Anticaries Drug Products for Over-the-Counter Human Use; Use of Intraoral Appliance Models for Compliance With Biological Testing Requirements; Request for Information and Comments; Reopening of Comment Period

Résumé

The Food and Drug Administration (FDA) is reopening until July 12, 2002, the comment period on the notice requesting information and comments on the use of intraoral appliance (IOA) models as a substitute for the animal caries reduction biological test required by the monograph for over-the-counter (OTC) anticaries drug products to demonstrate the availability of fluoride in OTC dentifrice formulations. The notice was published in the Federal Register of October 15, 2001 (66 FR 52418). FDA is taking this action in response to a request for extension of the comment period to allow interested persons additional time to submit comments and information on the use of IOA models. The comment period for this information closed on January 14, 2002.