[Federal Register Volume 66, Number 203 (Friday, October 19, 2001)]
[Rules and Regulations]
[Page 53088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. 76N-052G]
RIN 0910-AA01


Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug 
Products for Over-the-Counter Human Use; Partial Final Rule for 
Combination Drug Products Containing a Bronchodilator; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of September 27, 2001 (66 FR 
49276). The document issued a final rule establishing that cough-cold 
combination drug products containing any oral bronchodilator active 
ingredient in combination with any analgesic(s) or analgesic-
antipyretic(s), anticholinergic, antihistamine, oral antitussive, or 
stimulant active ingredient are not generally recognized as safe and 
effective and are misbranded for over-the-counter (OTC) use. The 
document published with two inadvertent errors. This document corrects 
those errors.

DATES: This rule is effective October 19, 2001.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, 
Planning, and Legislation (HF-27), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: In FR Doc. 01-24127, appearing on page 49276 
in the Federal Register of Thursday, September 27, 2001, the following 
corrections are made:
    1. On page 49276, in the second column, in the third line, ``Food 
and Drug Administration.'' is corrected to read ``Food and Drug 
Administration''.
    2. On page 49276, in the second column, in the fourth line, ``21 
CFR part 341'' is corrected to read ``21 CFR part 310''.

    Dated: October 9, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy
[FR Doc. 01-26315 Filed 10-18-01; 8:45 am]
BILLING CODE 4160-01-S