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Notice

Agency Information Collection Activities; Announcement of OMB Approval; Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed

Document Details

Information about this document as published in the Federal Register.

Published Document

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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AGENCY:

Food and Drug Administration, HHS.

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ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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FOR FURTHER INFORMATION CONTACT:

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

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SUPPLEMENTARY INFORMATION:

In the Federal Register of June 18, 2003 (68 FR 36676), 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 0910-0513. The approval expires on July 31, 2006. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/​ohrms/​dockets.

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Dated: August 4, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-20199 Filed 8-7-03; 8:45 am]

BILLING CODE 4160-01-S