[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Notices]
[Pages 78983-78985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28011]


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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, 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.
    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.
    The 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. Botulinum Toxin 
continues to pose a national security threat to the United States and 
has the potential to cause significant morbidity and mortality in the 
event of large-scale exposures. There is a lack of a commercial market 
for countermeasures against Botulinum Toxin, making PREP Act coverage 
critical to the engagement with potential product sponsors. Vaccines, 
therapeutics, and diagnostics

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for Botulinum Toxin will continue to be a part of the preparedness 
posture for the United States, both in terms of stockpiling current 
products and developing next-generation candidates. Extension of the 
PREP Act Declaration including vaccines, therapeutics, and diagnostics 
for Botulinum Toxin is essential.
    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 Botulinum Toxin Countermeasures

    This Declaration amends and republishes the October 10, 2008, 
Declaration under the Public Readiness and Emergency Preparedness Act, 
as amended and republished under 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 that there is a credible risk that exposure to 
botulinum toxin(s) and the resulting diseases or conditions from 
manmade or natural sources may in the future 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 vaccine, including all components 
and constituent materials of these vaccines, and all devices and their 
constituent components used in the administration of these vaccines; 
any antimicrobial/antibiotic; any other drug or antitoxin; any 
biologic; or any diagnostic or other device to identify, prevent or 
treat botulinum toxin or adverse events from such 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.

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 
botulism resulting from exposure to botulinum toxin(s).

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

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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)

    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.
    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, 2027, 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 
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 Botulinum Toxin Countermeasures was 
first published on October 17, 2008, and amended on January 1, 2016. 
This is the second amendment to that Declaration.
    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. 2022-28011 Filed 12-22-22; 8:45 am]
BILLING CODE 4150-37-P