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.

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”.