[Federal Register Volume 68, Number 196 (Thursday, October 9, 2003)]
[Rules and Regulations]
[Page 58273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25648]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 347

[Docket No. 78N-021A]
RIN 0910-AA01


Skin Protectant Drug Products for Over-the-Counter Human Use; 
Astringent Drug Products; Final Monograph; Direct Final Rule; 
Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of October 27, 2003, for the final rule that appeared in 
the Federal Register of June 13, 2003 (68 FR 35290). The direct final 
rule amends the regulation that established conditions under which 
over-the-counter (OTC) skin protectant astringent drug products are 
generally recognized as safe and effective and not misbranded. This 
action revises some labeling for astringent drug products to be 
consistent with the final rule for OTC skin protectant drug products 
(68 FR 33362, June 4, 2003) and adds labeling for certain small 
packages (styptic pencils). This document confirms the effective date 
of the direct final rule. This action is part of FDA's ongoing review 
of OTC drug products.

DATES: Effective date confirmed: October 27, 2003.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2307.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 13, 2003 (68 
FR 35290), FDA solicited comments concerning the direct final rule for 
a 75-day period ending August 27, 2003. FDA stated that the effective 
date of the direct final rule would be on October 27, 2003, 60 days 
after the end of the comment period, unless any significant adverse 
comment was submitted to FDA during the comment period. FDA did not 
receive any significant adverse comments.

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

    Accordingly, the amendments issued thereby are effective.

    Dated: October 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25648 Filed 10-8-03; 8:45 am]
BILLING CODE 4160-01-S