[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Pages 25273-25274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10055]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Determination and Declaration Regarding Emergency Use of in Vitro 
Diagnostics for Detection of the Avian Influenza A (H7N9) 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(b) of the Federal Food, Drug, and 
Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3(b)(4). On April 19, 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 the avian influenza A (H7N9) virus.
    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 the avian influenza A (H7N9) virus 
pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. Sec.  360bbb-
3(b)(1), subject to the terms of any authorization issued under that 
section. The Secretary also specified that this declaration is a 
declaration of an emergency with respect to in vitro diagnostics as 
defined under the Public Readiness and Emergency Preparedness (PREP) 
Act Declaration for Pandemic Influenza Diagnostics, Personal 
Respiratory Protection Devices, and Respiratory Support Devices signed 
by then Secretary Michael Leavitt on December 17, 2008.\1\
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    \1\ 73 FR 78362 (Dec. 22, 2008).

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DATES: The determination and declaration are effective April 19, 2013.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, M.D., MSPH, Assistant

[[Page 25274]]

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): (1) 
Authorizing 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 an emergency justifying the authorization based on 
one of four determinations: (1) A determination of a domestic 
emergency, or a significant potential for a domestic emergency, by the 
Secretary of Homeland Security; (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 \2\ sufficient to affect 
national security or the health and security of United States citizens 
living abroad; (3) a determination of a military emergency, or a 
significant potential for a military emergency, by the Secretary of 
Defense; 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 biological, chemical, radiological, 
or nuclear agent or agents, or a disease or condition that may be 
attributable to such agent or agents (see 21 U.S.C. 360bbb-3(b)(1)).\3\
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    \2\ 42 U.S.C. 247d-6b.
    \3\ 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 the avian influenza A (H7N9) virus to allow the Department 
to take preparedness measures based on information currently available 
about the avian influenza A (H7N9) virus detected in China. 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 the avian influenza A (H7N9) 
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(a) of the FD&C Act, 21 U.S.C. 360bbb-
3(a).

II. Determination by the Secretary of Health and Human Services

    On April 19, 2013, pursuant to section 564(b)(1)(C) of the FD&C 
Act, 21 U.S.C. 360bbb-3(b)(1)(C), 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 the 
avian influenza A (H7N9) virus.

III. Declaration of the Secretary of Health and Human Services

    Also on April 19, 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 abroad and that involves the 
avian influenza A (H7N9) virus, I declared that circumstances exist 
justifying the authorization of emergency use of in vitro diagnostics 
for detection of the avian influenza A (H7N9) virus pursuant to section 
564 of the FD&C Act, 21 U.S.C. 360bbb-3, subject to the terms of any 
authorization issued under that section.
    I also specified that this declaration is a declaration of an 
emergency with respect to in vitro diagnostics as defined under the 
PREP Act Declaration for Pandemic Influenza Diagnostics, Personal 
Respiratory Protection Devices, and Respiratory Support Devices signed 
by then Secretary Michael Leavitt on December 17, 2008.
    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 21 U.S.C. 360bbb-3(h).

     Dated: April 19, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-10055 Filed 4-29-13; 8:45 am]
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