Notice2022-19752
Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (Monkeypox)
Primary source
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Published
September 13, 2022
Effective
August 9, 2022
Issuing agencies
Health and Human Services Department
Abstract
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act. On August 9, 2022, the Secretary determined pursuant to his authority under 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 declared on September 7, 2022 that circumstances exist justifying authorizations of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act.
Full Text
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<title>Federal Register, Volume 87 Issue 176 (Tuesday, September 13, 2022)</title>
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[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56074-56075]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Declaration That Circumstances Exist Justifying Authorizations
Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act
(Monkeypox)
AGENCY: Department of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C)
Act. On August 9, 2022, the Secretary determined pursuant to his
authority under 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 declared on September 7,
2022 that circumstances exist justifying authorizations of emergency
use of in vitro diagnostics for detection and/or diagnosis of infection
with the monkeypox virus, including in vitro diagnostics that detect
and/or diagnose infection with non-variola Orthopoxvirus, pursuant to
the FD&C Act.
DATES: The determination was effective August 9, 2022 and the
declaration is effective September 7, 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, 21 U.S.C. 360bbb-3, 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
[[Page 56075]]
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 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]\
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 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 in
vitro diagnostics for detection and/or diagnosis of infection with the
monkeypox virus, including in vitro diagnostics that detect and/or
diagnose infection with non-variola Orthopoxvirus by the Secretary of
HHS, as described below, enable the Commissioner of Food and Drugs to
issue EUAs for in vitro diagnostics for detection and/or diagnosis of
infection with the monkeypox virus, including in vitro diagnostics that
detect and/or diagnose infection with non-variola Orthopoxvirus 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
On September 7, 2022, on the basis of my August 9, 2022
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
authorizations of emergency use of in vitro diagnostics for detection
and/or diagnosis of infection with the monkeypox virus, including in
vitro diagnostics that detect and/or diagnose infection with non-
variola Orthopoxvirus, 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.
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.
Footnotes
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.
[FR Doc. 2022-19752 Filed 9-12-22; 8:45 am]
BILLING CODE 4150-37-P
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