[Federal Register Volume 68, Number 198 (Tuesday, October 14, 2003)]
[Notices]
[Page 59189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25845]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry on 
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 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 September 9, 2003 
(68 FR 53174) , 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 March 31, 2004. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25845 Filed 10-10-03; 8:45 am]
BILLING CODE 4160-01-S