View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AH06 Publication ID: Fall 2014 
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: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1112   
Legal Authority: 21 USC 387j(g), Federal Food, Drug, and Cosmetic Act    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/00/2015 
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