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HHS/FDA RIN: 0910-AH44 Publication ID: Spring 2018 
Title: Premarket Tobacco Product Applications; Recordkeeping Requirements to Support the Legal Marketing of Certain Tobacco Products 

This proposed rule would establish content and format requirements to ensure that premarket tobacco product applications contain sufficient information for FDA to determine whether the marketing of a new tobacco product should be authorized. Additionally, the proposed rule would set forth the basic procedures for premarket tobacco product application review and require applicants receiving marketing authorization to establish records and make postmarket reports to FDA. The proposed rule would also require tobacco product manufacturers to keep records to support legal marketing of certain tobacco products, such as documents showing that a tobacco product does not need to undergo premarket review.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 1114   
Legal Authority: 21 U.S.C. 371    21 U.S.C. 387a    21 U.S.C. 387b    21 U.S.C. 387i    21 U.S.C. 387j    21 U.S.C. 374    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/00/2019 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Paul Hart
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:301 796-3894