Submission for OMB Review; Comment Request, 55051-55052 [E9-25259]

Download as PDF 55051 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices • Press release announcing the effective date of the cigarette flavor ban, • Flavored tobacco products fact sheet, and • Flavored tobacco products parental advisory. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN Activity and Form FDA 3734 No. of Respondents Reporting violations of section 907(a)(1)(A) of the FDCA Annual Frequency per Response 1,700 Dated: October 15, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–25604 Filed 10–23–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects: Total Annual Responses 1 Minutes per Response 1,700 Title: Community Services Block Grant (CSBG) Program Model Plan Application. OMB No.: New collection. Description: Sections 676 and 677 of the Community Services Block Grant Act require States, including the District of Columbia and the Commonwealth of Puerto Rico, Tribes, Tribal organizations and U.S. territories applying for Community Services Block Grant (CSBG) funds to submit an application and plan (Model Application Plan). The application plan must meet statutory requirements prior to being funded with CSBG funds. Applicants have the option Total Hours 10 283 to submit a detailed application annually or biannually. Entities that submit a biannual application must provide an abbreviated application the following year if substantial changes to the initial application will occur. OMB approval is being sought. Respondents: State Governments, including the District of Columbia and the Commonwealth of Puerto Rico, Tribal Governments, Tribal Organizations, and U.S. territories. ANNUAL BURDEN ESTIMATES Number of respondents Instrument mstockstill on DSKH9S0YB1PROD with NOTICES Model State CSBG Application ....................................................................... Model Indian Tribes & Tribal Organizations CSBG Application ...................... Estimated Total Annual Burden Hours: 860 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 VerDate Nov<24>2008 18:16 Oct 23, 2009 Jkt 220001 Dated: October 21, 2009. Robert Sargis, Reports Clearance Officer. [FR Doc. E9–25650 Filed 10–23–09; 8:45 am] PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 Average burden hours per response 1 1 10 10 56 30 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. BILLING CODE 4184–01–P Number of responses per respondent Total burden hours 560 300 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Cross-Site Evaluation of the Children’s Bureau Grantee Cluster: Supporting Evidence-Based Home Visiting Programs to Prevent Child Maltreatment (EBHV). OMB No.: New collection. Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing this crosssite evaluation data collection activity to identify successful strategies for adopting, implementing, and sustaining high-quality home visitation programs to prevent child maltreatment. An evaluation study will address four domains: (1) Systems change to develop infrastructure, (2) fidelity to evidence- E:\FR\FM\26OCN1.SGM 26OCN1 55052 Federal Register / Vol. 74, No. 205 / Monday, October 26, 2009 / Notices based models, (3) costs of home visiting programs, and (4) family and child outcomes (via a review of grantee analysis reports). A process study will focus on the broader grant initiative to understand how programs plan and develop the infrastructure needed to support home visitation services and how they ensure service quality. Information will be collected through biennial site visits, web-based data entry, a data quality progress table, a relationship questionnaire completed by participants and home visitors, and a grantee-partner network survey. In particular, site visits will include interviews with key grantee staff and stakeholders involved in the execution of the grant and in the efforts to make system changes. Grantees will complete systems web-based data entry on goals and operations every six months while agencies implementing home visiting programs associated with the grantee will utilize the fidelity/cost web-based data entry to provide EBHV program, provider, and participant characteristics along with yearly data on costs of home visiting programs. Respondents: EBHV grantee and key staff (evaluators, home visitors and supervisors), partners, implementing agencies, home visiting participants, and home visitors. ANNUAL BURDEN ESTIMATES Annual number of respondents Instrument Number of responses per respondent Average burden hour per response Estimated annual burden hours EBHV grantee and key staff-partner interview guide ...................................... EBHV grantee systems web-based data entry ............................................... EBHV agency fidelity/cost web-based data entry ........................................... EBHV grantee data quality progress table ...................................................... Participant-home visitor relationship questionnaire ......................................... Home visitor-participant relationship questionnaire ......................................... EBHV grantee-partner network survey ............................................................ 249 17 50 17 4,716 4,716 142 2 2 12 4 2 2 2 1.60 1.00 9.00 4.25 0.25 0.25 0.42 797 34 5,400 289 2,358 2,358 119 Estimated Total Burden Hours ................................................................. ........................ ........................ ........................ 11,355 mstockstill on DSKH9S0YB1PROD with NOTICES Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: OPREinfocollection@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: October 14, 2009. Seth F. Chamberlain, OPRE Reports Clearance Officer. [FR Doc. E9–25259 Filed 10–23–09; 8:45 am] BILLING CODE 4184–01–M VerDate Nov<24>2008 15:19 Oct 23, 2009 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0307 (formerly Docket No. 2007–D–0173)] Guidance for Industry on Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Investigator Responsibilities— Protecting the Rights, Safety, and Welfare of Study Subjects.’’ This guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA’s expectations concerning the investigator’s responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. 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 http:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Joseph Griffin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993, 301–796– 2270, Joseph.Griffin@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Investigator Responsibilities— Protecting the Rights, Safety, and Welfare of Study Subjects.’’ Under the regulations in part 312 (21 CFR part 312) (Investigational New Drug Application) and part 812 (21 CFR part 812) (Investigational Device Exemptions), an investigator is responsible for ensuring that a clinical investigation is conducted according to the signed investigator statement, the E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 74, Number 205 (Monday, October 26, 2009)]
[Notices]
[Pages 55051-55052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25259]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Cross-Site Evaluation of the Children's Bureau Grantee 
Cluster: Supporting Evidence-Based Home Visiting Programs to Prevent 
Child Maltreatment (EBHV).
    OMB No.: New collection.
    Description: The Administration for Children and Families (ACF), 
U.S. Department of Health and Human Services (HHS), is proposing this 
cross-site evaluation data collection activity to identify successful 
strategies for adopting, implementing, and sustaining high-quality home 
visitation programs to prevent child maltreatment. An evaluation study 
will address four domains: (1) Systems change to develop 
infrastructure, (2) fidelity to evidence-

[[Page 55052]]

based models, (3) costs of home visiting programs, and (4) family and 
child outcomes (via a review of grantee analysis reports). A process 
study will focus on the broader grant initiative to understand how 
programs plan and develop the infrastructure needed to support home 
visitation services and how they ensure service quality.
    Information will be collected through biennial site visits, web-
based data entry, a data quality progress table, a relationship 
questionnaire completed by participants and home visitors, and a 
grantee-partner network survey. In particular, site visits will include 
interviews with key grantee staff and stakeholders involved in the 
execution of the grant and in the efforts to make system changes. 
Grantees will complete systems web-based data entry on goals and 
operations every six months while agencies implementing home visiting 
programs associated with the grantee will utilize the fidelity/cost 
web-based data entry to provide EBHV program, provider, and participant 
characteristics along with yearly data on costs of home visiting 
programs.
    Respondents: EBHV grantee and key staff (evaluators, home visitors 
and supervisors), partners, implementing agencies, home visiting 
participants, and home visitors.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                  Annual  number     Number of        Average        Estimated
                   Instrument                           of         responses per    burden hour    annual burden
                                                    respondents     respondent     per response        hours
----------------------------------------------------------------------------------------------------------------
EBHV grantee and key staff-partner interview                 249               2            1.60             797
 guide..........................................
EBHV grantee systems web-based data entry.......              17               2            1.00              34
EBHV agency fidelity/cost web-based data entry..              50              12            9.00           5,400
EBHV grantee data quality progress table........              17               4            4.25             289
Participant-home visitor relationship                      4,716               2            0.25           2,358
 questionnaire..................................
Home visitor-participant relationship                      4,716               2            0.25           2,358
 questionnaire..................................
EBHV grantee-partner network survey.............             142               2            0.42             119
                                                 ---------------------------------------------------------------
    Estimated Total Burden Hours................  ..............  ..............  ..............          11,355
----------------------------------------------------------------------------------------------------------------

    Additional Information: Copies of the proposed collection may be 
obtained by writing to the Administration for Children and Families, 
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade, 
SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All 
requests should be identified by the title of the information 
collection. E-mail address: OPREinfocollection@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: October 14, 2009.
Seth F. Chamberlain,
OPRE Reports Clearance Officer.
[FR Doc. E9-25259 Filed 10-23-09; 8:45 am]
BILLING CODE 4184-01-M