Document ID: FDA-2011-N-0231-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2011-11-25T05:00Z

[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Page 72710]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30326]

[[Page 72710]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0231]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Adverse Experience Reporting for 
Licensed Biological Products; and General Records

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 ``Adverse Experience Reporting for 
Licensed Biological Products; and General Records'' 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 July 19, 2011, the Agency submitted a 
proposed collection of information entitled ``Adverse Experience 
Reporting for Licensed Biological Products; and General Records'' 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 0910-0308. The approval expires on November 
30, 2014. A copy of the supporting statement for this information 
collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: November 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30326 Filed 11-23-11; 8:45 am]
BILLING CODE 4160-01-P