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HHS/FDA RIN: 0910-AH44 Publication ID: Spring 2017 
Title: Premarket Tobacco Product Applications 

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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
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    ...   
Legal Deadline:  None
Action Date FR Cite
Next Action Undetermined  To Be Determined 
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
10903 New Hampshire Avenue, Building 71, Room G335,
Silver Spring, MD 20993
Phone:301 796-3894