Federal Register / Vol. 70, No. 21 / Wednesday, February 2, 2005 / Notices 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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Grants for Battered Women’s 

Shelters. 

OMB No.: New collection. 

Description: This information 

collection is authorized under Title III 

of the Child Abuse Amendments of 

1984, Public Law 98–457, as amended. 

In response to the program 

announcement, the respondents must 

submit information about their services 

program and their eligibility. 

Information that is collected is used to 

award grants under the Grants for 

Battered Women’s Shelters program. 

Respondents: State agencies 

administering the Family Violence 

Prevention and Services program.

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of

responses per 

respondent 

Average

burden hours 

per response 

Total burden 

hours 

State FVPSA Agencies .................................................................................... 53 1 6 318 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 318 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

grjohnson@acf.hhs.gov.

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, E-mail address: 

Katherine_T._Astrich@omb.eop.gov.

Dated: January 26, 2005. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 05–1895 Filed 2–1–05; 8:45 am] 

BILLING CODE 4184–01–M