Reports and guidance documents; availability, etc.: Medicare Prescription Drug, Improvement, and Modernization Act of 2003— Listed drugs, 30-month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended; questions and answers; correction,

[Federal Register: November 19, 2004 (Volume 69, Number 223)]

[Notices]

[Page 67746-67747]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19no04-62]

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Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription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.

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 This document announced the availability of a draft guidance for industry entitled ``Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare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