Proposed Information Collection Activity; Comment Request, 34078-34079 [2011-14106]

Download as PDF 34078 Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices ANNUAL BURDEN ESTIMATES Number of respondents Instrument Survey development field tests, respondent debriefing questionnaires, cognitive interviews and focus groups ............................................................... Estimated Total Annual Burden Hours: 2,500 In compliance with the requirements of Section 3506(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 Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. E-mail address: OPREinfocollection@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 Number of responses per respondent 5,000 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: May 31, 2011. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2011–14107 Filed 6–9–11; 8:45 am] BILLING CODE M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; 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 Average burden hours per response 1 0.5 Total annual burden hours 2,500 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 Number of responses per respondent Average burden hours per response Total annul burden hours Semi-Structured Discussion and Information-Gathering Protocol ................... WReier-Aviles on DSKGBLS3C1PROD with NOTICES Instrument 2,000 1 0.5 1,000 Estimated Total Annual Burden Hours: 1,000 In compliance with the requirements of Section 3506(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 VerDate Mar<15>2010 14:33 Jun 09, 2011 Jkt 223001 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. E-mail address: OPREinfocollection@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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 E:\FR\FM\10JNN1.SGM 10JNN1 Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: May 31, 2011. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2011–14106 Filed 6–9–11; 8:45 am] BILLING CODE 4184–22–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0405] Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection for in vivo Radiopharmaceuticals Used for Diagnosis and Monitoring. DATES: Submit either electronic or written comments on the collection of information by August 9, 2011. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal WReier-Aviles on DSKGBLS3C1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:33 Jun 09, 2011 Jkt 223001 agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring—21 CFR Part 315 (OMB Control Number 0910– 0409)—Extension FDA is requesting OMB approval of the information collection requirements contained in 21 CFR 315.4, 315.5, and 315.6. These regulations require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new diagnostic radiopharmaceutical or of a new indication for use of an approved diagnostic radiopharmaceutical. In response to the requirements of section 122 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115), FDA published a final rule in the Federal Register of May 17, 1999 (64 FR 26657), amending its regulations by adding provisions that clarify the Agency’s evaluation and approval of in vivo radiopharmaceuticals used in the PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 34079 diagnosis or monitoring of diseases. The regulation describes the kinds of indications of diagnostic radiopharmaceuticals and some of the criteria that the Agency would use to evaluate the safety and effectiveness of a diagnostic radiopharmaceutical under section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355) and section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). Information about the safety or effectiveness of a diagnostic radiopharmaceutical enables FDA to properly evaluate the safety and effectiveness profiles of a new diagnostic radiopharmaceutical or a new indication for use of an approved diagnostic radiopharmaceutical. The rule clarifies existing FDA requirements for approval and evaluation of drug and biological products already in place under the authorities of the FD&C Act and the PHS Act. The information, which is usually submitted as part of a new drug application or biologics license application or as a supplement to an approved application, typically includes, but is not limited to, nonclinical and clinical data on the pharmacology, toxicology, adverse events, radiation safety assessments, and chemistry, manufacturing, and controls. The content and format of an application for approval of a new drug are set forth in § 314.50 (21 CFR 314.50). Under 21 CFR part 315, information required under the FD&C Act and needed by FDA to evaluate the safety and effectiveness of in vivo radiopharmaceuticals still needs to be reported. Based on the number of submissions (that is, human drug applications and/ or new indication supplements for diagnostic radiopharmaceuticals) that FDA receives, the Agency estimates that it will receive approximately two submissions annually from two applicants. The hours per response refers to the estimated number of hours that an applicant would spend preparing the information required by the regulations. Based on FDA’s experience, the Agency estimates the time needed to prepare a complete application for a diagnostic radiopharmaceutical to be approximately 10,000 hours, roughly one-fifth, or 2,000 hours, of which is estimated to be spent preparing the portions of the application that would be affected by these regulations. The regulation does not impose any additional reporting burden for safety and effectiveness information on diagnostic radiopharmaceuticals beyond the estimated burden of 2,000 hours E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34078-34079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; 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 in-
person 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     Average  burden
                 Instrument                      Number of      responses  per     hours per       Total annul
                                                respondents       respondent        response       burden hours
----------------------------------------------------------------------------------------------------------------
Semi-Structured Discussion and Information-            2,000                1              0.5            1,000
 Gathering Protocol.........................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 1,000
    In compliance with the requirements of Section 3506(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 
Planning, Research and Evaluation, 370 L'Enfant Promenade, SW., 
Washington, DC 20447, Attn: OPRE Reports Clearance Officer. E-mail 
address: OPREinfocollection@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

[[Page 34079]]

other forms of information technology. Consideration will be given to 
comments and suggestions submitted within 60 days of this publication.

    Dated: May 31, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011-14106 Filed 6-9-11; 8:45 am]
BILLING CODE 4184-22-M