04-9324. 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.