[Federal Register Volume 69, Number 223 (Friday, November 19, 2004)]
[Notices]
[Pages 67746-67747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0460]


Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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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document announced the availability of a draft guidance for industry 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.

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.

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''.


[[Page 67747]]


    Dated: November 12, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-25647 Filed 11-18-04; 8:45 am]
BILLING CODE 4160-01-S