[Federal Register Volume 69, Number 93 (Thursday, May 13, 2004)]
[Notices]
[Pages 26612-26613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999N-1852]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Draft Guidance for Industry: Reports 
on the Status of Postmarketing Studies--Implementation of Section 130 
of the Food and Drug Administration Modernization Act of 1997

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; Reports on 
the Status of Postmarketing Studies--Implementation of Section 130 of 
the Food and Drug Administration Modernization Act of 1997'' 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

[[Page 26613]]

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 4, 2001 (66 
FR 17912), 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 0910-0528. 
The approval expires on March 31, 2007. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: April 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10833 Filed 5-12-04; 8:45 am]
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