[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50090-50091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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