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HHS/FDA RIN: 0910-AG59 Publication ID: Fall 2013 
Title: Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives 
Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires the Food and Drug Administration to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, that the agency determines should be tested to protect the public health. 
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: Private Sector 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 301 et seq    21 USC 387    The Family Smoking Prevention and Tobacco Control Act   
Legal Deadline:
Action Source Description Date
Final  Statutory  sec 915(a) of the Federal Food, Drug, and Cosmetic Act  04/00/2013 

Overall Description of Deadline: Final rule must issue no later than 36 months after April 1, 2010--see section 915(a) of the Federal Food, Drug, and Cosmetic Act and section 6 of the Family Smoking Prevention and Tobacco Control Act.

Timetable:
Action Date FR Cite
NPRM  12/00/2013 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Carol Drew
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Good Clinical Practice, WO 32, Room 5105, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3505
Email: carol.drew@fda.hhs.gov