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