Document ID: FDA-2011-N-0747-0004
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2012-06-27T04:00Z

[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 http://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]
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