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HHS/FDA RIN: 0910-AG60 Publication ID: 2012 
Title: Further Amendments to General Regulations of the Food and Drug Administration To Incorporate Tobacco Products 
Abstract: The Food and Drug Administration is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act. The final rule covers revisions to the document reporting requirements and definition of "product." 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1.21 (revised); 21 CFR 1.101 (revised); 21 CFR 7.3 (revised); 21 CFR 16.1 (revised); ... (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 333; 21 USC 371; 21 USC 381; 21 USC 387; 21 USC 387a; 21 USC 387c; 21 USC 387f; 21 USC 387j; 21 USC 387k; 15 USC 1333; 15 USC 4402; ... 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/14/2011  76 FR 20901 
NPRM Comment Period End  06/13/2011   
Final Action  02/02/2012  77 FR 5171 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Gerie Voss
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave.,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov

 
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