[Federal Register: August 12, 2004 (Volume 69, Number 155)]
[Notices]               
[Page 49906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au04-78]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0229]

 
Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Continuous 
Marketing Applications; Pilot 2--Scientific Feedback and Interactions 
During Development of Fast Track Products Under the Prescription Drug 
User Fee Act

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 ``Guidance for Industry: Continuous 
Marketing Applications; Pilot 2--Scientific Feedback and Interactions 
During Development of Fast Track Products Under PDUFA'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 26, 2004 
(69 FR 8978), 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 0910-0518. 
The approval expires on June 30, 2007. 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.fda.gov/ohrms/dockets.


    Dated: August 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18408 Filed 8-11-04; 8:45 am]

BILLING CODE 4160-01-S