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HHS/FDA RIN: 0910-AG55 Publication ID: Fall 2010 
Title: ●Amendments to the General Regulations of the Food and Drug Administration 
Abstract: The Food and Drug Administration is seeking to amend 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1.1(b)    21 CFR 1.1(c)    21 CFR 7.3(f)    21 CFR 14.55(f) (New)    21 CFR 14.100(h) (New)    21 CFR 17.1(j) (New)    21 CFR 17.2   
Legal Authority: 21 USC 321    21 USC 331    21 USC 333    21 USC 387    21 USC 387q   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM -- Companion to Direct Final Rule  12/00/2010    
NPRM Comment Period End  03/00/2011    
Direct Final Rule  12/00/2010    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
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