Proposed Information Collection Activity; Comment Request Proposed Projects:, 7746-7747 [05-2826]
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7746
Federal Register / Vol. 70, No. 30 / Tuesday, February 15, 2005 / Notices
Respondents: The respondents to
these follow-up surveys will be lowincome individuals from the five states
represented by the four sites currently
participating in the HtE Project: Kansas,
Missouri, New York, Pennsylvania and
Rhode Island. Many will be current or
former TANF participants, and many
will be current or former recipients of
site, respondents will have completed a
more detailed baseline survey, which is
required to establish baseline measures
of depression and related conditions.
The annual burden estimates are
detailed below, and the substantive
content of each survey are detailed in
the supporting statement.
Medicaid. These populations are at
heightened risk for all of the barriers
that cause people to be hard-to-employ.
Prior to these follow-up surveys, basic
demographic information for all survey
respondents will have been obtained
wherever possible from the existing
automated systems or brief baseline
information forms. In the Rhode Island
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Rhode Island, 6–month ...................................
Rhode Island, 15–month .................................
New York City, 12–month ...............................
Philadelphia, 12–month ..................................
Kansas/Missouri, 12–month ............................
Number of
responses per
respondent
734
734
1,000
750
680
1
1
1
1
1
Average burden
hours per
response
38
45
32
25
45
minutes
minutes
minutes
minutes
minutes
Estimated Total Annual Burden
Hours. 2,371.20
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
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.
Dated: February 8, 2005
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–2825 Filed 2–14–05; 8:45 am]
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
or
or
or
or
or
Proposed Information Collection
Activity; Comment Request Proposed
Projects:
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Title: Community-Based Child Abuse
Prevention Program (CBCAP).
OMB No.: 0970–0155.
Description: The Program Instruction,
prepared in response to the enactment
of the Community-Based Grants for the
Prevention of Child Abuse and Neglect
(administratively known as the
Community-Based Child Abuse
Prevention Program (CBCAP)), as set
forth in Title II of Pub. L. 108–36, Child
.63
.75
.53
.42
.75
hrs
hrs
hrs
hrs
hrs
Total burden
hours
.....................................
.....................................
.....................................
.....................................
.....................................
464.87
550.50
533.33
312.50
510.00
Abuse Prevention and Treatment Act
Amendments of 2003, provides
direction to the States and Territories to
accomplish the purposes of (1)
supporting community-based efforts to
develop, operate, expand and, where
appropriate, to network initiatives
aimed at the prevention of child abuse
and neglect and to support networks of
coordinated resources and activities to
better strengthen and support families to
reduce the incidence of child abuse and
neglect; and (2) fostering an
understanding, appreciation and
knowledge of diverse populations in
order to be effective in preventing and
treating child abuse and neglect. This
Program Instruction contains
information collection requirements that
are found in Pub. L. 108–36 at Sections
201, 202, 203, 205, 206, 207, and
pursuant to receiving a grant award. The
information submitted will be used by
the agency to ensure compliance with
the statute, complete the calculation of
the grant award entitlement, and
provide training and technical
assistance to the grantee.
Respondents: State Government.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Application .......................................................................................................
Annual Report ..................................................................................................
Estimated Total Annual Burden
Hours 3,328
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
VerDate jul<14>2003
17:50 Feb 14, 2005
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52
52
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average burden
hours per
response
40
24
Total burden
hours
2,080
1,248
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Information Services,
370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
E:\FR\FM\15FEN1.SGM
15FEN1
Federal Register / Vol. 70, No. 30 / Tuesday, February 15, 2005 / Notices
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail:
grjohnson@acf.hhs.gov.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility, (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: February 8, 2005.
Robert Sargis,
Reports Clearance, Officer.
[FR Doc. 05–2826 Filed 2–14–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0042]
Draft Guidance on the Open Public
Hearing; Food and Drug
Administration Advisory Committee
Meetings; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance
document entitled ‘‘The Open Public
Hearing; FDA Advisory Committee
Meetings.’’ This draft guidance is for
members of the public who choose to
participate in the open public hearing
(OPH) session of an FDA advisory
committee meeting. The draft guidance
is intended to answer more fully
questions about how the public may
participate at an OPH session, and it
includes topics such as meeting logistics
and administrative requirements.
DATES: Submit written or electronic
comments on this draft guidance by
June 15, 2005. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to
Linda Ann Sherman, Advisory
VerDate jul<14>2003
17:50 Feb 14, 2005
Jkt 205001
Committee Oversight and Management
Staff (HF–4), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Submit written
comments on the draft guidance to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.fda.gov.dockets/
ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Linda Ann Sherman, Office of the
Commissioner (HF–4), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1220, email: disclosure@oc.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance document entitled
‘‘The Open Public Hearing; FDA
Advisory Committee Meetings.’’
Guidance documents are prepared for
FDA staff, applicants/sponsors, and the
public that describe the agency’s
interpretation of, or policy on, a
regulatory issue. Every committee
meeting includes an OPH during which
interested persons may present relevant
information or views orally or in writing
21 CFR 14.25(a). The hearing is
conducted in accordance with 21 CFR
14.29. FDA encourages the participation
from all public speakers in its
decisionmaking processes. The draft
guidance is intended to answer more
fully questions about how (including
topics such as meeting logistics and
administrative requirements) the public
may participate at an OPH session. This
includes, but is not limited to, general
members of the public; individuals or
spokespersons from the regulated
industry; consumer advocacy groups;
and professional organizations,
societies, or associations.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices (21 CFR 10.115). The
draft guidance, when finalized will
represent the agency’s current thinking
on an FDA advisory committee open
public hearing. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
7747
comments on the draft guidance. Two
paper copies of mailed comments are to
be submitted, except that individuals
may submit one copy. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at
https://www.fda.gov/oc/advisory/
default.htm in the policy and guidance
section of FDA’s advisory committee
Intranet Web site.
Dated: February 8, 2005.
William K. Hubbard,
Associate Commissioner for Policy and
Planning.
[FR Doc. 05–2822 Filed 2–14–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0033]
Draft Guidance for Industry on Internal
Radioactive Contamination—
Development of Decorporation Agents;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Internal Radioactive
Contamination—Development of
Decorporation Agents.’’ This draft
document provides guidance to industry
on the development of decorporation
agents for the treatment of internal
radioactive contamination when
evidence is needed to demonstrate the
effectiveness of the agents, but human
efficacy studies are unethical or
infeasible. In such instances, the Animal
Efficacy Rule may be invoked to
approve new medical products not
previously marketed or new indications
for previously marketed products.
Specifically, this draft guidance
addresses chemistry, manufacturing and
controls (CMC) information; animal
efficacy, safety pharmacology, and
toxicology studies; clinical
pharmacology, biopharmaceutics, and
human safety studies; and postapproval
commitments.
DATES: Submit written or electronic
comments on the draft guidance by May
E:\FR\FM\15FEN1.SGM
15FEN1
Agencies
[Federal Register Volume 70, Number 30 (Tuesday, February 15, 2005)]
[Notices]
[Pages 7746-7747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2826]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Community-Based Child Abuse Prevention Program (CBCAP).
OMB No.: 0970-0155.
Description: The Program Instruction, prepared in response to the
enactment of the Community-Based Grants for the Prevention of Child
Abuse and Neglect (administratively known as the Community-Based Child
Abuse Prevention Program (CBCAP)), as set forth in Title II of Pub. L.
108-36, Child Abuse Prevention and Treatment Act Amendments of 2003,
provides direction to the States and Territories to accomplish the
purposes of (1) supporting community-based efforts to develop, operate,
expand and, where appropriate, to network initiatives aimed at the
prevention of child abuse and neglect and to support networks of
coordinated resources and activities to better strengthen and support
families to reduce the incidence of child abuse and neglect; and (2)
fostering an understanding, appreciation and knowledge of diverse
populations in order to be effective in preventing and treating child
abuse and neglect. This Program Instruction contains information
collection requirements that are found in Pub. L. 108-36 at Sections
201, 202, 203, 205, 206, 207, and pursuant to receiving a grant award.
The information submitted will be used by the agency to ensure
compliance with the statute, complete the calculation of the grant
award entitlement, and provide training and technical assistance to the
grantee.
Respondents: State Government.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Application..................................... 52 1 40 2,080
Annual Report................................... 52 1 24 1,248
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours 3,328
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Information Services, 370 L'Enfant Promenade, SW., Washington, DC
20447, Attn: ACF
[[Page 7747]]
Reports Clearance Officer. All requests should be identified by the
title of the information collection. E-mail: grjohnson@acf.hhs.gov.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility, (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: February 8, 2005.
Robert Sargis,
Reports Clearance, Officer.
[FR Doc. 05-2826 Filed 2-14-05; 8:45 am]
BILLING CODE 4184-01-M