Submission for OMB Review; Comment Request, 53682-53683 [2011-21863]

Download as PDF 53682 Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Notices regulated services to reflect external costs. Regulated cable operators submit this form to local franchising authorities or the Commission, in situations where the FCC has assumed jurisdiction. FCC Form is filed by cable operators quarterly. FCC Form 1240 is filed by cable operators seeking to adjust maximum permitted rates for regulated cable services to reflect changes in external costs. Cable operators submit FCC Form 1240 to their respective local franchising authorities (‘‘LFAs’’) to justify rates for the basic service tier and related equipment or with the Commission, in situations where the Commission has assumed jurisdiction. FCC Form 1240 is a filing alternative to FCC Form 1210. FCC Form 1240 is filed by cable operators annually. Federal Communications Commission. Avis Mitchell, Federal Register Liaison, Office of the Secretary, Office of Managing Director. [FR Doc. 2011–21986 Filed 8–26–11; 8:45 am] BILLING CODE 6712–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Formative Data Collections for Informing Policy Research. OMB No.: 0970–0356. Description: The Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), intends to request approval from the Office of Management and Budget (OMB) for a generic clearance that will allow OPRE to conduct a variety of qualitative data collections. Over the next three years, OPRE anticipates undertaking a variety of new research projects in the fields of cash welfare, employment and self-sufficiency, Head Start, child care, healthy marriage and responsible fatherhood, and child welfare. In order to inform the development of OPRE research, to maintain a research agenda that is rigorous and relevant, and to ensure that research products are as current as possible, OPRE will engage in a variety of qualitative data collections in concert with researchers and practitioners throughout the field. OPRE envisions using a variety of techniques including semi-structured discussions, focus groups, telephone interviews, and inperson observations and site visits, in order to integrate the perspectives of program operators, policy officials and members of the research community. Following standard Office of Management and Budget (OMB) requirements, OPRE will submit a change request to OMB individually for every group of data collection activities undertaken under this generic clearance. OPRE will provide OMB with a copy of the individual instruments or questionnaires (if one is used), as well as other materials describing the project. Respondents: Administrators or staff of State and local agencies or programs in the relevant fields; academic researchers; and policymakers at various levels of government. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Emcdonald on DSK2BSOYB1PROD with NOTICES Semi-Structured Discussion and Information-Gathering Protocol ................... Estimated Total Annual Burden Hours: 1200. 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. VerDate Mar<15>2010 16:45 Aug 26, 2011 Jkt 223001 2400 Dated: August 22, 2011. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2011–21868 Filed 8–26–11; 8:45 am] BILLING CODE 4184–22–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Pre-testing of Evaluation Surveys. OMB No.: 0970–0355. Description: The Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), intends to request approval from the Office of Management and Budget (OMB) for a generic clearance that a will allow OPRE to conduct a variety of data gathering activities aimed at identifying questionnaire and procedural problems PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 Average burden hours per response .5 Total annual burden hours 1200 in survey administration. Over the next three years, OPRE anticipates undertaking a variety of new surveys as part of research projects in the fields of cash welfare, employment and selfsufficiency, Head Start, child care, healthy marriage and responsible fatherhood, and child welfare, among others. In order to improve the development of its research and evaluation surveys, OPRE envisions using a variety of techniques including field tests, respondent debriefing questionnaires, cognitive interviews and focus groups in order to identify questionnaire and procedural problems, suggest solutions, and measure the relative effectiveness of alternative survey solutions. Following standard OMB requirements, OPRE will submit a change request to OMB individually for every data collection activity undertaken under this generic clearance. OPRE will provide OMB with a copy of the individual instrument or questionnaire, as well as other materials describing the project and specific survey pretest. E:\FR\FM\29AUN1.SGM 29AUN1 53683 Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Notices Respondents: The respondents will be identified at the time that each change request is submitted to OMB. Generally they will be individuals who are representative of the target groups for the public assistance research or evaluation project in question. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Survey development field tests, respondent debriefing questionnaires, cognitive interviews and focus groups ............................................................... Estimated Total Annual Burden Hours: 3000. 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: August 22, 2011. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2011–21863 Filed 8–26–11; 8:45 am] BILLING CODE 4184–07–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Emcdonald on DSK2BSOYB1PROD with NOTICES [Docket No. FDA–2011–D–0597] Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for SUMMARY: VerDate Mar<15>2010 16:45 Aug 26, 2011 Jkt 223001 6000 industry entitled ‘‘Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.’’ This guidance is intended to assist sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data. The guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities when conducting investigational new drug (IND) or investigational device exemption (IDE) studies. 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 either electronic or written comments on the draft guidance by November 28, 2011. 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 20993–0002; the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448; or the Office of Communication, Education and Radiation Programs, Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 Average burden hours per response .5 Total annual burden hours 3000 www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ann Meeker-O’Connell, Center for Drug Evaluation and Research (HFD–45), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5339, Silver Spring, MD 20993–0002, 301–796–3150; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210; or Chrissy Cochran, Center for Devices and Radiological Health (HFZ–311), Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 66, rm. 3453, Silver Spring, MD 20993–0002, 301–796–5490. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.’’ FDA is publishing this new draft guidance to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. This guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities during clinical investigations. This guidance describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to effectively oversee a study. For example, the guidance encourages greater use of centralized monitoring methods where appropriate. The guidance also makes recommendations about how to develop monitoring plans and document monitoring activities. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will E:\FR\FM\29AUN1.SGM 29AUN1

Agencies

[Federal Register Volume 76, Number 167 (Monday, August 29, 2011)]
[Notices]
[Pages 53682-53683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21863]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Pre-testing of Evaluation Surveys.
    OMB No.: 0970-0355.
    Description: The Office of Planning, Research and Evaluation 
(OPRE), Administration for Children and Families (ACF), U.S. Department 
of Health and Human Services (HHS), intends to request approval from 
the Office of Management and Budget (OMB) for a generic clearance that 
a will allow OPRE to conduct a variety of data gathering activities 
aimed at identifying questionnaire and procedural problems in survey 
administration. Over the next three years, OPRE anticipates undertaking 
a variety of new surveys as part of research projects in the fields of 
cash welfare, employment and self-sufficiency, Head Start, child care, 
healthy marriage and responsible fatherhood, and child welfare, among 
others. In order to improve the development of its research and 
evaluation surveys, OPRE envisions using a variety of techniques 
including field tests, respondent debriefing questionnaires, cognitive 
interviews and focus groups in order to identify questionnaire and 
procedural problems, suggest solutions, and measure the relative 
effectiveness of alternative survey solutions.
    Following standard OMB requirements, OPRE will submit a change 
request to OMB individually for every data collection activity 
undertaken under this generic clearance. OPRE will provide OMB with a 
copy of the individual instrument or questionnaire, as well as other 
materials describing the project and specific survey pretest.

[[Page 53683]]

    Respondents: The respondents will be identified at the time that 
each change request is submitted to OMB. Generally they will be 
individuals who are representative of the target groups for the public 
assistance research or evaluation project in question.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
                   Instrument                        Number of     responses per   burden hours    Total annual
                                                    respondents     respondent     per response    burden hours
----------------------------------------------------------------------------------------------------------------
Survey development field tests, respondent                  6000               1              .5            3000
 debriefing questionnaires, cognitive interviews
 and focus groups...............................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 3000.
    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: August 22, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011-21863 Filed 8-26-11; 8:45 am]
BILLING CODE 4184-07-M