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HHS/FDA RIN: 0910-AG39 Publication ID: Fall 2010 
Title: Tobacco Product Substantial Equivalence Exemptions 
Abstract: This rule implements the substantial equivalence exemption provision of the Family Smoking Prevention and Tobacco Control Act. The Secretary may exempt from the requirements relating to demonstration that a tobacco product is substantially equivalent, tobacco products that are modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines the modification would be a minor modification of a tobacco product that can be sold under the law, a report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health, and an exemption is otherwise appropriate. 
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: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: PL 111-31, sec 101(b)(3), The Family Smoking Prevention and Tobacco Control Act   
Legal Deadline:
Action Source Description Date
Final  Statutory    07/01/2011 
Timetable:
Action Date FR Cite
NPRM  12/00/2010    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
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:
Annette Marthaler
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Combination Products, 10903 New Hampshire Avenue, WO32, Room 5129,
Silver Spring, MD 20993
Phone:240 753-3043
Email: annette.marthaler@fda.hhs.gov