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HHS/FDA RIN: 0910-AH94 Publication ID: Spring 2018 
Title: ●Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments Regarding "Intended Uses" "Delay of Effective Date" 
Abstract:

FDA is delaying the effective date of amendments to the existing medical product ‘‘intended uses’ regulations, contained in the final rule of January 9, 2017, until further notice.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: 21 CFR 201    21 CFR 801   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 353    21 U.S.C. 371(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/16/2018  83 FR 2092   
NPRM Comment Period End  02/05/2018 
Final Rule  03/16/2018  83 FR 11639   
Final Action Effective  03/16/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Previously reported as 0910-AH19 
Agency Contact:
Kelley Nduom
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6221,
Silver Spring, MD 20993
Phone:301 796-8597
Email: kelley.nduom@fda.hhs.gov