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HHS/FDA RIN: 0910-AH06 Publication ID: Spring 2014 
Title: Investigational Tobacco Product Applications and General Information Regarding Submission of Information to Support Legal Marketing  
Abstract: The proposed rule would describe the information that must be included in an investigational tobacco product application, and how the Agency will act on these applications. This proposed rule would also require 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: Previously 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    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/00/2015 
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