Food and Drug Administration, HHS.
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 1995.Start Further Info
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.End Further Info End Preamble Start Supplemental 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://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 0910-0538.Start Signature
Dated: April 23, 2004.
Assistant Commissioner for Policy.
[FR Doc. 04-9971 Filed 4-30-04; 8:45 am]
BILLING CODE 4160-01-S