Notice of Amendment, 78981-78983 [2022-28010]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of the Secretary

[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Notices]
[Pages 78981-78983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28010]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Notice of Amendment

ACTION: Notice of amendment.

-----------------------------------------------------------------------

SUMMARY: The Secretary is amending the Declaration issued in the 
Federal Register of October 1, 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.
    Renewal of the PREP Act Declaration for anthrax is essential due to 
the continued national security threat posed by potential exposure to 
anthrax. An anthrax event, whether natural or man-made in origin, has 
potential to cause significant mortality and disrupt daily functions 
within the United States. PREP Act coverage of countermeasures is 
critical to the engagement with potential product sponsors in the 
anthrax space. Vaccines, antibiotics, antitoxins, and diagnostics for 
anthrax will continue to be a part of the preparedness posture in terms 
of stockpiling current products and development next-generation 
candidates. Extension of the PREP Act Declaration including vaccines, 
therapeutics, and diagnostics for anthrax is therefore deemed 
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 Anthrax Countermeasures.
    This Declaration amends the January 1, 2016, Republished 
Declaration under the Public Readiness and Emergency Preparedness Act. 
To the extent any term of the prior Declaration 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 the spread of 
Bacillus anthracis and/or the spores of Bacillus anthracis and the 
resulting disease or conditions may in the future constitute a public 
health emergency.

[[Page 78982]]

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 Act (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 biologic; or any 
diagnostic or other device to identify, prevent, or treat anthrax 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 PHS 
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 
anthrax, which may result from exposure to Bacillus anthracis and/or to 
Bacillus anthracis spores.

IX. Administration of Covered Countermeasures

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

    Administration of the Covered Countermeasures 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 the 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.

[[Page 78983]]

    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 Countermeasures, 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.
    Further, as to doses shipped by the Centers for Disease Control and 
Prevention (CDC) to the Department of Defense (DoD) pursuant to the 
DoD/CDC Interagency Agreement (IAA) dated March 10, 2008, an additional 
period of time of liability protection shall extend for as long as the 
SNS or its successor exists and the IAA remains in effect, plus, if the 
additional twelve (12) months following the time period in paragraph 1 
of this section has expired, an additional twelve (12) months upon 
expiration of the IAA.

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 1, 2008, Declaration Under the Public Readiness and 
Emergency Preparedness Act for Anthrax Countermeasures was first 
published on October 6, 2008, and amended and republished on January 1, 
2016. This is the second amendment to the 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. 2022-28010 Filed 12-22-22; 8:45 am]
BILLING CODE 4150-37-P