[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7316-7317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02496]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Determination of Public Health Emergency

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

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 February 4, 2020, the Secretary determined 
pursuant to his authority under section 564 of the FD&C Act that there 
is a public health emergency that has a significant potential to affect 
national security or the health and security of United States citizens 
living abroad and that involves a novel (new) coronavirus (nCoV) first 
detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). On 
the basis of this determination, he also declared that circumstances 
exist justifying the authorization of emergency use of in vitro 
diagnostics for detection and/or diagnosis of this novel coronavirus 
(2019-nCoV) 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 took effect February 4, 2020.

FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, M.D., MTM&H, MS, 
Assistant Secretary for Preparedness and Response, Office of the 
Secretary, 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 the 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 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 
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 FDA Commissioner may issue an EUA if the criteria for 
issuance of an authorization under section 564 of the FD&C Act are met.
    The determination of a public health emergency, and the declaration 
that circumstances exist justifying emergency use of in vitro 
diagnostics for detection and/or diagnosis of the novel coronavirus 
(2019-nCoV) by the Secretary of HHS, as described below, enable the FDA 
Commissioner to issue EUAs for certain in vitro diagnostics for 
emergency use under section 564 of the FD&C Act. The Centers for 
Disease Control and Prevention (CDC) requested that the FDA issue an 
EUA for its in

[[Page 7317]]

vitro diagnostic for detection of 2019-nCoV to allow the Department to 
take preparedness measures based on information currently available 
about 2019-nCoV.

II. Determination by the Secretary of Health and Human Services

    On February 4, 2020, pursuant to section 564 of the FD&C Act, I 
determined that there is a public health emergency that has a 
significant potential to affect national security or the health and 
security of United States citizens living abroad and that involves a 
novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei 
Province, China in 2019 (2019-nCoV).

III. Declaration of the Secretary of Health and Human Services

    Also on February 4, 2020, on the basis of my determination of a 
public health emergency that has a significant potential to affect 
national security or the health and security of United States citizens 
living abroad and that involves the novel (new) coronavirus (2019-
nCoV), I declared that circumstances exist justifying the authorization 
of emergency use of in vitro diagnostics for detection and/or diagnosis 
of the novel coronavirus (2019-nCoV) pursuant to section 564 of the 
FD&C Act, subject to the terms of any authorization issued under that 
section.
    Notice of any EUAs issued by the FDA Commissioner pursuant to this 
determination and declaration will be provided promptly in the Federal 
Register as required under section 564 of the FD&C Act.

Alex M. Azar II,
Secretary.
[FR Doc. 2020-02496 Filed 2-6-20; 8:45 am]
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