[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Notices]
[Pages 5341-5342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Termination, By Expiration, of Declaration of Emergency 
Justifying Emergency Use Authorization of Anthrax Vaccine Adsorbed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice, 
under the Federal Food, Drug, and Cosmetic Act (the act), of the 
termination, by expiration, of the declaration of emergency justifying 
emergency use authorization of Anthrax Vaccine Adsorbed (AVA) that was 
issued by the former Secretary of Health and Human Services Secretary 
Tommy G. Thompson (the former HHS Secretary) on January 14, 2005. The 
declaration of emergency terminated by expiration on January 14, 2006, 
which is the end of the 1-year period that began on the date that the 
declaration was made. Under the act, advance notice of the termination 
of the declaration was provided to the Department of Defense.

DATES: The Notice is effective as of February 1, 2006.

FOR FURTHER INFORMATION CONTACT: Boris Lushniak, Office of 
Counterterrorism Policy and Planning (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 10, 2004, the Deputy Secretary of Defense determined, 
under section 564(b)(1)(B) of the act (21 U.S.C. 360bbb-3(b)(1)(B)), 
that there was a significant potential for a military emergency 
involving a heightened risk to U.S. military forces of attack with 
anthrax. On the basis of such determination and under section 564(b)(1) 
of the act, the former HHS Secretary declared an emergency justifying 
the authorization of the emergency use of Anthrax Vaccine Adsorbed. A 
notice of the determination of the Deputy Secretary of Defense and the 
declaration of the former HHS Secretary was published in the Federal

[[Page 5342]]

Register of February 2, 2005 (70 FR 5452).

II. Advance Notice of Termination

    Under section 564(b)(3) of the act, the FDA Commissioner provided 
advance notice of the termination of the former HHS Secretary's 
declaration of emergency to the Department of Defense.
    The January 2006 letter notifying the Department of Defense of the 
termination of the declaration of emergency follows:

William Winkenwerder, Jr., M.D.,
Assistant Secretary of Defense for Health Affairs,
The Pentagon,
Washington, D.C. 20301-1200
Dear Dr. Winkenwerder:
    This letter is to provide advance notice of the termination of 
the above-referenced declaration of emergency that was issued by 
Secretary of Health and Human Services Tommy G. Thompson on January 
14, 2005, pursuant to section 564(b)(1) of the Federal Food, Drug, 
and Cosmetic Act (the Act), 21 U.S.C. Sec.  360bbb-3.
    In accordance with section 564(b)(2)(A)(ii) of the Act, the 
declaration of emergency will terminate by expiration on January 14, 
2006, which is the end of the one year period that began on the date 
that the declaration was made. This advance notice of termination 
will be published in the Federal Register, pursuant to section 
564(b)(4) of the Act.
Sincerely,

Andrew C. von Eschenbach, M.D.
Acting Commissioner of Food and Drugs

    Dated: January 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1311 Filed 1-31-06; 8:45 am]
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