[Federal Register Volume 69, Number 14 (Thursday, January 22, 2004)]
[Rules and Regulations]
[Page 3005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1262]


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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; and 
Confirmation of Effective Date; Corrections

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule and confirmation of effective date; 
corrections.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document that published in the Federal Register of June 13, 2003 (68 FR 
35290), that amended 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 revised some labeling for astringent drug products to be 
consistent with the final rule for OTC skin protectant drug products 
that published June 4, 2003 (68 FR 33362), and added labeling for 
certain small packages (styptic pencils). FDA is also correcting a 
document that confirmed the effective date of the direct final rule 
that published on October 9, 2003 (68 FR 58273). These documents were 
published with an incorrect effective date and an incorrect 
confirmation of effective date, respectively. This document corrects 
those errors.

DATES: The effective date of the direct final rule amending 21 CFR part 
347, published June 13, 2003 (68 FR 35290), and confirmed October 9, 
2003 (68 FR 58273), is corrected from October 27, 2003, to June 13, 
2004.

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: 
    1. In FR Doc. 03-14818, published on June 13, 2003 (68 FR 35290), 
make the following correction: On page 35291, in the first column, 
under the DATES caption, in the line beginning with ``Effective Date'', 
the phrase ``effective October 27, 2003'' is corrected to read 
``effective June 13, 2004''.
    2. In FR Doc. 03-25648, published on October 9, 2003 (68 FR 58273), 
make the following correction: On page 58273, in the second column, 
under the DATES caption, the phrase ``Effective date confirmed: October 
27, 2003'' is corrected to read ``Effective date confirmed: June 13, 
2004''.

    Dated: January 14, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1262 Filed 1-21-04; 8:45 am]
BILLING CODE 4160-01-S