Re: Citizen Petition

The undersigned submits this petition under the generic bioequivalence guidelines of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs under 2 1 CFR 5.10) to request the Commissioner of Food and Drugs to request specific action on the regulation of generic transdermal fentanyl delivery systems, and to request similar attention to new product approvals for transdennal fentanyl products. A. Action requested My request to the agency is twofold: 1) For any generic transdermal fentanyl product, the applicant should be required to demonstrate bioavailability / bioequivalence against Duragesic on both intact skin and on skin in which the stratum comeum has been stripped. 2) For any new fentanyl formulation, either from the innovator company (Alza) or a competitor, safety must be demonstrated when the device is placed on stripped skin. B. Statement of sounds The stratum comeum is a layer of dead, desiccated skin cells on the outermost surface of th