Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Correction

Summary:

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of April 22, 2004 (69 FR 21778). The document proposed to amend the agency's regulations governing the format and content of labeling for human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355). The document published with inadvertent errors. This document corrects those errors.

For further information contact:

Joyce 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. 04-9069, appearing on pages 21778 and 21779 in the Federal Register of Thursday, April 22, 2004, the following corrections are made:

1. On page 21778, in the third column, in the heading of the document, “[Docket No. 2003N-0324]” is corrected to read [Docket No. 2003N-0342]”.

2. On page 21778, in the third column, in the ADDRESSES section, in the second line beginning with “identified by”, “Docket No. 2003N-0324” is corrected to read “Docket No. 2003N-0342”.

3. On page 21779, in the first column, in the ADDRESSES section, in the ninth line beginning with “Docket No. 2003N-0324”, “Docket No. 2003N-0324” is corrected to read “Docket No. 2003N-0342”.

Dated: June 1, 2004. Jeffrey Shuren,

Assistant Commissioner for Policy.

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