[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 35100-35102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Second 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 issues this amendment pursuant to section 319F-3 
of the Public Health Service Act to clarify that Covered 
Countermeasures

[[Page 35101]]

under the Declaration include qualified pandemic and epidemic products 
that limit the harm COVID-19 might otherwise cause.

DATES: This amendment to the Declaration as published on March 17, 2020 
(85 FR 15198) was effective as of February 4, 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 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, Sec.  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. 
Section 319F-3 of the PHS Act has been amended by the Pandemic and All-
Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, 
enacted on March 13, 2013, and the Coronavirus Aid, Relief, and 
Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 
2020, to expand Covered Countermeasures under the PREP 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, 
effective January 27, 2020, for the entire United States to aid in the 
response of the nation's health care community to the COVID-19 
outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed 
that Declaration on April 26, 2020. On March 10, 2020, the Secretary 
issued a Declaration under the PREP Act for medical countermeasures 
against COVID-19 (85 FR 15198, Mar. 17, 2020). On April 10, the 
Secretary amended the March 10, 2020 Declaration under the PREP Act to 
extend liability immunity to covered countermeasures authorized under 
the CARES Act (85 FR 21012, Apr. 15, 2020).
    The Secretary now amends the March 10, 2020, Declaration to clarify 
that covered countermeasures under the Declaration include qualified 
products that limit the harm COVID-19 might otherwise cause. 42 U.S.C. 
247d-6d(i)(7)(A)(i)(II). This amendment is made in accordance with 
section 319F-3(b)(4) of the PHS Act, which authorizes the Secretary to 
amend a PREP Act Declaration at any time.

Description of This Amendment by Section

Section VI. Covered Countermeasures

    Section VI of the Declaration identifies the Covered 
Countermeasures for which the Secretary has recommended activities 
under section III of the Declaration. The PREP Act, as amended, 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.
    As described in section VI of the preamble to the March 10, 2020 
Declaration, the PREP Act further defines a ``qualified pandemic or 
epidemic product'' to mean a drug or device, as defined in the FD&C Act 
or a biological product, as defined in the PHS Act that is (i) 
manufactured, used, designed, developed, modified, licensed or procured 
to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic 
or limit the harm such a pandemic or epidemic might otherwise cause; 
(ii) manufactured, used, designed, developed, modified, licensed, or 
procured to diagnose, mitigate, prevent, treat, or cure a serious or 
life-threatening disease or condition caused by such a drug, biological 
product, or device; or (iii) a product or technology intended to 
enhance the use or effect of such a drug, biological product, or 
device. A qualified pandemic or epidemic product must also be approved, 
cleared, licensed, or authorized for investigational or emergency use 
under the FD&C Act or PHS Act. The Coronavirus Aid, Relief, and 
Economic Security (CARES) Act section 3103, Public Law 116-136 (Mar. 
27, 2020), amended the PREP Act to add respiratory protective devices 
to the list of covered countermeasures so long as they are NIOSH 
approved and determined by the Secretary to be a priority for use 
during a public health emergency declared by the Secretary under 
section 319 of the Public Health Service Act. 85 FR 21012 (Apr. 15, 
2020) (amending the Declaration effective March 27, 2020 to address 
this statutory change).
    The Secretary intended section VI of the March 10, 2020 Declaration 
to include all qualified pandemic and epidemic products defined under 
the PREP Act and described in the preamble to the Declaration. But 
section VI of the March 10, 2020 Declaration identified Covered 
Countermeasures under the Declaration as ``any antiviral, any other 
drug, any biologic, any diagnostic, any other 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.'' 85 FR 15202. That 
description omitted the phrase from the statutory definition that 
qualified pandemic and epidemic products may also include products that 
``limit the harm such a pandemic or epidemic might otherwise cause.'' 
The Secretary intended to identify the full range of qualified 
countermeasures in the March 10, 2020 Declaration. The Secretary 
accordingly amends section VI of the Declaration to clarify that 
intent.
    Qualified pandemic and epidemic products that limit the harm that 
COVID-19 might otherwise cause are those that would not have been 
manufactured, administered, used, designed, developed, modified, 
licensed, or procured but for the COVID-19 pandemic, even when the 
products are manufactured, administered, used, designed, developed, 
modified, licensed, or procured to diagnose, mitigate, prevent, treat, 
or cure health threats or conditions other than COVID-19. For example, 
the COVID-19 pandemic has resulted in shortages of certain drugs and 
devices that the FDA has authorized. These drugs and devices may be 
used for COVID-19 and other health conditions. Those shortages are 
``harm[s] [COVID-19] might otherwise cause.'' Filling those shortages 
caused by COVID-19 reduces the strain on the American healthcare system 
by mitigating the escalation of adverse

[[Page 35102]]

health conditions from COVID-19 and non-COVID-19 causes. And mitigating 
that escalation conserves limited healthcare resources--from personal 
protective equipment to healthcare providers--which are essential in 
the whole-of-Nation response to the COVID-19 pandemic.

Amendments to Declaration

    Amended Declaration for Public Readiness and Emergency Preparedness 
Act Coverage for medical countermeasures against COVID-19.
    Section VI of the March 10, 2020, Declaration under the PREP Act 
for medical countermeasures against COVID-19, as amended April 10, 
2020, is further 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 (Mar. 17, 2020) and amended at 85 
FR 21012 (Apr. 15, 2020).
    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
    (1) any antiviral, any other drug, any biologic, any diagnostic, 
any other device, any respiratory protective device, or any vaccine, 
used
    a. to treat, diagnose, cure, prevent, mitigate or limit the harm 
from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating 
therefrom, or
    b. to limit the harm that COVID-19, or the transmission of SARS-
CoV-2 or a virus mutating therefrom, might otherwise cause; or
    (2) 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 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.

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

    Dated: June 4, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020-12465 Filed 6-4-20; 4:15 pm]
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