciplinary and Adverse Actions
A. DISCIPLINE DEFINITION.

(ARTICLE 30 - Formal Meetings and Investigative Interviews)
Outline of Contract
B. ADVERSE ACTION DEFINITION.

C. ORAL ADMONISHMENT.
D. UNION REPRESENTATIVE / INFORMATION.
E. ADDRESSEE.
F. UNFOUNDED COMPLAINTS.
G. FINANCIAL OBLIGATIONS.
H. DISCIPLINE / ADVERSE ACTION PROCEDURES.
(1) Just Cause.
(2) Letter of Reprimand.
(3) Notice of Proposed Action.
(4) Timeliness.
I. APPEAL.
(1) Reprimands and Short Suspensions.
(2) Adverse Actions.
J. GRIEVANCE.
(1) Reprimands.
(2) Suspension or Adverse Action.
(3) Appeal Arbitrator.
(4) Appeal Performance Based Action.
K. UNWARRANTED DISCIPLINE.
F. INVESTIGATIVE INTERVIEW TRAVEL.
ARTICLE 32 - Actions Based Upon Unacceptable Performance

A. PERFORMANCE BASED ACTIONS.
B. PERFORMANCE IMPROVEMENT PLAN.
(1) Identify Problems.
(2) Explain Standards.
(3) Allow Improvement.
(4) Provide Assistance.
C. ADVANCE WRITTEN NOTICE.
(1) Identify Unacceptable Performance.
(2) Identify Critical Elements.
(3) Time to Review and Respond.
(4) Right to Representation.
(5) Written Decision.
D. ESTABLISHED PERFORMANCE STANDARDS.
E. RIGHT TO REVIEW DOCUMENTS.
F. PERFORMANCE BASED ACTION PROCEDURE.
(1) Notice, Information and Response.
(2) Decision.
G. ONE YEAR LIMIT.
H. RECORD RETENTION.
I. FINAL DECISION.
J. APPEAL.

Outline of Contract
ARTICLE 33 - Career Ladder Promotions and Within Grade Increases

A. PROMOTIONS.
B. GRADE INCREASES.
(1) Not Acceptable Level of Performance.
(2) Delayed Determination.
(a) 90 Day Review.
(b) New Position.
C. PERFORMANCE ASSISTANCE.
(1) Identify Problems.
(2) Explain Requirements.
(3) Warn of Consequences.
(4) Provide Assistance.
ARTICLE 34 - Quality Step Increase

A. DEFINITION.
B. PURPOSE.
C. CONSIDERATION.
D. DETERMINATION.
E. EFFECTIVE DATE.
F. UNION CONSULTATIONS.
ARTICLE 35 - Annual Leave

A. RIGHT TO USE.
B. EARN AND ACCRUE.
C. REQUEST PROCEDURES.
D. TIMELY LEAVE APPROVAL.
E. PROCEDURE TO SCHEDULE IN ADVANCE.
F. PRIORITY APPROVAL.
(1) Accrued Leave.
(2) Seniority.
(3) Children’s Vacation.
(4) Previous Requests.
G. THREE CONSECUTIVE WEEKS.
H. NO SEASONAL EXCLUSION.
I. RELIGIOUS HOLIDAY.
J. REASON FOR LEAVE.
K. CANCELED / CHANGED LEAVE.
(1) Employee Initiated Change.
(2) Operational Need.
(3) Restoration of Canceled Leave.
L. EMERGENCIES
(1) Procedure.
(2) Extension.

Outline of Contract
M. HABITUAL TARDINESS.
N. ADVANCE ANNUAL LEAVE.
O. BEREAVEMENT LEAVE.
(1) Spouse / In-laws.
(2) Children.
(3) Parents.
(4) Brothers / Sisters / In-laws.
(5) Grandparents / Grandchildren.
(6) Family Equivalent.
P. LEAVE BANK.
ARTICLE 36 - Sick Leave

A. EARN AND ACCRUE.
B. PURPOSES FOR SICK LEAVE.
(1) Medical Appointments.
(2) Incapacity.
(3) Family Care.
(4) Family Death.
(5) Contagious Disease.
(6) Adoption.
(7) FEFFLA
C. SICK LEAVE REQUEST PROCEDURES.
(1) Anticipated Sick Leave.
(2) Unanticipated Sick Leave.
D. EVIDENCE OF ILLNESS.
E. ANNUAL LEAVE FOR ILLNESS.
F. ADVANCED SICK LEAVE
(1) Requirements.
(a) Medical Certificate
(b) Repayment.
(c) Maximum Advance.
(d) Minimum Absence.
(2) Conditions for Advanced Sick Leave.
(a) Charged to Employee.
(b)Temporary Employees.
(c) Retiring Employees.
G. INCREMENT CHARGED.
ARTICLE 37 - Administrative Leave

A. DEFINITION.
B. VOTING IN CIVIL ELECTION.
(1) General Rule.
(2) Additional Time.

Outline of Contract
(3) Travel Time.

(4) In-person Registration.
(5) Costs.
C. BLOOD DRIVE.
D. Change of Duty Station.
E. COURT LEAVE.
F. SERVICE INTERVIEWS.
ARTICLE 38 - Home Leave

A. ACCRUAL.
B. GRANTING.
C. LIMITED USE.
D. COMBINED WITH ANNUAL LEAVE.
E. MANAGEMENT DISCRETION.
ARTICLE 39 - Leave Without Pay

A. DEFINITION.
B. MATTER OF RIGHT.
(1) Disabled Veteran.
(2) Military Reservist.
(3) Family Necessity.
C. NATIONAL UNION OFFICE.
D. ADMINISTRATIVE DISCRETION.
(1) Education.
(a) Related to Position.
(b) Acceptable Performance / Expected Return.
(2) Injury / Illness.
E. NINSC CONVENTION.
F. SUBSTITUTE FOR ANNUAL LEAVE.
(1) Family Death.
(2) Religious Holiday.
G. UNION REPRESENTATIVES.
ARTICLE 40 - Leave for Family Responsibilities

A. FAMILY CONSIDERATIONS.
B. FAMILY MEMBER DEFINITION.
(1) Spouse / In-laws.
(2) Children.
(3) Parents.
(4) Brothers / Sisters / In-laws.
(6) Family Equivalent.
C. MATERNITY LEAVE.
(1) Request Procedure.

(ARTICLE 38 - Home Leave)
Outline of Contract
(2) Advanced Sick Leave for Maternity.

(3) Advanced Annual Leave for Maternity.
D. ACCOMMODATION OF PREGNANCY.
E. CONTINUATION OF EMPLOYMENT.
F. PATERNITY AND ADOPTION LEAVE.
G. CARE FOR FAMILY MEMBERS.
H. LEAVE FOR THE DEATH OF FAMILY MEMBERS.
I. LEAVE FOR OTHER FAMILY PURPOSES.
J. VOLUNTARY LEAVE TRANSFER PROGRAM AND LEAVE BANK PROGRAM.
ARTICLE 41 - Counseling for Performance and Conduct

A. REASONABLE AND FAIR.
B. PRIVACY AND NOTICE.
C. UNION REPRESENTATIVE.
D. WRITTEN RECORD.
E. MISCONDUCT RECORD.
F. PERFORMANCE RECORD.
ARTICLE 42 - Holidays and Religious Observances

A. HOLIDAYS.
(1) New Year’s Day.
(2) Martin Luther King’s Birthday.
(3) Washington’s Birthday.
(4) Memorial Day.
(5) Independence Day.
(6) Labor Day.
(7) Columbus Day.
(8) Veterans Day.
(9) Thanksgiving Day.
(10) Christmas Day.
(11) Inauguration Day in Washington, D.C.
(12) Federal Statute / Executive Order.
B. IN LIEU OF HOLIDAY OBSERVANCE
(1) Federal Statute.
(2) Sunday.
(3) Saturday.
(4) Staffing Needs.
C. RELIGIOUS HOLIDAYS.
D. ACCOMMODATION OF RELIGIOUS BELIEFS.
(1) Religious Observance.
(2) Compensatory Time.
(3) Leave Procedures..
(4) Premium Pay Excluded.

(ARTICLE 41 - Counseling for Performance and Conduct)
Outline of Contract
(5) Unavailable Overtime.

E. STATE AND LOCAL HOLIDAYS.
(1) Building Closures.
(2) Local Transportation.
(3) Related Duties.
ARTICLE 43 - Probationary Employees

A. PERFORMANCE STANDARDS AND REVIEW.
B. NON-RETENTION AND NOTICE.
ARTICLE 44 - Equal Employment Opportunity

A. DEFINITION.
B. BARGAINING OBLIGATIONS.
C. DISCRIMINATION CLAIM PROCEDURES.
(1) Claims.
(a) Grievance.
(b) EEO Pre-complaint Counseling.
(c) MSPB.
(2) Elected Procedure.
(3) Grievance Appeal.
D. GRIEVANCE FILING DEADLINES..
(1) Incident.
(2) Awareness.
(3) Final Interview.
E. USE OF EEO COUNSELORS.
(1) Consultation.
(2) Counselor Lists.
(3) EEO Counselor Duties.
(a) Counsel.
(b) Inquire.
(c) Resolve.
(d) Document.
(e) Written Report.
(f) Inform of Right to Representative.
(5) Right to File Complaint.
(6) Neutrality of EEO Counselor.
(7) Confidentiality.
(8) Independence of EEO Counselor.
(10) Right to Represent Self.
F. UNION RIGHT TO BE PRESENT.
G. UNION NOTIFICATION OF CHANGE.

(ARTICLE 43 - Probationary Employees)
Outline of Contract
H. CONFLICT WITH CONTRACT.

(1) Notice and Opportunity to Bargain.
(2) Priority of Appellate Decisions.
I. PROCEDURES FOR SELECTING EEO COUNSELORS.
(1) Employer Responsibility.
(2) Volunteers.
(3) Conflict of Interest.
(4) Nominations.
(5) Selection.
J. EEO PLANS.
(1) Assessment.
(2) Union Comment.
(3) Opportunity to Bargain.
ARTICLE 45 - EEO Advisory Committees

A. EEO COMMITTEES.
(1) Purpose.
(2) Membership.
(3) Headquarters Committee.
(4) Meetings.
(5) Duty Hours.
(6) Time, Travel and Per Diem.
B. COMMITTEE RESPONSIBILITIES.
(1) Identify Issues.
(2) Exchange Ideas / Proposals.
C. EEO STATISTICS.
D. SUMMARY OF COMPLAINTS.
ARTICLE 46 - Sexual Harassment

A. WORKPLACE ATMOSPHERE.
B. UNWELCOME ADVANCES.
(1) Condition of Employment.
(2) Employment Decisions.
(3) Hostile Working Environment.
C. EMPLOYER’S RESPONSIBILITY.
(1) Managers and Supervisors.
(2) Fellow Employees.
(3) Lost Opportunity.
D. COMPLAINT PROCEDURES
(1) Investigation.
(2) Substantiation.
E. FILING A COMPLAINT.

(ARTICLE 45 - EEO Advisory Committees)
Outline of Contract
(1) Grievance.
(2) EEO Complaint.
(3) MSPB Appeal.
F. GRIEVANCE DEADLINES.
(1) Incident.
(2) Awareness.
G. EEO COUNSELORS.
(1) Optional Consultation.
(2) List of Counselors.
(3) Counselor Duties.
(a) Counsel.
(b) Inquire.
(c) Resolve.
(d) Document.
(e) Written Report.
(5) Right to File Complaint.
(6) Neutrality of EEO Counselor.
(8) Independence of EEO Counselor.
(10) Right to Represent Self.
H. UNION RIGHT TO BE PRESENT.
I. GRIEVANCE CONSIDERATIONS.
(1) Elevated Step.
(2) Closed Hearing.
J. ANNUAL ANNOUNCEMENT.
ARTICLE 47 - Grievance Procedure

A. PURPOSE.
B. DEFINITION:
(1) Violation of Agreements.
(2) Violation of Law, Rule, or Regulation.
Exclusion:
(1) Beyond Authority.
(2) Political Activities.
(3) Benefits.
(4) National Security.
(5) Hiring Authority.
(6) Classification.
(7) Statutory Discrimination Appeal.
(8) Statutory Adverse Action Appeal.
(9) Union Appeal of Non-represented Statutory Process.

Outline of Contract
(10) Already Filed.

(11) Probation.
(12) Temporary Appointments.
(13) Proposed Actions.
C. IDENTICAL GRIEVANCES.
D. RESOLVE AT LOWEST POSSIBLE LEVEL.
E. PROCEDURES FOR GRIEVANCES FILED BY EMPLOYEES:
(1) First Step
(2)Second Step
(3)Third Step
F. REQUESTED RELIEF GRANTED.
G. EXCEPTIONS TO STEP I.
(1) Policy of Director.
(2) Reprimands.
(3) Suspensions and Adverse Actions.
(4) MP&RP Violations.
(a) Step A.
(b) Step B.
H. GRIEVABILITY / ARBITRABILITY.
I. PROCEDURES FOR GRIEVANCES FILED BY THE UNION OR THE SERVICE:
(1) District Level Disputes:
(a) Step A.
(b) Step B.
(2) Regional Level Disputes.
(3) National Level Disputes.
J. TIME LIMITS.
(1) Extensions.
(2) Service of Process.
ARTICLE 48 - Arbitration
A. INVOKING ARBITRATION.
B. SELECTION OF PANELS.
(1) Replacements.
(2) Removal.
(3) Rotation.
(7) Headquarters Arbitrations.
C. THRESHOLD ISSUES.
(1) Arbitrators Decision.
(2) Postponement.
D. TRANSCRIPTS.
E. PROCEEDINGS.
F. DOCKET REVIEW.
G. EXPEDITED PROCEDURE.
(1) Hearing.

Outline of Contract
(2) Briefs.
(3) Decision.
H. COSTS.
I. CANCELLATION.
J. LOCATION.
K. PARTICIPANTS.
(1) Duty Status.
(2) Travel and Per Diem.
L. BINDING AWARDS.
ARTICLE 49 - Effective Date and Duration

A. EFFECT.
B. RENEGOTIATION.
ARTICLE 50 - Negotiation of Supplemental Agreements

A. SUPPLEMENTAL PROCEDURES.
B. MASTER AGREEMENT CONTROLLING .
C. SUBJECT MATTER.
(1) Physical Working Conditions.
(2) Training.
(3) Leave.
(4) Breaks.
(5) Overtime.
(6) Flexible Tours of Duty.
(7) Alternative Work Schedules.
(8) Local Official Time.
(9) Rough Duty Uniforms.
(10) Casual Dress Days.
(11) Overtime Cap Procedures.
(12) Office Space / Equipment.
(13) Training Committees.
(14) Additional Items.
D. NEGOTIABILITY DISPUTES.
E. EXPIRATION AND RENEGOTIATION.
ARTICLE 51 - Impasses in Supplemental Negotiations, Impact Bargaining, and

Mid-Term Negotiations.
A. IMPASSES DURING NEGOTIATIONS.
B. MEDIATION.
C. REFERRAL TO NATIONAL PARTIES AND IMPASSES PANEL.
D. AGREEMENTS ALLOWED.

(ARTICLE 49 - Effective Date and Duration)
Outline of Contract
ARTICLE 52 - Total Quality Management

A. TQM PHILOSOPHY.
B. PRINCIPLES.
C. RESERVATION OF RIGHTS.
D. MEMORANDUM OF UNDERSTANDING.
ARTICLE 53 - Employee Assistance Program

A. ASSIST EMPLOYEES.
B. INFORMATION TO UNION.
C. REHABILITATION.
D. DISCIPLINE.
E. ANNUAL REVIEW.
F. CHILD CARE / ELDER CARE.
ARTICLE 54 - Contracting
A. BRIEFINGS.
B. SITE VISITS.
C. UNION NOTIFICATION.
APPENDIX 1 - Merit Promotion Plan I
APPENDIX 2 - Dues Withholding

SECTION I -DEFINITIONS
A. DUES:
B. SF-1187:
C. SF-1188:
D. PAYROLL OFFICE:
E. SERVICING HUMAN RESOURCES OFFICE:
SECTION II - ELIGIBLE EMPLOYEES
A. BARGAINING UNIT EMPLOYEE.
B. MEMBER IN GOOD STANDING.
C. REGULAR SALARY.
D. REQUEST.
SECTION III - RESPONSIBILITIES OF THE UNION
A. VOLUNTARY NATURE.
B. PROVIDE SF-1187.
C. CERTIFY SF-1187.
D. FORWARD SF-1187.
E. LIST OF AUTHORIZED SIGNATURES.
F. WRITTEN NOTIFICATION.
(1) Changes.
(2) Terminations.

(ARTICLE 52 - Total Quality Management)
Outline of Contract
(3) Transfers.
G. MULTIPLE LOCALS.
SECTION IV - RESPONSIBILITIES OF THE EMPLOYER
A. SCREEN SF- 1187.
B. CERTIFY SF-1187.
C. REINSTATE FROM TEMPORARY ASSIGNMENTS.
D. REINSTATES FROM NON-PAY STATUS.
SECTION V – PROCEDURES
A. WITHHOLDING OF DUES.
(1) Arrange Withholding.
(2) Effective Date.
(3) Existing Withholdings.
B. CHANGES IN DUES.
(1) Union Certification Required.
(2) Once per Year.
(3) Effective Date.
C. TERMINATION OF ALLOTMENTS.
(1) Automatically:
(a) Loss of Recognition.
(b) Termination of Agreement.
(c) No longer Eligible.
(2) Voluntarily:
(a) Employee Revocation.
(b) Procedures.
D. REMITTANCES OF DUES.
(1) Composite Checks.
(2) Magnetic Tape.
(3) Code Combinations.
SECTION VI - COST OF WITHHOLDING
SECTION VII - UNDER PAYMENTS AND OVER PAYMENTS

REJECTIONS.

Outline of Contract
ADMINISTRATIVE ERRORS.
APPENDIX 3 - Side Letter on Intent of Article 7.C.(2): Official Time
APPENDIX 4 - TQM Memorandum of Understanding
APPENDIX 5 - Side letter on Intent of Article 53:Employee Assistance Program
APPENDIX 6 - Side Letter on Web Gear Equipment

(APPENDIX 3 - Side Letter on Intent of Article 7.C.(2): Official Time)
EXHIBIT B
Office ofthe Chief Human Capital Officer
U.S. Department of Homeland Security
Washington, DC 20528
Homeland
SEP - 5 2019
Security
MEMORANDUM FOR: Fanny Behar-Ostrow

President, AFGE Local 511
OPLA Miami
333 S. Miami Avenue, Suite 200
Miami, FL 33130
Matthew T. Albence
Deputy Director and
Senior Official Performing the Duties of the Director
Office of the Director
U.S. Immigration and Customs Enforcement
50012 th Street, SW, 11 th Floor
Washington, DC 20536
FROM: 41fo1~({~d~
Acting Executive Director
Human Capital Policy and Programs
SUBJECT: Agency Head Review of Collective Bargaining Agreement
Pursuant to title 5, United States Code§ 7114 (c) (l), the Collective Bargaining Agreement
negotiated between the U.S. Immigration and Customs Enforcement (ICE) and American
Federation of Government Employees (AFGE) Local 511, executed on August 29, 2019, was
submitted for review and is hereby approved.
CBA 2019
PROFESSIONAL
EMPLOYEES AGREEMENT
U.S IMMIGRATION AND CUSTOMS ENFORCEMENT
AND AFGE LOCAL 511
American Federation of Government Employees, AFL – CIO

Effective Date September 1, 2019
TABLE OF CONTENTS
Page
ARTICLE 1 RECOGNITION 1
ARTICLE 2 EFFECT OF LAW AND REGULATION AND OTHER 2
GENERAL PROVISIONS
ARTICLE 3 EMPLOYEE RIGHTS 5
ARTICLE 4 MANAGEMENT RIGHTS 11
ARTICLE 5 UNION RIGHTS 12
ARTICLE 6 STATUS OF EMPLOYEE REPRESENTATIVES 13
ARTICLE 7 USE OF OFFICIAL TIME 14
ARTICLE 8 FACILITIES, SERVICES AND ACCESS TO EMPLOYEES 19
ARTICLE 9 MID-TERM BARGAINING 24
ARTICLE 10 NOTICE TO EMPLOYEES 32
ARTICLE 11 TRAINING AND DEVELOPMENT 34
ARTICLE 12 SAFETY AND HEALTH 39
ARTICLE 13 TRAVEL 44
ARTICLE 14 TEMPORARY AND SPECIAL ASSIGNMENTS 50
ARTICLE 15 HOURS OF WORK 56
ARTICLE 16 PART-TIME EMPLOYMENT 66
ARTICLE 17 TELEWORK PROGRAM 69
ARTICLE 18 LEAVE 75
ARTICLE 19 COMPENSATORY TIME OFF FOR RELIGIOUS 82
OBSERVANCES
ARTICLE 20 PROMOTIONS AND PAY INCREASES 85
ARTICLE 21 PERFORMANCE AND INCENTIVE AWARDS 88
ARTICLE 22 GRIEVANCE AND ARBITRATION PROCEDURE 91
ARTICLE 23 EQUAL EMPLOYMENT OPPORTUNITY 103
ARTICLE 24 PERFORMANCE MANAGEMENT 107
ARTICLE 25 FORMAL DISCUSSIONS AND INVESTIGATIVE 115
EXAMINATIONS
ARTICLE 26 DISCIPLINARY AND ADVERSE ACTIONS 116
ARTICLE 27 EMPLOYEE ASSISTANCE PROGRAM 123
i
ARTICLE 28 REIMBURSEMENT OF EMPLOYEE EXPENSES 124

ARTICLE 29 CHILD CARE 126
ARTICLE 30 HARDSHIP REASSIGNMENT 127
ARTICLE 31 ISSUANCE AND CONTROL OF BADGES 130
ARTICLE 32 DEDUCTIONS FOR UNION DUES 132
ARTICLE 33 COMPENSATORY TIME OFF FOR REPRESENTING 135
AGENCY OUTSIDE OF HOURS OF WORK
ARTICLE 34 DURATION 138
CERTIFICATION OF AGREEMENT 139
APPENDIX A OFFICIAL TIME REQUEST FORM 140
APPENDIX B COMPENSATORY TIME OFF FOR TRAVEL FORM 141
APPENDIX C VOLUNTARY ASSIGNMENT REQUEST FORM 142
APPENDIX D REQUEST FOR AN EXEMPTION FROM INVOLUNTARY 143
TEMPORARY ASSIGNMENTS
APPENDIX E REQUEST FOR AN EXEMPTION FROM THE EXTENSION 144
OF A TEMPORARY ASSIGNMENT
APPENDIX F EMPLOYEE DECISION PERIOD WORK SCHEDULE 145
REQUEST FORM
APPENDIX G NOTIFICATION OF CONDITIONS OF PART-TIME 146

EMPLOYMENT
APPENDIX H TELEWORK PROGRAM AGREEMENT (AND ATTACHED 147

SUMMARY OF INFORMATION SECURITY ASSURANCE
REQUIREMENTS)
APPENDIX I TELEWORK PROGRAM WORK PLAN 151
APPENDIX J EQUAL EMPLOYMENT OPPORTUNITY COMPLAINT 152

INFORMATION
APPENDIX K AGENCY-INITIATED – AUTHORIZATION FOR 153

COMPENSATORY TIME OFF FOR WORK TO BE
PERFORMED OUTSIDE THE TOUR OF DUTY
APPENDIX L EMPLOYEE-INITIATED – AUTHORIZATION FOR 154
COMPENSATORY TIME OFF FOR WORK TO BE
PEFORMED OUTSIDE THE TOUR OF DUTY
ii
ARTICLE 1
RECOGNITION
A. U.S. Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement
(hereinafter, ICE or the Agency) recognizes the American Federation of Government
Employees, AFL-CIO (hereinafter, AFGE) as the exclusive collective bargaining
representative for all professional employees of the Agency, as certified by the Federal Labor
Relations Authority in Case No. WA-RP-07-0018 (June 22, 2007). Excluded from the
bargaining unit are non-professional employees, management officials, supervisors, and
employees described in 5 U.S.C. § 7112(b)(2), (3), (4), (6), and (7).
B. The Agency acknowledges that AFGE has delegated authority for administration of this
Agreement and for all other day-to-day representational functions to AFGE Local 511
(hereinafter, Local 511 or the Union). Accordingly, except for negotiation of this Collective
Bargaining Agreement and for matters affecting the certification of the bargaining unit, the
Agency will deal with Local 511 as AFGE’s authorized representative for all labor relations
matters, unless and until AFGE should give written notice to the Agency that its delegation of
authority to Local 511 has been amended or withdrawn.
1
ARTICLE 2
EFFECT OF LAW AND REGULATION
AND
OTHER GENERAL PROVISIONS
A. In the administration of all matters covered by this Agreement, the Parties are governed by
existing or future laws and by government-wide rules or regulations that are in effect on the
effective date of this Agreement. In the administration of this Agreement, should any conflict
arise between the terms of this Agreement and any present or future laws, provisions of such
laws shall supersede conflicting provisions of this Agreement.
B. Should any conflict arise in the administration of this Agreement between the terms of this
Agreement and any government-wide rule or regulation, such as the Code of Federal
Regulations, or DHS Orders, Directives, Instructions, Policies, Manuals, and issuances similar
to aforementioned (other than a rule or regulation implementing 5 U.S.C. § 2302), issued after
the effective date of this Agreement, the terms of this Agreement will supersede and govern.
C. In any conflict between the terms of this Agreement and any provision of ICE Orders,
Directives, Instructions, Handbooks, Manuals, policies, procedures, rules, or regulations,
including local office practices, personnel policies, and matters affecting conditions of
employment, regardless of date of issuance or establishment, the terms of the Agreement will
govern.
D. Should any part of this Agreement or any provision or provisions contained herein be rendered
or declared invalid by reason of any of the contingencies referred to in this Article, such
invalidation of such provision or provisions of this Agreement shall not invalidate those
unaffected parts or provisions contained in this Agreement and they shall remain in full force
and effect.
E. The requirements of this Article shall apply to all supplemental, implementing, subsidiary, or
informal agreements between the Parties.
F. In a number of the provisions of this Agreement, statutes or regulations are restated for the
convenience of the Parties and the employees covered by the Agreement. In restating the
provisions of such statutes and regulations, some minor changes to the statutory and regulatory
language have been made for clarity or to place that language in context. These wording
changes are not intended to change the meaning of the language in question. However, should
there be any conflict between the language of this Agreement and the language of applicable
statutes or regulations in effect at the time the Agreement became effective, the language of
the statutes and regulations is controlling.
2
G. The Parties have included a number of provisions of general applicability within this Article
for the sake of a centralized reference; however, the same terms remain in their original
Article(s) for the ease of the reader’s access and understanding of the terms within the context
in which they arise. The following provisions apply generally in implementation of this
Agreement:
1. “Seniority” means:
a. for attorneys, “seniority” is the time as an Agency attorney (including time as an

attorney with legacy U.S. Immigration and Naturalization Service and U.S. Customs
Service).
b. for all other bargaining unit positions, “seniority” is time based on the employee’s
service computation date.
2. “Day” means a calendar day unless otherwise specified.
3. Time limits established by this Agreement shall begin to run on the day after the date of
the event or action that triggers the time limit.
4. Whenever the last day by which an action must be accomplished falls on a weekend, federal
holiday, or other day when the Agency’s office is closed, the last day for action will be the
next day that the office is open.
5. Any time limit established by this Agreement may be extended by mutual agreement.
6. Neither Party will unreasonably deny a reasonable request for an extension of time. Absent
extraordinary circumstances, such requests must be made at least two (2) workdays in
advance of the deadline.
7. Service, filing, or delivery of notices, requests, demands, decisions, or other documents

(service) provided for in this Agreement shall be accomplished by personal delivery,
certified mail, or electronic mail (e-mail).
a. Where service is by e-mail, electronic read receipt will constitute proof of service. Each
Party may designate up to four (4) recipients. Documents transmitted by e-mail will
be sent to each Party’s designees at their government e-mail addresses. The Parties’
designees will ensure their electronic read receipt is enabled and, where requested, will
acknowledge receipt promptly.
b. When service is by e-mail, the subject line of the e-mail shall put the addressee on
notice that an identified document is being served (e.g., “Agency Notice of Proposed
Change” or “Union Request for Information under 5 U.S.C. § 7114(b)(4)”).
c. Facsimile (FAX) transmission may be used for service only when the receiving Party
expressly consents to such means in regard to a particular document.
3
d. The Parties will act in good faith in sending read receipts for documents and will not
attempt to evade the service of documents upon them.
8. Upon the sender’s request, the recipient(s) agree(s) to acknowledge receipt for Union-
related communications between Agency management officials and Union officers and
stewards. Read receipt notices generated by the Agency’s e-mail system constitute one
manner of acknowledgment.
4
ARTICLE 3
EMPLOYEE RIGHTS
Section 1. Employee Rights
Employees covered by this Agreement shall have the right to form, join, or assist any labor
organization, or to refrain from any such activity, freely and without fear of penalty or reprisal,
and each employee shall be protected in the exercise of such right.
A. Except as otherwise provided by law, such rights include the right:
1. to act for a labor organization in the capacity of a representative and the right, in that
capacity, to present the views of the labor organization to heads of agencies and other
officials of the Executive Branch of the government, the Congress, or other appropriate
authorities; and
2. to engage in collective bargaining with respect to conditions of employment through the

Union as provided by law and this Agreement.
B. Nothing in this Section, or this Agreement, authorizes participation in the management of a

labor organization by a management official, a supervisor, or a confidential employee, except
as specifically provided by law, or by an employee if the participation or activity would result
in a conflict or apparent conflict of interest or would otherwise be incompatible with law or
with the official duties of the employee.
Section 2. Prohibited Personnel Practices
Employees are protected by law from prohibited personnel actions. The law provides that any
federal employee who has authority to take, direct others to take, recommend, or approve any
personnel action shall not, with respect to such authority:
A. discriminate for or against any employee or applicant for employment:
1. on the basis of race, color, religion, sex, or national origin, as prohibited under § 717 of the
Civil Rights Act of 1964;
2. on the basis of age, as prohibited under §§ 12 and 15 of the Age Discrimination in

Employment Act of 1967;
3. on the basis of sex, as prohibited under § 6(d) of the Fair Labor Standards Act of 1938;
4. on the basis of handicapping condition, as prohibited under § 501 of the Rehabilitation Act
of 1973, as amended;
5
5. on the basis of marital status or political affiliation, as prohibited under any law, rule, or
regulation;
6. on the basis of sexual orientation, as prohibited by Executive Orders 11478 and 13087; or
7. on the basis of parental status, as prohibited by Executive Order 11478, as amended by

Executive Order 13152.
B. solicit or consider any recommendation or statement, oral or written, with respect to any
individual who requests or is under consideration for any personnel action, unless such
recommendation or statement is based on the personal knowledge or records of the person
furnishing it and consists of:
1. an evaluation of the work performance, ability, aptitude, or general qualifications of such

individual; or
2. an evaluation of the character, loyalty, or suitability of such individual.
C. coerce the political activity of any person (including the providing of any political contribution
or service) or take any action against any employee or applicant for employment as a reprisal
for the refusal of any person to engage in such political activity.
D. deceive or willfully obstruct any person with respect to such person’s right to compete for
employment.
E. influence any person to withdraw from competition for any position for the purpose of
improving or injuring the prospects of any other person for employment.
F. grant any preference or advantage not authorized by law, rule, or regulation to any employee
or applicant for employment (including defining the scope or manner of competition or the
requirements for any position) for the purpose of improving or injuring the prospects of any
particular person for employment.
G. appoint, employ, promote, advance, or advocate for appointment, employment, promotion, or

advancement in or to a civilian position any individual who is a relative (as defined in 5 U.S.C.)
of such employee if such position is in the Agency in which such employee is serving as a
public official (as defined in 5 U.S.C.) or over which such employee exercises jurisdiction or
control as such an official.
H. take or fail to take a personnel action with respect to any employee or applicant for employment
as reprisal for:
1. any disclosure of information by an employee or applicant that the employee or applicant

reasonably believes evidences:
a. a violation of any law, rule, or regulation; or
6
b. gross mismanagement, a gross waste of funds, an abuse of authority, or a substantial

and specific danger to public health or safety,
if such disclosure is not specifically prohibited by law and if such information is not
specifically required by Executive Order to be kept secret in the interest of national defense
or the conduct of foreign affairs; or
2. any disclosure to the Special Counsel or to the Inspector General of an agency or another
employee designated by the head of the agency to receive such a disclosure of information
that the employee or applicant reasonably believes evidences:
a. a violation of any law, rule, or regulation; or
b. gross mismanagement, a gross waste of funds, an abuse of authority, or a substantial

and specific danger to public health or safety.
I. take or fail to take, or threaten to take or fail to take, any personnel action against any employee
or applicant for employment because of:
1. the exercise of any appeal, complaint, or grievance right granted by any law, rule, or
regulation;
2. testifying for or otherwise lawfully assisting any individual in the exercise of any right
referred to in Subsection I.1;
3. cooperating with or disclosing information to the Inspector General of an agency or the

Special Counsel, in accordance with applicable provisions of law; or
4. refusing to obey an order that would require the individual to violate a law.
J. discriminate for or against an employee or applicant for employment on the basis of conduct
that does not adversely affect the performance of the employee or applicant or the performance
of others, except that nothing in this Subsection shall prohibit the Agency from taking into
account in determining suitability or fitness any conviction of the employee or applicant for
any crime under the laws of any State, of the District of Columbia, or of the United States.
K. knowingly take, recommend, or approve any personnel action, if the taking of the action would
violate a veterans’ preference requirement.
L. knowingly fail to take, recommend, or approve any personnel action, if the failure to take such
action would violate a veterans’ preference requirement.
M. take or fail to take any other personnel action, if the taking of or failure to take such action
violates any law, rule, or regulation implementing or directly concerning the merit system
principles contained in 5 U.S.C. § 2301.
7
Section 3. Information to Congress
Nothing in Section 2 shall be construed to authorize the withholding of information from Congress
or the taking of any personnel action against an employee who discloses information to Congress.
Section 4. Equal Employment Opportunity
Nothing in Section 2 shall be construed to extinguish or lessen any effort to achieve equal
employment opportunity through affirmative action or any right or remedy available to any
employee or applicant for employment in the civil service under:
1. § 717 of the Civil Rights Act of 1964, prohibiting discrimination on the basis of race, color,
religion, sex, or national origin;
2. §§ 12 and 15 of the Age Discrimination in Employment Act of 1967, prohibiting discrimination

on the basis of age;
3. § 6(d) of the Fair Labor Standards Act of 1938, prohibiting discrimination on the basis of sex;
4. § 501 of the Rehabilitation Act of 1973, prohibiting discrimination on the basis of

handicapping condition;
5. the provisions of any law, rule, or regulation prohibiting discrimination on the basis of marital
status or political affiliation;
6. Executive Orders 11478 and 13087, prohibiting discrimination on the basis of sexual
orientation; or
7. Executive Order 11478, as amended by Executive Order 13152, prohibiting discrimination on

the basis of parental status.
Section 5. Selection of Complaint Procedure
An employee aggrieved under Section 4 may raise the matter under a statutory procedure or the
grievance and arbitration procedure provided in this Agreement, but not under both.
A. An employee shall be deemed to have exercised his or her option under this Section at such
time as the employee timely initiates an action under the applicable statutory procedure or
timely files a written grievance under the provisions of this Agreement, whichever occurs first.
B. The selection of the negotiated grievance procedures contained in this Agreement to process a
complaint of discrimination shall in no manner prejudice the right of an aggrieved employee
to request the Merit Systems Protection Board (MSPB) to review the final decision in the case
of any personnel action that could have been appealed to the MSPB or, where applicable, to
request the Equal Employment Opportunity Commission (EEOC) to review a final decision in
any other matter involving a complaint of discrimination of the type prohibited by any law
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administered by the EEOC. Appeals to the MSPB or the EEOC shall be filed pursuant to such
regulations as the MSPB or the EEOC may prescribe.
C. Except as provided in Subsection B, an employee may only file his or her complaint under the
grievance and arbitration provisions contained in this Agreement.
Section 6. Private Discussions
Any discussions with individual employees concerning counseling, evaluations, workload review,
or disciplinary actions will be conducted so as to ensure the privacy and dignity of the employee.
Section 7. Voluntary Programs
Participation in the Combined Federal Campaign, U.S. bond drives, blood donor drives, and other
comparable programs will be on a voluntary basis.
Section 8. Gifts
Contributions to gifts for supervisors, management officials, or fellow employees will be strictly
voluntary and in compliance with the ethics program.
Section 9. Personnel Communications
A. Employees are strongly encouraged, but not required, to initiate individual personnel matters
with first-line supervisors and to follow the Agency chain of command where appropriate.
B. An employee also has the right to communicate with the appropriate member of the following
offices concerning individual personnel matters:
1. the servicing Human Resources Office;
2. the Equal Employment Opportunity (EEO) Office or the EEO Officer;
3. EEO Counselors; and
4. the Health and Safety Office.
Section 10. Maintenance of and Access to Official Records
A. An Official Personnel Folder (OPF) and Employee Performance Folder (EPF) will be
maintained in accordance with applicable laws and regulations. Only information authorized
by law or regulation will be maintained in the OPF/EPF.
B. Each employee and/or a formally designated representative may review and request copies of
any document(s) in the OPF/EPF. The Agency must explain, in writing, any denial.
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C. No record, file, or document filed in the OPF/EPF that is not available to the employee or his
or her representative for inspection will be made available to any unauthorized person for
inspection or photocopying. Such information will be made available to any authorized person
only for official use.
D. If an employee does not have access to his or her electronic OPF or, should it become available,
an electronic version of his or her EPF, the employee may make a written request to the
servicing Human Resources Office for a print version of the OPF or EPF. The Agency will
provide the requested material to the employee no later than 15 days after receipt of the request.
E. No derogatory material of any nature that might reflect adversely upon the employee’s
character or federal career will be placed in his or her OPF or EPF without his or her
knowledge.
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ARTICLE 4
MANAGEMENT RIGHTS
Section 1. Statutory Rights
Nothing in this Agreement shall affect the authority of any management official of the Agency:
A. to determine the mission, budget, organization, number of employees, and internal security
practices of the Agency;
B. in accordance with applicable laws:
1. to hire, assign, direct, lay off, and retain employees in the Agency, or to suspend, remove,
reduce in grade or pay, or take other disciplinary action against such employees; and
2. to assign work, to make determinations with respect to contracting out, and to determine
the personnel by which Agency operations shall be conducted;
C. with respect to filling positions, to make selections for appointment from:
1. among properly ranked and certified candidates for promotion; or
2. any other appropriate source; and
D. to take whatever action may be necessary to carry out the Agency mission during emergencies.
Section 2. Permissive Rights
Nothing in this Agreement shall preclude the Agency and the Union from negotiating:
A. at the election of the Agency, on the numbers, types, and grades of employees or positions
assigned to any organizational subdivision, work project, or tour of duty, or on the technology,
methods, and means of performing work;
B. procedures that the Agency will observe in exercising any authority under this Article; or
C. appropriate arrangements for employees adversely affected by the exercise of any authority
under this Article by the Agency.
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ARTICLE 5
UNION RIGHTS
A. The Agency recognizes the Union as the exclusive representative of all employees in the
bargaining unit, as described in Article 1. The Union shall have all such rights and be subject
to all such limitations as provided by law, and the Union is entitled to act for and, as provided
in Article 1, to negotiate agreements covering all employees in the unit. The Union is
responsible for representing the interest of all employees in the unit without discrimination and
without regard to labor organization membership.
The Union shall be given the opportunity to be represented at any formal discussion between
one or more representatives of the Agency and one or more employees in the unit or their
representatives concerning any grievance or any personnel policy, practice, or other general
condition of employment. The Union may choose the representative who may attend the
formal discussion, ordinarily at no expense to the Agency.
B. The Agency will give the Union as much advance notice as possible of such formal discussions.
Advance notice will be at least 48 hours, operational needs permitting. For formal discussions
having bargaining unit-wide implications (e.g., requiring a Union representative’s travel to
Washington, DC) advance notice will be at least 72 hours, operational needs permitting.
Where practicable, the Union will receive advance copies of documents, PowerPoint
presentations, videos, etc. to be supplied to employees at the discussion. Upon request, the
Agency will use its best efforts to provide the Union with telephone or video-teleconferencing
(VTC) access to a formal discussion. In the event telephone or VTC access to a formal
discussion is not provided by the Agency, the Agency may pay travel and per diem expenses
for a Union representative to attend.
C. The Union shall have the right to present its views, either orally or in writing, to the Agency
on any matters of concern regarding personnel policies and practices and matters affecting
working conditions.
D. Except as limited elsewhere in this Agreement, all matters affecting conditions of employment
of employees are appropriate subjects for consultation and, where required by applicable law,
negotiations between the Parties.
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ARTICLE 6
STATUS OF EMPLOYEE REPRESENTATIVES
A. The Agency shall not impose any restraint (except as may be otherwise provided in this
Agreement), interference, coercion, or discrimination against employees in the exercise of their
rights to organize and designate representatives of their own choosing for the purposes of
collective bargaining, the presentation of grievances, appeals from adverse actions, or labor-
management relations, or upon duly designated employee representatives acting on behalf of
an employee or group of employees within the bargaining unit.
B. A reasonable number of stewards may be designated by the Union who shall be recognized as
employee representatives for employees in the designated locations, or other Agency facility
in which they are designated to be stewards. The Union will supply the Agency with their
names, which may be posted on appropriate bulletin boards. It shall be the duty of the Union
to notify the Agency of any changes in the roster of stewards.
C. Upon request and approval in advance, Union representatives are authorized to perform and
discharge the duties and responsibilities which may be properly assigned to them under law by
the Union in accordance with this Agreement and any supplemental agreement or agreements
hereunder. Consistent with law, there shall be no restraint, interference, coercion, or
discrimination against Union representatives because of the performance of these duties while
they are serving as Union officials. Union representatives shall be relieved from official duties
and performance requirements during the period they are serving as Union representatives.
This does not preclude employees being called back to their official duties when there is an
operational need for their services. The Agency recognizes Union representatives may at times
conduct representational duties away from the work place subject to management approval.
D. The Union will furnish the Agency written notice of the names of the Union representatives
and advise the Agency of any changes in its list of designated Union representatives.
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ARTICLE 7
USE OF OFFICIAL TIME
Section 1. Purpose
Official time permits bargaining unit employees to perform authorized representational activities
on behalf of the Union during times they otherwise would be in a regular duty status, without loss
of pay or charge to annual leave. This Article specifies the types of activities for which official
time may be available, provides for the allocation of official time to various Union
representatives, and establishes the procedures applicable to the requesting, approval, and
recording of official time use.
Section 2. Activities for Which Official Time May be Permitted
Union representatives may be granted official time to conduct representational functions where
such is authorized pursuant to, and consistent with, applicable statutes, regulations, and Executive
Orders relating to complaints, grievances, appeals, and other matters involving dealings with
Agency officials. Official time may be authorized for the following, provided that the amount of
time requested and used is reasonable, necessary, and in the public interest:
A. to confer with employees or groups of employees regarding matters for which they may seek
relief under the terms of this Agreement;
B. to prepare, present, and/or respond to grievances;
C. to prepare replies and attend meetings regarding proposal notices of disciplinary actions,
adverse actions, or actions under 5 C.F.R. Part 432 based on unacceptable performance;
D. to prepare for arbitration, including preparation of witnesses, to present arbitration cases, and
for any purposes required by the arbitrator after the hearing (e.g., writing briefs);
E. to prepare a reconsideration statement for the denial of a within-grade increase and attend
related meetings;
F. to meet with national representatives of the Union regarding representational activities;
G. to participate in a U.S. Federal Labor Relations Authority (FLRA) investigation or hearing

preparation;
H. to attend discussions as described in Article 22;
I. to travel, participate in, or conduct approved labor-management relations (LMR) training as

described in Article 11, Section 9;
J. to prepare and/or modify Union records and reports required by federal law;
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K. to respond to requests by Members of Congress for information or to testify before Congress;
L. to prepare for or participate in or travel to and from negotiations (during normal duty hours)
for Mid-Term Bargaining as provided in Article 9 and on any related third-party proceedings
(e.g., related FLRA proceedings);
M. to present employee appeals under statutory or regulatory appeal procedures when the Union
is the designated representative;
N. to attend formal discussions and investigative examinations under Article 25;
O. to attend any other meeting scheduled by the Agency to which the Agency has invited the
Union as general representative of the bargaining unit; and
P. to attend Union-initiated discussions with Agency management officials concerning

Section 3. Prohibitions on Union Representative Use of Official Time
Union representatives shall not use official time for the following purposes:
A. lobbying activities in violation of 18 U.S.C. § 1913;
B. internal Union business in violation of 5 U.S.C. § 7131(b);
C. political activities in violation of 5 U.S.C. Chapter 73, Subchapter III;
D. any other activity prohibited by law, rule, or regulation; and
E. any activity not expressly authorized by this Article.
Section 4. Allocation of Official Time
A. Fixed Official Time for Union President
1. The Union President will be granted 100% official time to represent the Union and the
bargaining unit consistent with Section 2.
2. When the Union President is on leave for more than one continuous week, he or she may
designate another representative to act for the President. The employee acting for the
President will be granted a reasonable amount of official time upon request at a rate of no
greater than 50% official time during the period the President is on leave. The Union
shall notify the Chief, Labor and Employment Law Division, Office of the Principal Legal
Advisor (OPLA), or designee, of the designation of the other employee who will act for
the President two pay periods in advance, except in unforeseen circumstances.
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B. Treasurer
1. Upon request, the Treasurer will be granted two (2) hours per pay period to prepare and
complete reports required by federal law. In addition, up to 40 hours may be granted each
calendar year between the end of the Union’s fiscal year (December 31) and the federal
tax filing deadline (April 15) to file required reports and tax returns. The 40 hours may
be used at one time or in increments at the request of the Treasurer. There is no carryover
of time not used for this purpose from year-to-year.
2. If necessitated by changed circumstances, the Treasurer will be granted up to eight (8)

hours of additional official time to attend training regarding governmental requirements
for record keeping and reporting. “Changed circumstances” refers to such events as the
appointment of a new Treasurer or the issuance of new laws or regulations affecting
record keeping and reporting requirements.
C. Other Union representatives not specifically identified in Section 4 will be granted amounts
of official time as are reasonable, necessary, and in the public interest pursuant to 5 U.S.C.
§ 7131(d).
Section 5. Required Procedures
A. Prior to the use of official time, a Union representative must first obtain management
approval.
B. To obtain such approval, the representative must submit the form at Appendix A to
management prior to the use of official time, specifying the activity to be performed, the
number of hours to be used, where and when the official time will be used, and how the tasks
are related to representational duties.
C. If a request for official time to perform a certain representational activity is approved, and the
activity spans beyond a single pay period, the representative shall submit a new request on
the form at Appendix A for each pay period in which official time is requested.
D. If a request for official time to perform a certain representational activity is approved, and
more time is needed than was anticipated for that representational activity within the same
pay period, the representative will contact the approving official and obtain approval for the
amount of additional time that is needed. As soon as practicable, the representative must edit
the previously submitted form to memorialize the additional approved time and re-submit it
to the approving official for signature.
E. Management will only approve official time requests where the official time is reasonable,
necessary, and in the public interest. Requests that do not contain sufficient information for
management to render its decision will be denied. When a request is denied, in whole or in
part, the Agency will explain the reason for the denial on the official time request form.
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F. Where representational activity will involve meeting during the duty time of a bargaining unit
employee other than a Union representative, the employee or the Union representative must
obtain prior approval of the employee’s supervisor for the employee’s use of official time,
consistent with the procedures described within this Section.
G. A representative who uses official time without advance written authorization or for purposes
not specifically authorized by the Agency may be considered absent without leave and subject
to appropriate disciplinary action. Repeated misuse of official time may constitute serious
misconduct that impairs the efficiency of the federal service.
Section 6. Union Representative Use of Official Time
A. Official time for representational activities is available for use only during the tour of duty as
described in Article 15, during time when the Union representative otherwise would be in a
duty status. The Union representatives are required to report to their duty stations (i.e.,
normal worksite), except when it is necessary to be at another location to perform the
representational activity, in which case the representative will provide contact information so
that he or she can be contacted regarding labor-management relations matters or recalled if
needed to perform Agency work.
B. While on official time, Union representatives are relieved of official duties, but are subject to
recall to duty if needed to perform Agency work. In the event the representative is recalled
to perform Agency work, the charge to official time will be stopped until the representational
activity is resumed.
C. Union representatives will receive performance appraisals based only upon Agency-assigned
work.
D. Activities for which an employee normally would be required to charge to annual, sick, or
other appropriate leave, if he or she were not a Union representative, cannot be charged to
official time.
Section 7. Official Time for Labor-Management Relations Training
Union representatives will receive official time for approved LMR training, including official time
for travel in connection with that training, in accordance with the provisions of Article 11.
Section 8. Travel and Per Diem Expenses for Union Representatives
A. The Agency will pay Union representatives’ travel and per diem expenses for attending
meetings to which the Agency has invited the Union to attend in person away from the
respective Union representative’s duty station.
B. The Agency will pay for the grievant and Union representative’s travel and per diem expenses
for participation in an arbitration hearing in accordance with Article 22, only in the event a
Union representative is not locally available.
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C. The Agency will pay travel and per diem expenses for a Union representative who is
providing representation of an employee making an oral response to a proposed removal
action (i.e., under adverse action or 5 C.F.R. Part 432 performance-based action procedures)
only in the event a Union representative is not locally available.
D. The Agency will pay up to a cumulative total of $10,000 per fiscal year for Union
representatives’ travel and per diem expenses for Mid-Term Bargaining in accordance with
Article 9. Any allotted funds not used in a fiscal year will not be available in any subsequent
year.
E. Unless specifically granted under a provision of this Agreement, or at the sole discretion of
the Agency, the Agency will not pay travel or per diem expenses for any other
representational activity.
F. Payment of travel and per diem expenses under this Section will be consistent with the Federal
Travel Regulation (FTR).
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ARTICLE 8
FACILITIES, SERVICES, AND ACCESS TO EMPLOYEES
Section 1. General
National, regional, and local representatives of the Union shall normally be permitted access to all
Agency offices with bargaining unit employees. It is understood that such Union representatives
shall give reasonable advance notice to the supervisor in charge of the office of their impending
visit. If the supervisor cannot approve the visit for valid operational reasons, the supervisor will
make an alternative arrangement for the representatives. Upon arrival, the representatives shall
advise the supervisor of their presence. Such representatives shall not interfere with the work of
employees during duty hours.
Section 2. Bulletin Boards
A. Each Agency office will provide for the Union’s exclusive use a dedicated bulletin board space
in a place of prominence not ordinarily frequented by the public and reasonably accessible for
posting material published by the Union.
B. In each office facility with 30 or more bargaining unit employees, the Agency will provide to
the Union for its exclusive use a minimum of one lockable bulletin board (measuring
approximately 3x4 feet). The bulletin board will be permanently attached to the walls where
building regulations permit such permanent installations. Such bulletin board(s) shall be in an
employee high-traffic and -visibility area out of public view (e.g., in employee break rooms or
near elevators), such that all bargaining unit employees may have easy access. The key shall
be in the sole possession of the Union. Subject to mutually acceptable space and within
landlord requirements, the Union may install, at its own expense, a bulletin board of up to 3x4
feet in addition to the bulletin board supplied by the Agency.
C. In each office facility with fewer than 30 bargaining unit employees, where building and
landlord requirements permit, the Union may install at its own expense a bulletin board of up
to 3x4 feet.
D. Material that does not violate any law, contain libelous material, or contain personal attacks
may be posted on Union bulletin boards.
Section 3. Union Meetings
A. Upon reasonable advance request by the Union, the Agency will provide available meeting
space in areas occupied by the Agency for meetings during non-duty hours. The Union will
comply with all security, safety, and housekeeping rules in effect at that time and place.
B. Nothing in this Section shall be construed as permitting meetings or the use of Agency-
supplied equipment during duty time for the purpose of conducting internal Union business.
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C. Employees attending meetings under Subsection B will do so only during non-duty hours (e.g.,
lunch time or while they are in a leave status).
D. Upon reasonable advance request by the Union, the Agency will provide confidential meeting
space during official hours of business, in areas occupied by the Agency, for the following
purposes:
1. preparing or discussing a grievance or appeal;
2. caucusing immediately before, after, and during scheduled meetings with the Agency;
3. discussing matters directly related to the administration of this Agreement; or
4. matters relating to the Union’s representation of employees.
E. Upon reasonable advance request, mutually agreed upon space will be provided, if available,
by the Agency to be used in conjunction with elections governed by local by-laws. Space will
be made available for the ballot box for the duration of the election period. The Union will
comply with security and housekeeping rules in effect at that time and place. The Union
acknowledges that the Agency assumes no responsibility for the safety or security of the ballot
boxes.
Section 4. Photocopying
Except for internal Union business, the Union is authorized the use of Agency photocopying
equipment for representational purposes, such use being subject to the Agency’s need of the
equipment for Agency work requirements. For more than de minimis tasks, the Union will supply
its own paper.
Section 5. Use of Communication Equipment
A. Upon reasonable advance request by the Union, and where available at no additional cost to
the Agency, the Agency will provide access to teleconference facilities, video conference
facilities, video equipment (i.e., TV, DVD player, video camera recording equipment), and
other conferencing services routinely used in that work location. The Union will follow the
same use procedures as all other users.
B. Employee Union Officers or Stewards are authorized the use of the Agency’s e-mail system,
telephones, scanners, and FAX machines to conduct Union representational activities. The
Union’s use of the Agency’s communications systems and equipment will be solely for proper
and legitimate representational Union purposes, and not for internal Union business. The
Union acknowledges that the e-mail system is administered by the Agency’s Office of the
Chief Information Officer (OCIO), and that its use is subject to OCIO security procedures and
requirements and Office of Professional Responsibility investigations.
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C. The Agency will update the bargaining unit e-mail distribution lists for the Union. The Union
will designate up to two (2) points of contact who will be responsible for electronic
communication using the e-mail distribution lists and for coordination with the Agency’s
Chief, Labor and Employment Law Division, OPLA, or designee, regarding concerns that may
arise. The e-mail distribution lists will be updated by the 15th of each month.
D. The Union’s use of Agency communication facilities and services identified above is subject
to the Agency’s work requirements.
E. The Agency will not interfere with the reasonable access of the Union to the Agency’s internal
e-mail system (including archived files) and FAX transmission equipment, and will not
inquire into the content of Union communications. The Agency will make no effort to gain
purposeful knowledge of the content of such communications.
F. As described more fully in Article 9, notices, proposals, and correspondence related to

representational matters may be transmitted by e-mail with electronic read receipt requested,
where service is applicable. Electronic read receipt by one designee will constitute proof of
service. Documents transmitted by e-mail will be sent to all of a Party’s designees, not to
exceed four (4) government e-mail addressees by each Party. The Parties will exchange their
respective lists of designees. The Parties will provide an updated list of designees by the 15th
of each month. The Parties’ designees will ensure their electronic read receipt is enabled and,
where requested, will acknowledge receipt promptly. In the alternative, certified mail or
personal delivery will constitute formal service. FAX transmission may be used only when
the receiving Party expressly consents to such means in regard to a particular document.
Section 6. Computer Resources and Reference Materials
A. Access to the Agency’s administrative manuals, memoranda, procedures, etc., shall be

available through the Agency internet, Agency SharePoint site, intranet, or internal regulation
distribution.
B. The ordinarily available attorney online research tools, including Westlaw, may be used by the
Union for representational purposes, provided there is no additional cost to the Agency.
C. Wherever the Agency maintains print or any electronic reference material (e.g., Interpreter
Releases, Broida Law & Practice, CCH), this material will be made accessible for shared use,
provided there is no additional cost to the Agency.
Section 7. Mail
A. Consistent with postal regulations, the Union shall have de minimis use of Agency metered
mail for correspondence with the Chief, Labor and Employment Law Division, OPLA, or
designee, and other appropriate Agency officials (including a copy to the Chief, Labor and
Employment Law Division, OPLA, or designee) regarding labor relations representational
matters. This, however, does not permit the Union to use other types of mail services, such as
express, overnight, registered, or certified mail, at Agency expense. The Union may deposit
21
mail relating to representational matters for pick up by the Agency’s contract commercial
delivery service (e.g., FedEx, DHL, UPS) if such use does not result in any cost to the Agency.
B. The Union shall have use of existing local internal mail for labor relations representational
matters, other than mass mailings. However, this does not obligate the Agency to maintain
any internal mail delivery system.
Section 8. Orientation
A Union representative who is in duty status will be allowed to provide a 30-minute orientation to
each new employee/transferee. The Union representative will cover only the labor relations law,
the provisions of this Agreement, and Union/Management matters. No recruiting or other internal
Union business may be conducted during the orientation.
Section 9. Personnel Roster and Telephone Directory
A. By the 15th of each month, the Agency will provide the Union President with the following:
1. a list of bargaining unit members within OPLA;
2. a list of non-bargaining unit members within OPLA;
3. a list of bargaining unit members who are non-attorney professionals; and
4. a list of non-bargaining unit members who are non-attorney professionals.
B. These lists will identify employee names and duty stations. These lists will also indicate new
employees, separations, transfers, and changes in bargaining unit status.
C. The Agency will include a separate page in the attorney telephone directory listing the
following: the names, office locations and addresses, and office telephone numbers of all
Officers and Stewards of the Union. The Union will provide an updated list of Union
representatives when changes are made by the 15th of each month.
Section 10. Notice in Changes of Bargaining Unit Status
A. When the lists identified in Section 9.A indicate that a position/employee is no longer part of
the bargaining unit based on a work assignment, the Agency will indicate the reason for the
change in order to provide the Union with a timely opportunity to contest the change in
bargaining unit status. The Agency and the Union may agree that a change in duties may
exempt a position/employee from the bargaining unit.
B. When the Agency determines that an employee is no longer excluded from the bargaining unit,
a Union representative will be provided 30 minutes to communicate with that employee.
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Section 11. Union Office Space and Technology
A. Union Officers and Stewards on official time status will have use of their private government
office space for their representational duties and will be provided lockable storage space. The
Union Officer or Steward will also be permitted to maintain the same seniority status for office
selections.
B. For a Union Officer who qualifies for at least 50% official time status, the Agency will provide
a smartphone, laptop computer (with wireless connection), printer, and scanner for use at the
Officer’s government office or other authorized location for representational purposes. The
Agency will provide the Executive Vice President and the Union representative who has
primary responsibility for representing non-attorney bargaining unit positions (Chief Steward
for non-attorney professionals) with a smartphone.
C. The Union will be provided office space as needed at the Agency’s headquarters building.
Section 12. Parking
Employee safety is a mutual concern. When remote parking is the only option, the Parties agree
that, upon request by the Union on a case-by-case basis, the Agency will endeavor to provide after-
hours parking at adjacent Agency-controlled or other government-controlled parking facilities,
provided that such after-hours parking does not result in additional costs to the Agency.
Section 13. Copies of the Collective Bargaining Agreement
The Union will be provided 100 hard copies of this collective bargaining agreement for distribution
to Officers and Stewards. This collective bargaining agreement will be made available
electronically on the ICE intranet.
Section 14. Space Reallocation
The Parties agree that timely pre-decisional involvement (PDI) as described in Article 9, Section
1.F regarding potential/future space reallocation may benefit both the Agency and its employees.
Consistent with law and government-wide rules and regulations, the Agency will notify the Union
of any non-de minimis space reallocation and will bargain with the Union, to the extent required
by law and this Agreement. Space reallocation encompasses new acquisitions, relocations,
expansions, consolidations, or reductions of physical space that affect employee working
conditions anywhere within the Agency.
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ARTICLE 9
MID-TERM BARGAINING
Section 1. General Provisions
A. The purpose of this Article is to prescribe the circumstances and procedures under which the
Agency and the Union shall engage in negotiations during the term of this Agreement. The
Article shall be administered in accordance with 5 U.S.C. Chapter 71 and this Agreement.
B. The Parties will engage in mid-term bargaining as provided in Sections 2 and 3, or otherwise
only by mutual agreement.
C. The Parties recognize that from time to time during the life of the Agreement, the need will
arise for the Agency to introduce and/or modify existing Agency personnel policies, practices,
and/or working conditions not covered by this Agreement or to exercise its statutory
management rights in a manner that affects conditions of employment.
D. In applying the provisions of this Article:
1. Any time limit may be extended by mutual agreement.
2. “Day” means calendar day unless otherwise specified.
3. Whenever the last day by which an action must be accomplished falls on a weekend, federal
holiday, or other day when the Agency’s office is closed, the last day for action will be the
next day that the office is open.
E. In this Article, as elsewhere in this Agreement, the Parties use terms of art developed through
the precedent and regulations of third parties charged with administering the Civil Service
Reform Act of 1978 (e.g., FLRA, MSPB, U.S. Office of Personnel Management [OPM]).
These terms of art include, but are not limited to, “the necessary functioning of the agency”
and “covered by.” It is the intent of the Parties that where terms of art are used in this
Agreement, they are to be interpreted in a manner consistent with the precedent and regulations
of those third parties at the time this Agreement is negotiated.
F. The Parties are committed to the use of pre-decisional involvement (PDI) to allow the Parties
a reasonable period of time to make efforts to resolve issues through a consultative and
cooperative approach. However, PDI is not mandatory. If the Parties are unable to reach
agreement through PDI or in circumstances where PDI has not been used, bargaining may
occur in accordance with this Article.
G. Nothing in this Agreement shall be deemed to waive either Party’s statutory right unless such
waiver is clear and unmistakable.
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H. Post-Implementation Bargaining. Effective management of ICE and its resources is a mutual

concern. On some occasions, the necessary functioning of the Agency may require
implementation prior to bargaining. On those occasions, the Union retains the right to demand
post-implementation bargaining.
Section 2. Agency-Initiated Changes
A. Notice and Opportunity to Bargain. To the extent provided by law and this Agreement, the
Union shall be given notice and an opportunity to bargain over Agency-initiated changes in
matters affecting conditions of employment of bargaining unit employees. Any condition of
employment covered by this Agreement may not be changed except as permitted by law. The
Agency shall serve its notice of the proposed change upon the President of Local 511 or
designee.
B. Content of Notice. The notice will, at a minimum, contain the following information:
1. a description of the proposed change and the scope;
2. the Agency’s plans for implementing the change;
3. information that is relevant and necessary for the Union to understand the change; and
4. the proposed implementation date, which normally will be no fewer than 30 days after the
date of the notice.
C. Union Response to Notice of Proposed Change
1. Request for Briefing. Within seven (7) days after receipt of the notice of proposed change
and any supporting documentation, as provided in Subsection B, the President of Local
511, or designee, shall inform the Chief, Labor and Employment Law Division, OPLA, or
designee, whether the Union requests a briefing on the change and, if so, identify the issues
the Agency should address. The Chief, Labor and Employment Law Division, OPLA, or
designee, will determine the manner, nature, and extent of the briefing. Generally, within
seven (7) days of the Union’s request, the Parties will agree on a future date for the
informational briefing.
2. Request for Additional Information. Within 14 days after receipt of the notice of proposed
change or within seven (7) days after the briefing—if a briefing is conducted—the Union
may request additional information, in accordance with 5 U.S.C. § 7114(b)(4). The
Agency shall respond to the Union’s requests for information pursuant to 5 U.S.C. §
7114(b) in a timely fashion. Where practicable, the Agency may provide a partial response
containing immediately available information while other information is still being
gathered.
3. Demand to Bargain. The Union will submit any demand to bargain and its initial
bargaining proposals not later than:
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a. 21 days after receipt of the Agency’s response to the 5 U.S.C. § 7114(b)(4) information
request;
b. 21 days after the briefing, if no 5 U.S.C. § 7114(b)(4) information request is made; or
c. 30 days after receipt of the notice of proposed change, if the Union neither requests a
briefing nor makes a 5 U.S.C. § 7114(b)(4) information request.
The amendment of initial bargaining proposals or the submission of additional proposals

will be by mutual agreement, and neither party will unreasonably deny the request.
Section 3. Union-Initiated Mid-Term Bargaining
A. In addition to bargaining pursuant to Section 2, the Union can propose up to two (2) new
Articles at the middle of the original term of this Agreement to address matters that are
substantively negotiable (i.e., excluding matters affecting reserved management rights or
permissive subjects of bargaining) and that are not already covered by the specific provisions
of this Agreement, by the bargaining leading to this Agreement, or by bargaining under Section
2.
B. To exercise this right, the Union will serve notice, including the Union’s proposal(s), on the
Agency’s Chief, Labor and Employment Law Division, OPLA, or designee, during the 30-day
period preceding the mid-term anniversary date.
C. The Agency will respond to the Union’s notice within 30 days of receipt of the proposal(s).
D. Negotiations shall be conducted in accordance with the Ground Rules provided in Section 5.
E. The Union’s proposal will not be implemented except by agreement of the Parties or as directed
consequent to statutory impasse resolution procedures.
Section 4. Service of Notices and Demands
A. Service of all notices, requests, demands, or documents provided for under this Article shall
be accomplished by personal delivery, certified mail, or e-mail. As applicable, time limits
shall begin to run on the day after the date of the receipt of the document that triggers the
particular time limit. Electronic read receipt will constitute proof of service. Each Party may
designate up to four (4) recipients. Documents transmitted by e-mail will be sent to each
Party’s designees at their government e-mail addresses. The Parties’ designees will ensure
their electronic read receipt is enabled and, where requested, will acknowledge receipt
promptly. FAX transmission may be used only when the receiving Party expressly consents
to such means in regard to a particular document. The Parties will act in good faith in sending
read receipts for documents and will not attempt to evade the service of documents upon them.
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B. When service is by e-mail, the subject line of the e-mail shall put the addressee on notice that
an identified document is being served (e.g., “Agency Notice of Proposed Change” or “Union
Request for Information under 5 U.S.C. § 7114(b)(4)”).
Section 5. Ground Rules
A. Commencing Negotiations. If the Parties are unable to reach agreement on the proposed
changes during the procedures provided in Section 1.F or, as applicable, Section 2 or 3,
negotiations will commence as expeditiously as possible.
1. Mid-term bargaining negotiations may be conducted by telephone, VTC, or in person and,

unless otherwise agreed, shall begin at 9 a.m. Eastern Time on the second Tuesday
following the date a demand to bargain is received by the Agency under Section 2, or, if
applicable, the Agency’s response is received by the Union under Section 3.C. The Parties
recognize there may be emergent changes that must be implemented quickly. In these
instances, negotiations should begin as soon as practicable.
2. When the Agency-provided travel fund under Article 7, Section 7.D has been exhausted,
negotiations may be conducted by telephone or VTC, unless the Union elects to fund its
own travel expenses for its representatives.
B. Duty to Bargain in Good Faith. The duties of the Parties to negotiate in good faith under this
Article shall include the following obligations:
1. Resolve to Reach Agreement. To approach the negotiations with sincere resolve to reach
agreement;
2. Duly Authorized Representative. To be represented by duly authorized representatives

prepared to discuss and negotiate on the subjects authorized by this Article; and
3. Reasonable Times. To meet at reasonable times, as frequently as may be necessary, and

to avoid unnecessary delay.
C. Chief Negotiators. Each Party shall be represented at the negotiations at all times by one duly
authorized chief negotiator or an alternate chief negotiator who may act in the absence of the
chief negotiator. The chief negotiators will be prepared and authorized to reach agreement on
all matters subject to negotiations and to sign off on agreements for their respective Party.
D. Bargaining Teams
1. The Union will name up to two (2) representatives as its bargaining team or, if the Agency
has more than two (2) representatives, an equal number as the Agency.
a. When Agency travel authorizations will be required for Union team members, the
Union will inform the Agency of those employees at the earliest practicable date prior
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to the first date of travel for each negotiating session and will provide all information
the Agency needs for issuance of each employee’s travel authorization.
b. With supervisory approval, the Union representative may choose to travel outside the
regular duty hours for the convenience of the employee or the benefit of the government
based on such factors as cost and time away from his or her duty station. The maximum
reimbursement for per diem/subsistence will be limited to that which would have been
allowed had the employee traveled during regular duty hours.
2. The chief negotiators will inform each other of the members of their bargaining teams and
alternates five (5) days before the date bargaining is scheduled to begin and will give
reasonable advance notice of any changes thereafter. The name, title, location, e-mail
address, and telephone number of each team member will be provided.
3. Each Party may designate alternates who will participate in the negotiations in the absence
of any other team member.
E. Bargaining Procedures
1. The starting date will be governed by Section 5.A.1 unless the chief negotiators agree
otherwise. The daily schedule for negotiations will be established by the chief negotiators.
2. No official transcript or electronic recordings will be made during the negotiations;

however, each Party may designate a note taker to keep notes and records during the
session(s).
3. Either Party may call a caucus at any time. Caucuses will not exceed 60 minutes, except
by agreement of the chief negotiators. A Party may call no more than two (2) caucuses in
a day, except by agreement of the chief negotiators.
4. The Parties will strive to conduct negotiations as expeditiously as possible and will avoid
unnecessary delays. If a break in negotiations is necessary, the chief negotiators will agree
on a time and date to resume prior to any recess.
5. The chief negotiators may, through mutual agreement, permit a subject matter expert to
attend a negotiating session for the purpose of presenting information that will help the
Parties to resolve issues. The expert will leave the negotiating session as soon as the
presentation to the negotiating teams is finished, unless otherwise agreed.
6. All proposals and counterproposals will be provided in electronic format and, if applicable,
in hard copy. Proposals and counterproposals will be identified as either Union or Agency
and numbered successively. As each proposal or counterproposal is taken up, the Party
offering that proposal or counterproposal will explain it and will, at a minimum, provide
the meaning and objectives of the proposed language. There will be ample opportunity for
questions and answers, additional information, and other discussion. The Parties will
follow this procedure in a good-faith effort to reach agreement.
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7. Both Parties will strive to make the language in the agreement as clear, simple, and
understandable as possible.
8. When agreement is reached, the chief negotiators will sign and date two (2) copies of the
agreement (e.g., Memorandum of Agreement), and each chief negotiator will retain a copy.
F. Facilities and Equipment
1. When negotiations are conducted in person, they will be held in a suitable meeting room
arranged for by the Agency at ICE headquarters or other mutually agreed-upon site. Where
practicable, the Agency will furnish the Union negotiating team with a caucus room, such
as a conference room or other private meeting space in close proximity to the negotiation
room. Where providing a separate caucus room is not practicable, the Union will be
provided the negotiation room as its caucus room.
2. When negotiations are conducted at an ICE facility, the Agency will provide the Union
bargaining team with customary and routine office equipment, supplies, and services,
including, but not limited to, at least one computer hard-wired with internet access,
telephone(s) other than a conference phone, desks and/or tables and chairs, office supplies,
and access to at least one dedicated printer, one dedicated scanner, and one photocopier.
3. Whether negotiations are conducted in person or by telephone or VTC, Union bargaining

team members who are ICE employees may use their Agency-issued office equipment and
available local ICE office equipment and supplies.
G. Issues of Negotiability and Duty to Bargain
1. If either Party alleges that it is not obligated to negotiate on a particular proposal, the Parties
will make a reasonable effort to resolve their differences. If the Parties are not able to do
so, each Party is free to take appropriate action. For example, either Party may request, in
writing, a written declaration of non-negotiability/no duty to bargain, in which event the
other Party will provide a written statement explaining the basis of its non-negotiable
allegation. The written statement will be provided within 10 days of the other Party’s
written request.
2. If the Union files a negotiability appeal with the FLRA, and the Agency withdraws its
allegation of non-negotiability or the Union proposal or a portion of the proposal is ruled
negotiable before a final agreement has been reached, the Parties will commence
negotiations on the proposal or portion of the proposal within 30 days of the final
disposition of the negotiability appeal. Agreed-upon provisions will be incorporated into
the Agreement.
3. A pending negotiability appeal will not delay a final agreement. The Parties will make
every attempt to reach agreement on all other provisions and will initial/sign the agreement
once that agreement is reached.
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4. If the Agency files an unfair labor practice charge over a Union allegation that it has no
duty to bargain over a particular proposal, and the Union withdraws its allegation or a
dispositive ruling that there is a duty to bargain over the Agency proposal or a portion of
the proposal becomes final before a final agreement has been reached, the Parties will
commence negotiations on the proposal or portion of the proposal within 30 days of the
Union’s withdrawal or the ruling becoming final. Agreed-upon provisions will be
incorporated into the Agreement.
5. A pending unfair labor practice charge filed by the Agency over a Union declaration that
it has no duty to bargain over an Agency proposal will not delay a final agreement. The
Parties will make every attempt to reach agreement on all other provisions of the
Agreement and will initial/sign the Agreement once that agreement is reached.
I. Impasses. Impasses in mid-term bargaining negotiations will be resolved in accord with the
following:
1. Impasse During Negotiation. During mid-term negotiations, when it has been determined
that an impasse has been reached, the item shall be set aside. After all negotiable items on
which agreement can be reached have been disposed of, the Parties shall once more attempt
to resolve any existing impasse item.
2. Mediation. If such further consideration does not result in the resolution of the impasse,
the assistance of the Federal Mediation and Conciliation Service may be requested by either
Party.
3. Referral to Impasses Panel. Any impasse that remains unresolved following mediation
may be referred to the Federal Service Impasses Panel in accordance with 5 U.S.C. §
7119(b).
4. Agreements Allowed. The procedure described above shall not preclude the Parties from
agreeing on any issues or from entering into complete agreement with the assistance of the
Mediator or the Panel.
J. Agency Head or Designee Review and Effective Date
1. The agreement will go into effect on the earlier of the date it is approved by the Agency
Head, or designee, or 30 days after it is executed, in accordance with law.
2. If the Agency Head, or designee, disapproves the agreement, the Agency’s chief negotiator
will notify the Union’s chief negotiator immediately, including which particular provisions
were found to be contrary to law, rule, or regulation, as well as the particular law, rule, or
regulation that the Agency Head, or designee, claims was violated. The chief negotiators
will then set a date promptly to resume negotiations within 30 days in an effort to reach
agreement. If negotiations are resumed, the Agency will provide an explanation in order
to expedite and facilitate clarifications or changes the Parties may make to resolve the
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disapproval. In the alternative, the Union may decline further negotiations and instead take
appropriate legal action, including submitting the disputed issues to the FLRA and/or the
appropriate court, as provided by law. Upon a final disposition that a disapproved
provision is within the scope of bargaining, the provision shall automatically become part
of the agreement and go into effect immediately.
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ARTICLE 10
NOTICE TO EMPLOYEES
Section 1. Notice of Union Officers
The annual notice of employees’ right to request Union representation in investigative interviews,
provided in Article 25, will also inform employees that “AFGE, through Local 511, represents the
bargaining unit of ICE professional employees in all labor-management matters. The Collective
Bargaining Agreement is available online through the ICE Office of Human Capital (OHC)
website on the ICE intranet.”
Section 2. New Employees
A. The Agency will inform a new bargaining unit employee in writing: (1) that the Union is the
exclusive representative of employees in the bargaining unit; (2) that bargaining unit
employees have the right to freely and without fear of penalty or reprisal form, join, and assist
a labor organization or refrain therefrom; and (3) that the Union will be provided an
opportunity to give a 30-minute orientation pursuant to Article 8, Section 8.
B. The Agency will provide a new bargaining unit employee with the following in electronic
format:
1. a copy of this Agreement;
2. the OPLA Directory, which includes the names, e-mail addresses, and telephone numbers
of OPLA local stewards and national officers; and
3. the Non-Attorney Professional Union Directory, which includes the names, e-mail
addresses, and telephone numbers of the non-attorney professional local stewards and
national officers.
C. The Agency will notify the Union as soon as practicable when OPLA 101 and OPLA 201 are
scheduled. The Union will be invited, at its expense, to attend each offering of the OPLA 101
and OPLA 201 courses conducted by the Agency and will be introduced to the course
participants. The Union may invite the OPLA 101 and OPLA 201 course participants to arrive
before or remain after training hours for a presentation or reception, at the Union’s own
expense.
Section 3. Copy of Notice for Union Representative
An employee who receives a personally-addressed notice, proposal, or correspondence from the

Agency concerning:
1. an adverse action;
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2. a disciplinary action;
3. a reduction-in-force;
4. denial of a within-grade salary increase;
5. a fitness for duty examination; or
6. an involuntary reassignment or transfer
shall receive an additional copy, which states at the top of the first page, “This copy may at your
option be furnished to your Union representative.”
Section 4. Leave and Earnings Statements
Each employee will be furnished, on a biweekly basis, a National Finance Center payroll earnings
statement showing the employee’s total cumulative earnings and total cumulative deductions from
the first yearly pay period in each standard category. The statement shall also contain annual leave
and sick leave balances.
Section 5. Workplace Injuries and Illnesses
The Agency will provide an employee who is injured while in duty status with the following link
concerning the Employees’ Compensation Operations and Management Portal (ECOMP), the
web-based electronic system selected by the Agency for recording workplace injuries and illnesses
and for processing claims under the Federal Employees’ Compensation Act (FECA):
https://www.ecomp.dol.gov/. The Agency will ensure that injured/sick employees will be given
the appropriate ICE OHC Workers Compensation Program point of contact, as found at
https://insight.ice.dhs.gov/mgt/hc/Pages/workers_compensation/pocs.aspx, to obtain relevant
information and counseling pertaining to benefits under the FECA and will help facilitate their
return to work.
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ARTICLE 11
TRAINING AND DEVELOPMENT
Section 1. General
A. Training and development of employees is important to ensure maintenance of a

knowledgeable, skilled, and able workforce necessary for effective accomplishment of the
Agency mission.
B. Employees are encouraged to take advantage of training and educational opportunities that will
enhance skills and qualifications needed to increase efficiency in the performance of assigned
duties and to pursue career development interests. Such opportunities may include trial
advocacy/legal writing, auditing/accounting, library science, health sciences, architecture, and
engineering courses. Employees also are encouraged to pursue career interests through self-
education, self-development, and self-training.
C. Where the employee is attending job-related training approved by the Agency, the employee
will be in a duty status during periods of time the employee is attending training and would
otherwise be on duty. Upon request, the employee may be given an “in lieu of” Alternative
Work Schedule (AWS) day off, so long as it can be done within the same pay period, when
training takes place on the employee’s assigned AWS day off.
D. The Agency will maintain training records as required by law and regulation.
E. The selection for training will be free from prohibited personnel practices.
F. As soon as practicable, the Agency will notify the Union President of national Agency training
that bargaining unit members are eligible to attend, including the course title, location, and
dates of the training. Upon request, the Agency will provide the Union President a list of
selectees for any national Agency trainings.
Section 2. Mandatory Training
A. Mandatory training, both in person and electronic (e.g., DHS Performance and Learning
Management System [PALMS]), is training that the Agency determines is necessary for
employment with the Agency or for the performance of assigned duties.
B. When an employee is performing specialized duties as of the effective date of this Agreement
or has been selected to perform specialized duties in accordance with Article 14, the Agency
may assign the employee to attend the specialized mandatory training without regard to the
selection process identified in Section 3.
C. The Agency shall provide reasonable advance notice, normally by e-mail, of mandatory
training and reasonable duty time to complete the training.
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D. When an employee cannot attend or complete mandatory training due to unforeseen or exigent
circumstances, the employee may submit a request for temporary deferral of the mandatory
training. The employee must state the reason in sufficient detail to allow the Agency to make
an informed and timely decision on the request for deferral. This provision is not intended to
be used to request deferral of mandatory training provided through PALMS or other online
training for which an employee has been given at least 30 days’ advance notice of the required
completion date.
Section 3. Elective Training
A. Elective training may include training for human rights law, national security law, customs
law, worksite enforcement law, technological resources, etc.
B. Definitions
1. Justified, legitimate reasons. Justified, legitimate reasons include such matters as mission
needs, specific office conditions, direct and indirect costs, prior training attended, recent
conduct deficiency that bears on an employee’s attendance at training, performance issues,
placement on a performance improvement plan, and workload.
2. Seniority. For attorneys, seniority is time as an Agency (including legacy U.S. Immigration
and Naturalization Service and U.S. Customs Service) attorney. For all other bargaining
unit employees, seniority is service computation date.
C. Selection Process. Absent a justified, legitimate reason, the Agency will use the following
method for making employee selections for all elective, government-funded training:
1. Announce training opportunities to all eligible employees. The announcement will be by

e-mail.
2. Solicit volunteers.
3. Select on the basis of a fair and impartial seniority rotation process as determined on a local
level.
4. When training is necessary for the performance of specific or specialized job assignments,
initial selection(s) may be based on assignment of duties. If spaces remain thereafter, the
Agency shall make selections on a rotational basis based on seniority.
5. Prior selection for training will not preclude an employee from selection for an unfilled
training opportunity.
6. Upon request, the basis for disapproval of a request to attend elective training will be
explained in writing to the employee.
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Section 4. Continuing Education Required to Maintain Professional Licensure
Where possible to do so without incurring additional costs, the Agency shall provide continuing
education training opportunities to all attorneys and non-attorney professionals who are required
to complete continuing education for maintenance of their professional licenses (e.g., West Legal
Ed and in-house training). Such continuing education training opportunities will be related to an
employee’s work with the Agency. Employees may attend continuing education training during
duty hours with management approval and will be in duty status for the duration of the training.
Section 5. Employee-Initiated Training
A. An employee may submit (a) request(s) to the immediate supervisor for job-related training
and/or career development opportunities.
B. Training provided by non-governmental vendors or other entities (e.g., state or county bar
associations, law schools, or professional associations) may be considered when available
Agency or other government-sponsored training programs do not meet identified needs for
knowledge, skills, and abilities bearing directly upon the performance of official duties.
C. The training described in this Section may be approved under the following circumstances:
1. the training has been applied for and approved in advance;
2. reasonable inquiry has failed to disclose the availability of a suitable and adequate program
elsewhere in government;
3. funds are available to pay for the training program;
4. the course is not being taken solely for the purpose of obtaining a degree; and
5. the approval of such training will not create undue interference with operational
requirements or an imbalance in staffing patterns.
Section 6. Reassignment Training
When an employee is reassigned on the basis of management need or position abolishment,

sufficient training as determined by the Agency will be provided to the employee to enable him or
her to perform the duties of the new position. The employee will be given a reasonable time to
become proficient in the new position.
Section 7. New Technology Training
With the introduction of new technology, the Agency will provide appropriate basic training.
Upon request, the Agency may provide additional training to employees affected by the
introduction of such new technology.
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Section 8. Training Recommendations
The Union may submit recommendations to the Agency concerning employee training needs and
programs at any time.
Section 9. Labor-Management Relations Training for Union Officers or Stewards
A. General
1. On an annual basis, up to 25 Union representatives (i.e., officers or stewards for the Union)
will be granted official time to attend approved LMR training courses/conferences that are
of mutual benefit to the Parties. These courses/conferences will cover topics such as
contract administration, grievance handling, and information relating to federal
personnel/labor relations laws, regulations, and procedures.
2. Union representatives attending an approved LMR training course/conference pursuant to

Paragraph 1 will be on official time during such time they are attending training and would
otherwise be in duty status.
3. Union representatives referred to in Paragraph 1 will be authorized official time for travel
to and from the approved training course/conference during such time they would
otherwise be in duty status. Consistent with 5 C.F.R. § 550.1403 (definition of “Travel”),
time spent traveling in connection with Union activities cannot be used to accrue
compensatory time off. Training that relates to internal Union business will not be
conducted or attended on official time.
4. The President of the Union, or designee, will submit requests to the Agency’s Chief, Labor
and Employment Law Division, OPLA, or designee, for Union representatives to attend
the LMR training under this Subsection. The Union will make such requests reasonably in
advance of the scheduled training, and the Agency will approve or disapprove such
requests within a reasonable time.
5. Union representatives may from time to time be presented with the opportunity to take
advantage of last-minute or standby training slots, or the need for substitution of one Union
representative for another at a training course/conference when the person originally
approved for official time to attend the training course/conference experiences a problem
preventing attendance as planned. Upon reasonable request by the Union to the appropriate
Agency official, the Agency will act upon the request as soon as practicable and will
immediately notify the Union of its decision.
B. Official Time to Travel to Attend Training at the Union’s Annual Meeting
Where LMR training that is of mutual benefit to the Parties will be held in conjunction with the
Union’s annual meeting, up to 30 Union representatives will be granted official time to travel to
and from that training during such time they would otherwise be in duty status. Consistent with
37
5 C.F.R. § 550.1403 (definition of “Travel”), time spent traveling in connection with Union
activities cannot be used to accrue compensatory time off.
C. Collective Bargaining Agreement Training
1. In addition to what is provided in Section A.1, the Union will be authorized up to eight (8)
hours of official time each for up to 40 Union representatives to attend training that the
Union will provide on this Agreement. The Union may use the Agency’s video facilities
for this training. Representatives will use the facilities at their office or at the nearest
Agency office with that capability if their office does not have the necessary equipment.
The Agency will pay necessary travel expenses if a representative has to go to another
office.
2. Union representatives presenting the training will be authorized 60 hours of official time
per trainer for up to four (4) trainers to prepare, to travel to and from, and present the
training on this Agreement. Trainers may also conduct the training by video.
3. This training will occur during the first year the Agreement is in effect.
4. The Union will coordinate the scheduling of this training with the Agency’s Chief, Labor
and Employment Law Division, OPLA, or designee.
5. The Agency will reimburse the Union up to $500 for printing and materials costs associated
with this training. The Union will provide the Agency with receipts for any expenditures
for which the Union requests reimbursement and will provide the Agency with a copy of
any materials used in the training.
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ARTICLE 12
SAFETY AND HEALTH
Section 1. Safe and Healthful Working Conditions
The Agency will provide safe and healthful working conditions, taking into account the mission
of the Agency and the inherent hazards of the job performed. The Parties shall be governed by the
Health and Safety Regulations and this Agreement. The Parties will also be informed by the ICE
Occupational Safety and Health (OSH) Program Requirement Handbook. The Union President or
designee will request the participation of a Union representative on any national and local Safety
and Health Committee.
Section 2. Reporting of Unsafe Conditions
A. The Union will encourage employees to observe all safety rules and use all equipment and
safeguards provided. In the course of performing their normally-assigned work, employees
will be alert to observe unsafe practices and conditions. Any employee who believes that an
unsafe or unhealthy working condition exists in any workplace should report such condition to
the appropriate safety and health official or the Union.
B. In the case of a threat to life or danger of serious physical harm, the employee shall report the
situation to his or her supervisor as soon as possible.
C. When an employee reasonably believes that his or her life may be in imminent danger, the
employee shall immediately desist in performing his or her duties and evacuate the premises
to safety. The employee will notify his or her supervisor as soon as possible and provide an
explanation.
D. When an employee believes he or she is working under conditions that are unsafe or unhealthy
beyond normal hazards inherent in the operation in question, he or she shall refer the matter to
his or her supervisor. The supervisor will make an evaluation of the working conditions and
advise the employee that the work either be continued or stopped. If requested by the Union,
the supervisor will provide the rationale for the decision in writing. If the supervisor ordered
a cessation of work, any steps taken toward the immediate mitigation of the hazardous working
conditions will be explained to the best extent possible.
E. In the case of an immediate threat to life or danger of physical harm, the Agency shall take all
reasonable steps to ensure the protection and safety of employees, including, if necessary, the
relocation of the employees to relative safety or detail to another office. An on-site Union
representative will be notified of any action. If there is no on-site Union representative, the
Agency will notify the Union President, Executive Vice President, or other Board Member.
F. When the Agency receives a report that a dangerous and/or unhealthy condition, or potentially
dangerous and/or unhealthy condition, is present at a particular worksite, the Agency shall
39
immediately notify a Union representative. If there is no on-site Union representative, the

G. In these circumstances, where the Agency has been asked in writing by a Union representative
for information regarding any such condition, the Agency will acknowledge such inquiry
within 24 hours of receipt and will provide a written response to the Union’s inquiry within 10
days, if practicable.
Section 3. Unsafe Condition Move
In the event of an office relocation that involves the safety or health of employees, the Union will
be notified—in advance of such a move in accordance with Article 9.
Section 4. Assistance for Employees with a Disability
The Agency will develop procedures to ensure that all employees with a disability are provided
appropriate assistance to evacuate buildings in case of emergencies.
Section 5. Tuberculosis Screening
When an employee or the Agency believes that the employee has been exposed to a person with
active tuberculosis (TB) while in an official capacity, the Agency will refer the employee for a
voluntary TB screening. A TB screening test will be offered during normal business hours at no
cost to the employee.
Section 6. Temperature and Humidity
A. The Agency shall take reasonable steps to ensure a safe and healthful working environment,
including reasonable temperature and humidity levels, appropriate physical surroundings, and
reasonable space and equipment necessary to carry out official responsibilities.
B. During available hours of duty, when the indoor temperature falls below 55 degrees or rises
above 80 degrees, the Agency will take immediate and all appropriate action to bring the
temperature within those parameters. The Agency will initiate measures to reduce the risk to
employees by making reasonable efforts to first accommodate employees and then consider
placing them on administrative leave. This only applies to space owned or leased by the
Agency.
Section 7. Office Space and Equipment
The Agency will endeavor to provide employees appropriate physical surroundings, physical
security, and reasonable office space and equipment necessary to carry out official responsibilities
at their official station and any temporary duty location under the control of the Agency.
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Section 8. Environmental Safety
A. When the Agency conducts safety and health inspections and/or Occupational Safety and
Health Administration (OSHA) inspections, the Union will be provided at least 48 hours’
advance notice when practicable and be afforded the opportunity to accompany the inspector
in these inspections. The Agency will provide the Union President or designee with a copy of
the final report generated in connection with the inspection. Safety and health hazards
discovered in these inspections shall be corrected as expeditiously as possible in accordance
with federal requirements.
B. The Agency will ensure that employees who are working in offices or facilities with identified
health or safety hazards (i.e., beyond normal hazards inherent in the operation in question) are
made aware of such hazards, informed of safe and healthful work practices, and educated in
the appropriate use of those practices. Notice will be posted in a conspicuous location or where
general notices are posted.
C. Appropriate abatement procedures will be conducted pursuant to federal requirements when it

is determined by a competent authority that the office and/or facility is determined to be unsafe
or unhealthy.
D. The Agency will notify the Union prior to initiating procedures for asbestos removal.
E. The Agency will notify the Union at such time as it determines the need for an abatement
action. Asbestos abatement plans may include the discontinuance of work or the shifting of
the employee work location. To the extent required by law, the Agency will meet its bargaining
obligation.
F. If air sampling indicates that the airborne concentration of asbestos fibers exceeds regulatory
levels, the Agency will notify the exposed employees in writing within one day after discovery
of the excessive asbestos concentration.
Section 9. Workplace Injuries and Illnesses
A. Reporting. Employees shall report all work-related injuries or work-related illnesses to their
supervisor as soon as possible. The Agency will take appropriate action to ensure that:
1. the employee has the opportunity to report to the Employee Health Physician or his or her
personal physician for treatment, completion of reports, etc.;
2. the Agency will ensure that injured/sick employees are given the appropriate ICE OHC
Workers’ Compensation Program point of contact, as found at
https://insight.ice.dhs.gov/mgt/hc/Pages/workers_compensation/pocs.aspx, to obtain
relevant information and counseling pertaining to benefits under the Federal Employees’
Compensation Act (FECA) and will help facilitate their return to work.
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3. the Agency will provide an employee who is injured while in duty status with the following
link concerning the ECOMP, the web-based electronic system selected by the Agency for
recording workplace injuries and illnesses and for processing claims under the FECA:
https://www.ecomp.dol.gov/.
B. Return to Duty After Work-Related Injury. An employee who has sustained a work-related
injury or work-related illness may be required to perform duties to the extent and within the
limits prescribed by the treating physician or the Employee Health Physician. In the event that
limited duty is not available, the employee will be placed on continuation of pay, if determined
eligible by the Office of Workers’ Compensation Program, or placed in an appropriate leave
status. The Union may suggest limited duty opportunities. At an employee’s request, the
Union may represent the employee at any stage of this procedure.
C. Re-Crediting Leave. If an employee has been charged for sick or annual leave when he or she
is deemed to have been eligible for injury compensation benefits instead, the employee may
repay, in lump sum or by any other plan acceptable to his or her payroll office, the amount
collected while on annual or sick leave and have his or her annual or sick leave balances
credited accordingly, so that he or she may qualify for injury compensation.
Section 10. Toxic Chemicals, Biomedical, and Airborne Hazards
A. When the Agency knows or has a reasonable belief that chemicals generally recognized as
hazardous will be or have been used in areas where employees work, the Union, as well as
affected employees, will be notified. If there is no on-site Union representative, the Agency
will notify the Union President, Executive Vice President, or other Board Member.
B. The Agency will notify employees and the Union, as soon as practicable, of known workplace
biomedical hazards such as TB quarantine, chicken pox outbreaks, and airborne hazards such
as toxic mold and asbestos contamination. If there is no on-site Union representative, the
C. Where the Agency knows of any commercial or large-scale application of pesticides, the
Agency will notify employees and the Union/steward(s), at a minimum, 72 hours in advance
of the application. Individuals with special health needs will advise their immediate supervisor
and will be appropriately accommodated. If there is no on-site Union representative, the
Section 11. Computer Injuries
The Agency will provide reasonable and appropriate accommodation for a medically documented
computer-related work injury.
Section 12. Freedom from Reprisals
Employees shall be free from restraint, coercion, discrimination, or reprisal practiced as a result of
an employee exercising any provision of this Article.
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Section 13. Safety and Health Committee
A. The Agency and the Union agree to cooperate in a continuing effort to avoid and reduce the
possibility of and/or eliminate accidents, injuries, and health hazards in all areas under the
Agency’s control. In that respect, the Agency will ensure a position for and facilitate full
participation of a Union representative on Agency-sponsored Safety and Health Committees.
The Agency will use its best efforts to provide the Union with telephone or VTC access to an
Agency-sponsored Safety and Health Committee meeting. In the event telephone or VTC
access is not provided by the Agency, the Agency may pay travel and per diem expenses for a
Union representative to attend.
B. Upon request, the Union representative on the National Safety and Health Committee will be
invited to attend the ICE Field Collateral Duty Safety and Health Training Course. The Agency
may pay travel and per diem for attendance.
C. Subject to available funding, and upon request, the Agency will offer Union representatives
newly identified to serve on a Safety and Health Committee with a 10-hour OSHA Hazard
Awareness Course found at https://www.nsec.niu.edu/nsec//course-schedules/osha-
courses/osha-0501.shtml.
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ARTICLE 13
TRAVEL
Section 1. General
A. Employees shall be reimbursed for travel on official business in accordance with law and the
Federal Travel Regulation (FTR) and interpretations thereof by the Comptroller General of the
United States, interpretations of the Administrator of the General Services Administration,
Department of Homeland Security Financial Management Policy, and the ICE Travel Policy
Handbook or successive policy, and in accordance with this Agreement.
B. Any change in rates or reimbursements to federal employees by law or regulation during the
life of this Agreement will be adopted on the effective dates of the changes.
Section 2. Definitions
A. Official station. Official station is defined as:
1. the work location (e.g., a headquarters office, field sub-office, etc.) to which an employee
is assigned permanently (i.e., the employee’s permanent duty station (PDS), his or her
primary worksite); or
2. an alternative work location to which the employee is temporarily assigned to report for
duty that is within 50 miles of his or her PDS.
B. Temporary duty location. Temporary duty location is defined as any job site that is not the
employee’s official station, but does not include an alternate duty site under Article 17. The
definition of temporary duty location is applicable for determinations of mileage and other
related travel expenses subject to reimbursement under this Agreement.
C. Local travel. Local travel is defined as travel occurring while an employee is engaged on
official business within the local commuting area. The local commuting area is within 50 miles
of the work location to which an employee is assigned permanently (i.e., the employee’s PDS).
Local travel must be authorized by the employee’s supervisor or other authorizing official.
D. Predetermined Rotational Schedule. A schedule of one or more established rotational

assignments to an alternative work location(s) within the employee’s official station.
Section 3. Travel Status Outside The Local Commuting Area
A. To the maximum extent practicable, the Agency and employees shall schedule the time to be
spent by an employee in a travel status outside the local commuting area within the regularly
scheduled workweek of the employee.
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B. Subject to supervisory approval, where the Agency-designated travel day falls during non-duty
hours, the employee may perform the travel during duty hours on the preceding work day in
lieu of compensatory travel time. If an employee chooses to travel on a day or time other than
that designated by the Agency, the maximum reimbursement for transportation costs will be
limited to the lesser of (a) that which would have been reimbursed had the employee traveled
on the day or at the time selected by the Agency, or (b) the actual transportation costs. The
maximum reimbursement for per diem/subsistence will be limited to that which would have
been allowed had the employee traveled on the day or at the time selected by the Agency.
C. Time spent in a travel status outside the local commuting area of any employee is not hours of
work unless it satisfies the criteria specified in governing law and regulations.
D. In cases where employees are assigned outside the local commuting area and the travel time is
greater than their normal commuting time, the difference in time shall be considered travel in
a duty status, in accordance with 5 C.F.R. § 550.112(j)(2).
E. Except as provided in the FTR, an employee will not be required to travel without a signed and
approved Travel Authorization.
Section 4. Travel Expenses and Reimbursement
A. Generally, employees are responsible for any expenses associated with their normal commute
to and from their workplace (transit subsidy notwithstanding), whether the employee reports
to his or her PDS, or an alternative work location that is part of a predetermined rotational
schedule, subject to the following:
1. When employees are required to report to an alternative work location within their official
duty station that is not part of a predetermined rotational schedule, employees will be
reimbursed in accordance with Subsections B and C.
2. When employees are required to travel to different locations during the workday, after they
have initially reported to their primary or an alternative workplace that day, expenses
associated with that travel will be reimbursed in accordance with Subsection C.
3. When employees request to travel to different work locations during the workday, after
they have initially reported to their primary or an alternative workplace that day, and the
employee’s supervisor has approved the request, expenses associated with that travel may
be reimbursed at the sole discretion of the supervisor in accordance with Subsection C.
B. Employees are allowed reimbursement for that portion of local travel costs which exceeds their
normal commuting costs. To determine excess commuting costs, employees must perform a
constructive cost calculation. Travel costs included in the constructive cost calculation
include, but are not limited to, mileage, tunnel fees, tolls, parking, and ferry fees. After the
constructive cost calculation, final determination of reimbursable expenses for local travel
costs exceeding a normal commute is at the discretion of the employee’s approving official.
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The approving official’s decision will not violate applicable law, rule, regulation, or provisions
of this Agreement.
C. Employees will be reimbursed for local travel expenses by submitting reimbursable expenses
through the Agency’s authorized travel management system. Reimbursable expenses include,
but are not limited to, mileage; tunnel, bridge, and/or ferry fees; parking; and tolls. Employees
should accumulate local travel expenses and submit reimbursement for these expenses when
the total value is over $20 or every 30 days.
D. The Agency has discretion to determine which transportation mode and route are most
advantageous to the government. When the Agency determines that local travel or travel in
connection with assignment to a temporary duty location must be performed by automobile, a
government vehicle is presumed to be the most advantageous method of transportation. If a
government vehicle is not available and the employee does not have a privately-owned vehicle
(POV) or use of the employee’s POV is impracticable or would cause hardship, a rental vehicle
or other mode of transportation may be authorized. An employee using a POV to travel from
home to a temporary duty location and/or from a temporary duty location to his or her home
will be reimbursed for all travel expenses authorized by the FTR.
E. Per Diem
1. Employees are eligible for per diem or actual subsistence allowance when they travel to an
assignment located outside their official station.
2. Employees will not receive per diem unless in a travel status for more than 12 hours.
F. Travel Advances
1. To the maximum extent possible, travel or any extension thereof will be authorized or
ordered in advance in sufficient time for the employee to have in his or her possession a
travel advance prior to starting such travel, if needed.
2. Those employees who have a valid government credit card for travel purposes are to use
that credit card to obtain necessary and appropriate cash advances.
G. When an employee with a disability requires the assistance of an attendant or escort in

connection with official travel, the transportation and per diem expenses of the attendant will
be allowed as necessary expenses for the employee’s travel. Further, in accordance with 41
C.F.R. §§ 300-3.1, 301-13.2 and 301-13.3, the Agency may pay expenses it deems necessary
to accommodate an employee with special needs that are clearly visible and discernable or that
are substantiated in writing by a competent medical authority. Depending on the circumstances
and the employee’s particular special need(s), additional allowable expenses may include, but
are not limited to, specialized transportation to, from, and/or at temporary duty locations;
baggage handling costs that are the direct result of the employee’s special need(s);
transportation or rental of a wheelchair; and premium class common carrier accommodations
when necessary to accommodate the employee’s special need(s).
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H. Government-owned or government-leased automobiles are to be used for official purposes

only. Misuse of such vehicles subjects employees to penalties under 31 U.S.C. § 1349(b).
I. Use of a government-reimbursed rental vehicle.
1. Use of a government-reimbursed rental vehicle while on temporary duty is authorized only

for official purposes, which means travel to/from:
a. places of official business;
b. places of official business and places of temporary lodging;
c. restaurants, drug stores, barber shops, places of worship, cleaning establishments, and
similar places necessary for the sustenance, comfort, or health of the employee, as
reasonable under the circumstances to foster the continued efficient performance of
Agency business; and
d. the car rental location and any of the above.
J. The Agency will provide employees required to travel as part of their official duties with
necessary training on processing an authorization for official travel and filing a reimbursement
claim for official travel. Employees needing additional training on these topics shall, upon
request, receive such training from the Agency as soon as practicable.
K. Employees who are assigned to training or duty away from their official station, and who elect
to check out of their temporary lodging establishment and return home during non-work days,
will be reimbursed for round-trip transportation not to exceed the amount that would have been
reimbursed for per diem had they remained at the training or duty location during the non-work
days.
Section 5. Compensatory Time Off for Travel
A. Employees may accrue compensatory time off for official travel pursuant to 5 C.F.R. Part 550,
Subpart N.
B. Compensatory time off for travel is only available when an employee is required to travel away
from the official station and the travel time is not otherwise compensable hours of work under
other legal authority. Compensatory time off for travel may be earned in 15-minute
increments. To the extent practicable, official travel shall be accomplished during an
employee’s normal duty hours.
C. Procedure for Requesting and Taking Compensatory Time Off for Travel.
1. Prior to traveling on official business, an employee must submit to his or her supervisor a
proposed travel itinerary via e-mail. The itinerary must include: (a) the reason for the
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travel; (b) the proposed travel dates and times; (c) the proposed mode of travel; and (d) an
estimate of the travel time during non-working hours. Employees proposing to travel
during non-working hours should receive supervisory approval of their travel itinerary
prior to departure.
2. Within five (5) workdays after returning from travel, if an employee was in travel status
away from the employee’s official station during non-work hours that are not otherwise
compensable, the employee shall submit to his or her first-line supervisor a request for
compensatory time off for travel using the Compensatory Time Off for Travel Form (see
Appendix B). The request must include a copy of the employee’s travel authorization and
itinerary received from the contract travel agency, if applicable. After receiving
supervisory approval on the form, employees shall ensure a Premium Pay Request is
submitted through the Agency’s system of reporting time and attendance (e.g., WebTA) in
order to have the approved travel compensatory time off credited to their leave account.
The Premium Pay Type is “Compensatory Time Earned” and the Transaction Type is
“Comp Time/Travel Earned.”
3. Compensatory time off for travel may be taken in 15-minute increments. Requests to use
compensatory time off will be submitted using the Agency’s system of reporting time and
attendance (e.g., WebTA). If an employee fails to use the compensatory time off within
26 pay periods after it was credited, the employee forfeits it. An employee may not transfer
payment for unused compensatory time off upon leaving ICE.
D. Employees may accrue compensatory time off for travel in accordance with 5 C.F.R.
§ 550.1406. Specifically, the following guidelines apply:
1. Travel outside scheduled hours of work between an employee’s home and a transportation
terminal is considered creditable travel time only when the transportation terminal is
outside the limits of the employee’s official station and only to the extent that such travel
time exceeds the normal commuting time.
2. Travel time for travel involving more than one time zone shall be counted from the time
zone of first departure.
3. An “extended” waiting period (i.e., an unusually long wait during which the employee is
free to rest, sleep, or otherwise use the time for his or her own purposes) is not considered
time in a travel status.
4. For employees working a flexible work schedule, hours of travel during the “tour of duty,”
as defined in Article 15, on any assigned or scheduled workday are considered
compensable hours of work and not credited toward compensatory time off for travel unless
the employee has already fulfilled his or her basic work requirement.
5. Employees who elect to travel on a day or at a time other than that selected by the Agency
only receive the lesser of (a) the estimated time in a travel status had the employee traveled
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on the day or at the time selected by the Agency, or (b) the employee’s actual time in a
travel status.
Section 6. Travel for Continuing Education
Employees are encouraged to complete continuing education through online resources or at no

cost to the Agency. With management approval, an employee who is traveling to or from a
continuing education training course or session during his or her “tour of duty,” as defined in
Article 15, Section 2.M, will be traveling in a duty status for such time that exceeds his or her
normal commute to or from his or her official station, but only to the extent the total creditable
travel time does not exceed two (2) hours each way. Reimbursement for such travel expenses is
covered by Section 4.
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ARTICLE 14
TEMPORARY AND SPECIAL ASSIGNMENTS
Section 1. Purpose
The Agency will equitably select employees for temporary and special assignments. This Article
does not address reimbursement for travel on official business. Travel pursuant to temporary or
special assignments is addressed in Article 13.
For the purposes of this Article, the following definitions apply:
A. Temporary Assignment. An assignment of limited or a fixed duration involving: (1) different

job duties; (2) duties outside of the employee’s Area of Responsibility (AOR); (3) duties
outside of the local commuting area; or (4) duties at a higher or supervisory/management level.
1. Type I Temporary Assignment. Temporary assignment of an employee to substantially

similar job duties outside of the employee’s AOR or local commuting area (e.g.,
assignment to another OPLA field office, assignment to another financial operations office,
etc.) for a limited or fixed duration.
2. Type II Temporary Assignment. Temporary assignment of an employee to substantially

different job duties (e.g., Special Assistant U.S. Attorney, OPLA headquarters). Type II
may either be Short Term (duration of less than one year) or Long Term (duration of one
year or longer).
3. Type III Temporary Assignment. Temporary assignment of an employee to duties at a

higher or supervisory/management level (e.g., Acting Deputy Chief Counsel) for more than
120 days.
B. Special Assignment. The designation or assignment of an attorney to perform specialized

duties for a fixed or indefinite period of time in the following specialties: human rights law,
customs law, Violence Against Women Act, federal litigation, juvenile law, worksite
enforcement, and similar specializations that may exist or be created in the future. Special
assignments also include special projects expected to last over 15 days or to comprise at least
25% of the employee’s duty time. This also includes serving as a training instructor.
C. Area of Consideration. The office or geographic area from which volunteers may be solicited.
D. Qualified. The employee meets the prescribed and published knowledge, skills, abilities
(KSAs) and experience required for a particular temporary assignment.
E. Seniority. See Article 2, Section G.1.
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F. AOR. A predefined geographic region assigned to an OPLA field office.
Section 3. Management Rights and Obligations
A. The Agency retains the right to assign employees and shall exercise this authority under
applicable law, appropriate regulations, and this Agreement. This includes the right to:
1. determine the requisite KSAs, experience, competencies, and characteristics for temporary
and special assignments;
2. determine the area of consideration for a temporary assignment; and
3. select a qualified individual without issuing an announcement or seeking volunteers

under the following circumstances:
a. an exigent need resulting from emergent circumstances or circumstances unanticipated

by the Agency or program;
b. a temporary assignment relating to the knowledge, skills, training, experience, or job

duties of a uniquely qualified employee;
c. a predetermined rotational assignment; and
d. a temporary or special assignment given to a Senior Attorney.
B. The Agency will maintain an assignment process that is free of bias, favoritism, and prohibited
personnel practices and, where applicable, fully complies with statutory merit system
principles.
C. Absent the circumstances in Subsection A.3, the Agency shall use volunteers before requiring
employees to participate in a temporary assignment.
D. The Agency shall provide notice to employees of temporary and special assignment
opportunities as soon as practicable prior to the commencement of the assignment.
E. Selections will be made on the basis of the advertised requirements and any other criteria in
accordance with this Article.
Section 4. Competitive Service Employees: Temporary Assignments
Competitive service employee temporary assignments and promotions to higher-graded positions

will be processed under the applicable Agency merit promotion program.
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Section 5. Process for Announced Assignments
A. Announcements. In its announcements of temporary and special assignment opportunities, the

Agency will:
1. use the e-mail system to announce assignment opportunities to all eligible employees;
2. identify the area of consideration; nature of the duties; KSAs and any required special
experience, competencies, and characteristics; location; duration; and grade level of the
assignment in the announcement;
3. specify the open period for submission of volunteer interest forms in the announcement
(refer to Appendix C for Voluntary Assignment Request Form);
4. select the employee for the assignment in accordance with Subsections C and D;
5. provide as much advance notice as possible to employees selected for an assignment; and
6. announce the selectee by e-mail within the area of consideration.
B. Records. The Agency shall maintain copies of all assignment applications for 60 days beyond
the announcement of the selection. Upon request, such records will be made available for
inspection by the Union consistent with law and regulations.
C. Voluntary Temporary and Special Assignment Selection Procedures
The Voluntary Temporary and Special Assignment Selection Procedures will be as follows:
1. After the close of the announcement, the Agency will consider the following:
a. the volunteer’s written submission of the form in Appendix C, Voluntary Assignment

Request Form;
b. whether the volunteer possesses the requisite KSAs and other specified requirements;
c. the volunteer’s reliability, trustworthiness, and professionalism; and
d. the volunteer’s current assignment(s) and workload.
2. When specialized skills are required, the best-qualified volunteer may be selected. Where
equally qualified candidates exist for a temporary or special assignment requiring
specialized skills, the selection will be based on seniority.
3. When specialized skills are not required and after consideration of Subsection C.1, where
all other factors are considered equal, the selection for a temporary or special assignment
will be based on seniority.
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4. Selection for a prior voluntary temporary assignment does not automatically preclude
selection for a subsequent voluntary temporary assignment.
a. Type I Temporary Assignment. Once an employee has been selected for a Type I, the
Agency will not select the employee for a subsequent Type I for a period of 36 months
after the date the previous assignment ends, unless all qualified and available applicants
in the area of consideration also have served a Type I within the past 36 months.
Selection for a Type I does not preclude an employee from selection for a Type II or a
Type III.
b. Type II Temporary Assignment.
(1) Short Term. Once an employee has been selected for a Short-Term Type II, the
Agency will not select the employee for a subsequent Short-Term Type II for a
period of 36 months after the date the previous assignment ends, unless all qualified
and available applicants in the area of consideration also have served a Short-Term
Type II within the last 36 months. Selection for a Short-Term Type II does not
preclude selection for a Type I, a Long-Term Type II, or a Type III.
(2) Long Term. Once an employee has been selected for a Long-Term Type II, the
Agency will not select the employee for a subsequent Long-Term Type II for a
period of 36 months after the date the previous assignment ends, unless all qualified
and available applicants in the area of consideration also have served a Long-Term
Type II within the past 36 months. Selection for a Long-Term Type II does not
preclude selection for a Type I, a Short-Term Type II, or a Type III.
c. Type III Temporary Assignments. Once an employee has been selected for a Type III
temporary assignment, the Agency will not select the employee for a subsequent Type
III for a period of 12 months after the date the previous assignment ends, unless all
qualified and available applicants in the area of consideration also have served a Type
III within the past 12 months. Selection for a Type III does not preclude an employee
from selection for a Type I or a Type II.
5. Selection for one special assignment does not automatically preclude selection for a
subsequent special assignment.
6. An employee’s prior involuntary temporary assignment shall not exclude the employee
from consideration and potential selection for a voluntary temporary assignment.
7. Upon request, the local program office shall provide a list of its bargaining unit members’
entry on duty date or service computation date to the Union representative.
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D. Involuntary Temporary Assignment Selection Procedures
1. The Agency will make reasonable efforts to limit the imposition of involuntary temporary
assignments. When involuntary temporary assignments tasked to a particular program
office create undue hardship for the office, the Agency may consider expanding the area
of consideration to increase the pool of individuals from which involuntary assignees are
selected.
2. In the event there are no qualified volunteers to an announced temporary assignment, the
Agency will select an employee based on inverse seniority, the requisite KSAs and
experience, involuntary temporary assignment history, and workload. In an effort to
encourage volunteers, employees who previously volunteered and served for a Type I,
Type II, or Type III temporary assignment will not ordinarily be selected for an involuntary
assignment of the same type for 12 months after the date the previous assignment ends,
absent operational need. With Agency approval, a qualified employee from the area of
consideration may volunteer to fill in for an employee who has been selected for an
involuntary temporary assignment. In such cases, the temporary assignment will count as
neither a voluntary nor involuntary assignment for purposes of subsequent announcements.
3. Whenever practicable, once an employee serves an involuntary temporary assignment, the

Agency will not select the employee for another involuntary temporary assignment until
all qualified and available employees in the area of consideration also have served an
involuntary assignment.
4. An employee may request an exemption from an involuntary temporary assignment. The

exemption request shall be in writing and shall specify the reasons in sufficient detail to
allow the Agency to make an informed and reasonable decision on the request (refer to
Appendix D for Assignment Exemption Form). The exemption from involuntary
temporary assignments shall last for no more than six (6) months at a time. Any medical
information provided to support a request for an exemption from an involuntary temporary
assignment will be treated confidentially and with appropriate recognition of the
employee’s (and/or family member’s) right of privacy. Any medical or other confidential
documentation provided to support a request will be returned to the employee or
maintained in accordance with applicable law and regulation. This does not preclude the
Union’s right to information in accordance with applicable law and regulation.
5. Union Executive Board Members may request to be exempted from involuntary temporary
assignments.
6. Should the requirements of the Agency necessitate an employee being temporarily assigned
to a lower-graded position, this will in no way adversely affect the employee’s salary,
classification, overtime eligibility, or job standing.
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Section 6. Extension of Temporary Assignments
A. Where there is mission need, the Agency may extend a temporary assignment an additional 30
days beyond the duration set forth in the announcement for the temporary assignment. The
Agency may direct an additional extension.
B. Extending a temporary assignment will not change a Short-Term Type II temporary

assignment to a Long-Term Type II temporary assignment.
C. An employee may request an exemption from the extension of a temporary assignment. The
exemption request shall be in writing and shall specify the reasons in sufficient detail to allow
the Agency to make an informed and reasonable decision on the request (refer to Appendix E
for Voluntary Temporary Assignment Extension Exemption Request Form). Any medical
information provided to support a request for an exemption from the extension of a temporary
assignment will be treated confidentially and with appropriate recognition of the employee’s
(and/or family member’s) right of privacy. Any medical or other confidential documentation
provided to support a request will be returned to the employee or maintained in accordance
with applicable law and regulation.
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ARTICLE 15
HOURS OF WORK
Section 1. Purpose
This Article shall be administered in accordance with 5 U.S.C. Chapter 61, 5 C.F.R. Part 610, and
this Agreement. The purpose of this Article is to prescribe the policies covering hours of work for
all employees in accordance with applicable law and regulation.
A. Administrative Workweek means any period of seven (7) consecutive 24-hour periods
designated in advance by the head of the Agency under 5 U.S.C. § 6101.
B. Alternative Work Schedule (AWS) means both flexible and compressed work schedules.
C. Basic Work Requirement means the number of hours, excluding overtime hours, an employee
is required to work or to account for by charging leave or other approved absence. For full-
time employees, the basic work requirement is 80 hours per biweekly pay period. A part-time
employee’s basic work requirement is the number of hours the employee is scheduled to work
in a biweekly pay period.
D. Biweekly Pay Period means the two-week period for which an employee is scheduled to
perform work.
E. Compressed Work Schedule (CWS) means:
1. in the case of a full-time employee, an 80-hour biweekly basic work requirement that is
scheduled by the Agency for fewer than 10 workdays for a minimum of eight (8) hours and
a maximum of 10 hours in a day; and
2. in the case of a part-time employee, a biweekly basic work requirement of fewer than 80
hours that is scheduled by the Agency for fewer than 10 workdays and that may require the
employee to work a minimum of eight (8) hours and a maximum of 10.5 hours in a day.
F. Core Hours is the minimum time range in a workday during which an employee is required to
work or that an employee must otherwise account for by charging leave or other approved
absence.
G. Employee Decision Period (EDP) means the period during which an employee elects a work
schedule.
H. Flexible Hours means the times during the workday, workweek, or pay period within the tour
of duty in which an employee covered by a flexible work schedule may choose to vary his or
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her time of arrival to and departure from the worksite, consistent with the duties and
requirements of his or her position.
I. Flexible Work Schedule (FWS) means a work schedule established under 5 U.S.C. § 6122 that:
1. in the case of a full-time employee, has an 80-hour biweekly basic work requirement that
allows an employee to determine his or her own schedule within the limits set by this
Agreement; and
2. in the case of a part-time employee, has a biweekly basic work requirement of fewer than
80 hours that allows an employee to determine his or her own schedule within the limits
set by this Agreement.
J. Maxiflex Schedule is a type of FWS in which a full-time employee completes a basic work
requirement of 80 hours for the biweekly pay period in fewer than 10 workdays, and in which
an employee may vary the number of hours worked on a given workday or the number of hours
each week within the limits established by this Agreement.
K. Part-Time Work Schedule means a basic work requirement that is 80% or less of the full-time
80 hours per biweekly pay period requirement.
L. Tour of Duty means the hours of a day and the days of an administrative workweek that
constitute an employee’s regularly scheduled administrative workweek. Tour of duty under
an FWS means the limits set by this Agreement within which an employee must complete his
or her basic work requirement. Under a CWS or other fixed schedule, tour of duty is
synonymous with the basic work requirement.
M. Variable Week Schedule (VWS) is a type of FWS in which a full-time employee is required
to work five (5) days a week, but in which an employee may vary the number of hours worked
on a given workday or the number of hours each week within the limits established in this
Agreement.
Section 3. General Provisions
A. The administrative workweek will generally be a period of seven (7) consecutive days
beginning on Sunday.
B. The basic workweek shall be Monday through Friday. Exceptions may occur only when
mission requirements make it necessary to include Saturdays or Sundays as part of the basic
workweek for certain employees.
C. Normally, an employee’s workweek shall not extend over more than five (5) days of the period
Sunday through Saturday.
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Section 4. Hours of Duty
The hours of duty available for employee work schedules are between 6 a.m. and 7:30 p.m.
Exceptions may occur when necessitated by mission requirements or by mutual agreement of the
Parties. In such cases, the flexible hours will be modified accordingly.
Section 5. Core Hours
The core hours for all employees will be 9 a.m. to 3 p.m. 1 Notwithstanding the core hours,
employees must be present at work to fulfill all obligations on any given day, including, but not
limited to, court and duty attorney assignments, training programs, mandatory meetings, and other
Agency needs.
Where an office has a court requirement, the start of core hours for designated court attorneys will
be no later than 30 minutes before the start of that attorney’s court assignment. For backup/standby
attorneys, the start of core hours will be no later than 30 minutes before the earliest court
calendar/docket for that office. If an attorney is not assigned to court or as a backup/standby
attorney, the core hours will remain from 9 a.m. to 3 p.m.
Section 6. Flexible Hours
The flexible hours during which employees on a flexible schedule may begin their workday are
6 a.m. to 9 a.m. The flexible hours during which employees on a flexible schedule may end their
workday are 3 p.m. to 7:30 p.m.
Section 7. Meal Periods
Employees shall be granted, on a non-paid basis, a meal period each day. Normally, this will be
scheduled at or near the mid-point of the hours of duty. Meal periods cannot be credited toward
duty time or taken at the beginning or the end of the workday to adjust arrival or departure time.
The minimum lunch period is 30 minutes. The meal period for employees on an AWS may be up
to 60 minutes, provided that employees account for the entire work requirement for the day, either
by working or by using leave or other approved absence. Consistent with regulations, breaks may
not be combined with the meal period to extend the meal period.
Section 8. Breaks
Employees are to be provided two (2) 15-minute breaks, one in the morning and one in the
afternoon. Breaks shall be taken in a manner consistent with job responsibilities. The breaks may
not be taken at the beginning or the end of the workday to adjust arrival or departure time.
1
Only employees who have been working on a 4/9/4 schedule continuously since before January 1, 2011, may have
core hours other than 9 a.m. to 3 p.m. Those employees are grandfathered and may remain on the 4/9/4 schedule until
they select and are approved to work a different schedule. If at any EDP a 4/9/4 grandfathered employee changes to
a different schedule, that employee cannot subsequently return to a 4/9/4 schedule.
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Section 9. Timekeeping Procedures
All employees will maintain an accurate time and attendance record in the standard reporting
system for time and attendance (e.g., WebTA). The Agency may require employees to maintain a
separate record of arrival and departure times.
Section 10. Alternative Work Schedules
A. Employees may request any of the following work schedules that fulfill mission requirements
and meet the needs of the employees. Available work schedules are as follows:
1. Flexible Work Schedules
a. Variable Week Schedule. Employees working the VWS have a basic work requirement
of 80 hours in each biweekly pay period. They are required to work five (5) workdays
per week during the core hours established in Section 5. They may choose a different
arrival and departure time for each workday within the flexible hours established in
Section 6, and they may vary the number of hours worked each workday and/or
workweek.
The employee may work or account for time by use of leave or other form of excused
absence as few as five (5) hours and as many as 12.5 hours on any given workday,
excluding the meal period provided in Section 7, and a minimum of 25 hours and a
maximum of 55 hours in any given workweek.
An example of a VWS with a 30-minute meal period is:
First Monday 8 a.m. – 3:30 p.m. (7 hours)

First Tuesday 6 a.m. – 7:30 p.m. (12.5 hours) 2
First Wednesday 7 a.m. – 6 p.m. (10 hours)
First Thursday 8:15 a.m. – 3:30 p.m. (6.75 hours)
First Friday 8 a.m. – 4:30 p.m. (8 hours)
44.25 hours
Second Monday 8 a.m. – 4 p.m. (7.5 hours)
Second Tuesday 8 a.m. – 4:30 p.m. (8 hours)
Second Wednesday 7 a.m. – 3:30 p.m. (8 hours)
Second Thursday 8:15 a.m. – 3 p.m. (6.25 hours)
Second Friday 8:30 a.m. – 3 p.m. (6 hours)
35.75 hours
44.25 + 35.75 = 80 hours
b. Maxiflex Schedule. Employees working the Maxiflex Schedule are required to work
during the core hours established in Section 5 at least eight (8) workdays each biweekly
pay period. They may choose arrival and departure times within the flexible hours
2
Note that 12.5 hours is the maximum number of hours that can be worked in one day.
59
established in Section 6, as well as up to one day off per workweek within the biweekly
pay period. They may vary the number of hours worked on a workday or in a
workweek.
The employee may work or account for time by use of leave or other form of excused
absence as few as five (5) and as many as 12.5 hours on any given workday, excluding
the meal period provided in Section 7, provided the employee has a total of 80 hours
each biweekly pay period. In order to schedule court in advance and meet office
obligations, employees will be required to retain their preassigned AWS day off unless
a change is approved in advance by a supervisor.
An example of a “Maxiflex in 9” Schedule with a 30-minute meal period is:

First Tuesday 7 a.m. – 6:30 p.m. (11 hours)
First Wednesday 9 a.m. – 3 p.m. (5 hours) 3
First Thursday 8 a.m. – 3:30 p.m. (7 hours)
First Friday No work (0 hours)
30 hours
Second Monday 7 a.m. – 4:30 p.m. (9 hours)
Second Tuesday 6:30 a.m. – 7 p.m. (12.5 hours)
Second Wednesday 6:30 a.m. – 5:30 p.m. (10 hours) 4
Second Thursday 7 a.m. – 6 p.m. (10.5 hours)
Second Friday 7:30 a.m. – 4 p.m. (8 hours)
50 hours
30 + 50 = 80 hours
An example of a “Maxiflex in 8” Schedule with a 30-minute meal period is:

First Tuesday 7 a.m. – 6:30 p.m. (11 hours)
First Wednesday 8:30 a.m. – 6 p.m. (9 hours)
First Thursday 8 a.m. – 6:30 p.m. (10 hours)
First Friday No work (0 hours)
37 hours
Second Monday 7 a.m. – 6:30 p.m. (11 hours)
Second Tuesday 7 a.m. – 6 p.m. (10.5 hours)
Second Wednesday 7 a.m. – 6:30 p.m. (11 hours)
Second Thursday 7 a.m. – 6 p.m. (10.5 hours)
Second Friday No work (0 hours)
43 hours
37 + 43 = 80 hours
3
On this day, the employee took a 60-minute meal period.
4
On this day, the employee took a 60-minute meal period.
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2. Compressed Work Schedules
a. 5/4-9 Schedule
Employees working a 5/4-9 Schedule are required to work eight (8) nine-hour
workdays and one eight-hour workday, or otherwise account for time by use of leave
or other form of excused absence, for a total of 80 hours in a biweekly pay period,
excluding the meal period provided in Section 7.
b. 4-10 Schedule
Employees working a 4-10 Schedule are required to work four (4) 10-hour workdays
per week, or otherwise account for time by use of leave or other form of excused
absence, for a total of 40 hours a week and 80 hours a biweekly pay period, excluding
the meal period provided in Section 7.
c. Choices when requesting a compressed work schedule. During the EDP, the employee
must choose a fixed period of 30 to 60 minutes for the unpaid meal period and fixed
arrival and departure times that are the same for each workday (except for the short day
of a 5/4-9 Schedule). The selected schedule and arrival and departure times are fixed
for the duration of the EDP. The arrival and departure times must be within the hours
of duty established in Section 4. Employees are required to work during the core hours
established in Section 5each workday. In order to schedule court in advance and meet
office obligations, employees electing to participate in the compressed schedule must
maintain the same schedule identified during the EDP, unless a change is approved in
advance by a supervisor.
B. Requests for Alternative Work Schedules
1. An EDP will be held twice a year during the first two (2) weeks of the months of January
and July in order to permit employees an opportunity to elect a work schedule. A new
employee or transferee from within the bargaining unit may make an election request at his
or her entry on duty date. If the Agency determines that an employee is no longer excluded
from the bargaining unit, the employee may make an election request upon his or her return
to the bargaining unit. Requests will be in writing, which may include use of an EDP form
(see SAMPLE at Appendix F).
2. To facilitate each employee obtaining a mutually agreeable schedule, employees are

strongly encouraged to submit as many different AWS options as they wish to have
considered. Employees who do not submit a request for an AWS will be assigned to a
VWS consistent with Agency needs.
C. Approval/Disapproval of Work Schedule Requests
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1. A supervisor will use best efforts to review and approve or disapprove a proposed work
schedule as soon as practicable after the close of the EDP.
2. If more employees request the same work schedule or day(s) off than can be
accommodated, a manager will give priority to seniority, as defined in Article 2, Section
G, when determining employee work schedules and/or days off, subject to each office’s
mission needs. If none of an employee’s requested work schedule options is approved, the
employee will be assigned to a VWS consistent with Agency needs.
3. Supervisors will notify employees of the approval or disapproval of a work schedule in

writing. Upon request, the reason for disapproval will be explained in writing. Denials of
requests to work an AWS will not be arbitrary or capricious. The approved work schedules
will become effective the second pay period after the end of the EDP and will stay in effect
until the next EDP.
4. In the event a desired schedule cannot be accommodated at the beginning of the EDP, the
Agency may, in its sole discretion, implement the requested schedule once conditions
change allowing mission needs to be met. The new schedule will then be in effect until the
next EDP.
5. An employee may not request to change an approved work schedule between one EDP and
another unless the employee demonstrates a hardship. The Agency may direct an employee
to change his or her schedule either permanently or temporarily based on mission needs,
failure to comply with the time requirements of the employee’s approved schedule, or
substandard performance.
D. Impact of Temporary Assignment, Training, and Court Leave on Alternative Work Schedules
1. Temporary Assignment. Employees on temporary assignment may continue on their work

schedules provided prior supervisory approval is obtained from the temporary assignment
office and the circumstances of the temporary assignment so permit. Otherwise, an
extended temporary assignment may require that an employee be assigned to a VWS
consistent with the temporary assignment requirements.
2. Training. Employees attending training may continue on their work schedules provided
prior supervisory approval is obtained and the circumstances of the training so permit.
Otherwise, attending training may require that an employee be assigned to a VWS
consistent with the training program requirements.
3. When an employee is required to change his or her schedule for a temporary assignment
or training assignment and returns to his or her original position before the start of a new
pay period, the employee may resume his or her normal approved work schedule to the
extent possible.
4. Court Leave. Employees on court leave, as defined in Article 18, Section 5, may continue
on their work schedules provided the circumstances of the employee’s obligations to the
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court so permit. Otherwise, an employee on court leave may be assigned to a VWS with
prior supervisory approval.
Section 11. Alternative Work Schedules for Part-time Employees
Alternative work schedules will be made available to part-time employees in the bargaining unit.
A. Part-time employees on an FWS must, at a minimum, work two (2) days in each week and five
(5) days in each biweekly pay period. Subject to the core hours set forth in Section 5, part-
time employees on an FWS may vary the number of hours worked on a workday or in a
workweek, provided they meet the total number of hours in each biweekly pay period required
under their particular appointment, excluding any meal periods taken.
B. Part-time employees on a CWS must, at a minimum, work two (2) days in each week and five
(5) days in each biweekly pay period. Subject to the core hours set forth in Section 5, part-
time employees on a CWS work the same number of days of the week in every biweekly pay
period. The number of hours in each workday is the same. Arrival and departure times are
fixed and are the same for each day worked. The employee must select a fixed period of 30 to
60 minutes for the unpaid meal period. The employee works the total number of hours in each
biweekly pay period required under the employee’s particular appointment, excluding any
meal periods taken.
Section 13. Holidays
A. Legal Public Holidays. The following are legal public holidays for employees in the
bargaining unit:
1. New Year’s Day, January 1.

2. Birthday of Martin Luther King, Jr., the third Monday in January.
3. Washington’s Birthday, the third Monday in February (sometimes referred to as
Presidents’ Day).
4. Memorial Day, the last Monday in May.
5. Independence Day, July 4.
6. Labor Day, the first Monday in September.
7. Columbus Day, the second Monday in October.
8. Veterans Day, November 11.
9. Thanksgiving Day, the fourth Thursday in November.
10. Christmas Day, December 25.
11. Inauguration Day, January 20 of each fourth year after 1965, for employees in the District
of Columbia, Montgomery and Prince George’s Counties in Maryland, Arlington and
Fairfax Counties in Virginia, and the Cities of Alexandria and Falls Church in Virginia.
12. Any other day declared a holiday by federal statute or Executive Order.
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B. “In Lieu of” Holiday.
1. When a holiday falls on a non-workday outside a full-time employee’s basic workweek,

he or she is entitled to an “in lieu of” holiday. Except when the holiday falls on a Sunday,
the day to be treated as the “in lieu of” holiday is the workday immediately preceding the
non-workday.
2. For full-time employees on an AWS whose regularly scheduled AWS day off is a holiday
or holiday observed, the workday immediately preceding that day will be designated as the
employee’s “in lieu of” holiday. The Agency may select an alternative “in lieu of” holiday
for employees on a CWS if the Agency head or designee determines that a different “in
lieu of” holiday is necessary to prevent an “adverse agency impact,” as defined in 5 U.S.C.
§ 6131(b). As a matter of administrative discretion, the Agency may select an alternative
“in lieu of” holiday for employees on an FWS where required to meet Agency needs.
3. When a holiday falls on a non-workday of a part-time employee, that employee is not

entitled to an “in lieu of” holiday.
C. Flexible Work Schedule Holiday Hours
1. Employees on an FWS will be paid for holiday hours as follows:
a. A full-time employee on an FWS is entitled to eight (8) hours of pay on a holiday when
the employee does not work.
b. A part-time employee is entitled to a holiday when the holiday falls on a day when he
or she would otherwise be required to work or take leave. A part-time employee on an
FWS is generally excused from duty for the number of hours of his or her basic work
requirement on that day, not to exceed eight (8) hours. Part-time employees who are
excused from work on a holiday receive their rate of basic pay for the hours they are
regularly scheduled to work on that day.
2. If an employee on a Maxiflex Schedule wishes to “make up” a shortage in the basic work
requirement resulting from a holiday, the employee may, with prior supervisory approval,
work on his or her preassigned AWS day off, subject to the core hours requirement. With
prior supervisory approval, a part-time employee may work on his or her non-workday,
subject to the core hours requirement.
D. Compressed Work Schedule Holiday Hours
A full-time or part-time employee on a CWS who does not work because of a holiday receives
his or her rate of basic pay for the number of hours he or she was scheduled to work on the
holiday. For example, if a holiday falls on a 10-hour workday, the employee’s holiday is 10
hours.
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Section 14. Emergency Situations
If an employee wants to “make up” a shortage in the basic work requirement resulting from a
delayed opening or limited early dismissal, the employee may, with prior supervisory approval,
work on his or her preassigned AWS day off. A part-time employee, with prior supervisory
approval, may work on a day he or she is not otherwise scheduled to work. Any hours worked on
the preassigned AWS day off must be a minimum of two (2) hours and within the hours of duty
established in Section 4. Any hours worked by a part-time employee on a day not regularly
scheduled for work must be a minimum of two (2) hours and within the hours of duty established
in Section 4.
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ARTICLE 16
PART-TIME EMPLOYMENT
Section 1. Introduction
A. Where consistent with mission requirements, part-time employment can be an effective tool
for recruitment and retention because it provides management with the flexibility to meet work
requirements and allows current or potential employees to maintain a reduced work schedule
to balance work-life demands, including, but not limited to, hardship or temporary personal
situations (e.g., child care, elder care, family medical situations, educational pursuits).
B. In accordance with 5 U.S.C. § 3401(2), a part-time permanent employee works between 16

and 32 hours in a week (or 32 and 64 hours in a biweekly pay period in the case of an
Alternative Work Schedule under Article 15).
Section 2. General Considerations
A. A part-time permanent employee is eligible for benefits in accordance with government-wide

regulations, which generally provide the same benefits as a full-time employee but on a
prorated basis (e.g., leave, retirement, health and life insurance coverage).
B. To the extent practicable, part-time employees will be given the same opportunities for
professional development and training as their full-time counterparts. Part-time employees
shall not be excluded from consideration for promotion because of their part-time status;
however, promotion may require the employee to convert to and maintain a full-time schedule
to accept the position.
C. Employees in a part-time status are eligible to receive awards.
D. To the extent practicable, the Agency will ensure that part-time employees receive assignments
of similar quality and character as those provided to full-time employees.
E. To the extent practicable, the Agency will take into consideration a part-time employee’s
available work hours when making work assignments, including court coverage and out-of-
court preparation.
F. A part-time employee earns a full year of service for each calendar year worked (regardless of
schedule) for the purpose of computing dates for retirement eligibility, career tenure,
completion of probationary period, within-grade pay increases, change in leave category, and
time-in-grade restrictions on advancement.
Section 3. Submission, Renewal, and Approval/Disapproval of Part-Time Requests
A. An employee who desires to work part-time must submit a written request to his or her
immediate supervisor. The employee will state the reason part-time employment is being
66
requested; the schedule the employee is seeking, including the number of hours per week and
per pay period; and any additional considerations relevant to the request. If additional
information is needed, the employee will be given an opportunity to provide the information.
Any confidential medical information provided to support a request will be returned to the
employee or maintained in accordance with applicable law and regulation.
B. If approved for a part-time schedule, an employee must request renewal of the part-time
schedule, modification of the part-time schedule, or conversion to a full-time schedule with a
brief written explanation of the reasons for the request to his or her immediate supervisor once
a year during the month of July (renewal period). If the first renewal period occurs within the
first year of the initial approval for part-time employment, the supervisor may defer the
requirement that the employee request renewal until the following renewal period.
C. The Agency will render a decision on the request within 30 days of receipt of the request. If
additional information is requested, the Agency will render its decision within five (5) days of
receipt of the additional information or within 30 days of receipt of the initial request,
whichever is later. Any decision denying a request will explain the reason(s) for the denial.
Upon written request, the Agency will provide an explanation of the conditions, if any, under
which the employee’s request may be approved.
Section 4. Implementation
A. When the Agency approves a part-time schedule, the Agency shall ensure:
1. all appropriate personnel actions are initiated and processed in accordance with existing
regulations;
2. if necessary, the employee’s Performance Work Plan is revised and provided to the
employee in accordance with the Agency’s Performance Management Program and Article
27; and
3. Notification of Conditions of Part-Time Employment (Appendix G) is received and

acknowledged in writing by the employee.
B. Employees interested in converting to part-time employment are encouraged to read the online
information provided by OPM outlining the effect of conversion to part-time employment in
the areas of leave and holidays, retirement, health and life insurance, qualification
determinations (e.g., for promotions), pay, reduction in force, adverse and performance-based
actions, service credit (e.g., for step increases), etc. This information is available at
www.opm.gov, Hiring Information Part-Time & Job Sharing.
Section 5. Modifications to Part-Time Schedules
A. Part-time employees may be asked to temporarily modify their schedule to meet the needs of
the Agency. Notice that the employee’s schedule must be modified will be provided as soon
as possible after the need arises. Where it is foreseeable that the modified schedule will be in
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effect for more than two (2) pay periods, the employee will be provided written notice stating
why the schedule is being modified, and either how long the modification is expected to
continue or the conditions under which the original schedule will be reinstated.
B. Part-time employees may temporarily modify their schedule to attend Agency-approved

training with management approval. Part-time employees who temporarily modify their
schedule to attend Agency-approved training must, to the extent possible, account for such
hours (including travel time in excess of normal commuting time) by reducing or eliminating
hours from their existing schedule to ensure the existing biweekly pay period hourly
requirement is not exceeded. If management determines that it is not possible for the employee
to modify his or her existing schedule to account for training time, the employee will be
compensated for any excess hours worked.
C. Generally, a part-time employee shall be given at least 21 days’ notice prior to termination or
permanent modification of the employee’s part-time schedule. The notice may state the basis
for requiring the employee to work full-time or to modify his or her part-time schedule. A
part-time employee may submit a request for reconsideration to the Agency within the 21-day
notice period. The Agency will provide a response to the reconsideration request within a
reasonable period of time. Where arrangements to permanently modify or terminate the part-
time schedule cannot be completed within the time established by this Article, additional time
may be authorized. Such change to an employee’s part-time work schedule will become
effective at the beginning of a pay period.
D. Employees who wish to change their number of hours of work or convert from part-time to
full-time must make a written request to their immediate supervisor. The Agency makes no
explicit or implicit guarantee of a return to a full-time position in the event an employee
requests a return to full-time employment. The Agency will render a decision on the request
within 30 days of receipt of the request. If additional information is requested, the Agency
will render its decision within five (5) days of receipt of the additional information or within
30 days of receipt of the initial request, whichever is later. Any decision denying the request
will explain the reason(s) for the denial.
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ARTICLE 17
TELEWORK PROGRAM
A. Telework is a work arrangement in which the employee performs officially assigned duties at
an approved worksite or Alternate Duty Station (ADS) away from the employee’s primary
worksite. Telework is intended to provide benefits to the Agency and employees through
increased productivity, flexibility, and reduced commuting time and expenses. Telework also
relieves congestion on the nation’s transportation systems and conserves resources. Telework
may also play a critical role in emergency situations by establishing communication patterns
and dispersed offsite capabilities, thereby ensuring the continuity of essential functions
following a serious disruption to the Agency’s operations. An ADS can include a government
or private telework center, the employee’s home, or other approved location equipped with the
necessary standard office equipment as described in Section 5.F.
B. Eligible employees may telework to the maximum extent possible without negatively
impacting employee performance or mission accomplishment. Eligible employees are
employees in a position with tasks determined by the Agency as being suitable for telework.
Employees must also meet the Telework Program eligibility requirements described in Section
3.
C. Decisions to approve telework will be made on a case-by-case basis. Teleworking is not an

entitlement or right, and a telework agreement may be terminated by either the employee or
the Agency.
A. Telework schedules may vary depending upon the individual arrangements agreed to by the
employee and the authorizing Agency official.
B. This program provides for two (2) types of telework pursuant to a telework agreement:
1. Core Telework. Work scheduled in advance and performed at an ADS on a regular and
recurring basis one or more days per pay period.
2. Situational/Episodic. A telework arrangement used on an occasional, non-routine, or

irregular basis at the Agency’s discretion, for part of a day, for individual days or hours
within a pay period, or for several pay periods on a temporary basis for an appropriate
purpose, such as:
a. temporary incapacitation due to injury or illness;
b. more efficient completion of a project;
69
c. potential emergency situations;
d. temporary accommodation of an employee’s disability; or
e. other legitimate reasons as determined by the Agency.
C. Participants in telework may be permitted to use alternative work schedules.
Section 3. Eligibility Criteria
A. When determining whether a task, function, or project may be suitable for telework,
consideration should be given to the following position-related eligibility criteria:
1. whether tasks are portable and can be performed effectively outside the employee’s
primary worksite;
2. whether tasks are measurable or project-oriented;
3. whether client or customer contacts are foreseeable or may be satisfied by frequently

checking voicemail for messages;
4. whether work contacts can be adjusted to allow for telephone communications or work
assignment can be accomplished when the teleworking employee is not at the primary
worksite;
5. whether materials, data, and communications needed to carry out telework tasks present a
security risk or breach of confidentiality to DHS, ICE, or its customers;
6. whether the integrity and confidentiality of any document removed from the Agency would
be protected from disclosure;
7. whether tasks require extensive face-to-face contact with the supervisor, other employees,
stakeholders, customers, or the general public; and
8. whether tasks involve the employee receiving substantial supervision or oversight or

providing mentoring or assistance on a continuous basis.
B. The Authorizing Official has sole discretion to determine the weight to be given to each of the
various factors listed in Subsection A.
C. Employees who have worked for the Agency less than one year will not be allowed to
participate in the telework program, except on an occasional Situational/Episodic basis.
D. An employee may be authorized to telework if the following eligibility criteria are met:
1. the employee has not received disciplinary action within the last 12 months;
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2. the employee’s most recent performance appraisal reflects a rating of at least “Fully
Successful,” “Meets Expectations,” or the equivalent for each critical element;
3. the employee is not on a Performance Improvement Plan (PIP), as provided in Article 24;
4. the employee is not on leave restriction;
5. the employee has a history of reliable and responsible performance of duties,

trustworthiness, professionalism, and subject matter expertise;
6. the employee has the workspace, utilities, and equipment suitable for the work to be
performed at the designated ADS as specified in a telework agreement;
7. the designated ADS complies with reasonable safety standards, including, but not limited
to, the building’s electrical system is grounded and all equipment is free of hazards that
would cause physical harm (e.g., frayed, bare, loose, or exposed wiring); telephone lines,
electrical cords, and extension wires are secured under a desk or alongside a baseboard; the
work area is free of obstructions and hazardous materials; the temperature is conducive to
health, comfort, and proper equipment maintenance; equipment and furniture are in good
condition and ergonomic;
8. the employee signs and abides by a telework agreement;
9. there is no more than a de minimis adverse impact on other employees in terms of workload,
exposure to standby responsibilities, or reassignment of duties;
10. the employee has dependent care arrangements to permit concentration on work
assignments and acknowledges that telework is not to be used as a substitute for dependent
care; and
11. the employee’s absence from the primary worksite would not interrupt normal operations.
Section 4. Approval/Disapproval/Termination of Telework Agreements
A. Employees desiring to participate in telework will submit a written request to their immediate
supervisor using the Telework Program Agreement (Appendix H). The Parties acknowledge
that rare circumstances may exist where the Agency may approve an employee’s request to
telework prior to the execution of a written agreement.
B. Employees must identify portable work or a specific work project or assignment and will
include the proposed work schedule and days to be worked away from the primary worksite.
C. The Agency will use its best efforts to review and approve or disapprove the request in writing
within 14 days of receipt or as soon thereafter as practicable.
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D. If the request is approved, the Telework Program Agreement will be signed and executed. If
the request is disapproved, the employee will be provided a written explanation.
E. Telework agreements for participation on a Core Telework basis are in effect for six (6) months
from the date of signing and may be initiated or renewed only during the Employee Decision
Period (EDP) set forth in Article 15. Upon entry on duty, a transferee may request participation
in telework without waiting for the next EDP. On a case-by-case basis, the employee may be
allowed or required, as applicable, to change the established schedule to meet special needs of
the employee or the Agency.
F. The Agency may suspend, modify, or terminate the Telework Program Agreement on account
of such factors as employee performance concerns or failure to abide by telework program
requirements, operational needs of the Agency, and changed circumstances, such as budget,
staffing, workload demands, and availability of portable work. Notice shall be provided to the
employee in writing with reasons for the action. The employee must be provided a reasonable
opportunity to return to the primary worksite (generally, one pay period for Core Telework
participants). Where arrangements to return to the primary worksite cannot be completed
within the time established by the Agency, additional time may be authorized. An employee
may reapply to participate in a Core Telework schedule during the subsequent EDP.
Section 5. Guidelines
A. In cases of scheduling conflicts between two (2) or more employees where the employees do
not reach agreement, and all factors are equal, the employee with the most seniority, as defined
in this Agreement, will be given priority in choosing a telework schedule. In case of a tie, the
conflict will be resolved by a toss of a coin in the presence of the employees. Upon request,
the supervisor will give the Union an opportunity to be present either in person or by phone
during any meeting to resolve the conflict.
B. In the event that an employee’s scheduled workday at an ADS falls on a holiday, the employee
may not substitute any other day in the workweek as his or her telework day.
C. Employees may be required to report to their primary worksite for events, including, but not
limited to, training programs, conferences, or meetings, or to perform on a short-term basis
work that cannot otherwise be performed at the ADS. When situations occur that require the
employee to report to the primary worksite, travel to and from the office is normal commuting
time and is not considered hours of work, nor compensable as local travel. In cases requiring
that an employee report to the primary worksite, the employee will be provided reasonable
advance notice and reasonable time to report. Where notice is given after the beginning of the
employee’s scheduled workday, the employee’s normal travel time will be considered hours
of work. The employee should make every effort to report as soon as possible. With good and
sufficient reason, the employee will be permitted up to two (2) hours to report.
D. Except as specified otherwise in this Article, employees performing work at the ADS are
eligible for the same benefits and privileges and are subject to the same requirements and other
provisions of this Agreement as employees performing work at the primary worksite.
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E. Teleworking employees must be vigilant in maintaining information security. The employee

will adhere to DHS and ICE policies and applicable government regulations governing
information management and electronic security procedures for safeguarding data.
F. The Agency will provide, maintain, and repair any electronic equipment it deems necessary
(e.g., computers, printers, scanners, FAX machines) for the employee to perform the portable
work at the ADS.
G. The employee will exercise care and due diligence in safeguarding all government equipment.
H. Where the ADS is the employee’s home, the employee will be responsible for home
maintenance and any other incidental costs (e.g., electricity, phone, lockable storage, furniture,
insurance) associated with the use of the ADS.
I. On a day when an employee is scheduled to work at the ADS and his or her official duty station
building is closed as a result of an emergency situation for all or part of the day, the employee
is required to perform work at the ADS unless the emergency situation prevents the work from
being performed at the ADS or causes the employee to be unable to perform assigned duties.
J. If an emergency or other situation occurs at the ADS that affects the employee’s ability to
perform official duties, the employee will notify his or her supervisor as soon as practicable.
The employee will be directed to report to the primary or another worksite, granted leave if
requested, or directed to make other arrangements as necessary to meet the needs of the
Agency.
K. Employees working at an ADS are entitled to early dismissals and/or administrative leave
granted by the Agency for holidays or other special observances to the same extent as the
employees at the primary worksite.
L. In case of injury, theft, loss, or potential tort liability related to telework arrangements at the
employee’s home, the teleworking employee will allow timely inspection of the telework site.
The Agency will give the employee reasonable notice prior to any inspection of the telework
site where the ADS is the employee’s home.
M. The Agency shall provide to the Union President or designee copies of any new or modified
Telework Program Agreements that are approved during each EDP for bargaining unit
employees who participate on a Core Telework basis.
Section 6. Effect of Telework with Regard to Temporary Assignments
A. An employee who participates in a telework program may apply for temporary assignments on
the same basis as those who are not on a telework schedule.
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B. The Agency may involuntarily assign an employee who is working a telework schedule to
temporary assignments on the same basis as those who do not participate in the telework
program.
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ARTICLE 18
LEAVE
The purpose of this Article is to prescribe the policies covering the different types of leave pertinent
to bargaining unit employees in accordance with applicable law and regulation. This Article shall
be administered in accordance with 5 U.S.C. Chapter 63, 5 C.F.R. Part 630, and this Agreement.
Section 2. Annual Leave
A. Right to Use. Use of annual leave is a right of the employee and not a privilege. The
scheduling of annual leave is subject to the needs of the Agency and advance approval by the
supervisor. Leave may be used in 15-minute increments.
B. Earn and Accrue. Annual leave will be earned and accrued in accordance with applicable laws
and regulations.
C. Request Procedure. Annual leave will normally be requested in advance on the Agency’s
system of reporting time and attendance (e.g., WebTA). The Agency will not set unreasonable
restrictions on when leave requests must be submitted. The employee will properly record
actual leave usage in the system.
D. Timely Leave Approval. Consistent with the needs of the Agency and the employee, annual
leave requests will be decided in a timely manner. Upon written request, written explanation
for a denial will be provided to the employee in a timely manner.
E. Approval. When multiple requests for annual leave for the same period cannot be granted, the
supervisor will attempt to resolve the conflict between the employees. Factors that would
weigh in favor of an employee’s request may include, but are not limited to:
1. Accrued Leave. The employee’s accrued leave balance (e.g., the request of an employee
who has “use or lose” leave could be given preference over one who has a lower leave
balance).
2. Children’s Vacation. An employee has children of school age and would benefit from
vacations taken when the children are not in school. This consideration does not affect
previously approved leave for other employees.
3. Previous Request. Whether the requesting employee was denied leave at the desired time
during a previous leave year.
Unresolved conflicts will be settled by use of seniority, with the same meaning and usage as
elsewhere in this Agreement. In case of a tie, the conflict will be resolved by a toss of a coin
in the presence of the employees.
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F. Previously Approved Leave. An employee’s approved annual leave will not be disapproved
because an employee with an earlier seniority date subsequently requests leave for the same
period.
G. Cancellation of Leave. An employee may cancel previously approved leave. The Agency
must be informed of this decision in a timely manner (e.g., as far in advance of returning to
work as possible).
H. Advancing Annual Leave. Annual leave that can be earned in a given leave year will be
available for use from the beginning of each leave year. Annual leave may be approved in
advance of accrual, not to exceed the amount that is expected to accrue during the remainder
of the same leave year.
Section 3. Sick Leave
A. Earn and Accrue. Sick leave will be earned and accrued in accordance with applicable laws
and regulations. Leave may be used in 15-minute increments.
B. Request Procedure. Sick leave will be requested in the Agency’s system for reporting time
and attendance (e.g., WebTA), in advance where practicable. The employee will properly
record actual leave usage in the system.
C. Unforeseeable Requests for Sick Leave. When the need for sick leave arises in unforeseeable
circumstances that prevent the employee from reporting to duty on time, the employee will
contact the immediate supervisor or designated Agency official(s) to provide notice and
request sick leave before the beginning of his or her reporting time or as soon as possible
thereafter. In particular, where the employee is scheduled to represent the Agency in court or
make another appearance of high importance, the employee is to make every reasonable effort
to ensure the Agency is provided notice in sufficient time to take necessary action to protect
the Agency’s interests. The Agency shall provide employees the supervisor’s alternate contact
numbers.
D. Timely Responses to Requests. Consistent with the needs of the Agency and the employee,
sick leave requests will be decided in a timely manner. Upon written request, written
explanation for a denial will be provided to the employee in a timely manner. Denials of
requests for sick leave will not be arbitrary or capricious.
E. Granting Sick Leave. Subject to the employee’s having followed leave request procedures
and, if applicable, submitting acceptable supporting evidence, and subject to 5 C.F.R.
§ 630.401(b)-(e), the Agency must grant accrued sick leave to an employee when he or she:
1. is incapacitated for performance of one’s duties by physical or mental illness, injury,

pregnancy, or childbirth. In this context, an employee with a disability who depends on an
aid, mechanical or otherwise, to perform work is normally incapacitated without the aid.
A seeing-eye dog, a personal assistant, a wheelchair, or any prosthetic device may be
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considered an extension of the employee, and a grant of sick leave for such purposes as
training, replacement, or repair is appropriate under the same conditions as any other
incapacitation;
2. receives medical, dental, or optical examination or treatment;
3. provides care for a family member incapacitated by a medical or mental condition or

attends to a family member receiving medical, dental, or optical examination or treatment;
4. provides care for a family member with a serious health condition;
5. would jeopardize the health of others by coming to work because the employee has been
exposed to a communicable disease (i.e., a disease that requires isolation or quarantine, as
determined by the health authorities having jurisdiction or by a health care provider);
6. makes arrangements necessitated by the death of a family member or attends the funeral of
a family member; or
7. must be absent from duty for purposes relating to his or her adoption of a child, including
appointments with adoption agencies, social workers, and attorneys; court proceedings;
required travel; and any other activities necessary to allow the adoption to proceed.
F. Medical Evidence
1. Employees will normally not be required to furnish administratively acceptable evidence

to substantiate a request for approval of sick leave for three (3) consecutive workdays or
fewer. Where the Agency has reasonable grounds to believe that an employee is abusing
the sick leave benefit (e.g., when sick leave is used frequently or in unusual patterns or
circumstances), the Agency may require the employee to furnish administratively
acceptable evidence for sick leave requests of fewer than three (3) days. Depending on the
particular circumstances, the Agency may accept the following as administratively
acceptable evidence of an employee’s illness: a doctor’s note, medical records, a
prescription for treatment, evidence of a pending medical appointment, or the employee’s
written statement.
2. Any medical information provided to support a request for sick leave will be treated
confidentially and with appropriate recognition of the employee’s (and/or family
member’s) rights of privacy. Normally, administratively acceptable evidence to support a
request for sick leave will be provided to an employee’s first- or second-level supervisor.
However, in unusual circumstances where the employee has a specific basis for not
providing such medical information to his or her supervisor, the employee may provide it
to the Agency’s Chief, Labor and Employment Law Division, OPLA, or designee.
3. Employees who suffer from a chronic medical condition that requires occasional absence
from work, but does not necessarily require medical treatment, and who have previously
furnished medical certification of the chronic condition, at the Agency’s discretion, may
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not be required to furnish a medical certificate to substantiate sick leave for subsequent
occurrences of the same condition. The Agency may periodically require further medical
certification to substantiate that the condition still exists.
G. Advanced Sick Leave. Unless there is documented leave abuse, when an employee’s sick
leave balance has been exhausted, the Agency may approve requests for advanced sick leave
in cases of serious disability or ailment of an employee, or to provide care for an employee’s
family member with a serious disability or ailment, or for purposes related to the adoption of
a child, or family bereavement. Approval is subject to the following:
1. Medical Certificate. The application is adequately supported by a medical certificate from

an appropriate health care provider.
2. Repayment. Repayment may be reasonably expected.
3. Maximum Advance. The amount advanced to a full-time employee may not exceed 30
days. Part-time employees, working under a regular tour of duty, may be advanced sick
leave on a pro rata basis.
H. Medical Review. If there are questions regarding an employee’s medical information

supporting a request for sick leave, it will be reviewed and assessed by the Agency’s medically
licensed designee. Following the designee’s written assessment of the information, the
employee and the employee’s medical representative will receive a copy of the assessment
within three (3) days after the assessment has been provided to the Agency.
I. Use of Sick Leave During Annual Leave. Whenever illness or injury occurs during approved
annual leave, the employee may request to change the period of illness to sick leave and the
charge to annual leave will be reduced accordingly. The employee will notify a supervisor of
the need for sick leave at the time the employee becomes aware of the need to take sick leave
or as soon as possible.
Section 4. Administrative Leave/Excused Absence
Administrative leave is an excused absence from duty administratively authorized without loss of
pay and without charge to an employee’s accrued leave. Matters for which administrative leave
may be granted include, but are not limited to:
A. Voting.
B. Agency-Sponsored or -Approved Blood Drives.
C. Health, Safety, and Weather Hazards.
1. Whenever it becomes necessary to modify the normal operation of a workplace because of

inclement weather or any other emergency situation, the Agency may grant administrative
leave for the duration of the closure. Such situations include, but are not limited to, such
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events as heavy snow or severe icing conditions, floods, earthquakes, hurricanes or other
natural disasters, severe pollution, massive power failure, terrorist attacks, major fires, or
serious interruptions to public transportation caused by incidents such as strikes of local
transit employees or mass demonstrations.
2. Local management is in the best position to assess the situation on the ground as to when
office closure, delayed opening, or early dismissal is necessary. Local management will
make decisions regarding operating status as soon as possible to ensure that employees
have sufficient time to travel to or from the workplace safely. Office closure and other
operating status policies and procedures will be consistent with the OPM Washington, DC,
Area Dismissal and Closure Procedures.
3. Employees with the option of requesting unscheduled leave as a result of a delayed opening
on a particular day may also, within the same pay period, request, and with management
approval, take the unscheduled leave day as an Alternative Work Schedule (AWS) day off
and thereafter work on the subsequent preassigned AWS day off.
D. Brief Absences or Tardiness. If an employee is unavoidably or necessarily absent, or tardy,

for less than one hour, the Agency, for adequate reason, may excuse the employee without
charge to leave. Where appropriate, the Agency may approve an employee’s request to
telework on a Situational/Episodic basis, in accordance with Article 17.
E. Funeral Leave for Combat-Related Death of Immediate Relative of Armed Forces. Upon
request, an employee will be granted up to three (3) work days of administrative leave without
loss of or reduction in pay to make arrangements for, or attend the funeral or memorial service
of, a family member or an immediate relative who died as the result of a wound, disease, or
injury incurred while serving as a member of the armed forces in a combat zone. The leave
need not be consecutive, but the employee shall provide the supervisor justification for the
requested non-consecutive days (see 5 C.F.R. Part 630, Subpart H).
F. The Parties agree that the above reasons for granting administrative leave are not all-inclusive
and that there may be other situations supporting a request for the granting of such leave. Such
requests shall be considered based on the reasons presented at the time; the Agency may require
documentation as appropriate to support the reasons for and/or the duration of such
administrative leave requests.
Section 5. Court Leave
A. An employee will be excused from duty without charge to leave if summoned to serve as a
juror or witness in a judicial proceeding, including time spent waiting to be called or selected
and related travel, but not including time during which the employee is excused or discharged
by the court for an indefinite period subject to call by the court or for a definite period in excess
of one day. 1
1
An employee who is summoned as a witness in an official capacity on behalf of the federal government is on official
duty, not court leave.
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B. If any employee is on annual leave when called for jury duty, court leave should be substituted
for the annual leave.
C. Employees are required to contact their supervisors upon notification by the court of being
excused or discharged. An employee who is excused or released by the court for any day or
substantial portion of a day is expected to return to duty, telework, or be charged with a form
of approved absence, excluding court or administrative leave. In this regard, management will
consider the distance or travel time from the court to the employee’s duty station. In the event
that the employee is released such that less than one hour of the work day would be involved
and thus no appreciable amount of Agency service would be rendered, management may grant
the employee administrative leave. In the event that the employee is released such that one
hour or more of the work day would be involved, management may approve telework on a
Situational/Episodic basis for the remainder of the employee’s daily work requirement.
Section 6. Leave Without Pay
A. Definition. Leave Without Pay (LWOP) is a temporary non-pay status and absence from that
duty, in most cases, is granted at the employee’s request.
B. Administrative Discretion. In most circumstances, approval of LWOP is a matter of

management discretion. Circumstances in which LWOP may be approved include, but are not
limited to, the following:
1. to allow an employee to pursue an educational opportunity;
2. to provide time for recovery from an illness or disability not of a permanent nature;
3. to protect an employee’s rights and benefits while a claim for disability retirement is
pending with OPM; and
4. to maintain federal employment status while seeking employment in connection with a

family relocation.
C. Entitlement to LWOP. Employees will be granted LWOP for the following purposes:
1. for necessary medical treatment of a disabled veteran, pursuant to Executive Order 5396;
2. for periods of active duty as a member of the uniformed services, pursuant to the Uniformed
Services Employment and Reemployment Rights Act of 1994;
3. for certain family and medical needs, pursuant to the Family and Medical Leave Act of
1993 (FMLA) (see 5 C.F.R. Part 630, Subpart L); and
4. for the first year during which an employee is receiving workers’ compensation payments
from the U.S. Department of Labor, pursuant to 5 U.S.C. Chapter 81.
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D. Upon written request, written explanation for a denial will be provided to the employee in a
timely manner.
Section 7. Leave for Family Responsibilities
A. Family Considerations. Under applicable law, Executive Order, and regulation, the Agency
may grant annual leave, sick leave, and/or LWOP for family circumstances. These
circumstances may include maternity/paternity, adoption, bereavement, and family care. Upon
written request, written explanation for a denial will be provided to the employee in a timely
manner.
B. Pursuant to 5 C.F.R. § 630.201(b), family member means the following relatives of the
employee:
1. spouse, and parents thereof;
2. sons and daughters, including adopted children, and spouses thereof;
3. parents, and spouses thereof;
4. brothers and sisters, and spouses thereof;
5. grandparents and grandchildren, and spouses thereof;
6. domestic partner (in accordance with the definitions at 5 C.F.R. § 630.201(b)), and parents
thereof, including domestic partners of any individual in Paragraphs (1) through (5) of this
definition; and
7. any individual related by blood or affinity whose close association with the employee is
the equivalent of a family relationship.
C. A more limited definition applies to employees requesting LWOP under the FMLA. The
FMLA definitions are found in 5 C.F.R. § 630.1202.
D. Legislation pending before Congress at the time this Article is being negotiated would provide
federal employees a specified period of paid “parental leave” following the birth or adoption
of a child. If this or similar legislation is enacted into law before the current negotiations are
completed or during the life of this Agreement, this Section will be amended to include the
legislation if either Party believes it necessary to do so for bargaining unit employees to receive
the benefit of the legislation and/or its implementing regulations.
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ARTICLE 19
COMPENSATORY TIME OFF FOR RELIGIOUS OBSERVANCES
Section 1. Working Alternative Hours to Engage in Religious Observance
An employee whose personal religious beliefs require that he or she abstain from work at certain
times of the workday or workweek will be permitted to work alternative hours to accommodate
the employee’s religious observance, unless doing so would cause an undue hardship on the
efficient accomplishment of the Agency’s mission. The alternative hours (i.e., compensatory time)
may be worked either before or after the time taken off for the religious observance.
Section 2. Employee Responsibilities
A. An employee is required to provide his or her supervisor with a written request for religious
compensatory time off. The employee must submit the request at least 30 days in advance of
earning or using religious compensatory time off, absent extenuating circumstances.
B. At the time the religious compensatory time off is requested, the employee must provide the
Agency with the following information:
1. the name and/or description of the religious observance that is the basis of the employee’s
request to be absent from work in order to meet the employee’s personal religious
requirements;
2. the date(s) and time(s) the employee plans to be absent to participate in the religious
observances identified in Subsection B.1; and
3. the date(s) and time(s) the employee plans to work to earn religious compensatory time
off to make up for the absence. The hours worked in lieu of the normal work schedule
must occur during the available tour of duty as defined in Article 15.
C. In the event that an adjustment to the date(s) and time(s) of planned work in lieu of the normal
work schedule is required due to unforeseen circumstances, the employee must submit for
approval a revised schedule to reflect those changes.
D. Employees must submit a WebTA Premium Pay Request for compensatory time off within the
pay period for which it was earned so that the request can be approved prior to validation and
certification of the timecard for that pay period. The WebTA request must be made after the
supervisor approves the written request described in Section 2.A.
Section 3. Agency Responsibilities
A. The Agency must approve the employee’s request to use religious compensatory time off
unless the Agency determines that approving the request would interfere with the Agency’s
ability to efficiently carry out its mission.
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B. If the employee’s request to use religious compensatory time off is denied, the Agency must
provide a written explanation as to the reason(s) the request has been denied.
C. The specific timing of when an employee will be allowed to earn religious compensatory time
off is a matter of Agency discretion based on the needs of the Agency.
Section 4. Scheduling Time to Earn and Use Religious Compensatory Time Off
A. The scheduling of time to earn and use religious compensatory time off by an employee is
subject to the Agency’s approval.
B. Compensatory time off for religious observance will be earned and used in 15-minute
increments. Amounts less than 7.5 minutes must be rounded down to the nearest 15-minute
increment; amounts equal to or greater than 7.5 minutes must be rounded up to the nearest
15-minute increment.
C. Earning Compensatory Time Off Prior to Using It
For an employee who earns religious compensatory time off prior to using it, religious
compensatory time off may be earned up to 13 pay periods in advance of the pay period in which
the targeted religious observance commences and must be linked to specific dates and times for
future use, as compatible with Agency mission requirements.
D. Using Compensatory Time Off Prior to Earning It
1. An employee who uses religious compensatory time off prior to earning it must fulfill his
or her obligation to perform work in exchange for the advanced religious compensatory
time off within 13 pay periods after the pay period in which he or she used religious
compensatory time off, or the Agency must take action as provided in Subsection D.3.
2. The 13 pay periods described in Subsection D.1 are calculated beginning with the first pay
period after the date on which the religious compensatory time off was used.
3. If the employee fails to earn religious compensatory time off within 13 pay periods after
taking religious compensatory time off, the Agency may take corrective action to eliminate
or reduce the negative balance by making a corresponding reduction in the employee’s
balance of annual leave, credit hours, compensatory time off in lieu of regular overtime
pay, compensatory time off for travel, or time-off awards. The Agency may determine the
order of precedence for applying the various types of paid time off to offset the negative
balance. Any negative balance of religious compensatory time off remaining after any
charging of these types of paid time off must be resolved by charging the employee LWOP,
which would result in an indebtedness that is subject to the Agency’s internal debt
collection procedures.
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E. When possible, time taken off on any given day should be repaid in a block of time equal to
the number of hours taken on the day of the observance. When the time cannot be repaid in
an equal block, repayment must be in increments of no less than one hour or the balance of
compensatory time owed, whichever is less. If an employee is absent when he or she is
scheduled to perform compensatory time work, the employee must take annual leave, request
LWOP, or, if appropriate, be charged absent without leave—the same options that apply to any
other absence from the employee’s basic work schedule.
Section 5. Other Considerations
For issues regarding the accumulation and documentation of religious compensatory time off,
record keeping, employee separation or transfers, and general application of these rules, the Parties
shall abide by 5 C.F.R. § 550.1001 et seq. To the extent there is any conflict between this Article
and such regulations, the regulations shall be controlling.
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ARTICLE 20
PROMOTIONS AND PAY INCREASES
A. Career ladder. Career ladder refers to a formally recognized succession of positions that
represent the anticipated career progression for most permanent employees assigned to a
specific occupation. Career ladders are established for large groups of like positions that have
established career progression and known promotion potential. Career ladders are established
within a single occupational series. Career ladders establish a pathway for career advancement
leading to the full performance level of the position.
B. Career ladder promotion. A career ladder promotion is a noncompetitive promotion when

competition was held at an earlier stage to permit entry into an established career pattern.
Promotion within an established career ladder to the identified full performance level may be
effected without further competition.
C. Expedited promotion. An expedited promotion is a one-time waiver of the one-year minimum

service period for promotion within the General Schedule (GS) pay scale from
GS-11 to GS-12 or from GS-12 to GS-13 (if hired at GS-12), if the attorney has served at his
or her current grade level for a minimum of six (6) months and the attorney’s chain of
command certifies to the Deputy Principal Legal Advisor that the attorney is performing at the
next grade level consistent with the promotion criteria.
D. Within-grade increases. Within-grade increases (WGI) or step increases are periodic increases
in a GS employee’s rate of basic pay from one step of the grade of his or her position to the
next higher step of that grade. For WGI purposes, an employee’s rate of basic pay is the rate
of pay fixed by law or administrative action for the position held by the employee before any
deductions and exclusive of additional pay of any kind.
Section 2. Career Ladder Promotions
A. Career ladder promotions shall be processed in a timely manner in accordance with applicable
law and regulation. Once an authorized Agency official has made the determination that the
required criteria are met, the promotions will be made effective on the first day of the first pay
period following the completion of the required waiting period. Promotions will be processed
retroactively if an administrative delay occurs after the authorized official has approved the
promotion (i.e., the authorized official has determined that the requirements have been met).
Career ladder promotions for competitive GS positions are governed by 5 C.F.R. § 300.603.
B. Expedited Promotions
1. Upon entry on duty, the Agency will notify attorneys hired at the GS-11 and GS-12 levels
of the possibility of a one-time expedited promotion.
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Section 3. Within-Grade Increases
A. Effective Date. A WGI shall be effective on the first day of the first pay period following the
completion of the required waiting period. There are two (2) exceptions:
1. when there has been a determination that the employee is not performing at an acceptable
level of competence; or
2. when a determination of the employee’s acceptable level of competence is delayed because

the employee:
a. has not had 90 days to demonstrate acceptable performance on the employee’s elements
and standards; or
b. was reduced in grade because of unacceptable performance and has not served 90 days
under performance standards in the new position.
B. Delay. If a WGI is delayed under Subsection A.2 and the employee is subsequently found to
be performing at the acceptable level of competence, the increase will be granted retroactively
to the beginning of the pay period following the completion of the waiting period.
C. Remedial Action. When the Agency’s evaluation leads to a conclusion that the employee’s
work is not at an acceptable level of competence for a WGI, the Agency will advise the
employee in writing and take the following actions:
1. explain each aspect of performance in which the employee’s performance falls below an
acceptable level and relate deficiencies to specific job elements and performance standards;
2. explain what is required to meet the acceptable level and what the employee must do to
elevate his or her performance to that level, and inform the employee that if performance
does not improve to the acceptable level, the WGI, for which the employee otherwise
would be eligible, will be denied; and
3. provide assistance (e.g., formal training, on-the-job training, counseling, or closer

supervision) in improving performance rated below the fully successful level.
After a WGI has been denied, the Agency may grant the WGI at any time after it determines
that the employee has demonstrated performance at an acceptable level of competence. In
such cases, the WGI will become effective the first day of the first pay period after the
acceptable determination is made.
Section 4. Promotions to Bargaining Unit Positions
A. All bargaining unit positions above the full performance or journey level will be announced
internally. Positions will be announced via e-mail notification to all bargaining unit employees
within the geographical and/or organizational (e.g., OPLA and Office of the Chief Financial
86
Officer) area of consideration. If the area of consideration is later expanded, the announcement
will be sent to all bargaining unit employees in the new area of consideration.
B. Announcements under Subsection A will generally include information reasonably necessary

for an employee to determine whether to apply for the position, such as:
1. title, series, and grade of the position;
2. that the position is in the Professional Employees Bargaining Unit;
3. date by which an application must be submitted;
4. organizational and/or geographical area of consideration;
5. organizational and geographical location of the position;
6. whether relocation expenses will be paid;
7. primary duties and responsibilities of the position;
8. specific qualification requirements;
9. the number of positions the Agency expects to fill at each location, if more than one;
10. how to submit an application, including any supplemental materials that must be provided;
and
11. any other information applicable to the position (e.g., change in level of
sensitivity/clearance; promotion potential, if any; unusual travel requirements; unusual tour
of duty; and selective placement factors).
C. In accordance with 5 U.S.C. § 7106(a)(2)(C)(ii), the Agency retains the right to fill positions
from any appropriate source.
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ARTICLE 21
PERFORMANCE AND INCENTIVE AWARDS
A. The Agency will recognize and, subject to the availability of funds, reward bargaining unit
employees when they perform in an exemplary manner or make significant contributions to
the efficiency and effectiveness of the Agency.
B. The granting of awards will be fair, objective, free from discrimination, and based on merit.
C. All awards will be granted in accordance with this Article and Agency policy.
Section 2. Definitions and Types of Awards
A. Award. Something bestowed or an action taken to recognize and reward an individual or team
achievement that contributes to meeting organizational goals or improving the efficiency,
effectiveness, and economy of the Agency, or that is otherwise in the public interest.
B. Contribution. An accomplishment achieved through an individual or group effort in the form

of a special act or service in the public interest, connected with or related to official
employment, that contributes to the efficiency, economy, or other improvement of Agency
operations.
C. Length of Service Award. Consists of a certificate and/or pin given for years of service in the
federal government. The recognized years of service are in five-year increments beginning
with the fifth year of service.
D. Monetary or Cash Award. An award that is in the form of a lump-sum cash payment that does
not increase the employee’s rate of basic pay and is based on tangible or intangible benefits to
the Agency. This includes Special Achievement and Special Act Awards, Performance
Awards, and On-The-Spot Awards.
E. Non-Monetary or Honorary Award. An award that does not include a cash payment (e.g., a
Director’s Award, commendation, certificate, medal, plaque with citation, and pin or similar
item that can be worn or displayed).
F. On-the-Spot Award. A nominal value cash award presented to employees by supervisors for
actions worthy of recognition where it is important to recognize the achievement or
contribution quickly.
G. Performance Award. An award that is linked directly to the employee’s annual performance
appraisal and recognizes superior performance during the performance rating cycle.
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H. Quality Step Increase. A faster-than-normal within-grade step increase in recognition of

sustained high-quality performance.
I. Special Achievement Award. An award for exemplary acts or achievements providing tangible
and/or intangible benefits or savings to the Agency for a non-recurring contribution, either
within or outside of job responsibilities.
J. Team or Group Award. An award that recognizes two (2) or more participants in a joint
accomplishment or achievement.
K. Time-Off Award. An award in which time off from duty is granted without loss of pay or
charge to leave in recognition of superior contribution or accomplishment. A time-off award
shall not be converted to a cash payment. Time off awarded must be scheduled and used within
one year after the award is granted.
Section 3. Awards Process
A. The Agency will maintain all manuals, instructions, and directives concerning its award
process on the ICE intranet under an awards topic.
B. Criteria. The Agency may consider, among other criteria, the following factors when making
award decisions:
1. a suggestion, invention, superior accomplishment, productivity gain, or other personal

effort that contributes to the efficiency, economy, or other improvement of Agency
operations or achieves a significant reduction in time and/or costs, including paperwork;
2. a project or initiative that significantly advances the Agency’s mission;
3. a special act or service in the public interest in connection with or related to official
employment; or
4. performance as reflected in the employee’s most recent rating of record (as defined in
5 C.F.R. § 430.203).
C. Recommendation and Recognition of Award Recipients
1. All bargaining unit employees may be considered eligible for an award using the criteria
set forth above.
2. Supervisors are encouraged to identify employees whom they believe should be recognized
for an award based on the employees’ performance or contribution to the Agency.
3. Any employee may recommend himself or herself or any other employee for an award.
Such recommendations will be in writing and should include the proposed recipient’s
name, a description of his or her accomplishment or contribution and its significance, and
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the name of the employee submitting the recommendation. Such recommendations must
be submitted through the proposed recipient’s chain of command and may include
suggestions for the type of award to be granted.
4. Supervisors, at their discretion and with the consent of impacted employees, may announce
the names of award recipients at local award ceremonies or through other means in order
to provide an opportunity for local recognition and congratulations.
D. Records and Reports
Within 30 days of the Union’s written request, the Agency shall furnish to the Union President
the number, types, and amounts of awards given to bargaining unit professional employees, as
well as the names and office locations of those employees. Award recipients will be given the
opportunity to have their names deleted from the information to be disclosed to the Union
President. The Union President may disclose information received under this Subsection to
other members of the Union Executive Board. Before making any disclosure other than to
members of the Executive Board that would allow the identification of any individual
employee(s), the Union President or Executive Board will obtain a written release from the
affected employee(s).
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ARTICLE 22
GRIEVANCE AND ARBITRATION PROCEDURE
Section 1. General
A. The purpose of this Article is to provide a fair, simple, and expeditious means of processing
grievances. This negotiated procedure shall be the exclusive administrative procedure
available to the Union and employees in the unit for resolving grievances that come within its
coverage, except as specifically provided in 5 U.S.C. § 7121(d), (e), (g).
B. Any employee or group of employees in the unit may present such grievances to the Agency
and have them adjusted, without the intervention of the exclusive representative, as long as the
adjustment is consistent with the terms of this Agreement and the exclusive representative has
been given an opportunity to be present as provided in this Article.
C. Employees and their representatives will be free from restraint, interference, coercion,
discrimination, or reprisal, consistent with 5 U.S.C. Chapter 71 and this Agreement, in seeking
adjustment of grievances. The initiation or presentation of a grievance by an employee will
not negatively impact his or her standing with the Agency.
D. Grievances should be processed in a fair, orderly, and expeditious manner to promote the
efficiency of the Agency and the morale of employees. All individuals involved in the
grievance procedure are expected to conduct themselves in a respectful, courteous manner.
The aggrieved Party(ies) will make every effort to resolve grievances at the lowest possible
level.
E. The Agency will give the employee and his or her representative a reasonable amount of
official time to consult, prepare, and present the grievance.
Section 2. Representation.
A. Upon filing of a grievance, an employee may elect to be self-represented or represented by a

Union representative. The Union in its sole discretion shall designate in writing its authorized
representative, including any change in representative.
B. The designated Union representative may be disqualified only for conflict of interest or conflict
of position.
C. The Union has the right to be present during any discussion with a bargaining unit member
conducted under the negotiated grievance procedure. If the Union is not the designated
representative, a copy of the grievance will be provided to the Union within seven (7) days of
the grievance’s receipt by the Agency. The Agency will provide the Union reasonable advance
notice, not less than 48 hours excluding weekends and federal holidays, of any grievance
discussions when the Union is not the designated representative.
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D. Where the grievant elects Union representation, any communications with regard to the
grievance and any attempts at resolution shall be made through the designated Union
representative.
E. The Parties will make a reasonable effort to schedule discussions in the grievance process for
a time that is mutually acceptable to all Parties.
Section 3. Grievances
A. Grievance. A grievance means any complaint by:
1. any employee concerning any matter relating to the employment of the employee;
2. the Union concerning any matter relating to the employment of any employee; or
3. any employee, the Union, or the Agency concerning:
a. the effect or interpretation, or a claim of breach, of a collective bargaining agreement;

or
b. any claimed violation, misinterpretation, or misapplication of any law, rule, or

regulation affecting conditions of employment, or past practice.
B. Exclusions. This procedure does not cover grievances concerning:
1. any claimed violation of 5 U.S.C. Chapter 73, Subchapter III (relating to prohibited
political activities);
2. retirement, life insurance, or health insurance;
3. a suspension or removal under 5 U.S.C. § 7532 for reasons of national security;
4. any examination, certification, or appointment;
5. the classification of any position that does not result in a reduction in grade or pay of any
employee;
6. any matter that is not subject to the direct control of the Agency or the Union;
7. a complaint of discrimination that is listed in 5 U.S.C. § 2302(b)(1), if the employee has

elected to use the statutory appeal procedure;
8. an action covered by 5 U.S.C. § 4303 (because of unacceptable performance) or by

5 U.S.C. § 7512 (adverse actions), if the employee has elected to use the statutory appeal
procedure;
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9. the termination of an employee during his or her probationary or trial period;
10. the termination of a temporary appointment;
11. the loss or suspension of an employee’s security clearance; and
12. a notice of proposed disciplinary or adverse action, furlough, or removal. Issues relating
to such proposal notices may, however, be raised in connection with any grievance over
the final decision on the proposed action.
C. Identical Grievance. In the case of employee grievances that the Parties agree are identical,
one employee’s grievance may be selected by the Union for processing. For the purposes of
this Section, identical grievances are ones arising from a common or related set of
circumstances that adversely affect the grievants in a common or related manner and where all
of the witnesses would be testifying to the same or substantially similar facts. The term
“substantially similar” means facts that are sufficiently alike so that a reasonable person would
conclude that application of the same rules to the facts in each grievance would result in the
same conclusions with regard to the outcome of those grievances. All decisions for the selected
grievance will be binding on the remaining grievance(s).
Section 4. Grievability/Arbitrability
A. A Party will raise any questions of grievability or arbitrability of a grievance as early in the
grievance procedure as possible. Where a Party declares a grievance non-grievable or non-
arbitrable, the dispute between the Parties shall be considered amended to include this issue.
B. If a Party’s assertion of non-grievability or non-arbitrability occurs less than 14 days before

the scheduled arbitration hearing and the assertion causes the other Party to request a delay of
the hearing, the Party asserting non-grievability or non-arbitrability shall be responsible for
paying any costs the arbitrator may charge for late cancellation or rescheduling.
C. Upon motion by a Party, the arbitrator will resolve any issue of grievability/arbitrability prior
to hearing the merits of the grievance. The issue of grievability/arbitrability may be presented
on brief where there are no factual issues requiring live witness testimony and in the alternative
by telephone or VTC.
D. In the event the arbitrator determines the grievance is non-grievable or non-arbitrable, the
arbitration will be concluded. Any hearing on the merits will be scheduled on a mutually
agreeable date at least five (5) days following the Parties’ receipt of the decision that the matter
is grievable/arbitrable.
E. Where the issue of grievability/arbitrability is heard and decided in advance of a hearing on

the merits of the grievance, the Party asserting non-grievability or non-arbitrability shall be
responsible for paying the arbitrator’s fees and expenses for the resolution of this issue.
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Section 5. Grievance Procedure: Employee Grievances
A. Step 1
1. The Step 1 grievance must be filed in writing within 30 days after a particular act or
occurrence, or within 30 days from the date on which the employee knew or had reason to
know of the act or occurrence which is the subject of the grievance. The grievance should
be filed with the first level of management having the authority to resolve the concern. If
the management official with whom the grievance is filed does not have authority to
resolve the grievance, the official will forward the grievance to the appropriate official
within seven (7) days of receiving the grievance and will so notify the grievant and the
Union. The grievant may, if he or she desires, be assisted by a Union representative.
2. The grievant shall set forth the basis for the grievance, including the underlying facts, the
names of any individual(s) alleged to have acted improperly, the Article(s) and Section(s)
of the Agreement and/or legal or regulatory provision(s) alleged to have been violated, the
reason(s) for dissatisfaction, and the corrective action requested. The grievance will also
include the name and contact information of any known witness(es).
3. Within 10 days after receipt of the grievance and prior to issuance of a decision, the Parties
may confer (e.g., in person, in writing, by telephone) to attempt to resolve the grievance.
The Union has the right to be present during any discussion(s) between the Agency and the
grievant relating to a Step 1 grievance, even if the grievant has not designated a Union
representative.
4. The Agency will respond in writing with a grievance decision within 21 days of receipt of
the grievance. The decision will include the basis for the decision. Copies of any materials
cited in a decision that denies the relief in whole or in part will be provided if they are not
otherwise readily available to the grievant or his or her representative and release is not
prohibited by law. The decision will include the name, title, and contact information of the
Step 2 management official.
5. Any decision will be delivered to the grievant’s Union representative. If the employee is
representing himself or herself, the decision will be provided to the employee and also to
the Union President or designee.
B. Step 2
1. If the grievant is dissatisfied with the Step 1 decision and desires to advance the grievance
to Step 2, the grievant (or the grievant’s Union representative acting on behalf of the
grievant) must submit a written grievance to the Step 2 management official identified in
the Step 1 decision, within 14 days after receiving the Step 1 decision on the grievance.
2. The grievant, or Union representative if designated, will present the Step 2 management
official with the written grievance, a copy of the Step 1 decision, any additional evidence
to which the grievant has access and that is relevant to resolution of the grievance, all
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reasons why the Step 1 decision is incorrect, and the corrective action requested, if different
than as stated in the Step 1 grievance. The Step 2 grievance will also include the name and
address of any witness(es) not previously provided with the Step 1 grievance.
3. Within 21 days after receiving the grievance, the Step 2 management official or designee
may hold such meeting(s) and complete such inquiry as he or she deems necessary. If any
meeting is held with the grievant, the following guidelines will apply:
a. If the Step 2 management official or designee meets with the grievant at this stage and
the grievant has designated the Union as a representative, both the grievant and the
grievant’s Union representative will be given the opportunity to be present. The Union
has the right to be given the opportunity to be present at such meetings and discussions
even if the grievant has not designated a Union representative.
b. When a Step 2 meeting is held, the Agency will pay applicable travel and per diem
expenses for the grievant.
c. Where the Union is the employee’s designated representative and (1) there is no Union
steward or member of the Local 511 Executive Board at the duty station where the
meeting is held and (2) the Union has presented good cause to believe that effective
representation cannot be provided by telephone due to particular circumstances
applicable to the grievance, the Agency will provide applicable travel and per diem
expenses necessary for the Union representative to be present on-site. This provision
will not be applied to require the Agency to pay such expenses for a non-employee
Union representative.
4. The Step 2 management official or designee will render a written decision on the grievance
within 21 days of receipt of the grievance. The decision will include the basis for the
decision. Copies of any materials cited in a decision that denies the relief in whole or in
part will be provided if they are not otherwise readily available to the grievant or his or her
representative and release is not prohibited by law. The Step 2 decision will include the
name, title, and contact information of the Step 3 management official, if a Step 3 grievance
is available pursuant to Section C.1. Any decision will be delivered to the grievant’s Union
representative. If the grievant is representing himself or herself, the decision will be
delivered to the grievant and to the Union President or designee.
C. Step 3
1. If the grievant is dissatisfied with the Step 2 decision and desires to advance the grievance
to Step 3, the grievant (or the grievant’s Union representative acting on behalf of the
grievant) must submit a written grievance to the Step 3 management official identified in
the Step 2 decision within 21 days after receiving the Step 2 decision on the grievance.
2. The grievant, or Union representative if designated, will present the Step 3 management
official with the written grievance, a copy of the Step 2 decision, any additional evidence
to which the grievant has access and that is relevant to resolution of the grievance, all
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reasons why the Step 2 decision is incorrect, and the corrective action requested, if different
than as stated in the Step 2 grievance. The Step 3 grievance will also include the name and
address of any witness(es) not previously provided at Step 1 and/or Step 2 of the grievance
procedure.
3. Within 21 days after receiving the grievance, the Step 3 management official or designee
may hold such meeting(s) and complete such inquiry as he or she deems necessary. If any
meeting is held with the grievant, the following guidelines will apply:
a. If the Step 3 management official or designee meets with the grievant at this stage, and
the grievant has designated the Union as representative, both the grievant and the
representative will be given the opportunity to be present. The Union has the right to
be present at such meetings and discussions even if the grievant has not designated a
b. When a Step 3 meeting is held, the Agency will pay applicable travel and per diem
expenses for the grievant.
c. Where the Union is the employee’s designated representative and (1) there is no Union
steward or member of the Local 511 Executive Board at the duty station where the
meeting is held and (2) the Union has presented good cause to believe that effective
representation cannot be provided by telephone due to particular circumstances
applicable to the grievance, the Agency will provide applicable travel and per diem
expenses necessary for the Union representative to be present on-site. This provision
will not be applied to require the Agency to pay such expenses for a non-employee
4. The Step 3 management official or designee will render a written decision on the grievance
within 21 days of receipt of the grievance. The decision will include the basis for the
decision. Copies of any materials cited in a decision that denies the relief in whole or in
part will be provided if they are not otherwise readily available to the grievant or his or her
representative and release is not prohibited by law. If the Step 3 decision denies the
grievance in whole or in part, it will inform the grievant of the Union’s right to invoke
arbitration if the grievant wishes to challenge the decision. Any decision will be delivered
to the grievant’s Union representative. If the grievant is representing himself or herself,
the decision will be delivered to the grievant and to the Union President or designee.
D. A grievance decision issued at Step 1 or Step 2 by a Headquarters Program Office Head or

designee will be the final Agency decision on the grievance prior to arbitration. (A
Headquarters Program Office Head is the Principal Legal Advisor, Chief Financial Officer, or
similar program head).
E. If the Agency grants the relief requested, the grievance will terminate at that Step.
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F. If the Agency does not grant the relief requested in the Final or Step 3 decision, the Union in
its sole discretion may elect to invoke arbitration by filing a Form R-43, or other applicable
form, with the Federal Mediation and Conciliation Service (FMCS).
G. Except as otherwise specified below, all employee grievances are to be initiated at Step 1 of
the grievance procedure within the timeframe as stated at Step 1.
1. The grievant shall initiate grievances that are based on the written decision or policy of a
Chief Counsel or Finance Center Director (or equivalent position in any other program
area) at Step 2 of the grievance procedure within the time frame specified at Step 1.
2. The grievant shall initiate grievances concerning written reprimands at the next higher level
of authority above the issuer of the reprimand. The grievance must be filed within the time
frame specified at Step 1.
3. The Union shall initiate grievances concerning suspensions, including indefinite

suspensions, reductions in grade or pay, furloughs of 30 days or less, or removal at the final
pre-arbitration step.
Section 6. Grievance Procedure: Institutional Grievances by the Union or the Agency
A. Local Level Disputes
1. Step A. If a dispute arises between local representatives of the Union and an OPLA field
office or a Finance Center Director (or equivalent position in any other program area), one
Party may file a written grievance with the other Party, provided such grievance is filed
within 30 days after the particular act or occurrence which is the subject of the grievance
or within 30 days from the date on which the grievant knew or had reason to know of the
act or occurrence. Any such grievance must include the relevant facts; the provisions of
any law, rule, or contract allegedly violated; and the relief being sought. When a grievance
is filed, the Parties may meet and/or discuss the matter within 10 days after receipt. The
Union has the right to be present during formal discussion(s) between the Agency and an
employee relating to a Step A grievance. The Party with whom the grievance was filed
shall render a written decision on the grievance within 21 days after receipt of the
grievance. The decision will include the basis for the decision. Copies of any materials
cited in a Step A decision that denies the relief in whole or in part will be provided if they
are not otherwise readily available to the grievant or his or her representative.
2. Step B. If the grievant is dissatisfied with the Step A decision, the grievant may advance
the grievance to the Headquarters Program Office Head (i.e., Principal Legal Advisor,
Chief Financial Officer, or similar program head) (or designee) or the appropriate Union
Officer within 21 days after receipt of the Step A decision. The grievant shall include the
written grievance, a copy of the Step A decision, any additional evidence to which the
grievant has access and that is relevant to resolution of the grievance, all reasons why the
Step A decision is incorrect, and the corrective action requested, if different than as stated
in the Step A grievance process. The Union has the right to be present during formal
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discussion(s) between the Agency and an employee relating to a Step B grievance. The
Union Officer or Headquarters Program Office Head (or designee) will render a written
decision on the grievance within 21 days of receipt. Copies of any materials cited in a Step
B decision that denies the relief in whole or in part will be provided if they are not otherwise
readily available to the grievant or his or her representative.
3. If the grievance is not resolved to the mutual satisfaction of the Parties, the dissatisfied
Party may invoke arbitration within the time frame stated in Section 8.
B. National Level Disputes
If a dispute arises between the Union and a Headquarters Program Office Head (i.e., Principal
Legal Advisor, Chief Financial Officer, or similar program head), including a dispute affecting
more than one local office of a program, either the Union President or the Chief Human Capital
Officer (or their respective designees) may file a written grievance with the other Party within
30 days after the particular act or occurrence which is the subject of the grievance, or within
30 days from the date on which the grieving Party knew or had reason to know of the act or
occurrence. The Party with whom the grievance was filed will render a written decision on
the grievance within 21 days after receipt of the grievance. The decision will include the basis
for the decision. If the grievance is not resolved to the mutual satisfaction of the Parties, the
dissatisfied Party may invoke arbitration within the time frame stated in Section 8.
C. Where the same issue or decision is present in grievances filed under Subsection A at more
than one locality, either Party may consolidate the Local Level Disputes into a National Level
Dispute.
Section 7. Time Limits and Service
A. For purposes of this Article, a day is a calendar day.
B. The Parties may, by mutual agreement, extend all time limits.
C. If a grievant should fail to meet an applicable time limit for moving a grievance forward, the
grievance shall be deemed to have been withdrawn. If a Party fails to meet the time limit for
rendering a decision on the grievance, such failure shall entitle the grievant to advance the
grievance to the next step (including arbitration, if appropriate) within the applicable time
frame for such action as measured from the date the Party should have rendered his or her
decision.
D. All time limits of this grievance procedure, including arbitration, shall be controlling. As
applicable, time limits shall begin to run on the day after the date of receipt of the document
that triggers the particular time limit.
E. Grievances, grievance decisions, invocation of arbitration, and any correspondences related to

such representational matters may be transmitted by e-mail with electronic read receipt
requested. Electronic read receipt will constitute proof of service. Each Party may designate
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up to four (4) recipients. Documents transmitted by e-mail will be sent to each Party’s
designees at their government e-mail addresses. The Parties’ designees will ensure their
electronic read receipt is enabled and, where requested, will acknowledge receipt promptly. In
the alternative, certified mail or personal delivery will constitute formal service. FAX
transmission may be used only when the receiving Party expressly consents to such means in
regard to a particular document. The Parties will act in good faith in sending read receipts for
documents and will not attempt to evade the service of documents on each other.
Section 8. Arbitration
A. If the Agency and the Union fail to resolve any grievance processed under the negotiated
grievance procedures, either Party may invoke arbitration in writing within 30 days after the
date the Agency or the Union’s final decision is received. In cases involving suspensions of
fewer than 15 days or adverse actions, requests for arbitration must be filed after receipt of the
Notice of Decision, but not later than 30 days after the effective date of the action. Requests
for arbitration shall be submitted by the Union President or his or her designee in the case of
the Union or the Chief, Labor and Employment Law Division, OPLA, or designee in the case
of the Agency. Designations of authority to invoke arbitration shall be served on the other
Party in writing.
B. Within 15 days of invoking arbitration, both Parties shall identify the arbitration
representatives and identify the name, title, and contact information of the representatives.
C. Both Parties have the sole discretion to identify and select their representatives. A Party’s
designated representative may be disqualified only for conflict of interest, or conflict of
position.
D. When invoking arbitration, the Union or the Agency shall submit a properly prepared Form R-
43, or other applicable form, to the FMCS for a list of seven (7) arbitrators, and shall serve a
copy of the FMCS form on the other Party. The Party invoking arbitration shall share equally
the cost of any fee charged by the FMCS for the arbitrator’s list. The Parties shall
telephonically select an arbitrator within 14 days after receipt of such a list, or at a later date
upon mutual agreement by the Parties. If they cannot mutually agree on one of the listed
arbitrators, the Agency and the Union will each strike one arbitrator's name from the list of
seven (7) names and will repeat this procedure. The Party invoking arbitration will exercise
the first strike. The remaining person shall be the duly selected arbitrator.
E. If, for any reason, either Party refuses to participate in the selection of an arbitrator, the FMCS
will be empowered to make a direct designation of an arbitrator to hear the case.
F. Each Party has the obligation to cooperate promptly with the designated arbitrator in setting a
date for a hearing. Where an information request pursuant to 5 U.S.C. § 7114(b)(4) has been
submitted in advance of an arbitration hearing and the Agency’s response is still pending at
the time the Parties seek to establish a hearing date, the Union may request that the arbitrator
not schedule the hearing date until after the Agency response is received. Failure of either
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Party to proceed with due diligence in responding to an offer of dates may serve as a basis for
establishment of a hearing date by the arbitrator.
G. Any request to cancel a scheduled hearing will be made at least 48 hours in advance of the date
scheduled. The Party that cancels the hearing will be responsible for any cancellation fees and
any other expenses of the arbitrator, except that where the Parties jointly request to cancel a
hearing, including where a case is settled, the Parties will equally share any cancellation fees
and other expenses of the arbitrator.
H. Where an information request pursuant to 5 U.S.C. § 7114(b)(4) has been served on the Agency
in advance of an arbitration hearing, the Agency shall respond within a reasonable period of
time. The Parties recognize that the arbitrator may grant the Union’s reasonable request for a
continuance of the hearing where the Agency’s response was provided so close in time to the
scheduled hearing that the Union would be prejudiced in preparing for the hearing.
I. The Union may contact Agency employees regarding issues relevant to the arbitration. Agency
employees at their discretion may or may not respond. The Union will make best efforts to
notify management prior to contacting employees regarding arbitration.
J. Either Party shall be given, at the other Party’s request, a complete list of the other Party’s
anticipated witnesses, a summary of expected testimony, and a copy of exhibits to be
introduced, no later than 21 days prior to the hearing.
K. All motions must be filed 30 days prior to the hearing unless otherwise agreed upon by the
Parties. Responses to any motions must be filed within 15 days of the hearing unless otherwise
agreed upon by the Parties.
L. No later than 14 days prior to the start of the arbitration hearing, each Party will inform the
other whether it desires a transcript of the hearing.
M. If the Parties mutually agree on the need for a transcript, they shall equally share the cost of
the transcript and the Agency will make the arrangements for securing a transcript. If they do
not agree on the need for a transcript, the Party desiring a transcript will arrange for the
transcript and will bear the full cost. However, should the other Party change its mind prior to
the close of the arbitration hearing and indicate its desire for a copy, that Party shall be
responsible for half of the costs. A copy of the transcript shall not be provided to the other
Party absent such a timely change of mind. This provision is not intended to preclude the other
Party from purchasing a copy of the transcript directly from the court reporting service.
N. Either Party may record the hearing.
O. The arbitration hearing will be held, if possible, on the Agency’s premises during the regular
day shift of the basic workweek. The location of the arbitration of an Employee Grievance
filed pursuant to Section 5 will be held within the commuting area of the grievant, or at another
location by mutual agreement. The location of the arbitration of a Local Level Dispute filed
pursuant to Section 6.A will be determined by mutual agreement. The location of the
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arbitration of a National Level Dispute filed pursuant to Section 6.B will be at the Agency’s
headquarters in Washington, DC, or at another location by mutual agreement.
P. When the arbitration is held at the Agency’s premises, the Agency will provide the Union
representative(s) with a confidential meeting space that includes a telephone, as well as access
to a computer, printer, scanner, and photocopier.
Q. The Agency is responsible for appropriate travel and per diem costs incurred by the grievant
and the Union’s representative if the hearing is held away from their respective duty stations.
This Paragraph does not apply to non-employee representatives. Travel time for Agency
employee participants will be official time and will be compensated consistent with applicable
regulations and this Agreement.
R. The Agency will pay appropriate local travel expenses to bring witnesses (who are Agency
employees) located within a 50-mile radius from the site of the hearing to appear for testimony.
Telephone or VTC testimony will be used when practicable for presenting hearing testimony
from witnesses located outside the 50-mile radius. If there is no VTC facility/equipment
reasonably available, the Agency may elect to bring the relevant witness to the nearest VTC
facility or the site of the hearing. Either Party may bring relevant witnesses from outside the
50-mile radius to a hearing at its own expense. The arbitrator is not authorized to order the
appearance at the site of the hearing of any witness who is otherwise available by VTC.
S. All necessary and relevant Union participants in the hearing (e.g., grievant, representative,
relevant witnesses) shall be on official time, if they would otherwise be in a duty status.
T. To the extent possible, the Agency shall ensure that all witnesses who are employed by the
Agency are available for the hearing. In those instances when a witness cannot be made
available on the day required, the arbitration may be postponed.
U. The arbitrator will be requested to render his or her decision as quickly as possible but, in any
event, no later than 30 days after the conclusion of the hearing, unless the Parties mutually
agree to extend the time limit.
V. The arbitrator’s award shall be final and binding on the Parties unless either Party files
exceptions to the award with the FLRA under the regulations prescribed by the FLRA or seeks
judicial review in accordance with 5 U.S.C. § 7121(f), except that adverse action appeals shall
not be presented to the FLRA.
W. The Parties shall share equally the arbitrator’s fee and the expenses. Fees to be paid by the
Agency will be governed by existing regulations.
X. Reasonable attorney fees and expenses will be provided to the Union consistent with governing
statute or case precedent. An arbitrator retains jurisdiction, consistent with applicable law,
rule, or regulation, to resolve a motion for attorney fees by the Union after an award becomes
final and binding.
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The arbitrator’s award on the issue of attorney fees will normally be issued within 30 days of
the arbitrator’s receipt of the Agency’s response to the Union’s request. The arbitrator will
provide a detailed explanation of the award on attorney fees.
All charges of the arbitrator in connection with the award of attorney fees will be shared equally
by the Parties.
Y. Discussion of any arbitration cases where a Form R-43 has been issued and pending will be
conducted telephonically at the request of either the Agency or the Union on a quarterly basis.
Such discussions may include possible settlements in pending cases or in pending grievance
matters.
Z. The Parties recognize the importance of promptly handling cases involving removal, indefinite
suspensions, and suspensions of 30 days or more. When the moving Party submits the Form
R-43 to the FMCS, the Parties will request that the arbitrator be available to hear the case
within 30 days.
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ARTICLE 23
EQUAL EMPLOYMENT OPPORTUNITY
Section 1. General
A. A federal employee (current or former) or an applicant for federal employment has a right to
initiate a complaint of discrimination. The bases of discrimination are race; color; sex
(includes pregnancy, equal pay, gender identity, and sexual orientation); religion; national
origin; age (40 and over); disability; genetic information; retaliation (for having participated
in activity protected by the various civil rights); and parental status.
B. If employees have questions or believe they have been subjected to acts of discrimination;
harassment, including sexual and non-sexual harassment; or retaliation, they should call the
ICE Office of Diversity and Civil Rights at (202) 732-0192/0193. If they receive the office
voicemail, employees should leave a message.
C. The Agency shall publicize to all employees by posting on a bulletin board in each office
facility the EEO Complaint Information (located at Appendix J of this Agreement), which will
include the contact information for the ICE Office of Diversity and Civil Rights: EEO-ADR-
[email protected]; (202) 732-0192/0193 (telephone); (202) 732-0104 (FAX);
U.S. Immigration and Customs Enforcement, 801 I Street NW, Suite 800, Mail Stop 5010
Washington, DC 20536.
Bulletin boards will be in the employee high-traffic and -visibility area (e.g., in employee break
rooms, near photocopiers), such that all bargaining unit employees may have easy access to
the information.
Section 2. Bargaining Obligations
Where the development and implementation of the Agency’s EEO Plans and Programs involve
changes in personnel policies, practices, or working conditions, the Agency will fulfill its
bargaining obligations with the Union under 5 U.S.C. Chapter 71.
Section 3. Filing Options
A. Any employee who believes that he or she has been discriminated against on the grounds set
forth in Section 1 may file any one of the following:
1. a grievance pursuant to the provisions of Article 22;
2. a complaint of discrimination with the Agency subsequent to required EEO pre-complaint

counseling;
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3. an appeal to the MSPB where an action is otherwise appealable to the MSPB and the
employee alleges that the basis for the action was discrimination prohibited by Section 1;
or
4. a complaint of discrimination with the Office of Special Counsel.
B. An employee shall be deemed to have exercised his or her option under this Section at such
time as the employee timely files one of the following: (1) a formal complaint of
discrimination; (2) an MSPB appeal; (3) a grievance in writing in accordance with the
provisions of this Agreement; or (4) a complaint of discrimination with the Office of Special
Counsel.
C. The selection of the negotiated grievance procedure contained in this Agreement to process a
complaint of discrimination shall in no manner prejudice the right of an aggrieved employee
to request the MSPB to review the final decision in the case of any personnel action that could
have been appealed to the MSPB, or, where applicable, to request the EEOC to review a final
decision in any other matter involving a complaint of discrimination of the type prohibited by
any law administered by the EEOC. Appeals to the MSPB, the EEOC, or the Office of Special
Counsel shall be filed pursuant to such regulations as those agencies may prescribe.
Section 4. Grievance Procedures Pursuant to Article 22
A. An employee may file a grievance pursuant to Article 22 within 30 days following:
1. the date of the alleged discriminatory incident or, in the case of a personnel action, the
effective date of the action; or
2. the date of the employee’s final interview with the EEO Contact Counselor.
B. The time limit provided in Subsection A.1 shall be extended where the individual shows that
he or she did not know and reasonably should not have known that the discriminatory matter
or personnel action occurred, or that despite due diligence, he or she was prevented by
circumstances beyond his or her control from filing a grievance within the time limits.
C. If the employee elects to pursue the complaint under the grievance procedure in Article 22 and
elects to process the grievance without representation, the Union shall have the right to be
present at any meeting between the Agency and the employee concerning the grievance.
D. Where the corrective or remedial action to be taken as a result of statutory adjudicatory

procedures would conflict with, or appear to conflict with, the provisions of this Agreement,
the Agency shall afford the Union reasonable notification and opportunity to negotiate the
impact of the Agency's action effectuating the decision.
E. The provisions of this Agreement may not serve to prevent implementation of statutory equal
employment opportunity decisions (i.e., the MSPB, the EEOC, or the federal courts) where the
provisions:
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1. violate applicable law, order, or regulations in effect at the time this Agreement was
approved;
2. are themselves discriminatory in their impact on employees; or
3. leave no reasonable alternative for taking required action.
Section 5. Equal Employment Opportunity Process
A. Pursuant to 29 C.F.R. § 1614.105(a), aggrieved persons who believe they have been
discriminated against on the basis of race, color, religion, sex, national origin, age, disability,
or genetic information must consult with an EEO Counselor prior to filing a complaint to try
to informally resolve the matter.
1. An aggrieved person must initiate contact with an EEO Counselor within 45 days of the
date of the matter alleged to be discriminatory or, in the case of personnel action, within
45 days of the effective date of the action.
2. The Agency or the EEOC shall extend the 45-day time limit in Subsection A.1 when the
individual shows (1) that he or she was not notified of the time limits and was not otherwise
aware of them; (2) that he or she did not know, and reasonably should not have known,
that the discriminatory matter or personnel action occurred; (3) that despite due diligence,
he or she was prevented by circumstances beyond his or her control from contacting the
EEO Counselor within the time limits; or (4) other reasons considered sufficient by the
Agency or the EEOC.
B. EEO Counselors are provided by the ICE Office of Diversity and Civil Rights. They may be
contacted by telephone at (202) 732-0192/0193 or TTY (202) 732-0097; by e-mail at
[email protected]; or by mail at ICE Office of Diversity and Civil Rights,
U.S. Immigration and Customs Enforcement, 801 I Street NW, Suite 800, Mail Stop 5010
Washington, DC 20536.
C. The aggrieved employee has the right to have a Union representative or other representative of
his or her own choosing present throughout all stages of the discrimination complaints process.
The aggrieved employee shall also have the right to present the discrimination complaint
without representation.
D. The EEO Counselor shall, insofar as is practicable, conduct a final interview with the aggrieved
employee within 30 days after the date on which the matter was called to the attention of the
EEO Counselor by the aggrieved employee.
E. If the final interview with the EEO Counselor is not concluded within 30 days and the matter
has not been previously resolved to the satisfaction of the aggrieved employee, the aggrieved
employee has the right to immediately file a complaint of discrimination by exercising one of
the options in Section 3.A.
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F. The aggrieved employee shall in no way be restrained from filing a discrimination complaint,
nor encouraged to file a discrimination complaint.
G. The aggrieved employee has a right to request the EEO Counselor not to reveal the identity of
an aggrieved employee who has come to him or her for counseling, except when authorized to
do so by the aggrieved employee, until a written discrimination complaint has been filed.
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ARTICLE 24
PERFORMANCE MANAGEMENT
A. The Agency and the Union are committed to providing quality public service. Performance
management is the systematic process by which the Agency involves its employees, as
individuals and members of groups, in improving organizational effectiveness in the
accomplishment of Agency mission and goals. This Article shall be interpreted consistently
with all appropriate statutes and government-wide regulations relating to performance
management.
B. The performance management program ensures honest feedback and open, two-way
communications between employees and their supervisors.
C. The performance management program integrates the processes the Agency uses to:
1. communicate and clarify organizational goals to employees;
2. identify individual and, where applicable, team accountability for accomplishing

organizational goals;
3. identify and address developmental needs for individuals and, where applicable, teams;
4. assess and improve individual, team, and organizational performance;
5. apply appropriate measures of performance as a basis for recognizing and rewarding

accomplishments; and
6. draw on the results of performance appraisals as a basis for appropriate personnel actions.
D. The Agency shall not establish a forced distribution of summary rating levels. A rating of
record shall be based only on the evaluation of actual job performance for the designated
appraisal period.
A. Application of the employee performance management program shall be fair, reasonable, and
based on work assignments and responsibilities.
B. As used in this Article, terms that relate to the performance management program, such as
“appraisal,” “critical element,” “performance rating,” “rating officials,” or “reviewing
officials,” have the same meaning as in government-wide regulation.
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Section 3. Critical Elements
A. Critical element means a work assignment or responsibility of such importance that

unacceptable performance on the element would result in a determination that the employee’s
overall performance is unacceptable. Critical elements shall be used to measure performance
only at the individual level.
B. All critical elements to be used for performance appraisals will be directly related to the
employee’s work assignments and responsibilities. Critical elements shall be communicated
to the employee at the beginning of the rating period or whenever elements or expectations
change during the rating period.
Section 4. Performance Standards
A. Performance means accomplishment of work assignments or responsibilities. Performance

standard means the management-approved expression of the performance threshold(s),
requirement(s), or expectation(s) that must be met to be appraised at a particular level of
performance. A performance standard may include, but is not limited to, quality, quantity,
timeliness, and manner of performance.
B. Performance standards will, to the maximum extent feasible, permit the accurate evaluation of
job performance on the basis of objective criteria related to the job in question for each
employee or position under the program. The criteria shall be reasonable, attainable, and job-
related. Based on the nature of work performed and where appropriate, the criteria should also
be observable and/or measurable to reflect accurately whether objectives have been met.
C. Application of all performance standards shall be fair, reasonable, and consistent with
regulatory requirements.
Section 5. Impact of New Technology, Methods, or Means of Performing Work
The Agency will consider the effects of new technology, methods, or means of performing work
when rating an employee. An accommodation period of a reasonable length will be provided
where the new technology, methods, or means of performing work will have a direct impact on a
critical element affecting the employee’s rating.
Section 6. New and Revised Critical Elements and Performance Standards
Upon execution of this Agreement, the Union will be provided copies of all current critical
elements and standards for bargaining unit employees. Subsequently, the Union will be provided
copies of proposed changes to critical elements and standards. The Union will be afforded an
opportunity to bargain, consistent with applicable law and regulations, pursuant to the provisions
of Article 9 before the revised critical elements and standards are implemented and issued to an
employee.
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Section 7. Communications
A. Employees are encouraged to participate in the development and discussion of their

performance plan. Employees will be provided final performance plans, which will be in
writing and reflect critical elements and standards.
B. Absent exigent and/or unforeseen circumstances, an employee must be placed on a

performance plan generally within 30 days after (1) the employee enters on duty or is assigned
to a new position; (2) the Agency determines that an employee is no longer excluded from the
bargaining unit, resulting in changes to the elements and standards in the employee’s
performance plan; or (3) the beginning of the appraisal period. Notwithstanding the above
requirement, the Agency will not be required to place an employee who is on maternity,
paternity, medical, or military leave on a performance plan until 30 days after the employee’s
return to work.
C. Discussions between the employee and rating official may be held at any time, including, but
not limited to, a(n):
1. employee’s entry on duty or change in position, to include reassignment, promotion, or

reduction in grade;
2. request submitted by the employee;
3. change in the supervisor of record;
4. detail of 90 days or more;
5. temporary promotion of 90 days or more; or
6. return from an extended absence of 90 days or more.
D. Ongoing Performance Discussions
1. Discussions may be initiated by the supervisor, rating official (if not the immediate
supervisor), or employee. If an employee requests a discussion with his or her rating
official to discuss his or her performance, it will be scheduled within a reasonable period
of time of the employee’s request.
2. The discussion will provide an opportunity to address progress, identify any problems in
the employee’s work product, and seek further guidance, if needed.
Section 8. Mechanics
A. All bargaining unit employees will receive an annual performance rating for the rating cycle
established by the Agency. Absent exigent and/or unforeseen circumstances, the performance
rating will be issued in writing to the employees, generally within 30 days of the end of the
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appraisal period. Notwithstanding the above requirement, the Agency will not be required to
issue a performance rating to an employee who is on maternity, paternity, medical, or military
leave until 30 days after the employee’s return to work. This period may be extended where
an employee is subject to a Performance Improvement Plan (PIP) under Section 12.
B. When an employee has not been under a formal performance plan for a period of at least 90
days as of the end of the specified appraisal period, the appraisal period must be extended until
such time as the 90-day requirement has been met.
C. When an employee’s performance plan changes less than 90 days before the end of the rating
period, the employee will be evaluated based on those parts of the performance plan that had
previously been in place.
D. In the event an employee is detailed to a position with a different performance plan or is

temporarily promoted for more than 90 days, the employee will be placed on a formal written
performance plan for the detail or temporary promotion as soon as practicable, but not later
than 30 days after the beginning of the detail or temporary promotion. At the completion of
the detail or temporary promotion, documented input on the employee’s performance will be
prepared, which the employee’s rating official shall consider in preparing the employee’s
rating of record.
E. The extended absence of the rating official or the employee is a circumstance that may warrant
extending the appraisal period.
F. The rating official will evaluate the employee’s performance against the standards for each
performance element and assign the applicable summary rating level to each element.
G. At least one formal progress review, either oral or written, must be conducted normally near
the mid-point of the rating cycle. Progress reviews should be documented by the signatures of
the rating official and the employee on the Performance Appraisal Record. If, at the time of a
progress review, the rating official is aware of an instance or instances of performance
deficiency, the employee should be so informed. The Agency shall provide a clear and
accurate assessment regarding whether objectives are being met. The progress review is
intended to provide feedback during the rating cycle; a “rating of record” is not issued as a part
of the progress review.
H. A rating of record shall be based only on the evaluation of actual job performance for the
designated appraisal period. The Agency shall not issue a rating of record that assumes a level
of performance by an employee without an actual evaluation of that employee’s job
performance. The Agency encourages a rating official who is departing the Agency during an
appraisal period to provide a written assessment of the employee’s job performance prior to
departure.
I. If there is insufficient information during the appraisal period to evaluate the employee’s
performance against the standards of a particular performance element, the rating official
should make a statement to that effect on the performance appraisal record.
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J. If any element is rated as “Unacceptable Performance” or “Fails to Meet Expectations,” written

comments, supported by specific examples, are required to explain how the performance was
deficient.
K. Employees may contest a rating of record by exercising their right to grieve such rating under
Article 22. Except as provided in 5 C.F.R. § 430.208(i), a rating of record is final when it is
issued to an employee with all appropriate reviews and signatures.
Section 9. Appraisal Levels
A. Within the context of formal performance appraisal requirements, rating means evaluating
employee performance against the elements and standards in an employee’s performance plan
and assigning a summary rating of record. The rating of record is completed at the end of the
appraisal period, and a summary level must be assigned. The summary level assigned is based
on work performed during the employee’s appraisal period.
B. Employees represented by the Union and covered by this Agreement are employed within
several of the Agency’s program offices. Program offices may use two (2), three (3), four (4),
or five (5) summary levels.
Section 10. Uses of the Performance Rating of Record
The performance rating given to employees under this performance management program is used
for a number of purposes. The rating of record may be used in consideration for appropriate
awards, promotions, and other personnel actions. This performance rating will be considered in
making determinations regarding reductions-in-force within the Agency in accordance with
applicable law and regulation.
Section 11. Changes in an Established Appraisal Program
The Union will be provided notice of any changes to a program office’s appraisal program and
will be afforded an opportunity to bargain to the extent required by law before the changes are
implemented and issued to the employees.
Section 12. Performance Improvement Plan
A. Consistent with 5 C.F.R. § 432.104, whenever an employee’s performance is determined to be

unacceptable in one or more critical elements during the performance appraisal cycle, the
Agency shall notify the employee of the critical element(s) for which performance is
unacceptable and inform the employee of the performance requirement(s) or standard(s) that
must be attained to demonstrate acceptable performance in his or her position.
B. Consistent with 5 U.S.C. § 4302(c)(6), a Performance Improvement Plan (PIP) provides an

employee who is performing at an unacceptable level in one or more critical elements a
specifically identified opportunity to demonstrate whether he or she can perform at an
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acceptable level in the critical element(s). The purpose of the activities and requirements set
forth in a PIP is to assist the employee in attaining acceptable performance.
C. If at any time during the rating period the rating official determines that an employee is
performing at an unacceptable level, the supervisor (or rating official) may place the employee
on a PIP.
D. When an employee is on a PIP at the end of a rating period, the rating period shall be extended
until the completion of the PIP. A formal rating shall not be issued until the completion of the
PIP.
E. When the Agency informs an employee at the end of a rating cycle that he or she is performing
at an unacceptable level, and that he or she is being placed on a PIP, the rating period will be
extended and the formal rating will be held in abeyance until the completion of the PIP.
F. When a rating period has been extended because the employee is on a PIP, the subsequent
rating period shall commence upon completion of the PIP.
G. Guiding principles for the creation and nature of a PIP include:
1. The PIP will identify the critical element(s) for which performance is unacceptable or fails
to meet expectations, provide example(s) of the employee’s unacceptable performance, and
inform the employee of the performance requirement(s) or standard(s) that must be attained
in order to demonstrate acceptable performance. The PIP will state that unless performance
in the critical element(s) improves to an acceptable level by the end of the PIP and is
sustained at an acceptable level for a minimum period of one year from the beginning of
the PIP, the employee may be reduced in grade or removed from federal service.
2. The PIP will afford the employee a reasonable opportunity of at least 90 days to resolve
the identified performance-related problem(s). During this period, the employee normally
will not be subject to an adverse action based on performance-related problems. However,
this would not prevent the Agency from imposing an adverse action for neglect of duty or
other serious deficiency.
3. The PIP will be tailored to the specific needs of the employee and may include formal
training, on-the-job training, counseling, assignment of a journeyman mentor, or other
assistance as appropriate. Employees should request additional assistance from the
supervisor or rating official, if needed.
4. The PIP will state which supervisor or management official(s) will be overseeing the PIP
and available to assist the employee in reaching an acceptable level of performance.
5. Ongoing communication between a supervisor and an employee during the PIP is essential;
accordingly, a supervisor shall meet with the employee throughout the assessment period
to provide feedback on progress made during the PIP period.
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H. In the event that unforeseen circumstances arising during the PIP period prevent the rating
official from assessing the employee’s performance at the end of the period (e.g., prolonged
absence due to illness or injury), the rating official may extend the PIP period until an
assessment can be made, consistent with law.
I. When it appears to the employee that his or her performance may not reach an acceptable level
prior to the conclusion of the PIP, the employee may request the PIP to be extended for an
additional reasonable period of time to allow an opportunity to improve his or her performance
level. The decision to extend is in the Agency’s sole discretion.
Section 13. Chapter 43 Action Based on Unacceptable Performance
A. In accordance with 5 U.S.C. § 4303, an employee who does not improve his or her performance
to an acceptable level after having been provided a reasonable opportunity to do so (i.e., a PIP)
may be reassigned to another position, reduced in grade, or removed from federal service.
B. An employee whose reduction in grade or removal is proposed for unacceptable performance

is entitled to:
1. 30 days advance written notice of the proposed action, which identifies the specific basis
for the proposed action, including specific instances of unacceptable performance and the
critical element(s) of the employee’s position involved in each cited instance of
unacceptable performance. The proposed action may not be based on unacceptable
performance that occurred more than one year before the date of the notice of the proposed
action.
2. the right to be represented by an attorney or other representative. The employee must

inform the deciding official, in writing, of the representative’s name.
3. a reasonable time, not to exceed 10 days, to answer orally and in writing, and to provide
affidavits and work product or other evidence to challenge the proposed action. Upon
request, the Agency may grant an extension to the period of time for an answer.
C. The advance written notice period may be extended for 30 days or for a longer period, but only
as consistent with 5 C.F.R. § 432.105(a)(4)(i)(B)(1)-(6) or (C).
D. A final Agency decision to reduce in grade or remove an employee shall be made not later than
30 days after the expiration of the advance notice period. The employee will be given this
decision in writing. Unless the action is proposed by the Head of the Agency, the deciding
official will be at a higher management level than the proposing official. The decision will
specify:
1. the instances of unacceptable performance on which the decision is based; and
2. the action to be taken, the effective date, and the employee’s applicable appeal and/or
grievance rights.
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E. The employee may appeal to the MSPB in accordance with applicable law; the Union, on
behalf of the employee, may timely file a written request to invoke arbitration under the terms
of Article 22; or the employee may contest the action pursuant to applicable EEO law and
regulation. An employee shall be deemed to have exercised the appellate option at such time
as the employee timely files an MSPB appeal or a formal discrimination complaint or the
Union, on behalf of the employee, timely files a written request to invoke arbitration,
whichever occurs first. Arbitration must be invoked no later than 30 days after the effective
date of the action, unless the employee has initiated EEO action as provided at Article 23,
Section 4.A.2.
F. If a third-party adjudicator, including an arbitrator, determines that the Agency has established,
by substantial evidence, that the employee’s performance was unacceptable on at least one
critical element, the Agency’s action must be sustained. The Agency’s decision to remove or
reduce in grade taken under the authority of 5 U.S.C. § 4303 is not subject to mitigation.
Section 14. Chapter 75 Performance-Based Actions
Nothing in this Article limits the Agency’s discretion to employ Chapter 75 procedures to address
the unacceptable performance of an employee. A PIP is not required prior to initiating an action
under 5 U.S.C. Chapter 75.
Section 15. Electronic Performance Management System
Should the Agency determine to establish an electronic system for processing any part of the
performance management program, the Union will be notified and have an opportunity to bargain
in accordance with law and Article 9.
Section 16. Retention of Records
The Agency will retain copies of progress reviews, ratings of record, and other correspondence
related to performance management pursuant to applicable law and regulation. Upon request, the
Agency will grant employees access to such documents.
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ARTICLE 25
FORMAL DISCUSSIONS AND INVESTIGATIVE EXAMINATIONS
A. The Union shall be given the opportunity to be represented at any formal discussion between
one or more representatives of the Agency and one or more employees in the unit or their
representatives concerning any grievance or any personnel policy or practices or other general
B. The Agency will provide the Union the opportunity to be represented at any examination of an
employee in the unit by a representative of the Agency in connection with an investigation if:
1. the employee reasonably believes that the examination may result in disciplinary action
against the employee; and
2. the employee requests representation.
C. If an employee who is entitled to representation requests such representation, no further

questioning will take place until a representative is available. The Union will determine which
representative will be assigned to any particular investigatory examination. The Union’s
selection of a particular representative may not cause an unreasonable delay or obstruct the
Agency’s investigation. If the Union’s selected representative has a scheduling conflict, the
Union may request that the Agency make appropriate accommodations, where practicable.
Any travel necessitated by this selection will be at the Union’s expense.
D. The Agency will advise, in writing, employees of the unit of this right annually.
E. In some circumstances, a written memorandum may be used as a substitute for an oral

examination in connection with an investigation. In such cases, where the criteria of Section
B are met, the employee is entitled to the opportunity to consult with a Union representative
prior to completing the memorandum.
F. Examinations in connection with misconduct investigations may be conducted at any

reasonable hour.
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ARTICLE 26
DISCIPLINARY AND ADVERSE ACTIONS
A. The Agency has the right and obligation to identify and correct conduct and performance
deficiencies. Performance-based adverse actions are addressed by Article 24 and are not
addressed by this Article. The objective of disciplinary and adverse actions is to promote the
efficiency of the service. Generally, the Agency’s objective is to correct deficiencies in
employee conduct, not to punish the employee.
B. When appropriate, the Agency may consider an oral or written warning or counseling in lieu
of a disciplinary or adverse action. The Agency generally follows the sound principle of
progressive disciplinary action, which involves using a higher range of penalties for second
and subsequent incidents of employee misconduct. Where discipline is necessary, a common
pattern of progressive discipline is reprimand, short-term suspension, long-term suspension,
and removal. However, various factors, such as the severity of the behavior in question, may
necessitate a higher range of penalties for a first offense.
C. Corrective action can include:
1. non-disciplinary actions, such as an oral warning, an oral or written counseling, and other
non-disciplinary actions;
2. disciplinary actions, such as letters of reprimand and suspensions of up to 14 days; and
3. adverse actions, such as suspensions of 15 days or more, reductions of grade or pay, and
removal.
D. Disciplinary or adverse actions pursuant to 5 U.S.C. Chapter 75 will only be taken for such
cause as will promote the efficiency of the service. The Agency will administer disciplinary
and adverse action procedures and determine penalties for all employees in a fair and equitable
manner. The standard of proof for disciplinary and adverse actions taken pursuant to 5 U.S.C.
Chapter 75 is preponderance of the evidence. The deciding official will always be different
from the official who proposes a disciplinary or adverse action. Normally, the deciding official
will be at a higher level of management than the proposing official.
E. In arriving at its written decision on any proposed disciplinary or adverse action, the Agency
shall not consider any reasons for action other than those of which the employee received
notice and to which the employee had an opportunity to respond. It shall consider any written
and/or oral reply that the employee and/or his or her representative made to a designated
official prior to the end of the reply period specified in the proposal or any extended deadline,
where applicable, and any medical documentation furnished prior to the expiration of the reply
period, as well as all the information relied on in proposing the action. The Agency will
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consider relevant factors when taking an action governed by 5 U.S.C. § 7512 to the extent
consistent with applicable law.
F. The Agency will provide the employee and his or her designated representative, where they
are not co-located, with a copy of the materials it relied on to support the reasons for the
proposed action. Where an action has been proposed under Section 7 or 8 and a formal
investigation has been conducted, the materials provided will include the report of
investigation.
G. When the Union is designated as the representative in a disciplinary or an adverse action, the
employee will notify the Agency, in writing, of such designation. The designation will include
the name, address, e-mail address, and telephone number of the representative. All
correspondence will be served by the Agency to the representative and the employee.
H. If the employee elects not to be represented by the Union, correspondence will be addressed
to the employee and it will remain the employee’s prerogative as to whether he or she wishes
to furnish the Union with copies of such correspondence.
I. No record of a complaint determined to be unfounded or not investigated will be placed in the

employee’s OPF.
For the purposes of this Article,
1. day is a calendar day, unless otherwise specified;
2. furlough means the placing of an employee in a temporary status without duties and pay
because of lack of work or other non-disciplinary cause;
3. suspension means placing an employee in a temporary nonduty status without pay;
4. removal is a separation from federal service initiated by the Agency, OPM, or the MSPB under
5 C.F.R. Parts 359, 432, 731, or 752; 5 U.S.C. § 1201; or comparable agency statutes or
regulations; and
5. reinstatement means the noncompetitive reemployment for service as a career or career-

conditional employee of a person formally employed in the competitive service who had a
competitive status or was serving probation when he was separated from the service; for
excepted service employees, it means to put back or establish again, as in a former position or
state.
Section 3. Investigations
A. Prior to issuing a proposed disciplinary or adverse action, the Agency may investigate
allegations of misconduct.
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B. The Union shall be given the opportunity to be represented at any examination (i.e.,
questioning) of an employee by a representative of the Agency in connection with an
investigation if the employee reasonably believes that the questioning may result in
disciplinary action against the employee and the employee requests representation. The
Agency will annually inform employees of this right in accordance with Article 25.
C. If the employee reasonably believes that the questioning may result in disciplinary action
against him or her and the employee requests Union representation, the Agency will not
continue the questioning until a Union representative is present, unless proceeding with the
interview in the absence of Union representation is not prohibited by law.
D. Employees interviewed in a formal Agency investigation (e.g., conducted by the Office of

Professional Responsibility), whether as a subject or witness, shall be appropriately advised of
their rights and responsibilities in connection with giving a statement.
E. When the subject of a formal Agency investigation is made aware of that investigation, the
Agency will advise the employee when the investigation is concluded, if the allegations are
found to be without merit.
Section 4. Timeliness of Disciplinary and Adverse Actions
A. The Agency will initiate disciplinary or adverse actions in a timely manner. Pursuant to 5
U.S.C. §§ 7503 and 7513, the deciding official shall issue the decision letter at the earliest
practicable date. Extenuating circumstances that can delay the issuance of a proposal letter
include, but are not limited to, the need to conduct a thorough investigation and/or obtain
additional information regarding particular matters, the need to consult with Employee and
Labor Relations or OPLA, and the requirement to follow specified procedures. Extenuating
circumstances that can delay the issuance of a decision letter include, but are not limited to,
the need to consult with Employee and Labor Relations or OPLA and difficulties in arranging
meetings because the employee and the deciding official are at different locations.
B. Delay in taking a disciplinary or adverse action will not excuse an employee’s misconduct, but
may be considered by the Agency when making its final decision, depending on the facts of
the case.
Section 5. Last-Chance Agreements
A. A Last-Chance Agreement (LCA) is an agreement in which an employee against whom the

Agency has proposed a disciplinary or adverse action agrees to conform to certain conduct
expectations for a set period of time in exchange for the Agency’s commitment to hold the
proposed action in abeyance for the same period and, upon successful conclusion, to forego
imposing the action. If the employee does not meet his or her obligation under the LCA, then
the Agency is free to impose the proposed disciplinary or adverse action without issuance of a
new notice and opportunity to reply. In any subsequent grievance, appeal, or other challenge
to the disciplinary or adverse action, the only issues that can be reviewed are whether the
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employee conformed to the conduct expectations to which he or she had committed in the LCA
and whether the Agency abided by the provisions of the LCA.
B. An offer of an LCA is not an employee right. The Agency’s determination of whether to offer
an employee an LCA in any particular case is a matter solely within the Agency’s discretion,
including when the LCA has been offered at the specific request of the employee and/or his or
her representative. An offer of an LCA establishes no precedent or presumption that it will be
offered in any other case.
C. In executing an LCA, the employee takes full responsibility for his or her actions and meeting
the obligations under the LCA.
D. The “probationary period” required by an LCA shall not exceed five (5) years, unless the
Parties mutually agree otherwise.
E. The Union will be notified and given an opportunity to be present at any meeting in which the
Agency offers an LCA to a bargaining unit employee.
Section 6. Disciplinary Actions: Reprimands
A. A letter of reprimand is considered the mildest level of a disciplinary action. A letter of

reprimand is a written disciplinary action that specifies the reasons for the action, places the
employee on notice that he or she may be subject to more severe disciplinary action upon any
further offense, and informs the employee that a copy of the reprimand will be made a part of
his or her OPF.
B. When the Agency issues a letter of reprimand, the Agency will allow the employee and his or
her representative 10 days to make a written request for reconsideration. The employee and/or
his or her representative, if an Agency employee, will be given a reasonable amount of official
time to prepare the request.
C. A letter of reprimand will inform the employee that he or she has the right to file a grievance
regarding the reprimand under the negotiated grievance procedure; the time period for filing a
grievance; the name, telephone number, and e-mail address of the management official to
whom a grievance should be addressed (normally, an Agency official one level higher than the
official who issued the reprimand); and the right to Union representation.
D. A letter of reprimand will stay in the employee’s OPF for a period of up to, but not exceeding,
two (2) years or upon resignation or retirement, whichever is earlier. If a subsequent
disciplinary or adverse action has been proposed after the reprimand is removed from the
employee’s OPF, the reprimand may no longer be considered a “prior disciplinary action” but
continues to serve as specific notice to the employee that the underlying conduct is
unacceptable.
E. Where an employee has consistently exhibited exemplary conduct and performance for one
year following issuance of a reprimand, the Union may make a single written request that the
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reprimand be removed from the employee’s OPF. The Agency will give good-faith
consideration to the request. The Agency’s decision on such a request for early removal of the
reprimand is final and not subject to the negotiated grievance procedure.
Section 7. Disciplinary Actions: Short-Term Suspensions
A. An employee against whom a suspension for 14 days or less is proposed is entitled to:
1. an advance written notice of at least 20 days stating the specific reasons for the proposed
action;
2. receive and review materials pursuant to Section 1.F;
3. at least 14 days to respond orally and/or in writing and to furnish affidavits and other
documentary evidence to a deciding official; and
4. be represented by an attorney or other representative.
B. The employee and/or his or her representative, if an employee, will be given a reasonable
amount of official time to prepare and present an oral and/or written response to the proposal.
C. If the Agency wishes to add additional charges to a pending proposed action between the time
it proposes a disciplinary action and when a decision is issued, the Agency may rescind the
original proposal and issue a new one, including the new charges, thus starting the process all
over.
D. If the deciding official determines to impose a suspension, the decision will include the
applicable grievance and/or appeal rights specified in Section 11.
Section 8. Adverse Actions: Removal, Suspension for More than 14 Days, Reduction-in-
Grade, Reduction-in-Pay, and Furlough of 30 Days or Less
A. An employee against whom a removal, suspension for more than 14 days, reduction-in-grade,
reduction-in-pay, or furlough of 30 days or less is proposed is entitled to:
1. an advance written notice of at least 30 days (except where a shortened notice period is
authorized by law or regulation, such as 5 U.S.C. § 7513(b) and 5 C.F.R. § 752.404(d)),
stating the specific reasons for the proposed action;
2. the right to receive and review materials pursuant to Section 1.F;
3. at least 14 days to respond orally and/or in writing and to furnish affidavits and other
documentary evidence to a deciding official (normally at a level higher than the proposing
official) (or at least seven [7] days where there is reasonable cause to believe the employee
has committed a crime for which a sentence of imprisonment may be imposed [5 U.S.C. §
7513(b) and 5 C.F.R. § 752.404(d)]); and
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4. be represented by an attorney or other designated representative.
B. The employee and/or his or her representative, if an employee, will be given a reasonable
amount of official time to prepare and present an oral and/or written response to the proposal.
C. If the Agency wishes to add additional charges to a pending proposed action between the time
it proposes an adverse action and when a decision is issued, the Agency may rescind the
original proposal and issue a new one, including the new charges, thus starting the process all
over.
D. If the deciding official determines to impose an adverse action, the decision will include the
applicable grievance and/or appeal rights specified in Section 11.
Section 9. Medical Condition
An employee who wishes consideration of any medical condition that the employee claims has
contributed to a conduct, performance, or leave problem shall supply supporting medical
documentation within the time limits allowed for the employee’s response to the proposal notice.
Section 10. Agency Decisions
A. Where the Agency proposed a form of discipline or adverse action covered under Section 7 or
8, it will follow the procedural requirements of law, regulation, and this Agreement in
rendering a written decision.
B. In arriving at its written decision on any proposed disciplinary or adverse action, the Agency
shall not consider any reasons for action other than those specified in the notice of proposed
action. It shall consider any timely response that the employee and/or his or her representative
made to a designated official and any timely medical documentation furnished, as well as all
the information gathered in the investigation.
C. If the decision is to effect an action identified in Section 7 or 8, the decision will state the
specific reason(s) for the decision, the effective date, the action to be taken, and the employee’s
appeal rights regarding the decision.
D. When represented by the Union, a second copy of the letter, labeled “Copy for Union
Representative” and including any attachments, will be provided to the employee.
Section 11. Appeal Rights
A. A decision to take an action specified in Section 6 or 7 may be grieved under Article 22. The
grievance would be filed at the final pre-arbitration step. The reprimand or decision letter will
specify the time limits under the grievance procedure and the name, telephone number, and
e-mail address of the Agency official to whom a grievance should be addressed.
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B. For an action addressed in Section 8, an employee may grieve under Article 22 or appeal to
the MSPB, but not do both. The choice of forum, by either filing a grievance or appealing to
the MSPB, is irrevocable. An employee shall be deemed to have exercised his or her option
at such time as the employee timely files a written grievance or timely initiates an appeal to
the MSPB, whichever occurs first. A grievance will be filed at the final pre-arbitration step.
C. For an action addressed in Section 8, the decision letter will specify the time limits under the
grievance procedure and the name, telephone number, and e-mail address of the management
official to whom a grievance should be addressed. The decision letter will also provide the
notice of appeal rights to the MSPB consistent with 5 C.F.R. § 1201.21.
Section 12. Unjustified or Unwarranted Personnel Actions
A. Where it has been ultimately determined through administrative action or applicable third-
party adjudication that a disciplinary or adverse action was unjustified or unwarranted, the
Agency will take whatever action is required to correct the employee’s personnel and pay
records, in accordance with law and regulation. The Agency will also take other remedial
action in accordance with the third-party determination, law, and regulation (e.g., the Back Pay
Act). Evidence of any unjustified or unwarranted personnel action will be timely removed
from the official file(s) of the employee or otherwise disposed of in accordance with
government records requirements. Upon request, the Agency will provide written notification
to the employee and the employee’s representative when such actions have been accomplished.
The Agency retains the right to maintain any information, including documentation of any
expunged personnel actions, in its litigation files. Any dispute over whether the Agency has
complied with such requirements may be resolved through the negotiated grievance procedure
or compliance proceedings before the applicable third-party adjudicatory forum.
B. Where action taken under Section 8 is later found to have been unwarranted or where an
independent determination has been made to reinstate an employee, the Agency shall timely
reinstate the employee, in good-faith compliance with the lawful order of the adjudicatory
body, by returning the employee to his or her previous position or one of equal status and pay,
provided the employee meets the applicable suitability and clearance requirements at the time
of reinstatement.
Section 13. Requests for Time Extensions
The Agency will not unreasonably deny a reasonable request for an extension of time. Absent
extraordinary circumstances, such requests must be made at least two (2) workdays in advance of
the deadline.
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ARTICLE 27
EMPLOYEE ASSISTANCE PROGRAM
A. Under the Employee Assistance Program (EAP), the Agency will continue efforts to identify,
counsel, and assist in rehabilitating employees with alcohol, drug-related, or personal
problems that may adversely affect job performance. The Union will cooperate fully with the
Agency in this program, while complying with the provisions for confidentiality in
safeguarding client information.
B. The Agency will provide an orientation for Union officials concerning EAP policies, referral
procedures, and program resources.
C. Employees may access information (including telephone number) regarding the EAP (which
is available 24 hours per day, seven [7] days per week) on the Agency’s website.
D. An employee will neither be required to participate nor be penalized for declining to participate
in the program, unless participation in the program is pursuant to a written agreement.
E. Supervisors may grant a reasonable amount of time during normal working hours to an
employee to attend EAP counseling sessions during duty hours. An employee may have his
or her tour of duty modified to accommodate his or her attendance at such sessions. Permission
to attend EAP counseling sessions on duty time will include travel to and from such sessions.
F. The Agency recognizes its responsibility to identify and make reasonable effort at
rehabilitation of employees with alcohol or drug problems at an early stage. Employees who
are undergoing a prescribed program of treatment will be granted leave in accordance with
Article 18.
G. The Agency and the Union jointly acknowledge that employees entering the EAP are not
immune from disciplinary action. However, the fact that an employee is actively pursuing, or
indicates a commitment to enter, an established program of rehabilitation will be given weight
in considering appropriate disciplinary action.
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ARTICLE 28
REIMBURSEMENT OF EMPLOYEE EXPENSES
Section 1. Professional Credentials
A. Pursuant to 5 U.S.C. § 5757(a), the Agency may reimburse eligible employees each fiscal year
for qualifying expenses to obtain professional credentials required as a condition of
employment, subject to the availability of funds. This includes mandatory dues and fees paid
in one jurisdiction during each fiscal year for professional accreditation, licenses (e.g., state
bar membership), certifications, and the costs of examinations to obtain such credentials.
B. The Agency will not reimburse an employee for late payment penalties, non-mandatory
contributions, certification fees for a specialized area of practice, payment of professional
taxes, or dues or other costs incurred prior to the individual’s employment with the Agency or
that qualify the employee for initial consideration for a professional position (e.g., an
employee’s costs for initial admission to a state bar following completion of law school or an
accounting technician’s college tuition to obtain an accounting degree). The Agency may pay
for court admission fees required of attorneys for admission to practice before a court, if
admission is necessary to carry out the Agency mission.
C. Eligible employees include the following:
1. every attorney required by the Agency to be a member in good standing of the bar of the
highest court of any state, possession, territory, commonwealth, or the District of
Columbia; and
2. every other professional employee within the bargaining unit who is required to maintain
professional credentials as a condition of employment.
D. Procedures
1. The employee will initiate the process by presenting to his or her supervisor evidence of
payment of qualifying expense(s) during the current fiscal year (e.g., cancelled check, copy
of bank statement showing payment, credit card statement, statement from bar or
professional association showing payment) and a completed reimbursement request,
currently an SF-1164.
2. Reimbursement of qualifying expenses is only available during the fiscal year in which the
expense is incurred by the employee.
3. The employee must submit a request for reimbursement as soon as possible after incurring
the expense to ensure that the Agency will be able to obligate the funds for reimbursement
by the end of the fiscal year cutoff date.
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4. The Agency will take reasonable steps to ensure prompt processing, adjudication, and
timely reimbursement.
Section 2. Professional Liability Insurance
As permitted by law and subject to the availability of funds, the Agency may reimburse up to
50% of the annual premium for professional liability insurance paid by bargaining unit employees
whose primary duties include the investigation, apprehension, prosecution, or detention of
individuals suspected or convicted of offenses against the criminal laws of the United States
(including OPLA attorneys whose primary duties involve enforcement of immigration laws of the
United States).
Section 3. Transportation Subsidy
A. Consistent with applicable law and regulations, and subject to availability of funds, the Agency
shall provide a subsidy of an employee’s eligible commuting costs for mass transportation or
vanpools, up to the maximum amount authorized at the time the subsidy is paid. The amount
of the subsidy cannot exceed the actual costs incurred.
B. Employees will apply for and receive the transportation subsidy in accordance with local
procedures and schedules.
C. The transportation subsidy may be used only for the employee’s eligible mass transportation
or vanpool commuting costs. No part of the subsidy may be used for any other purpose or
transferred to anyone else, without regard to whether the employee receives anything in
exchange.
D. When the Agency is directed to increase or decrease the maximum amount of the transit
subsidy by law, regulation, or Executive Order, the Agency will implement the change for all
employees in the bargaining unit in a timely manner consistent with the guidance or
requirements of the applicable law, regulation, or Executive Order.
E. When the Agency is given discretion to increase the maximum amount of the transit subsidy
by law, regulation, or Executive Order, the Union may negotiate over any changes in transit
subsidy amounts within 30 calendar days of when the Agency receives this new discretion.
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ARTICLE 29
CHILD CARE
Section 1. Policy and Purpose
The Parties recognize that working parents may have special child care needs during working
hours, including the need to secure appropriate child care arrangements.
Section 2. Child Care Activities
A. The Agency will continue to provide child care and parenting information, child care resource
and referral information, and counseling as available through the Employee Assistance
Program (EAP).
B. If it is determined that training for an employee who assumes oversight responsibility for a
federal child care facility is necessary and readily available, the Agency will consider paying
for it in light of other competing demands for local training.
Section 3. Employee Needs
A. Whenever practicable, the Agency will grant emergency requests for annual leave and leave
without pay necessitated by unexpected changes in child care arrangements.
B. The Agency will consider requests from employees for such arrangements as part-time
employment, job sharing, flextime, etc., to assist with the employees’ child care needs.
C. The Agency recognizes that it may be necessary for employees to contact child care providers
during duty hours.
Section 4. Facilities
In accordance with 29 U.S.C. § 207(r)(1), the Agency will provide a properly furnished private
space, other than a bathroom, that is shielded from view and free from intrusion from coworkers
and the public for nursing mothers to express breast milk. Where necessary and practicable, the
space will include a mini refrigerator and, to ensure privacy, will be lockable from the inside or
clearly identified as private.
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ARTICLE 30
HARDSHIP REASSIGNMENT
A. Situations may arise during an employee’s career where a personal hardship exists that could
be alleviated if the employee is temporarily or permanently reassigned to an office other than
the employee’s current duty station.
B. This Article provides procedures and requirements that apply when an employee requests a
geographic reassignment because of personal hardship.
C. Requests for reassignment because of personal hardship will be considered in a fair and
equitable manner. While reassignment is not an entitlement and is at the sole discretion of the
Agency, the Agency will make efforts to accommodate employees who establish personal
hardships.
D. If a request for reassignment because of personal hardship is granted, the employee will be
responsible for any relocation expenses associated with the reassignment.
A. Reassignment means a change from one position to another in a different geographic location
at least 50 miles away from the employee’s permanent duty station and from the employee’s
current residence while the employee is serving continuously within the same position
classification series. Reassignment because of personal hardship may be approved only to a
position with the same or lower promotion potential and at the same or a lower grade level.
B. Immediate family refers to spouses, domestic partners, parents, spouses’ parents, domestic
partners’ parents, former legal guardians, brothers, sisters, and children. “Step” relationships
and relationships by affinity equivalent to one of the listed family relationships are also
included in the definition of immediate family. The immediate family member must be a
member of the employee’s household or an individual for whom the employee has a primary
duty for providing or directly overseeing the individual’s care.
C. A serious medical condition is a serious illness, injury, impairment, or physical or mental

health condition, any of which involves (1) inpatient hospital care; (2) continuing treatment by
a health care provider; (3) ongoing treatment for a serious chronic condition; (4)
permanent/long-term conditions that require supervision; and/or (5) non-chronic conditions
that require multiple treatments.
D. A licensed medical practitioner includes, but is not limited to, the following: physician,
physician assistant, nurse practitioner, psychologist, and other licensed mental health
counselor such as a marriage and family therapist or licensed clinical social worker.
E. Personal hardship means a serious difficulty (excluding an employee’s own medical issue) that
would negatively affect an employee’s performance caused by:
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1. a permanent relocation related to the employment of a spouse or domestic partner as

defined in 5 C.F.R. § 875.213;
2. an immediate family member’s serious medical condition that a licensed medical

practitioner expects to be substantially alleviated or controlled by residence in another
geographic location;
3. an immediate family member’s serious medical condition that requires ready access to a
hospital that specializes in treatment of the condition; or
4. an immediate family member’s substantial disability or handicapping condition, including,

but not limited to, deafness, blindness, or a serious learning disability that requires ready
access to special education facilities.
Section 3. Pre-requisites for Requesting a Reassignment Because of Personal Hardship
A. Absent extreme medical circumstances, an employee must have at least two (2) years of current
employment with the Agency before requesting a reassignment because of personal hardship.
B. The personal hardship for which reassignment is requested must have arisen after the beginning
of the employee’s current employment with the Agency.
C. The employee’s performance must be at or above an acceptable level and the employee must
not have been on a Performance Improvement Plan (PIP) within the last two (2) years.
D. The employee must have had no disciplinary actions issued within the last two (2) years.
Section 4. Procedures for Requesting a Reassignment Because of Personal Hardship
A. In order to make a request for reassignment because of personal hardship, an employee must:
1. submit a written request for reassignment because of personal hardship to the head of his
or her current office; and
2. provide administratively acceptable documentation to support the hardship request (e.g.,

physician’s letter, letter from the spouse or domestic partner, letter from the spouse or
domestic partner’s employer, letter from the specialized education facility). The
documentation must contain an explanation as to why the move has to be to the location
identified, or to a nearby location, where the hardship could be alleviated. The Agency
will consider the licensed medical practitioner’s diagnosis of a serious medical condition
relating to the employee’s immediate family member. The Agency may request additional
documentation from the employee as necessary to assist in making its decision. Any
medical documentation submitted by the employee will be stored in accordance with
applicable law, rule, and regulation. When more than one duty location is available to
alleviate the hardship, the employee will specify in the request the order of preference.
B. The Agency may require an interview prior to deciding whether to grant a hardship
reassignment request. In most cases, such interviews may be by telephone or VTC. However,
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if an in-person interview is required, it will be the responsibility of the requesting employee to

pay for any travel expenses associated with the interview.
C. While reassignment is at the sole discretion of the Agency, the Agency will make efforts to
accommodate an employee who has established a personal hardship. The Agency will notify
the employee of its decision as soon as practicable.
D. All hardship requests will be kept confidential within the Agency; the fact that an employee
has made a hardship request and the information provided in support of the hardship request
will only be disclosed on a need-to-know basis.
E. When an employee’s request for reassignment because of personal hardship is denied, the
employee may ask that the request remain open for up to one year. In the event circumstances
change that would allow the request to be approved, the employee may amend or supplement
the initial request.
F. Only one request may be submitted per year, unless the new request is based on an entirely
different personal hardship situation that arose subsequent to the previous request.
G. If multiple requests for the same location are pending, the Agency has discretion to determine
the order of consideration of the requests.
H. If an employee declines an offer of a position at the desired location in the same series and
grade, the employee’s request for hardship reassignment will be closed without further action.
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ARTICLE 31
ISSUANCE AND CONTROL OF BADGES
A. This Article will be interpreted and administered in accordance with DHS and ICE directives
and instructions regarding issuance and control of DHS badges.
B. While reserving its right to determine internal security practices, the Agency will issue a
metallic badge to all Agency attorneys who prosecute cases for the United States or represent
the United States in immigration court proceedings, or other Agency attorneys deemed
appropriate, as part of the service credentials to be displayed for identification purposes.
C. All ICE attorneys provided a badge as part of the service credentials acknowledge no arrest
authority is created by the issuance of the badge.
Section 2. Guiding Principles and Procedures
A. Guiding Principles
1. ICE attorneys issued a badge pursuant to this Article are responsible for the proper use,
display, accountability, and return of the badge.
2. DHS badges issued to ICE attorneys shall only be used in conjunction with the performance
of official duties. Displaying any DHS badge that has not been officially issued is
prohibited.
3. Badges are the property of the U.S. government and must be returned to the issuing office
upon termination of employment or upon demand. Badges are subject to inventory and
inspection.
4. All badges are considered accountable property. Due to the grave potential for misuse if
lost or stolen, all badges are to be treated as sensitive high-valued items in accordance with
DHS Management Directive 1120, Capitalization and Inventory of Personal Property.
5. Employees will not use their badges to exert influence, to obtain directly or indirectly any
privilege, favor, preferred treatment, or reward for themselves or others, or to improperly
enhance their own prestige. Employees involved in the inappropriate use or misuse of
badges are subject to criminal and civil penalties, including removal from employment.
B. Procedures
1. Issuance of DHS Badges. ICE attorneys must satisfactorily complete any DHS and ICE
requirements before issuance of a DHS badge.
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2. Reporting Loss or Theft of DHS Badges. In the event of loss, theft, or destruction of
badges, the employee responsible for the badge, or the employee discovering the condition,
will:
a. take immediate action to effect recovery of the lost or stolen badge, and obtain all
available information concerning the loss, theft, or damage for inclusion in reports
required by DHS Management Directive 1120.
b. notify as soon as practicable, but within 24 hours, the property management officer and
other appropriate official(s) and the supervisor of the employee with the affected badge.
Care should be taken to ensure that those supervisors in the employee’s chain of
command see all notification documents.
3. Retirement of Badges. Badges may be retired and kept as a memento of honorable service
to the United States and ICE by clearly marking the badge as retired (e.g., embedding the
badge in Lucite or permanently affixing a retired demarcation) at the individual employee’s
expense. Property accountability of the badge ends when the badge has been properly
retired, presented to the employee, and removed from property accountability records.
Badges shall be retired under the following circumstances:
a. upon retirement from federal service by the individual attorney after satisfactory
completion of at least one year of ICE employment where a badge was authorized.
b. at the request of the family of a deceased employee, regardless of the length of ICE
employment.
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ARTICLE 32
DEDUCTIONS FOR UNION DUES
A. The Agency shall deduct Union dues from bargaining unit employees who voluntarily
authorize such deduction if their net salary, after other legal and required deductions, is
sufficient to cover the amount of the authorized allotment.
B. Deduction for Union dues from bargaining unit employees shall be administered in accordance
with 5 U.S.C. Chapter 71, as amended, and this Agreement.
Section 2. Deduction Process
A. Bargaining unit employees may make an allotment for payment of dues to the Union by
voluntarily completing a SF-1187, Request for Payroll Deductions for Labor Organization
Dues, or its equivalent.
B. Such allotment forms will be submitted to the Union President or other authorized officer who
will complete the certification portion of the form. The Union, in turn, will promptly submit
all such forms received from employees to the servicing human resources office or other
Agency designee for processing. The Agency will acknowledge the receipt and notify the
Union of the form being forwarded for processing.
C. Allotments will be effective not later than the beginning of the second pay period following
the receipt of a properly completed allotment form by the servicing human resources office or
other Agency designee. The Union may contact the servicing human resources office or other
Agency designee for assistance in resolving discrepancies.
Section 3. Remittance and Report of Dues Withheld
A. The Agency will make a remittance to the Union for all deductions for Union dues by
bargaining unit members on a biweekly basis by electronic funds transfer (EFT). The Union
will provide the Agency with the appropriate bank routing number/bank account number.
B. The Agency will coordinate with the National Finance Center to ensure that a biweekly Report
of Organization or Association Dues Withheld is provided to the Union containing:
1. identification of the Agency;
2. identification of the Union Local;
3. date and pay period;
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4. name of employee, location of employee’s office, the amount deducted, and the effective
date of the authorization;
5. names of employees for whom deductions previously authorized were not taken with the
reason for no deduction;
6. total amount of remittance; and
7. total number of members for whom dues are withheld.
C. The biweekly report will be sent electronically to the Union President and Treasurer, or
designee(s).
Section 4. Changes in Union Dues Deduction
A. The Union may change the amount of the Union dues deducted per employee. The Union
President or Treasurer shall certify in a statement to the servicing human resources office or
other Agency designee indicating the dues change.
B. Such statement must be received at least two (2) pay periods prior to the first day of the pay
period in which such change is to be effective. Changes will be effective not later than the
second full pay period after receipt by the servicing human resources office or other Agency
designee.
Section 5. Cancellation/Reinstatement of Union Dues
A. The Union will be made whole for any inadvertent cancellation of Union dues of members
whose dues were improperly cancelled by the Agency, so long as the error was brought to the
attention of the Agency’s Chief, Labor and Employment Law Division, OPLA, or designee,
within four (4) pay periods of the improper cancellation. When the Agency or applicable third
party determines that the cancellation was in error, the Agency will promptly withhold the back
dues amount from the employee(s) and transmit the payment to the Union by EFT.
B. If the Agency cancels an employee deduction of Union dues based on a belief that the
employee’s position is outside the bargaining unit and the FLRA determines that the Agency
acted improperly, the Agency will promptly comply with any applicable remedial order.
C. Union members who have authorized Union dues withholding may at any time submit an
SF-1188, Cancellation of Payroll Deductions for Labor Organization Dues, to the servicing
human resources office. Regardless of when the SF-1188 is received in the servicing human
resources office, it will be processed in accordance with the following:
1. employees within their first year of membership may revoke dues withholding effective on
the anniversary date of their first year of membership; or
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2. employees with more than one (1) year of membership may revoke dues withholding
effective no later than two (2) pay periods of such request being received by the servicing
human resources office or other Agency designee.
D. Employees whose dues allotment terminates because of a temporary assignment to a position

not in the bargaining unit will have their dues withholding reinstated upon submission of a new
SF-1187. The Agency will notify the Union immediately or as soon as possible, but no later
than 30 days of any employee whose dues allotment was canceled by the Agency because of a
temporary assignment to a non-bargaining unit position. Upon the employee’s return to a
bargaining unit position, the Union will contact that employee for the submission of a new
SF-1187 to re-commence the deduction of Union dues.
E. If an employee who has been separated by the Agency is reinstated by an arbitrator, the MSPB,
the EEOC, or a court of competent authority, and the Agency is required to make the employee
whole, dues withholding will be reinstated for the employee upon the submission of a new
SF-1187.
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ARTICLE 33
COMPENSATORY TIME OFF FOR WORK PERFORMED OUTSIDE OF
THE TOUR OF DUTY
Section 1. General Principles
A. This Article applies only to employees who are General Attorney Series 0905.
B. Compensatory time off earned as a result of work performed outside the tour of duty is
governed by applicable law, rule, and regulation.
C. Compensatory time off is not a substitute for prioritizing and completing an employee’s
assigned workload within regularly scheduled duty hours.
D. The Agency will exercise its discretion to order or approve employees to perform work outside
the tour of duty on rare and infrequent occasions and solely based on mission needs.
E. An employee may not accrue compensatory time off for work performed unless the Agency,
in writing and in advance, orders or approves the employee to perform the work.
F. The Agency, as a matter of law, can deny any request to earn compensatory time off for work
performed outside the tour of duty. Although not required, the Agency’s denial should be in
writing.
Section 2. Procedures for Agency-Initiated Compensatory Time Off
A. The Agency may order an employee to perform work outside the tour of duty to further the
mission (e.g., to respond to extraordinarily burdensome discovery requests or unanticipated
and time-sensitive taskings).
B. Completion of Appendix K, Agency-Initiated – Authorization for Compensatory Time Off for

Work to be Performed Outside the Tour of Duty (the Form)
1. The Agency must complete Sections I and II of the Form before the employee performs
the work for which compensatory time off will be authorized.
2. The employee must complete Section III of the Form no later than two (2) business days
after completion of the work for which compensatory time off has been authorized.
3. The Agency will then complete Section IV of the Form within two (2) business days of
receiving the completed Form from the employee.
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4. Both the Agency and the employee should endeavor to complete the Form in time for the
employee to enter the approved compensatory time off into WebTA prior to validation for
the pay period in which the time off was earned.
Section 3. Procedures for Employee-Initiated Compensatory Time Off
A. Requests to accrue compensatory time off for completing routine work assignments (e.g.,
preparing filings and briefs or conducting legal sufficiency reviews) outside the tour of duty
are not appropriate. An employee may request approval to perform work outside the tour of
duty only in order to represent the Agency in a manner not typical of his or her daily job duties
(e.g., a job fair or academic forum).
B. Completion of Appendix L, Employee-Initiated – Authorization for Compensatory Time Off

for Work to be Performed Outside the Tour of Duty (the Form)
1. The employee must complete Section I of the Form at least five (5) business days before
the event for which the employee is seeking compensatory time off.
2. The Agency must complete Section II of the Form within two (2) business days of receipt
of the Form from the employee.
3. If compensatory time off is authorized, the employee must complete Section III of the Form
within two (2) business days of the event for which the compensatory time off was
authorized and earned.
4. The Agency will then complete Section IV of the Form within two (2) business days of
receiving the completed Form from the employee.
5. Both the Agency and the employee should endeavor to complete the Form in time for the
employee to enter the approved compensatory time off into WebTA prior to validation for
the pay period in which the time off was earned.
Section 4. Agency Action Where Work Has Been Ordered or Approved
When the Agency exercises discretion to order or approve an employee to perform work outside
the tour of duty, the Agency will determine and specify relevant details, such as:
1. the maximum number of hours to be worked, including any extensions;
2. the timeframe within which the work must be performed;
3. whether compensatory time off will be available for any travel within the local commuting
area associated with the work performed outside the tour of duty (temporary duty travel is
governed by Article 13); and
4. any other instructions or requirements.
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Section 5. Accrual and Use of Compensatory Time Off
A. Accrual of Compensatory Time Off
1. Compensatory time off will be earned in 15-minute increments. Amounts less than
7.5 minutes must be rounded down to the nearest 15-minute increment; amounts equal to
or greater than 7.5 minutes must be rounded up to the nearest 15-minute increment.
2. An employee may only accrue compensatory time off for the time spent performing the
ordered or approved duties (including approved local travel). If the event or assignment is
completed earlier than anticipated, the employee will only receive compensatory time off
for the actual duration of the event or assignment, not the maximum number of hours
originally authorized.
3. Employees must take one uncompensated meal break of at least 30 minutes for every six
(6) hours worked; this time must be excluded from the total amount of compensatory time
off ordered or approved.
B. Premium Pay Request
Employees must submit a WebTA Premium Pay Request for compensatory time off within the
pay period for which it was earned so that the request can be approved prior to validation and
certification of the timecard for that pay period.
C. Use of Compensatory Time Off
1. The scheduling of the use of compensatory time off is subject to the needs of the Agency
and requires advance approval by the supervisor.
2. An employee’s request to use compensatory time off earned will be submitted using
WebTA.
3. Compensatory time off may only be used in 15-minute increments.
4. If an employee fails to use the compensatory time off within 26 pay periods after it was
credited, the employee forfeits the unused compensatory time off.
5. When an employee separates from employment with ICE, forfeiture of or payment for
unused compensatory time off will be governed by applicable law, rule, or regulation.
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ARTICLE 34
DURATION
A. This Agreement is effective on September 1, 2019.
B. This Agreement may only be amended, modified, supplemented, or renegotiated in accordance

with and consistent with the provisions of this Agreement. Any amendments or supplements
to this Agreement will run concurrently with the Agreement.
C. This Agreement shall remain in effect for five (5) years and will automatically renew itself
from year to year thereafter, except that upon completion of the original five-year term and
consistent with 5 U.S.C. § 7116(a)(7), any rules or regulations prescribed prior to a renewal
date will thereafter be in effect and shall supersede any conflicting Agreement provision.
D. If either Party desires to renegotiate this Agreement, it will furnish written notice to the other
Party not less than 90 days but not more than 180 days prior to the expiration, including
expiration of a renewal term, of this Agreement.
1. Either Party may notify the other during the window period that it withdraws from any
agreement(s) over “permissive subjects of bargaining” under the Federal Service Labor-
Management Relations Statute. In such cases, that provision(s) will be voided as of the
renewal date of this Agreement.
2. Notwithstanding the window for requesting renegotiation of the Agreement, the Party
receiving notice will have 30 days to request renegotiation of the Agreement following a
notification under Subsection 1.
E. If either Party requests renegotiation of the Agreement, negotiation of Ground Rules shall
commence no later than 60 days after the request. The Parties will use statutory procedures to
resolve any impasses in the negotiations of Ground Rules. Renegotiations of this Agreement
will proceed under the terms of the Ground Rules. Both Parties will make best efforts to
complete an Agreement expeditiously.
138
139
APPENDIX A
OFFICIAL TIME REQUEST FORM
U.S. Department of Homeland Security Submitted:

Immigration and Customs Enforcement
To Supervisory Official: (Designated by Agency to approve official From Union Representative or Bargaining Unit Employee:
time) (Name, union title and duty location)
I. Pursuant to Article 7 of the negotiated collective bargaining agreement, official time is hereby requested as follows:
Date and Time Requested: Total Hours Place of Contact/Phone Number:
Anticipated:
Activities to Be Performed:
II. Endorsement by Supervisor:

The above requested official time is: ☐ Approved ☐ Denied
(Retain two copies and return one copy to requestor)

III. Final endorsement as recorded on time and attendance report:
For Date: Total Hours/Minutes Used: Charged to Transaction Code:
Actual Time Began: Actual Time Returned to Duty:
Form G-826 (8/2019)
INSTRUCTIONS
Transaction Codes Type of Official Time
35 Basic Negotiations, Renegotiations or Reopened Negotiations
36 Midterm Negotiations or Personal Representation/Union Affiliated
37 On-Going Labor Management Relationship, Regular Duty Hours
38 Representation During Grievances, Appeals, etc.

Regular Duty Hours (including Travel Time)
Employees/Supervisors: Enter appropriate Transaction Code at Section III and on the employee’s time and attendance report
(WebTA)
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APPENDIX B
COMPENSATORY TIME OFF FOR TRAVEL FORM
(Supervisory approval of travel itinerary is required in advance of travel)
Name: Dates of Travel: to
Work Schedule:  Flexible (Maxiflex, Variable)  Compressed (5/4-9, 4/10)
ITINERARY
Attach a copy of approved travel authorization and itinerary.
All times must be reported based on the time zone of the departure city.
Outbound:
Date: Scheduled hours of work: to
Departed from:  Home  Official Station Departure time: a.m./p.m.
Name of Terminal: Arrival time at terminal: a.m./p.m.

Within 50 miles of Official Station?  Yes  No
If No, normal commuting time:
Actual departure time from departure terminal: a.m./p.m.
Arrival time at hotel or Temporary Duty Location: a.m./p.m.
Return:
Date: Scheduled hours of work: to
Departure time from Temporary Duty Location: a.m./p.m.
Name of Terminal: Arrival time at terminal: a.m./p.m.
Actual departure time from departure terminal: a.m./p.m.
Arrival time at destination terminal: a.m./p.m.

Within 50 miles of Official Station?  Yes  No
If No, normal commuting time:
Returned to:  Home  Official Station Arrival time: a.m./p.m.
APPROVAL
Travel Compensatory Time Requested: Outbound: Return:

Signature of Traveler: Date:
Total Travel Compensatory Time Approved:
Signature of Supervisor: Date:
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APPENDIX C
VOLUNTARY ASSIGNMENT REQUEST FORM
Temporary Assignment _____________________________________________________________________________
Volunteer’s Name ___________________________ Duty Station __________________________GS Level ________
Seniority Date _______________ (start date as an Agency attorney, including time as an attorney with legacy INS, USCIS,
or GSA; see “Seniority” definition in Article 2)
Briefly describe any special skills, knowledge, and abilities you have that may relate to this assignment:
List all your Type I and II temporary assignments within the past 36 months (see Article 14):
Type I Temporary Assignment. Temporary assignment of an employee to substantially similar job duties outside of the employee’s
AOR or local commuting area (e.g., assignment to another OPLA field office, assignment to another financial operations office, etc.)
for a limited or fixed duration.
Type II Short Term Temporary Assignment. Temporary assignment of an employee to substantially different job duties (e.g.,
SAUSA, HQ) for less than one year.
Type II Long Term Temporary Assignment. Temporary assignment of an employee to substantially different job duties (e.g.,
SAUSA, HQ) for one year or longer.
List all your Type III temporary assignments within the past 12 months (see Article 14):
Type III Temporary Assignment. Temporary assignment of an employee to duties at a higher or supervisory/management level (e.g.,
Acting Deputy Chief Counsel) for more than 120 days
List any current assignments/workload that may be affected:
Request was submitted to:
Supervisor ________________________________________________________ Date __________________________

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APPENDIX D
REQUEST FOR AN EXEMPTION FROM

INVOLUNTARY TEMPORARY ASSIGNMENTS
Name__________________________________________ Date of Request
Duty Station_____________________________________ Seniority Date
Reason for Exemption Request:
☐ I previously volunteered and served a Type I voluntary temporary assignment ending on

___________________________, which is within the past 12 months. (See Article 14.)
☐ I previously volunteered and served a Type II short-term voluntary temporary assignment ending on
_____________________________, which is within the past 12 months. (See Article 14.)
☐ I previously volunteered and served a Type II long-term voluntary temporary assignment ending on
_____________________________, which is within the past 12 months. (See Article 14.)
☐ I previously volunteered and served a Type III voluntary temporary assignment ending
on_____________________________, within the past 12 months. (See Article 14.)
☐ I previously served an involuntary temporary assignment ending on____________________. (See Article 14.)
☐ I was granted a Temporary Assignment Exemption on___________________________.
☐ Other (please explain)
☐ Medical documentation provided, if applicable:
Certification: I understand that a grant of an exemption from involuntary temporary assignments shall last
for no more than six (6) months at a time.
Signature of Employee Date
☐ Approved ☐ Denied
Signature of Supervisor Date
143
APPENDIX E
REQUEST FOR AN EXEMPTION FROM THE EXTENSION OF A

TEMPORARY ASSIGNMENT
Name__________________________________________ Date of Request
Duty Station_____________________________________ Seniority Date
Reason for Requesting an Exemption:
☐ List the medical documentation provided, if applicable:
Certification: I understand that the Agency may extend a temporary assignment an additional 30 days
beyond the duration set forth in the announcement for the temporary assignment, as well as direct an
additional extension, based on mission needs. (See Article 14.)
☐ Approved ☐ Denied
144
APPENDIX F
Employee Decision Period Work Schedule Request Form
Employee’s Name: ___________________________________ EDP: ______________________________________

Employee’s Signature: ________________________________ Seniority Date: _____________ (see CBA, Article 2)
Available Duty Hours: Core Hours: Meal Period:

6:00 a.m. to 7:30 p.m. 9:00 a.m. to 3:00 p.m. 30 minutes – 60 minutes
Preference # _____ Preference # _____ Preference # _____

☐ 5/4/9 Compressed ☐ 5/4/9 Compressed ☐ 5/4/9 Compressed
Arrival Time: ___________ Arrival Time: ___________ Arrival Time: ___________
Departure Time: ___________ Departure Time: ___________ Departure Time: ___________
Requested Day Off: Requested Day Off: Requested Day Off:
Week One: ___________ Week One: ___________ Week One: ___________
OR OR OR
Week Two: ___________ Week Two: ___________ Week Two: ___________
☐ 4/10 Compressed ☐ 4/10 Compressed ☐ 4/10 Compressed

Arrival Time: ___________ Arrival Time: ___________ Arrival Time: ___________
Departure Time: ___________ Departure Time: ___________ Departure Time: ___________
Requested Days Off: Requested Days Off: Requested Days Off:
AND AND AND
☐ Maxiflex in 9 Days ☐ Maxiflex in 9 Days ☐ Maxiflex in 9 Days

Requested Day Off: Requested Day Off: Requested Day Off:
OR OR OR
☐ Maxiflex in 8 Days ☐ Maxiflex in 8 Days ☐ Maxiflex in 8 Days

Requested Days Off: Requested Days Off: Requested Days Off:
AND/OR AND/OR AND/OR
☐ Variable Week [No Days Off] ☐ Variable Week [No Days Off] ☐ Variable Week [No Days Off]
☐ Core Telework ☐ Core Telework ☐ Core Telework

Requested Telework Day(s): Requested Telework Day(s): Requested Telework Day(s):
AND/OR AND/OR AND/OR
☐ Preference # ____ Approved

☐ All Preferences Disapproved Supervisor’s Signature ______________________________________________
If none of an employee’s preferences are approved, the employee is assigned to a Variable Week Schedule. An employee
should use a continuation sheet or another copy of this form if submitting more than 3 schedule preferences.
145
APPENDIX G
NOTIFICATION OF CONDITIONS OF PART-TIME EMPLOYMENT

Employees approved to work a part-time schedule should review the Professional Employees
Agreement 2019 (Collective Bargaining Agreement), Article 16, “Part-Time Employment,” as
well as the information provided by the U.S. Office of Personnel Management, available at:
www.opm.gov
Policy
Hiring Information
Part-Time & Job Sharing
Part-time employees are required to work core hours consistent with Article 15, Section 5,
typically 9 a.m. to 3 p.m.
Part-time employment is at the discretion of the Agency; in the event that the Agency requires an
employee to modify his or her work schedule, the part-time schedule may be modified by the
Agency in compliance with Article 16.
A part-time employee must request renewal of the part-time schedule, modification of the part-
time schedule, or conversion to a full-time schedule by submitting a brief written explanation of
the reasons for the request to his or her immediate supervisor once a year during the month of July
in compliance with Article 16.
The Agency makes no explicit or implicit guarantee of a return to a full-time position in the
event an employee requests a return to full-time employment. Any request to modify the current
part-time schedule will be considered as outlined in Article 16.
I have read and understand this notification of part-time employment.
Employee Date
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APPENDIX H
TELEWORK PROGRAM AGREEMENT
The following constitutes an agreement between the Agency and
_____________________________ [Name of Employee] on the terms and conditions of the
employee’s participation in the telework program, consistent with Article 17 of the Collective
Bargaining Agreement (CBA). The employee certifies that:
1. The employee’s Alternate Duty Station (ADS) is located at the following address:
___________________________________________________
___________________________________________________
Telephone #____________________
2. The ADS may not be changed without prior approval of the Authorizing Official.
3. The ADS has the workspace, utilities, and equipment necessary to perform official business.
4. The employee’s home ADS complies with reasonable safety standards and is free from
obvious safety hazards. This includes, but is not limited to, the following: the building’s
electrical system is grounded and all equipment is free of hazards that would cause physical
harm (frayed, bare, loose, or exposed wiring); telephone lines, electrical cords, and extension
wires are secured under a desk or alongside a baseboard; the work area is free of obstructions
and hazardous materials; the temperature is conducive to health, comfort, and proper
equipment maintenance; and equipment and furniture are in good condition and ergonomic.
Additionally, the employee will ensure that the ADS is conducive to productivity, comfort,
safety, and health.
5. When performing work at the ADS, the employee will adhere to the work schedule approved
pursuant to the EDP (i.e., duty hours and days remain the same).
6. If the employee has children, elderly family members, or other dependents who require care,
the employee has made arrangements that permit full concentration on work duties. The
employee acknowledges that telework is not to be used as a substitute for dependent care.
7. The employee will record time and attendance for work performed at the ADS in the
Agency’s system of reporting time and attendance (e.g., WebTA).
8. The employee will follow established procedures for requesting and obtaining approval for
leave at the ADS.
9. On a day when the employee is scheduled to work at the ADS and the employee’s official
duty station is closed for all or part of the day as a result of an emergency, the employee will
perform work at the ADS as scheduled unless the emergency prevents the work from being
performed at the ADS or causes the employee to be unable to perform his or her duties. If
an emergency or other situation occurs that affects the employee’s ability to perform official
duties at the ADS, the employee will notify a supervisor as soon as practicable.
147
10. An employee performing work at the ADS on a core basis will work in accordance with an
approved Telework Program Work Plan (see Appendix I). Upon reasonable notice,
employees may be required to report to the primary worksite for training programs,
conferences, meetings, or other Agency needs.
11. The employee will be responsible for home maintenance and any other incidental costs (e.g.,
furniture, lockable storage, insurance, telephone, electricity) associated with the use of the
employee’s home as the ADS.
12. The employee retains entitlement to reimbursement for appropriately authorized expenses
incurred while conducting business for the Agency, as provided for by law and implementing
regulations.
13. The Agency will provide, maintain, and repair any electronic equipment it deems necessary
(e.g., computers, printers, scanners, FAX machines) for the employee to perform the portable
work at the ADS.
14. Any accident or injury occurring at the ADS must be brought to the attention of a supervisor
as soon as practicable. Where the ADS is the employee’s home, the employee will allow
timely inspection of the telework site. The Agency will give the employee reasonable notice
prior to any inspection of the telework site where the ADS is the employee’s home. An
injured employee will be provided information on submission of a claim to the Office of
Workers’ Compensation Programs, U.S. Department of Labor.
15. All government-issued equipment will be used for official purposes only. The employee will
exercise care and due diligence in safeguarding such equipment.
16. Teleworking employees must be vigilant in maintaining information security. The employee
will adhere to DHS and ICE policies and applicable government regulations governing
information management and electronic security procedures for safeguarding data.
Attachment 1 to this Telework Program Agreement summarizes some of the more pertinent
requirements applicable to a telework environment.
17. I have read and will abide by the requirements and conditions for telework as stated above.
EMPLOYEE: Date
(Signature of Employee)
APPROVED: Date
(Signature of Authorizing Official)
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ATTACHMENT 1 to
Telework Program Agreement
SUMMARY STATEMENT OF
U.S. DEPARTMENT OF HOMELAND SECURITY AND
U.S. IMMIGRATION AND CUSTOMS ENFORCEMENT
INFORMATION SECURITY ASSURANCE REQUIREMENTS
Teleworking Employees Must Be Vigilant in Maintaining Information Security:
A. Consistent with government-wide, DHS, and ICE security and information technology
policies, only government-furnished computer equipment shall be used to create, store, receive,
and transmit government information for all telework. All government-issued equipment such
as laptops, desktop computers, or removable media, including mobile devices, USB data ports,
thumb drives, and portable or removable hard drives, used in a telework arrangement shall be
encrypted in compliance with DHS encryption requirements in order to protect their contents
in case of loss or theft. Employees who have been granted the opportunity to telework are
responsible for the security of all government information and the protection of all
government-issued equipment at the Alternate Duty Station (ADS).
B. Personally Identifiable Information (PII). PII is DHS-owned information in any form that
permits the identity of an individual to be directly or indirectly inferred, including any other
information that links or is linkable to that individual regardless of whether the individual is a
U.S. citizen, a lawful permanent resident, a visitor to the United States, or an ICE employee or
contractor.
C. Sensitive PII is personally identifiable information that, if lost, compromised, or disclosed

without authorization, could result in substantial harm, embarrassment, inconvenience, or
unfairness to an individual. Information that is always considered Sensitive PII includes social
security numbers and biometric identifiers, such as fingerprints and iris scans. Except when
used as a case number, an alien registration number is considered Sensitive PII. In addition,
groupings of information which contain an individual’s name or other unique identifier plus
certain other information (e.g., full date of birth, financial account number, driver’s license
number, medical information, and account passwords or personal identification numbers) may
be considered Sensitive PII. Other PII may be “sensitive” depending upon its context, such as
a list of employees with less than satisfactory performance ratings or an unlisted home address
or phone number. In contrast, a business card or a public phone directory of Agency employees
contains PII but is not “sensitive.”
D. Sensitive but Unclassified or “For Official Use Only” (FOUO) Information. FOUO is
information not otherwise categorized by statute or regulation that, if disclosed, could have an
adverse impact on the welfare or privacy of individuals, the conduct of federal programs, or
other programs or operations essential to the national interest. FOUO is unclassified but due
to its nature must be protected from loss, misuse, modification, and unauthorized access.
149
Examples of FOUO include Sensitive PII, trade secrets, system vulnerability information, pre-
solicitation procurement documents, and law enforcement investigative methods.
E. Teleworking employees:
1. shall not remove and transfer any classified data from their primary worksite to their ADS.
2. shall not physically remove Sensitive PII or FOUO from a DHS facility or their primary
worksite unless it is properly secured during transport to and storage at their ADS. For
information that requires explicit permission for removal, e.g., electronic PII, the
information may not be removed from a DHS facility without such permission.
a. Sensitive PII and FOUO in electronic form shall be encrypted during transport to and
from the ADS and shall be encrypted while stored on government-issued equipment or
portable media at the ADS. Portable media that once contained Sensitive PII and
FOUO must be destroyed or appropriately wiped of all data once retention of the
information is no longer necessary. Portable media may not be reused by employees
for other non-work purposes. Program Office Information System Security Officers
(ISSOs) can assist employees with appropriate means to encrypt, wipe, or destroy
Sensitive PII and FOUO.
b. Sensitive PII and FOUO in paper form shall be secured at the ADS by keeping the
materials in a locked container when not in use and protecting the information from
access by others present at the site (such as family members, roommates, visitors, etc.).
Employees shall secure Sensitive PII and FOUO in paper form during transport to and
from the ADS by enclosing the paper in a closed container or opaque envelope that is
sealed to prevent inadvertent opening and show evidence of tampering. Such
documents must remain in the employee’s possession or in a safe, locked container at
all times. Materials no longer needed at the ADS shall be shredded or returned to the
primary worksite for appropriate disposal.
c. Sensitive PII and FOUO that was physically removed or extracted from an information
technology (IT) system (printouts, CDs, etc.) shall be properly disposed of within 90
days, unless it is appropriately deemed necessary to retain such information for a longer
period.
3. must ensure that any records subject to the Privacy Act, DHS Privacy Policy Guidance
Memorandum 2007-01, and FOUO are not disclosed to anyone except those who have
been authorized to access such information in order to perform their duties.
4. may not, under any circumstances, allow any unauthorized person who may have access to
their ADS to use any government-issued electronic equipment.
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APPENDIX I
TELEWORK PROGRAM WORK PLAN

(Note: This Telework Program Work Plan is to be completed jointly by the employee and
immediate supervisor.)
1. The employee’s portable work, as described in Section 3.A of Article 17 of the Collective
Bargaining Agreement, is as follows:
2. The employee is scheduled to perform work at the ADS on the following day(s) of each pay
period (circle as appropriate):
First week: Mon. Tues. Wed. Thurs. Fri.
Second week: Mon. Tues. Wed. Thurs. Fri.
3. The following is an inventory of equipment and/or reference material that will be provided by
the government in order for the work to be performed at the ADS. The inventory is guided by
the responsibilities or assignments, or portion thereof, that the employee will perform at the
ADS.
Signature of Authorizing Official Date
151
APPENDIX J
EQUAL EMPLOYMENT OPPORTUNITY COMPLAINT INFORMATION

If you are a federal employee (current or former) or an applicant for federal employment, you have
a right to initiate a complaint of discrimination. If you believe that you have been subjected to
unlawful discrimination in an employment matter within the control of the Agency, you may begin
the complaint process by choosing an administrative process that addresses your concern. The
bases for discrimination include the following:
• Race
• Color
• Sex (includes pregnancy, equal pay, gender identity, and sexual orientation)
• Religion
• National origin
• Age (40 and over)
• Disability
• Genetic information
• Retaliation (for having participated in activity protected by the various civil rights
statutes)
• Parental status
To begin the Equal Employment Opportunity (EEO) complaint process, you must contact an EEO
official, typically within the Office of Diversity and Civil Rights’ Complaints and Resolution
Division, within 45 calendar days of the alleged incident or effective date of the personnel action.
Contact Information:
By e-mail: [email protected]
By telephone: (202) 732-0192/93
By FAX: (202) 732-0104
By mail: U.S. Immigration and Customs Enforcement
801 I Street, NW, Suite 800
Mail Stop 5010 Washington, DC 20536
You must state your intention to begin the EEO complaint process or state that you believe that
you have been subject to unlawful discrimination.
152
APPENDIX K
AGENCY-INITIATED – AUTHORIZATION FOR COMPENSATORY TIME OFF FOR
WORK TO BE PERFORMED OUTSIDE THE TOUR OF DUTY
Supervisor: Employee:
Duty Location:
I. Pursuant to Article 33 of the negotiated agreement, compensatory time off is hereby ordered as follows:
Date Ordered: Estimated Amount of Compensatory Employee’s Phone Number and Address While Performing
Time Off Ordered (excluding any the Work for Which Compensatory Time Off Is Being
local travel time): Ordered:
Estimated Total Local Travel Time:
Work to Be Performed (Explain how the event/assignment advances the mission of the Agency and, if applicable, provide a
detailed itinerary that includes the proposed times of travel and the start and end times of the event/assignment):
II. Completed by Authorizing Official

Compensatory time off is ordered as follows:
Approved maximum number of hours/minutes of compensatory time off (including any approved local travel):
Approved timeframe in which the work is to be done:
Authorizing Official:
Signature of Authorizing Official: Date:
Notes/Comments:
III. Final Reporting by Employee

For Pay Period: Actual Date/Time Began (including local travel): Actual Date/Time Ended (including local travel):
Total Compensatory Time

Off Earned: Employee Signature: Date:
IV. Final Management Approval: Hours to be Recorded on Time and Attendance Report (WebTA)
Date: Total Compensatory Time Off Approved (WebTA Transaction Code 32 - Comp Time Earned):
Approving Official:
Approving Official Signature:
ADDITIONAL INFORMATION / INSTRUCTIONS:

• Compensatory time off may only be earned and used in 15-minute increments.
• Employees must take one uncompensated meal break of at least 30 minutes for every 6 hours worked; this time must be
excluded from the total amount of compensatory time off ordered or approved.
• Employees must submit a Premium Pay Request in WebTA for compensatory time off within the Pay Period for which it
was earned so that the request can be approved prior to validation and certification of the time card for that Pay Period.
153
APPENDIX L
EMPLOYEE-INITIATED – AUTHORIZATION FOR COMPENSATORY TIME OFF
FOR WORK TO BE PERFORMED OUTSIDE THE TOUR OF DUTY
Supervisor: Employee:
Duty Location:
I. Pursuant to Article 33 of the negotiated agreement, compensatory time off is hereby requested as follows:
Date Requested: Estimated Amount of Compensatory Employee’s Phone Number and Address While Performing
Time Off Requested (excluding any the Work for Which Compensatory Time Off Is Being
local travel time): Requested:
Estimated Total Local Travel Time:
Work to Be Performed (Explain how the event/assignment advances the mission of the Agency and, if applicable, provide a
detailed itinerary that includes the proposed times of travel and the start and end times of the event/assignment):
II. Completed by Authorizing Official

Compensatory time off is:  Approved  Denied
Approved maximum number of hours/minutes of compensatory time off (including any approved local travel):
Approved timeframe in which the work is to be done:
Authorizing Official:
Signature of Authorizing Official: Date:
Notes/Comments:
III. Final Reporting by Employee

For Pay Period: Actual Date/Time Began (including local travel): Actual Date/Time Ended (including local travel):
Total Compensatory Time

Off Earned: Employee Signature: Date:
IV. Final Management Approval: Hours to be Recorded on Time and Attendance Report (WebTA)
Date: Total Compensatory Time Off Approved (WebTA Transaction Code 32 - Comp Time Earned):
Approving Official:
Approving Official Signature:
ADDITIONAL INFORMATION / INSTRUCTIONS:

• Compensatory time off may only be earned and used in 15-minute increments.
• Employees must take one uncompensated meal break of at least 30 minutes for every 6 hours worked; this time must be
excluded from the total amount of compensatory time off ordered or approved.
• Employees must submit a Premium Pay Request in WebTA for compensatory time off within the Pay Period for which it
was earned so that the request can be approved prior to validation and certification of the time card for that Pay Period.
154
EXHIBIT E

GALVESTON DIVISION
v.
DECLARATION OF JOSEPH
DR. ANTHONY FAUCI, in his official SALVATOR
capacity, et al.,
Defendants.
I, Joseph Salvator, hereby declare as follows:
1. I am the Deputy Assistant Administrator for Operations Management in the
Security Operations office of the Transportation Security Administration (“TSA”), a
component of the U.S. Department of Homeland Security. Since April 2002, I have served in
various roles in the Department of Transportation, TSA, and the Federal Bureau of
Investigation before returning to TSA in 2010 to become the Director of Vetting Operations
for TSA’s Intelligence & Analysis office. During my tenure with TSA since 2010, I have served
as the Deputy Assistant Administrator for Security Operations, the Assistant Administrator
for TSA’s Office of Inspection, and returned to Security Operations in 2015 as the Deputy
Division Director for Mission Support, a post that I continue to occupy as the Deputy
Assistant Administrator for Operations Management. Within Security Operations,
Operations Management is responsible for providing strategic and tactical leadership,
direction, management, and support services to all Security Operations employees and
programs, as well as providing coordination and logistical support, resource and operations
management through staffing allocations and budgetary and financial management, human
resources management, emergency preparedness, and operational and administrative directive
development and oversight. Operations Management also provides expert management and
administrative support services required to achieve Security Operations’ mission, goals, and
objectives.
2. Presently, I also have a lead role in coordinating TSA’s implementation efforts
in accordance with the President’s mandate that all Federal workers be vaccinated against the
COVID-19 virus.
3. The statements in this Declaration are based on my personal knowledge or
information provided to me in my official capacity.
4. Consistent with Executive Order No. 14043, TSA will require its employees to
be vaccinated against COVID-19, subject to such exceptions as required by law.
5. TSA anticipates following guidance from the Safer Federal Workforce Task
Force, which provides (1) that a federal civilian employee who requests an exception to the
COVID-19 vaccination requirement should not be disciplined for being unvaccinated as long
as the exception request remains pending; and (2) that when an employee’s exception request
is denied, the employee should be given at least two weeks to initiate the process of becoming
vaccinated before being subject to discipline.
6. TSA has not yet finalized the process by which it will enforce the COVID-19
vaccination requirement with respect to employees who fail to timely provide proof of
vaccination and do not have a pending exception request.
2
7. Plaintiff George Gammon is a TSA employee assigned to its Law
Enforcement/Federal Air Marshal Service office.
8. The database TSA uses to track exemption requests reflects that on November
8, 2021, Plaintiff Gammon requested an exception to the requirement that TSA employees be
vaccinated against COVID-19. That request remains pending.
9. Plaintiff Gammon has not been counseled or disciplined for not being
vaccinated against COVID-19. Pursuant to the guidance described in Paragraph 5, above, as
long as Plaintiff Gammon’s exception request remains pending, Plaintiff Gammon will not be
disciplined for being unvaccinated. Further, if Plaintiff Gammon’s exception request is
denied, he will be given at least two weeks to initiate the process of becoming vaccinated,
during which time he will not be disciplined for being unvaccinated.
10. TSA has a workforce of approximately 60,000 and has received numerous
exemption requests that will take some time to evaluate. To my knowledge, TSA has not yet
begun to evaluate any exception requests.
///

Springfield, Virginia
Joseph Salvator
Deputy Assistant Administrator
Operations Management
Security Operations
Transportation Security Administration
U.S. Department of Homeland Security
3
EXHIBIT F

GALVESTON DIVISION
v.
DECLARATION OF LAURA
DR. ANTHONY FAUCI, in his official GLADING
capacity, et al.,
Defendants.
I, Laura Glading, hereby declare as follows:
1. I am the Director of Labor and Employee Relations in the Office of Human
Resource Management at the Federal Aviation Administration FAA , an operating
administration of the Department of Transportation . In this position, I serve as the
ief negotiator and oversee the development, issuance, guidance, evaluation and
program control of policies, standards, procedures and system for adverse action, grievances,
appeals, conduct and discipline, labor practices and union management relations. Statements
in this Declaration are based on my personal knowledge and information provided to me in
my official capacity.
2. Consistent with Executive Order No. 14043, FAA is requiring its employees to
be vaccinated against COVID-19, subject to such exceptions as required by law. FAA plans
to use a phased process for enforcing this COVID-19 vaccination requirement with respect
to employees who have not timely provided proof of vaccination and do not have a pending
exception request. The goal of this process is to help employees understand and accept the
benefit of becoming fully vaccinated.
3.
with every opportunity to become vaccinated. If an unvaccinated employee takes steps toward
becoming vaccinated, the enforcement process would be put on hold to give him or her time
to become fully vaccinated. In addition, if an unvaccinated employee requests an exception at
any time during the enforcement process, the enforcement process would be put on hold until
the exception request has been adjudicated.
4. For unvaccinated employe
enforcement process begins with a period of education and counseling about the benefits of
vaccination and ways to obtain the vaccine. After this counseling period concludes,
unvaccinated employees may be subject to progressive formal discipline that would begin with
a Letter of Reprimand and could include a proposed suspension followed by, where
appropriate, proposed removal from employment.
5. Plaintiff Michelle Morton is an FAA employee and has been since
approximately 2007. She is currently an Air Traffic Control Specialist (ATCS), 2152 job series.
6. On November 8, 2021, Plaintiff Morton requested an exception to the
requirement that FAA employees be vaccinated against COVID-19. That request remains
pending.
7. FAA has not yet begun its review of pending exception requests. In the coming
weeks, FAA intends to request additional information from employees seeking an exception
in order to make a determination regarding a specific accommodation request. See generally
2
DOT, Notice of a New System of Records, Employee Accommodations Files, 86 Fed. Reg.
64,597 (Nov. 18, 2021).
8. Pursuant to FAA policy, as long as Plaintiff Morton
pending, Plaintiff Morton will not be disciplined for being unvaccinated against COVID-19.
9. If Plaintiff exception request is denied, she will be given at least two
weeks to initiate the process of becoming vaccinated, during which time she will not be
disciplined for being unvaccinated. If Plaintiff Morton fails to initiate the process of becoming
vaccinated within that time period, the Department would expect to initiate the enforcement
process outlined in paragraphs 2 4, above.
Respectfully submitted,
3
EXHIBIT H

GALVESTON DIVISION
v.
DECLARATION OF JOSEPH
DR. ANTHONY FAUCI, in his official ABBOTT
capacity, et al.,
Defendants.
I, Joseph Abbott, hereby declare as follows:
1. I am the Chief Human Capital Officer, Office of Management, Food Safety and
Inspection Service (“FSIS”), a component of the United States Department of Agriculture
(“USDA”). In this position, I am responsible for human capital programs and services, including
but not limited to hiring, labor and employee relations, workers’ compensation, workplace
violence prevention, employee assistance, classification, veterans’ programs, performance and
recognition, human resources information systems, retirements, work-life programs, and other
facets of human capital. The statements in this Declaration are based on my personal knowledge
and information provided to me in my official capacity.
2. Consistent with Executive Order No. 14043, FSIS is requiring its employees to be
vaccinated against COVID-19, subject to such exceptions as required by law. FSIS plans to use a
phased process for enforcing this COVID-19 vaccination requirement with respect to employees
who have not timely provided proof of vaccination and do not have a pending exception request.
The goal of this process is to help employees understand and accept the benefit of becoming fully
vaccinated.
3. FSIS’s enforcement process is intended to provide unvaccinated employees with
every opportunity to become vaccinated. If an unvaccinated employee takes steps toward
becoming vaccinated, the enforcement process would be put on hold to give him or her time to
become fully vaccinated. In addition, if an unvaccinated employee requests an exception at any
time during the enforcement process, the enforcement process would be put on hold until the
exception request has been adjudicated.
4. For an unvaccinated employee with no pending exception request, FSIS’s
enforcement process begins with issuance of a non-disciplinary Letter of Caution which
encompasses a period of education and counseling about the benefits of vaccination and ways to
obtain the vaccine. After this counseling period concludes, an unvaccinated employee may be
subject to progressive formal discipline, to include a proposed suspension followed by, where
appropriate, proposed removal from employment.
5. Plaintiff Edward Surgeon is an employee of FSIS, and has been for twenty-five
years. Plaintiff Susan Reynolds is an employee of FSIS, and has been for ten years. Plaintiff
Waddie Jones is an employee of FSIS, and has been for nine years.
6. During the first week of November 2021, Plaintiffs Surgeon, Reynolds, and Jones
each requested an exception to the requirement that FSIS employees be vaccinated against
COVID-19. All three requests remain pending. The Agency does not currently have a projected
timeline for making determinations on exception requests.
7. Pursuant to FSIS policy, Plaintiffs Surgeon, Reynolds, and Jones will not be
disciplined for being unvaccinated as long as their respective exception requests remain pending.
2
8. If the exception request for any of these three Plaintiffs is denied, the Plaintiffs will
have at least two weeks to initiate the process of becoming vaccinated against COVID-19, during
which time the Plaintiffs will not be disciplined for being unvaccinated against COVID-19.
9. If the exception request for any of these three Plaintiffs is denied, and any of the
Plaintiffs fail to initiate the process of becoming vaccinated within two weeks thereafter, FSIS
would expect to initiate the enforcement process outlined in paragraphs 2–4, above, with respect
to that Plaintiff.
Joseph T. Abbott
Chief Human Capital Officer
Food Safety and Inspection Service

Defendant Exhibits To Response in Oppo To Motion For Prelim Injunction Rodden V Biden 23-1-8

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Case 3:21-cv-00317 Document 23-1 Filed on 11/22/21 in TXSD Page 1 of 209

IN THE UNITED STATES DISTRICT COURT

JAMES RODDEN, et al.,

Plaintiffs, Civil Action 3:21-cv-00317

DR. ANTHONY FAUCI, in his official

DECLARATION OF PETER MARKS, M.D., Ph.D.

and blood products, and cellular, tissue, and gene therapies.

facts stated herein. This declaration is based on my personal knowledge, my background,

training, and experience and my review and consideration of information available to me in my

official duties. My conclusions have been reached in accordance therewith.

marketing through applications known as Biologics License Applications (“BLA”); a vaccine

(“NDA”) under 21 U.S.C. § 355. 42 U.S.C. § 262(a), (j).

applicant consents to inspection of the manufacturing facility. 42 U.S.C. § 262(a)(2)(C). FDA

License Applications (BLA) Process, https://www.fda.gov/vaccines-blood-

Guidance, Compliance & Regulatory Information (Biologics), https://www.fda.gov/vaccines-

blood-biologics/guidance-compliance-regulatory-information-biologics; Vaccine and Related

Biological Product Guidances, https://www.fda.gov/vaccines-blood-biologics/biologics-

guidances/vaccine-and-related-biological-product-guidances; Vaccine Development 101,

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age

nucleus of the cell and does not affect DNA.

known as Pfizer-BioNTech Covid-19 vaccine, was available under an emergency use

authorization (“EUA”). See https://www.fda.gov/news-events/press-announcements/fda-takes-

key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19. FDA has

product. 21 U.S.C. § 360bbb-3(c).2

safety or effectiveness. Exhibit B at 10.

formulation is available at this time in the United States. See https://www.fda.gov/emergency-

covid-19-vaccine. As a result, all currently available Pfizer-BioNTech vaccine in the United

comparing it with a biological product manufactured by a different company. Under 42 U.S.C.

product.” “Reference product” is defined at 42 U.S.C. § 262(i)(4) as a “single biological product

application submitted under [42 U.S.C. § 262(k)].” The statutory interchangeability

Comirnaty, pp. 12-13 (August 23, 2021), available at

biological products); Exhibit B at 15.

of Authorization for the EUA—including the condition requiring vaccination providers to

for Regulatory Action – Comirnaty (“SBRA”), p. 27 (Nov. 8, 2021), attached as Exhibit C.

Serious Conditions – Drugs and Biologics (May 2014), available at

https://www.fda.gov/media/86377/download. Fast Track designation was granted for Comirnaty

to earlier drug approval and access by patients.” https://www.fda.gov/patients/fast-track-

approval. Vaccines typically undergo three phases of clinical trial. See

development-101. Phase 1 generally involves 20 to 100 healthy volunteers and focuses on

conducted sequentially, they may overlap.”). Also, because COVID-19 continues to be

diabetes, and infection with HIV, hepatitis B or hepatitis C. Id. at 16.

objectives, design, methodology, statistical considerations, and organization of a clinical trial,

see Glossary of Clinical Trial Terms, available at

0the,in%20other%20protocol%20referenced%20documents), participants ages 16 and older in

and Services Administration, 2017, https://www.hrsa.gov/sites/default/files/hrsa/vaccine-

compensation/vaccine-injury-table.pdf), FDA determined that a BLA for a COVID-19 vaccine

Licensure of Vaccines to Prevent COVID-19, at 15 (June 2020), attached as Exhibit D. Because

for C4591001 is May 2023, see

19. BNT162-01 an ongoing Phase 1/2, open-label, dose-finding study with 24

https://www.fda.gov/vaccines-blood-biologics/comirnaty (click on Approval History, Letters,

Reviews, and Related Document – COMIRNATY).

Exhibit A, FDA Approval Letter (Aug. 23, 2021).

C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech

pericarditis following administration of COMIRNATY; (2) Study C4591021, entitled “Post

Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence

of myocarditis and pericarditis following administration of COMIRNATY; (3) Study C4591021

sub-study to prospectively assess the incidence of subclinical myocarditis following

administration of the second dose of COMIRNATY in a subset of participants 5 through 15

myocarditis following administration of a third dose of COMIRNATY in a subset of participants

16 to 30 years of age; (7) Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine

Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and

Infant Outcomes in the Organization of Teratology Information Specialists