Notice: Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry: Cooperative 
Manufacturing Arrangements for Licensed Biologics

Federal Register: October 9, 2008 (Volume 73, Number 197)            
                  Page 59633

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry: Cooperative 
Manufacturing Arrangements for Licensed Biologics'' 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 Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 19, 2007 
(72 FR 65034), 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 0910-0629. 
The approval expires on September 30, 2011. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.reginfo.gov/public/do/PRAMain. 

    Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23907 Filed 10-8-08; 8:45 am]

BILLING CODE 4160-01-S