Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Health-Care Antiseptic Drug Products; Reopening of the Administrative Record

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The Food and Drug Administration (FDA) is reopening until August 27, 2003, the administrative record for the rulemaking for over- the-counter (OTC) topical antimicrobial drug products to accept comments and data concerning OTC health-care antiseptic drug products that have been filed with the Dockets Management Branch, FDA, since the administrative record officially closed. The agency is also providing for the administrative record to remain open until August 27, 2003, to allow for public comment on the comments and data being accepted into the rulemaking. This action is part of FDA's ongoing review of OTC drug products.