0910-AG81 201110 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 Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined 21 CFR 1150 (new) 21 USC 371 21 USC 387s PL111-31 No NPRM 09/00/2012 Undetermined Businesses None No No No No Annette Marthaler 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