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HHS/FDA RIN: 0910-AH06 Publication ID: Fall 2019 
Title: Investigational Tobacco Product Applications  

The proposed rule would define an investigational tobacco product (ITP) and describe the procedures and requirements relating to the use of investigational tobacco products in a clinical investigation, including the procedures and requirements for the submission to, and review by, FDA of an ITP application. The proposed rule will also set forth responsibilities of those involved with the investigation along with reporting and recordkeeping requirements.

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: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 1112   
Legal Authority: 21 U.S.C. 387j(g), Federal Food, Drug, and Cosmetic Act    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/00/2021 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Annette L. Marthaler
Supervisory 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:877 287-1373
Fax:877 287-1426