
[Federal Register Volume 78, Number 93 (Tuesday, May 14, 2013)]
[Notices]
[Page 28224]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11364]



[[Page 28224]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0902]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Prescription Drug Product Labeling; 
Medication Guide Requirements

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 ``Prescription Drug Product 
Labeling; Medication Guide Requirements'' has been approved by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On April 30, 2012, the Agency submitted a 
proposed collection of information entitled ``Prescription Drug Product 
Labeling; Medication Guide Requirements'' 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 
0910-0393. The approval expires on January 31, 2016. A copy of the 
supporting statement for this information collection is available on 
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11364 Filed 5-13-13; 8:45 am]
BILLING CODE 4160-01-P


