Document ID: FDA-2013-N-0578-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; General Licensing Provisions:
Biologics License Application, Changes to an Approved Application,
Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567
Posted Date: 2014-01-23T05:00Z

[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3821-3822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01233]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0578]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; General Licensing Provisions: 
Biologics License Application, Changes to an Approved Application, 
Labeling, Revocation and Suspension, Postmarketing Studies Status 
Reports, and Forms FDA 356h and 2567

AGENCY: Food and Drug Administration, HHS.

[[Page 3822]]

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Biologics License Application, 
Changes to an Approved Application, Labeling, Revocation and 
Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h 
and 2567'' has been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On November 13, 2013, the Agency submitted a 
proposed collection of information entitled ``Biologics License 
Application, Changes to an Approved Application, Labeling, Revocation 
and Suspension, Postmarketing Studies Status Reports, and Forms FDA 
356h and 2567'' 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 0910-0338. The approval 
expires on January 31, 2017. A copy of the supporting statement for 
this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01233 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P