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HHS/FDA RIN: 0910-AH06 Publication ID: Spring 2015 
Title: Investigational Tobacco Product Applications  
Abstract: The proposed rule would define "investigational tobacco product" and describe the procedures and requirements relating to the use of investigational tobacco products in nonclinical laboratory studies and clinical investigations. 
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 
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
Timetable:
Action Date FR Cite
NPRM  06/00/2016 
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
Email: ctpregulations@fda.hhs.gov