Submission for OMB Review; Comment Request, 41086-41087 [E8-16183]
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41086
Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Notices
nation’s Adoption and Foster Care
populations, nor report meaningful and
reliable information to Congress about
the extent of problems facing these
children or the effectiveness of
assistance provided to this population,
without access to timely and accurate
information. Currently, SACWIS
support State efforts to meet the
following Federal reporting
requirements: The Adoption and Foster
Care Analysis and Reporting System
(AFCARS) required by section 479(b)(2)
of the Social Security Act; the National
Child Abuse and Neglect Data System
(NCANDS); Child Abuse Prevention and
Treatment Act (CAPTA); and the Chafee
Independent Living Program. These
systems also support state efforts to
provide the information to conduct the
Child and Family Service Reviews.
Currently, forty-two States and the
District of Columbia have developed, or
are developing, a SACWIS with Federal
financial participation. The purpose of
these reviews is to ensure that all
aspects of the project, as described in
the approved Advance Planning
Document, have been adequately
completed, and conform to applicable
regulations and policies.
To initiate a review, States will
submit the completed SACWIS
Assessment Review Guide (SARGE) and
other documentation at the point that
they have completed system
development and the system is
operational statewide. The additional
documents submitted as part of this
process should all be readily available
to the State as a result of good project
management practices.
The information collected in the
SACWIS Assessment Review Guide will
allow State and Federal officials to
determine if the State’s SACWIS meets
the requirements for title IV–E Federal
Financial Participation (FFP) defined at
45 CFR 1355.50. Additionally, other
States will be able to use the
documentation provided as part of this
review process in their own system
development efforts.
Respondents: State Governments.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
responses
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Review .............................................................................................................
1
1
200
200
Estimated Total Annual Burden
Hours: 200.
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: ACE
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail
address:infocollection@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, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 10, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–16180 Filed 7–16–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Child Care and Development
Fund Tribal Plan (Form ACF–118–A).
OMB No.: 0970–0198.
Description: The Child Care and
Development Fund (CCDF) Tribal Plan
serves as the agreement between the
applicant (Indian Tribes, tribal consortia
and tribal organizations) and the Federal
Government that describes how tribal
applicants will operate CCDF Block
Grant programs. The Tribal Plan
provides assurances that the CCDF
funds will be administered in
conformance with legislative
requirements, Federal regulations at 45
CFR parts 98 and 99 and other
applicable instructions or guidelines
issued by the Administration for
Children and Families (ACF). Tribes
must submit a new CCDF Tribal Plan
every two years in accordance with 45
CFR 98.17.
Respondents: Tribal CODE programs
(259 total).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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CCDF Tribal Plan ............................................................................................
CCDF Tribal Plan Amendments ......................................................................
Estimated Total Annual Burden
Hours: 4,921.
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
VerDate Aug<31>2005
21:03 Jul 16, 2008
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Average burden hours per
response
1
1
17.5
1.5
259
259
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:infocollection@acf.hhs.gov.
PO 00000
Number of
responses per
respondent
Total burden
hours
4,532.5
388.5
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
E:\FR\FM\17JYN1.SGM
17JYN1
41087
Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Notices
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, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 10, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–16183 Filed 7–16–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: The OC5E–157 Child Support
Enforcement Annual Data Report.
OMB No.: 0970–0177.
Description: The information obtained
from this form will be used to: (1)
Report Child Support Enforcement
activities to the Congress as required by
law; (2) calculate incentive measures
performance and performance
indicators utilized in the program; and
(3) assist the Office of Child Support
Enforcement in monitoring and
evaluating State Child Support
programs.
Respondents: State, Local or Tribal
Government.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
OCSE–157 Child Support Annual Data Report ...............................................
54
1
7
378.
Estimated Total Annual Burden
Hours: 378
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: ACE
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail
address:infocollection@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, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 10, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–16197 Filed 7–16–08; 8:45 am]
mstockstill on PROD1PC66 with NOTICES
BILLING CODE 4184–01–M
VerDate Aug<31>2005
21:03 Jul 16, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–D–0208]
(formerly Docket No. 2005D–0438)
Guidance for Industry: Safety, Efficacy,
and Pharmacokinetic Studies to
Support Marketing of Immune Globulin
Intravenous (Human) as Replacement
Therapy for Primary Humoral
Immunodeficiency; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Safety, Efficacy,
and Pharmacokinetic Studies to Support
Marketing of Immune Globulin
Intravenous (Human) as Replacement
Therapy for Primary Humoral
Immunodeficiency,’’ dated June 2008.
The guidance document provides
recommendations for the design of
clinical trials to assess the safety,
efficacy, and pharmacokinetics of
immune globulin intravenous (human)
(IGIV) products as replacement therapy
in primary humoral immunodeficiency.
The guidance announced in this notice
finalizes the draft guidance of the same
title dated November 2005.
DATES: Submit written or electronic
comments on agency guidances at any
time. Submit written requests for single
copies of the guidance to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
ADDRESSES: Submit written comments
on the 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.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
´
Denise Sanchez, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Safety, Efficacy, and
Pharmacokinetic Studies to Support
Marketing of Immune Globulin
Intravenous (Human) as Replacement
Therapy for Primary Humoral
Immunodeficiency,’’ dated June 2008.
This guidance provides investigational
new drug application (IND) and
biologics license application (BLA)
sponsors with recommendations for the
design of clinical trials to assess the
safety, efficacy, and pharmacokinetics of
investigational IGIV products when
used as replacement therapy in primary
humoral immunodeficiency. This
E:\FR\FM\17JYN1.SGM
17JYN1
Agencies
[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Notices]
[Pages 41086-41087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16183]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Child Care and Development Fund Tribal Plan (Form ACF-118-
A).
OMB No.: 0970-0198.
Description: The Child Care and Development Fund (CCDF) Tribal Plan
serves as the agreement between the applicant (Indian Tribes, tribal
consortia and tribal organizations) and the Federal Government that
describes how tribal applicants will operate CCDF Block Grant programs.
The Tribal Plan provides assurances that the CCDF funds will be
administered in conformance with legislative requirements, Federal
regulations at 45 CFR parts 98 and 99 and other applicable instructions
or guidelines issued by the Administration for Children and Families
(ACF). Tribes must submit a new CCDF Tribal Plan every two years in
accordance with 45 CFR 98.17.
Respondents: Tribal CODE programs (259 total).
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
CCDF Tribal Plan................................ 259 1 17.5 4,532.5
CCDF Tribal Plan Amendments..................... 259 1 1.5 388.5
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 4,921.
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:infocollection@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
[[Page 41087]]
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, Fax: 202-395-6974, Attn: Desk Officer for the Administration
for Children and Families.
Dated: July 10, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8-16183 Filed 7-16-08; 8:45 am]
BILLING CODE 4184-01-M