[Federal Register Volume 70, Number 21 (Wednesday, February 2, 2005)]
[Notices]
[Pages 5450-5451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2027]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Determination and Declaration Regarding Emergency Use of Anthrax 
Vaccine Adsorbed for Prevention of Inhalation Anthrax

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Secretary of the Department of Health and Human Services 
is issuing this notice pursuant to section 564(b)(4) of the Federal 
Food, Drug, and Cosmetic Act to justify the emergency use of Anthrax 
Vaccine Adsorbed (AVA) for prevention of inhalation anthrax. The 
Secretary provides notice of the determination of the Department of 
Defense that there is a significant potential for a military emergency 
involving a heightened risk to United States military forces of attack 
with anthrax. The determination of the Department of Defense was 
effective as of December 10, 2004. The Secretary also provides notice 
that, on the basis of such determination, he has declared an emergency 
justifying the authorization of the emergency use of AVA.

DATES: This Notice and the referenced declaration are effective as of 
January 14, 2005.

FOR FURTHER INFORMATION CONTACT: Stewart Simonson, Assistant Secretary 
for Public Health Emergency Preparedness, (202) 205-2882.

SUPPLEMENTARY INFORMATION:

I. Background

    AVA was first licensed by the National Institutes of Health in 
November 1970. Upon the delegation of vaccine regulation to FDA in 
1972, FDA undertook a comprehensive review of the safety, 
effectiveness, and labeling of all vaccines. See 21 CFR 601.25. Under 
this review, independent advisory panels evaluated the safety and 
effectiveness data of vaccines to assure that they met appropriate 
standards. The advisory panel that reviewed AVA concluded that it is 
safe, effective, and not misbranded, and FDA issued a proposal to adopt 
the panel's recommendation (the Bacterial Vaccines

[[Page 5451]]

and Toxoids Efficacy Review). 50 FR 51002 (Dec. 13, 1985).
    In March 2003, six plaintiffs, known as John and Jane Doe 1 through 
6, filed suit in the United States District Court for the District of 
Columbia (the Court) seeking the Court to enjoin the Anthrax Vaccine 
Immunization Program (AVIP) of the Department of Defense, and to 
declare AVA an investigational drug when used for protection against 
inhalation anthrax. On December 22, 2003, the Court issued a 
preliminary injunction barring inoculations under the AVIP in the 
absence of informed consent or a Presidential waiver of the informed 
consent requirement.
    In the Federal Register of January 5, 2004 (69 FR 255), FDA 
published a final rule and final order in response to the report and 
recommendations of the independent advisory panel that reviewed the 
safety and effectiveness data pertaining to AVA. Following FDA's 
issuance of the final rule and final order, the Court lifted the 
preliminary injunction on January 7, 2004, except as it applied to the 
six Doe plaintiffs.
    On October 27, 2004, the Court issued a memorandum opinion vacating 
and remanding the January 2004 final rule and final order to FDA for 
reconsideration, following an appropriate notice and comment period. 
The Court also enjoined operation of the AVIP for inoculation using AVA 
to prevent inhalation anthrax. On December 29, 2004, FDA reopened the 
comment period on the Bacterial Vaccine and Toxoids Efficacy Review for 
90 days. As a result of the Court's October 27, 2004, order, the use of 
AVA for the prevention of inhalation anthrax under the AVIP is deemed 
an unapproved use of an approved product.

II. Determination of the Department of Defense

    On December 10, 2004, pursuant to section 564(b)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1)(B), the 
Deputy Secretary of Defense determined that there is a significant 
potential for a military emergency involving a heightened risk to 
United States military forces of attack with anthrax.
    By letter dated December 22, 2004, the Assistant Secretary of 
Defense for Health Affairs (Assistant Secretary) requested that the 
Food and Drug Administration issue an Emergency Use Authorization for 
the use of AVA for protection against inhalation anthrax. The letter of 
the Assistant Secretary states that the Deputy Secretary of Defense has 
assigned authority from the Secretary of Defense to make the statutory 
determination under section 564(b)(1)(B) of the Federal Food, Drug, and 
Cosmetic Act.

III. Declaration of the Secretary of Health and Human Services

    On December 10, 2004, the Deputy Secretary of Defense determined 
that there is a significant potential for a military emergency 
involving a heightened risk to United States military forces of attack 
with anthrax. Pursuant to 21 U.S.C. 360bbb-3(b) and on the basis of 
such determination, I hereby declare an emergency justifying the 
authorization of the emergency use of Anthrax Vaccine Adsorbed subject 
to the conditions described in the authorization issued under 21 U.S.C. 
360bbb(a). Notice of the authorization issued under 21 U.S.C. 360bbb(a) 
is provided elsewhere in this issue of the Federal Register.

    Dated: January 14, 2005.
Tommy G. Thompson,
Secretary.
[FR Doc. 05-2027 Filed 1-31-05; 11:39 am]
BILLING CODE 4150-03-P