[Federal Register Volume 87, Number 190 (Monday, October 3, 2022)]
[Notices]
[Pages 59799-59805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Notice of Amendment to the January 1, 2016 Republished 
Declaration Under the Public Readiness and Emergency Preparedness Act

ACTION: Notice of amendment.

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SUMMARY: The Secretary is amending the declaration first issued on 
October 10, 2008, and amended and republished effective January 1, 2016 
for Smallpox countermeasures and countermeasures against other 
orthopoxviruses pursuant to section 319F-3 of the Public Health Service 
Act to emphasize that the declaration applies to monkeypox virus, to 
expand the categories of providers authorized to administer vaccines 
and therapeutics against smallpox (variola virus), monkeypox virus, and 
other orthopoxviruses in a declared emergency, and to extend the 
duration of the declaration.

[[Page 59800]]


DATES: This amendment of the January 1, 2016 republished declaration is 
effective September 28, 2022.

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, 
though publication in the Federal Register, amend any portion of a 
declaration. Using this authority, the Secretary issued a declaration 
for smallpox countermeasures against variola virus or other 
orthopoxviruses on October 10, 2008, amended the declaration effective 
January 1, 2016, and is further amending this 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, 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.
    On August 4, 2022, the Secretary determined pursuant to section 319 
of the PHS Act, 42 U.S.C. 247d, that a public health emergency exists 
nationwide as a result of the consequences of an outbreak of monkeypox 
cases across multiple states. Monkeypox is a rare disease caused by 
infection with the monkeypox virus. Monkeypox virus is an 
orthopoxvirus, part of the same family of viruses as variola virus, the 
virus that causes smallpox.
    The Secretary is now amending this PREP Act declaration to: amend 
the title of the declaration to emphasize that it covers monkeypox 
virus; add to Section I his determination that the 2022 outbreak of 
monkeypox cases in the United States caused by the monkeypox virus 
presents a public health emergency for the purposes of the PREP Act; 
make more explicit in Section I that the declaration applies to public 
health threats arising from smallpox (variola virus), monkeypox virus, 
and other orthopoxviruses; authorize in section V additional qualified 
persons to administer vaccines and therapeutics to address the current 
public health emergency caused by the 2022 outbreak of monkeypox cases 
and the risk of future public health threats arising from smallpox 
(variola virus), monkeypox virus, or other orthopoxviruses; update in 
Section VI the definition of Covered Countermeasures to reflect 
amendments to the PREP Act and to refer explicitly to monkeypox; update 
section VIII to refer explicitly to monkeypox; extend in Section XII 
the effective time period of the declaration; and republish the 
declaration in its entirety, as amended.
    Unless otherwise noted, all statutory citations below are to the 
U.S. Code.

Description of Amendments by Section

    The Secretary is amending the title of the declaration to 
``Declaration, as Amended, for Public Readiness and Emergency 
Preparedness Act Coverage for Countermeasures against Smallpox, 
Monkeypox, and other Orthopoxviruses.''
    Section I, Determination of Public Health Emergency or Credible 
Risk of Future Public Health Emergency
    Before issuing a declaration under the PREP Act, the Secretary is 
required to determine that a disease or other health condition or 
threat to health constitutes a public health emergency or that there is 
a credible risk that the disease, condition, or threat may in the 
future constitute such an emergency. This determination is separate and 
apart from a declaration issued by the Secretary under section 319 of 
the PHS Act that a disease or disorder presents a public health 
emergency or that a public health emergency, including significant 
outbreaks of infectious diseases or bioterrorist attacks, otherwise 
exists, or other declarations or determinations made under other 
authorities of the Secretary.
    The Secretary is amending this determination to clarify that a risk 
of future public health threats is posed by smallpox (variola virus), 
monkeypox virus, or other orthopoxviruses, and to state that the 2022 
outbreak of monkeypox cases in the United States presents a public 
health emergency for purposes of the PREP Act.

Section V, Covered Persons

    The PREP Act's liability immunity applies to ``Covered Persons'' 
with respect to administration or use of a Covered Countermeasure. The 
term ``Covered Persons'' has a specific meaning and is defined in the 
PREP Act to include manufacturers, distributors, program planners, and 
qualified persons, and their officials, agents, and employees, and the 
United States.
    A ``qualified person'' is one category of ``covered person.'' A 
qualified person means a licensed health professional or other 
individual who is authorized to prescribe, administer, or dispense 
Covered Countermeasures under the law of the state in which the 
countermeasure was prescribed, administered, or dispensed; or a person 
within a category of persons identified as qualified in the Secretary's 
declaration. Under this definition, the Secretary can describe in the 
declaration other qualified persons, who are Covered Persons.
    Subject to certain limitations, a covered person is immune from 
suit and liability under Federal and State law with respect to all 
claims for loss caused by, arising out of, relating to, or resulting 
from the administration or use of a Covered Countermeasure if a 
declaration under the PREP Act has been issued with respect to such 
countermeasure. To the extent that any State law that would otherwise 
prohibit a ``qualified person'' from prescribing, dispensing, or 
administering Covered Countermeasures, such law is preempted.\1\ A 
State remains free to expand the universe of individuals authorized to 
administer Covered Countermeasures within its jurisdiction under State 
law.
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    \1\ See, ``Preemption of State and Local Requirements Under a 
PREP Act Declaration,'' Memorandum Opinion for the General Counsel 
Department of Health and Human Services, January 19, 2021, available 
at: https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf.
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    The Secretary anticipates that there will be a need to increase the 
available pool of providers should a large-scale vaccination or 
therapeutic administration effort be required for the current monkeypox 
outbreak or future public health threats arising from smallpox (variola 
virus), monkeypox virus, or other orthopoxviruses. Variola virus, 
monkeypox virus, and other orthopoxviruses have the potential to

[[Page 59801]]

inflict significant burden and strain on the U.S. healthcare system in 
their own right; and in conjunction with the ongoing COVID-19 pandemic, 
a spike in current monkeypox cases could overwhelm healthcare 
providers. The health care system capacity and the healthcare workforce 
are likely to become increasingly strained throughout the nation. 
Allowing additional healthcare providers to administer smallpox 
(variola virus), monkeypox virus, or other orthopoxvirus vaccines or 
therapeutics in accordance with applicable Federal Food and Drug 
Administration (FDA) licenses, approvals, or authorizations during a 
declared emergency allows states maximum flexibility in limiting 
potential impacts of illness.
    By this amendment to the declaration, the Secretary identifies 
additional categories of persons who are qualified persons covered by 
the PREP Act.

Section VI, Covered Countermeasures

    The Secretary is amending Section VI to update the definition as 
amended by the CARES Act.

Section VIII, Category of Disease, Health Condition, or Threat

    The Secretary is amending the category of disease, health 
condition, or threat for which he recommends the administration or use 
of the Covered Countermeasures to include explicitly disease and 
disease threat resulting from exposure to monkeypox virus.

Section XII, Effective Time Period

    The Secretary must identify, for each Covered Countermeasure, the 
period or periods during which liability immunity is in effect, 
designated by dates, milestones, or other description of events, 
including factors specified in the PREP Act.
    The Secretary is amending the declaration to extend the period for 
which liability immunity is in effect. The previous amended declaration 
was in effect through December 31, 2022. We have extended the effective 
time period to December 31, 2032.

Declaration, as Amended, for Public Readiness and Emergency 
Preparedness Act Coverage for Countermeasures Against Smallpox, 
Monkeypox, and Other Orthopoxviruses

    This declaration amends and republishes the January 1, 2016 Amended 
Declaration Under the Public Readiness and Emergency Preparedness Act 
(``PREP Act'') for smallpox and other orthopoxvirus countermeasures. To 
the extent any term of the January 1, 2016 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 smallpox 
(variola virus), monkeypox virus, or other orthopoxviruses and the 
resulting disease or conditions may in the future constitute a public 
health emergency and that the 2022 outbreak of monkeypox cases in the 
United States presents 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 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, subject to the requirements of this 
paragraph:
    The person so authorized must have documentation of completion of 
the Centers for Disease Control and Prevention (CDC)-provided or -
recommended training for the countermeasure and any additional training 
required in the FDA license, approval, or authorization. In the absence 
of training requirements or recommendations from the CDC, other 
training(s) may be substituted if:
    (i) it is approved or accredited training from a national or state 
recognized accrediting body or association, the FDA, or equivalent 
organization for the administration route of the medical 
countermeasure,
    (ii) it includes hands-on instruction for the administration route 
as appropriate for the countermeasure, supervised by someone that 
administers within their normal scope of practice,
    (iii) it includes clinical evaluations of indications or 
contraindications of smallpox (variola virus), monkeypox virus, or 
other orthopoxvirus countermeasures, and
    (iv) it includes the recognition and treatment of emergency 
reactions to smallpox (variola virus), monkeypox virus, or other 
orthopoxvirus countermeasures;
    If applicable, such additional training as may be required by the 
State, territory, locality, or Tribal area in which they are 
prescribing, dispensing, or administering smallpox (variola virus), 
monkeypox virus, or other orthopoxvirus vaccines or therapeutics.
    (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 Food, Drug, and Cosmetic (FD&C) Act.
    (c) any person authorized to prescribe, administer, or dispense 
Covered Countermeasures in accordance with Section 564A of the FD&C 
Act.
    (d) The following healthcare professionals and students in a 
healthcare profession training program following a declaration of an 
emergency as defined in section VII of this declaration, subject to the 
requirements of this paragraph:
    1. To the extent not already licensed or authorized under state 
law, any dentist, advanced or intermediate emergency medical 
technician, licensed or certified professional midwife, nurse, advanced 
practice registered nurse,

[[Page 59802]]

registered nurse, licensed practical nurse, optometrist, paramedic, 
pharmacist, pharmacy intern, pharmacy technician, physician, physician 
assistant, podiatrist, respiratory therapist, or veterinarian who is 
licensed or certified to practice under the law of any state who 
prescribes, dispenses, or administers smallpox (variola virus), 
monkeypox virus, or other orthopoxvirus vaccines or therapeutics by the 
route of administration and to the population specified in the relevant 
FDA license, approval, or authorization, including intramuscular, 
intradermal, or subcutaneous injection, dermal/percutaneous 
scarification, intranasal or oral administration, that are Covered 
Countermeasures under section VI of this declaration in any 
jurisdiction where the PREP Act applies in association with a smallpox 
(variola virus), monkeypox virus, or other orthopoxvirus vaccination or 
therapeutics effort by a State, local, Tribal or territorial authority 
or by an institution in which the smallpox (variola virus), monkeypox 
virus, or other orthopoxvirus vaccine or therapeutic is administered;
    2. Any dentist, advanced or intermediate emergency medical 
technician, licensed or certified professional midwife, nurse, advanced 
practice registered nurse, registered nurse, licensed practical nurse, 
optometrist, paramedic, pharmacist, pharmacy intern, physician, 
physician assistant, podiatrist, respiratory therapist, or veterinarian 
who has held an active license or certification under the law of any 
State within the last five years, which is inactive, expired or lapsed, 
who prescribes, dispenses, or administers smallpox (variola virus), 
monkeypox virus, or other orthopoxvirus vaccines or therapeutics by the 
route of administration and to the population specified in the relevant 
FDA license, approval or authorization, including intramuscular, 
intradermal, or subcutaneous injection, dermal/percutaneous 
scarification, intranasal or oral administration, that are Covered 
Countermeasures under section VI of this declaration in any 
jurisdiction where the PREP Act applies in association with a smallpox 
(variola virus), monkeypox virus, or other orthopoxvirus vaccination or 
therapeutics effort by a State, local, Tribal or territorial authority 
or by an institution in which the smallpox (variola virus), monkeypox 
virus, or other orthopoxvirus vaccine or therapeutic is administered, 
so long as the license or certification was active and in good standing 
prior to the date it went inactive, expired or lapsed and was not 
revoked by the licensing authority, surrendered while under suspension, 
discipline or investigation by a licensing authority or surrendered 
following an arrest, and the individual is not on the List of Excluded 
Individuals/Entities maintained by the Office of Inspector General;
    3. Any dental, advanced or intermediate emergency medical 
technician, medical, licensed or certified professional midwife, 
nursing, optometry, paramedic, pharmacy, pharmacy intern, physician 
assistant, podiatry, respiratory therapist, or veterinary student with 
appropriate training in administering vaccines or therapeutics as 
determined by their school or training program and supervision by a 
currently practicing healthcare professional, experienced in the route 
of administration and to the population specified in the relevant FDA 
license, approval, or authorization, who administers smallpox (variola 
virus), monkeypox virus, or other orthopoxvirus vaccines or 
therapeutics by the route of administration and to the population 
specified in the relevant FDA license, approval, or authorization, 
including intramuscular, intradermal, or subcutaneous injection, 
dermal/percutaneous scarification, intranasal or oral administration 
that are Covered Countermeasures under section VI of this declaration 
in any jurisdiction where the PREP Act applies in association with a 
smallpox (variola virus), monkeypox virus, or other orthopoxvirus 
vaccination or therapeutics effort by a State, local, Tribal or 
territorial authority or by an institution in which the smallpox 
(variola virus), monkeypox virus, or other orthopoxvirus vaccine or 
therapeutic is administered;
    Subject to the following requirements:
    (i) The vaccine or therapeutic must be authorized, approved, or 
licensed by the FDA;
    (ii) Vaccination must be ordered and administered according to 
CDC's/ACIP's smallpox (variola virus), monkeypox virus, or other 
orthopoxvirus vaccine recommendation(s);
    (iii) The healthcare professionals and students must have 
documentation of completion of the CDC-provided or -recommended 
training for the countermeasure and any additional training required in 
the FDA licensing, approval, authorization. In the absence of training 
requirements or recommendations from the CDC, other training(s) may be 
substituted if:
    (1) it is approved or accredited training from a national or state 
recognized accrediting body or association, the FDA, or equivalent 
organization for the administration route of the medical 
countermeasure,
    (2) it includes hands-on instruction for the administration route 
as appropriate for the countermeasure, supervised by someone that 
administers within their normal scope of practice,
    (3) it includes clinical evaluations of indications or 
contraindications of smallpox (variola virus), monkeypox virus, or 
other orthopoxvirus countermeasures, and
    (4) it includes the recognition and treatment of emergency 
reactions to smallpox (variola virus), monkeypox virus, or other 
orthopoxvirus countermeasures;
    If applicable, such additional training as may be required by the 
State, territory, locality, or Tribal area in which they are 
prescribing, dispensing, or administering smallpox (variola virus), 
monkeypox virus, or other orthopoxvirus vaccines or therapeutics;
    (iv) The healthcare professionals and students must have 
documentation of an observation period by a currently practicing 
healthcare professional experienced in the appropriate route of 
intradermal, subcutaneous, or intramuscular injections, dermal/
percutaneous scarification, intranasal or oral administration and for 
whom the appropriate route of intradermal, subcutaneous, or 
intramuscular injections, dermal/percutaneous scarification, intranasal 
or oral administration is in their ordinary scope of practice, who 
confirms competency of the healthcare provider or student in 
preparation and administration of the smallpox (variola virus), 
monkeypox virus, or other orthopoxvirus vaccines or therapeutics to be 
administered and, if applicable, such additional training as may be 
required by the State, territory, locality, or Tribal area in which 
they are prescribing, dispensing, or administering smallpox (variola 
virus), monkeypox virus, or other orthopoxvirus vaccines or 
therapeutics;
    (v) The healthcare professionals and students must have a current 
certificate in basic cardiopulmonary resuscitation;
    (vi) The healthcare professionals and students must comply with 
recordkeeping and reporting
    requirements of the jurisdiction in which they administer vaccines 
or therapeutics, including informing the patient's primary-care 
provider when available, submitting the required immunization 
information to the State or local immunization information system 
(vaccine registry), complying with requirements with respect to 
reporting adverse events, and complying

[[Page 59803]]

with requirements whereby the person administering a vaccine must 
review the vaccine registry or other vaccination records prior to 
administering a vaccine; and
    (viii) The healthcare professionals and students comply with any 
applicable requirements (or conditions of use) as set forth in the CDC 
provider agreement and any other federal requirements that apply to the 
administration of smallpox (variola virus), monkeypox virus, or other 
orthopoxvirus vaccines or therapeutics.
    (e) Any healthcare professional or other individual who holds an 
active license or certification permitting the person to prescribe, 
dispense, or administer vaccines or therapeutics under the law of any 
State as of the effective date of this amendment, or healthcare 
professional as authorized under the sections V(d)(1) and (2) of this 
declaration, who, following a declared emergency as defined in section 
VII of this declaration, prescribes, dispenses, or administers smallpox 
(variola virus), monkeypox virus, or other orthopoxvirus vaccines or 
therapeutics by the route of administration and to the population 
specified in the relevant FDA license, approval, or authorization, 
including intramuscular, intradermal, or subcutaneous injection, 
dermal/percutaneous scarification, intranasal or oral administration 
that are Covered Countermeasures under section VI of this declaration 
in any jurisdiction where the PREP Act applies, other than the State in 
which the license or certification is held, in association with a 
smallpox (variola virus), monkeypox virus, or other orthopoxvirus 
vaccination or therapeutics effort by a federal, State, local Tribal or 
territorial authority or by an institution in the State in which the 
smallpox (variola virus), monkeypox virus, or other orthopoxvirus 
vaccine or therapeutic is administered, so long as the license or 
certification of the healthcare professional has not been suspended or 
restricted by any licensing authority, surrendered while under 
suspension, discipline or investigation by a licensing authority or 
surrendered following an arrest, and the individual is not on the List 
of Excluded Individuals/Entities maintained by the Office of Inspector 
General, subject to:
    (i) documentation of completion of the appropriate training; CDC 
provided or recommended training for the countermeasure and any 
additional training required in the FDA license, approval, or 
authorization. In the absence of training requirements or 
recommendations from the CDC, other training(s) may be substituted if:
    (1) it is approved or accredited training from a national or state 
recognized accrediting body or association, the FDA, or equivalent 
organization for the administration route of the medical 
countermeasure,
    (2) it includes hands-on instruction for the administration route 
as appropriate for the countermeasure, supervised by someone that 
administers within their normal scope of practice,
    (3) it includes clinical evaluations of indications or 
contraindications of smallpox (variola virus), monkeypox virus, or 
other orthopoxvirus countermeasures, and
    (4) it includes the recognition and treatment of emergency 
reactions to smallpox (variola virus), monkeypox virus, or other 
orthopoxvirus countermeasures;
    If applicable, such additional training as may be required by the 
State, territory, locality, or Tribal area in which they are 
prescribing, dispensing, or administering smallpox (variola virus), 
monkeypox virus, or other orthopoxvirus vaccines or therapeutics;
    and
    (ii) for healthcare providers who are not currently practicing, 
documentation of an observation period by a currently practicing 
healthcare in experienced in the appropriate route of intradermal, 
subcutaneous, or intramuscular injections, dermal/percutaneous 
scarification, intranasal or oral administration, and for whom the 
appropriate route of intradermal, subcutaneous, or intramuscular 
injections, dermal/percutaneous scarification, intranasal or oral 
administration is in their ordinary scope of practice, who confirms 
competency of the healthcare provider in preparation and administration 
of the smallpox (variola virus), monkeypox virus, or other 
orthopoxvirus vaccines or therapeutics to be administered.
    (f) Any member of a uniformed service (including members of the 
National Guard in a Title 32 duty status) (hereafter in this paragraph 
``service member'') or Federal government employee, contractor, or 
volunteer who prescribes, administers, delivers, distributes, or 
dispenses smallpox (variola virus), monkeypox virus, or other 
orthopoxvirus Covered Countermeasures. Such Federal government service 
members, employees, contractors, or volunteers are qualified persons if 
the following requirements are met:
    (i) The executive department or agency by or for which the Federal 
service member, employee, contractor, or volunteer is employed, 
contracts, or volunteers has authorized or could authorize that service 
member, employee, contractor, or volunteer to prescribe, administer, 
deliver, distribute, or dispense the Covered Countermeasure as any part 
of the duties or responsibilities of that service member, employee, 
contractor, or volunteer, even if those authorized duties or 
responsibilities ordinarily would not extend to members of the public 
or otherwise would be more limited in scope than the activities such 
service member, employees, contractors, or volunteers are authorized to 
carry out under this declaration;
    (ii) The Federal service member or Federal government, employee, 
contractor, or volunteer must have documentation of completion of the 
CDC provided or recommended training for the countermeasure and any 
additional training required in the FDA license, approval, or 
authorization. In the absence of training requirements or 
recommendations from the CDC, other training(s) may be substituted if:
    (1) it is approved or accredited training from a national or state 
recognized accrediting body or association, the FDA, or equivalent 
organization for the administration route of the medical 
countermeasure,
    (2) it includes hands-on instruction for the administration route 
as appropriate for the countermeasure, supervised by someone that 
administers within their normal scope of practice,
    (3) it includes clinical evaluations of indications or 
contraindications of smallpox (variola virus), monkeypox virus, or 
other orthopoxvirus countermeasures, and
    (4) it includes the recognition and treatment of emergency 
reactions to smallpox (variola virus), monkeypox virus, or other 
orthopoxvirus countermeasures;
    If applicable, such additional training as may be required by the 
State, territory, locality, or Tribal area in which they are 
prescribing, dispensing, or administering smallpox (variola virus), 
monkeypox virus, or other orthopoxvirus vaccines or therapeutics.

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 antiviral; any other drug; any biologic; or any diagnostic or other 
device to identify, or any respiratory protective device to prevent or 
treat smallpox (variola virus),

[[Page 59804]]

monkeypox virus, or other orthopoxvirus 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, or a respiratory protective device 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 
smallpox resulting from exposure to variola virus, monkeypox resulting 
from exposure to monkeypox virus, or other infectious disease resulting 
from exposure to other orthopoxviruses, and the threat of disease 
resulting from exposure to any of these viruses.

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)
    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, 2032.
    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, 2032, whichever occurs first.
    Liability immunity for Covered Countermeasures administered and 
used by additional qualified persons in sections V(d) and V(e) begins 
with a declaration and lasts through (1) the final day the emergency 
declaration is in effect or (2) December 31, 2032, whichever occurs 
first.
    Covered Countermeasures obtained for the Strategic National 
Stockpile (SNS) during the effective period of this declaration for 
Covered Countermeasures are covered through the date of administration 
or use pursuant to a distribution or release from the SNS.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(A), (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 such other actions as are appropriate to limit the 
administration or use of the Covered Countermeasures.

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

[[Page 59805]]

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 855-266-2427 
(toll-free) or http://www.hrsa.gov/cicp/.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)
    The October 10, 2008 declaration under the PREP Act for smallpox 
countermeasures was first published on October 17, 2008 and amended and 
republished on January 1, 2016. This is the second amendment to and 
republication of the declaration.
    Any further amendments to this declaration will be published in the 
Federal Register.

(Authority: 42 U.S.C. 247d-6d)

Xavier Becerra,
Secretary.
[FR Doc. 2022-21412 Filed 9-30-22; 8:45 am]
BILLING CODE 4150-28-P