[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]
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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.
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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]
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