[Federal Register Volume 69, Number 109 (Monday, June 7, 2004)]
[Proposed Rules]
[Page 31773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12841]



[[Page 31773]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 208, and 209

[Docket No. 2003N-0342]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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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.
[FR Doc. 04-12841 Filed 6-4-04; 8:45 am]
BILLING CODE 4160-01-S