[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Notices]
[Page 47141]
From the Federal Register Online via the Government Publishing 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.

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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, 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.
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    \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.''
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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 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]
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