[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44926-44927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18937]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Renewal of Declaration Regarding Emergency Use of Doxycycline 
Hyclate Tablets Accompanied by Emergency Use Information and Amendment 
To Include All Oral Formulations of Doxycycline

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 this determination, the Secretary 
of Health and Human Services is renewing the October 1, 2008 
declaration by former Secretary Michael O. Leavitt of an emergency 
justifying the authorization of emergency use of doxycycline hyclate 
tablets 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) and amending the declaration to include all oral 
formulations of doxycyline 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 Federal Food, Drug, and 
Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).

DATES: This Notice and referenced HHS declaration are effective as of 
July 20, 2011.

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

[[Page 44927]]

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. Pursuant to section 
564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-
3(b), and on the basis of such determination, on October 1, 2008, 
former Secretary of Health and Human Services, Michael O. Leavitt, 
declared an emergency justifying the authorization of 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\
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    \1\ Pursuant to section 564(b)(4) of the Federal Food, Drug, and 
Cosmetic 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).
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    Pursuant to section 564(b)(2)(B) of the Federal Food, Drug, and 
Cosmetic Act, 21 U.S.C. 360bbb-3(b), and on the basis of Secretary 
Chertoff's September 23, 2008 determination, I hereby renew former 
Secretary Leavitt's October 1, 2008 declaration of an emergency 
justifying the authorization of 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) and amend 
the declaration to justify the authorization 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 
previously renewed the declaration on October 1, 2009 and October 1, 
2010.\2\ I am issuing this notice in accordance with section 564(b)(4) 
of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).
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    \2\ Pursuant to section 564(b)(4) of the Federal Food, Drug, and 
Cosmetic 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).

    Dated: July 20, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-18937 Filed 7-26-11; 8:45 am]
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