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HHS/FDA RIN: 0910-AH90 Publication ID: Fall 2017 
Title: ●Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems 

This rule would propose to establish a product standard to require testing standards for batteries used in electronic nicotine delivery systems (ENDS) and require design protections through a battery management system for ENDS using batteries.  This product standard would protect the safety of users of battery-powered tobacco products and will help to streamline the FDA premarket review process, ultimately reducing the burden on both manufacturers and the Agency. The proposed rule would be applicable to tobacco products that include a non-user replaceable battery as well as products that include a user replaceable battery.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 301 et. seq.    21 U.S.C. 371    21 U.S.C. 387(b)    21 U.S.C. 387(g)    21 U.S.C. 387i   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Colleen Lee
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Aveue, WO 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373