[Federal Register Volume 85, Number 60 (Friday, March 27, 2020)]
[Notices]
[Pages 17335-17336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06541]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Emergency Use Authorization Declaration
ACTION: Notice of Emergency Use Authorization Declaration.
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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). The
virus is now named SARS-CoV-2, which causes the illness COVID-19. On
the basis of this determination, he also declared that circumstances
exist justifying the authorization of emergency use of medical devices,
including alternative products used as medical devices, pursuant to
section 564 of the FD&C Act, subject to the terms of any authorization
issued under that section.
DATES: The determination was effective February 4, 2020, and this
declaration is effective March 24, 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
[[Page 17336]]
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[thinsp]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.
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 Office of the Assistant Secretary for Preparedness and Response,
HHS, requested that the FDA, HHS, issue an EUA for certain medical
devices to allow the Department to take response measures based on
information currently available about the virus that causes COVID-19.
The determination of a public health emergency, and the declaration
that circumstances exist justifying emergency use of certain medical
devices by the Secretary of HHS, as described below, enable the FDA
Commissioner to issue an EUA for these devices for emergency use under
section 564 of the FD&C Act.
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). The virus is now named SARS-CoV-2,
which causes the illness COVID-19.
III. Declaration of the Secretary of Health and Human Services
On March 24, 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, SARS-CoV-2, I
declared that circumstances exist justifying the authorization of
emergency use of medical devices, including alternative products used
as medical devices, 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 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.
Dated: March 24, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020-06541 Filed 3-25-20; 4:15 pm]
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