Notice2022-17503
Office of the Secretary; Emergency Use Authorization; Monkeypox Virus Vaccine
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 15, 2022
Issuing agencies
Health and Human Services Department
Abstract
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On August 9, 2022, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of vaccines for use against monkeypox virus pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Full Text
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<title>Federal Register, Volume 87 Issue 156 (Monday, August 15, 2022)</title>
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[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50090-50091]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17503]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Department of Health and Human Services
Office of the Secretary; Emergency Use Authorization; Monkeypox
Virus Vaccine
ACTION: Notice.
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SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to section 564 of the Federal Food, Drug, and
Cosmetic (FD&C) Act. On August 9, 2022, the Secretary determined
pursuant to his authority under section 564 of the FD&C Act that there
is a public health emergency, or a significant potential for a public
health emergency, that affects, or has a significant potential to
affect, national security or the health and security of United States
citizens living abroad that involves monkeypox virus.
On the basis of this determination, he also declared that
circumstances exist justifying the authorization of emergency use of
vaccines for use against monkeypox virus pursuant to section 564 of the
FD&C Act, subject to the terms of any authorization issued under that
section.
DATES: The determination and declaration are valid August 9, 2022.
FOR FURTHER INFORMATION CONTACT: Dawn O'Connell, Assistant Secretary
for Preparedness and Response, Administration for Strategic
Preparedness and Response, Department of Health and Human Services, 200
Independence Avenue SW, Washington, DC 20201, Telephone (202) 205-2882
(this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act, the Commissioner of Food and
Drugs of the U.S. Food and Drug Administration (FDA), acting under
delegated authority from the Secretary of HHS, may issue an Emergency
Use Authorization (EUA) authorizing: (1) the emergency use of an
unapproved drug, an unapproved or uncleared device, or an unlicensed
biological product; or (2) an unapproved use of an approved drug,
approved or cleared device, or licensed biological product. Before an
EUA may be issued, the Secretary of HHS must declare that circumstances
exist justifying the authorization based on one of four determinations:
(1) A determination by the Secretary of Homeland Security that there is
a domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk
[[Page 50091]]
of attack with a, chemical, biological, radiological, or nuclear
(``CBRN'') agent or agents; (2) the identification of a material threat
by the Secretary of Homeland Security pursuant to section 319F-2 of the
Public Health Service (PHS) Act \1\ sufficient to affect national
security or the health and security of United States citizens living
abroad; (3) a determination by the Secretary of Defense that there is a
military emergency, or a significant potential for a military
emergency, involving a heightened risk to United States military
forces, including personnel operating under the authority of title 10
or title 50, of attack with (i) a biological, chemical, radiological,
or nuclear agent or agents; or (ii) an agent or agents that may cause,
or are otherwise associated with, an imminently life-threatening and
specific risk to United States military forces; or (4) a determination
by the Secretary that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of United States citizens living abroad, and that involves
a CBRN agent or agents, or a disease or condition that may be
attributable to such agent or agents.\2\
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\1\ 42 U.S.C. 247d-6b.
\2\ As amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act, Public Law 113-5, the Secretary may make a
determination of a public health emergency, or a significant
potential for a public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to make a
determination of a public health emergency in accordance with
section 319 of the PHS Act, 42 U.S.C. 247d to support a
determination or declaration made under section 564 of the FD&C Act.
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Based on any of these four determinations, the Secretary of HHS may
then declare that circumstances exist that justify the EUA, at which
point the Commissioner of Food and Drugs may issue an EUA if the
criteria for issuance of an authorization under section 564 of the FD&C
Act are met.
The ASPR requested that the Secretary issue the determination and
declaration to allow the Department to take measures based on
information currently available about monkeypox virus. The
determination of a public health emergency or a significant potential
for a public health emergency, and the declaration that circumstances
exist justifying emergency use of vaccines by the Secretary of HHS, as
described below, enable the Commissioner of Food and Drugs to issue an
EUA for vaccines for emergency use under section 564 of the FD&C Act.
II. Determination by the Secretary of Health and Human Services
On August 9, 2022, pursuant to section 564 of the FD&C Act, I
determined that there is a public health emergency, or a significant
potential for a public health emergency, that affects, or has a
significant potential to affect, national security or the health and
security of United States citizens living abroad that involves
monkeypox virus.
III. Declaration of the Secretary of Health and Human Services
Also on August 9, 2022, on the basis of my determination that there
is a public health emergency, or a significant potential for a public
health emergency, that affects, or has a significant potential to
affect, national security or the health and security of United States
citizens living abroad and that involves monkeypox virus, I declared
that circumstances exist justifying the authorization of emergency use
of vaccines pursuant to section 564 of the FD&C Act, subject to the
terms of any authorization issued under that section.
Notice of the EUAs issued by the Commissioner of Food and Drugs
pursuant to this determination and declaration will be provided
promptly in the Federal Register as required under section 564 of the
FD&C Act.
Dated: August 10, 2022.
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.
[FR Doc. 2022-17503 Filed 8-12-22; 8:45 am]
BILLING CODE 4150-37-P
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</html>Indexed from Federal Register on August 15, 2022.
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