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HHS/FDA RIN: 0910-AH22 Publication ID: Fall 2015 
Title: Requirements for Tobacco Product Manufacturing Practice 
Abstract:

FDA is proposing requirements that govern the methods used in, and the facilities and controls used for, the pre-production design validation, manufacture, packing, and storage of tobacco products.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 1120   
Legal Authority: 21 U.S.C. 371    21 U.S.C. 387b    21 U.S.C. 387f   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  03/19/2013  78 FR 16824   
ANPRM Comment Period End  05/20/2013 
NPRM  04/00/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Darin Achilles
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
14-101-11, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov