Proposed Information Collection Activity; Comment Request, 13545-13546 [E8-4805]
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13545
Federal Register / Vol. 73, No. 50 / Thursday, March 13, 2008 / Notices
the contact person below well in advance of
the meeting.
For Further Information Contact: Christine
Branche, Ph.D., Executive Secretary, NIOSH,
CDC, 395 E Street, SW., Suite 9200,
Washington, DC 20201, telephone (513) 533–
6800, toll free 1 (800) 35–NIOSH, e-mail
ocas@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: March 6, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 08–1014 Filed 3–10–08; 9:14 am]
BILLING CODE 4163–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request Title: Children’s
Justice Act Program.
OMB No.: 0980–0196.
Description: The Program Instruction,
prepared in response to the enactment
of the Children’s Justice Act (CJA), 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 assisting
States in developing, establishing and
operating programs designed to
improve: (1) The handling of child
abuse and neglect cases, particularly
child sexual abuse and exploitation, in
a manner that limits additional trauma
to the child victim; (2) the handling of
cases of suspected child abuse or
neglect-related fatalities; (3) the
investigation and prosecution of cases of
child abuse and neglect, particularly
child sexual abuse and exploitation; and
(4) the handling of cases involving
children with disabilities or serious
health-related problems who are victims
of abuse and neglect. This Program
Instruction contains information
collection requirements that are found
in Pub. L. 108–36 at Sections 107(b) and
107(d), and pursuant to receiving a grant
award. The information being collected
is required by statute to be submitted
pursuant to receiving a grant award. The
information submitted will be used by
the agency to ensure compliance with
the statute; to monitor, evaluate and
measure grantee achievements in
addressing the investigation and
prosecution of child abuse and neglect;
and to report to Congress.
Respondents: State Governments
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Application & Annual Report ...........................................................................
52
1
60
3,120
Estimated Total Annual Burden
Hours: 3,120.
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
mstockstill on PROD1PC66 with NOTICES
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
VerDate Aug<31>2005
16:19 Mar 12, 2008
Jkt 214001
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: March 5, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–4804 Filed 3–12–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Title IV–E State Plan for the
Foster care, Independent Living and
Adoption Assistance Programs.
OMB No.: 0980–0141.
Description: A State plan is required
by sections 471 and 477(b)(2), part IV–
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
E of the Social Security Act (the Act) for
each public child welfare agency
requesting Federal funding for foster
care, independent living services and
adoption assistance under the Act. The
State plan is a comprehensive narrative
description of the nature and scope of
a State’s programs and provides
assurances the programs will be
administered in conformity with the
specific requirements stipulated in title
IV–E. The plan must include all
applicable State statutory, regulatory, or
policy references and citations for each
requirement as well as supporting
documentation. A State may use the
pre-print format prepared by the
Children’s Bureau of the Administration
for Children and Families or a different
format, on the condition that the format
used includes all of the title IV–E State
plan requirements of the law.
Respondents: State and Territorial
Agencies (State Agencies) administering
or supervising the administration of the
title IV–E programs.
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13546
Federal Register / Vol. 73, No. 50 / Thursday, March 13, 2008 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Title IV–E State Plan .......................................................................................
12
1
15
180
Estimated Total Annual Burden
Hours: 180.
In compliance with the requirements
of Section 506(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 Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
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: March 5, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–4805 Filed 3–12–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on PROD1PC66 with NOTICES
[Docket No. FDA–2008–D–0150]
Draft Guidance for Industry on
Hypertension Indication: Drug
Labeling for Cardiovascular Outcome
Claims; Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<31>2005
16:19 Mar 12, 2008
Jkt 214001
ACTION:
I. Background
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims.’’ This
draft guidance is intended to assist
applicants in developing labeling for
cardiovascular outcome claims for drugs
that are indicated to treat hypertension.
Because blood pressure control is well
established as beneficial in preventing
serious cardiovascular events, FDA
believes that the appropriate use of
these drugs can be encouraged by
making the connection between lower
blood pressure and improved
cardiovascular outcomes more explicit
in labeling. This draft guidance is
intended to recommend standard
labeling for antihypertensive drugs
except where differences are clearly
supported by clinical data.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance byMay 12, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that
office in processing your requests.
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.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
SUMMARY:
Devi
Kozeli, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 4183, Silver Spring,
MD 20993–0002, 301–796–1128.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
PO 00000
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FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Hypertension Indication: Drug
Labeling for Cardiovascular Outcome
Claims.’’ On June 15, 2005, the
Cardiovascular and Renal Drugs
Advisory Committee met in open public
session to discuss class labeling for
cardiovascular outcome claims for drugs
that are indicated to treat hypertension.
With few exceptions, current labeling
for antihypertensive drug products only
includes the information that these
drugs are indicated to reduce blood
pressure; the labeling does not include
information on the clinical benefits
related to cardiovascular outcomes
expected from such blood pressure
reduction. However, blood pressure
control is well established as beneficial
in preventing serious cardiovascular
events, and inadequate treatment of
hypertension is acknowledged as a
significant public health problem. The
committee voiced a broad consensus in
favor of labeling changes to describe
briefly the clinical benefits related to
cardiovascular outcomes expected from
lowering blood pressure with any
antihypertensive drug. The labeling
proposed in this draft guidance is
consistent with the advisory
committee’s recommendations.
This draft guidance is being made
available to afford the public the
opportunity to comment on both the
intent of the labeling revisions and the
specific proposed language. This draft
guidance is intended to recommend
standard labeling for antihypertensive
drugs except where differences are
clearly supported by clinical data. After
this guidance has been finalized,
applicants will be encouraged to submit
labeling supplements containing the
new language.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on labeling for cardiovascular outcome
claims for drugs indicated to treat
hypertension. 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
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]]>Agencies
[Federal Register Volume 73, Number 50 (Thursday, March 13, 2008)]
[Notices]
[Pages 13545-13546]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4805]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Title IV-E State Plan for the Foster care, Independent
Living and Adoption Assistance Programs.
OMB No.: 0980-0141.
Description: A State plan is required by sections 471 and
477(b)(2), part IV-E of the Social Security Act (the Act) for each
public child welfare agency requesting Federal funding for foster care,
independent living services and adoption assistance under the Act. The
State plan is a comprehensive narrative description of the nature and
scope of a State's programs and provides assurances the programs will
be administered in conformity with the specific requirements stipulated
in title IV-E. The plan must include all applicable State statutory,
regulatory, or policy references and citations for each requirement as
well as supporting documentation. A State may use the pre-print format
prepared by the Children's Bureau of the Administration for Children
and Families or a different format, on the condition that the format
used includes all of the title IV-E State plan requirements of the law.
Respondents: State and Territorial Agencies (State Agencies)
administering or supervising the administration of the title IV-E
programs.
[[Page 13546]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Title IV-E State Plan....................... 12 1 15 180
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 180.
In compliance with the requirements of Section 506(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
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
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: March 5, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8-4805 Filed 3-12-08; 8:45 am]
BILLING CODE 4184-01-M
