Senior Regulatory Counsel

0910-AI38 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Modified Risk Tobacco Product Applications

This proposed rule would establish content and format requirements to ensure that modified risk tobacco product applications contain sufficient information for FDA to determine whether it should permit the marketing of a modified risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified risk tobacco product application review and require applicants receiving authorization to market a modified risk tobacco product to establish and maintain records, conduct postmarket surveillance and studies, and submit annual reports to FDA.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 1115 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 387b 21 U.S.C. 387c 21 U.S.C. 387i 21 U.S.C. 387k ... No NPRM 11/00/2021 Undetermined None No No No No Paul Hart Senior Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3894 ctpregulations@fda.hhs.gov Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring MD 20993