[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Notices]
[Pages 78978-78981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Notice of amendment

ACTION: Notice of amendment.

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SUMMARY: The Secretary is amending the Declaration issued in the 
Federal Register of October 10, 2008, as amended April 26, 2009; 
December 17, 2008; February 29, 2012; and as amended and republished 
January 1, 2016, pursuant to section 319F-3 of the Public Health 
Service Act to extend the effective time period of the Republished 
Declaration, as amended.

DATES: This amendment of the January 1, 2016 Republished Declaration is 
effective January 1, 2023.

FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Administration for 
Strategic Preparedness and Response, Department of Health and Human 
Services, 200 Independence Avenue SW, Washington, DC 20201; 202-260-
0365, [email protected].

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 administration or use of medical 
countermeasures (Covered Countermeasures), except for claims that meet 
the PREP Act's definition of willful misconduct. The Secretary may, 
through publication in the Federal Register, amend any portion of a 
Declaration. Using this authority, the

[[Page 78979]]

Secretary issued several Declarations for countermeasures against 
pandemic influenza: (1) An October 10, 2008, Declaration covering the 
neuraminidase class of antivirals Oseltamivir Phosphate (e.g., Tamiflu) 
and Zanamivir (e.g., Relenza) (hereinafter, ``antivirals 
Declaration''); (2) a December 17, 2008, Declaration covering pandemic 
influenza diagnostics, personal respiratory protection devices, and 
respiratory support devices (hereinafter ``diagnostics and other 
devices Declaration''); (3) a February 29, 2012, amended Declaration 
covering pandemic influenza vaccines (hereinafter, ``vaccines 
Declaration''); and (4) a January 1, 2016, amendment republishing the 
prior Declarations as a single Declaration in its entirety, as amended 
(hereinafter, ``Declaration''); and is amending the Republished 
Declaration.
    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 in the U.S. Code as 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.
    This Secretary is now amending the Republished Declaration to 
extend the time period for which liability immunity is in effect for 
all of the Covered Countermeasures to December 31, 2027. Pandemic 
influenza A viruses and influenza A viruses with pandemic potential 
continue to pose a public health threat to the United States. These 
Influenza A viruses have the potential to become highly transmissible 
in the U.S. population, causing significant morbidity and mortality. 
PREP Act coverage of Influenza A countermeasures is critical to enable 
continuity of ongoing programs for development of critical diagnostics, 
vaccines, and therapeutics, and accomplish national pandemic 
preparedness goals. In addition, PREP Act declaration renewal is 
essential to support uninterrupted readiness and access to stockpiled 
pre-pandemic influenza vaccines to mitigate an emerging pandemic.
    Unless otherwise noted, all statutory citations below are to the 
U.S. Code.

Republished Declaration

Declaration, as Amended, for Public Readiness and Emergency 
Preparedness Act Coverage for Pandemic Influenza Countermeasures

    This Declaration amends the October 17, 2008, Declaration under the 
Public Readiness and Emergency Preparedness Act, as amended on April 
26, 2009; the December 17, 2008, Declaration under the Public Readiness 
and Emergency Preparedness Act; the February 29, 2012, Declaration 
under the Public Readiness and Emergency Preparedness Act; and the 
January 1, 2016 Republished Declaration under the Public Readiness and 
Emergency Preparedness Act. To the extent any term of the prior 
Declarations is inconsistent with any provision of this Republished 
Declaration, the terms of this Republished Declaration are controlling.

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

42 U.S.C. 247d-6d(b)(1)

    I have determined there is a credible risk that pandemic influenza 
A viruses and influenza A viruses with pandemic potential could cause 
an influenza pandemic with resulting disease that may constitute a 
public health emergency.

II. Factors Considered

42 U.S.C. 247d-6d(b)(6)

    I have considered the desirability of encouraging the design, 
development, clinical testing, or investigation, manufacture, labeling, 
distribution, formulation, packaging, marketing, promotion, sale, 
purchase, donation, dispensing, prescribing, administration, licensing, 
and use of the Covered Countermeasures.

III. Recommended Activities

42 U.S.C. 247d-6d(b)(1)

    I recommend, under the conditions stated in this Declaration, the 
manufacture, testing, development, distribution, administration, or use 
of the Covered Countermeasures.

IV. Liability Immunity

42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

    Liability immunity as prescribed in the Public Readiness and 
Emergency Preparedness (PREP) Act and conditions stated in this 
Declaration is in effect for the Recommended Activities described in 
Section III.

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

    Covered Persons who are afforded liability immunity under this 
Declaration are manufacturers, distributors, program planners, 
``qualified persons,'' and their officials, agents, and employees, as 
those terms are defined in the PREP Act, and the United States.
    In addition, I have determined that the following additional 
persons are qualified persons: (a) Any person authorized in accordance 
with the public health and medical emergency response of the Authority 
Having Jurisdiction, as described in section VII below, to prescribe, 
administer, deliver, distribute or dispense the Covered 
Countermeasures, and their officials, agents, employees, contractors 
and volunteers, following a declaration of an emergency; (b) Any person 
authorized to prescribe, administer, or dispense the Covered 
Countermeasures or who is otherwise authorized to perform an activity 
under an Emergency Use Authorization in accordance with section 564 of 
the Federal Food, Drug, and Cosmetic (FD&C) Act, and; (c) Any person 
authorized to prescribe, administer, or dispense Covered 
Countermeasures in accordance with Section 564A of the FD&C Act.

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 
biological product, any diagnostic, any respiratory protective device, 
any other device, or any vaccine used against pandemic influenza A 
viruses and influenza A viruses with pandemic potential, all components 
and constituent materials of vaccines, and all devices and their 
constituent components used in the administration of vaccines, except 
that vaccines against influenza A and their associated components, 
constituent materials and devices covered under the National Vaccine 
Injury Compensation Program are not Covered Countermeasures.
    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.

[[Page 78980]]

VII. Limitations on Distribution

42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

    I have determined that liability immunity is afforded to Covered 
Persons only for Recommended Activities involving Covered 
Countermeasures that are related to:
    (a) Present or future Federal contracts, cooperative agreements, 
grants, other transactions, interagency agreements, memoranda of 
understanding, or other Federal agreements, or activities directly 
conducted by the Federal Government;
    or
    (b) Activities authorized in accordance with the public health and 
medical response of the Authority Having Jurisdiction to prescribe, 
administer, deliver, distribute or dispense the Covered Countermeasures 
following a declaration of an emergency.
    i. The Authority Having Jurisdiction means the public agency or its 
delegate that has legal responsibility and authority for responding to 
an incident, based on political or geographical (e.g., city, county, 
tribal, state, or Federal boundary lines) or functional (e.g., law 
enforcement, public health) range or sphere of authority.
    ii. A declaration of emergency means any declaration by any 
authorized local, regional, state, or Federal official of an emergency 
specific to events that indicate an immediate need to administer and 
use the Covered Countermeasures, with the exception of a Federal 
Declaration in support of an Emergency Use Authorization under section 
564 of the FD&C Act unless such Declaration specifies otherwise;
    I have also determined that for governmental program planners only, 
liability immunity is afforded only to the extent such program planners 
obtain Covered Countermeasures through voluntary means, such as (1) 
donation; (2) commercial sale; (3) deployment of Covered 
Countermeasures from Federal stockpiles; or (4) deployment of donated, 
purchased, or otherwise voluntarily obtained Covered Countermeasures 
from state, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

42 U.S.C. 247d-6d(b)(2)(A)

    The category of disease, health condition, or threat for which I 
recommend the administration or use of the Covered Countermeasures is 
the threat of or actual human influenza that results from the infection 
of humans following exposure to pandemic influenza A viruses or 
influenza A viruses with pandemic potential.
    Pandemic influenza A viruses and influenza A viruses with pandemic 
potential mean: Animal viruses and/or human influenza A viruses 
circulating in wild birds, domestic animals and/or humans that cause or 
have significant potential to cause sporadic or ongoing human 
infections, or historically have caused pandemics in humans, or have 
mutated to cause pandemics in humans, and for which the majority of the 
population is immunologically naive.

IX. Administration of Covered Countermeasures

42 U.S.C. 247d-6d(a)(2)(B)

    Administration of the Covered Countermeasure means physical 
provision of the countermeasures to recipients, or activities and 
decisions directly relating to public and private delivery, 
distribution and dispensing of the countermeasures to recipients, 
management and operation of countermeasure programs, or management and 
operation of locations for purpose of distributing and dispensing 
countermeasures.

X. Population

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

    The populations of individuals include any individual who uses or 
is administered the Covered Countermeasures in accordance with this 
Declaration.
    Liability immunity is afforded to manufacturers and distributors 
without regard to whether the countermeasure is used by or administered 
to this population; liability immunity is afforded to program planners 
and qualified persons when the countermeasure is used by or 
administered to this population, or the program planner or qualified 
person reasonably could have believed the recipient was in this 
population.

XI. Geographic Area

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

    Liability immunity is afforded for the administration or use of a 
Covered Countermeasure without geographic limitation.
    Liability immunity is afforded to manufacturers and distributors 
without regard to whether the countermeasure is used by or administered 
in these geographic areas; liability immunity is afforded to program 
planners and qualified persons when the countermeasure is used by or 
administered in these geographic areas, or the program planner or 
qualified person reasonably could have believed the recipient was in 
these geographic areas.

XII. Effective Time Period

42 U.S.C. 247d-6d(b)(2)(B)

    For any Covered Countermeasure subsequently covered under the 
National Vaccine Injury Compensation Program, liability immunity under 
this Declaration expires immediately upon such coverage.
    Liability immunity for Covered Countermeasures obtained through 
means of distribution other than in accordance with the public health 
and medical response of the Authority Having Jurisdiction extends 
through December 31, 2027, or until a Covered Countermeasure is covered 
under the National Vaccine Injury Compensation Program, as applicable, 
whichever occurs first.
    Liability immunity for Covered Countermeasures administered and 
used in accordance with the public health and medical response of the 
Authority Having Jurisdiction begins with a Declaration and lasts 
through (1) the final day the emergency Declaration is in effect; (2) 
December 31, 2027; or (3) until a Covered Countermeasure is covered 
under the National Vaccine Injury Compensation Program, as applicable, 
whichever occurs first.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(B) and (C)

    I have determined that an additional twelve (12) months of 
liability protection is reasonable to allow for the manufacturer(s) to 
arrange for disposition of the Covered Countermeasure, including return 
of the Covered Countermeasures to the manufacturer, and for Covered 
Persons to take other appropriate actions to limit the administration 
or use of the Covered Countermeasures.
    Covered Countermeasures obtained for the Strategic National 
Stockpile (SNS) during the effective period of this Declaration for 
Covered Countermeasures obtained through means of distribution other 
than in accordance with the public health and medical response of the 
Authority Having Jurisdiction are covered through the date of 
administration or use pursuant to a distribution or release from the 
SNS

XIV. Countermeasures Injury Compensation Program

42 U.S.C. 247d-6e

    The PREP Act authorizes the Countermeasures Injury Compensation

[[Page 78981]]

Program (CICP) to provide benefits to certain individuals or estates of 
individuals who sustain a serious physical covered injury as the direct 
result of the administration or use of the Covered Countermeasures and/
or benefits to certain survivors of individuals who die as a direct 
result of the administration or use of the Covered Countermeasures. The 
causal connection between the countermeasure and the serious physical 
injury must be supported by compelling, reliable, valid, medical, and 
scientific evidence in order for the individual to be considered for 
compensation. The CICP is administered by the Health Resources and 
Services Administration, within the Department of Health and Human 
Services. Information about the CICP is available at the toll-free 
number 1-855-266-2427 or https://www.hrsa.gov/cicp/ /cicp/.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)

    The October 10, 2008, Declaration Under the Public Readiness and 
Emergency Preparedness Act for pandemic influenza antivirals was first 
published on October 17, 2008, and amended effective April 26, 2009.
    The December 17, 2008, Declaration Under the Public Readiness and 
Emergency Preparedness Act for diagnostics and other devices was first 
published on December 22, 2008.
    The Declaration for the Use of the Public Readiness and Emergency 
Preparedness Act for H5N1 vaccines was first published on January 26, 
2007. The Declaration was amended on November 30, 2007, to add H7 and 
H9 vaccines; amended on October 17, 2008, to add H2 and H6 vaccines; 
amended on June 15, 2009, to add 2009 H1N1 vaccines and republished in 
its entirety; amended on September 28, 2009, to provide targeted 
liability protections for pandemic countermeasures to enhance 
distribution and to add provisions consistent with other Declarations 
and republished in its entirety; amended on March 1, 2010, to revise 
the Covered Countermeasures to include countermeasures against pandemic 
influenza A viruses, extend the effective date and republished in its 
entirety; and amended on February 29, 2012, to extend the effective 
time period, reformat the Declaration, and republish the Declaration.
    The January 1, 2016, Republished Declaration Under the Public 
Readiness and Emergency Preparedness Act amended all Declarations and 
amendments prior to the date of its publication in the Federal Register 
and republished the prior Declarations in the Federal Register as a 
single Declaration in its entirety, as amended.
    This Declaration republishes the January 1, 2016 Declaration to 
extend the effect time period. Further amendments to this Declaration 
will be published in the Federal Register.
    Authority: 42 U.S.C. 247d-6d.

Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2022-28014 Filed 12-22-22; 8:45 am]
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