Laxative Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record

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The Food and Drug Administration (FDA) is reopening until January 20, 2004, the administrative record for the rulemaking for over-the-counter (OTC) laxative drug products to accept comments and data concerning these drug products that have been filed with FDA's Division of Dockets Management, because the administrative record officially closed at various times during the course of this rulemaking. The administrative record will remain open until January 20, 2004, to allow for public comment on the comments and data being accepted into the rulemaking at this time. This action is part of FDA's ongoing review of OTC drug products.