Notice2022-21412
Notice of Amendment to the January 1, 2016 Republished Declaration Under the Public Readiness and Emergency Preparedness Act
Primary source
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Published
October 3, 2022
Effective
September 28, 2022
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 190 (Monday, October 3, 2022)</title>
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[Federal Register Volume 87, Number 190 (Monday, October 3, 2022)]
[Notices]
[Pages 59799-59805]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#4d3d2c242a28632837283f232c2e260d25253e632a223b"><span class="__cf_email__" data-cfemail="97e7f6fef0f2b9f2edf2e5f9f6f4fcd7ffffe4b9f0f8e1">[email protected]</span></a>.
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: <a href="https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf">https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf</a>.
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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 <a href="http://www.hrsa.gov/cicp/">http://www.hrsa.gov/cicp/</a>.
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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.