[Federal Register Volume 85, Number 73 (Wednesday, April 15, 2020)]
[Notices]
[Pages 21012-21014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Amendment to Declaration Under the Public Readiness and Emergency 
Preparedness Act for Medical Countermeasures Against COVID-19

ACTION: Notice of amendment.

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SUMMARY: The Secretary is issuing this amendment pursuant to section 
319F-3 of the Public Health Service Act to extend liability immunity 
for activities related to medical countermeasures against COVID-19 
authorized under the Coronavirus Aid, Relief, and Economic Security 
Act.

DATES: The amendment to the Declaration published on March 17, 2020 (85 
FR 15198) was effective as of March 27, 2020.

FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS, 
Assistant Secretary for Preparedness and Response, Office of the 
Secretary, Department of Health and Human Services, 200 Independence 
Avenue

[[Page 21013]]

SW, Washington, DC 20201; Telephone: 202-205-2882.

SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency 
Preparedness Act (PREP Act) authorizes the Secretary of Health and 
Human Services (the Secretary) to issue a Declaration to provide 
liability immunity to certain individuals and entities (Covered 
Persons) against any claim of loss caused by, arising out of, relating 
to, or resulting from the manufacture, distribution, administration, or 
use of medical countermeasures (Covered Countermeasures), except for 
claims involving ``willful misconduct'' as defined in the PREP Act. 
Under the PREP Act, a Declaration may be amended as circumstances 
warrant.
    The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, Section 2. It amended the Public Health Service (PHS) 
Act, adding Section 319F-3, which addresses liability immunity, and 
Section 319F-4, which creates a compensation program. These sections 
are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. 
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public 
Law 116-136 was enacted on March 27, 2020. The CARES Act amended 
section 319F-3(i)(1)(D) of the PHS Act, first added by the Families 
First Coronavirus Response Act, Public Law 116-127 on March 18, 2020. 
These amendments created a new category of covered countermeasures 
eligible for liability immunity under the PREP Act, namely, respiratory 
protective devices approved by the National Institute for Occupational 
Safety and Health (NIOSH) under 42 CFR part 84, or any successor 
regulations, that the Secretary determines to be a priority for use 
during a public health emergency declared under section 319 of the PHS 
Act.
    On January 31, 2020, the Secretary declared a public health 
emergency, pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, for 
the entire United States to aid in the response of the nation's health 
care community to the COVID-19 outbreak. On March 10, 2020, the 
Secretary issued a Declaration under the PREP Act for medical 
countermeasures against COVID-19 (85 FR 15198 (March 17, 2020)). The 
Secretary is amending the March 10, 2020 Declaration under the PREP Act 
to extend liability immunity to covered countermeasures authorized 
under the CARES Act. This amendment is made in accordance with section 
319F-3 of the PHS Act, which authorizes the Secretary to amend a PREP 
Act declaration at any time.

Description of This Amendment by Section

Section I. Determination of Public Health Emergency or Credible Risk of 
Future Public Health Emergency

    Before issuing a Declaration under the PREP Act, the Secretary is 
required to determine that a disease or other health condition or 
threat to health constitutes a public health emergency or that there is 
a credible risk that the disease, condition, or threat may constitute 
such an emergency. This determination is separate and apart from the 
Declaration issued by the Secretary on January 31, 2020 under section 
319 of the PHS Act that a disease or disorder presents a public health 
emergency or that a public health emergency, including significant 
outbreaks of infectious diseases or bioterrorist attacks, otherwise 
exists, or other Declarations or determinations made under other 
authorities of the Secretary. As amended by the CARES Act, to extend 
the Declaration to respiratory protective devices approved by NIOSH, 
the Secretary must also determine that a respiratory protective device 
approved by NIOSH under 42 CFR part 84, or any successor regulations, 
is a priority for use during the public health emergency declared by 
the Secretary under section 319 of the PHS Act.
    Accordingly, in Section I of the Declaration, the Secretary is 
amending his determination that the spread of SARS-CoV-2 or a virus 
mutating therefrom and the resulting disease, COVID-19, constitutes a 
public health emergency for purposes of this Declaration under the PREP 
Act to include the determination that the use of any respiratory 
protective devices approved by NIOSH under 42 CFR part 84, or any 
successor regulations, is a priority for use during the public health 
emergency declared by the Secretary on January 31, 2020 under section 
319 of the PHS Act for the entire United States to aid in the nation's 
health care community response to the COVID-19 outbreak.

Section VI. Covered Countermeasures

    Section VI of the Declaration identifies the Covered 
Countermeasures for which the Secretary has recommended such 
activities. As amended by the CARES Act, the PREP Act states that a 
``Covered Countermeasure'' must be a ``qualified pandemic or epidemic 
product,'' a ``security countermeasure,'' a drug, biological product, 
or device authorized for emergency use in accordance with sections 564, 
564A, or 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act, or a 
respiratory protective device approved by NIOSH under 42 CFR part 84, 
or any successor regulations, that the Secretary determines to be a 
priority for use during a public health emergency declared under 
section 319 of the PHS Act. Accordingly, in Section VI of the 
Declaration, the Secretary is amending the list of medical 
countermeasures against COVID-19 that are covered countermeasures under 
the declaration to include covered countermeasures authorized by the 
CARES Act, namely respiratory protective devices approved by NIOSH 
under 42 CFR part 84, or any successor regulations, that the Secretary 
determines to be a priority for use during a public health emergency 
declared under section 319 of the PHS Act.

Section XII. Effective Time Period

    The Secretary must identify, for each Covered Countermeasure, the 
period or periods during which liability immunity is in effect, 
designated by dates, milestones, or other description of events, 
including factors specified in the PREP Act. Accordingly, the Secretary 
is amending Section XII of the Declaration to specify the effective 
time period for covered countermeasures authorized by the CARES Act.

Amendments to Declaration

    Amended Declaration for Public Readiness and Emergency Preparedness 
Act Coverage for medical countermeasures against COVID-19.
    Sections I, VI and XII of the March 10, 2020, Declaration under the 
PREP Act for medical countermeasures against COVID-19 are amended 
pursuant to section 319F-3(b)(4) of the PHS Act as described below. All 
other Sections of the Declaration remain in effect as published at 85 
FR 15198 (March 17, 2020).
    1. Determination of Public Health Emergency, Section I: Delete in 
full and replace with:
I. Determination of Public Health Emergency
42 U.S.C. 247d-6d(b)(1)

    I have determined that the spread of SARS-CoV-2 or a virus mutating 
therefrom and the resulting disease COVID-19 constitutes a public 
health emergency. I further determine that use of any respiratory 
protective device approved by NIOSH under 42 CFR part 84, or any 
successor regulations, is a priority for use during the public health 
emergency that I declared on January

[[Page 21014]]

31, 2020 under section 319 of the PHS Act for the entire United States 
to aid in the response of the nation's health care community to the 
COVID-19 outbreak.
    2. Covered Countermeasures, Section VI, delete in full and replace 
with:
VI. Covered Countermeasures
42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

    Covered Countermeasures are any antiviral, any other drug, any 
biologic, any diagnostic, any other device, any respiratory protective 
device, or any vaccine, used to treat, diagnose, cure, prevent, or 
mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus 
mutating therefrom, or any device used in the administration of any 
such product, and all components and constituent materials of any such 
product.
    Covered Countermeasures must be ``qualified pandemic or epidemic 
products,'' or ``security countermeasures,'' or drugs, biological 
products, or devices authorized for investigational or emergency use, 
as those terms are defined in the PREP Act, the FD&C Act, and the 
Public Health Service Act, or any respiratory protective device 
approved by NIOSH under 42 CFR part 84, or any successor regulations.
    3. Effective Time Period, Section XII, delete in full and replace 
with:
XII. Effective Time Period
42 U.S.C. 247d-6d(b)(2)(B)

    Liability immunity for any respiratory protective device approved 
by NIOSH under 42 CFR part 84, or any successor regulations, through 
means of distribution, as identified in Section VII(a) of this 
Declaration, other than in accordance with the public health and 
medical response of the Authority Having Jurisdiction, begins on March 
27, 2020 and extends through October 1, 2024.
    Liability immunity for all other Covered Countermeasures identified 
in Section VI of this Declaration, through means of distribution, as 
identified in Section VII(a) of this Declaration, other than in 
accordance with the public health and medical response of the Authority 
Having Jurisdiction, begins February 4, 2020 and extends through 
October 1, 2024.
    Liability immunity for all Covered Countermeasures administered and 
used in accordance with the public health and medical response of the 
Authority Having Jurisdiction begins with an emergency declaration and 
lasts through (1) the final day the emergency Declaration is in effect, 
or (2) October 1, 2024, whichever occurs first.

    Authority:  42 U.S.C. 247d-6d.

    Dated: April 10, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020-08040 Filed 4-13-20; 4:15 pm]
 BILLING CODE 4150-28-P