Garfield V MTSU Original Complaint

Middle Tennessee State University
Avery Garfield and Dr. Jenny Sauls

1301 East Main Street
Murfreesboro, TN 37132-0001
Russell A. Newman
6688 Nolensville Road
Suite 108-22
Brentwood, TN 37027
(615) 554-1510
Avery Garfield and Dr. Jenny Sauls
Dr. Jenny Sauls

1301 East Main Street
Murfreesboro, TN 37132-0001
Russell A. Newman
6688 Nolensville Road
Suite 108-22
Brentwood, TN 37027
(615) 554-1510
IN THE RUTHERFORD COUNTY CHANCERY COURT
FOR THE SIXTEENTH JUDICIAL DISTRICT AT MURFREESBORO
AVERY GARFIELD,
Petitioner,
v. Civil Action No. : _________________
MIDDLE TENNESSEE STATE JURY DEMAND

UNIVERSITY and DR. JENNY SAULS,
Respondents.
COMPLAINT FOR DECLARATORY JUDGMENT
COMES NOW Petitioner Avery Garfield and, pursuant to Tenn. Code Ann. § 29-14-101 et
seq., hereby files this Complaint for Declaratory Judgment and requests that this Honorable Court
declare the rights, status and/or legal relations between the parties and, in support thereof, Petitioner
would show unto the Court the following:
I. PARTIES
1. Petitioner Avery Garfield is a citizen of the State of Tennessee and she currently
resides in Murfreesboro, Rutherford County, Tennessee.
2. Respondent Middle Tennessee State University is a public university located in
Murfreesboro, Rutherford County, Tennessee.
3. Respondent Dr. Jenny Sauls is the Director of the School of Nursing at Middle
Tennessee State University.
II. JURISDICTION AND VENUE
4. This matter is a Complaint for Declaratory Judgment pursuant to Tenn. Code Ann. §
29-14-101 et seq.
5. Pursuant to Tenn. Code Ann. § 29-14-102, this Court has subject matter jurisdiction
“to declare rights, status, and other legal relations whether or not further relief is or could be
claimed.” Tenn. Code Ann. § 29-14-102 (a) (emphasis added).
6. This Declaratory Judgment action shall not be open to objection: “No action or
proceeding shall be open to objection on the ground that a declaratory judgment or decree is prayed
for.” Tenn. Code Ann. § 29-14-102(b) (emphasis added).
7. Petitioner respectfully requests that this Honorable Court render a declaration of her
rights, status or other legal relations, either in the affirmative or the negative, for every request in this
Complaint for Declaratory Judgment, as required by law: “The declaration may be either affirmative
or negative in form and effect; and such declaration shall have the force and effect of a final judgment
or decree.” Tenn. Code Ann. § 29-14-102(c).
8. Venue is proper pursuant to Tenn. Code Ann. § 20-4-101.
III. PETITIONER HAS STANDING FOR A DECLARATION OF HER RIGHTS AND

A REDRESS OF GRIEVANCES RELATED TO FEDERAL LAW VIOLATIONS
9. Petitioner has standing for a declaration of her legal rights pursuant to Tenn. Code
Ann. § 29-14-101 et seq.
10. Petitioner has standing for a redress of grievances pursuant to The Constitution of the
United States: “Congress shall make no law respecting an establishment of religion, or prohibiting
the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people
peaceably to assemble, and to petition the Government for a redress of grievances.” U.S. Const.
amend. I (emphasis added).
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11. Pursuant to the First Amendment to The Constitution of the United States, as applied
to the States through the Due Process Clause of the Fourteenth Amendment, Petitioner Avery
Garfield has standing to petition a Tennessee court for a redress of grievances. MTSU is a public
university. “It has long been established that these First Amendment freedoms are protected by the
Fourteenth Amendment from invasion by the States.” Edwards v. South Carolina, 372 U.S. 229,
235 (1963) (citing Gitlow v. New York, 268 U.S. 652, 45 S.Ct. 625, 69 L.Ed. 1138; Whitney v.
California, 274 U.S. 357, 47 S.Ct. 641, 71 L.Ed. 1095; Stromberg v. California, 283 U.S. 359, 51
S.Ct. 532, 75 L.Ed. 1117; De Jonge v. Oregon, 299 U.S. 353, 57 S.Ct. 255, 81 L.Ed. 278; Cantwell
v. Connecticut, 310 U.S. 296, 60 S.Ct. 900, 84 L.Ed. 1213) (emphasis added).
12. “This Court’s precedents confirm that the Petition Clause protects the right of
individuals to appeal to courts and other forums established by the government for resolution of
legal disputes. ‘[T]he right of access to courts for redress of wrongs is an aspect of the First
Amendment right to petition the government.’” Borough of Duryea v. Guarnieri, 564 U.S. 379, 387
(2011) (citing Sure– Tan, Inc. v. NLRB, 467 U.S. 883, 896–897, 104 S.Ct. 2803, 81 L.Ed.2d 732
(1984) ; see also BE & K Constr. Co. v. NLRB, 536 U.S. 516, 525, 122 S.Ct. 2390, 153 L.Ed.2d 499
(2002) ; Bill Johnson's Restaurants, Inc. v. NLRB, 461 U.S. 731, 741, 103 S.Ct. 2161, 76 L.Ed.2d 277
(1983) ; California Motor Transport Co. v. Trucking Unlimited, 404 U.S. 508, 513, 92 S.Ct. 609, 30
L.Ed.2d 642 (1972) (emphasis added).
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13. Pursuant to The Constitution of the State of Tennessee Petitioner Avery Garfield has
standing to file suit against the Respondents for a redress of grievances: “Section 23. That the citizens
have a right, in a peaceable manner, to assemble together for their common good, to instruct their
representatives, and to apply to those invested with the powers of government for redress of
grievances, or other proper purposes, by address of remonstrance.” (Emphasis added).
14. Pursuant to The Constitution of the State of Tennessee: “Section 17. That all courts
shall be open; and every man, for an injury done him in his lands, goods, person or reputation, shall
have remedy by due course of law, and right and justice administered without sale, denial, or delay.
Suits may be brought against the state in such manner and in such courts as the Legislature may
by law direct.” The Constitution of the State of Tennessee, Article I. Declaration of Rights, Section
17 (emphasis added).
15. Pursuant to well-established Tennessee law, “Notwithstanding any law to the
contrary, a cause of action shall exist under this chapter for any affected person who seeks
declaratory or injunctive relief in any action brought regarding the legality or constitutionality of
a governmental action. A cause of action shall not exist under this chapter to seek damages.” Tenn.
Code Ann. § 1-3-121 (emphasis added).
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16. The plain language of Tenn. Code Ann. § 1-3-121 conveys standing to “any affected
person” for the purpose of filing a lawsuit “regarding the legality or constitutionality of governmental
action.” To be sure, the actual word “standing” was not in the statute so let’s examine the legislative
intent behind passing Tenn. Code Ann. § 1-3-121 in 2018.
17. The Tennessee General Assembly regarding the legislative intent behind HB1949 and
SB1870 passing Tenn. Code Ann. § 1-3-121 can be found here: https://vimeo.com/560004237 and
the hearing proceeded as follows:
Representative Glen Casada: Madame Speaker, this bill clarifies

that citizens have standing to take government to court on a
declaratory action so I move … I move … I renew my motion.
….
Representative Glen Casada: This legislation has nothing to do with

that [answer to question posed] or any other specific pending court
case, or if has to do with, but giving the right of the citizen to take
government to court if they violate our state law or our
constitutional rights. It makes it very clear and cold that we have
that right. ….
.…
Representative John Ray Clemmons: Uh, Mr. Leader, the breadth of

this provision in Title 1, Chapter 3, is this intended um to apply
across the board to any action against the government?
Representative Glen Casada: Declaratory action.
Representative John Ray Clemmons: Or injunctive relief?
Representative Glen Casada: Or injunctive. But not…
Representative John Ray Clemmons: Across the board?
Representative Glen Casada: That is the intent. We have a

constitutional right to take our complaints to court on a
government that doesn’t comply with state law.
….
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Representative John Ray Clemmons: I’m aware of that. I just want
to make sure the intent of this legislation is as I understand it, which
is the breadth, so if any cause of action against the government,
in the code or elsewhere, does not currently contain a cause of,
a private cause of action, you are creating one with this
legislation.
Representative Glen Casada: I would submit that we are making

it clear that it already exists. Uh, I think that when we pass
legislation in the past, lower courts have opined that citizens
don’t have a right to take uh their government to court. I
contend that we on many occasions we have made that clear that
they do, but we’re making it very clear.
….
Representative John Ray Clemmons: Well, you still have a standing

issue. The standing issue. Is that what you are trying to address? Or
are you saying everybody, regardless if they are impacted or not, has
standing?
Representative Glen Casada: No I am giving standing to the

citizens in that particular jurisdiction, that they …. So I am giving
standing. You are correct.
….
Representative John Ray Clemmons: Regardless of whether or not

they have been impacted by it, as defined by the courts, with regard
to standing.
Representative Glen Casada: Madame Speaker, can I defer this to

Chairman Carter? … This is a technical question that I want to get
right and I would like, because this is being recorded, I want to make
sure it’s said properly.
….
Representative John Ray Clemmons: Maybe we need to roll this a

spot or two. I just want to make sure the intent is clear. My question
was with regard to standing. Are you trying to create standing for
everyone to bring a cause of action whether or not they actually have
standing as that’s defined in the rules and the law?
….
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Representative Mike Carter: Currently, the law generally in
Tennessee is that a taxpaying citizen does not have standing to bring
a case. This changes that. And says if you are affected and are a
taxpayer, you can bring a case. These statutes are going throughout
America now everywhere so it’s nothing unusual.
….
Representative John Ray Clemmons: I appreciate that response and

Mr. Leader that kind of answers my question, my original question
was if we are creating this new, or at least clarifying, that everyone
has standing, that it then opens up the entire code for any other
code that does not currently, or may not have, a private cause of
action for something prohibited, that we are opening that door
up. I just want to make that clear.
Representative Mike Carter: Yes, sir.
Tennessee’s 110th General Assembly Hearing on House Bill 1949 regarding the Issue of
“Standing”, March 15, 2018 (emphasis added).
18. Middle Tennessee State University is a public university located in Murfreesboro,
Tennessee.
19. As such, Petitioner has standing to file a Complaint for Declaratory Judgment to
ascertain her rights, status and other legal relations between her and Middle Tennessee State
University.
IV. PETITIONER’S GREIVANCES AGAINST MTSU AND DR. SAULS
A. ON JANUARY 31, 2020, THE SECRETARY OF THE U.S. HEALTH AND HUMAN
SERVICES DECLARED A PUBLIC HEALTH EMERGENCY EXISTS.
20. Pursuant to 21 U.S.C. § 360bbb-3(b)(1), the Health and Human Services Secretary
“may make a declaration that the circumstances exist justifying the authorization under this subsection
for a product on the basis of - … (C) a determination by the Secretary that there is a public health
emergency, or a significant potential for a public health emergency, that affects, or has a significant
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potential to affect, national security… and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents….”
21. On January 31, 2020, The Secretary of Health and Human Services, Alex M. Azar, II,
declared a Public Health Emergency. U.S. Department of Health & Human Services, Determination
that a Public Health Emergency Exists, https://www.phe.gov/emergency/news/healthactions/phe
/Pages/2019-nCoV.aspx (last visited July 31, 2021) (attached as Exhibit “1”.
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B. DURING A PUBLIC HEALTH EMERGENCY, FEDERAL LAW PERMITS USE OF
UNAPPROVED MEDICAL PRODUCTS.
22. During a Public Health Emergency, the Health and Human Services Secretary “may
authorize … during the effective period of a declaration [of a state of emergency] … a drug, device,
or biological product intended for use in an actual or potential emergency…. [The Secretary] may
authorize an emergency use of a product that – (A) is not approved, licensed, or cleared for
commercial distribution under section 355, 360(k), 360b, or 360e of this title or section 351 of the
Public Health Service Act [42 U.S.C. § 262] or conditionally approved under section 360ccc of this
title … (referred to in this section as unapproved product)….” 21 U.S.C. § 360bbb-3(a)(1)-(2).
C. THERE IS NO FDA-APPROVED COVID-19 VACCINE. ALL COVID VACCINES

ARE ADMINISTERED UNDER THE EMERGENCY USE AUTHORIZATION.
23. As of August 1, 2021, the Janssen Fact Sheet states “there is no FDA-approved
vaccine to prevent COVID-19.” The Janssen Fact Sheet for Recipients and Caregivers,
https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-
Recipient-fact-sheet.pdf (last visited August 1, 2021) (emphasis added) (attached as Exhibit “2”).
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24. As of August 1, 2021, the Janssen COVID-19 Fact Sheet stated “The Janssen COVID-
19 Vaccine is an unapproved vaccine….” Id (emphasis added).
25. As of August 1, 2021, “The FDA has authorized the emergency use of the Janssen
COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an
Emergency Use Authorization (EUA).” Id (emphasis added).
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26. As of August 1, 2021, Moderna states, “There is no-FDA-approved vaccine to
prevent COVID-19.” Fact Sheet for Recipients and Caregivers Emergency Use Authorization
(EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)
in Individuals 18 Years of Age and Older, https://www.modernatx.com/covid19vaccine-eua/eua-fact-
sheet-recipients.pdf (last visited August 1, 2021) (emphasis added) (attached as Exhibit “3”).
27. As of August 1, 2021, the Moderna Fact Sheet states “The Moderna COVID-19
Vaccine is an unapproved vaccine that may prevent COVID-19.” Id (emphasis added).
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28. As of August 1, 2021, the Moderna Fact Sheet states, “The FDA has authorized the
emergency use of the Moderna COVID-19 Vaccine ….” Id (emphasis added).
29. As of August 1, 2021, the Pfizer Fact Sheet stated, “There is no U.S. Food and Drug
Administration (FDA) approved vaccine to prevent COVID-19.” Fact Sheet for Recipients and
Caregivers Emergency Use Authorization (EUA) of the Pfizer-Biontech COVID-19 Vaccine to
Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 12 Years of Age and Older,
https://www.fda.gov/media/144414/download (last visited August 1, 2021) (emphasis added)
(attached ad Exhibit “4”).
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30. As of August 1, 2021, the Pfizer Fact Sheet stated the “Pfizer-BioNTech COVID-19
Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine
to prevent COVID-19.” Id (emphasis added).
31. As of August 1, 2021, the Pfizer Fact Sheet stated that “The FDA has authorized the
emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 12
years of age and older under an Emergency Use Authorization (EUA).” Id (emphasis added).
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32. As required by 21 U.S.C. § 366bbb-3(b)(4), “the Secretary shall promptly publish in
the Federal Register each declaration, determination, and advance notice of termination under this
subsection.” 85 Fed. Reg. 52, 15198-15203 (March 17, 2020) (attached as Exhibit “5”).
33. As required by 21 U.S.C. § 360bbb-3(b)(2)(A), a “Declaration under this subsection
shall terminate upon the earlier of- (i) a determination by the Secretary … that the circumstances
[public health emergency] described in paragraph (1) have ceased to exist; or (ii) a change in approval
status of the product such that the circumstances described in subsection (a)(2) have ceased to exist.”
34. Pursuant to the Federal Register website, a Seventh Amendment to Declaration Under
the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against
COVID-19 was published on March 16, 2021. National Archives, Federal Register,
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https://www.federalregister.gov/documents/2021/03/16/2021-05401/seventh-amendment-to-
declaration-under-the-public-readiness-and-emergency-preparedness-act-for (last visited July 31,
2021); 86 Fed. Reg. 49, 14462-14468 (March 16, 2021) (attached as Exhibit “6”).
35. On January 31, 2020, The Secretary of Health and Human Services, Alex M. Azar, II,
declared a Public Health Emergency. U.S. Department of Health & Human Services, Determination
that a Public Health Emergency Exists, https://www.phe.gov/emergency/news/healthactions/phe
/Pages/2019-nCoV.aspx (last visited July 31, 2021) (attached as Exhibit “1”).
36. The Public Health Emergency was renewed on the following dates: April 21, 2020;
July 23, 2020; October 2, 2020; January 7, 2021; April 15, 2021; and July 19, 2021. United States
Department of Health & Human Services, Public Health Emergency Declarations in response to the
COVID-19 disaster, https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
(last visited July 31, 2021) (screenshot of the July 19, 2021 Renewal attached as Exhibit “7”).
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D. DURING A PUBLIC HEALTH EMERGENCY THE GOVERNMENT CAN PERMIT
THE USE OF UNAPPROVED PRODUCTS, SUCH AS THE COVID-19
VACCINCES, BUT HEALTH CARE PROVIDERS MUST COMPLY WITH THE
REQUIRED CONDITIONS OF THE UNAPPROVED PRODUCT’S EMERGENCY
USE AND PEOPLE MUST HAVE THE OPTION TO REFUSE THE PRODUCT.
37. Pursuant to 21 U.S.C. § 366bbb-3(e), there are “required conditions” that must be met
as part of an emergency use of an “unapproved product” during a Public Health Emergency.
38. “With respect to the emergency use of an unapproved product, the Secretary … shall
… establish such conditions on an authorization under this section as the Secretary finds necessary or
appropriate to protect the public health, including the following: … (ii)Appropriate conditions
designed to ensure that individuals to whom the product is administered are informed— … (II)of
the significant known and potential benefits and risks of such use, and of the extent to which such
benefits and risks are unknown; and (III)of the option to accept or refuse administration of the
product, of the consequences, if any, of refusing administration of the product, and of the alternatives
to the product that are available and of their benefits and risks.” 21 U.S.C. § 366bbb-3(e)(1)(A)
(emphasis added).
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39. Stated slightly different, federal law requires that people be given an option “to refuse
administration of the [unapproved] product [COVID-19 vaccine]” during a Public Health Emergency
that is administered under the Emergency Use Authorization. See id.
40. On July 19, 2021, Petitioner received a communication from Middle Tennessee State
University that mandated vaccines for all Middle Tennessee State University Nursing Students.
41. The unapproved vaccine mandate was ordered by Dr. Jenny Sauls. The university’s
public website states that Dr. Sauls is a “Professor and Director of the School of Nursing.”
Dr. Jenny Sauls, Professor and Director, School of Nursing, https://www.mtsu.edu/faculty/jenny-
sauls (last visited August 1, 2021).
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42. In violation of federal law, MTSU mandated that Petitioner take an unapproved
vaccine or suffer she will suffer consequences. Petitioner was sent the following “EMERGENT
COMMUNICATION”:
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E-mail from MTSU Professor and Director of Nursing, Dr. Jenny Sauls (July 19, 2021) (on file with
Petitioner) (attached as Exhibit “8”).
43. MTSU asked its students to comply with the laws, policies and guidelines regarding
COVID-19.
44. In violation of federal law, which requires informed consent and an option to refuse
to participate in an unapproved vaccination program, MTSU mandated that Petitioner take the vaccine
and that there would be NO EXCEPTIONS.
to participate in an unapproved vaccination program, MTSU is mandating that Petitioner take part in
unapproved experimental medicine against her will by August 20, 2021.
to participate in an unapproved vaccination program, MTSU mandated that Petitioner take part in
unapproved experimental medicine against her will to avoid possible suspension from MTSU.
to participate in an unapproved vaccination program, MTSU is demanding compliance with the
COVID-19 guidelines and threatened Petitioner that her “failure to cooperate with our health officials
… may be grounds for campus disciplinary action, up to and including suspension.”
to participate in an unapproved vaccination program, the MTSU Nursing Students were thanked for
their “compliance” while MTSU flagrantly violated federal law.
49. Apparently students reacted to MTSU’s vaccine mandate as another e-mail was sent
out to all MTSU Nursing Students and Dr. Sauls doubled down on MTSU’s illegal vaccine mandate.
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20
Email sent to Petitioner on behalf of Dr. Sauls (July 21, 2021) (attached as Exhibit “9”).
to participate in an unapproved vaccination program, Dr. Sauls doubled down on her illegal conduct
and “confirmed that NO EXCEPTIONS means exactly that, regardless of the reason.” Id.
to participate in an unapproved vaccination program, Petitioner was told that “If you choose not to be
vaccinated, you will forfeit you right to attend clinical and progress in our program.” Id.
to participate in an unapproved vaccination program, MTSU instructed its nursing students that they
must take the vaccine even if they are going to a clinic that does not require vaccines.
to participate in an unapproved vaccination program, MTSU is demanding that its students cease and
desist from obtaining an exemption that is guaranteed by federal law for an unapproved vaccine.
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E-mail from Dr. Sauls to MTSU Nursing Students (July 27, 2021) (on file with Petitioner) (attached
as Exhibit “10”).
E. THE CODE OF FEDERAL REGULATIONS REQUIRE THAT HUMAN BEINGS

MUST BE GIVEN A CHOICE ON “WHETHER OR NOT TO PARTICIPATE” AS A
SUBJECT IN RESEARCH WITH AN UNAPPROVED VACCINE.
54. The Code of Federal Regulations applies to all FDA regulated clinical investigations.
21 C.F.R § 50.1.
55. The Code of Federal Regulations applies to clinical investigations regulated by the
FDA and clinical investigations that support applications for research for products regulated by the
FDA, which includes “drugs for human use”. See id.
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56. “Compliance with [the Code of Federal Regulations] is intended to protect the rights
and safety of subjects involved in investigations filed with the Food and Drug Administration….”
Id (emphasis added).
57. The Code of Federal Regulations requires that people – i.e., human beings, ALL
HUMAN BEINGS – must be given a choice on “whether or not to participate” as a subject in research
with an unapproved vaccine. See 21 C.F.R § 50.20.
58. All three current COVID-19 vaccines are unapproved by the FDA.
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59. As all CODID-19 vaccines are currently unapproved, the Code of Federal
Regulations requires that “no investigator may involve a human being as a subject in research
covered by these regulations unless the investigator has obtained the legally effective informed
consent of the subject…. An investigator shall seek such consent only under circumstances that
provide the prospective subject … sufficient opportunity to consider whether OR NOT to
participate and that minimize the possibility of COERCION or UNDUE INFLUENCE.” 21
C.F.R § 50.20 (emphasis added).
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60. In violation of the Code of Federal Regulations, MTSU subjected human beings to
research without their informed consent.
61. In violation of the Code of Federal Regulations, MTSU mandated that all nursing
students take an unapproved and optional vaccine.
62. In violation of the Code of Federal Regulations, MTSU was required to inform
students that they had a choice of whether or not to participate in research for an unapproved vaccine,
but MTSU refused to inform its students that they had a right to refuse an unapproved and optional
vaccine.
63. In violation of the Code of Federal Regulations, MTSU did not provide its students
with any opportunity – much less “sufficient opportunity” as required by law – to consider their
options and decide whether or not to participate in the research.
64. In violation of the Code of Federal Regulations, MTSU mandated the unapproved
optional vaccine.
65. In violation of the Code of Federal Regulations, MTSU threatened students with
forfeiture of their right to attend clinicals and progress in its nursing program for refusing to take an
optional vaccine.
disciplinary action for refusing an unapproved and optional vaccine.
suspension for refusing an unapproved and optional vaccine.
68. In violation of the Code of Federal Regulations, MTSU coerced its students to take an
unapproved and optional vaccine.
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69. In violation of the Code of Federal Regulations, MTSU placed undue influence on its
students to take an unapproved and optional vaccine.
70. The exception provided in 21 C.F.R § 50.23 does not apply to Petitioner.
71. The exception provided in 21 C.F.R § 50.24 does not apply to Petitioner.
72. The exception provided in 21 C.F.R § 50.23 does not apply to Petitioner because
obtaining Petitioner’s informed consent is entirely feasible, but MTSU has made no effort whatsoever
to obtain any informed consent. Instead, MTSU demanded compliance with an optional program.
73. Moreover, Petitioner is not currently confronted with a life-threatening “situation” that
necessitates the use of the test article – or an experimental COVID-19 vaccine.
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74. Petitioner’s informed consent can be obtained from the Petitioner.
75. Petitioner would deny the COVID-19 unapproved and optional vaccine if she was
provided with a choice, as required by law.
76. Petitioner is of the age of majority, is competent and she has no need for a legal
representative. MTSU can obtain the Petitioner’s refusal to participate in unapproved shots if asked.
77. Petitioner’s desired “alternative method” to survive COVID-19 is to obtain the
antibodies should she contract COVID-19. Petitioner is a young healthy female, she is enrolled in
college, and she does not need to be forced to be a human test subject for an unapproved and optional
vaccine program. Petitioner is not in a “life-threatening situation” as required by the Code of Federal
Regulations. The requirements for this § 50.23 exception have not been met.
78. The exception provided in 21 C.F.R § 50.24 does not apply.
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79. The Petitioner is not currently in a “life-threatening situation” as required to
implement the exception.
80. Obtaining Petitioner’s informed refusal to participate in the unapproved and optional
vaccine is feasible if she were asked.
81. Petitioner does not consent to being a human subject in experimental medicine.
82. There is no need for an intervention on behalf of Petitioner.
83. Petitioner is a young healthy female and does not need an unapproved and optional
vaccine.
84. The requirements of 21 C.F.R § 50.24 have not been met.
85. MTSU has not complied with mandatory federal law or federal regulations, which
require the human subject’s informed consent before participating in research.
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86. In violation of the Code of Federal Regulations, MTSU failed/refused to provide
Petitioner with a statement regarding her rights as required by 21 C.F.R § 50.25(a)(8).
87. In violation of the Code of Federal Regulations, MTSU failed/refused to inform
Petitioner that her participation in the unapproved and optional vaccine program was voluntary.
Petitioner that she had a right to refuse to participate in an optional vaccine program.
Petitioner that she would not be penalized for refusing to participate in an optional vaccine program.
90. In violation of the Code of Federal Regulations, MTSU threatened penalties,
disciplinary action and even suspension for not complying with an optional vaccine program.
Petitioner that she would not lose benefits (i.e., participating in her clinicals and progressing in the
program) if she refused to participate in an optional vaccine program.
92. In violation of the Code of Federal Regulations, MTSU threatened, and promised, the
loss of benefits for refusing to participate in an optional vaccine program.
Petitioner that she may discontinue participation in the optional program at any time without penalty
or loss of benefits.
F. MTSU VIOLATED THE FOOD AND DRUG ADMINISTRATION GUIDANCE FOR

INDUSTRY BY FAILING/REFUSING TO INFORM ITS STUDENTS THAT THEY
HAVE THE OPTION TO ACCEPT OR REFUSE A THE VOLUNTARY VACCINE.
94. The Food and Drug Administration (“FDA”) issues guidance, which is the current
thinking of the FDA on the Emergency Use Authorization (“EUA”) topic. See Emergency Use
Authorization of Medical Products and Related Authorities: Guidance for Industry and Other
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Stakeholders, U.S. Department of Health and Human Services, Food and Drug Administration, p. 1
(January 2017) (attached as Exhibit “11”).
95. The scope of the FDA’s Guidance is “intended to inform all stakeholders1 involved in
emergency response activities and FDA staff of FDA’s general recommendations and procedures for
Issuance of EUAs, implementation of emergency use authorities and reliance on the governmental
pre-positioning authority. Id at 2.
1
For purposes of this guidance, “stakeholders” include industry and government sponsors and other government
stakeholders/entities involved in emergency response activities (including Federal, State, local, tribal, or territorial
government stakeholders/entities). The term “government stakeholders” refers to the public health and/or emergency
response agencies or their agents/delegates that have legal responsibility and authority for responding to an incident,
based on political or geographical boundaries (e.g., city, county, tribal, territorial, State, or Federal), or functional
range or sphere of authority (e.g., law enforcement, public health, military health) to prescribe, administer, deliver,
distribute, hold, or dispense a medical product during an emergency situation.
30
96. While the FDA Guidance is not mandatory, it summarizes the law and provides help
to industry on how to implement and use the products under an Emergency Use Authorization.
97. MTSU’s Nursing School is aware of, or should be aware of, the FDA Guidelines for
Emergency Use Authorization of Medical Products.
98. The FDA Guidelines instruct industry that the statute requires that FDA ensures that
recipients of an EUA product are informed “That they have the option to accept or refuse the EUA
product and of any consequences of refusing administration of the product….”
99. In violation of the FDA Guidelines, MTSU failed/refused to inform Petitioner that she
has the option to accept or refuse the EUA product.
G. MTSU VIOLATED CENTERS FOR DISEASE CONTROL AND PREVENTION

GUIDANCE, WHICH STATES COVID-19 VACCINES ARE NOT MANDATED.
100. MTSU instructed its students to comply with CDC recommendations.
101. The CDC makes recommendations for different people, situations, and circumstances.
31
102. MTSU follows the CDC recommendations and clinical facility mandates.
103. MTSU asked its students to “continue to comply with all regulations and guidelines
established by the university regarding COVID-19.
104. The CDC website has published regulations and/or guidelines with respect to
mandating COVID-19 vaccines.
105. The CDC states that COVID-19 vaccines are not mandated under EUAs.
32
Centers for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/recommendations/essentialworker/workplace-vaccination-program.html (Last
accessed August 1, 2021).
106. MTSU was aware, or should have been aware, that the CDC was instructing the public
at large that COVID-19 vaccines are not mandated in under the Emergency Use Authorization.
107. MTSU cannot mandate COVID-19 vaccines for either its students or its employees.
108. MTSU violated the CDC guidance that COVID-19 vaccines are not mandated (as it’s
illegal) under the Emergency Use Authorization.
WHEREFORE, as a result of the foregoing, Petitioner would respectfully request that proper
process be issued and served on Defendants, requiring them to answer or otherwise respond in the
time period allotted by law, and that this Honorable Court would award judgment against Defendants
as follows:
1. GRANT Petitioner’s Application for a Temporary Restraining Order to immediately
restrain Defendants from implementing their unlawful and illegal COVID-19 vaccine mandate.
2. That this Court issue an Order GRANTING the following declarations:
a. DECLARE that since January 30, 2020, until the present time, that the United
States has been under an ongoing Public Health Emergency.
b. DECLARE that 21 U.S.C. § 366bbb-3 permits emergency use of an otherwise
unapproved drug.
c. DECLARE that all three COVID-19 vaccines (Janssen, Moderna and Pfizer) are
not FDA approved.
d. DECLARE that all three COVID-19 vaccines (Janssen, Moderna and Pfizer) are
unapproved vaccines.
33
e. DECLARE that all three COVID-19 vaccines (Janssen, Moderna and Pfizer) are
being used pursuant to the laws governing the Emergency Use Authorization.
f. DECLARE that the Public Health Emergency has not expired and that the
Emergency Use Authorization has not terminated.
g. DECLARE that under the Emergency Use Authorization, MTSU must comply
with federal law.
h. DECLARE that under the Emergency Use Authorization, MTSU must comply
with 21 U.S.C. § 366bbb-3 (e) Conditions of authorization (1) Unapproved
product (A) Required conditions.
i. DECLARE that under the Emergency Use Authorization, MTSU must “ensure
that individual to whom the product is administered are informed … of the
significant known and potential benefits and risks of such use, and of the extent to
which such benefits and risks are unknown….” 21 U.S.C. § (e)(1)(A)(ii).
j. DECLARE that under the Emergency Use Authorization, MTSU must “ensure
that individual who whom the product is administered are informed … of the
option to accept or refuse administration of the product, of the consequences, if
any, of refusing administration of the product, and of the alternatives to the
product that are available and of their benefits and risks.” 21 U.S.C. § (e)(1)(A)(ii).
k. DECLARE that under the Emergency Use Authorization, MTSU has no
authority to mandate the COVID-19 vaccine.
l. DECLARE that under the Emergency Use Authorization, MTSU must inform its
students of the significant known and potential benefits and risks of such use, and
34
of the extent to which such benefits and risks are unknown….” 21 U.S.C. §
(e)(1)(A)(ii).
m. DECLARE that under the Emergency Use Authorization, MTSU must inform its
students of the option to accept or refuse administration of the product, of the
consequences, if any, of refusing administration of the product, and of the
alternatives to the product that are available and of their benefits and risks.” 21
U.S.C. § (e)(1)(A)(ii).
n. DECLARE that under the Emergency Use Authorization, MTSU must recognize,
and must not discriminate against, students who refuse administration of an
unapproved and voluntary vaccine.
o. DECLARE that under the Emergency Use Authorization, MTSU’s vaccine
mandate is null, void ab initio and of no legal consequence.
p. DECLARE that the Code of Federal Regulations requires MTSU to obtain
informed consent, which includes but is not limited to informing the students of
their right to accept or refuse the unapproved voluntary vaccine.
q. DECLARE that the Code of Federal Regulations requires MTSU to cease and
desist any unlawful conduct, such as threatening students with disciplinary action,
suspension, forfeiture of the nursing program and/or denying entry to clinicals for
refusing to participate in a voluntary vaccine program.
r. DECLARE that the Code of Federal Regulations requires MTSU to cease and
desist any unlawful conduct, such as using coercion or undue influence to force
students to take an unapproved and voluntary vaccine against their will.
35
s. DECLARE that the Code of Federal Regulations requires MTSU to provide
Petitioner with a statement that the COVID-19 vaccine program “is voluntary, and
that refusal to participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and that the subject may discontinue participation at
any time without penalty or loss of benefits to which the subject is otherwise
entitled.” 21 C.F.R § 50.25(a)(8).
t. DECLARE that MTSU’s COVID-19 vaccine mandate is unlawful as it violates
21 U.S.C. § 366bbb-3 et seq. and 21 C.F.R § 50.1 et seq.
u. DECLARE that MTSU must immediately cease and desist from implementing
its unlawful vaccine mandate for the COVID-19 vaccine.
3. For an award of attorneys’ fees and costs incurred as a result of this action.
4. That this Honorable Court ISSUE a permanent injunction enjoining and/or restraining
respondents from violating the aforementioned federal law and Code of Federal Regulations hereafter
declared by this Honorable Court.
5. That oral arguments on Petitioner’s Complaint for Declaratory Judgment regarding
declarations of her rights be set as soon as practicable.
6. Such other relief to which Petitioner may show himself to be entitled.
Respectfully submitted this 2nd day of August, 2021.
THE NEWMAN LAW FIRM
By: /s/ Russell A. Newman _

Russell A. Newman, BPR # 033462
6688 Nolensville Rd., Ste. 108-22
Brentwood, TN 37027
(615) 554-1510 (Telephone)
(615) 283-3529 (Facsimile)
[email protected]
Attorney for Petitioner Avery Garfield
36
7/30/2021 https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx
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Response Information
Declarations of a Public
As a result of confirmed cases of 2019 Novel Coronavirus (2019-nCoV), on this date and after consultation with public health
Health Emergency
officials as necessary, I, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority vested in me
Public Health Emergency
under section 319 of the Public Health Service Act, do hereby determine that a public health emergency exists and has
Determinations to Support an
existed since January 27, 2020, nationwide.
Emergency Use Authorization
01/31/2020
/s/
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_____________________________ _____________________________ Emergency Use
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Exhibit "1"
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx 1/1
FACT SHEET FOR RECIPIENTS AND CAREGIVERS
EMERGENCY USE AUTHORIZATION (EUA) OF

THE JANSSEN COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019
(COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER
You are being offered the Janssen COVID-19 Vaccine to prevent Coronavirus Disease 2019
(COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you
understand the risks and benefits of receiving the Janssen COVID-19 Vaccine, which you may
receive because there is currently a pandemic of COVID-19.
The Janssen COVID-19 Vaccine may prevent you from getting COVID-19. There is no U.S. Food
and Drug Administration (FDA) approved vaccine to prevent COVID-19.
Read this Fact Sheet for information about the Janssen COVID-19 Vaccine. Talk to the vaccination
provider if you have questions. It is your choice to receive the Janssen COVID-19 Vaccine.
The Janssen COVID-19 Vaccine is administered as a single dose, into the muscle.
The Janssen COVID-19 Vaccine may not protect everyone.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit
www.janssencovid19vaccine.com.
WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE
WHAT IS COVID-19?
COVID-19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been
seen before. You can get COVID-19 through contact with another person who has the virus. It is
predominantly a respiratory illness that can affect other organs. People with COVID-19 have had
a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms
may appear 2 to 14 days after exposure to the virus. Common symptoms may include: fever or
chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or
smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.
WHAT IS THE JANSSEN COVID-19 VACCINE?
The Janssen COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is
no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of the Janssen COVID-19 Vaccine to prevent
COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization
(EUA).
For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?”
section at the end of this Fact Sheet.
1
Exhibit "2"
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE
YOU GET THE JANSSEN COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if you:
• have any allergies,
• have a fever,
• have a bleeding disorder or are on a blood thinner,
• are immunocompromised or are on a medicine that affects your immune system,
• are pregnant or plan to become pregnant,
• are breastfeeding,
• have received another COVID-19 vaccine.

WHO SHOULD GET THE JANSSEN COVID-19 VACCINE?
FDA has authorized the emergency use of the Janssen COVID-19 Vaccine in individuals 18 years
of age and older.
WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?
You should not get the Janssen COVID-19 Vaccine if you:
• had a severe allergic reaction to any ingredient of this vaccine.

WHAT ARE THE INGREDIENTS IN THE JANSSEN COVID-19 VACCINE?
The Janssen COVID-19 Vaccine includes the following ingredients: recombinant,

replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid
monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD),
polysorbate-80, sodium chloride.
HOW IS THE JANSSEN COVID -19 VACCINE GIVEN?
The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle.
The Janssen COVID-19 Vaccine vaccination schedule is a single dose.
HAS THE JANSSEN COVID-19 VACCINE BEEN USED BEFORE?
The Janssen COVID-19 Vaccine is an unapproved vaccine. In an ongoing clinical trial, 21,895
individuals 18 years of age and older have received the Janssen COVID-19 Vaccine.
2
WHAT ARE THE BENEFITS OF THE JANSSEN COVID-19 VACCINE?
In an ongoing clinical trial, the Janssen COVID-19 Vaccine has been shown to prevent COVID-19
following a single dose. The duration of protection against COVID-19 is currently unknown.
WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?
Side effects that have been reported with the Janssen COVID-19 Vaccine include:
• Injection site reactions: pain, redness of the skin and swelling.
• General side effects: headache, feeling very tired, muscle aches, nausea, and fever.
Severe Allergic Reactions

There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic
reaction. A severe allergic reaction would usually occur within a few minutes to one hour after
getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may
ask you to stay at the place where you received your vaccine for monitoring after vaccination.
Signs of a severe allergic reaction can include:
• Difficulty breathing,
• Swelling of your face and throat,
• A fast heartbeat,
• A bad rash all over your body,
• Dizziness and weakness.

Blood Clots with Low Levels of Platelets
Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of
platelets (blood cells that help your body stop bleeding), have occurred in some people who have
received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels
of platelets, symptoms began approximately one to two-weeks following vaccination. Reporting of
these blood clots and low levels of platelets has been highest in females ages 18 through 49 years.
The chance of having this occur is remote. You should seek medical attention right away if you
have any of the following symptoms after receiving Janssen COVID-19 Vaccine:
• Shortness of breath,
• Chest pain,
• Leg swelling,
• Persistent abdominal pain,
• Severe or persistent headaches or blurred vision,
3
• Easy bruising or tiny blood spots under the skin beyond the site of the injection.
These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and
unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical
trials.
Guillain Barré Syndrome

Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages
nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who
have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within
42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is
very low. You should seek medical attention right away if you develop any of the following
symptoms after receiving the Janssen COVID-19 Vaccine:
• Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading
to other parts of the body
• Difficulty walking
• Difficulty with facial movements, including speaking, chewing, or swallowing
• Double vision or inability to move eyes
• Difficulty with bladder control or bowel function
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects that bother
you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS).
The VAERS toll-free number is 1-800-822-7967 or report online to
https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the
first line of box #18 of the report form.
In addition, you can report side effects to Janssen Biotech, Inc. at the contact information provided
below.
e-mail Fax number Telephone numbers

[email protected] 215-293-9955 US Toll Free: 1-800-565-4008
US Toll: (908) 455-9922
You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based
tool that uses text messaging and web surveys to check in with people who have been vaccinated
to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC
4
monitor the safety of COVID-19 vaccines. V-safe also provides live telephone follow-up by CDC
if participants report a significant health impact following COVID-19 vaccination. For more
information on how to sign up, visit: www.cdc.gov/vsafe.
WHAT IF I DECIDE NOT TO GET THE JANSSEN COVID-19 VACCINE?
It is your choice to receive or not receive the Janssen COVID-19 Vaccine. Should you decide not
to receive it, it will not change your standard medical care.
ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES

JANSSEN COVID-19 VACCINE?
Currently, there is no FDA approved alternative vaccine available for prevention of COVID-19.
Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.
CAN I RECEIVE THE JANSSEN COVID-19 VACCINE WITH OTHER VACCINES?
There is no information on the use of the Janssen COVID-19 Vaccine with other vaccines.
WHAT IF I AM PREGNANT OR BREASTFEEDING?
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
WILL THE JANSSEN COVID-19 VACCINE GIVE ME COVID-19?
No. The Janssen COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you
COVID-19.
KEEP YOUR VACCINATION CARD
When you receive the Janssen COVID-19 Vaccine, you will get a vaccination card to document
the name of the vaccine and date of when you received the vaccine.
ADDITIONAL INFORMATION
If you have questions or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan
the QR code using your device, visit the website or call the telephone numbers provided below.
QR Code Fact Sheets Website Telephone numbers

www.janssencovid19vaccine.com. US Toll Free: 1-800-565-4008
US Toll: (908) 455-9922
5
HOW CAN I LEARN MORE?
• Ask the vaccination provider.
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-

regulatory-and-policy-framework/emergency-use-authorization.
Contact your local or state public health department.
WHERE WILL MY VACCINATION INFORMATION BE RECORDED?
The vaccination provider may include your vaccination information in your state/local
jurisdiction’s Immunization Information System (IIS) or other designated system. For more
information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.
CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THE COVID-19

VACCINE?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an
out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19
vaccination. However, vaccination providers may seek appropriate reimbursement from a program
or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private
insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured
recipients).
WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?
Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination
Program requirements are encouraged to report them to the Office of the Inspector General, U.S.
Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
WHAT IS THE COUNTERMEASURE INJURY COMPENSATION PROGRAM?
The Countermeasures Injury Compensation Program (CICP) is a federal program that may help
pay for costs of medical care and other specific expenses for certain people who have been
seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must
be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more
about this program, visit www.hrsa.gov/cicp or call 1-855-266-2427.
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
The United States FDA has made the Janssen COVID-19 Vaccine available under an emergency
access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human
Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and
biological products during the COVID-19 pandemic.
6
The Janssen COVID-19 Vaccine has not undergone the same type of review as an FDA-approved
or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there
are no adequate, approved, and available alternatives. In addition, the FDA decision is based on
the totality of scientific evidence available showing that the product may be effective to prevent
COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the
product outweigh the known and potential risks of the product. All of these criteria must be met to
allow for the product to be used during the COVID-19 pandemic.
The EUA for the Janssen COVID-19 Vaccine is in effect for the duration of the COVID-19
declaration justifying emergency use of these products, unless terminated or revoked (after which
the products may no longer be used).
Manufactured by:
Janssen Biotech, Inc.
a Janssen Pharmaceutical Company of Johnson & Johnson
Horsham, PA 19044, USA
© 2021 Janssen Pharmaceutical Companies
For more information, call US Toll Free: 1-800-565-4008, US Toll: (908) 455-9922 or go to www.janssencovid19vaccine.com
Revised: Jul/08/2021
cp-205985v4
Scan to capture that this Fact Sheet was provided to vaccine

recipient for the electronic medical records/immunization
information systems.
Barcode Date: 02/2021
7
THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019
(COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER
You are being offered the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019
(COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you
understand the risks and benefits of the Moderna COVID-19 Vaccine, which you may receive
because there is currently a pandemic of COVID-19.
The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19.
There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.
Read this Fact Sheet for information about the Moderna COVID-19 Vaccine. Talk to the
vaccination provider if you have questions. It is your choice to receive the Moderna COVID-19
Vaccine.
The Moderna COVID-19 Vaccine is administered as a 2-dose series, 1 month apart, into the
muscle.
The Moderna COVID-19 Vaccine may not protect everyone.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit
www.modernatx.com/covid19vaccine-eua.
WHAT IS COVID-19?
COVID-19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not
been seen before. You can get COVID-19 through contact with another person who has the
virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-
19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness.
Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or
chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or
WHAT IS THE MODERNA COVID-19 VACCINE?

The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There
is no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent
COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization
(EUA).
For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?”
section at the end of this Fact Sheet.
Revised: Jun/24/2021 1
Exhibit "3"
YOU GET THE MODERNA COVID-19 VACCINE?
Tell your vaccination provider about all of your medical conditions, including if you:
• have any allergies
• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of
the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects your immune system
• are pregnant or plan to become pregnant
• are breastfeeding
• have received another COVID-19 vaccine
WHO SHOULD GET THE MODERNA COVID-19 VACCINE?

FDA has authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18
years of age and older.
WHO SHOULD NOT GET THE MODERNA COVID-19 VACCINE?

You should not get the Moderna COVID-19 Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine
WHAT ARE THE INGREDIENTS IN THE MODERNA COVID-19 VACCINE?

The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid
(mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG],
cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine,
tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose.
HOW IS THE MODERNA COVID-19 VACCINE GIVEN?

The Moderna COVID-19 Vaccine will be given to you as an injection into the muscle.
The Moderna COVID-19 Vaccine vaccination series is 2 doses given 1 month apart.
If you receive one dose of the Moderna COVID-19 Vaccine, you should receive a second dose of
the same vaccine 1 month later to complete the vaccination series.
HAS THE MODERNA COVID-19 VACCINE BEEN USED BEFORE?

The Moderna COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately
15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna
COVID-19 Vaccine.
WHAT ARE THE BENEFITS OF THE MODERNA COVID-19 VACCINE?

In an ongoing clinical trial, the Moderna COVID-19 Vaccine has been shown to prevent
COVID-19 following 2 doses given 1 month apart. The duration of protection against COVID-19
is currently unknown.
WHAT ARE THE RISKS OF THE MODERNA COVID-19 VACCINE?
There is a remote chance that the Moderna COVID-19 Vaccine could cause a severe allergic
reaction. A severe allergic reaction would usually occur within a few minutes to one hour after
getting a dose of the Moderna COVID-19 Vaccine. For this reason, your vaccination provider
may ask you to stay at the place where you received your vaccine for monitoring after
vaccination. Signs of a severe allergic reaction can include:
• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining
outside the heart) have occurred in some people who have received the Moderna COVID-19
Vaccine. In most of these people, symptoms began within a few days following receipt of the
second dose of the Moderna COVID-19 Vaccine. The chance of having this occur is very low.
You should seek medical attention right away if you have any of the following symptoms after
receiving the Moderna COVID-19 Vaccine:
• Chest pain
• Shortness of breath
• Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported in a clinical trial with the Moderna COVID-19 Vaccine
include:
• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm
of the injection, swelling (hardness), and redness
• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and
vomiting, and fever
Side effects that have been reported during post-authorization use of the Moderna COVID-19
Vaccine include:
• Severe allergic reactions
• Myocarditis (inflammation of the heart muscle)
• Pericarditis (inflammation of the lining outside the heart)
These may not be all the possible side effects of the Moderna COVID-19 Vaccine. Serious and
unexpected side effects may occur. The Moderna COVID-19 Vaccine is still being studied in
clinical trials.

Call the vaccination provider or your healthcare provider if you have any side effects that bother
you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System
(VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to
https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID-19 Vaccine EUA” in
the first line of box #18 of the report form.
In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-
3762).
You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based
tool that uses text messaging and web surveys to check in with people who have been vaccinated
to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help
CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if
needed and live telephone follow-up by CDC if participants report a significant health impact
following COVID-19 vaccination. For more information on how to sign up, visit:
www.cdc.gov/vsafe.
WHAT IF I DECIDE NOT TO GET THE MODERNA COVID-19 VACCINE?

It is your choice to receive or not receive the Moderna COVID-19 Vaccine. Should you decide
not to receive it, it will not change your standard medical care.

MODERNA COVID-19 VACCINE?
Currently, there is no FDA-approved alternative vaccine available for prevention of COVID-19.
Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.
CAN I RECEIVE THE MODERNA COVID-19 VACCINE WITH OTHER VACCINES?

There is no information on the use of the Moderna COVID-19 Vaccine with other vaccines.

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
WILL THE MODERNA COVID-19 VACCINE GIVE ME COVID-19?

No. The Moderna COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you
COVID-19.

When you receive your first dose, you will get a vaccination card to show you when to return for
your second dose of the Moderna COVID-19 Vaccine. Remember to bring your card when you
return.
If you have questions, visit the website or call the telephone number provided below.
To access the most recent Fact Sheets, please scan the QR code provided below.
Moderna COVID-19 Vaccine website Telephone number
www.modernatx.com/covid19vaccine-eua 1-866-MODERNA
(1-866-663-3762)

• Ask the vaccination provider
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-
regulatory-and-policy-framework/emergency-use-authorization
• Contact your state or local public health department

jurisdiction’s Immunization Information System (IIS) or other designated system. This will
ensure that you receive the same vaccine when you return for the second dose. For more
information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

VACCINE?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged
an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19
vaccination. However, vaccination providers may seek appropriate reimbursement from a
program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient
(private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured
recipients).

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination
Program requirements are encouraged to report them to the Office of the Inspector General, U.S.
Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help
pay for costs of medical care and other specific expenses of certain people who have been
seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim
must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To
learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

The United States FDA has made the Moderna COVID-19 Vaccine available under an
emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health
and Human Services (HHS) declaration that circumstances exist to justify the emergency use of
drugs and biological products during the COVID-19 pandemic.
The Moderna COVID-19 Vaccine has not undergone the same type of review as an FDA-
approved or cleared product. FDA may issue an EUA when certain criteria are met, which
includes that there are no adequate, approved, and available alternatives. In addition, the FDA
decision is based on the totality of the scientific evidence available showing that the product may
be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and
potential benefits of the product outweigh the known and potential risks of the product. All of
these criteria must be met to allow for the product to be used during the COVID-19 pandemic.
The EUA for the Moderna COVID-19 Vaccine is in effect for the duration of the COVID-19
EUA declaration justifying emergency use of these products, unless terminated or revoked (after
which the products may no longer be used).
Moderna US, Inc.

Cambridge, MA 02139
©2021 ModernaTX, Inc. All rights reserved.

Patent(s): www.modernatx.com/patents
Revised: Jun/24/2021


THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
IN INDIVIDUALS 12 YEARS OF AGE AND OLDER
You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus
Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains
information to help you understand the risks and benefits of the Pfizer-BioNTech
COVID-19 Vaccine, which you may receive because there is currently a pandemic of
COVID-19.
The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting
COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to
prevent COVID-19.
Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine.
Talk to the vaccination provider if you have questions. It is your choice to receive the
Pfizer-BioNTech COVID-19 Vaccine.
The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks

apart, into the muscle.
The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please see
www.cvdvaccine.com.
WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of
coronavirus has not been seen before. You can get COVID-19 through contact with
another person who has the virus. It is predominantly a respiratory illness that can
affect other organs. People with COVID-19 have had a wide range of symptoms
reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to
14 days after exposure to the virus. Symptoms may include: fever or chills; cough;
shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or
WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE?

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent
COVID-19. There is no FDA-approved vaccine to prevent COVID-19.
Exhibit "4"
1 Revised: 25 June 2021
The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine
to prevent COVID-19 in individuals 12 years of age and older under an Emergency Use
Authorization (EUA).
For more information on EUA, see the “What is an Emergency Use Authorization
(EUA)?” section at the end of this Fact Sheet.

YOU GET THE PFIZER-BIONTECH COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if
you:
• have any allergies
• have had myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects your immune system
• are pregnant or plan to become pregnant
• are breastfeeding
• have received another COVID-19 vaccine
• have ever fainted in association with an injection
WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?

FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in
individuals 12 years of age and older.
WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE?

You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine.
WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE?

The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: mRNA,
lipids ((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), potassium chloride, monobasic potassium
phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN?

The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the
muscle.
The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks

apart.
If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive
a second dose of this same vaccine 3 weeks later to complete the vaccination series.

HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?
The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials,
approximately 23,000 individuals 12 years of age and older have received at least
1 dose of the Pfizer-BioNTech COVID-19 Vaccine.
WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COVID-19 VACCINE?

In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to
prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection
against COVID-19 is currently unknown.
WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?

There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a
severe allergic reaction. A severe allergic reaction would usually occur within a few
minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. For
this reason, your vaccination provider may ask you to stay at the place where you
received your vaccine for monitoring after vaccination. Signs of a severe allergic
reaction can include:
• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining
outside the heart) have occurred in some people who have received the Pfizer-BioNTech
COVID-19 Vaccine. In most of these people, symptoms began within a few days following
receipt of the second dose of the Pfizer-BioNTech COVID-19 Vaccine. The chance of having
this occur is very low. You should seek medical attention right away if you have any of the
following symptoms after receiving the Pfizer-BioNTech COVID-19 Vaccine:
• Chest pain
• Shortness of breath
• Feelings of having a fast-beating, fluttering, or pounding heart.
Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine
include:
• severe allergic reactions
• non-severe allergic reactions such as rash, itching, hives, or swelling of the face
• myocarditis (inflammation of the heart muscle)
• pericarditis (inflammation of the lining outside the heart)
• injection site pain
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
• injection site swelling

• injection site redness
• nausea
• feeling unwell
• swollen lymph nodes (lymphadenopathy)
• diarrhea
• vomiting
• arm pain
These may not be all the possible side effects of the Pfizer-BioNTech COVID-19
Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19
Vaccine is still being studied in clinical trials.

Call the vaccination provider or your healthcare provider if you have any side effects
that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System
(VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to
https://vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19
Vaccine EUA” in the first line of box #18 of the report form.
In addition, you can report side effects to Pfizer Inc. at the contact information provided
below.
Website Fax number Telephone number
www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985
You may also be given an option to enroll in v-safe. V-safe is a new voluntary
smartphone-based tool that uses text messaging and web surveys to check in with
people who have been vaccinated to identify potential side effects after COVID-19
vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19
vaccines. V-safe also provides second-dose reminders if needed and live telephone
follow-up by CDC if participants report a significant health impact following COVID-19
vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.
WHAT IF I DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-19 VACCINE?

It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine.
Should you decide not to receive it, it will not change your standard medical care.

PFIZER-BIONTECH COVID-19 VACCINE?
Currently, there is no approved alternative vaccine available for prevention of COVID-19.
Other vaccines to prevent COVID-19 may be available under Emergency Use
Authorization.
CAN I RECEIVE THE PFIZER-BIONTECH COVID-19 VACCINE WITH OTHER

VACCINES?
There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with
other vaccines.

If you are pregnant or breastfeeding, discuss your options with your healthcare
provider.

WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19?
No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and
cannot give you COVID-19.

When you get your first dose, you will get a vaccination card to show you when to
return for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to bring
your card when you return.
If you have questions, visit the website or call the telephone number provided below.
To access the most recent Fact Sheets, please scan the QR code provided below.
Global website Telephone number

www.cvdvaccine.com
1-877-829-2619
(1-877-VAX-CO19)

• Ask the vaccination provider.
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-
legal-regulatory-and-policy-framework/emergency-use-authorization.
• Contact your local or state public health department.

jurisdiction’s Immunization Information System (IIS) or other designated system. This
will ensure that you receive the same vaccine when you return for the second dose. For
more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

VACCINE?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be
charged an out-of-pocket vaccine administration fee or any other fee if only receiving a
COVID-19 vaccination. However, vaccination providers may seek appropriate
reimbursement from a program or plan that covers COVID-19 vaccine administration
fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health
Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-
insured recipients).

Individuals becoming aware of any potential violations of the CDC COVID-19
Vaccination Program requirements are encouraged to report them to the Office of the
Inspector General, U.S. Department of Health and Human Services, at
1-800-HHS-TIPS or https://TIPS.HHS.GOV.
WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?

The Countermeasures Injury Compensation Program (CICP) is a federal program that
may help pay for costs of medical care and other specific expenses of certain people
who have been seriously injured by certain medicines or vaccines, including this
vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the
date of receiving the vaccine. To learn more about this program, visit
www.hrsa.gov/cicp/ or call 1-855-266-2427.

The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available
under an emergency access mechanism called an EUA. The EUA is supported by a
Secretary of Health and Human Services (HHS) declaration that circumstances exist to
justify the emergency use of drugs and biological products during the COVID-19
pandemic.
The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as
an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are
met, which includes that there are no adequate, approved, available alternatives. In
addition, the FDA decision is based on the totality of scientific evidence available
showing that the product may be effective to prevent COVID-19 during the COVID-19
pandemic and that the known and potential benefits of the product outweigh the known
and potential risks of the product. All of these criteria must be met to allow for the
product to be used in the treatment of patients during the COVID-19 pandemic.
The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the
COVID-19 EUA declaration justifying emergency use of these products, unless
terminated or revoked (after which the products may no longer be used).

Manufactured by
Pfizer Inc., New York, NY 10017
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
LAB-1451-4.2a
Revised: 25 June 2021


15198 Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
Ohio, Court of Federal Claims No: 20– enacted on March 13, 2013. Among requires a sustained, coordinated
0225V other things, PAHPRA added sections proactive response by the Government
71. Shannon Pyers, Dresher, Pennsylvania, 564A and 564B to the Federal Food, in order to contain and mitigate the
Court of Federal Claims No: 20–0231V Drug, and Cosmetic (FD&C) Act to spread of COVID–19.2
72. Lisa Macon, Englewood, New Jersey,
provide new authorities for the
Court of Federal Claims No: 20–0232V Description of This Declaration by
emergency use of approved products in
[FR Doc. 2020–05525 Filed 3–16–20; 8:45 am] Section
emergencies and products held for
BILLING CODE 4165–15–P emergency use. PAHPRA accordingly Section I. Determination of Public
amended the definitions of ‘‘Covered Health Emergency or Credible Risk of
Countermeasures’’ and ‘‘qualified Future Public Health Emergency
DEPARTMENT OF HEALTH AND pandemic and epidemic products’’ in
HUMAN SERVICES Before issuing a Declaration under the
Section 319F–3 of the Public Health PREP Act, the Secretary is required to
Service Act (PREP Act provisions), so determine that a disease or other health
Office of the Secretary
that products made available under condition or threat to health constitutes
Declaration Under the Public these new FD&C Act authorities could a public health emergency or that there
Readiness and Emergency be covered under PREP Act is a credible risk that the disease,
Preparedness Act for Medical Declarations. PAHPRA also extended condition, or threat may constitute such
Countermeasures Against COVID–19 the definition of qualified pandemic and an emergency. This determination is
epidemic products that may be covered separate and apart from the Declaration
ACTION: Notice of declaration. under a PREP Act Declaration to include issued by the Secretary on January 31,
products or technologies intended to 2020 under Section 319 of the PHS Act
SUMMARY: The Secretary is issuing this enhance the use or effect of a drug, that a disease or disorder presents a
Declaration pursuant to section 319F–3 biological product, or device used public health emergency or that a public
of the Public Health Service Act to against the pandemic or epidemic or health emergency, including significant
provide liability immunity for activities against adverse events from these outbreaks of infectious diseases or
related to medical countermeasures products. bioterrorist attacks, otherwise exists, or
against COVID–19. COVID–19 is an acute respiratory other Declarations or determinations
DATES: The Declaration was effective as disease caused by the SARS-CoV-2 made under other authorities of the
of February 4, 2020. betacoronavirus or a virus mutating Secretary. Accordingly in Section I of
FOR FURTHER INFORMATION CONTACT:
therefrom. This virus is similar to other the Declaration, the Secretary
Robert P. Kadlec, MD, MTM&H, MS, betacoronaviruses, such as Middle determines that the spread of SARS-
Assistant Secretary for Preparedness Eastern Respiratory Syndrome (MERS) CoV-2 or a virus mutating therefrom and
and Response, Office of the Secretary, and Severe Acute Respiratory Syndrome the resulting disease, COVID–19,
Department of Health and Human (SARS). Although the complete clinical constitutes a public health emergency
Services, 200 Independence Avenue picture regarding SARS-CoV-2 or a virus for purposes of this Declaration under
SW, Washington, DC 20201; Telephone: mutating therefrom is not fully the PREP Act.
202–205–2882. understood, the virus has been known
to cause severe respiratory illness and Section II. Factors Considered by the
SUPPLEMENTARY INFORMATION: The Secretary
death in a subset of those people
Public Readiness and Emergency infected with such virus(es).
Preparedness Act (PREP Act) authorizes In deciding whether and under what
In December 2019, the novel circumstances to issue a Declaration
the Secretary of Health and Human coronavirus was detected in Wuhan
Services (the Secretary) to issue a with respect to a Covered
City, Hubei Province, China. Today, Countermeasure, the Secretary must
Declaration to provide liability over 101 countries, including the United
immunity to certain individuals and consider the desirability of encouraging
States have reported multiple cases. the design, development, clinical testing
entities (Covered Persons) against any Acknowledging that cases had been
claim of loss caused by, arising out of, or investigation, manufacture, labeling,
reported in five WHO regions in one distribution, formulation, packaging,
relating to, or resulting from the month, on January 30, 2020, WHO
manufacture, distribution, marketing, promotion, sale, purchase,
declared the COVID–19 outbreak to be donation, dispensing, prescribing,
administration, or use of medical a Public Health Emergency of
countermeasures (Covered administration, licensing, and use of the
International Concern (PHEIC) following countermeasure. In Section II of the
Countermeasures), except for claims a second meeting of the Emergency
involving ‘‘willful misconduct’’ as Declaration, the Secretary states that he
Committee convened under the has considered these factors.
defined in the PREP Act. This International Health Regulations (IHR).
Declaration is subject to amendment as To date, United States traveler- Section III. Activities Covered by This
circumstances warrant. associated cases have been identified in Declaration Under the PREP Act’s
The PREP Act was enacted on a number of States and community- Liability Immunity
December 30, 2005, as Public Law 109– based transmission is suspected. On The Secretary must delineate the
148, Division C, Section 2. It amended January 31, 2020, Secretary Azar activities for which the PREP Act’s
the Public Health Service (PHS) Act, declared a public health emergency liability immunity is in effect. These
adding Section 319F–3, which pursuant to section 319 of the PHS Act, activities may include, under conditions
khammond on DSKJM1Z7X2PROD with NOTICES
addresses liability immunity, and 42 U.S.C. 247d, for the entire United as the Secretary may specify, the
Section 319F–4, which creates a States to aid in the nation’s health care manufacture, testing, development,
compensation program. These sections community response to the COVID–19 distribution, administration, or use of
are codified at 42 U.S.C. 247d-6d and 42 outbreak.1 The outbreak remains a one or more Covered Countermeasures
U.S.C. 247d–6e, respectively. significant public health challenge that
The Pandemic and All-Hazards 2 CDC COVID–19 Summary; https://www.cdc.gov/
Preparedness Reauthorization Act 1 https://www.phe.gov/emergency/news/ coronavirus/2019-ncov/summary.html, accessed
(PAHPRA), Public Law 113–5, was healthactions/phe/Pages/2019-nCoV.aspx. 27Feb2020,
VerDate Sep<11>2014 17:32 Mar 16, 2020 Jkt 250001 PO 00000 Exhibit
Frm 00090 "5"
Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1
Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices 15199
(Recommended Activities). In Section common carriers; contract carriers; air A qualified pandemic or epidemic
III of the Declaration, the Secretary sets carriers; own-label distributors; private- product means a drug or device, as
out the activities for which the label distributors; jobbers; brokers; defined in the FD&C Act or a biological
immunity is in effect. warehouses and wholesale drug product, as defined in the PHS Act that
warehouses; independent wholesale is (i) manufactured, used, designed,
Section IV. Limited Immunity
drug traders; and retail pharmacies. developed, modified, licensed or
The Secretary must also state that A program planner means a state or procured to diagnose, mitigate, prevent,
liability protections available under the local government, including an Indian treat, or cure a pandemic or epidemic or
PREP Act are in effect with respect to tribe; a person employed by the state or limit the harm such a pandemic or
the Recommended Activities. These local government; or other person who epidemic might otherwise cause; (ii)
liability protections provide that, supervises or administers a program manufactured, used, designed,
‘‘[s]ubject to other provisions of [the with respect to the administration, developed, modified, licensed, or
PREP Act], a covered person shall be dispensing, distribution, provision, or procured to diagnose, mitigate, prevent,
immune from suit and liability under use of a Covered Countermeasure, treat, or cure a serious or life-
federal and state law with respect to all including a person who establishes threatening disease or condition caused
claims for loss caused by, arising out of, requirements, provides policy guidance, by such a drug, biological product, or
relating to, or resulting from the or supplies technical or scientific advice device; (iii) or a product or technology
administration to or use by an or assistance or provides a facility to intended to enhance the use or effect of
individual of a covered countermeasure administer or use a Covered such a drug, biological product, or
if a Declaration has been issued with Countermeasure in accordance with the device.
respect to such countermeasure.’’ In Secretary’s Declaration. Under this A security countermeasure is a drug
Section IV of the Declaration, the definition, a private sector employer or or device, as defined in the FD&C Act
Secretary states that liability protections community group or other ‘‘person’’ can or a biological product, as defined in the
are in effect with respect to the be a program planner when it carries out PHS Act that (i)(a) The Secretary
Recommended Activities. the described activities. determines to be a priority to diagnose,
mitigate, prevent, or treat harm from any
Section V. Covered Persons A qualified person means a licensed
biological, chemical, radiological, or
Section V of the Declaration describes health professional or other individual
nuclear agent identified as a material
Covered Persons, including Qualified authorized to prescribe, administer, or
threat by the Secretary of Homeland
Persons. The PREP Act defines Covered dispense Covered Countermeasures
Security, or (b) to diagnose, mitigate,
Persons to include, among others, the under the law of the state in which the
prevent, or treat harm from a condition
United States, and those that Covered Countermeasure was
that may result in adverse health
manufacturer, distribute, administer, prescribed, administered, or dispensed; consequences or death and may be
prescribe or use Covered or a person within a category of persons caused by administering a drug,
Countermeasures. This Declaration identified as qualified in the Secretary’s biological product, or device against
includes all persons and entities defined Declaration. Under this definition, the such an agent; and (ii) is determined by
as Covered Persons under the PREP Act Secretary can describe in the the Secretary of Health and Human
(PHS Act 317F–3(i)(2)) as well as others Declaration other qualified persons, Services to be a necessary
set out in paragraphs (3), (4), (6), (8)(A) such as volunteers, who are Covered countermeasure to protect public health.
and (8)(B). Persons. Section V describes other To be a Covered Countermeasure,
The PREP Act’s liability immunity qualified persons covered by this qualified pandemic or epidemic
applies to ‘‘Covered Persons’’ with Declaration. products or security countermeasures
respect to administration or use of a The PREP Act also defines the word also must be approved or cleared under
Covered Countermeasure. The term ‘‘person’’ as used in the Act: A person the FD&C Act; licensed under the PHS
‘‘Covered Persons’’ has a specific includes an individual, partnership, Act; or authorized for emergency use
meaning and is defined in the PREP Act corporation, association, entity, or under Sections 564, 564A, or 564B of
to include manufacturers, distributors, public or private corporation, including the FD&C Act.
program planners, and qualified a federal, state, or local government A qualified pandemic or epidemic
persons, and their officials, agents, and agency or department. product also may be a Covered
employees, and the United States. The Section VI. Covered Countermeasures Countermeasure when it is subject to an
PREP Act further defines the terms exemption (that is, it is permitted to be
‘‘manufacturer,’’ ‘‘distributor,’’ As noted above, Section III of the used under an Investigational Drug
‘‘program planner,’’ and ‘‘qualified Declaration describes the activities Application or an Investigational Device
person’’ as described below. (referred to as ‘‘Recommended Exemption) under the FD&C Act and is
A manufacturer includes a contractor Activities’’) for which liability the object of research for possible use
or subcontractor of a manufacturer; a immunity is in effect. Section VI of the for diagnosis, mitigation, prevention,
supplier or licenser of any product, Declaration identifies the Covered treatment, or cure, or to limit harm of
intellectual property, service, research Countermeasures for which the a pandemic or epidemic or serious or
tool or component or other article used Secretary has recommended such life-threatening condition caused by
in the design, development, clinical activities. The PREP Act states that a such a drug or device.
testing, investigation or manufacturing ‘‘Covered Countermeasure’’ must be a A security countermeasure also may
of a Covered Countermeasure; and any ‘‘qualified pandemic or epidemic be a Covered Countermeasure if it may
or all the parents, subsidiaries, affiliates, product,’’ or a ‘‘security reasonably be determined to qualify for
successors, and assigns of a countermeasure,’’ as described approval or licensing within 10 years
manufacturer. immediately below; or a drug, biological after the Department’s determination
A distributor means a person or entity product or device authorized for that procurement of the countermeasure
engaged in the distribution of drugs, emergency use in accordance with is appropriate.
biologics, or devices, including but not Sections 564, 564A, or 564B of the Section VI lists medical
limited to: Manufacturers; re-packers; FD&C Act. countermeasures against COVID–19 that
VerDate Sep<11>2014 17:32 Mar 16, 2020 Jkt 250001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1
are Covered Countermeasures under this Section VIII. Category of Disease, Health example, liability claims alleging
declaration. Condition, or Threat negligence by a manufacturer in creating
Section VI also refers to the statutory The Secretary must identify in the a vaccine, or negligence by a health care
definitions of Covered Countermeasures Declaration, for each Covered provider in prescribing the wrong dose,
to make clear that these statutory Countermeasure, the categories of absent willful misconduct. Likewise, the
definitions limit the scope of Covered diseases, health conditions, or threats to Act precludes a liability claim relating
Countermeasures. Specifically, the health for which the Secretary to the management and operation of a
Declaration notes that Covered countermeasure distribution program or
recommends the administration or use
Countermeasures must be ‘‘qualified site, such as a slip-and-fall injury or
of the countermeasure. In Section VIII of
pandemic or epidemic products,’’ or vehicle collision by a recipient receiving
the Declaration, the Secretary states that
‘‘security countermeasures,’’ or drugs, a countermeasure at a retail store
the disease threat for which he
biological products, or devices serving as an administration or
recommends administration or use of
dispensing location that alleges, for
authorized for investigational or the Covered Countermeasures is
example, lax security or chaotic crowd
emergency use, as those terms are COVID–19 caused by SARS-CoV-2 or a
control. However, a liability claim
defined in the PREP Act, the FD&C Act, virus mutating therefrom.
alleging an injury occurring at the site
and the Public Health Service Act.
Section IX. Administration of Covered that was not directly related to the
Section VII. Limitations on Distribution Countermeasures countermeasure activities is not
The PREP Act does not explicitly covered, such as a slip and fall with no
The Secretary may specify that direct connection to the
liability immunity is in effect only to define the term ‘‘administration’’ but
countermeasure’s administration or use.
Covered Countermeasures obtained does assign the Secretary the
In each case, whether immunity is
through a particular means of responsibility to provide relevant
applicable will depend on the particular
distribution. The Declaration states that conditions in the Declaration. In Section
facts and circumstances.
liability immunity is afforded to IX of the Declaration, the Secretary
Covered Persons for Recommended defines ‘‘Administration of a Covered Section X. Population
Activities related to (a) present or future Countermeasure,’’ as follows: The Secretary must identify, for each
federal contracts, cooperative Administration of a Covered Covered Countermeasure specified in a
agreements, grants, other transactions, Countermeasure means physical Declaration, the population or
interagency agreements, or memoranda provision of the countermeasures to populations of individuals for which
of understanding or other federal recipients, or activities and decisions liability immunity is in effect with
agreements; or (b) activities authorized directly relating to public and private respect to administration or use of the
in accordance with the public health delivery, distribution, and dispensing of countermeasure. Section X of the
and medical response of the Authority the countermeasures to recipients; Declaration identifies which individuals
Having Jurisdiction to prescribe, management and operation of should use the countermeasure or to
administer, deliver, distribute, or countermeasure programs; or whom the countermeasure should be
dispense the Covered Countermeasures management and operation of locations administered—in short, those who
following a Declaration of an for purpose of distributing and should be vaccinated or take a drug or
emergency. dispensing countermeasures. other countermeasure. Section X
The definition of ‘‘administration’’ provides that the population includes
Section VII defines the terms extends only to physical provision of a
‘‘Authority Having Jurisdiction’’ and ‘‘any individual who uses or who is
countermeasure to a recipient, such as administered a Covered Countermeasure
‘‘Declaration of an emergency.’’ We have vaccination or handing drugs to
specified in the definition that in accordance with the Declaration.’’
patients, and to activities related to It should be noted that under the
Authorities having jurisdiction include management and operation of programs PREP Act, liability protection extends
federal, state, local, and tribal and locations for providing beyond the Population specified in the
authorities and institutions or countermeasures to recipients, such as Declaration. Specifically, liability
organizations acting on behalf of those decisions and actions involving security immunity is afforded (1) To
governmental entities. and queuing, but only insofar as those manufacturers and distributors without
For governmental program planners activities directly relate to the regard to whether the countermeasure is
only, liability immunity is afforded only countermeasure activities. Claims for used by or administered to this
to the extent they obtain Covered which Covered Persons are provided population, and (2) to program planners
Countermeasures through voluntary immunity under the Act are losses and qualified persons when the
means, such as (1) donation; (2) caused by, arising out of, relating to, or countermeasure is either used by or
commercial sale; (3) deployment of resulting from the administration to or administered to this population or the
Covered Countermeasures from federal use by an individual of a Covered program planner or qualified person
stockpiles; or (4) deployment of Countermeasure consistent with the reasonably could have believed the
donated, purchased, or otherwise terms of a Declaration issued under the recipient was in this population.
voluntarily obtained Covered Act. Under the definition, these liability Section X of the Declaration includes
Countermeasures from state, local, or claims are precluded if they allege an these statutory conditions in the
private stockpiles. This last limitation injury caused by a countermeasure, or if Declaration for clarity.
on distribution is intended to deter the claims are due to manufacture,

program planners that are government delivery, distribution, dispensing, or Section XI. Geographic Area
entities from seizing privately held management and operation of The Secretary must identify, for each
stockpiles of Covered Countermeasures. countermeasure programs at Covered Countermeasure specified in
It does not apply to any other Covered distribution and dispensing sites. the Declaration, the geographic area or
Persons, including other program Thus, it is the Secretary’s areas for which liability immunity is in
planners who are not government interpretation that, when a Declaration effect, including, as appropriate,
entities. is in effect, the Act precludes, for whether the Declaration applies only to
individuals physically present in the immunity is afforded during the any portion of this Declaration through
area or, in addition, applies to ‘‘Effective Time Period,’’ described publication in the Federal Register.
individuals who have a described under Section XII of the Declaration,
Declaration
connection to the area. Section XI of the plus the ‘‘Additional Time Period’’
Declaration provides that liability described under Section XIII of the Declaration for Public Readiness and
immunity is afforded for the Declaration. Emergency Preparedness Act Coverage
administration or use of a Covered Section XIII of the Declaration for medical countermeasures against
Countermeasure without geographic provides for 12 months as the COVID–19.
limitation. This could include claims Additional Time Period of coverage I. Determination of Public Health
related to administration or use in after expiration of the Declaration. Emergency
countries outside the U.S. It is possible Section XIII also explains the extended
that claims may arise in regard to coverage that applies to any product 42 U.S.C. 247d–6d(b)(1)
administration or use of the Covered obtained for the SNS during the I have determined that the spread of
Countermeasures outside the U.S. that effective period of the Declaration. SARS-CoV–2 or a virus mutating
may be resolved under U.S. law. therefrom and the resulting disease
In addition, the PREP Act specifies Section XIV. Countermeasures Injury COVID–19 constitutes a public health
that liability immunity is afforded (1) to Compensation Program emergency.
manufacturers and distributors without Section 319F–4 of the PHS Act, 42
regard to whether the countermeasure is II. Factors Considered
U.S.C. 247d-6e, authorizes the
used by or administered to individuals Countermeasures Injury Compensation 42 U.S.C. 247d–6d(b)(6)
in the geographic areas, and (2) to Program (CICP) to provide benefits to I have considered the desirability of
program planners and qualified persons eligible individuals who sustain a encouraging the design, development,
when the countermeasure is either used serious physical injury or die as a direct clinical testing, or investigation,
or administered in the geographic areas result of the administration or use of a manufacture, labeling, distribution,
or the program planner or qualified Covered Countermeasure. formulation, packaging, marketing,
person reasonably could have believed Compensation under the CICP for an promotion, sale, purchase, donation,
the countermeasure was used or injury directly caused by a Covered dispensing, prescribing, administration,
administered in the areas. Section XI of Countermeasure is based on the licensing, and use of the Covered
the Declaration includes these statutory requirements set forth in this Countermeasures.
conditions in the Declaration for clarity.
Declaration, the administrative rules for III. Recommended Activities
Section XII. Effective Time Period the Program, and the statute. To show
direct causation between a Covered 42 U.S.C. 247d–6d(b)(1)
The Secretary must identify, for each
Covered Countermeasure, the period or Countermeasure and a serious physical I recommend, under the conditions
periods during which liability immunity injury, the statute requires ‘‘compelling, stated in this Declaration, the
is in effect, designated by dates, reliable, valid, medical and scientific manufacture, testing, development,
milestones, or other description of evidence.’’ The administrative rules for distribution, administration, and use of
events, including factors specified in the the Program further explain the the Covered Countermeasures.
PREP Act. Section XII of the Declaration necessary requirements for eligibility
IV. Liability Immunity
extends the effective period for different under the CICP. Please note that, by
statute, requirements for compensation 42 U.S.C. 247d–6d(a), 247d–6d(b)(1)
means of distribution of Covered
Countermeasures through October 1, under the CICP may not align with the Liability immunity as prescribed in
2024. requirements for liability immunity the PREP Act and conditions stated in
provided under the PREP Act. Section this Declaration is in effect for the
Section XIII. Additional Time Period of XIV of the Declaration, Recommended Activities described in
Coverage ‘‘Countermeasures Injury Compensation Section III.
The Secretary must specify a date Program,’’ explains the types of injury
V. Covered Persons
after the ending date of the effective and standard of evidence needed to be
time period of the Declaration that is considered for compensation under the 42 U.S.C. 247d–6d(i)(2), (3), (4), (6),
reasonable for manufacturers to arrange CICP. (8)(A) and (B)
for disposition of the Covered Further, the administrative rules for Covered Persons who are afforded
Countermeasure, including accepting the CICP specify that if countermeasures liability immunity under this
returns of Covered Countermeasures, are administered or used outside the Declaration are ‘‘manufacturers,’’
and for other Covered Persons to take United States, only otherwise eligible ‘‘distributors,’’ ‘‘program planners,’’
appropriate actions to limit individuals at United States embassies, ‘‘qualified persons,’’ and their officials,
administration or use of the Covered military installations abroad (such as agents, and employees, as those terms
Countermeasure. In addition, the PREP military bases, ships, and camps) or at are defined in the PREP Act, and the
Act specifies that, for Covered North Atlantic Treaty Organization United States.
Countermeasures that are subject to a (NATO) installations (subject to the In addition, I have determined that
Declaration at the time they are obtained NATO Status of Forces Agreement) the following additional persons are
for the Strategic National Stockpile where American servicemen and qualified persons: (a) Any person
(SNS) under 42 U.S.C. 247d-6b(a), the servicewomen are stationed may be authorized in accordance with the
effective period of the Declaration considered for CICP benefits. Other public health and medical emergency
extends through the time the individuals outside the United States response of the Authority Having
countermeasure is used or administered. may not be eligible for CICP benefits. Jurisdiction, as described in Section VII
Liability immunity under the provisions below, to prescribe, administer, deliver,
Section XV. Amendments
of the PREP Act and the conditions of distribute or dispense the Covered
the Declaration continue during these Section XV of the Declaration Countermeasures, and their officials,
additional time periods. Thus, liability confirms that the Secretary may amend agents, employees, contractors and
volunteers, following a Declaration of an boundary lines) or functional (e.g., law qualified persons when the
emergency; (b) any person enforcement, public health) range or countermeasure is used by or
authorized to prescribe, administer, or sphere of authority. administered to this population, or the
dispense the Covered Countermeasures ii. A Declaration of Emergency means program planner or qualified person
or who is otherwise authorized to any Declaration by any authorized local, reasonably could have believed the
perform an activity under an Emergency regional, state, or federal official of an recipient was in this population.
Use Authorization in accordance with emergency specific to events that
XI. Geographic Area
Section 564 of the FD&C Act; and (c) indicate an immediate need to
any person authorized to prescribe, administer and use the Covered 42 U.S.C. 247d–6d(a)(4), 247d–
administer, or dispense Covered Countermeasures, with the exception of 6d(b)(2)(D)
Countermeasures in accordance with a federal Declaration in support of an Liability immunity is afforded for the
Section 564A of the Emergency Use Authorization under administration or use of a Covered
FD&C Act. Section 564 of the FD&C Act unless Countermeasure without geographic
such Declaration specifies otherwise; limitation.
VI. Covered Countermeasures I have also determined that, for Liability immunity is afforded to
42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. governmental program planners only, manufacturers and distributors without
247d–6d(i)(1) and (7) liability immunity is afforded only to regard to whether the countermeasure is
Covered Countermeasures are any the extent such program planners obtain used by or administered in any
antiviral, any other drug, any biologic, Covered Countermeasures through designated geographic area; liability
any diagnostic, any other device, or any voluntary means, such as (1) donation; immunity is afforded to program
vaccine, used to treat, diagnose, cure, (2) commercial sale; (3) deployment of planners and qualified persons when
prevent, or mitigate COVID–19, or the Covered Countermeasures from federal the countermeasure is used by or
transmission of SARS-CoV–2 or a virus stockpiles; or (4) deployment of administered in any designated
mutating therefrom, or any device used donated, purchased, or otherwise geographic area, or the program planner
in the administration of any such voluntarily obtained Covered or qualified person reasonably could
product, and all components and Countermeasures from state, local, or have believed the recipient was in that
constituent materials of any such private stockpiles. geographic area.
product. VIII. Category of Disease, Health
Covered Countermeasures must be XII. Effective Time Period
Condition, or Threat
‘‘qualified pandemic or epidemic 42 U.S.C. 247d–6d(b)(2)(B)
products,’’ or ‘‘security 42 U.S.C. 247d–6d(b)(2)(A) Liability immunity for Covered
countermeasures,’’ or drugs, biological The category of disease, health Countermeasures through means of
products, or devices authorized for condition, or threat for which I distribution, as identified in Section
investigational or emergency use, as recommend the administration or use of VII(a) of this Declaration, other than in
those terms are defined in the PREP Act, the Covered Countermeasures is accordance with the public health and
the FD&C Act, and the Public Health COVID–19 caused by SARS-CoV–2 or a medical response of the Authority
Service Act. virus mutating therefrom. Having Jurisdiction and extends through
VII. Limitations on Distribution IX. Administration of Covered October 1, 2024.
Countermeasures Liability immunity for Covered
42 U.S.C. 247d–6d(a)(5) and (b)(2)(E) Countermeasures administered and
I have determined that liability 42 U.S.C. 247d–6d(a)(2)(B) used in accordance with the public
immunity is afforded to Covered Administration of the Covered health and medical response of the
Persons only for Recommended Countermeasure means physical Authority Having Jurisdiction begins
Activities involving Covered provision of the countermeasures to with a Declaration and lasts through (1)
Countermeasures that are related to: recipients, or activities and decisions the final day the emergency Declaration
(a) Present or future federal contracts, directly relating to public and private is in effect, or (2) October 1, 2024,
cooperative agreements, grants, other delivery, distribution and dispensing of whichever occurs first.
transactions, interagency agreements, the countermeasures to recipients,
management and operation of XIII. Additional Time Period of
memoranda of understanding, or other
countermeasure programs, or Coverage
federal agreements; or
(b) Activities authorized in management and operation of locations 42 U.S.C. 247d–6d(b)(3)(B) and (C)
accordance with the public health and for purpose of distributing and I have determined that an additional
medical response of the Authority dispensing countermeasures. 12 months of liability protection is
Having Jurisdiction to prescribe, X. Population reasonable to allow for the
administer, deliver, distribute or manufacturer(s) to arrange for
dispense the Covered Countermeasures 42 U.S.C. 247d–6d(a)(4), 247d– disposition of the Covered
following a Declaration of an 6d(b)(2)(C) Countermeasure, including return of the
emergency. The populations of individuals Covered Countermeasures to the
As used in this Declaration, the terms include any individual who uses or is manufacturer, and for Covered Persons
Authority Having Jurisdiction and administered the Covered to take such other actions as are
Declaration of Emergency have the Countermeasures in accordance with appropriate to limit the administration
following meanings: this Declaration. or use of the Covered Countermeasures.
i. The Authority Having Jurisdiction Liability immunity is afforded to Covered Countermeasures obtained
means the public agency or its delegate manufacturers and distributors without for the SNS during the effective period
that has legal responsibility and regard to whether the countermeasure is of this Declaration are covered through
authority for responding to an incident, used by or administered to this the date of administration or use
based on political or geographical (e.g., population; liability immunity is pursuant to a distribution or release
city, county, tribal, state, or federal afforded to program planners and from the SNS.
XIV. Countermeasures Injury Name of Committee: National Institute of DEPARTMENT OF HEALTH AND
Compensation Program Diabetes and Digestive and Kidney Diseases HUMAN SERVICES
Special Emphasis Panel; PAR–18–423:
42 U.S.C 247d–6e NIDDK Multi-Center Clinical Study National Institutes of Health
The PREP Act authorizes the Implementation Planning Cooperative
Countermeasures Injury Compensation Agreements (U34) in Digestive Diseases. Center for Scientific Review; Amended
Program (CICP) to provide benefits to Date: May 22, 2020. Notice of Meeting
certain individuals or estates of Time: 11:00 a.m. to 1:00 p.m.
Notice is hereby given of a change in
individuals who sustain a covered Agenda: To review and evaluate grant
the meeting of the Center for Scientific
serious physical injury as the direct applications.
Review Special Emphasis Panel, PAR
result of the administration or use of the Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
19–059: Global Noncommunicable
Covered Countermeasures, and benefits
Boulevard, Bethesda, MD 20892 (Telephone
Diseases and Injury Across the Lifespan
to certain survivors of individuals who
Conference Call). (R21), March 23, 2020, 8:00 a.m. to 5:00
die as a direct result of the
Contact Person: Dianne Camp, Ph.D., p.m., at the Hotel Palomar, 2121 P Street
administration or use of the Covered
Scientific Review Officer, Review Branch, NW, Washington, DC 20037, which was
Countermeasures. The causal
Division of Extramural Activities, NIDDK, published in the Federal Register on
connection between the countermeasure
National Institutes of Health, Room 7013, February 25, 2020, 85 FR 10708.
and the serious physical injury must be
6707 Democracy Boulevard, Bethesda, MD The meeting will be held at the
supported by compelling, reliable, valid,
20892–2542, (301) 594–7682, campd@ National Institutes of Health, 6701
medical and scientific evidence in order
extra.niddk.nih.gov. Rockledge Drive, Bethesda, MD 20892.
for the individual to be considered for
The format of the meeting has been
compensation. The CICP is (Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
changed to a Video Assisted Meeting.
administered by the Health Resources
Endocrinology and Metabolic Research;
The meeting date and time remain the
and Services Administration, within the
93.848, Digestive Diseases and Nutrition same. The meeting is closed to the
Department of Health and Human
Research; 93.849, Kidney Diseases, Urology public.
Services. Information about the CICP is
available at the toll-free number 1–855– and Hematology Research, National Institutes Dated: March 11, 2020.
266–2427 or http://www.hrsa.gov/cicp/. of Health, HHS) Ronald J. Livingston, Jr.,
Dated: March 10, 2020. Program Analyst, Office of Federal Advisory
XV. Amendments Committee Policy.
Miguelina Perez,
42 U.S.C. 247d–6d(b)(4) [FR Doc. 2020–05419 Filed 3–16–20; 8:45 am]
Program Analyst, Office of Federal Advisory
Amendments to this Declaration will Committee Policy.
BILLING CODE 4140–01–P
be published in the Federal Register, as [FR Doc. 2020–05361 Filed 3–16–20; 8:45 am]
warranted.
BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND
Authority: 42 U.S.C. 247d–6d. HUMAN SERVICES
Dated: March 10, 2020.
Alex M. Azar II, DEPARTMENT OF HEALTH AND National Institutes of Health
Secretary of Health and Human Services. HUMAN SERVICES
National Institute of Diabetes and
[FR Doc. 2020–05484 Filed 3–12–20; 4:15 pm] Digestive and Kidney Diseases; Notice
National Institutes of Health
BILLING CODE P of Closed Meeting
Center for Scientific Review; Amended
Notice of Meeting Pursuant to section 10(d) of the
DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as
HUMAN SERVICES Notice is hereby given of a change in amended, notice is hereby given of the
the meeting of the Center for Scientific following meeting.
National Institutes of Health The meeting will be closed to the
Review Special Emphasis Panel, Small
public in accordance with the
National Institute of Diabetes and Business: Cardiovascular Sciences,
provisions set forth in sections
Digestive and Kidney Diseases; Notice March 19, 2020 08:00 a.m. to March 20, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
of Closed Meeting 2020, 01:00 p.m., Embassy Suites as amended. The grant applications and
Alexandria Old Town, 1900 Diagonal the discussions could disclose
Pursuant to section 10(d) of the Road, Alexandria, VA 22314 which was
Federal Advisory Committee Act, as confidential trade secrets or commercial
published in the Federal Register on property such as patentable material,
amended, notice is hereby given of the February 20, 2020, 85 FR 9791.
following meeting. and personal information concerning
The meeting will be closed to the The meeting location is being held at individuals associated with the grant
public in accordance with the the National Institutes of Health, 6701 applications, the disclosure of which
provisions set forth in sections Rockledge Drive, Bethesda, MD 20892, would constitute a clearly unwarranted
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., at 09:00 a.m. The meeting date remains invasion of personal privacy.
as amended. The grant applications and the same. The meeting is closed to the Name of Committee: National Institute of
the discussions could disclose public. Diabetes and Digestive and Kidney Diseases
confidential trade secrets or commercial Special Emphasis Panel; Consortium for the
Dated: March 11, 2020. Study of Chronic Pancreatitis, Diabetes, and
property such as patentable material, Miguelina Perez, Pancreatic Cancer Clinical Centers Special
and personal information concerning Emphasis Panel.
individuals associated with the grant Program Analyst, Office of Federal Advisory
Committee Policy. Date: April 2, 2020.
applications, the disclosure of which Time: 10:00 a.m. to 6:00 p.m.
would constitute a clearly unwarranted [FR Doc. 2020–05417 Filed 3–16–20; 8:45 am]
Agenda: To review and evaluate grant
invasion of personal privacy. BILLING CODE 4140–01–P applications.
DEPARTMENT OF HEALTH AND ‘‘Currently under Review—Open for Focus groups may also be used to gain
HUMAN SERVICES Public Comments’’ or by using the partner input that will inform the design
search function. of mail, electronic and/or telephone
Health Resources and Services FOR FURTHER INFORMATION CONTACT: To surveys. Focus groups, in-class
Administration request a copy of the clearance requests evaluation forms, mail surveys,
submitted to OMB for review, email Lisa electronic surveys, and telephone
Agency Information Collection surveys are expected to be the preferred
Wright-Solomon, the HRSA Information
Activities: Submission to OMB for data collection methods for this
Collection Clearance Officer at
Review and Approval; Public Comment information collection.
[email protected] or call (301) 443–
Request; Voluntary Partner Surveys To A generic approval allows HRSA to
1984.
Implement Executive Order 12862 in conduct a limited number of partner
the Health Resources and Services SUPPLEMENTARY INFORMATION:
Information Collection Request Title: surveys without a full-scale OMB
Administration review of each survey. If this generic
Voluntary Partner Surveys to Implement
AGENCY: Health Resources and Services Executive Order 12862 in the Health information collection request receives
Administration (HRSA), Department of Resources and Services Administration, continued approval, information on
Health and Human Services. OMB No. 0915–0212—Extension. each individual partner survey will not
ACTION: Notice. Abstract: In response to Executive be published in the Federal Register.
Order 12862, HRSA is proposing to A 60-day notice published in the
SUMMARY: In compliance with the conduct voluntary customer surveys of Federal Register on December 15, 2020,
Paperwork Reduction Act of 1995, its partners to assess strengths and vol. 85, No. 241; pp. 81210–11. There
HRSA submitted an Information weaknesses in program services and were no public comments.
Collection Request (ICR) to the Office of processes. HRSA partners are typically Burden Statement: Burden in this
Management and Budget (OMB) for state or local governments, health care context means the time expended by
review and approval. Comments facilities, health care consortia, health persons to generate, maintain, retain,
submitted during the first public review care providers, and researchers. HRSA disclose, or provide the information
of this ICR will be provided to OMB. is requesting continued approval of a requested. This includes the time
OMB will accept further comments from generic clearance from OMB to conduct needed to review instructions; to
the public during the review and the partner surveys. develop, acquire, install and utilize
approval period. OMB may act on Partner surveys to be conducted by technology and systems for the purpose
HRSA’s ICR only after the 30 day HRSA might include, for example, mail, of collecting, validating and verifying
comment period for this notice has electronic, and/or telephone surveys of information, processing and
closed. grantees to determine satisfaction with maintaining information, and disclosing
DATES: Comments on this ICR should be grant processes or technical assistance and providing information; to train
received no later than April 15, 2021. provided by a contractor, or in-class or personnel and to be able to respond to
ADDRESSES: Written comments and virtual evaluation forms completed by a collection of information; to search
recommendations for the proposed providers who receive training from data sources; to complete and review
information collection should be sent HRSA grantees to measure satisfaction the collection of information; and to
within 30 days of publication of this with the training experience. Results of transmit or otherwise disclose the
notice to www.reginfo.gov/public/do/ these surveys will be used to plan and information. The total annual burden
PRAMain. Find this particular redirect resources and efforts as needed hours estimated for this ICR are
information collection by selecting to improve services and processes. summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
In-class evaluations ............................................................. 40,000 1 40,000 .05 2,000

Mail/Telephone surveys ....................................................... 12,000 1 12,000 .25 3,000
Focus groups ....................................................................... 250 1 250 1.50 375
Total .............................................................................. 52,250 ........................ 52,250 ........................ 5,375
HRSA specifically requests comments technology to minimize the information DEPARTMENT OF HEALTH AND
on (1) the necessity and utility of the collection burden. HUMAN SERVICES
proposed information collection for the
Maria G. Button,
proper performance of the agency’s Office of the Secretary
functions, (2) the accuracy of the Director, Executive Secretariat.
estimated burden, (3) ways to enhance [FR Doc. 2021–05349 Filed 3–15–21; 8:45 am] Seventh Amendment to Declaration
the quality, utility, and clarity of the BILLING CODE 4165–15–P Under the Public Readiness and
jbell on DSKJLSW7X2PROD with NOTICES
information to be collected, and (4) the Emergency Preparedness Act for

use of automated collection techniques Medical Countermeasures Against
or other forms of information COVID–19
ACTION: Notice of amendment.
SUMMARY: The Acting Secretary issues 2020, October 23, 2020, and January 21, February 16, 2021, the Acting Secretary
this amendment pursuant to section 2021. amended the Declaration to add
319F–3 of the Public Health Service Act On March 10, 2020, former Secretary additional categories of Qualified
to add additional categories of Qualified Azar issued a Declaration under the Persons authorized to prescribe,
Persons authorized to prescribe, PREP Act for medical countermeasures dispense, and administer COVID–19
dispense, and administer covered against COVID–19 (85 FR 15198, Mar. vaccines that are covered
countermeasures under section VI of 17, 2020) (the Declaration). On April 10, countermeasures under the Declaration
this Declaration. the former Secretary amended the (86 FR 9516, February 16, 2021) and on
DATES: This amendment to the Declaration under the PREP Act to February 22, 2021, the Department filed
Declaration is effective as of March 11, extend liability immunity to covered a notice of correction to the February 2
2021. countermeasures authorized under the and February 16 notices correcting
CARES Act (85 FR 21012, Apr. 15, effective dates stated in the Declaration,
FOR FURTHER INFORMATION CONTACT: L. and correcting the description of
Paige Ezernack, Office of the Assistant 2020). On June 4, the former Secretary
amended the Declaration to clarify that qualified persons added by the February
Secretary for Preparedness and 16, 2021 amendment. (86 FR 10588,
Response, Office of the Secretary, covered countermeasures under the
Declaration include qualified February 22, 2021).
Department of Health and Human The Acting Secretary now amends
Services, 200 Independence Avenue countermeasures that limit the harm
COVID–19 might otherwise cause. (85 section V of the Declaration to revise
SW, Washington, DC 20201; 202–260– subsection (f) to clarify that observers
0365, [email protected]. FR 35100, June 8, 2020). On August 19,
should be experienced in administering
the former Secretary amended the
SUPPLEMENTARY INFORMATION: The intramuscular injections; delete
declaration to add additional categories
Public Readiness and Emergency subsection (g), change the prior
of Qualified Persons and amend the
Preparedness Act (PREP Act) authorizes subsection (h) to subsection (g) and add
category of disease, health condition, or
the Secretary of Health and Human a new subsection (h) to add additional
threat for which he recommended the
Services (the Secretary) to issue a categories of qualified persons covered
administration or use of the Covered
Declaration to provide liability under the PREP Act, and thus
Countermeasures. (85 FR 52136, August
immunity to certain individuals and authorizes: (h) The following healthcare
24, 2020). On December 3, 2020, the
entities (Covered Persons) against any professionals and students in a
former Secretary amended the healthcare profession training program
claim of loss caused by, arising out of, declaration to incorporate Advisory
relating to, or resulting from the subject to the requirements of this
Opinions of the General Counsel paragraph:
manufacture, distribution, interpreting the PREP Act and the
administration, or use of medical 1. Any midwife, paramedic, advanced
Secretary’s Declaration and or intermediate emergency medical
countermeasures (Covered authorizations issued by the
Countermeasures), except for claims technician (EMT), physician assistant,
Department’s Office of the Assistant respiratory therapist, dentist, podiatrist,
involving ‘‘willful misconduct’’ as Secretary for Health as an Authority optometrist or veterinarian licensed or
defined in the PREP Act. Under the Having Jurisdiction to respond; added certified to practice under the law of
PREP Act, a Declaration may be an additional category of qualified any state who prescribes, dispenses, or
amended as circumstances warrant. persons under Section V of the administers COVID–19 vaccines that are
The PREP Act was enacted on Declaration; made explicit that the Covered Countermeasures under section
December 30, 2005, as Public Law 109– Declaration covers all qualified VI of this Declaration in any jurisdiction
148, Division C, section 2. It amended pandemic and epidemic products as where the PREP Act applies in
the Public Health Service (PHS) Act, defined under the PREP Act; added a association with a COVID–19
adding section 319F–3, which addresses third method of distribution to provide vaccination effort by a State, local,
liability immunity, and section 319F–4, liability protections for, among other Tribal or territorial authority or by an
which creates a compensation program. things, private distribution channels; institution in which the COVID–19
These sections are codified at 42 U.S.C. made explicit that there can be vaccine covered countermeasure is
247d–6d and 42 U.S.C. 247d–6e, situations where not administering a administered;
respectively. Section 319F–3 of the PHS covered countermeasure to a particular 2. Any physician, advanced practice
Act has been amended by the Pandemic individual can fall within the PREP Act registered nurse, registered nurse,
and All-Hazards Preparedness and the Declaration’s liability practical nurse, pharmacist, pharmacy
Reauthorization Act (PAHPRA), Public protections; made explicit that there are intern, midwife, paramedic, advanced
Law 113–5, enacted on March 13, 2013 substantive Federal legal and policy or intermediate EMT, respiratory
and the Coronavirus Aid, Relief, and issues and interests in having a unified therapist, dentist, physician assistant,
Economic Security (CARES) Act, Public whole-of-nation response to the COVID– podiatrist, optometrist, or veterinarian
Law 116–136, enacted on March 27, 19 pandemic among Federal, state, who has held an active license or
2020, to expand Covered local, and private-sector entities; revised certification under the law of any State
Countermeasures under the PREP Act. the effective time period of the within the last five years, which is
On January 31, 2020, the former Declaration; and republished the inactive, expired or lapsed, who
Secretary, Alex M. Azar II, declared a declaration in full. (85 FR 79190, prescribes, dispenses, or administers
public health emergency pursuant to December 9, 2020). On February 2, COVID–19 vaccines that are Covered
section 319 of the PHS Act, 42 U.S.C. 2021, the Acting Secretary Norris Countermeasures under section VI of
247d, effective January 27, 2020, for the Cochran amended the Declaration to this Declaration in any jurisdiction
entire United States to aid in the add additional categories of Qualified where the PREP Act applies in
response of the nation’s health care Persons authorized to prescribe, association with a COVID–19
community to the COVID–19 outbreak. dispense, and administer COVID–19 vaccination effort by a State, local,
Pursuant to section 319 of the PHS Act, vaccines that are covered Tribal or territorial authority or by an
the Secretary renewed that declaration countermeasures under the Declaration institution in which the COVID–19
effective on April 26, 2020, July 25, (86 FR 7872, February 2, 2021). On vaccine covered countermeasure is
VerDate Sep<11>2014 16:52 Mar 15, 2021 Jkt 253001 PO 00000 Exhibit
Fmt 4703 Sfmt"6"
Frm 00061 4703 E:\FR\FM\16MRN1.SGM 16MRN1
administered, so long as the license or in basic cardiopulmonary individual who is authorized to

certification was active and in good resuscitation; 1 prescribe, administer, or dispense such
standing prior to the date it went vi. The healthcare professionals and countermeasures under the law of the
inactive, expired or lapsed and was not students must comply with State in which the countermeasure was
revoked by the licensing authority, recordkeeping and reporting prescribed, administered, or dispensed;
surrendered while under suspension, requirements of the jurisdiction in or (B) ‘‘a person within a category of
discipline or investigation by a licensing which he or she administers vaccines, persons so identified in a declaration by
authority or surrendered following an including informing the patient’s the Secretary’’ under subsection (b) of
arrest, and the individual is not on the primary-care provider when available, the PREP Act. 42 U.S.C. 247d–6d(i)(8).
List of Excluded Individuals/Entities submitting the required immunization By this amendment to the Declaration,
maintained by the Office of Inspector information to the State or local the Acting Secretary identifies an
General; immunization information system additional categories of persons who are
3. Any medical, nursing, pharmacy, (vaccine registry), complying with qualified persons under section 247d–
pharmacy intern, midwife, paramedic, requirements with respect to reporting 6d(i)(8)(B): licensed healthcare
advanced or intermediate EMT, adverse events, and complying with professionals who may not ordinarily
physician assistant, respiratory therapy, requirements whereby the person prescribe, dispense or administer
dental, podiatry, optometry or administering a vaccine must review the vaccines, additional healthcare
veterinary student with appropriate vaccine registry or other vaccination providers with recently expired
training in administering vaccines as records prior to administering a vaccine; licenses, and students in a healthcare
determined by his or her school or and profession training program, subject to
training program and supervision by a vii. The healthcare professionals and appropriate training, supervision, and
currently practicing healthcare students comply with any applicable other specified requirements. The
professional experienced in requirements (or conditions of use) as Acting Secretary anticipates that
administering intramuscular injections set forth in the Centers for Disease significantly more vaccines will be
who administers COVID–19 vaccines Control and Prevention (CDC) COVID– available to the public in the spring and
that are Covered Countermeasures 19 vaccination provider agreement and summer of 2021, and wants to ensure
under section VI of this Declaration in any other federal requirements that that states have the greatest flexibility in
any jurisdiction where the PREP Act apply to the administration of COVID– mobilizing the workforce they will need
applies in association with a COVID–19 19 vaccine(s). to engage in the largest vaccination
vaccination effort by a State, local, effort in our Nation’s history. This
Tribal or territorial authority or by an Description of This Amendment by amendment thus expands the pool of
institution in which the COVID–19 Section vaccinators to individuals who have or
vaccine covered countermeasure is Section V. Covered Persons can obtain training and the capability to
administered; administer vaccines even if prescribing,
Under the PREP Act and the
Subject to the following requirements: dispensing and administering vaccines
Declaration, a ‘‘qualified person’’ is a
i. The vaccine must be authorized, is not within the scope of their license
‘‘covered person.’’ Subject to certain
approved, or licensed by the FDA; or usual responsibilities, allowing
ii. Vaccination must be ordered and limitations, a covered person is immune
States, Territories, local areas and Tribes
administered according to ACIP’s from suit and liability under Federal
to use these individuals in their
COVID–19 vaccine recommendation(s); and State law with respect to all claims
vaccination programs.
iii. The healthcare professionals and for loss caused by, arising out of, The Acting Secretary has determined
students must have documentation of relating to, or resulting from the that there is an urgent need to expand
completion of the Centers for Disease administration or use of a covered the pool of available COVID–19
Control and Prevention COVID–19 countermeasure if a declaration under vaccinators in order to respond
Vaccine Training Modules and, if the PREP Act has been issued with effectively to the pandemic. As vaccine
applicable, such additional training as respect to such countermeasure. supply is made more widely available
may be required by the State, territory, ‘‘Qualified person’’ includes (A) a over the coming months, health care
locality, or Tribal area in which they are licensed health professional or other system capacity and the vaccination
prescribing, dispensing, or workforce are likely to become
1 This requirement is satisfied by, among other
administering COVID–19 vaccines; things, a certification in basic cardiopulmonary
increasingly strained throughout the
iv. The healthcare professionals and resuscitation by an online program that has Nation.
students must have documentation of an received accreditation from the American Nurses As qualified persons, these healthcare
observation period by a currently Credentialing Center, the ACPE, or the professionals and students in healthcare
practicing healthcare professional Accreditation Council for Continuing Medical profession training programs will be
Education. The phrase ‘‘current certificate in basic
experienced in administering cardiopulmonary resuscitation,’’ when used in the afforded liability protections in
intramuscular injections, and for whom September 3, 2020 or October 20, 2020 OASH accordance with the PREP Act and the
administering intramuscular injections authorizations, shall be interpreted the same way. terms of this amended Declaration.
is in their ordinary scope of practice, See Guidance for Licensed Pharmacists and Second, to the extent that any State law
Pharmacy Interns Regarding COVID–19 Vaccines
who confirms competency of the and Immunity under the PREP Act, OASH, Sept. 3,
that would otherwise prohibit the
healthcare provider or student in 2020, available at https://www.hhs.gov/guidance/ healthcare professionals and students in
preparation and administration of the sites/default/files/hhs-guidance-documents// healthcare profession training programs
COVID–19 vaccine(s) to be administered licensed-pharmacists-and-pharmacy-interns- who are a ‘‘qualified person’’ from
regarding-covid-19-vaccines-immunity.pdf (last
and, if applicable, such additional prescribing, dispensing, or
visited Jan. 24, 2021); Guidance for PREP Act

training as may be required by the State, Coverage for Qualified Pharmacy Technicians and administering COVID–19 vaccines or
territory, locality, or Tribal area in State-Authorized Pharmacy Interns for Childhood other Covered Countermeasures, such
which they are prescribing, dispensing, Vaccines, COVID–19 Vaccines, and COVID–19 law is preempted. On May 19, 2020, the
Testing, OASH, Oct. 20, 2020, available at https://
or administering COVID–19 vaccines; www.hhs.gov/guidance/sites/default/files/hhs-
Office of the General Counsel issued an
v. The healthcare professionals and guidance-documents//prep-act-guidance.pdf (last advisory opinion concluding that,
students must have a current certificate visited Jan. 24, 2021). because licensed pharmacists are
‘‘qualified persons’’ under this 3, 2020, and as amended on February 2, (b) Any person authorized to
declaration, the PREP Act preempts 2021, is further amended pursuant to prescribe, administer, or dispense the
state law that would otherwise prohibit section 319F–3(b)(4) of the PHS Act as Covered Countermeasures or who is
such pharmacists from ordering and described below. All other sections of otherwise authorized to perform an
administering authorized COVID–19 the Declaration remain in effect as activity under an Emergency Use
diagnostic tests.2 The opinion relied in republished at 85 FR 79190 (December Authorization in accordance with
part on the fact that the Congressional 9, 2020). Section 564 of the FD&C Act;
delegation of authority to the Secretary 1. Covered Persons, section V, delete (c) Any person authorized to
under the PREP Act to specify a class of in full and replace with: prescribe, administer, or dispense
persons, beyond those who are Covered Countermeasures in accordance
V. Covered Persons
authorized to administer a covered with Section 564A of the FD&C Act;
countermeasure under State law, as 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (d) A State-licensed pharmacist who
‘‘qualified persons’’ would be rendered (8)(A) and (B) orders and administers, and pharmacy
a nullity in the absence of such Covered Persons who are afforded interns who administer (if the pharmacy
liability immunity under this intern acts under the supervision of
preemption. This opinion is
Declaration are ‘‘manufacturers,’’ such pharmacist and the pharmacy
incorporated by reference into this
‘‘distributors,’’ ‘‘program planners,’’ intern is licensed or registered by his or
declaration. Based on the reasoning set
‘‘qualified persons,’’ and their officials, her State board of pharmacy),5 (1)
forth in the May 19, 2020 advisory
agents, and employees, as those terms vaccines that the Advisory Committee
opinion, any State law that would
are defined in the PREP Act, and the on Immunization Practices (ACIP)
otherwise prohibit a member of any of
United States. ‘‘Order’’ as used herein recommends to persons ages three
the classes of ‘‘qualified persons’’
and in guidance issued by the Office of through 18 according to ACIP’s standard
specified in this declaration from
the Assistant Secretary for Health 3 immunization schedule or (2) FDA
administering a covered countermeasure
means a provider medication order, authorized or FDA licensed COVID–19
is likewise preempted. In accordance
which includes prescribing of vaccines, vaccines to persons ages three or older.
with section 319F–3(i)(8)(A) of the
or a laboratory order, which includes Such State-licensed pharmacists and the
Public Health Service Act, a State
prescribing laboratory orders, if State-licensed or registered interns
remains free to expand the universe of
required. In addition, I have determined under their supervision are qualified
individuals authorized to administer
that the following additional persons are persons only if the following
covered countermeasures within its
qualified persons: requirements are met:
jurisdiction under State law. (a) Any person authorized in i. The vaccine must be authorized,
The plain language of the PREP Act accordance with the public health and approved, or licensed by the FDA;
makes clear that there is preemption of medical emergency response of the ii. In the case of a COVID–19 vaccine,
state law as described above. Authority Having Jurisdiction, as the vaccination must be ordered and
Furthermore, preemption of State law is described in Section VII below, to administered according to ACIP’s
justified to respond to the nation-wide prescribe, administer, deliver, distribute COVID–19 vaccine recommendation(s);
public health emergency caused by or dispense the Covered
COVID–19 as it will enable States to Countermeasures, and their officials, www.hhs.gov/guidance/sites/default/files/hhs-
quickly expand the vaccination agents, employees, contractors and guidance-documents//licensed-pharmacists-and-
workforce with additional qualified volunteers, following a Declaration of an
pharmacy-interns-regarding-covid-19-vaccines-
healthcare professionals where State or immunity.pdf (last visited Jan. 24, 2021); Guidance
Emergency, as that term is defined in for PREP Act Coverage for Qualified Pharmacy
local requirements might otherwise Section VII of this Declaration; 4 Technicians and State-Authorized Pharmacy
inhibit or delay allowing these Interns for Childhood Vaccines, COVID–19
healthcare professionals to participate 3 See Guidance for Licensed Pharmacists, COVID–
Vaccines, and COVID–19 Testing, OASH, Oct. 20,
2020, available at https://www.hhs.gov/guidance/
in the COVID–19 vaccination program. 19 Testing, and Immunity Under the PREP Act, sites/default/files/hhs-guidance-documents//prep-
OASH, Apr. 8, 2020, available at https:// act-guidance.pdf (last visited Jan. 24, 2021); PREP
Amendments to Declaration www.hhs.gov/guidance/sites/default/files/hhs- Act Authorization for Pharmacies Distributing and
guidance-documents//authorizing-licensed-
Amended Declaration for Public pharmacists-to-order-and-administer-covid-19-
Administering Certain Covered Countermeasures,
Readiness and Emergency Preparedness Oct. 29, 2020, available at https://www.hhs.gov/
tests.pdf (last visited Jan. 24, 2021); Guidance for guidance/sites/default/files/hhs-guidance-
Act Coverage for medical Licensed Pharmacists and Pharmacy Interns documents//prep-act-authorization-pharmacies-
countermeasures against COVID–19. Regarding COVID–19 Vaccines and Immunity under administering-covered-countermeasures.pdf (last
the PREP Act, OASH, Sept. 3, 2020, available at visited Jan. 24, 2021) (collectively, OASH PREP Act
Section V of the March 10, 2020 https://www.hhs.gov/guidance/sites/default/files/ Authorizations). Nothing herein shall suggest that,
Declaration under the PREP Act for hhs-guidance-documents//licensed-pharmacists- for purposes of the Declaration, the foregoing are
medical countermeasures against and-pharmacy-interns-regarding-covid-19-vaccines- the only persons authorized in accordance with the
COVID–19, as amended April 10, 2020, immunity.pdf (last visited Jan. 24, 2021). public health and medical emergency response of
4 See, e.g., Guidance for Licensed Pharmacists,
June 4, 2020, August 19, 2020, as the Authority Having Jurisdiction.
COVID–19 Testing, and Immunity Under the PREP 5 Some states do not require pharmacy interns to
amended and republished on December Act, OASH, Apr. 8, 2020, available at https:// be licensed or registered by the state board of
www.hhs.gov/guidance/sites/default/files/hhs- pharmacy. As used herein, ‘‘State-licensed or
2 Department of Health and Human Services guidance-documents//authorizing-licensed- registered intern’’ (or equivalent phrases) refers to
General Counsel Advisory Opinion on the Public pharmacists-to-order-and-administer-covid-19- pharmacy interns authorized by the state or board
Readiness and Emergency Preparedness Act, May tests.pdf (last visited Jan. 24, 2021); Guidance for of pharmacy in the state in which the practical
19, 2020, available at: https://www.hhs.gov/ PREP Act Coverage for COVID–19 Screening Tests pharmacy internship occurs. The authorization can,
guidance/sites/default/files/hhs-guidance- at Nursing Homes, Assisted-Living Facilities, Long- but need not, take the form of a license from, or
documents/prep-act-advisory-opinion-hhs-ogc.pdf/ Term-Care Facilities, and other Congregate registration with, the State board of pharmacy. See
(last visited Jan. 24, 2021). See also, Department of Facilities, OASH, Aug. 31, 2020, available at Guidance for PREP Act Coverage for Qualified
Justice Office of Legal Counsel Advisory Opinion https://www.hhs.gov/guidance/sites/default/files/ Pharmacy Technicians and State-Authorized
for Robert P. Charrow, General Counsel of the hhs-guidance-documents/prep-act-coverage-for- Pharmacy Interns for Childhood Vaccines, COVID–
Department of Health and Human Services, January screening-in-congregate-settings.pdf (last visited 19 Vaccines, and COVID–19 Testing, OASH, Oct.
12, 2021, available at: https://www.justice.gov/sites/ Jan. 24, 2021); Guidance for Licensed Pharmacists 20, 2020 at 2, available at https://www.hhs.gov/
default/files/opinions/attachments/2021/01/19/ and Pharmacy Interns Regarding COVID–19 guidance/sites/default/files/hhs-guidance-
2021-01-19-prep-act-preemption.pdf (last visited Vaccines and Immunity under the PREP Act, documents//prep-act-guidance.pdf (last visited Jan.
Jan. 24, 2021). OASH, Sept. 3, 2020, available at https:// 24, 2021).
iii. In the case of a childhood vaccine, provider when available, submitting the prescribes, dispenses, or administers
the vaccination must be ordered and required immunization information to COVID–19 vaccines that are Covered
administered according to ACIP’s the State or local immunization Countermeasures under section VI of
standard immunization schedule; information system (vaccine registry), this Declaration in any jurisdiction
iv. The licensed pharmacist must complying with requirements with where the PREP Act applies, other than
have completed the immunization respect to reporting adverse events, and the State in which the license or
training that the licensing State requires complying with requirements whereby certification is held, in association with
for pharmacists to order and administer the person administering a vaccine must a COVID–19 vaccination effort by a
vaccines. If the State does not specify review the vaccine registry or other federal, State, local Tribal or territorial
training requirements for the licensed vaccination records prior to authority or by an institution in the
pharmacist to order and administer administering a vaccine; State in which the COVID–19 vaccine
vaccines, the licensed pharmacist must ix. The licensed pharmacist must covered countermeasure is
complete a vaccination training program inform his or her childhood-vaccination administered, so long as the license or
of at least 20 hours that is approved by patients and the adult caregiver certification of the healthcare
the Accreditation Council for Pharmacy accompanying the child of the professional has not been suspended or
Education (ACPE) to order and importance of a well-child visit with a restricted by any licensing authority,
administer vaccines. Such a training pediatrician or other licensed primary surrendered while under suspension,
program must include hands on care provider and refer patients as discipline or investigation by a licensing
injection technique, clinical evaluation appropriate; and authority or surrendered following an
of indications and contraindications of x. The licensed pharmacist and the arrest, and the individual is not on the
vaccines, and the recognition and licensed or registered pharmacy intern List of Excluded Individuals/Entities
treatment of emergency reactions to must comply with any applicable maintained by the Office of Inspector
vaccines; requirements (or conditions of use) as General, subject to: (i) Documentation of
v. The licensed or registered set forth in the Centers for Disease completion of the Centers for Disease
pharmacy intern must complete a Control and Prevention (CDC) COVID– Control and Prevention COVID–19
practical training program that is 19 vaccination provider agreement and (CDC) Vaccine Training Modules 8 and,
approved by the ACPE. This training any other federal requirements that for healthcare providers who are not
program must include hands-on apply to the administration of COVID– currently practicing, documentation of
injection technique, clinical evaluation 19 vaccine(s). an observation period by a currently
of indications and contraindications of (e) Healthcare personnel using practicing healthcare professional
vaccines, and the recognition and telehealth to order or administer experienced in administering
treatment of emergency reactions to Covered Countermeasures for patients intramuscular injections, and for whom
vaccines; in a state other than the state where the administering intramuscular injections
vi. The licensed pharmacist and healthcare personnel are licensed or is in their ordinary scope of practice,
licensed or registered pharmacy intern otherwise permitted to practice. When who confirms competency of the
must have a current certificate in basic ordering and administering Covered healthcare provider in preparation and
cardiopulmonary resuscitation; 6 Countermeasures by means of telehealth administration of the COVID–19
vii. The licensed pharmacist must to patients in a state where the vaccine(s) to be administered;
complete a minimum of two hours of healthcare personnel are not already (g) Any member of a uniformed
ACPE-approved, immunization-related permitted to practice, the healthcare service (including members of the
continuing pharmacy education during personnel must comply with all National Guard in a Title 32 duty status)
each State licensing period; requirements for ordering and (hereafter in this paragraph ‘‘service
viii. The licensed pharmacist must administering Covered Countermeasures member’’) or Federal government,
comply with recordkeeping and to patients by means of telehealth in the employee, contractor, or volunteer who
reporting requirements of the state where the healthcare personnel are prescribes, administers, delivers,
jurisdiction in which he or she permitted to practice. Any state law that distributes or dispenses a Covered
administers vaccines, including prohibits or effectively prohibits such a Countermeasure. Such Federal
informing the patient’s primary-care qualified person from ordering and government service members,
6 This requirement is satisfied by, among other
administering Covered Countermeasures employees, contractors, or volunteers
things, a certification in basic cardiopulmonary
by means of telehealth is preempted.7 are qualified persons if the following
resuscitation by an online program that has Nothing in this Declaration shall requirement is met: the executive
received accreditation from the American Nurses preempt state laws that permit department or agency by or for which
Credentialing Center, the ACPE, or the additional persons to deliver telehealth
Accreditation Council for Continuing Medical
the Federal service member, employee,
Education. The phrase ‘‘current certificate in basic services; contractor, or volunteer is employed,
cardiopulmonary resuscitation,’’ when used in the (f) Any healthcare professional or contracts, or volunteers has authorized
September 3, 2020 or October 20, 2020 OASH other individual who holds an active or could authorize that service member,
authorizations, shall be interpreted the same way. license or certification permitting the
See Guidance for Licensed Pharmacists and
employee, contractor, or volunteer to
Pharmacy Interns Regarding COVID–19 Vaccines
person to prescribe, dispense, or prescribe, administer, deliver,
and Immunity under the PREP Act, OASH, Sept. 3, administer vaccines under the law of distribute, or dispense the Covered
2020, available at https://www.hhs.gov/guidance/ any State as of the effective date of this Countermeasure as any part of the
sites/default/files/hhs-guidance-documents// amendment, or as authorized under the
licensed-pharmacists-and-pharmacy-interns- duties or responsibilities of that service
regarding-covid-19-vaccines-immunity.pdf (last section V(d) of this Declaration, who member, employee, contractor, or
visited Jan. 24, 2021); Guidance for PREP Act volunteer, even if those authorized
Coverage for Qualified Pharmacy Technicians and 7 See, e.g., Advisory Opinion 20–02 on the Public
duties or responsibilities ordinarily
State-Authorized Pharmacy Interns for Childhood Readiness and Emergency Preparedness Act and the
Vaccines, COVID–19 Vaccines, and COVID–19 Secretary’s Declaration under the Act, May 19, would not extend to members of the
Testing, OASH, Oct. 20, 2020, available at https:// 2020, available at https://www.hhs.gov/guidance/
www.hhs.gov/guidance/sites/default/files/hhs- sites/default/files/hhs-guidance-documents/ 8 See COVID–19 Vaccine Training Modules,
guidance-documents//prep-act-guidance.pdf (last advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last available at https://www.cdc.gov/vaccines/covid-19/

visited Jan. 24, 2021). visited Jan. 24, 2021). training.html.
public or otherwise would be more currently practicing healthcare vi. The healthcare professionals and
limited in scope than the activities such professional experienced in students must comply with
service member, employees, contractors, administering intramuscular injections recordkeeping and reporting
or volunteers are authorized to carry out who administers COVID–19 vaccines requirements of the jurisdiction in
under this declaration; and that are Covered Countermeasures which he or she administers vaccines,
(h) The following healthcare under section VI of this Declaration in including informing the patient’s
professionals and students in a any jurisdiction where the PREP Act primary-care provider when available,
healthcare profession training program applies in association with a COVID–19 submitting the required immunization
subject to the requirements of this vaccination effort by a State, local, information to the State or local
paragraph: Tribal or territorial authority or by an immunization information system
1. Any midwife, paramedic, advanced institution in which the COVID–19 (vaccine registry), complying with
or intermediate emergency medical vaccine covered countermeasure is requirements with respect to reporting
technician (EMT), physician assistant, administered; adverse events, and complying with
respiratory therapist, dentist, podiatrist, Subject to the following requirements: requirements whereby the person
optometrist or veterinarian licensed or i. The vaccine must be authorized, administering a vaccine must review the
certified to practice under the law of approved, or licensed by the FDA; vaccine registry or other vaccination
any state who prescribes, dispenses, or ii. Vaccination must be ordered and records prior to administering a vaccine;
administers COVID–19 vaccines that are administered according to ACIP’s and
Covered Countermeasures under section COVID–19 vaccine recommendation(s); vii. The healthcare professionals and
VI of this Declaration in any jurisdiction iii. The healthcare professionals and students comply with any applicable
where the PREP Act applies in students must have documentation of requirements (or conditions of use) as
association with a COVID–19 completion of the Centers for Disease set forth in the Centers for Disease
vaccination effort by a State, local, Control and Prevention COVID–19 Control and Prevention (CDC) COVID–
Tribal or territorial authority or by an Vaccine Training Modules and, if 19 vaccination provider agreement and
institution in which the COVID–19 applicable, such additional training as any other federal requirements that
vaccine covered countermeasure is may be required by the State, territory, apply to the administration of COVID–
administered; locality, or Tribal area in which they are 19 vaccine(s).
2. Any physician, advanced practice prescribing, dispensing, or Nothing in this Declaration shall be
registered nurse, registered nurse, administering COVID–19 vaccines; construed to affect the National Vaccine
practical nurse, pharmacist, pharmacy iv. The healthcare professionals and Injury Compensation Program,
intern, midwife, paramedic, advanced students must have documentation of an including an injured party’s ability to
or intermediate EMT, respiratory observation period by a currently obtain compensation under that
therapist, dentist, physician assistant, practicing healthcare professional program. Covered countermeasures that
podiatrist, optometrist, or veterinarian experienced in administering are subject to the National Vaccine
who has held an active license or intramuscular injections, and for whom Injury Compensation Program
certification under the law of any State administering vaccinations is in their authorized under 42 U.S.C. 300aa–10 et
within the last five years, which is ordinary scope of practice, who seq. are covered under this Declaration
inactive, expired or lapsed, who confirms competency of the healthcare for the purposes of liability immunity
prescribes, dispenses, or administers provider or student in preparation and and injury compensation only to the
COVID–19 vaccines that are Covered administration of the COVID–19 extent that injury compensation is not
Countermeasures under section VI of vaccine(s) to be administered and, if provided under that Program. All other
this Declaration in any jurisdiction applicable, such additional training as terms and conditions of the Declaration
where the PREP Act applies in may be required by the State, territory, apply to such covered countermeasures.
association with a COVID–19 locality, or Tribal area in which they are 2. Effective Time Period, section XII,
vaccination effort by a State, local, prescribing, dispensing, or delete in full and replace with:
Tribal or territorial authority or by an administering COVID–19 vaccines; Liability protections for any
institution in which the COVID–19 v. The healthcare professionals and respiratory protective device approved
vaccine covered countermeasure is students must have a current certificate by NIOSH under 42 CFR part 84, or any
administered, so long as the license or in basic cardiopulmonary successor regulations, through the
certification was active and in good resuscitation; 9 means of distribution identified in
standing prior to the date it went
Section VII(a) of this Declaration, begin
inactive, expired or lapsed and was not 9 This requirement is satisfied by, among other
on March 27, 2020 and extend through
revoked by the licensing authority, things, a certification in basic cardiopulmonary
resuscitation by an online program that has October l, 2024.
surrendered while under suspension, Liability protections for all other
received accreditation from the American Nurses
discipline or investigation by a licensing Credentialing Center, the ACPE, or the Covered Countermeasures identified in
authority or surrendered following an Accreditation Council for Continuing Medical Section VI of this Declaration, through
arrest, and the individual is not on the Education. The phrase ‘‘current certificate in basic
means of distribution identified in
List of Excluded Individuals/Entities cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH Section VII(a) of this Declaration, begin
maintained by the Office of Inspector authorizations, shall be interpreted the same way. on February 4, 2020 and extend through
General; See Guidance for Licensed Pharmacists and October l, 2024.
3. Any medical, nursing, pharmacy, Pharmacy Interns Regarding COVID–19 Vaccines
Liability protections for all Covered
pharmacy intern, midwife, paramedic, and Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/ Countermeasures administered and
advanced or intermediate EMT,
sites/default/files/hhs-guidance-documents// used in accordance with the public

physician assistant, respiratory therapy, licensed-pharmacists-and-pharmacy-interns- health and medical response of the
dental, podiatry, optometry or regarding-covid-19-vaccines-immunity.pdf (last
Authority Having Jurisdiction, as
veterinary student with appropriate visited Jan. 24, 2021); Guidance for PREP Act
Coverage for Qualified Pharmacy Technicians and
training in administering vaccines as State-Authorized Pharmacy Interns for Childhood www.hhs.gov/guidance/sites/default/files/hhs-
determined by his or her school or Vaccines, COVID–19 Vaccines, and COVID–19 guidance-documents//prep-act-guidance.pdf (last
training program and supervision by a Testing, OASH, Oct. 20, 2020, available at https:// visited Jan. 24, 2021).
identified in Section VII(b) of this evaluation of individual intramural burden (i.e., the time, effort, and
Declaration, begin with a Declaration of programs and projects conducted by the resources used by the respondents to
Emergency as that term is defined in NATIONAL INSTITUTE OF DENTAL & respond), the estimated cost to the
Section VII (except that, with respect to CRANIOFACIAL RESEARCH, including respondent, and the actual information
qualified persons who order or consideration of personnel collection instruments.
administer a routine childhood qualifications and performance, and the DATES: Comments are encouraged and
vaccination that ACIP recommends to competence of individual investigators, will be accepted for 60 days until May
persons ages three through 18 according the disclosure of which would 17, 2021.
to ACIP’s standard immunization constitute a clearly unwarranted
schedule, liability protections began on ADDRESSES: All submissions received
invasion of personal privacy.
August 24, 2020), and last through (a) must include the OMB Control Number
Name of Committee: Board of Scientific 1615–0046 in the body of the letter, the
the final day the Declaration of Counselors, National Institute of Dental and
Emergency is in effect, or (b) October l, agency name and Docket ID USCIS–
Craniofacial Research.
2024, whichever occurs first. Date: May 18–19, 2021. 2006–0062. Submit comments via the
Liability protections for all Covered Time: 9:00 a.m. to 4:15 p.m. Federal eRulemaking Portal website at
Countermeasures identified in Section Agenda: To review and evaluate personnel https://www.regulations.gov under e-
VII(c) of this Declaration begin on qualifications and performance, and Docket ID number USCIS–2006–0062.
December 9, 2020 and last through (a) competence of individual investigators. USCIS is limiting communications for
Place: National Institutes of Health, 6701 this Notice as a result of USCIS’ COVID–
the final day the Declaration of
Democracy Blvd., Bethesda, MD 20892 19 response actions.
Emergency is in effect, or (b) October l, (Virtual Meeting).
2024, whichever occurs first. Contact Person: Alicia J. Dombroski, Ph.D., FOR FURTHER INFORMATION CONTACT:
Liability protections for Qualified Director, Division of Extramural Activities, USCIS, Office of Policy and Strategy,
Persons under section V(f) of the Natl Inst of Dental and Craniofacial Research, Regulatory Coordination Division,
declaration begin on February 2, 2021, National Institutes of Health, Bethesda, MD Samantha Deshommes, Chief, telephone
and last through October 1, 2024. 20892. number (240) 721–3000 (This is not a
Liability protections for Qualified (Catalogue of Federal Domestic Assistance toll-free number. Comments are not
Persons under section V(g) of the Program No. 93.121, Oral Diseases and accepted via telephone message). Please
declaration begin on February 16, 2021, Disorders Research, National Institutes of
Health, HHS) note contact information provided here
and last through October 1, 2024. is solely for questions regarding this
Liability protections for Qualified Dated: March 10, 2021. notice. It is not for individual case
Persons who are physicians, advanced Melanie J. Pantoja, status inquiries. Applicants seeking
practice registered nurses, registered Program Analyst, Office of Federal Advisory information about the status of their
nurses, or practical nurses under section Committee Policy. individual cases can check Case Status
V(h) of the declaration begins on [FR Doc. 2021–05351 Filed 3–15–21; 8:45 am] Online, available at the USCIS website
February 2, 2021 and last through BILLING CODE 4140–01–P at https://www.uscis.gov, or call the
October 1, 2024, with additional USCIS Contact Center at 800–375–5283
conditions effective as of March 11, (TTY 800–767–1833).
2021 and liability protections for all DEPARTMENT OF HOMELAND
other Qualified persons under section SUPPLEMENTARY INFORMATION:
SECURITY
V(h) begins on March 11, 2021 and last Comments
through October 1, 2024. U.S. Citizenship and Immigration You may access the information
Authority: 42 U.S.C. 247d–6d. Services collection instrument with instructions
Norris Cochran, [OMB Control Number 1615–0046] or additional information by visiting the
Acting Secretary, Department of Health and Federal eRulemaking Portal site at:
Human Services. Agency Information Collection https://www.regulations.gov and
[FR Doc. 2021–05401 Filed 3–11–21; 4:15 pm]
Activities; Extension, Without Change, entering USCIS–2006–0062 in the
of a Currently Approved Collection: search box. All submissions will be
BILLING CODE 4150–37–P
Interagency Alien Witness and posted, without change, to the Federal
Informant Record eRulemaking Portal at https://
DEPARTMENT OF HEALTH AND AGENCY: U.S. Citizenship and www.regulations.gov, and will include
HUMAN SERVICES Immigration Services, Department of any personal information you provide.
Homeland Security. Therefore, submitting this information
National Institutes of Health makes it public. You may wish to
ACTION: 60-day notice.
consider limiting the amount of
National Institute of Dental & SUMMARY: The Department of Homeland personal information that you provide
Craniofacial Research; Notice of Security (DHS), U.S. Citizenship and in any voluntary submission you make
Closed Meeting Immigration Services (USCIS) invites to DHS. DHS may withhold information
Pursuant to section 10(d) of the the general public and other Federal provided in comments from public
Federal Advisory Committee Act, as agencies to comment upon this viewing that it determines may impact
amended, notice is hereby given of a proposed extension of a currently the privacy of an individual or is
meeting of the Board of Scientific approved collection of information. In offensive. For additional information,
Counselors, National Institute of Dental accordance with the Paperwork please read the Privacy Act notice that
and Craniofacial Research. Reduction Act (PRA) of 1995, the is available via the link in the footer of
The meeting will be closed to the information collection notice is https://www.regulations.gov.
public as indicated below in accordance published in the Federal Register to Written comments and suggestions
with the provisions set forth in section obtain comments regarding the nature of from the public and affected agencies
552b(c)(6), Title 5 U.S.C., as amended the information collection, the should address one or more of the
for the review, discussion, and categories of respondents, the estimated following four points:
7/30/2021 https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx
Preparedness Emergency About ASPR
Search...
PHE Home > Emergency > News & Multimedia > Public Health Actions > PHE > Renewal of
Determination That A Public Health Emergency Exists
Renewal of Determination That A Public Health More Emergency and

Response Information
Emergency Exists Declarations of a Public
Health Emergency
As a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after Public Health Emergency
consultation with public health officials as necessary, I, Xavier Becerra, Secretary of Health and Human Services, pursuant to Determinations to Support an
the authority vested in me under section 319 of the Public Health Service Act, do hereby renew, effective July 20, 2021, the Emergency Use Authorization
January 31, 2020, determination by former Secretary Alex M. Azar II, that he previously renewed on April 21, 2020, July 23, Section 1135 Waivers
2020, October 2, 2020, and January 7, 2021, and that I renewed on April 15, 2021, that a public health emergency exists and Emergency Use
has existed since January 27, 2020, nationwide. Authorizations
July 19, 2021

/s/
_____________________________ _____________________________
Date Xavier Becerra
This page last reviewed: July 19, 2021
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HealthCare.gov in Other Languages
Exhibit "7"
https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx 1/1
From: Avery Garfield
To: [email protected]
Subject: Fwd: Sent on behalf of Dr. Sauls – EMERGENT COMMUNICATION
Date: Sunday, August 1, 2021 2:35:16 PM
Attachments: image001.jpg
image002.png
Hello Mr. Newman,
These next few emails are from my school email. This is the first email sent to us from the
school of nursing.
-Avery Garfield
Get Outlook for iOS
From: Yvonne M. Creighton <[email protected]>

Sent: Monday, July 19, 2021 5:18 PM
To:
Avery Garfield;
Cc: Mary Hubbard; Karin Randolph; Rene Jacobs

Subject: Sent on behalf of Dr. Sauls – EMERGENT COMMUNICATION
Dear MTSU Nursing Student:
As the pandemic continues, we adjust our requirements based on CDC recommendations and clinical facility
mandates. That being stated, for your safety and that of your patients, your faculty, your family, and those whom
you come in contact, I ask that you continue to comply with all regulations and guidelines established by the
university regarding COVID-19. (https://www.mtsu.edu/coronavirus/).
We have received notice from one of our clinical facilities mandating vaccines for all students, NO EXCEPTIONS.
It has been a long-time policy that we follow the requirements mandated by the facility that has the most stringent
requirements. That means all Nursing students must be vaccinated prior to the beginning of the fall semester, 2021.
Because we must have time to enter data as required by the facility in advance of clinical rotations, you must have
proof of vaccination (vaccine card) uploaded into Medatrax no later than August 20, 2021.
In addition, the current plan is for the university to discontinue mask requirements in the classroom as well as social
distancing. I’m reminding you that if you become ill or have a known exposure, you MUST report to your faculty
and to Health Services for follow up on contact tracing, quarantine, and/or isolation. That also means you must not
attend class or clinical for the recommended period of quarantine/isolation. Just because you might not feel ill, that
doesn’t mean that you don’t have the capacity to make one of your vulnerable patients ill or someone in your family,
Exhibit "8"
and it could be deadly for them.

Please know that failure to comply with the university mandate regarding COVID-19 can result in suspension from
the university as quoted from the President’s email on September 20, 2020, “failure to cooperate with our health
officials, and/or failure to observe all the restrictions of quarantine and isolation, may be grounds for campus
disciplinary action, up to and including suspension”.

With appreciation for your compliance,

Dr. Sauls

Jenny
Jenny L. Sauls, PhD, MSN, RN, CNE
Professor and Director
School of Nursing
PO Box 81
Murfreesboro, TN 37132
Office: 615-904-8488
Email: [email protected]

Yvonne
Yvonne Creighton, MSN, FNP-c, PMHNP-BC (she/her/hers)
Assistant Professor, PMHNP Track Coordinator
School of Nursing
CKNB 233
PO Box 81, Murfreesboro, TN 37132
Office Phone: 615-904-8181

Subject: Fwd: COVID Vaccine Requirement Update
Attachments: image001.png
Get Outlook for iOS
From: Kim Floyd-Tune <[email protected]>

Sent: Wednesday, July 21, 2021 2:14:07 PM
Subject: FW: COVID Vaccine Requirement Update
Please see below from Dr. Sauls.
From: Jenny Sauls <[email protected]>

Sent: Wednesday, July 21, 2021 12:53 PM
To: Kim Floyd-Tune <[email protected]>; Yvonne M. Creighton
<[email protected]>; Richard C. Meeks <[email protected]>; Lisa Murphree
<[email protected]>; Brandi Lindsey <[email protected]>
Cc: Harold Whiteside <[email protected]>; Kimberly Edgar <[email protected]>;
Sondra Wade <[email protected]>; LJ Mcanly <[email protected]>
Subject: COVID Vaccine Requirement Update
Please send this email to all students. I appreciate you!
Sent on behalf of Dr. Sauls – COVID Vaccine Mandate Update
Dear MTSU Nursing Student:
Having heard from several of you or your parents about the COVID Vaccine mandate, it seems necessary to provide
an update. Let me be clear that this policy is not university or School of Nursing generated, nor is it relevant to
campus activities. This is a clinical issue that relates to compliance with our contractual agreements with our clinical
affiliates. There is no amount of statistics or data that will change this requirement as Vanderbilt has every legal
right to implement this requirement, and we must comply in order to maintain our partnership with them. I have
confirmed that NO EXCEPTIONS means exactly that, regardless of the reason. Again, not my rule.
If you choose not to be vaccinated, you will forfeit you right to attend clinical and progress in our program.
Vanderbilt provides clinical opportunities for every single one of our Nursing students. Our program cannot operate
without our partnership with them and the clinical placements they provide. While Vanderbilt is currently the only
facility that has mandated the vaccine requirement, I believe it is only a matter of time until other facilities follow
suit. And yes, whether you attend Vanderbilt this semester or in future semesters, you must be vaccinated now as the
requirement will not change, and eventually all students will attend clinical at Vanderbilt in one or more clinical
rotations.
If you have questions about the process, please reach out to your clinical course coordinator. I would ask that you
not send emails asking for an exemption for any reason because we cannot accommodate that request. No form of
discussion or debate will change this requirement.
Exhibit "9"
Thank you for your cooperation,

Dr. Sauls

Jenny
School of Nursing
PO Box 81
Office: 615-904-8488

Subject: Fwd: COVID Vaccine Mandate - Update
Attachments: image001.png
Get Outlook for iOS
From: Kim Floyd-Tune <[email protected]>

Sent: Tuesday, July 27, 2021 1:50:20 PM
Subject: FW: COVID Vaccine Mandate - Update
Please see below.
From: Jenny Sauls <[email protected]>

Sent: Tuesday, July 27, 2021 1:36 PM
To: Kim Floyd-Tune <[email protected]>
Cc: Yvonne M. Creighton <[email protected]>; Richard C. Meeks
<[email protected]>; Melissa Palicka <[email protected]>; Brandi Lindsey
<[email protected]>; Todd Vickrey <[email protected]>; Mary Hubbard
<[email protected]>; Karin Randolph <[email protected]>
Subject: COVID Vaccine Mandate - Update
Kim – please send to all students.
Sent on behalf of Dr. Sauls and Vanderbilt Student Placement Office
Dear Student,
Please do not contact anyone at Vanderbilt asking for an exception to the vaccine policy. See email
from Vanderbilt student placement below highlighted in yellow.
We have noticed that students are submitting exemption requests for the COVID-19 vaccine via
email to our colleagues at Vanderbilt University Equal Access. I’m not sure why this is happening,
but if you are able to communicate with your students/instructors not to do this that will be helpful.
Thank you so much.
Best,
Erin Crawford
Program Manager | Student Placement | Clinical Orientation
Nursing Education and Professional Development
Vanderbilt University Medical Center
3401 West End Avenue, Suite 790
Exhibit "10"
Nashville, TN 37203

Dr. Sauls
School of Nursing
PO Box 81
Office: 615-904-8488

of Medical Products and
Related Authorities
Guidance for Industry and Other Stakeholders
U.S. Department of Health and Human Services

Food and Drug Administration
Office of the Commissioner
Office of the Chief Scientist
Office of Counterterrorism and Emerging Threats
January 2017
Procedural
OMB Control No. 0910-0595
Expiration Date 08/31/2022
See additional PRA statement in section IX of this guidance.
Exhibit "11"
of Medical Products and
Related Authorities
Guidance for Industry and
Other Stakeholders
Additional copies are available from:

Office of the Chief Scientist, Office of the Commissioner
10903 New Hampshire Ave., Silver Spring, MD 20993
Tel: 301-796-8510; Fax: 301-847-8615; Email: [email protected]
http://www.fda.gov/medicalcountermeasures
U.S. Department of Health and Human Services

Office of the Commissioner
Office of the Chief Scientist
Procedural
ii
TABLE OF CONTENTS
I. INTRODUCTION ........................................................................................... 1
II. SCOPE OF GUIDANCE................................................................................. 2
III. EMERGENCY USE AUTHORIZATIONS ................................................... 4
A. EUA DECLARATION JUSTIFYING EMERGENCY USE ........................... 5

1. Determinations to Support an EUA Declaration ..................................... 5
2. Termination of an EUA Declaration ........................................................ 6
B. EUA MEDICAL PRODUCTS ......................................................................... 7

1. Criteria for Issuance ................................................................................. 7
2. Categories of Products ............................................................................. 9
C. PRE-EUA ACTIVITIES AND SUBMISSIONS.............................................. 9
D. REQUEST FOR AN EUA .............................................................................. 11

1. Preparedness and Response ................................................................... 11
2. Information Recommendations .............................................................. 11
3. Format of Submissions .......................................................................... 16
4. FDA Processing of an EUA Request ..................................................... 18
E. CONDITIONS OF AUTHORIZATION ........................................................ 22

1. Information Relating to the EUA Product ............................................. 22
2. Monitoring and Reporting of Adverse Events ....................................... 25
3. Records .................................................................................................. 26
4. Additional Conditions of Authorization ................................................ 26
5. Waivers or Limitations of Compliance With Other Requirements ....... 27
F. CATEGORIZATION OF LABORATORY TESTS UNDER AN EUA ....... 28
G. DURATION AND REVISION OF AN EUA ................................................ 28

1. Revision and Revocation ....................................................................... 29
2. Product Disposition and Continued Use ................................................ 29
H. PUBLICATION .............................................................................................. 29
I. OPTION TO CARRY OUT AUTHORIZED ACTIVITIES .......................... 30
IV. EMERGENCY USE OF ELIGIBLE FDA-APPROVED MCMs WITHOUT

AN EUA ........................................................................................................ 30
A. ELIGIBLE PRODUCTS ................................................................................. 31
iii
B. EXPIRATION DATE EXTENSIONS WITHOUT AN EUA........................ 31
1. In General............................................................................................... 33
2. Procedures for Request and Issuance ..................................................... 33
D. EMERGENCY DISPENSING WITHOUT AN EUA .................................... 34

1. Procedures for Issuing Emergency Dispensing Orders ......................... 35
2. Scope and Conditions of Emergency Dispensing Orders ...................... 37
3. Duration of an Emergency Dispensing Order ........................................ 37
E. EMERGENCY USE INSTRUCTIONS WITHOUT AN EUA...................... 38
V. GOVERNMENTAL PRE-POSITIONING OF MCMs ................................ 38
VI. PREEMPTION .............................................................................................. 39
VII. LIABILITY PROTECTION ......................................................................... 41
VIII. IMPORTING AND EXPORTING MEDICAL PRODUCTS UNDER AN

EUA ............................................................................................................... 42
IX. PAPERWORK REDUCTION ACT OF 1995 .............................................. 43
List of Acronyms .............................................................................................................. 44
Appendix A. EUA Conditions of Authorization: Required vs. Discretionary ................ 45
iv
Contains Nonbinding Recommendations
Emergency Use Authorization of Medical Products

and Related Authorities 1
Guidance for Industry and Other Stakeholders
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 office
responsible for this guidance as listed on the title page.
I. INTRODUCTION
This guidance explains FDA's general recommendations and procedures applicable to the
authorization of the emergency use of certain medical products under sections 564, 564A, and
564B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 2 as amended or added by the
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) 3. The
provisions in PAHPRA, described in section II of this guidance, include key legal authorities to
sustain and strengthen national preparedness for public health, military, and domestic
emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including
emerging infectious disease threats such as pandemic influenza. PAHPRA clarifies and
enhances FDA’s authority to support emergency preparedness and response and foster the
1
This guidance was prepared by the Office of Counterterrorism and Emerging Threats (OCET) in
cooperation with the Center for Biologics Evaluation and Research (CBER), Center for Devices and
Radiological Health (CDRH), and Center for Drug Evaluation and Research (CDER).
2
21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b. Section 564 was first added to the FD&C Act by the
Project BioShield Act of 2004 (Public Law 108-276). Hereafter in this document, statutory references (e.g.,
“section __”) are to the FD&C Act, except where otherwise indicated.
3
Public Law 113-5. Section 3088 of the 21st Century Cures Act, signed into law by the President on
December 13, 2016, amends sections 564, 564A, and 564B of the FD&C Act to add new authorities to: (1)
authorize emergency use of unapproved animal drugs, (2) make applicable other emergency use authorities
(e.g., to issue emergency dispensing orders, waive compliance with current good manufacturing practices
(CGMPs), make available Centers for Disease Control and Prevention (CDC) emergency use instructions,
and extend expiration dates) to approved animal drugs, and (3) allow unapproved animal drugs to be held
for emergency use. While much of what is described in this guidance will apply to these new authorities,
this guidance does not by its terms reference them; FDA asks anyone interested in utilizing these
authorities to contact FDA directly to discuss how to proceed. FDA plans to review these new authorities
and address any new procedural issues raised as we develop more experience with these new authorities.
1
development and availability of medical products for use in these emergencies. These medical
products, also referred to as “medical countermeasures” or “MCMs,” include drugs 4 (e.g.,
antivirals and antidotes), biological products (e.g., vaccines, blood products, and biological
therapeutics), and devices (e.g., in vitro diagnostics and personal protective equipment). This
guidance finalizes the draft guidance, Emergency Use Authorization of Medical Products and
Related Authorities (April 2016) and replaces the following two guidance documents, Emergency
Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions
and Answers (April 2009).
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. SCOPE OF GUIDANCE
This document is intended to inform all stakeholders 5 involved in emergency response activities
and FDA staff of FDA's general recommendations and procedures for:
(1) Issuance of Emergency Use Authorizations (EUAs) under section 564;
(2) Implementation of the emergency use authorities set forth in section 564A; and
(3) Reliance on the governmental pre-positioning authority set forth in section 564B."
4
Throughout this guidance references to “drugs” and “drug products” include both drugs approved under
the FD&C Act and biological products licensed under the Public Health Service (PHS) Act, but not
biological products that also meet the definition of a device in section 201(h) of the FD&C Act (21 U.S.C.
321(h)).
5
For purposes of this guidance, “stakeholders” include industry and government sponsors and other
government stakeholders/entities involved in emergency response activities (including Federal, State, local,
tribal, or territorial government stakeholders/entities). The term “government stakeholders” refers to the
public health and/or emergency response agencies or their agents/delegates that have legal responsibility
and authority for responding to an incident, based on political or geographical boundaries (e.g., city,
county, tribal, territorial, State, or Federal), or functional range or sphere of authority (e.g., law
enforcement, public health, military health) to prescribe, administer, deliver, distribute, hold, or dispense a
medical product during an emergency situation.
2
Section 564, as amended by PAHPRA, permits the Commissioner 6 to authorize the emergency
use of an unapproved medical product or an unapproved use of an approved 7 medical product for
certain emergency circumstances (discussed in section III.A of this guidance) after the HHS
Secretary has made a declaration of emergency or threat justifying authorization of emergency
use. The Commissioner may issue an EUA to allow an MCM to be used in an emergency to
diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a CBRN
agent when there are no adequate, approved, and available alternatives. Section III of this
guidance addresses EUAs.
Section 564A, as added by PAHPRA, establishes streamlined mechanisms to facilitate

preparedness and response activities involving certain FDA-approved MCMs without FDA
issuing an EUA, which can be a resource-intensive process. These authorities, and the definition
of eligible products to which they apply, are discussed in section IV of this guidance. These
authorities, which apply only to eligible FDA-approved medical products intended for use during
a CBRN emergency, include provisions that:
• Empower FDA to extend the expiration date of an eligible FDA-approved MCM

stockpiled for use in a CBRN emergency and to establish appropriate conditions
relating to such extensions, such as appropriate storage, sampling, and labeling;
• Permit FDA to waive otherwise-applicable current good manufacturing practice

(CGMP) requirements 8 (e.g., storage or handling) to accommodate emergency
response needs;
• Allow emergency dispensing of MCMs during an actual CBRN emergency event

without requiring an individual prescription for each recipient 9 of the MCM or all of
the information otherwise required or by responders who may not otherwise be
6
As provided in section 1003 and existing delegations of authority (found in the FDA Staff Manual Guide
1410.10), the Secretary of Health and Human Services (HHS Secretary or Secretary of HHS) has delegated
most of the authorities under sections 564, 564A, and 564B to the Commissioner of FDA (Commissioner).
Thus, this guidance refers to either FDA or the Commissioner rather than the HHS Secretary, except where
the HHS Secretary has traditionally exercised the authority or has delegated it to another official (e.g., the
authority to issue emergency use instructions pursuant to section 564A(e) was delegated to the Director of
the CDC).
7
Unless otherwise specified, the terms “approved product” and “FDA-approved product” refer to a product
that is approved, licensed, or cleared under section 505, 510(k), or 515 of the FD&C Act or section 351 of
the PHS Act, as applicable. For purposes of this document, an "unapproved" product refers to a product that
is not approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of the
FD&C Act or section 351 of the PHS Act; an "unapproved use of an approved product" refers to a product
that is approved, licensed, or cleared under such a provision but for which the specific use is not an
approved, licensed, or cleared use of the product. See section 564(a)(2).
8
As applied to medical devices, these are referred to as “Quality System Regulation” requirements. See 21
CFR 820.
9
For purposes of this guidance, the term "recipient(s)" refers to individual(s) to whom an MCM product is
administered or on whom the product is used.
3
licensed to dispense, if permitted by state law in the state where such dispensing
occurs or if in accordance with an order issued by FDA; and
• Permit the Centers for Disease Control and Prevention (CDC) to create and issue
“emergency use instructions” (EUI) concerning the FDA-approved conditions of use
for eligible products. 10
In addition, PAHPRA amended section 505-1(k) to authorize FDA to waive Risk Evaluation and
Mitigation Strategy (REMS) requirements for CBRN emergencies.
Finally, section 564B, also added by PAHPRA, permits government stakeholders to pre-position
(e.g., stockpile, forward-deploy) MCMs in anticipation of FDA approval or clearance,
authorization of an investigational use, or the issuance of an EUA, to enable these stakeholders
to prepare for potential rapid deployment during an actual CBRN emergency. This authority is
discussed in section V of this guidance.
III. EMERGENCY USE AUTHORIZATIONS
The EUA authority under section 564 allows FDA to facilitate availability and unapproved uses
of MCMs needed to prepare for and respond to CBRN emergencies. The EUA authority is
separate and distinct from use of a medical product under an investigational application (i.e.,
Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)),
section 561 expanded access authorities, 11 and section 564A emergency use authorities discussed
in section IV of this guidance.
10
U.S. Department of Health and Human Services, Delegation of Authority of section 564A(e) of the
Federal Food, Drug, and Cosmetic Act, December 16, 2013, see
http://www.fda.gov/downloads/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCM
LegalRegulatoryandPolicyFramework/UCM510446.pdf.
11
For general information on expanded access mechanisms, see
http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm.
4
A. EUA DECLARATION JUSTIFYING EMERGENCY USE
1. Determinations to Support an EUA Declaration
Before FDA may issue an EUA, the HHS Secretary must declare that circumstances exist
justifying the authorization (section 564(b)(1)). This declaration (referred to in this guidance as
an “EUA declaration”), 12 must be based on one of the following actions:
1. A determination by the Secretary of Homeland Security that there is a domestic

emergency, or a significant potential for a domestic emergency, involving a
heightened risk of attack with a CBRN agent(s); 13
2. A determination by the Secretary of Defense that there is a military emergency, or a

significant potential for a military emergency, involving a heightened risk to United
States military forces of attack with a CBRN agent(s); 14
3. A determination by the Secretary of HHS that there is a public health emergency, or a

significant potential for a public health emergency, that affects, or has a significant
potential to affect, national security or the health and security of United States
citizens living abroad, and that involves a CBRN agent or agents, or a disease or
condition that may be attributable to such agent(s); 15 or
12
The HHS declaration of emergency or threat of emergency is issued only for purposes of empowering the
FDA Commissioner to issue an EUA. It is distinct from, and is not dependent on, an HHS public health
emergency declaration under section 319 of the PHS Act, a Public Readiness and Emergency Preparedness
(PREP) Act declaration (discussed in section VII of this document), or any other type of emergency
declaration.
13
Section 564(b)(1)(A).
14
Section 564(b)(1)(B).
15
Section 564(b)(1)(C). Prior to the PAHPRA amendments, the Secretary would have made the
determination that there is a public health emergency under section 319 of the PHS Act. Under amended
section 564(b)(1)(C), the Secretary can make the emergency or threat of emergency determination that
includes any and all of the elements required by statute (e.g., that the emergency affects national security,
U.S. citizens living abroad, etc.) when making the declaration justifying the EUA under section
564(b)(1)(C). If there is an applicable section 319 public health emergency determination in place, the
Secretary may conclude that any additional elements required by the statute (e.g., that the emergency
affects national security, citizens living abroad, etc.) are met when issuing a declaration under section
564(b)(1).
5
4. The identification of a material threat, by the Secretary of Homeland Security

pursuant to section 319F-2 of the Public Health Service (PHS) Act, that is sufficient
to affect national security or the health and security of United States citizens living
abroad. 16
After the Secretary of HHS issues an EUA declaration based on one of these four determinations,
and after consulting (to the extent feasible and appropriate given the applicable circumstances)
with the Assistant Secretary for Preparedness and Response (ASPR), the Director of the National
Institutes of Health (NIH), and the Director of CDC, 17 the Commissioner may authorize the
emergency use of an unapproved product or an unapproved use of an approved product, provided
that other statutory criteria are met.
In appropriate circumstances, an HHS EUA declaration may support issuance of more than one
EUA. For example, based on an HHS EUA declaration that circumstances exist to justify the
authorization of emergency use of diagnostics for a specified biological agent, FDA may
authorize emergency use for multiple diagnostic tests to meet the need, provided that each EUA
meets the statutory criteria for issuance.
2. Termination of an EUA Declaration
When an EUA declaration is terminated, then any EUA(s) issued based on that declaration will
no longer remain in effect. 18 The HHS Secretary’s EUA declaration will terminate on 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 Homeland
Security or 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 (section 564(b)(2)). For
example, an EUA issued to allow an unapproved use of an approved product may no longer be
needed if that product is later approved by FDA for the use permitted by the EUA.
16
Section 564(b)(1)(D). We note that, while section 564(b)(1)(D) specifically refers to the identification of
a material threat "sufficient to affect national security or the health and security of United States citizens
living abroad," section 319F-2 of the PHS Act, 42 USC 274d-6b, refers only to a “material threat against
the United States population sufficient to affect national security," without specific reference to "the health
and security of United States citizens living abroad." Because Congress chose not to amend the latter
provision when it added the "material threat" provision to section 564, FDA concludes that a material threat
determination necessarily encompasses the health and security of U.S. citizens living abroad. And as such,
it would be an appropriate basis for a declaration. Thus, an EUA could be justified by a threat to the health
and security of U.S. citizens living abroad whether or not a particular material threat determination issued
pursuant to section 319F-2 expressly refers to the health and security of U.S. citizens living abroad.
17
Section 564(c).
18
As discussed in section III.G of this guidance, an EUA may also be revoked under certain conditions.
6
Before an EUA declaration terminates, the Secretary of HHS must provide advance notice that is
sufficient to allow for the disposition of an unapproved product, and of any labeling or other
information provided related to an unapproved use of an approved product (section 564(b)(3)). 19
B. EUA MEDICAL PRODUCTS
1. Criteria for Issuance
During the effective period of the HHS Secretary's EUA declaration, FDA may authorize the
introduction of a medical product into interstate commerce when the product is intended for use
during an actual or potential emergency. EUA candidate products include medical products and
uses that are not approved, cleared, or licensed under sections 505, 510(k), and 515 of the FD&C
Act or section 351 of the PHS Act.
After the requisite determination and declaration have been issued, and after feasible and
appropriate consultations, FDA may issue an EUA only if FDA concludes that the following four
statutory criteria for issuance have been met. If the product does not meet the statutory criteria
for issuance or is not otherwise an appropriate candidate, an alternative regulatory mechanism
(i.e., access under an IND or IDE, which can include expanded access protocols 20) may be an
appropriate means to provide patients access to an unapproved use of a product in a CBRN
emergency.
a. Serious or Life-Threatening Disease or Condition
For FDA to issue an EUA, the CBRN agent(s) referred to in the HHS Secretary’s EUA
declaration must be capable of causing a serious or life-threatening disease or condition.
b. Evidence of Effectiveness
Medical products that may be considered for an EUA are those that "may be effective" to
prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by
a CBRN agent(s) identified in the HHS Secretary’s declaration of emergency or threat of
emergency under section 564(b). Potential EUA products also include those that may be
effective to mitigate a disease or condition caused by an FDA-regulated product (including a
product authorized for emergency use under section 564 or an approved product) used to
diagnose, treat, or prevent a disease or condition caused by a CBRN agent.
19
The Secretary of HHS publishes in the Federal Register notice of each EUA declaration justifying
issuance of an EUA, with an explanation of the basis of the declaration under section 564(b)(1), as well as
any advance notice of termination of such a declaration.
20
For general information on expanded access mechanisms, see
http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm.
7
The "may be effective" standard for EUAs provides for a lower level of evidence than the
"effectiveness" standard that FDA uses for product approvals. 21 FDA intends to assess the
potential effectiveness of a possible EUA product on a case-by-case basis using a risk-benefit
analysis, as explained below. If, based on the totality of the scientific evidence available, it is
reasonable to believe that the product may be effective for the specified use, FDA may authorize
its emergency use, provided that other statutory criteria for issuing an EUA also are met.
c. Risk-Benefit Analysis
A product may be considered for an EUA if the Commissioner determines that the known and
potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or
condition, outweigh the known and potential risks of the product. In making this assessment,
FDA must take into consideration the material threat posed by the CBRN agent(s) identified in
the HHS Secretary’s declaration of emergency or threat of emergency if applicable (section
564(c)).
In determining whether the known and potential benefits of the product outweigh the known and
potential risks, FDA intends to look at the totality of the scientific evidence to make an overall
risk-benefit determination. Such evidence, which could arise from a variety of sources, may
include (but is not limited to): results of domestic and foreign clinical trials, in vivo efficacy data
from animal models, and in vitro data, available for FDA consideration. FDA will also assess
the quality and quantity of the available evidence, given the current state of scientific knowledge.
The types of evidence that FDA may consider and that should be submitted to support a request
for an EUA are discussed more fully in section III.D.2 of this guidance.
d. No Alternatives
For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the
candidate product for diagnosing, preventing, or treating the disease or condition. A potential
alternative product may be considered “unavailable” if there are insufficient supplies of the
approved alternative to fully meet the emergency need. A potential alternative product may be
considered "inadequate" if, for example, there are contraindicating data for special circumstances
or populations (e.g., children, immunocompromised individuals, or individuals with a drug
allergy), if a dosage form of an approved product is inappropriate for use in a special population
(e.g., a tablet for individuals who cannot swallow pills), or if the agent is or may be resistant to
approved and available alternative products.
21
Regulations regarding treatment INDs and IDEs also use the terminology “may be effective.” A request
for a treatment IND for a drug or biologic intended to treat an immediately life-threatening disease may be
granted when, among other things, there is evidence that the drug may be effective for its intended use in its
intended population (21 CFR 312.320(a)(3)(ii)). For devices, a treatment IDE may be withdrawn if FDA
determines that the available scientific evidence fails to provide a reasonable basis for concluding that the
device “may be effective for its intended population” (21 CFR 812. 36(d)(2)(iv)(A)). It should be noted
that FDA's decisions on requests for EUAs and treatment INDs and IDEs involve product-specific and
circumstance-dependent determinations of risks and benefits. FDA also notes that the amount, type, and
quality of evidence available to support an EUA may not always be the same as that required for expanded
access, IDEs, or humanitarian device exemptions under the FD&C Act and FDA regulations.
8
2. Categories of Products
MCMs that may be considered for an EUA include unapproved products as well as approved
products intended for unapproved uses. 22 Examples of "unapproved uses of approved products"
include:
• Use of an approved antibiotic as prophylaxis based on exposure to, or treatment of, a

disease caused by a bacterium (or class of bacteria) that is not included in the
indications and usage section of the approved labeling for the antibiotic;
• Substitution of a critical reagent of a cleared in vitro diagnostic (IVD) with another

reagent that has not been cleared for use with the device.
Submission of an IND or IDE is not required for potential EUA products, although FDA
anticipates that many unapproved products for which an EUA is requested will already be under
evaluation through such mechanisms. In fact, human data derived in the course of studies
conducted under an IND or IDE may help to support an FDA conclusion that the available
evidence is adequate to support an EUA consistent with the statutory criteria for issuance.
C. PRE-EUA ACTIVITIES AND SUBMISSIONS
Early engagement between an industry or government sponsor 23 and FDA about potential EUA
products will facilitate more complete EUA requests and enhance FDA’s ability to review and
ultimately grant the EUA as appropriate. FDA also recognizes that circumstances can change
rapidly, and planning for a potential emergency may unexpectedly transition to a response effort.
Therefore, FDA strongly encourages the sponsor of a product that might be considered for an
EUA, particularly one at an advanced stage of development, to contact the appropriate FDA
Center before submitting a formal request for an EUA. For purposes of this guidance, these
submissions and related interactions are referred to as “pre-EUA” activities.
FDA’s review of a pre-EUA submission is not an indication of FDA’s views on the product’s
potential to be used under an EUA, or that the sponsor has obtained or submitted all the
information necessary for FDA to review a formal request for consideration of an EUA. Pre-
EUA activities are not a substitute for sponsor efforts to develop the product toward approval,
including submission and, when appropriate, implementation of proposals for clinical trials
22
EUAs may be requested and issued to authorize prescribing for unapproved uses of approved products,
often referred to as “off-label” uses because, under emergency circumstances, licensed prescribers may not
be able to make the case-by-case individual patient prescribing decisions that occur within the practice of
medicine. CDC, for example, may act as the nation's doctor in recommending an unapproved use of an
approved product. In such cases, CDC may request that FDA issue an EUA to authorize such unapproved
use, often with the intended purpose of preserving liability protections afforded under the Public Readiness
and Emergency Preparedness (PREP) Act, described in section VI of this guidance.
23
For purposes of this guidance, the term "sponsor" is used when referring to the applicant, submitter, or
person requesting an EUA. If specifically referring to a government or industry sponsor only, then
"government" or "industry" is used as an adjective to describe the specific type of sponsor, e.g. government
sponsor or industry sponsor.
9
designed to determine whether the product is safe and effective for its intended use. In addition
to design and implementation of clinical trials for development efforts in non-emergency
settings, for some MCMs and for some emergency response plans, FDA encourages sponsors to
design and propose appropriately controlled clinical trials that could be conducted during the
emergency response either to run in parallel with an EUA or instead of an EUA.
Pre-EUA activities may include discussions with FDA about a potential EUA product. Such
discussions may occur prior to the submission of a formal request for consideration of an EUA or
issuance by the HHS Secretary of an EUA declaration. They may also include discussions about
the appropriate vehicle to use (e.g., IND or IDE, Master File, pre-EUA submission) for
submitting data on the product prior to submission of a formal request for consideration of an
EUA.
Generally, FDA recommends that a sponsor submitting data as part of "pre-EUA” activities
follow recommendations for submitting pre-IND, IND, and device pre-submissions to the
relevant medical product Center. 24 A "pre-EUA" submission is typically separate from other
developmental submissions on file with FDA; its existence does not imply that any specific set
of qualifications has been met but represents the initiation of a series of preliminary interactions
to discuss potential suitability for EUA consideration. In addition, FDA requests that the sponsor
follow the recommendations for the content of the submission outlined in section III.D.2 of this
guidance and for the format of the submission contained in section III.D.3 of this guidance.
As with requests for issuance of EUAs, FDA prioritizes its pre-EUA activities based on a variety
of factors. Many of these are discussed more fully in section III.D.4.a of this guidance.
Examples of additional factors FDA may take into account in prioritizing pre-EUA activities
may include: progress on product development targets or milestones; competing FDA
obligations or exigent circumstances (e.g., user fee deadlines, other Agency priorities); and
whether there is a significant likelihood that the product would be retained in or added to
government stockpiles if the product is authorized for use in an emergency. The extent of, and
timelines for, review of such submissions will be determined on a case-by-case basis and will
depend on the nature of the submission (e.g., whether an IND or IDE for the product already is
on file), the circumstances of the emergency, and the workload of the review staff.
24
For detailed information on meetings about product development with CDER and CBER, see FDA’s
guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants (Revision 1). In the
Federal Register of March 11, 2015 (80 FR 12822), FDA published a notice announcing the availability of
a draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
(Revision 2). The revised draft guidance updates the guidance for industry Formal Meetings Between the
FDA and Sponsors or Applicants (Revision 1) and, when finalized, will represent the Agency’s current
thinking on the topic. For detailed information on meetings about product development for a device,
including those that are regulated by CBER, see Requests for Feedback on Medical Device Submissions:
The Pre-Submission Program and Meetings with Food and Drug Administration Staff (February 2014) at
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UC
M311176.pdf.
10
D. REQUEST FOR AN EUA
1. Preparedness and Response
FDA can issue an EUA not only during an emergency to support a rapid public health response,
but also for significant potential of an emergency (e.g., in advance of an emergency) based on
the requisite EUA declaration by the HHS Secretary, to support preparedness planning. The
circumstances of a CBRN emergency may afford FDA or other stakeholders little time to
consider the statutory criteria and appropriate conditions to ensure safe and effective use of an
MCM when an event occurs. For instance, some CBRN events may require dispensing of
MCMs within just a few hours of identification or notification of an exposure. It may be
necessary to use other MCMs, such as IVDs, to identify the presence of a CBRN agent in an
individual. An EUA issued before an emergency could permit use of an MCM during an
emergency without the need for further authorization by FDA, assuming no new information
about the product or emergency requires amendment and/or reissuance of the EUA. Section 564
thus reflects the fact that some scenarios may support issuance of an EUA before an emergency
(including if the emergency is occurring in another country but not yet in the U.S.) to better
enable federal, state, local, tribal, and territorial governments to plan for such use during an
emergency.
Based on experience, FDA expects that many requests for an EUA will be submitted by
government sponsors (e.g., HHS or the Department of Defense (DoD)), although industry
sponsors may also submit such a request.
2. Information Recommendations
a. Summary of Recommended Information and/or Data
FDA recommends that a request for an EUA include a well-organized summary of the available
scientific evidence regarding the product's safety and effectiveness, risks (including an adverse
event profile) and benefits, and any available, approved alternatives to the product. The exact
type and amount of data needed to support an EUA may vary depending on the nature of the
declared emergency or threat of emergency and the nature of the candidate product. FDA may
seek additional data and information on a case-by-case basis to ensure that the statutory criteria
for issuance of an EUA are met. 25
FDA recommends that the following information be submitted in any request for an EUA:
• A description of the product and its intended use (e.g., identification of the serious or
life-threatening disease or condition for which the product may be effective; where,
when, and how the product is anticipated to be used; and/or the population(s) for
which the product may be used);
25
FDA recognizes that data and information available in support of a request for an EUA for preparedness
purposes and a request for an EUA during an emergency response may differ.
11
• A description of the product's FDA approval status (e.g., whether the product is
unapproved or whether it is approved but the EUA is for an unapproved use); whether
the product or intended use is under an investigational application (e.g., if an
IND/IDE is in effect or has been submitted; whether the product is approved in a
foreign country for either the proposed use or another use; information on the use of
the medical product by either a foreign country or an international organization (e.g.,
the World Health Organization (WHO));
• The need for the product, including identification of any approved alternative
product(s) and their availability and adequacy for the proposed use, and the unmet
need(s) the EUA would address;
• Available safety and effectiveness information for the product (discussed in more
detail below);
• A discussion of risks and benefits, including available information concerning the

threats posed by the CBRN agent(s) involved (discussed in more detail below within
this section);
• Information on chemistry (as applicable), manufacturing, and controls; a list of each

site where the product, if authorized, is or would be manufactured, and the current
CGMP status of the manufacturing site(s);
• Information about the quantity of finished product on hand and the surge capabilities
of the manufacturing site(s);
• Information comparable to an FDA-approved package insert or instructions for use;

drafts of the “Fact Sheets” to be furnished to health care professionals or authorized
dispensers 26 and recipients of the product, which typically are part of pre-EUA
discussions (see section III.E.1 of this guidance); and a discussion of the feasibility of
providing such information in an emergency;
26
It may be appropriate in certain emergency scenarios for responders (e.g., government personnel,
volunteers) to administer or dispense an MCM authorized for use under an EUA. These responders could
include individuals who are not licensed health care professionals or who are licensed health care
professionals yet would be acting outside of their State’s professional scope of practice by administering or
dispensing the MCM. Such responders are referred to in this guidance as “authorized dispensers.”
12
• If seeking an extension of a product’s labeled expiration date, any available

information in support of such an extension 27 (e.g., information on product stability
such as test results; prior and anticipated storage and handling conditions; the lots,
batches, or other units affected; any prior expiration date extensions; and for medical
devices, an explanation of labeled expiration date, such as whether the inclusion of
such information was based on a premarket requirement, requirements of another
regulatory body, or a business decision); and
• Any right of reference 28, as applicable.
b. Recommended Safety Information
(i) In General
The amount and type(s) of safety information that FDA recommends be submitted as part of a
request for an EUA will differ depending upon a number of factors, including whether the
product is approved for another indication and, in the case of an unapproved product, the
product's stage of development. FDA anticipates that, for some products, data from controlled
clinical trials will be available. For others, FDA expects to consider clinical experience from
other than a controlled trial if the circumstances warrant. In addition, for some devices (e.g.,
IVDs), if clinical data are not available, FDA may consider accepting data solely from bench
testing, if the circumstances warrant. FDA expects to interpret safety information in light of the
seriousness of the clinical condition, alternative diagnostics, prophylaxis, or alternative therapies
(if any), and the specific circumstances of the emergency or threat of emergency. FDA
encourages any sponsor of a candidate product to have early discussions with FDA (even before
a determination of actual or potential emergency) about the nature and type of safety data that
might be appropriate to submit to FDA.
(ii) Unapproved Uses of Approved Products
If the new indication uses a similar dose, duration, route of administration, or mechanism of
action (as appropriate given the nature of the product), and the intended patient population is
27
Although FDA generally intends to address extensions of product expiration dates pursuant to section
564A(b) separately (see section IV.B of this guidance), there may be instances when an EUA candidate
product may be beyond or nearing its labeled expiration date during an emergency. For example, if FDA
issues an EUA for an approved product (i.e., to address unapproved use of that product), then the EUA may
include expiration date extension as part of the authorization (section 564(e)(2)(B)(i)). Thus, FDA
recommends that a request for an EUA for use, or anticipated use, of an approved product that is
approaching or beyond its labeled expiration date include any available information that may support an
extension of the product's expiration date (e.g., storage conditions, name of manufacturer, lot number(s),
labeled expiration date, etc.).
28
For purposes of this guidance, a “right of reference” means the authority to rely upon, and otherwise use,
data submitted from reports of an investigation or data previously submitted to FDA in support of an
application, including the ability to make available the underlying raw data for FDA audit, if necessary.
Sponsors who are not the owner of the submitted document(s)/data may need to seek written permission
demonstrating their right of reference.
13
similar, to that for which the product is approved, FDA recommends that the request for an EUA
reference the approved application, including right of reference as applicable. If the new use
poses a different risk to the patient population (e.g., suggesting the possibility of increased
toxicity), FDA recommends that information from relevant in vitro studies, animal toxicology
studies, and (if available) human clinical data and experience be provided to support such a use.
(iii) Unapproved Products
The range of available data for unapproved products will differ widely. FDA recommends that
any request for consideration for an EUA include available preclinical testing data, such as in
vitro and animal toxicology data. FDA also encourages that human safety information from
clinical trials and individual patient experience be provided, if available. Data submitted in the
request should attempt to link the likely exposure to the MCM to any relevant, existing
preclinical data. Similarly, when animal data are used, sufficient information should be provided
to link the results of these data to expected exposures to the MCMs related to the proposed use in
humans. Any information on safety associated with use in humans of this or related compounds
or devices of a similar design should also be submitted.
c. Recommended Effectiveness Information
FDA recognizes that comprehensive effectiveness data are unlikely to be available for every
EUA candidate product, and the information necessary to authorize emergency use of a product
will also depend on the circumstances of the CBRN emergency, as well as available knowledge
about the product's safety profile. FDA plans to assess the sufficiency of the effectiveness data
and the risk-benefit profile of each candidate product on a case-by-case basis.
FDA recommends that requests for consideration for EUAs include 29 any available relevant
scientific evidence regarding the following:
• Product's mechanism(s) of action to diagnose, treat, or prevent the disease or

condition underlying the request;
• For drugs, preclinical testing data, such as in vitro evidence of the effect of the
product in preventing or reducing the toxicity of the specified agent;
• Data on activity or effectiveness in animals that would contribute to understanding

potential effects in humans, including but not limited to any animal efficacy studies
available for products being developed under the Animal Rule; 30
29
For products under an IND or IDE, or for which there is a Drug or Device Master File, sponsors may
refer to the appropriate document on file containing such information, with appropriate right of reference as
applicable.
30
See 21 CFR 314.600 (drugs) or 21 CFR 601.90 (biological products); see also Product Development
Under the Animal Rule – Guidance for Industry (October 27, 2015), available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM39921
7.pdf .
14
• Evidence from human experience relevant to assessing activity, effectiveness, and

dosing (e.g., in published case reports, uncontrolled trials, controlled trials, and any
other relevant human use experience);
• For drugs, data to support the proposed dosage for the intended use (including
pharmacokinetics and pharmacodynamics data, and for vaccines or antibody
therapies, immunogenicity and/or achievement of protective levels of relevant
parameters of immunity); and
• For IVDs, device performance data to support the intended use such as analytical
sensitivity and analytical specificity, and data from testing fresh, contrived, banked or
archived specimens.
d. Other Data Considerations
FDA recommends that a request for an EUA include the following types of data, as appropriate
and to the extent feasible:
• Well-organized study reports that provide a complete assessment and analysis,

including any statistical analyses, of available safety and effectiveness data and an
interpretation of the findings. If final study reports are not yet available, any
available interim study reports should be provided and clearly identified as such; and
• Source data for clinical studies, nonclinical laboratory studies, and any animal studies
that contribute to assessing activity or effectiveness of the product in the treatment of
the underlying disease or condition or a closely related disease or condition, such as
case report tabulations for key studies; case report forms for all patients who died
during the clinical studies and for all persons who did not complete the study due to
an adverse event, regardless of causality; relevant reports in the published literature;
and translations of source materials that are in a language other than English.
FDA recommends that requests for EUAs include statements on whether the nonclinical
laboratory studies were conducted in compliance with applicable Good Laboratory Practice for
Nonclinical Laboratory Studies regulations (GLP) 31 and whether the clinical studies were
conducted in compliance with applicable Good Clinical Practice standards 32. FDA also
recommends specifying the methods and quality systems used to ensure the quality and integrity
of data from any animal studies submitted in support of an EUA request but not performed under
GLP.
Data from any ongoing testing (e.g., longer term stability data) or other data or information that
may change FDA's evaluation of the product's safety or effectiveness and that become available
31
See 21 CFR Part 58.
32
Information available at
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
15
during the period of review or the term of the EUA. Such data should be submitted to FDA when
such data become available, including any appropriately controlled clinical trials conducted in
parallel with the EUA during the emergency response. Data that are required to be submitted
under the condition(s) established as part of the authorization of an EUA should be submitted as
specified in the EUA.
e. Discussion of Risks and Benefits
FDA recommends that a request for an EUA include a discussion of the candidate product's
known and potential risks and benefits, which includes a synthesis of the data and information
requested above, including:
• Measures taken to mitigate risk or optimize benefit;
• Limitations, uncertainty, and data gaps;
• A description of circumstances, if any, under which the product should not be used
(e.g., contraindications); and
• To the extent known, information concerning the threats posed by the CBRN agent(s)
(actually or potentially) involved, and anticipated response and operational
considerations that may be relevant to an assessment of risks and benefits.
3. Format of Submissions
FDA recommends that each submission begin with a section that describes the contents and
organization of the included materials. The sponsor of an investigational or marketing
application for the product or anyone with a right of reference may refer to data or other
information previously submitted to the FDA in a marketing application, investigational
application, or Master File. 33
FDA expects material to be provided in a reviewable form and sufficiently complete to permit
substantive review. Nevertheless, FDA recognizes that, in rapidly developing or unexpected
emergency circumstances, or when previously unanticipated or unavailable MCMs are being
considered, it may not be possible for a sponsor to provide all of the requested data or to provide
it in the format suggested in a timely manner. In such circumstances, FDA will accept and
evaluate the request for an EUA based on data in the form the sponsor is able to submit.
However, a request that is missing data, poorly documented, or otherwise incomplete will make
FDA’s determination of whether the product's benefits outweigh its risks more difficult and
could result in a request for additional information, the need for a longer time period for review,
or a decision not to authorize emergency use of the candidate product.
Prior to submitting any materials to FDA, FDA recommends contacting the relevant
medical product Center (e-mails provided below) for any specific directions unique to the
33
FDA requests that references to previously submitted data or information specify where the data or
information can be found (e.g., identify file by submission date, name, reference number, volume, and page
number).
16
submission. Submissions, including a cover letter, may be provided in electronic or

paper format. General information, as well as links to Center-specific submission
preparation guidelines, is included in the Center contact information below. When a
request is submitted in paper, FDA recommends that a minimum of three copies be
provided to the relevant medical product Center address below.
In addition, FDA recommends that an email alert, highlighting the urgency if related to
an imminent or ongoing emergency and including the cover letter to the submission, be
sent to the following email addresses:
• The identified Center email address below;
• [email protected]; and
• Any other previously established contacts within the Center familiar with the
submission.
For the Center for Biologics Evaluation and Research:
Emails for EUAs related to biological products regulated by CBER: [email protected]
Paper submissions:
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
WO71-G112
Silver Spring, MD 20993-0002
Electronic submissions:
CBER is prepared to receive electronic EUA submissions in standardized electronic Common
Technical Document (eCTD). Contact [email protected] for information or visit
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/Electr
onicSubmissions/ucm153574.htm
17
For the Center for Devices and Radiological Health:
Email for EUAs related to IVD medical devices: [email protected]
Email for EUAs related to non-IVD medical devices: [email protected]
Paper submissions for both:

Center for Devices and Radiological Health
Document Control Center
10903 New Hampshire Avenue
WO66-G609
Silver Spring, MD 20993-0002
ATTN: EUA
For the Center for Drug Evaluation and Research:
Emails for drug and biological products regulated by CDER: [email protected]
Paper submissions:
Center for Drug Evaluation and Research Central Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266
Electronic submissions:
CDER is prepared to receive electronic EUA submissions in standardized electronic
Common Technical Document (eCTD) format as well as non-eCTD format. Contact
[email protected] for information or visit
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirement
s/ElectronicSubmissions/ucm153574.htm.
4. FDA Processing of an EUA Request
a. Prioritization of Requests
(i) In General
FDA intends to establish priorities for its review of requests to issue an EUA based on a variety
of factors. These include:
• The seriousness and incidence of the clinical disease or condition (e.g., based on
federal requirements, federal partner prioritization requests);
18
• The public health need for the product and, when known, the safety and effectiveness
of other potential MCMs;
• The urgency of the treatment need (i.e., the window of opportunity for treatment can
vary for different medical conditions);
• Availability and adequacy of the information concerning the likelihood that the
product may be safe and effective in preventing, treating, or diagnosing the condition;
• The potential role that use of the product may have in ensuring national security;
• Whether the product is included in government stakeholder stockpiles;
• The extent to which the product would serve a significant unmet medical need,
including in:
o A subpopulation (e.g., pregnant women, infants, and children, and

immunocompromised persons)
o The stage of the emergency response (e.g., evolving understanding of

the disease or condition and/or MCMs in the context of an ongoing
public health response, availability of previously authorized MCMs);
• Whether the request is from (or supported by) a government stakeholder (e.g., the
proposed emergency use will be appropriately coordinated with, augment, and not
interfere with official government stakeholder response efforts 34);
• The availability of the product, (e.g., the quantity and manufacturing capacity); and
• Whether other mechanisms, such as developing a clinical study protocol under an

IND or IDE for investigational use, typically in coordination with government
stakeholders, or granting access to an investigational product under an IND or IDE
expanded access authority, might be more appropriate for allowing emergency access
to products under development (e.g., when there are little or no safety or efficacy data
available).
(ii) Additional Considerations for Prioritizing Requests for an

EUA in Advance of an Emergency
The statutory criteria for issuing an EUA are the same whether the EUA is issued before or
during a CBRN emergency. Therefore, in deciding whether to issue an EUA in advance of an
emergency for preparedness purposes, FDA will make a case-by-case assessment of product
risks and benefits based on the totality of available safety and efficacy data consistent with the
34
For example, FDA often encourages EUA submissions from commercial developers of diagnostic tests to
expand laboratory testing capacity during emergencies, consistent with U.S. government response plans.
19
criteria for issuance of an EUA in section 564(c), just as it would in considering a request for an
EUA to be issued during an emergency response.
It will not be appropriate to issue an EUA for every potential MCM or in anticipation of each
emergency scenario. For example, FDA anticipates that, in all but the most catastrophic
scenarios, only comparatively mature products (e.g., those with demonstrated safety data and in
advanced stages of efficacy testing) are likely to meet the minimum risk-benefit criteria for an
EUA for preparedness purposes. In addition, the extent to which the proposed use of an MCM is
supported by operational planning, whether the MCM is already held in a government stockpile,
and whether timely and comprehensive pre-EUA submissions have been available for FDA
review will be relevant to the prioritization of a request for an EUA for preparedness purposes.
Nevertheless, the extent to which the sponsor is actively pursuing FDA approval for the MCM is
relevant to FDA’s prioritization of requests to issue an EUA in advance of an emergency for
preparedness purposes 35, and the duration of such an EUA if issued. An EUA is not a long-term
alternative to obtaining FDA approval, licensure, or clearance for MCMs; the issuance of an
EUA in advance of an emergency (or during an emergency) is not an appropriate endpoint for
new product development.
Section 564 expressly states that FDA’s authority to allow emergency use of an unapproved
product, or unapproved use of an approved product, does not authorize a delay in FDA's review
or other consideration of any pending application. If an EUA remains in effect for more than one
year, FDA must provide the sponsor written explanation of obstacles to approval and specific
actions to be taken by FDA and the sponsor to overcome them. 36 Moreover, FDA is required to
review the circumstances and appropriateness of an EUA periodically, including progress made
with respect to the approval of the product. 37 FDA generally does not anticipate allowing an
EUA issued in advance of an emergency for preparedness purposes to remain in effect
indefinitely. If the sponsor is not actively working to advance the MCM’s development for an
approval, FDA may reconsider the EUA's status and/or consider terminating the EUA.
b. Review of Requests to Issue an EUA
A formal request to issue an EUA generally should not be submitted until the Secretary of HHS
has issued an EUA declaration under section 564(b)(1). In particular, although section 564
allows FDA to issue an EUA for preparedness purposes, in such cases the HHS Secretary must
first declare that circumstances exist justifying such an authorization in advance of an actual
emergency based on a formal determination of a significant potential for emergency or a material
35
As stated in section III.C with regard to pre-EUA activities, an EUA is not a substitute for sponsor efforts
to develop the product toward approval, including conducting clinical trials designed to determine whether
the product is safe and effective for its intended use. When appropriate, FDA encourages sponsors to
design and propose appropriately controlled clinical trials that could be conducted during the emergency
response either to run in parallel with an EUA or instead of an EUA.
36
Section 564(b)(5).
37
Section 564(g)(1).
20
threat determination. FDA typically coordinates closely with HHS and other relevant
government sponsors throughout the EUA process, from pre-EUA submissions to final
disposition, including the need for issuance of the EUA declaration and any consultations on
EUAs with federal partners. 38 Moreover, a formal request for issuance of an EUA typically will
have the benefit of FDA feedback based on pre-EUA submission activities.
A sponsor seeking an EUA should submit its formal request in the form of an EUA submission,
including reference to relevant pre-EUA submissions previously reviewed by FDA, and request
to issue the EUA through the same process outlined in section III.D.3 of this guidance.
Typically the data and other information in EUA submissions have already been reviewed by
FDA and have had the benefit of FDA Center feedback based on pre-EUA submissions and
interactions with FDA prior to submission of the request to issue an EUA.
c. Disposition of Requests
FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances
warrant and adequate information has been made available for prior review through pre-EUA
interactions. Generally, the timelines for FDA review and action on a request to issue an EUA
will be determined on a case-by-case basis and will depend on factors such as:
• The product profile;
• The existence, if any, of pending applications for the product;
• The nature of the emergency, potential emergency, or threat of emergency;
• The organization and completeness of the request submission; and
• The workload of the reviewing Center’s personnel.
A letter to the sponsor authorizing the emergency use(s) of an MCM will be signed by the
Commissioner (or his/her designee) and will include a description of the authorized product and
its use(s), any contraindications for the product, the criteria for issuance of the authorization, the
scope of the authorization, waiver of certain requirements (if applicable), and any conditions on
the authorized use. An authorized EUA will consist of (1) the signed letter of authorization and
(2) any accompanying authorized materials (e.g., Fact Sheet for health care professionals, Fact
Sheet for recipients, instructions for use, etc.). 39
FDA may decline to review or issue an EUA based on any number of factors. For example, the
candidate product may fail to meet the necessary criteria identified in section 564 and discussed
in section III.B.1 of this guidance, or it may fail to meet any one of the factors given the
38
Section 564(c).
39
The EUA letter of authorization and accompanying authorized materials will be posted on FDA’s
website at:
http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegul
atoryandPolicyFramework/ucm182568.htm#current.
21
circumstances of the emergency or threat of emergency (see section III.D.4.a of this guidance for
a discussion of factors FDA will consider in reviewing requests for prioritization of EUA
requests). Under such circumstances, the relevant product Center will notify the sponsor that the
EUA review cannot be prioritized or FDA declines to issue an EUA for the candidate product.
E. CONDITIONS OF AUTHORIZATION
FDA may establish conditions on an EUA necessary or appropriate to protect the public health.
Section 564(e)(1) establishes conditions applicable to unapproved products; section 564(e)(2)
sets forth conditions applicable to unapproved use of approved products, which are similar, but
not identical, to those applicable to unapproved products. Within these sections, some conditions
are required (to the extent practicable given the applicable circumstances of the emergency or
threat of emergency), whereas others may be imposed entirely at the discretion of FDA. 40
1. Information Relating to the EUA Product
a. Information for Health Care Professionals or Authorized

Dispensers
For an unapproved product (section 564(e)(1)(A)(i)) and for an unapproved use of an approved
product (section 564(e)(2)(A)), FDA must (to the extent practicable given the circumstances of
the emergency) establish conditions to ensure that health care professionals who administer the
EUA 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, 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:
• A description of the disease/condition;
• Any contraindications or warnings;
40
See Appendix A for a table of required and discretionary conditions. Note that the statute states that
FDA shall “establish such conditions on an authorization under this section as [FDA] finds necessary or
appropriate to protect the public health” with respect to unapproved products and then provides examples
of such conditions by use of the term “including” (section 564(e)(1)(A)). FDA interprets this language as
giving FDA the authority and the responsibility to impose other conditions, not specified as examples in the
statutory language, that may be necessary or appropriate in the circumstances of a particular emergency.
22
• Dosing information (if applicable), including any specific instructions for special
populations; and
• Contact information for reporting adverse events and additional information about the
product.
Health care professionals or authorized dispensers will likely have very limited time to
review Fact Sheets during an emergency and, therefore, FDA anticipates that Fact Sheets
typically will be brief (i.e., a few pages). FDA makes available on its website Fact Sheets
for products for which an EUA is issued. 41
FDA further recommends that Fact Sheets target the health care professional or authorized
dispenser who has the most basic level of training, recognizing that individuals responding to an
emergency may have different levels of training, could come from a variety of backgrounds, and
may have different types of experience or speak different languages. FDA recommends that Fact
Sheets accompany the EUA product in an accessible form (e.g., printable as a hard copy) when
the product is distributed to the health care professional or authorized dispenser if practicable.
To the extent consistent with other conditions of authorization, information on the EUA product
also may be disseminated to health care professionals or authorized dispensers through mass
media (including print, broadcast, radio, satellite, Internet, or other electronic means of
dissemination), videos/DVDs, or direct communication from public health agencies.
For unapproved drug products, which do not have FDA-approved labeling for any indication,
FDA recommends that, 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. For medical devices regulated, such as
in vitro diagnostics, in addition to the brief summary information found in a Fact Sheet, FDA
recommends the sponsor also develop separate Instructions for Use. 42
With respect to an EUA that authorizes a change in labeling of an approved product, but for
which the manufacturer chooses not to make such labeling change, the EUA may not authorize
the product's distributor or any other person to alter or obscure the manufacturer's labeling
(section 564(e)(2)(B)). 43 In such a situation, however, FDA must, to the extent practicable given
the applicable circumstances, authorize a person acting pursuant to such EUA to provide, in
41
For examples of Health Care Professional Fact Sheets, see FDA's website at:
42
For examples of Instructions for Use, see FDA's website at:
43
We note that this prohibition does not apply to changes in expiration dating permitted pursuant to section
564A(b). See section IV.B of this guidance.
23
addition to the manufacturer's labeling, appropriate information with respect to the product, such
as that provided in the brief Fact Sheet described above. 44
b. Information for Recipients
Although informed consent as generally required under FDA regulations 45 is not required for
administration or use of an EUA product, section 564 does provide EUA conditions to ensure
that recipients are informed about the MCM they receive under an EUA. For an unapproved
product (section 564(e)(1)(A)(ii)) and for an unapproved use of an approved product (section
564(e)(2)(A)), the statute requires that FDA ensure that recipients are informed to the extent
practicable given the applicable circumstances:
• That FDA has authorized emergency use of the product;
• Of the significant known and potential benefits and risks associated with the
emergency use of the product, and of the extent to which such benefits and risks are
unknown;
• That they have the option to accept or refuse the EUA product and of any
consequences of refusing administration of the product; 46 and
• Of any available alternatives to the product and of the risks and benefits of available
alternatives.
Therefore, FDA recommends that a request for an EUA include a “Fact Sheet" for recipients that
includes essential information about the product. In addition to the above information, the
Agency recommends that the content of the Fact Sheets for recipients include the following
information:
• Product name and explanation of the intended use of the product;
• A description of the disease/condition;
44
Additional information provided under section 564(e)(2)(B)(ii) as a condition of authorization is not
considered "labeling" for purposes of section 502 of the FD&C Act while the EUA for the product is
effective.
45
See 21 CFR part 50.
46
The President may under certain circumstances waive the option for members of the armed forces to
accept or refuse administration of an EUA product (10 U.S.C. 1107a). In addition, the option to accept or
refuse may not be practicable with regard to certain diagnostics because, for example, when a sample is
taken from an individual it may be unknown, even to the health care professional, which diagnostic test will
be used to test the sample. For this reason, Fact Sheets for both health care professionals and recipients
may not accompany an EUA diagnostic product, but instead be publicly posted for reference when
receiving test results.
24
• A description of items to discuss with a health care provider and adverse event
information, including contact information for how to get more information and for
reporting adverse reactions; and
• Dosing information (if applicable), including specific instructions for home use or
preparation (if applicable).
FDA recommends that recipients be given as much appropriate information as possible given the
nature of the emergency and the conditions of the authorization. 47 Ordinarily, FDA expects that
some written form of information will be given to recipients with the MCM, similar to the Fact
Sheet for health care professionals or authorized dispensers. FDA recognizes that these Fact
Sheets, like those for health care professionals or authorized dispensers, will generally be brief.
To ensure that individuals of varying educational levels comprehend the information provided,
FDA recommends that all written information be stated in the simplest language possible using
techniques to improve health literacy. 48 In addition, translations to other languages may be
appropriate if practicable. 49 FDA recognizes that some flexibility may be needed for health care
providers or authorized dispensers to make minor, nonsubstantive changes to the fact sheets for
recipients such as adding local contact information, using specific letterhead or minor format
changes.
FDA acknowledges that exigent circumstances may dictate the use of other appropriate
dissemination methods. Therefore, FDA expects that information would be disseminated in the
most effective and expeditious way possible to reach the recipient before administration or use of
an EUA product. 50 If, however, taking the time needed to provide such information would
diminish or negate the effectiveness of the product for the recipient, FDA may include as a
condition of authorization that the information be provided to the recipient as soon as practicable
after dispensing. Other methods of dissemination may include internet posting, mass media,
videos/DVDs, or direct communication from health care professionals and public health
agencies.
2. Monitoring and Reporting of Adverse Events
For an unapproved product (section 564(e)(1)(A)(iii)), EUA conditions for monitoring and
reporting of adverse events are required to the extent practicable given the circumstances of the
emergency; such conditions may be established for an EUA for an unapproved use of an
approved product (section 564(e)(2)(A)), at the discretion of FDA.
47
For examples of Patient/Recipient Fact Sheets, see FDA's website at:
48
See, e.g., http://www.health.gov/communication/literacy/quickguide/healthinfo.htm.
49
When the translation of a fact sheet to a foreign language is determined to be appropriate and necessary,
the party producing the translation is responsible for the accuracy and completeness of the translation; FDA
does not intend to review translations to ensure their accuracy.
50
As noted above, however, this may not be practicable or appropriate for certain diagnostic tests.
25
Conditions may be placed to enable the collection and analysis of information on the safety and
effectiveness of the EUA product during the period when the authorization is in effect and for a
reasonable time following such period. FDA expects that the primary focus of adverse event-
related conditions will be capturing serious adverse events and applying appropriate
mechanism(s) for the collection of follow-up clinical information. Some reporting may be
directed to predefined mechanisms to capture adverse event data (e.g., FDA’s Safety Information
and Adverse Event Reporting System (MedWatch) or Vaccine Adverse Event Reporting System
(VAERS)). FDA will work with product sponsors in some circumstances to develop proposals
for more active data collection and follow-up mechanisms to capture adverse event information
under the EUA. FDA encourages EUA sponsors to provide proposals for data collection and
follow-up during pre-EUA interactions.
3. Records
To the extent practicable given the circumstances of the emergency, FDA must establish
conditions for a manufacturer of an unapproved product to maintain records and to grant FDA
access to records concerning the EUA product. 51 FDA anticipates that such conditions may
relate to, for example, the number of doses, devices, or other unit(s) (including lot identification)
that have been shipped or sold under an EUA; or the name and addresses of the facilities to and
from which the EUA product was shipped. FDA may also impose comparable recordkeeping
requirements on any person (e.g., an authorized distributor or dispenser) other than a
manufacturer who carries out any activity for an unapproved EUA product (section
564(e)(1)(B)(iv)).
FDA may also impose recordkeeping and records access requirements on any person (including
a manufacturer) engaged in an activity for which an EUA is issued for an unapproved use of an
approved product (section 564(e)(2)(A)). In addition to the examples noted above for
unapproved EUA products, examples may include conditions relating to actual use of the product
and disposition of any unused product, and monitoring of patients who have been administered
the product under an EUA.
4. Additional Conditions of Authorization
FDA, on a case-by-case basis and to the extent feasible given the circumstances of the
emergency, may establish additional conditions that FDA finds to be necessary or appropriate to
protect the public health (section 564(e)) 52, such as the following:
• Distribution and administration— conditions may be placed on which entities may

distribute and who may administer the product, and how distribution and
administration are to be performed. In addition, conditions may be placed on the
51
Section 564(e)(1)(A)(iv).
52
Section 564(e)(1)(B) (for unapproved products) and 564(e)(2)(A) (for unapproved uses of approved
products).
26
categories of individuals to whom, and the circumstances under which, the product
may be administered. FDA anticipates that distribution and administration of EUA
products will be performed according to existing official government response plans,
as practicable and appropriate. In some cases, administration of an MCM may go
hand-in-hand with dispensing the MCM. In establishing conditions with respect to
the distribution and administration of an approved product for an unapproved use,
FDA may not impose conditions that would restrict distribution or administration of
the product when distributed or administered for the approved use. 53
• Advertising 54— conditions (e.g., limitations) may be placed 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) and requirements applicable to restricted
devices under section 502(r).
5. Waivers or Limitations of Compliance With Other Requirements
a. CGMPs
FDA generally expects that EUA products will be produced, stored, and distributed in
compliance with CGMPs; however, limits or waivers may be granted in an EUA on a case-by-
case basis, after consideration of the circumstances and of any alternative proposed approach
(section 564(e)(3)). 55
b. Prescription Requirements
FDA may waive otherwise applicable prescription requirements, to the extent appropriate given
the circumstances of an emergency (section 564(e)(3)). For example, operational considerations
for a large-scale emergency response may demand that large numbers of individuals receive a
medical product at centralized locations or locations that are not traditional health care settings,
typically called “points of dispensing” (PODs). In such situations, the goal is to dispense
medical product as quickly as possible to protect the public health, so it may not be practicable
for each person to interact with a licensed practitioner before receiving a product authorized
under an EUA (e.g., authorized dispensers may be responsible for dispensing or administering
some or all MCMs). FDA also expects to include such waivers in EUAs on a case-by-case basis,
53
Section 564(e)(2)(C).
54
Section 564(e)(4).
55
Section 564A(c) separately empowers FDA to authorize deviations from otherwise applicable CGMP
requirements for the manufacture, processing, packing, or holding of eligible, FDA-approved products
without issuing an EUA. This independent authority is discussed in section IV.C of this guidance.
27
after consideration of the anticipated or actual circumstances of an emergency and the

operational plans for a response. 56
c. REMS
FDA may waive otherwise applicable REMS requirements based on all CBRN emergencies that
would trigger an EUA (section 505-1(k)). If it is determined that a waiver is needed, the waiver
may apply to all REMS elements. 57
F. CATEGORIZATION OF LABORATORY TESTS UNDER AN EUA
Section 564(m) allows FDA, if issuing an EUA for a diagnostic device, to indicate whether the
test can be performed at a point-of-care setting or only in a laboratory able to handle more
complex tests. FDA may determine that a laboratory examination or procedure associated with
such a device shall be deemed, for purposes of section 353 of the PHS Act, to be in a particular
category of examinations and procedures, including the category described by subsection (d)(3)
of such section (commonly termed “waived” devices) if, based on the totality of scientific
evidence available:
• The categorization would be beneficial to protecting the public health; and
• The known and potential benefits of such categorization under the circumstances of
the authorization outweigh the known and potential risks of the categorization.
FDA may also establish appropriate conditions on the performance of the test. The complexity
categorization made under this authority is effective for the same period as the EUA and is
independent of that made under Clinical Laboratory Improvement Amendments (CLIA)
regulations.
G. DURATION AND REVISION OF AN EUA
FDA will specify the effective date of an EUA issued under section 564. In general, an EUA
will remain in effect for the duration of the EUA declaration under which it was issued (see
section III.A.2 of this guidance, which describes termination of an EUA declaration and its
impact on existing EUAs), unless the EUA is revoked because the criteria for issuance as
described in section III.B of this guidance are no longer met or revocation is appropriate to
protect public health or safety (section 564(f),(g)).
56
Section 564A(d) separately empowers FDA to issue an order authorizing emergency dispensing of
eligible, FDA-approved products without issuing an EUA. This independent authority is discussed in
section IV.D of this guidance.
57
For further information on REMS, see FDA's draft Guidance for Industry Format and Content of
Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS
Modifications (October 2009) at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-
gen/documents/document/ucm184128.pdf.
28
1. Revision and Revocation
FDA will periodically review the circumstances and appropriateness of an EUA, including
circumstances that might warrant revocation of the EUA. The review will include regular
assessment based on additional information provided by the sponsor of the progress made with
respect to the approval, licensure, or clearance of the unapproved product, or of the unapproved
use of an approved product, for which an EUA was issued.
FDA may revise or revoke an EUA if the 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. 58 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.
2. Product Disposition and Continued Use
Upon revocation of an EUA or its termination as a result of the termination of the HHS EUA
declaration supporting it, an unapproved product or its labeling, and product information for an
unapproved use of an approved product, must be disposed of pursuant to section 564(b)(2)(B)
and (b)(3). 59 Notwithstanding any such revocation or termination, under section 564(f)(2) an
authorization shall continue to be effective to provide for continued use in any patient who began
treatment before revocation or termination (to the extent found necessary by the patient's
attending physician). Any study or future use of an EUA product beyond the term of a
declaration is subject to investigational product regulations (e.g., IND regulations).
H. PUBLICATION
FDA will promptly publish in the Federal Register a notice of each EUA, including an
explanation of the reasons for issuance, a description of the intended use, and any
contraindications of the EUA product. The Agency also will promptly publish in the Federal
Register each termination or revocation of an EUA and an explanation of the reasons for the
decision. Although FDA is not required to publish notice of an EUA revision(s) in the Federal
58
Section 564(g)(2).
59
Section 564(b)(2)(B) provides that FDA shall consult with the manufacturer of the product with respect
to the appropriate disposition.
29
Register, FDA plans to post any revisions to EUAs on FDA's website at

http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCML
egalRegulatoryandPolicyFramework/ucm182568.htm. 60
I. OPTION TO CARRY OUT AUTHORIZED ACTIVITIES
If a manufacturer is the sole source of an unapproved product authorized for emergency use, that
manufacturer must inform FDA, within a reasonable time after the authorization, if the
manufacturer does not intend to make its product available for use under the EUA (section
564(l)). The Commissioner does not have the authority under section 564 to require a person to
carry out any activity for which an EUA is issued. Section 564(l), however, does not limit
FDA's authority to impose conditions on persons who carry out any activity for which an EUA is
issued.
IV. EMERGENCY USE OF ELIGIBLE FDA-APPROVED MCMs WITHOUT

AN EUA
Section 564A allows FDA to facilitate certain emergency activities involving FDA-approved
MCMs without an EUA. This authority is independent of the EUA authority under section 564.
In the past, to address concerns about potential FD&C Act violations related to the activities
discussed in this section involving MCMs, FDA has either: (1) exercised its enforcement
discretion with respect to the activity; or (2) issued an EUA to ensure that use of such MCMs
remains covered under any otherwise applicable protections under the PREP Act 61 (discussed in
section VII of this guidance). MCMs used under this authority qualify for applicable PREP Act
protection. 62
In some cases, FDA and CDC may coordinate activities under section 564A authorities including
the issuance of an emergency dispensing order, waiver of cGMPs, waiver of REMS, extension of
expiration dating, and/or issuance of EUI for specific MCMs. 63
60
In publicly releasing information on an EUA, FDA will take necessary steps to protect nonpublic
information and information otherwise protected by law, as appropriate.
61
See 42 U.S.C. 247d-6d.
62
See 42 U.S.C. 247d-6d(i)(1)(C), (i)(7)(B)(iii).
63
See, e.g., Emergency Dispensing Information tables for doxycycline and ciprofloxacin at:
atoryandPolicyFramework/ucm495126.htm#doxy
atoryandPolicyFramework/ucm495126.htm#cipro.
30
A. ELIGIBLE PRODUCTS
The emergency authorities in section 564A apply only to those medical products that are
“eligible” (as defined in section 564A(a)) (referred to in this document as “eligible MCMs”).
Eligible MCMs must be:
• Approved by FDA;
• Intended for their approved use to prevent, diagnose, or treat a disease or condition
involving a CBRN agent(s), or a serious or life-threatening disease or condition
caused by a product used for such a purpose; and
• Intended for use during circumstances in which there has been either:
o A determination of an emergency or a significant potential for an emergency

made by the Secretary of Homeland Security, the Secretary of Defense, or the
Secretary of HHS (as described in subparagraph (A), (B), or (C) , respectively,
of section 564(b)(1)) (i.e., one of the three EUA determinations that may
support issuance of an EUA declaration, as described in section III.A of this
guidance); or
o A material threat (described in subparagraph (D) of section 564(b)(1))

identified by the Secretary of Homeland Security pursuant to section 319F–2
of the PHS Act that is sufficient to affect national security or the health and
security of U.S. citizens living abroad (i.e., a Department of Homeland
Security (DHS) material threat determination, which may also support
issuance of an EUA declaration, as described in section III.A of this
guidance). 64
B. EXPIRATION DATE EXTENSIONS WITHOUT AN EUA
FDA may extend the expiration date of an eligible, FDA-approved MCM stockpiled for use in a
CBRN emergency if the extension is supported by an appropriate scientific evaluation that is
conducted or accepted by FDA. An "expiration date" is defined as “the date established through
appropriate stability testing…to ensure that the product meets applicable standards of identity,
strength, quality, and purity at the time of use” (section 564A(b)(4)).
For each expiration date extension granted, FDA must identify the “specific lot, batch, or
other unit of the product” 65 and the duration of the extension. 66 In addition, FDA must
64
As noted previously with respect to EUAs, FDA has construed a material threat identification pursuant to
section 319F-2 to apply to the health and security of U.S. citizens living abroad, even though that provision
does not specifically focus on citizens outside the United States. Thus, a material threat determination may,
in appropriate circumstances, serve as a basis for exercise of emergency authorities under section
564A(b),(c), and (d) and 505-1 as necessary for the protection of U.S. citizens living abroad.
65
Section 564A(b)(2)(A).
31
identify any other requirements or conditions related to each expiration date extension
that the Agency deems appropriate for the protection of the public health, which may
include requirements for, or conditions on:
• Product sampling,
• Storage,
• Packaging or repackaging,
• Transport,
• Labeling,
• Notice to product recipients,
• Recordkeeping,
• Periodic testing or retesting, or
• Product disposition.67
The expiration date extension authority in section 564A applies to any eligible MCM, including
eligible MCMs tested through the federal Shelf-Life Extension Program (SLEP). Since the mid-
1980s FDA has engaged with federal partners in SLEP; DoD administers the program, while
FDA tests the stability of certain federally stockpiled drug products to assess and extend, as
appropriate, the useful shelf-life of such products. The explicit expiration date extension
authority added by PAHPRA does not displace the longstanding federal SLEP, but eliminates
any uncertainty about the legal status of eligible products for which FDA authorizes an extended
expiration date, whether or not FDA also issues an EUA.
At this time FDA is not proposing or recommending any changes to SLEP or procedures for
expiration date extensions for products tested through SLEP. For drugs tested within the SLEP
program, federal participants should continue to submit requests to extend the expiration date of
eligible MCMs using established processes. FDA is considering approaches for expiration
extension for eligible products that are not tested within the SLEP program. Government
stakeholders should consult with FDA via email or letter to the relevant Center and OCET points
of contact identified in section III.D.3 of this guidance. 68
66
Section 564A(b)(2)(B).
67
Section 564A(b)(2)(C).
68
For additional information about expiration dating extensions see
atoryandPolicyFramework/ucm411446.htm.
32
Although FDA may rely on section 564A to authorize an expiration date extension without
issuing an EUA, if an EUA is requested for a product that is nearing or beyond its labeled
expiration date, FDA may consider extending that expiration date and imposing conditions in
connection with an EUA request as discussed in section III.D.2.a of this guidance.
1. In General
FDA may authorize deviations from otherwise applicable CGMP requirements for the
manufacture, processing, packing, or holding of eligible, FDA-approved products without
issuing an EUA (section 564A(c)). Products that receive a waiver from applicable CGMPs will
not be considered adulterated or misbranded under the FD&C Act. This includes requirements
under section 501 or 520(f)(1) or applicable conditions prescribed with respect to the eligible
product by an order under section 520(f)(2).
Although FDA may rely on section 564A to waive CGMP requirements without issuing an EUA,
if an EUA is requested for a product for which a CGMP waiver is also requested, FDA may
consider waiving CGMP requirements and imposing conditions in connection with the EUA as
discussed in section III.E.5 of this guidance.
2. Procedures for Request and Issuance
FDA may issue waivers on its own initiative, but expects that any such action will be
uncommon. Since the need for a waiver will be driven by the exigencies and other demands of
responding to a CBRN emergency, FDA expects that in most cases a waiver will be based on a
request from a government stakeholder or other interested party. For example, government
stakeholders or manufacturers of products intended for use in a CBRN emergency may submit a
request for a CGMP waiver for eligible products based on actual or anticipated emergency
response activities that necessitate the waiver. FDA recommends, however, that requests be
submitted only after consultation with and among relevant government stakeholders (e.g., CDC,
and government officials in adjacent jurisdictions) that are or eventually may be part of a
coordinated or related response effort involving the CBRN agent(s) or MCM. For example,
absent compelling justification and to maintain response consistency, FDA does not expect to
grant multiple CGMP waivers for the same MCM or CBRN use. FDA generally will not issue a
waiver based on a request from an individual state if FDA has already issued the same type of
waiver for the same MCM on a nationwide basis. Similarly, if FDA receives CGMP waiver
requests for a particular MCM from multiple states or federal partners at the same time, FDA
generally anticipates it will issue a single waiver (if a waiver is appropriate). Advance
consideration and coordination are critical to ensure appropriate consistency and avoid
unnecessary duplication.
FDA intends to evaluate requests for CGMP waivers pursuant to section 564A(c) on a case-by-
case basis. A waiver may be issued when, based on the information available, the Agency
concludes it is reasonable to issue a waiver to facilitate a CBRN emergency response or
preparedness efforts. Requests for waivers should include the following information:
33
• The identity and quantity of the medical product involved (e.g., product name(s);
dosage form(s) and strength(s); number of doses, units, lots, or other unit(s); and
unit/lot identifiers, as appropriate);
• The manufacturer's name, address, and contact information;
• The FDA application file number for the product, if known (e.g., NDA, BLA, IND,
IDE);
• The actual or potential CBRN emergency for which the product is intended to be
used;
• The anticipated conditions (e.g., storage, handling, transport, packaging) that will or
may deviate from CGMP requirements and for which a waiver is being requested,
including why such deviation may be necessary and the anticipated duration; and
• Available information about the potential impact of the deviation on the safety or
efficacy of the product (e.g., strength, purity, quality).
FDA may request additional information to assess the request and decide whether to grant a
waiver. A waiver of CGMP requirements pursuant to section 564A(c) may either (1) be issued
independent of any other FDA action or, when appropriate, (2) be included with an emergency
dispensing order under section 564A(d) (see section IV.D of this guidance).
Submit a request for a CGMP waiver for an eligible MCM via e-mail or letter to the relevant
Center and OCET points of contact identified in section III.D.3 of this guidance.
D. EMERGENCY DISPENSING WITHOUT AN EUA
Emergency dispensing of eligible, FDA-approved products is allowed under section 564A(d)

without adhering to the requirements of section 503(b) or 520(e). This authority includes
dispensing such products without an individual prescription for each recipient (often referred to
as “mass dispensing”) 69 if: (1) permitted by state law where the product is dispensed (section
564A(d)(2)(A)) or (2) dispensed in accordance with an emergency dispensing order issued by
FDA (section 564A(d)(2)(B)). This streamlined mechanism permits emergency response
activities that involve an emergency dispensing strategy needed to meet immediate public health
needs, but that otherwise may not comply with the FD&C Act’s prescription requirements. 70
Like other provisions in section 564A, FDA may issue an emergency dispensing order to allow
emergency dispensing of eligible products without having to issue an EUA. Products that are
69
The term “emergency dispensing” includes, but is not limited to, the public health response activity of
“mass dispensing” of MCMs (e.g., through points of dispensing).
70
This may include dispensing without an individual prescription, or dispensing with an incomplete
prescription, e.g., without all of the information otherwise required by FDA, such as the name and address
of the dispenser, name of the prescriber, serial number, etc. (see, e.g., section 503(b)(2) (21 U.S.C. §
353(b)(2)). This also may include dispensing by a non-health care professional.
34
dispensed pursuant to section 564A(d) (i.e., under state law or under an FDA emergency
dispensing order) will not be considered unapproved, adulterated, or misbranded under the
FD&C Act.
Although FDA may rely on section 564A to allow emergency dispensing of FDA-approved
products without issuing an EUA, if an EUA is requested for a product for which emergency
dispensing is also requested, FDA may consider waiving prescription requirements and imposing
conditions in connection with considering the EUA (as discussed in section III.E.5 of this
guidance).
1. Procedures for Issuing Emergency Dispensing Orders
States may have in place provisions that facilitate emergency dispensing of eligible
MCMs or may choose to take legal actions (e.g., pass laws, issue emergency orders) that
facilitate emergency dispensing of eligible MCMs. 71
Section 564A(d) provides a mechanism for FDA to fill any gaps in state law or to ensure
adequate and consistent emergency response within and across state lines by issuing an order to
allow emergency dispensing of eligible MCMs (i.e., an emergency dispensing order). FDA may
issue such an order before or during an emergency. However, to receive the protections from
potential violations of the FD&C Act under section 564A(d), eligible MCMs may only be
dispensed during (not before) an emergency, as may be determined by relevant government
stakeholders (see section IV.D.2 of this guidance).
FDA intends to issue orders to allow emergency dispensing when, based on available
information about the MCM, emergency response plans, and operational needs, the Agency
concludes that it is reasonable to permit emergency dispensing of eligible FDA-approved
products. FDA anticipates that government stakeholders will submit a request for an emergency
dispensing order. However, in the event that FDA deems it appropriate to issue an order without
such a request, FDA will notify the relevant government stakeholders (e.g., ASPR, CDC, DHS,
and/or DoD, regional authorities) as appropriate.
a. Federal requests
FDA expects that federal government stakeholders will initiate any requests relating to federally-
maintained or federally-controlled MCMs, and to the extent possible, will consider emergency
dispensing activities of the same MCMs at all jurisdictional levels including state, local, tribal,
and territorial jurisdictions. For example, if both the CDC Strategic National Stockpile and state
or local jurisdictions stockpile an antibiotic for use for post-exposure prophylaxis of inhalational
71
Whether or not a particular state legal provision or action is sufficient to permit the government
stakeholder's anticipated emergency dispensing strategy within their state rests in large part on the
interpretation of that state's law, which is a matter that should first be directed to the appropriate legal
authority within the relevant jurisdiction (e.g., the state Attorney General). To ensure clarity, and perhaps
increase the likelihood that state laws, regulations, orders, or other legal actions to permit emergency
dispensing are deemed legally sufficient, it is recommended that such actions address the same eligibility,
scope, duration, and other elements that FDA intends to address in its emergency dispensing orders.
35
anthrax, FDA anticipates that a CDC request for an order to allow emergency dispensing for that
antibiotic would address all other relevant government stakeholder stockpiles. FDA also expects
that a federal stakeholder seeking an emergency dispensing order, or to which such an order is
otherwise directed, will communicate with other government stakeholders as necessary to ensure
a coordinated emergency response.
b. Non-federal requests
FDA also anticipates receiving requests relating to MCMs maintained or controlled solely by
non-federal government stakeholders (e.g., public health officials at the state level or in major
metropolitan areas that independently maintain MCM stockpiles) to address the possibility that
such assets may be deployed independent of reliance on federal assets. FDA strongly
recommends that such requests be submitted only after consultation with relevant federal
government stakeholders (e.g., CDC), as well as other relevant government stakeholders (e.g.,
officials in adjacent jurisdictions) that are or may be part of a coordinated or related response
effort involving the same CBRN agent(s) or MCM.
c. Content of requests
FDA anticipates that a request for an emergency dispensing order will include the following
information:
• The CBRN agent(s) involved;
• The FDA-approved product(s) for which the order is requested (including the product
name(s), manufacturer, quantity, dosage form(s), strength(s), dosing regimen(s), lot
or batch number(s), expiration date(s), and any other identifying information);
• The intended use(s) of the product;
• The jurisdiction(s) to be covered (e.g., nationwide, state, region);
• How soon the order needs to be issued;
• The source of the product (e.g., Strategic National Stockpile (SNS), state or local
MCM stockpile, multiple sources);
• The proposed duration of the order; and
• The relevant government stakeholders’ roles in an anticipated response.
FDA may also request additional information to evaluate and make a decision on the request.
Examples of additional information include: information about anticipated dispensing strategies,
dispensing locations, dispensing personnel, recipient screening, or how health care professionals
or authorized dispensers and recipients will be informed about product safety, efficacy, and use
during an emergency (e.g., whether corresponding CDC-issued EUI will be needed to
accompany the product).
36
d. Processing of Requests
Submit a request for an emergency dispensing order for an eligible MCM via email or letter to
the relevant Center and OCET points of contact identified in section III.D.3 of this guidance.
2. Scope and Conditions of Emergency Dispensing Orders
An emergency dispensing order issued by FDA would authorize emergency dispensing, but not
direct or require emergency dispensing to occur; government stakeholders typically will be
responsible for determining when to commence emergency dispensing consistent with the
conditions specified in the order. The Agency expects that in most cases, an emergency
dispensing order will allow dispensing in all circumstances in which government stakeholders
reasonably believe that a need exists because of their constituent recipients’ known, suspected, or
likely imminent exposure to the CBRN agent(s) identified in the order. FDA also expects that
any dispensing contemplated within government stakeholder emergency response plans will, to
the extent possible, involve guidance from licensed health care professionals in the dispensing of
product. Nevertheless, an emergency dispensing order issued under section 564A(d) may also
state that, in some circumstances, direct or immediate involvement or guidance by licensed
health care practitioners may not be possible, and the emergency dispensing order may authorize
others, provided the product is otherwise dispensed as part of the official government emergency
response plan during a CBRN event.
FDA may specify in the emergency dispensing order who is responsible for contacting additional
government stakeholders who may become engaged in a response to a CBRN event covered by
the order (1) to ensure that relevant government emergency response plans are coordinated or
revised as appropriate, (2) to specify different or additional conditions as appropriate, including
information provided in support of a request for issuance of an emergency dispensing order (e.g.,
to accommodate or address specific response strategies or operational considerations), and (3)
when appropriate, to waive CGMP requirements under section 564A(c), as discussed more fully
in section IV.C of this guidance.
In appropriate cases, FDA may also coordinate with CDC so that FDA issuance of an emergency
dispensing order accompanies CDC issuance of emergency use instructions for the same MCM,
as discussed in section IV.E of this guidance.
3. Duration of an Emergency Dispensing Order
In most cases, an emergency dispensing order issued by FDA for preparedness purposes in
advance of a CBRN event will remain in effect until it is revised or revoked by a subsequent
FDA order. FDA may specify a duration (e.g., 1 year) for an emergency dispensing order, but, if
it does so, may extend the order as appropriate.
37
E. EMERGENCY USE INSTRUCTIONS WITHOUT AN EUA
CDC may create, issue, and disseminate special emergency use instructions (EUI) concerning an
eligible MCM’s approved, licensed, or cleared conditions of use (section 564A(e)). 72 EUI are
intended to be similar to “Fact Sheets” that have been authorized in past EUAs, and may be
directed to health care professionals and authorized dispensers or to recipients of an eligible
MCM. EUI may be created and disseminated both before a CBRN event occurs and during a
response.
During past public health emergencies, there were concerns that instructions for administering
MCMs, even those MCMs that were FDA-approved for the disease or condition (e.g.,
doxycycline for post-exposure prophylaxis of inhalational anthrax), that deviate from FDA-
approved product labeling would violate the FD&C Act and thus invalidate any liability
protection otherwise provided under the PREP Act. When an EUI is issued pursuant to this
provision, that issuance would not deprive the product of otherwise-applicable PREP Act
protection. Therefore, the EUI provisions offer enhanced flexibility for CDC to prepare and
disseminate EUI concerning a disease or condition for which an MCM is FDA-approved,
licensed, or cleared without further limitation. FDA and CDC interpret this provision as
permitting the creation of EUI that describe how the approved drug may be used, for the disease
or condition for which it is approved, but in ways that may deviate from or extend beyond the
FDA-approved labeling. EUI would not, on the other hand, be permitted to describe uses of an
FDA-approved product for diseases or conditions for which the product has not been approved.
V. GOVERNMENTAL PRE-POSITIONING OF MCMs
A new provision added by PAHPRA permits pre-positioning of MCMs without FDA approval
when the product(s) is intended to be held (and not used) for emergency use (section 564B),
allowing stakeholders to prepare for rapid deployment of MCMs during an emergency. This
authority allows government stakeholders, or a person acting on behalf of a government
stakeholder, e.g., an agent of the government stakeholder, to introduce into interstate commerce
(e.g., stockpile or transport) a medical product intended for emergency use without violating the
FD&C Act regardless of a product’s regulatory status (i.e., without an IND, IDE, or any other
acknowledgement by FDA), but in anticipation that use will be permitted under an appropriate
regulatory mechanism (i.e., FDA approval, authorization, or for investigational use).
The authority to pre-position MCMs applies to all categories of medical products intended for
emergency use, including those that are approved, unapproved, investigational, or authorized for
use under an EUA. However, a government stakeholder may only rely on this authority if the
72
Section 564A(e) allows a designated HHS official to create and issue EUI. Although EUI authority is
part of the FD&C Act, on the joint recommendation of FDA, CDC, and the ASPR, the Secretary of HHS
granted the authority to create EUI to the Director of CDC (or his/her designee). Allowing CDC to create
and disseminate EUI is consistent with CDC’s clinical expertise in providing event-driven treatment
recommendations and facilitating emergency response with external stakeholders, as well as its front-line
role in managing the SNS of medical products for which EUI may be most needed. See FDA and CDC’s
Memorandum of Understanding related to EUI coordination at FDA’s website:
http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/u
cm487464.htm.
38
MCMs are in fact held and not used to diagnose, treat, or prevent the CBRN-related disease or
condition until permitted under one of these mechanisms. This means, for example, that even
though a government stakeholder may stockpile an unapproved MCM, additional action likely
will be required to ensure that any pre-positioned MCM can be used when needed. FDA,
therefore, recommends that government stakeholders also consider and, if appropriate, initiate
steps to ensure an approval can be granted, or that an IND/IDE or EUA is in place or can be
readily put in place if necessary.
Those relying on this provision will have to maintain documentation that shows the product
qualifies to be held for emergency use, including records reflecting the government stakeholder’s
initial intent to hold and not use the MCM until such time as it may be used under an appropriate
regulatory mechanism. At this time, FDA is not specifying any additional recordkeeping
methods relating specifically to pre-positioned MCMs. The Agency recommends, however, that
to the extent feasible government stakeholders maintain sufficient records or other information to
be able to readily identify their pre-positioned MCMs (e.g., by product name, manufacturer's
name, dosage form and strength, quantity held, lot number) as well as the distribution, storage,
and ultimate disposition of those MCMs. 73 For unapproved products, this information likely will
be an element of the records required to be maintained for use under an IND/IDE or EUA. In
addition, this information will help minimize the risks of misidentification, theft or other loss,
and product deterioration. As an example, an MCM that a government stakeholder cannot verify
has been properly stored might not qualify for use under an EUA or for an otherwise applicable
extension of the product’s shelf life because of a lack of information about the condition of the
product.
VI. PREEMPTION
FDA anticipates that conflicts between federal and state law 74 may arise when FDA acts under
sections 564, 564A, and 564B if states have existing requirements governing the shipment,
holding, dispensing, administration, or labeling of unapproved medical products or approved
medical products for unapproved uses. 75 Courts have stated that the Supremacy Clause of the
U.S. Constitution can operate to nullify both state legislative requirements and state common-law
73
Absent a CGMP waiver (see section III.E.5 of this guidance), government stakeholders, or person(s) acting on
their behalf, should continue to store and handle pre-positioned MCMs to support their use according to CGMP
standards.
74
While FDA believes that preemption applies here, it recognizes that this is a controversial area of the
law. Because attorneys advising some state response programs may take a different view than that
expressed here, FDA encourages state programs to consult with their legal counsel as to whether they
believe that their states would need to take complementary legal action to assure that their state laws would
not conflict with actions that the Federal government might take pursuant to section 564 and 564A or that
might affect pre-positioning under section 564B. If such state action is considered to be necessary, it will
be important that any required changes in state law, or any steps necessary to implement state laws to
permit emergency preparedness actions pursuant to these sections, be determined as part of the state’s
emergency planning.
75
Such issues may also arise when FDA issues a waiver of CGMP requirements pursuant to section
564A(c), or an order to permit emergency dispensing pursuant to section 564A(d).
39
duties. 76 Under the legal principles of implied conflict preemption, courts have found state law
preempted where it is impossible to comply with both federal and state law, or when the state
law "stands as an obstacle to the accomplishment and execution of the full purposes and
objectives of Congress." 77 Consistent with this case law, section 4(a) of Executive Order 13132
states that "[a]gencies shall construe... a Federal statute to preempt State law only where the
statute contains an express preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of State authority conflicts
with the exercise of Federal authority under the Federal statute." 78
FDA believes that the terms and conditions of an EUA issued under section 564 preempt
state or local law, both legislative requirements and common-law duties, that impose
different or additional requirements on the medical product for which the EUA was
issued in the context of the emergency declared under section 564. Similarly, an order or
waiver issued under section 564A and pre-positioning under section 564B preempt state
or local law, both legislative requirements and common-law duties, that impose different
or additional requirements related to the activity authorized under sections 564A or 564B.
To the extent state or local law may impose requirements different from or in addition to
those imposed by the EUA for a particular medical product within the scope of the
declared emergency or threat of emergency (e.g., requirements on prescribing,
dispensing, administering, or labeling of the medical product), such law “stands as an
obstacle to the accomplishment and execution of the full purposes and objectives of
Congress,” and “conflicts with the exercise of Federal authority under [§ 564].” The same
rationale applies to an order or waiver issued under section 564A and pre-positioning of
an MCM under section 564B.
Affected state laws may include, but are not limited to, laws governing the administration
of investigational medical products, such as informed consent laws and laws requiring
Institutional Review Board approval, and laws governing the prescribing or dispensing of
medical products, such as laws limiting who may prescribe or dispense medical products
and under what circumstances.
Moreover, the PREP Act, which expressly provides immunity from tort liability
associated with certain MCM activities, preempts state laws that are different from, or in
conflict with, any requirement applicable to a covered countermeasure under the PREP
76
Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., concurring in part and concurring in the
judgment); id. at 510 (O'Connor, J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring in part
and dissenting in part); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521 (1992) (plurality opinion); id. at
548-49 (Scalia, J., joined by Thomas, J., concurring in judgment in part and dissenting in part). Under the
same reasoning, state regulations and local ordinances would also be preempted.
77
See Arizona v. United States, 132 S. Ct. 2492, 2501, 2505, 2507 (2012); Crosby v. National Foreign
Trade Council, 530 U.S. 363, 373 (2000); Geier v. American Honda Motor Company, Inc., 529 U.S. 861,
873 (2000); Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
78
Exec. Order No. 13132, 64 FR 43255 (August 4, 1999).
40
Act and relating to, among other things, any matter applicable because of a requirement
of the FD&C Act. 79 This includes actions taken to meet the terms of an EUA, an order or
waiver issued under section 564A, pre-positioning of an MCM under section 564B, an
IND or IDE, or any FDA approval of an MCM.
In an emergency, it is critical that the conditions that are part of the EUA or an order or waiver
issued pursuant to section 564A—those that FDA has determined to be necessary or appropriate
to protect the public health—be strictly followed, and that no additional conditions be imposed.
To the extent there may be circumstances in which FDA would like people carrying out activities
under an EUA to also comply with requirements contained in preempted state law, FDA
anticipates incorporating such requirements into the terms and conditions of the EUA.
Similarly, an extension of expiration dating under section 564A(b), a waiver of CGMP

requirements under section 564A(c), and an FDA order permitting emergency dispensing
pursuant to section 564A(d) are actions intended to protect the public health by enabling rapid
public access to potentially life-saving medical products during an emergency. State laws that
govern CGMP requirements or the dispensing of products covered by an FDA extension of
expiration dating, CGMP waiver, or emergency dispensing order and that impose different or
additional conditions that would limit the access to eligible products covered by FDA’s action,
would be an obstacle to achieving that goal. Therefore, FDA believes that state laws within the
jurisdictional coverage of an FDA extension of expiration dating, CGMP waiver, or emergency
dispensing order that impose more restrictive conditions or requirements on dispensing products
covered by the FDA order, or pre-positioning of MCMs under section 564B will be preempted.
As noted above, however, state laws may permit emergency dispensing of eligible MCMs.
Under section 564A(d), such laws may provide another basis on which government stakeholders
may be able to provide for emergency dispensing without a prescription or adherence to other
prescription requirements that might otherwise apply. 80 An FDA order issued under section
564A(d) is not intended to replace those frameworks as long as they are not more restrictive than
the FDA’s order in providing for access to the FDA-approved product(s) that the order covers.
VII. LIABILITY PROTECTION
Apart from any applicable preemption principles, sections 564, 564A, and 564B do not confer
explicit liability protections for stakeholders who carry out any activity under these authorities.
79
42 U.S.C. § 247d-6d(b)(8).
80
Whether or not a particular state legal provision or action is sufficient to permit the emergency
dispensing strategy that state or local government stakeholders anticipate conducting within their state rests
in large part on the interpretation of that state law, which is a matter that should first be directed to the
appropriate legal authority within the relevant jurisdiction (e.g., the state Attorney General). To ensure
clarity, and perhaps increase the likelihood that state laws, regulations, orders, or other legal actions to
permit emergency dispensing are deemed sufficient, it is recommended that such actions address the same
eligibility, scope, duration, and other elements FDA intends to address in its emergency dispensing orders,
as described above.
41
The PREP Act, 81 however, may provide for immunity from tort liability related to activities
authorized under such authorities. More specifically, the PREP Act authorizes the HHS
Secretary to issue a declaration (called a PREP Act declaration) that provides immunity (except
for willful misconduct) for claims related to administration or use of countermeasures against
CBRN agents to entities and individuals involved in the development, manufacture, testing,
distribution, administration, and use of such countermeasures. 82 The PREP Act authority,
including the authority to issue PREP Act declarations, resides with the Secretary of HHS and
has not been delegated to FDA.
The PREP Act liability protections apply to “covered countermeasures” as defined by the
statute. 83 Covered countermeasures include medical products that are approved, cleared, or
licensed by FDA; authorized for investigational use under an IND or IDE by FDA; authorized
for emergency use under section 564; or otherwise permitted to be held or used pursuant to
sections 564A and 564B. As discussed in section IV of this guidance, in the past, EUAs have
been issued in part to address concerns that certain activities related to MCMs potentially
violated provisions of the FD&C Act, jeopardizing otherwise-applicable PREP Act protections.
PAHPRA added sections 564A and 564B to the definitions of “covered countermeasure” in part
to preserve these otherwise-applicable PREP Act protections.
VIII. IMPORTING AND EXPORTING MEDICAL PRODUCTS UNDER AN

EUA
Although an EUA is not an FDA-approval, a medical product authorized for emergency

use under an EUA may be introduced into interstate commerce during the effective
period of the EUA declaration, and as such, contingent upon compliance with the terms
and conditions of the authorization, may be legally imported and exported under section
801 of the FD&C Act (21 U.S.C. 381). The letter of authorization should serve as
appropriate documentation or certification that the product may be legally imported or
exported.
In the past, FDA has received EUA requests for which the primary emergency use of the
investigational medical product would be in a foreign country (e.g. for use in West Africa
during the Ebola crisis). The assessment of whether to issue an EUA in these cases is the
same as for any other emergency use: FDA must determine whether the requisite EUA
determination, declaration, and criteria (as described in section III.A and III.B of this
guidance) are met and consider whether it is feasible or practicable in the foreign setting
to comply with the necessary and appropriate conditions of use (as described in section
III.E of this guidance).
81
42 U.S.C. 247d-6d. For information on the PREP Act, see HHS’s website at
http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
82
42 U.S.C. 247d-6d(b).
83
42 U.S.C.247d-6d(i)(1) and (7).
42
IX. PAPERWORK REDUCTION ACT OF 1995
This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 85

hours per response, including the time to review instructions, search existing data
sources, gather the data needed, and complete and review the information collection.
Send comments regarding this burden estimate or suggestions for reducing this burden to:
Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002.
This guidance refers to previously approved collections of information found in FDA

regulations. The collections of information for: adverse experience reporting for
biological products is approved under OMB control number 0910-0308; adverse drug
experience reporting is approved under OMB control number 0910-0230; adverse device
experience reporting is approved under OMB control number 0910-0471; investigational
new drug application regulations are approved under OMB control number 0910-0014;
and investigational device exemption reporting is approved under OMB control number
0910-0078.
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The
OMB control number for this information collection is 0910-0595 (expires 08/31/2019).
43
List of Acronyms
Assistant Secretary for Preparedness and Response (ASPR)

Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Centers for Disease Control and Prevention (CDC)
Center for Drug Evaluation and Research (CDER)
Chemical, biological, radiological, and nuclear (CBRN)
Clinical Laboratory Improvement Amendments (CLIA)
Current Good Manufacturing Practice (CGMP)
Department of Health and Human Services (HHS)
Department of Homeland Security (DHS)
Department of Defense (DoD)
Emergency Use Authorizations (EUAs)
Emergency Use Instructions (EUI)
Federal Food, Drug, and Cosmetic Act (FD&C Act)
Federal Shelf-Life Extension Program (SLEP)
Food and Drug Administration (FDA)
Good Laboratory Practice for Nonclinical Laboratory Studies regulations (GLP)
Investigational Device Exemption (IDE)
Investigational New Drug Application (IND)
In Vitro Diagnostic (IVD)
Medical Countermeasure (MCM)
National Institutes of Health (NIH)
Office of Counterterrorism and Emerging Threats (OCET)
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
Points of Dispensing (PODs)
Public Health Service (PHS) Act
Public Readiness and Emergency Preparedness (PREP) Act
Risk Evaluation and Mitigation Strategy (REMS)
Safety Information and Adverse Event Reporting System (MedWatch)
Secretary of Health and Human Services (HHS Secretary or Secretary of HHS)
Strategic National Stockpile (SNS)
Vaccine Adverse Event Reporting System (VAERS)
World Health Organization (WHO)
44
Appendix A. EUA Conditions of Authorization: Required a vs. Discretionary b
Condition Unapproved Unapproved FD&C Act

Product Use of an Section
Approved
Product
Information (“fact sheets”) for healthcare Required Required § 564(e)(1)(A)(i)
providers administering the product § 564(e)(2)(A)
(significant known/potential benefits/risks of
product and extent to which benefits/ risks are
unknown; FDA has authorized emergency use)
Information (“fact sheets”) for product Required Required § 564(e)(1)(A)(ii)
recipients § 564(e)(2)(A)
(significant known/potential benefits/risks of
product and extent to which benefits/ risks are
unknown, option to accept or refuse product,
consequences of refusing, available alternatives,
FDA has authorized emergency use)
Adverse event monitoring and reporting Required Discretionary § 564(e)(1)(A)(iii)
§ 564(e)(2)(A)
Recordkeeping and reporting Required Discretionary § 564(e)(1)(A)(iv)
(by product manufacturers) § 564(e)(2)(A)
Recordkeeping and reporting Discretionary Discretionary § 564(e)(1)(B)(iv)
(by persons other than product manufacturers) § 564(e)(2)(A)
Product distribution Discretionary Discretionary c § 564(e)(1)(B)(i)
(which entities may distribute product and how to § 564(e)(2)(A)
perform distribution)
Product administration Discretionary Discretionaryc § 564(e)(1)(B)(ii)
(who may administer product and categories of § 564(e)(2)(A)
individuals to whom, and circumstances under
which, product may be administered )
Data collection and analysis Discretionary Discretionary § 564(e)(1)(B)(iii)
(concerning product safety/effectiveness) § 564(e)(2)(A)
CGMP and prescription waiver or limit Discretionary Discretionary § 564(e)(3)
Advertising/other promotional material Discretionary Discretionary § 564(e)(4)
Other Discretionary Discretionary § 564(e)(1)(B)
(any other condition FDA finds necessary or § 564(e)(2)(A)
appropriate to protect the public health)
a
Under section 564(e)(1)(A) of the FD&C Act, “required conditions” must be imposed by FDA in an EUA
to the extent practicable given the applicable circumstances described in the HHS Secretary’s EUA
declaration under section 564(b)(1) of the FD&C Act. See also section 564(e)(2)(A) (same rule for
unapproved uses of an approved drug).
b
Discretionary conditions may be included in an EUA at FDA’s discretion as deemed necessary to protect
the public health. See section 564(e)(1)(B); section 564(e)(2)(A).
c
Such conditions for an unapproved use of an approved product may not restrict distribution or
administration of the product when it is distributed or administered for the approved use. See section
564(e)(2)(C).
45

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Middle Tennessee State University

Avery Garfield and Dr. Jenny Sauls

Middle Tennessee State University

Dr. Jenny Sauls

v. Civil Action No. : _________________

MIDDLE TENNESSEE STATE JURY DEMAND

COMPLAINT FOR DECLARATORY JUDGMENT

would show unto the Court the following:

resides in Murfreesboro, Rutherford County, Tennessee.

2. Respondent Middle Tennessee State University is a public university located in

Murfreesboro, Rutherford County, Tennessee.

Tennessee State University.

II. JURISDICTION AND VENUE

claimed.” Tenn. Code Ann. § 29-14-102 (a) (emphasis added).

for.” Tenn. Code Ann. § 29-14-102(b) (emphasis added).

or decree.” Tenn. Code Ann. § 29-14-102(c).

8. Venue is proper pursuant to Tenn. Code Ann. § 20-4-101.

III. PETITIONER HAS STANDING FOR A DECLARATION OF HER RIGHTS AND

Ann. § 29-14-101 et seq.

amend. I (emphasis added).

L.Ed.2d 642 (1972) (emphasis added).

grievances, or other proper purposes, by address of remonstrance.” (Emphasis added).

15. Pursuant to well-established Tennessee law, “Notwithstanding any law to the

Code Ann. § 1-3-121 (emphasis added).

intent behind passing Tenn. Code Ann. § 1-3-121 in 2018.

the hearing proceeded as follows:

Representative Glen Casada: Madame Speaker, this bill clarifies

Representative Glen Casada: This legislation has nothing to do with

Representative John Ray Clemmons: Uh, Mr. Leader, the breadth of

Representative Glen Casada: Declaratory action.

Representative John Ray Clemmons: Or injunctive relief?

Representative Glen Casada: Or injunctive. But not…

Representative John Ray Clemmons: Across the board?

Representative Glen Casada: That is the intent. We have a

Representative Glen Casada: I would submit that we are making

Representative John Ray Clemmons: Well, you still have a standing

Representative Glen Casada: No I am giving standing to the

Representative John Ray Clemmons: Regardless of whether or not

Representative Glen Casada: Madame Speaker, can I defer this to

Representative John Ray Clemmons: Maybe we need to roll this a

Representative John Ray Clemmons: I appreciate that response and

Representative Mike Carter: Yes, sir.

“Standing”, March 15, 2018 (emphasis added).

18. Middle Tennessee State University is a public university located in Murfreesboro,

IV. PETITIONER’S GREIVANCES AGAINST MTSU AND DR. SAULS

that a Public Health Emergency Exists, https://www.phe.gov/emergency/news/healthactions/phe

/Pages/2019-nCoV.aspx (last visited July 31, 2021) (attached as Exhibit “1”.

title … (referred to in this section as unapproved product)….” 21 U.S.C. § 360bbb-3(a)(1)-(2).

C. THERE IS NO FDA-APPROVED COVID-19 VACCINE. ALL COVID VACCINES

19 Vaccine is an unapproved vaccine….” Id (emphasis added).

Emergency Use Authorization (EUA).” Id (emphasis added).

in Individuals 18 Years of Age and Older, https://www.modernatx.com/covid19vaccine-eua/eua-fact-

Vaccine is an unapproved vaccine that may prevent COVID-19.” Id (emphasis added).

emergency use of the Moderna COVID-19 Vaccine ….” Id (emphasis added).

Caregivers Emergency Use Authorization (EUA) of the Pfizer-Biontech COVID-19 Vaccine to

https://www.fda.gov/media/144414/download (last visited August 1, 2021) (emphasis added)

(attached ad Exhibit “4”).

to prevent COVID-19.” Id (emphasis added).