Regulatory Counsel

0910-AH45 201610 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 for Certain Submissions to FDA

The Food and Drug Administration is proposing regulations to establish recordkeeping requirements for certain submissions to FDA. This regulation would establish recordkeeping requirements for premarket tobacco product applications, modified risk tobacco product applications, requests for exemption from substantial equivalence, and abbreviated reports. This regulation would also establish recordkeeping requirements for 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 No 21 CFR 1100 21 CFR 1107 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 387i to 387k No NPRM 07/00/2017 Undetermined Businesses None No 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 Bryant Godfrey Senior Regulatory Counsel 0910 Food and Drug Administration FDA 877 287-1373 ctpregulations@fda.hhs.gov 10903 New Hampshire Ave., , Silver Spring MD 20993