[Federal Register Volume 70, Number 195 (Tuesday, October 11, 2005)]
[Notices]
[Page 59072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0083]


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, and Forms FDA 356h and 2567

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 ``General Licensing Provisions: 
Biologics License Application, Changes to an Approved Application, 
Labeling, Revocation and Suspension, 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: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 21, 2005 (70 
FR 42068), the agency announced that the proposed information 
collection had been submitted 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 September 30, 2008. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20306 Filed 10-7-05; 8:45 am]
BILLING CODE 4160-01-S