[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33842-33843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Determination and Declaration Regarding Emergency Use of In Vitro 
Diagnostics for Detection of Middle East Respiratory Syndrome 
Coronavirus (MERS-CoV)

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 May 29, 2013, the Secretary 
determined that there is a significant potential for 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 Middle East respiratory syndrome coronavirus (MERS-CoV).
    On the basis of this determination, she also declared that 
circumstances exist justifying the authorization of emergency use of in 
vitro diagnostics for detection of Middle East respiratory syndrome 
coronavirus (MERS-CoV) 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 May 29, 2013.

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, 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 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.\2\
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    \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.
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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 Centers for Disease Control and Prevention (CDC), HHS, 
requested that the FDA, HHS, issue an EUA for in vitro diagnostics for 
detection of Middle East respiratory syndrome coronavirus (MERS-CoV) to 
allow the Department to take preparedness measures based on information 
currently available about the Middle East respiratory syndrome 
coronavirus (MERS-CoV). The determination of a significant potential 
for a public health emergency, and the declaration that circumstances 
exist justifying emergency use of in vitro diagnostics for detection of 
Middle East respiratory syndrome coronavirus (MERS-CoV) 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. Determination by the Secretary of Health and Human Services

    On May 29, 2013, pursuant to section 564 of the FD&C Act, I 
determined that there is a significant potential for 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 Middle East respiratory syndrome coronavirus (MERS-CoV).

III. Declaration of the Secretary of Health and Human Services

    Also on May 29, 2013, on the basis of my determination of a 
significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of United States citizens living

[[Page 33843]]

abroad and that involves Middle East respiratory syndrome coronavirus 
(MERS-CoV), I declared that circumstances exist justifying the 
authorization of emergency use of in vitro diagnostics for detection of 
Middle East respiratory syndrome coronavirus (MERS-CoV) 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 May 29, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-13333 Filed 6-4-13; 8:45 am]
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