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HHS/FDA RIN: 0910-AH06 Publication ID: Fall 2013 
Title: ●Investigational Tobacco Product Applications and General Information Regarding Submission of Information to Support Legal Marketing  
Abstract: The investigational tobacco product application regulation would codify procedures and requirements relating to the use of investigational tobacco products in nonclinical and clinical studies. Both the Agency and industry are seeking more certainty regarding the conditions under which FDA will, under section 910(g) of the FD&C Act, exempt tobacco products intended for investigational use from the tobacco product provisions in Chapter IX of the FD&C Act. The investigational tobacco product application regulation would describe the information that must be included in an investigational tobacco product application and how the Agency will act on these applications. The general information regulations would codify procedures relating generally to the submission of information to support the legal marketing and/or investigational use of tobacco products, including the submission of information to tobacco product master files. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1112; 21 CFR 1114 
Legal Authority: 21 USC 387j(g), Federal Food, Drug, and Cosmetic Act 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2014   
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:
Gail L. Schmerfeld
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFV-100, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov

 
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