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HHS/FDA RIN: 0910-AH06 Publication ID: Spring 2018 
Title: Investigational Tobacco Product Applications  

The proposed rule would define investigational tobacco product (ITP) and describe the procedures and requirements relating to the use of investigational tobacco products in investigations. The proposed rule would establish the information an ITP application to FDA must include, such as study protocol and adverse events. FDA will use this information to review the investigation for important concerns, such as the protection of human subjects. The proposed rule will provide detail on what happens when an investigation does not meet regulatory requirements. Finally, the proposed rule will also state responsibilities of those involved with administering the investigation 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  01/00/2020 
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:
Laura Rich
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, 10903 New Hampshire Avenue, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373