[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Pages 82907-82910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 
[email protected].

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 https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx.
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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 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6637750/.
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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:
     Bundibugyo virus
     Ebola virus
     Sudan virus
     Ta[iuml] Forest virus
     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 http://www.hrsa.gov/cicp/.
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]
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