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Proposed Rule

Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph; Extension of Comment Period; Correction

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Food and Drug Administration, HHS.


Advance notice of proposed rulemaking; extension of comment period; correction.


The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of August 25, 2003 (68 FR 50991). The document announced that FDA extended to November 25, 2003, the comment period for an advance notice of proposed rulemaking (ANPR) for over-the-counter antigingivitis/antiplaque drug products. The ANPR was published in the Federal Register of May 29, 2003 (68 FR 32232). The document published with an inadvertent error. This document corrects that error.


Submit written or electronic comments by November 25, 2003. Submit reply comments by February 23, 2004.

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

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In FR Doc. 03-21669, appearing on page 50992 in the Federal Register of August 25, 2003, the following correction is made:

1. On page 50992, in the second column, under IV. Comments, in the sixth line, “two” is corrected to read “three”.

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Dated: September 25, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-25044 Filed 10-3-03; 8:45 am]