69 FR 223 pgs. 67746-67747 - Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription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
Type: NOTICEVolume: 69Number: 223Pages: 67746 - 67747
Docket number: [Docket No. 2004D-0460]
FR document: [FR Doc. 04-25647 Filed 11-18-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription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 This document announced the availability of a draft guidance for industry entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare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".
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