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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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

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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​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.

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Dated: April 23, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 04-9971 Filed 4-30-04; 8:45 am]