Document ID: FDA-2012-N-0471-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug User Fee Cover Sheet; Form FDA 3397
Posted Date: 2013-08-09T04:00Z

[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48689-48690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19276]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0471]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Prescription Drug User Fee Cover 
Sheet; Form FDA 3397

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 User Fee Cover 
Sheet; Form FDA 3397'' 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 Operations, 
Food and Drug Administration, 1350 Piccard

[[Page 48690]]

Dr., PI50-400B, Rockville, MD 20850, 301-796-7726, 
ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On November 6, 2012, the Agency submitted a 
proposed collection of information entitled ``Prescription Drug User 
Fee Cover Sheet; Form FDA 3397'' 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 0910-0297. 
The approval expires on December 31, 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: August 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19276 Filed 8-8-13; 8:45 am]
BILLING CODE 4160-01-P