Notice2023-26075
Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Countermeasures Against Ebolavirus and/or Ebola Disease and Marburgvirus and/or Marburg Disease
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Published
November 27, 2023
Effective
January 1, 2024
Issuing agencies
Health and Human Services Department
Abstract
The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to amend the Declaration for Countermeasures against Marburgvirus and/or Marburg Disease to cover both Ebolaviruses and Marburgviruses and republishes the declaration, as amended. The amended republished Declaration clarifies that the disease threat includes Ebolaviruses and Marburgviruses, updates the title of the Declaration, expands the Covered Countermeasures, and extends the effective time period.
Full Text
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<title>Federal Register, Volume 88 Issue 226 (Monday, November 27, 2023)</title>
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[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82907-82910]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Notice of Declaration Under the Public Readiness and Emergency
Preparedness Act for Countermeasures Against Ebolavirus and/or Ebola
Disease and Marburgvirus and/or Marburg Disease
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 amend the Declaration for
Countermeasures against Marburgvirus and/or Marburg Disease to cover
both Ebolaviruses and Marburgviruses and republishes the declaration,
as amended. The amended republished Declaration clarifies that the
disease threat includes Ebolaviruses and Marburgviruses, updates the
title of the Declaration, expands the Covered Countermeasures, and
extends the effective time period.
DATES: The amendment is effective as of January 1, 2024.
FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Office of the
Assistant Secretary for Preparedness and Response, Office of the
Secretary, U.S. Department of Health and Human Services, 200
Independence Avenue SW, Washington, DC 20201; 202-260-0365,
<a href="/cdn-cgi/l/email-protection#2e7e7c6b7e6f4d5a6e46465d00494158"><span class="__cf_email__" data-cfemail="98c8caddc8d9fbecd8f0f0ebb6fff7ee">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes the Secretary of the U.S.
Department of Health and Human Services (the HHS 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, 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.
The PREP Act Declaration for Countermeasures Against Marburgvirus
and/or Marburg Disease was first issued effective November 25, 2020.
(85 FR 79198 (December 9, 2020)). The PREP Act Declaration for Ebola
Virus Disease Vaccines was first issued December 3, 2014 (79 FR 73315
(Dec.10, 2014)), and amended December 3, 2015 (80 FR 76541 (Dec. 9,
2015)), December 3, 2016 (81 FR 89471 (Dec. 12, 2016)), and December 1,
2018 (84 FR 764 (Jan. 31, 2019)). The Declaration for Ebola Virus
[[Page 82908]]
Disease Therapeutics was issued effective February 27, 2015 (80 FR
22534 (April 22, 2015)), and amended February 27, 2015 (80 FR 76536
(December 9, 2015)), and December 1, 2018 (84 FR 757 (January 31,
2019)).
I am extending PREP Act Coverage for both Ebolaviruses and
Marburgviruses due to the continued national security threat posed by
these viruses. Ebolaviruses and Marburgviruses have the potential to
cause significant morbidity and mortality during outbreaks. The risk of
domestic cases is high due to ongoing outbreaks in other countries over
the past decade. Development of and stockpiling vaccines, therapeutics,
devices, and diagnostics for all species of both Ebolaviruses and
Marburgviruses is needed for continued U.S. preparedness against the
credible threat of a public health emergency due to outbreaks of these
viruses.
I am amending the PREP Act Declaration for Countermeasures Against
Marburgvirus and/or Marburg Disease to cover countermeasures previously
covered under the Declaration for Ebola Virus Disease Vaccines and the
Declaration for Ebola Virus Disease Therapeutics due to the
similarities of the viruses and the need to expand Covered
Countermeasures against Ebola Disease to include all vaccines,
diagnostics, and devices in addition to previously covered vaccines and
therapeutics, and to cover these countermeasures when administered or
used by an Authority Having Jurisdiction to respond to a declared
emergency, in addition to previously covered activities directly
supported by the United States. All previously Covered Countermeasures
for Ebolavirus and distribution activities continue to be covered. This
action has the effect of combining the three previous Declarations into
one amended Declaration and makes PREP Act coverage for Ebolavirus
countermeasures consistent with PREP Act coverage provided for other
health threats, including Marburg, Smallpox, Pandemic Influenza,
Anthrax, and Acute Radiation Syndrome and emerging infectious diseases
such as COVID-19.\1\ This amended Declaration for Countermeasures
Against Ebolavirus and/or Ebola Disease and Marburgvirus and/or Marburg
Disease supersedes the PREP Act Declaration for Ebola Virus Disease
Vaccines and the PREP Act Declaration for Ebola Virus Disease
Therapeutics. The Declarations for Ebola Virus Disease Vaccines and
Ebola Virus Disease Therapeutics will expire under their own terms on
December 31, 2023 and this amended Declaration becomes effective
January 1, 2024, effectively replacing the three prior Declarations.
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\1\ See <a href="https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx">https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx</a>.
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To be consistent with the most current World Health Organization
International Classification of Diseases, the term Ebola disease or
``EBOD'' is used in this Declaration to refer to the disease, health
condition, or threat to health that constitutes or may constitute a
public health emergency. The term Marburg Disease or ``MARD'' is used
in this Declaration to refer to the disease, health condition, or
threat to health that constitutes or may constitute a public health
emergency.\2\
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\2\ See <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6637750/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6637750/</a>.
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Specifically, I am now amending the PREP Act Declaration Against
Marburgvirus and/or Marburg Disease Countermeasures to: amend the title
of the declaration to reflect that it covers Ebolaviruses and
Marburgviruses; update Section I to identify the public health threat
as arising from Ebolaviruses and Marburgviruses; update Section VI to
amend the definition of Covered Countermeasures and to extend coverage
to all vaccines, diagnostics, and devices for Ebolavirus in addition to
vaccines and therapeutics; extend Section VII of the Declaration to
provide coverage for Ebolavirus Countermeasures when administered or
used by an Authority Having Jurisdiction to respond to a declared
emergency; update Section VIII to amend the category of disease to be
inclusive of Ebolaviruses and Marburgviruses; extend in Section XII the
effective time period of the declaration through December 31, 2028; and
republish the declaration in its entirety, as amended.
Unless otherwise noted, all statutory citations below are to the
U.S. Code.
Description of This Amendment by Section
I am now amending the title of the Declaration to ``Declaration, as
Amended, for Public Readiness and Emergency Preparedness Act Coverage
for Countermeasures against Ebolaviruses and/or Ebola Disease and
Marburgvirus and/or Marburg Disease.''
Section I. Determination of Public Health Emergency or Credible Risk of
Future Public Health Emergency
I am amending Section I of the Declaration to update the
determination of a public health emergency to state that the spread of
Ebolaviruses and Marburgviruses, and any resulting diseases or
conditions including EBOD and MARD, and any virus or disease
subcategories of these, presents a credible risk of a future public
health emergency. Continued coverage under the PREP Act, as provided in
this Declaration, is intended to prepare for and mitigate that credible
risk.
Section VI. Covered Countermeasures
I am amending Section VI of the Declaration to include any
antiviral, any other drug, any biologic, any diagnostic, any other
device, or any vaccine, used to diagnose, mitigate, prevent, treat,
cure, or limit EBOD, MARD, or the transmission of Ebolaviruses,
Marburgviruses, 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.
Section VIII. Category of Disease, Health Condition, or Threat
I am amending Section VIII of the Declaration to update the
category of disease to include any diseases or conditions including
EBOD and MARD caused by Ebolaviruses and Marburgviruses, or any virus
or disease subcategories of these or virus mutating therefrom.
Section XII. Effective Time Period
I am extending the effective time period for the Declaration
through December 31, 2028.
Other conforming changes and technical corrections may be made
throughout the Declaration for consistency and clarity.
Declaration, as Amended, for Public Readiness and Emergency
Preparedness Act Coverage for Countermeasures Against Ebolavirus and/or
Ebola Disease and Marburgvirus and/or Marburg Disease
To the extent any term previously included in the Declaration for
Countermeasures Against Marburgvirus and/or Marburg Disease, the
Declaration for Vaccines Against Ebola Virus Disease, or the
Declaration for Therapeutics Against Ebola Virus Disease, including
amendments, are inconsistent with any provision of this Republished
Declaration, the terms of this Republished Declaration are controlling.
I. Determination of Public Health Emergency
42 U.S.C. 247d-6d(b)(1)
I have determined that there is a credible risk that the spread of
Ebolaviruses and Marburgviruses, and
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any resulting diseases or conditions including Ebola Disease (EBOD) and
Marburg Disease (MARD), and any virus or disease subcategories of these
may in the future constitute a public health emergency. For the
purposes of this Declaration, MARD is the illness resulting from
infection by any virus of the Orthomarburgvirus genus. EBOD is the
illness resulting from infection of any of the following virus species
of the Orthoebolavirus genus:
<bullet> Bundibugyo virus
<bullet> Ebola virus
<bullet> Sudan virus
<bullet> Ta[iuml] Forest virus
<bullet> Ebolaviruses with undefined pathogenicity in humans
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, and
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 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 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: (1) any antiviral, any other drug, any
biologic, any diagnostic, any other device, or any vaccine, used to
diagnose, mitigate, prevent, treat, cure, or limit the harm EBOD, MARD,
or the transmission of Ebolaviruses, Marburgviruses, or a virus
mutating therefrom, any device used in the administration of any such
product, and all components and constituent materials of any such
product; (2) any product to diagnose, mitigate, prevent, treat, or cure
a serious or life-threatening disease or condition caused by a product
described in clause (1); or (3) a product or technology intended to
enhance the use or effect of a drug, biological product, or device
described in clause (1) or (2).
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.
VII. Limitations on Distribution
42 U.S.C. 247d{time} 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
any diseases or conditions including EBOD and MARD caused by
Ebolaviruses and Marburgviruses, or any virus or disease subcategories
of these or virus mutating therefrom.
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
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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 any designated geographic area; liability immunity is afforded to
program planners and qualified persons when the countermeasure is used
by or administered in any designated geographic area, or the program
planner or qualified person reasonably could have believed the
recipient was in that geographic area.
XII. Effective Time Period
42 U.S.C. 247d-6d(b)(2)(B)
Liability immunity for Covered Countermeasures through means of
distribution other than in accordance with the public health and
medical response of the Authority Having Jurisdiction and extends
through December 31, 2028.
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, or
(2) December 31, 2028, 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 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 such other actions as are appropriate 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 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
Program (CICP) to provide benefits to certain individuals or estates of
individuals who sustain a covered serious physical injury as the direct
result of the administration or use of the Covered Countermeasures, and
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="http://www.hrsa.gov/cicp/">http://www.hrsa.gov/cicp/</a>.
XV. Amendments
42 U.S.C. 247d-6d(b)(4)
The December 3, 2014, Declaration under the PREP Act for
Countermeasures Against Ebola Virus Disease Vaccines was first
published on December 10, 2014, and amended and republished on December
9, 2015, December 12, 2016, and January 31, 2019. The republished
amended Declaration for Countermeasures Against Ebolavirus and/or Ebola
Disease and Marburgvirus and/or Marburg Disease supersedes the
Declaration for Countermeasures Against Ebola Virus Disease Vaccines.
The February 27, 2015, Declaration under the PREP Act for
Countermeasures Against Ebola Virus Disease Therapeutics was first
published on April 22, 2015, and amended and republished on December 9,
2015, December 12, 2016, and January 31, 2019. The republished amended
Declaration for Countermeasures Against Ebolavirus and/or Ebola Disease
and Marburgvirus and/or Marburg Disease supersedes the Declaration for
Countermeasures Against Ebola Virus Disease Therapeutics.
The November 25, 2020, Declaration under the PREP Act for
Countermeasures Against Marburgvirus and/or Marburg Disease was
published on December 9, 2020. This is the first amendment to and
republication of the Declaration.
Any further amendments to this Declaration will be published in the
Federal Register, as warranted.
Authority: 42 U.S.C. 247d-6d.
Dated: November 21, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-26075 Filed 11-24-23; 8:45 am]
BILLING CODE 4150-37-P
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