04-7815. Bar Code Label Requirement for Human Drug Products and Biological Products; 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 26, 2004 (69 FR 9120). The document included typographical and inadvertent errors. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Office of Policy and Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0587.

SUPPLEMENTARY INFORMATION:

In FR Doc. 04-4249, appearing on page 9120 in the Federal Register of Thursday, February 26, 2004, the following corrections are made:

1. On page 9151, in the third column, the first sentence of the first full paragraph, is corrected to read “We estimate that the rule provides net benefits to society of $4.3 billion to $4.5 billion annually, depending on whether a discount rate of 3 percent or 7 percent is used.”

2. On page 9167, in the first column, the first sentence under the heading “ P. Small Business Analysis and Discussion of Alternatives” is corrected to read “For the reasons cited in the following paragraphs, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.”

Dated: March 31, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.