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HHS/FDA RIN: 0910-AG81 Publication ID: Fall 2011 
Title: ●Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products 
Abstract: Section 919 of the Federal Food, Drug, and Cosmetic Act requires FDA to assess and collect user fees from manufacturers and importers of certain tobacco products. These user fees are allocated based on the market share of specific classes of tobacco products and then the market share of individual manufacturers and importers within each class. Section 919 requires that FDA determine these allocations based on section 625 of Public Law 108-357, which applies to tobacco transition assessments that are administered by the U.S. Department of Agriculture (USDA). Currently FDA obtains necessary market share information directly from USDA and uses this information to assess user fees. However, beginning in October 2014 (Fiscal Year 2015), USDA's program sunsets. This proposed rule would require manufacturers and importers of tobacco products to provide FDA with certain data that is currently collected by USDA so that FDA will have the ability to directly calculate market share percentages needed to assess and collect user fees as required in section 919. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 1150 (new)   
Legal Authority: 21 USC 371    21 USC 387s    PL111-31   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2012    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Annette Marthaler
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Combination Products, 10903 New Hampshire Avenue, WO32, Room 5129,
Silver Spring, MD 20993
Phone:240 753-3043
Email: annette.marthaler@fda.hhs.gov