0910-AG81 201210 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 FDA is proposing to require manufacturers and importers of tobacco products to submit certain market share data to FDA. USDA currently collects such data, but its program sunsets at the end of September 2014 and USDA will cease collection of this information. FDA is taking this action so that it may continue to calculate market share percentages needed to compute user fees. Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 1150 (new) 21 USC 371 21 USC 387s PL111-31 No NPRM 02/00/2013 Yes Businesses None No Yes No Annette Marthaler L. 0910 Food and Drug Administration FDA 877 287-1373 240 276-3904 annette.marthaler@fda.hhs.gov Center for Tobacco Products, 9200 Corporate Boulevard, Room 340K, Rockville MD 20850