Guidance for Industry on Changes to an Approved New Drug Application or Abbreviated New Drug Application; Availability; Correction

---
identifier: "/us/fr/04-9324"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Guidance for Industry on Changes to an Approved New Drug Application or Abbreviated New Drug Application; Availability; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "04-9324"
section_name: "Guidance for Industry on Changes to an Approved New Drug Application or Abbreviated New Drug Application; Availability; Correction"
positive_law: false
currency: "2004-04-26"
last_updated: "2004-04-26"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "04-9324"
document_type: "notice"
publication_date: "2004-04-26"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "69 FR 22540"
fr_volume: 69
docket_ids:
  - "Docket No. 1999D-0529"
fr_action: "Notice; correction."
---


#  Guidance for Industry on Changes to an Approved New Drug Application or Abbreviated New Drug Application; 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 April 8, 2004 (69 FR 18768). The document announced the availability of a revised guidance for industry entitled “Changes to an Approved NDA or ANDA.” The document was published with inadvertent errors. This document corrects those errors.

**FOR FURTHER INFORMATION CONTACT:**

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

**SUPPLEMENTARY INFORMATION:**

In FR Doc. 04-7533, appearing on page 18768 in the *Federal Register* of Thursday, April 8, 2004, the following corrections are made:

1. On page 18768, in the first column, under the *FOR FURTHER INFORMATION CONTACT* section, the contact information is corrected to read “David J. Cummings, Center for Drug Evaluation and Research (HFD-357), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5187.”

2. On page 18768, in the third column, the second full paragraph is removed.

Dated: April 19, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.