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

The Food and Drug Administration (FDA) is requesting information and comments on the use of intraoral appliance (IOA) models as a substitute for the animal caries reduction (“rat caries models”) biological test required by the monograph for over-the-counter (OTC) anticaries drug products to demonstrate the availability of fluoride in OTC dentifrice formulations. This notice is part of the ongoing review of OTC drug products conducted by FDA. DATES: Submit written or electronic comments by [insert date 90 days ajler date of publication in the Federal Register]. ADDRESSES: Submit written comments to the Dockets M.anagement Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, r-m. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Robert L. Sherman, Center for Drug Evaluation and Research (HIFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.