[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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]
BILLING CODE 4150-28-P