Submission for OMB Review; Comment Request, 5451 [05-1895]

Download as PDF 5451 Federal Register / Vol. 70, No. 21 / Wednesday, February 2, 2005 / Notices 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 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. 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. 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 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 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 ........................ ........................ ........................ 318 Estimated Total Annual Burden Hours ..................................................... 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 VerDate jul<14>2003 14:19 Feb 01, 2005 Jkt 205001 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. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 E:\FR\FM\02FEN1.SGM 02FEN1

Agencies

[Federal Register Volume 70, Number 21 (Wednesday, February 2, 2005)]
[Notices]
[Page 5451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1895]


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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
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          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