[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18250-18251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06905]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Emergency Use Authorization Declaration
AGENCY: Department of Health and Human Services.
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 drugs and
biological products during the COVID-19 pandemic, 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 27, 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, 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 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 drugs and biological
products 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 drugs and
biological products by the Secretary of HHS, as described below, enable
the FDA Commissioner to issue an EUA for drugs and biological products
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 27, 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, I declared that
circumstances exist justifying the authorization of emergency use of
drugs
[[Page 18251]]
and biological products during the COVID-19 pandemic, 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 27, 2020.
Alex M. Azar II,
Secretary.
[FR Doc. 2020-06905 Filed 3-30-20; 2:00 pm]
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