Notice2022-28014
Notice of amendment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 23, 2022
Effective
January 1, 2023
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 246 (Friday, December 23, 2022)</title>
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[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Notices]
[Pages 78978-78981]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#9aeafbf3fdffb4ffe0ffe8f4fbf9f1daf2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="f88899919f9dd69d829d8a96999b93b890908bd69f978e">[email protected]</span></a>.
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.
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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 <a href="https://www.hrsa.gov/cicp/">https://www.hrsa.gov/cicp/</a> /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]
BILLING CODE 4150-37-P
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</html>Indexed from Federal Register on December 23, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.