Senior Regulatory Counsel

0910-AH89 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Format and Content of Reports Intended to Demonstrate Substantial Equivalence

This proposed rule would establish the format and content of reports intended to demonstrate substantial equivalence (SE) in tobacco products and would provide information as to how the Agency will review and act on these submissions.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No Undetermined Other 21 CFR 1107 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 387 42 U.S.C. 4332 Yes NPRM 08/00/2018 No None 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