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
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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,

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(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
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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

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 15200 Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices

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.
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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

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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
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(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

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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
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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.

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 Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices 15203

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
khammond on DSKJM1Z7X2PROD with NOTICES

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.

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