03-6232. Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of February 6, 2003 (68 FR 6062). The document amended FDA's regulations to require that the labeling for all systemic antibacterial drug products intended for human use include certain statements about using antibiotics in a way that will reduce the development of drug-resistant bacterial strains. The document was published with an inadvertent error. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

In FR Doc. 03-2969, appearing on page 6062 in the Federal Register of Thursday, February 6, 2003, the following correction is made:

1. On page 6081, in the second column, at the end of the document, the phrase “Dated: October 4, 2002” is corrected to read “Dated: December 4, 2002”.

Dated: March 10, 2003.

William K. Hubbard,

Associate Commissioner for Policy and Planning.