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HHS/FDA RIN: 0910-AI38 Publication ID: Fall 2023 
Title: Modified Risk Tobacco Product Applications 
Abstract:

This proposed rule would establish content and format requirements to ensure that modified risk tobacco product applications contain sufficient information for FDA to determine whether it should permit the marketing of a modified risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified risk tobacco product application review and require applicants receiving authorization to market a modified risk tobacco product to establish and maintain records, conduct postmarket surveillance and studies, and submit 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 
CFR Citation: 21 CFR 1115   
Legal Authority: 21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 387b    21 U.S.C. 387c    21 U.S.C. 387i    21 U.S.C. 387k    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2024 
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:
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