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Notice

Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003-Questions and Answers; Availability; Correction

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.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of November 4, 2004. This document announced the availability of a draft guidance for industry entitled “Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—Questions and Answers.” The document was published with an incorrect docket number. This document corrects that error.

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FOR FURTHER INFORMATION CONTACT:

Joyce A. Strong, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857, 301-827-7010.

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SUPPLEMENTARY INFORMATION:

In FR Doc. 04-24675, appearing on page 64314 in the Federal Register of Thursday, November 4, 2004, the following correction is made:

1. On page 64314, in the second column, “Docket No. 2004N-0087” is corrected to read “Docket No. 2004D-0460”.

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Dated: November 12, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 04-25647 Filed 11-18-04; 8:45 am]

BILLING CODE 4160-01-S