Regulatory Counsel

0910-AH74 201710 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 Record Keeping Requirements Related to Tobacco Product Applications

The Food and Drug Administration is proposing regulations to establish recordkeeping and record inspection requirements for persons who submit certain tobacco product submissions to FDA, such as premarket tobacco product applications, modified risk tobacco product applications, requests for exemption from substantial equivalence, and abbreviated reports. The manufacturer would be required to maintain all records necessary to support the application or submission. This regulation would also establish recordkeeping requirements for persons who commercially market tobacco products that were commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Regulatory 21 CFR 1100 21 CFR 1107 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 387i 21 U.S.C. 387j 21 U.S.C. 387k No NPRM 08/00/2018 Undetermined Undetermined Undetermined No No Darin Achilles Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-4040 darin.achilles@fda.hhs.gov Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103, Silver Spring MD 20993