Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription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

---
identifier: "/us/fr/04-25647"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription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"
title_number: 0
title_name: "Federal Register"
section_number: "04-25647"
section_name: "Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription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"
positive_law: false
currency: "2004-11-19"
last_updated: "2004-11-19"
format_version: "1.1.0"
generator: "[email protected]"
agency: "DEPARTMENT OF HEALTH AND HUMAN SERVICES"
document_number: "04-25647"
document_type: "notice"
publication_date: "2004-11-19"
agencies:
  - "DEPARTMENT OF HEALTH AND HUMAN SERVICES"
  - "Food and Drug Administration"
---


#  Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription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 This document announced the availability of a draft guidance for industry entitled “Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare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.