[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39708-39709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16531]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Renewal of Declaration Regarding Emergency Use of All Oral 
Formulations of Doxycycline Accompanied by Emergency Use Information

AGENCY: Office of the Secretary (OS), HHS.

ACTION: Notice.

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SUMMARY: The Secretary of Homeland Security determined on September 23, 
2008 that there is a significant potential for a domestic emergency 
involving a heightened risk of attack with a specified biological, 
chemical, radiological, or nuclear agent or agents--in this case, 
Bacillus anthracis. On the basis of that determination, and pursuant to 
section 564(b) of the Federal Food, Drug, and Cosmetic Act (``FD&C 
Act''), the Secretary of Health and Human Services is renewing her July 
20, 2011 declaration of an emergency justifying the authorization of 
emergency use of all oral formulations of doxycycline accompanied by 
emergency use information subject to the terms of any authorization 
issued by the Commissioner of Food and Drugs under 21 U.S.C. 360bbb-
3(a). This notice is being issued in accordance with section 564(b)(4) 
of the FD&C Act, 21 U.S.C. 360bbb-3(b)(4).

DATES: This Notice and referenced HHS declaration are effective as of 
June 28, 2012.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, 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: On September 23, 2008, former Secretary of 
Homeland Security, Michael Chertoff, determined that there is a 
significant potential for a domestic emergency, involving a heightened 
risk of attack with a specified biological, chemical, radiological, or 
nuclear agent or agents--in this case, Bacillus anthracis--although 
there is no current domestic emergency involving anthrax, no current 
heightened risk of an anthrax attack, and no credible information 
indicating an imminent threat of an attack involving Bacillus 
anthracis.
    On October 1, 2008, on the basis of that determination, and 
pursuant to section 564(b) of the FD&C Act, 21 U.S.C. 360bbb-3(b), 
former Secretary of Health and Human Services, Michael O. Leavitt, 
declared an emergency justifying the emergency use of doxycycline 
hyclate tablets accompanied by emergency use information subject to the 
terms of any authorization issued under 21 U.S.C. 360bbb-3(a).\1\ On 
October 1, 2009 and October 1, 2010, I renewed the former Secretary's 
declaration,\2\ and on July 20, 2011, I renewed and amended the 
declaration to declare that the emergency justifies emergency use of 
all oral formulations of doxycycline accompanied by emergency use 
information subject to the terms of any authorization issued under 21 
U.S.C. 360bbb-3(a).\3\
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    \1\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the 
determination by the Secretary of Homeland Security and the 
declaration by the Secretary of Health and Human Services was 
provided at 73 FR 58242 (October 6, 2008).
    \2\ Pursuant to section 564(b)(4) of the FD&C Act, notices of 
the renewal of the declaration of the Secretary of Health and Human 
Services were provided at 74 FR 51,279 (Oct. 6, 2009) and 75 FR 
61,489 (Oct. 5, 2010).
    \3\ Pursuant to section 564(b)(4) of the FD&C Act, notice of the 
renewal and amendment of the declaration of the Secretary of Health 
and Human Services was provided at 76 FR 44,926 (July 27, 2011).
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    On the basis of the September 23, 2008 determination by the 
Secretary of Homeland Security and pursuant to section 564(b) of the 
FD&C Act, I hereby renew my July 20, 2011 declaration that the 
emergency justifies emergency use of all oral formulations of 
doxycycline accompanied by emergency use information subject to the 
terms of any authorization issued under 21 U.S.C. 360bbb-3(a). I am 
issuing this notice in accordance with section 564(b)(4) of the

[[Page 39709]]

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Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).

    Dated: June 28, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-16531 Filed 7-3-12; 8:45 am]
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