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HHS/FDA RIN: 0910-AG81 Publication ID: 2012 
Title: Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
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  02/00/2013   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Annette L. Marthaler
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue,
Silver Spring , MD 20993
Phone:877 287-1373
Fax:877 287-1426
Email: ctpregulations@fda.hhs.gov

 
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