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FDA Seeks Participants for Tobacco E-submissions Pilot


Federal Register Notice: FDA’s Center for Tobacco Products (CTP) is soliciting applications from regulated tobacco product manufacturers to participate in a voluntary pilot program to help CTP evaluate a potential new portal, the CTP eSubmissions Portal (CTP Portal), that is being designed to improve the process in connection with providing certain regulatory submissions electronically to CTP. The Center plans to accept up to six participants for the pilot program, which is intended to provide CTP regulatory review staff with an opportunity to evaluate the CTP Portal, including its capability for sending and receiving secure messages and providing information as to the documents submitted to it (for example, receipt date and tracking number). Interested parties should submit an electronic application to participate in this pilot program by 3/2. To view this notice, click here.