[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56074-56075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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