[Federal Register Volume 68, Number 51 (Monday, March 17, 2003)]
[Rules and Regulations]
[Page 12584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6232]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 00N-1463]
RIN 0910-AB78


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.
[FR Doc. 03-6232 Filed 3-14-03; 8:45 am]
BILLING CODE 4160-01-S