[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Page 51279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24086]


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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

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 Food and Drug Commissioner 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 
October 1, 2009.

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. 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\ 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). 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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    \1\ Pursuant to section 564(b)(4) of the FFDCA, notice of the 
determination by the Secretary, DHS, and the declaration by the 
Secretary, HHS, was provided at 73 FR 58242 (October 6, 2008).

    Dated: October 1, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-24086 Filed 10-1-09; 4:15 pm]
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