Proposed Information Collection Activity; Comment Request, 13545-13546 [E8-4805]

Download as PDF 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. E:\FR\FM\13MRN1.SGM 13MRN1 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 http:// 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 Frm 00023 Fmt 4703 Sfmt 4703 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 E:\FR\FM\13MRN1.SGM 13MRN1

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]


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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