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HHS/FDA RIN: 0910-AH06 Publication ID: Fall 2016 
Title: Investigational Tobacco Product Applications  

The proposed regulations will establish the conditions for exempting investigational tobacco products (ITPs) from certain FD&C Act requirements.  The proposed rule will set out the proposed procedures to obtain an investigational tobacco product application.   It also will delineate the responsibilities of sponsors, institutional review boards, and clinical investigators with respect to clinical investigations of ITPs.  Furthermore, the proposed rule will set forth informed consent requirements and will specify recordkeeping and reporting 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: uncollected 
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  03/00/2018 
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, G335,
Silver Spring, MD 20993
Phone:877 287-1373