[Federal Register: May 3, 2004 (Volume 69, Number 85)]
[Page 24170]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 1999N-0193]

Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Supplements and Other Changes to an 
Approved Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Supplements and Other Changes to 
an Approved Application; Final Rule'' has been approved by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 

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 June 28, 1999 (64 
FR 34608), 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 0910-0538. 
The approval expires on March 31, 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.

    At this time the agency has incorporated the information 
collection's reporting burden, previously identified by OMB control 
number 0910-0431, entitled ``Changes to an Approved NDA or ANDA,'' into 
this collection of information, identified by OMB control number 0910-

    Dated: April 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9971 Filed 4-30-04; 8:45 am]