Senior Regulatory Counsel

0910-AH44 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Premarket Tobacco Product Applications; Recordkeeping Requirements to Support the Legal Marketing of Certain Tobacco Products

This proposed rule would establish content and format requirements to ensure that premarket tobacco product applications contain sufficient information for FDA to determine whether the marketing of a new tobacco product should be authorized. Additionally, the proposed rule would set forth the basic procedures for premarket tobacco product application review and require applicants receiving marketing authorization to establish records and make postmarket reports to FDA. The proposed rule would also require tobacco product manufacturers to keep records to support legal marketing of certain tobacco products, such as documents showing that a tobacco product does not need to undergo premarket review.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No Regulatory 21 CFR 1114 21 U.S.C. 371 21 U.S.C. 387a 21 U.S.C. 387b 21 U.S.C. 387i 21 U.S.C. 387j 21 U.S.C. 374 ... No NPRM 01/00/2019 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