Senior Regulatory Counsel

0910-AI38 202310 The Regulatory Plan and the 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 reports to FDA.

]]> Other Significant Previously Published in The Unified Agenda Long-Term Actions 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 11/00/2024 Undetermined None No No No No Annette Marthaler Senior Regulatory Counsel 0910 Food and Drug Administration FDA 240 753-3043 annette.marthaler@fda.hhs.gov Office of Combination Products, 10903 New Hampshire Avenue, WO32, Room 5129, Silver Spring MD 20993