Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus, 47141 [2014-19026]
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Federal Register / Vol. 79, No. 155 / Tuesday, August 12, 2014 / Notices
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[FR Doc. 2014–19079 Filed 8–11–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Declaration Regarding Emergency Use
of In Vitro Diagnostics for Detection of
Ebola Virus
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
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, 21 U.S.C. 360bbb–3. On
September 22, 2006, then Secretary of
Homeland Security, Michael Chertoff,
determined pursuant to section 319F–2
of the Public Health Service Act, 42
U.S.C. 247d–6b, that the Ebola virus
presents a material threat against the
United States population sufficient to
affect national security.
On the basis of this determination, on
August 4, 2014 the Secretary declared
that circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection of Ebola
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 effective August 4, 2014.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, M.D., MSPH, 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).
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SUMMARY:
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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 biological, chemical, 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 of attack with a
CBRN agent or agents; 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 Department of Defense requested
that the FDA issue an EUA for in vitro
diagnostics for detection of Ebola virus
1 42 U.S.C. 247d–6b, which states: ‘‘[t]he
Homeland Security Secretary, in consultation with
the Secretary and the heads of other agencies as
appropriate, shall on an ongoing basis—(i) assess
current and emerging threats of chemical,
biological, radiological, and nuclear agents; and (ii)
determine which of such agents present a material
threat against the United States population
sufficient to affect national security.’’
PO 00000
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Fmt 4703
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47141
to allow the Defense Department to take
preparedness and response measures
based on information currently available
about the Ebola virus in Western Africa.
The material threat determination by the
Secretary of Homeland Security, and the
declaration that circumstances exist
justifying emergency use of in vitro
diagnostics for detection of Ebola virus
by the Secretary of HHS, as described
below, enable the FDA Commissioner to
issue an EUA for certain in vitro
diagnostics for emergency use under
section 564 of the FD&C Act.
II. Material Threat Determination by
the Secretary of Homeland Security
On September 22, 2006, then
Secretary of Homeland Security,
Michael Chertoff, determined pursuant
to section 319F–2 of the Public Health
Service Act, 42 U.S.C. 247d–6b, that the
Ebola virus presents a material threat
against the United States population
sufficient to affect national security.
III. Declaration of the Secretary of
Health and Human Services
On August 4, 2014, on the basis of the
Secretary of Homeland Security’s
determination that the Ebola virus
presents a material threat against the
United States population sufficient to
affect national security, I declared that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection of Ebola
virus 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: August 5, 2014.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2014–19026 Filed 8–11–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
SUMMARY:
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12AUN1
]]>Agencies
[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Notices]
[Page 47141]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19026]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Declaration Regarding Emergency Use of In Vitro Diagnostics for
Detection of Ebola Virus
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, 21 U.S.C. 360bbb-3. On September 22, 2006, then
Secretary of Homeland Security, Michael Chertoff, determined pursuant
to section 319F-2 of the Public Health Service Act, 42 U.S.C. 247d-6b,
that the Ebola virus presents a material threat against the United
States population sufficient to affect national security.
On the basis of this determination, on August 4, 2014 the Secretary
declared that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection of Ebola 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 effective August 4, 2014.
FOR FURTHER INFORMATION CONTACT: Nicole Lurie, M.D., MSPH, 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 biological, chemical,
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 of attack with a CBRN agent or
agents; 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.
---------------------------------------------------------------------------
\1\ 42 U.S.C. 247d-6b, which states: ``[t]he Homeland Security
Secretary, in consultation with the Secretary and the heads of other
agencies as appropriate, shall on an ongoing basis--(i) assess
current and emerging threats of chemical, biological, radiological,
and nuclear agents; and (ii) determine which of such agents present
a material threat against the United States population sufficient to
affect national security.''
---------------------------------------------------------------------------
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 Department of Defense requested that the FDA issue an EUA for
in vitro diagnostics for detection of Ebola virus to allow the Defense
Department to take preparedness and response measures based on
information currently available about the Ebola virus in Western
Africa. The material threat determination by the Secretary of Homeland
Security, and the declaration that circumstances exist justifying
emergency use of in vitro diagnostics for detection of Ebola virus by
the Secretary of HHS, as described below, enable the FDA Commissioner
to issue an EUA for certain in vitro diagnostics for emergency use
under section 564 of the FD&C Act.
II. Material Threat Determination by the Secretary of Homeland Security
On September 22, 2006, then Secretary of Homeland Security, Michael
Chertoff, determined pursuant to section 319F-2 of the Public Health
Service Act, 42 U.S.C. 247d-6b, that the Ebola virus presents a
material threat against the United States population sufficient to
affect national security.
III. Declaration of the Secretary of Health and Human Services
On August 4, 2014, on the basis of the Secretary of Homeland
Security's determination that the Ebola virus presents a material
threat against the United States population sufficient to affect
national security, I declared that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection of
Ebola virus 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: August 5, 2014.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2014-19026 Filed 8-11-14; 8:45 am]
BILLING CODE 4150-37-P
