Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles, 38299 [2012-15721]

Download as PDF 38299 Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices participants in the study Management Information System (MIS). Annual Burden Estimates previously-approved field data collection instrument, and the current request. Burden for all instruments is annualized over three years. The following table provides the combined burden estimates for the Annual number of respondents Activity/respondent Average burden per response (minutes) Number of responses per respondent Total annual burden hours Collection of Field Data (Approved April 20, 2012) Selecting Study Grantees Discussions/grantee and partner organization staff ........................................................................................................... 50 1 60 50 30 2,105 70.2 1 10 10 351 351 2,000 1 30 2,517 2 Introductory Script and Baseline Survey (Currently Requested) Introductory Script: (1) Grantee staff ................................................................................... (2) Program applicants ......................................................................... Baseline Survey: (1) Study participants ........................................................................... 1.000 Study MIS (Currently Requested) Study MIS: (1) Grantee staff ................................................................................... 30 Estimated Total Annual Burden Hours: 4,269. DEPARTMENT OF HEALTH AND HUMAN SERVICES Additional Information Food and Drug Administration 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. Email address: OPREinfocollection@acf. hhs.gov. [Docket No. FDA–2011–N–0747] srobinson on DSK4SPTVN1PROD 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 of Management and Budget, Paperwork Reduction Project, Email: OIRA SUBMISSION@OMB.E0P.GOV, Attn: Desk Officer for the Administration for Children and Families. Steven M. Hanmer, Reports Clearance, Officer. [FR Doc. 2012–15440 Filed 6–26–12; 8:45 am] BILLING CODE 4184–37–M 19:05 Jun 26, 2012 AGENCY: Jkt 226001 Food and Drug Administration, HHS. ACTION: OMB Comment VerDate Mar<15>2010 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–7651, Juanmanuel.Vilela@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 19, 2012, the Agency submitted a proposed collection of information entitled ‘‘Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 2,517 Articles’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0575. The approval expires on June 30, 2015. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: June 20, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–15721 Filed 6–26–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0357] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot Study AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the SUMMARY: E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Page 38299]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0747]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Waivers of In Vivo Demonstration of 
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and 
Type A Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Waivers of In Vivo Demonstration 
of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form 
and Type A Medicated Articles'' has been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
Juanmanuel.Vilela@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On March 19, 2012, the Agency submitted a 
proposed collection of information entitled ``Waivers of In Vivo 
Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral 
Dosage Form and Type A Medicated Articles'' to OMB for review and 
clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has now 
approved the information collection and has assigned OMB control number 
0910-0575. The approval expires on June 30, 2015. A copy of the 
supporting statement for this information collection is available on 
the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: June 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15721 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P
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