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HHS/FDA RIN: 0910-AH90 Publication ID: Fall 2018 
Title: Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems 
Abstract:

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 including a battery management system for ENDS using batteries and protective housing for replaceable 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: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  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
Timetable:
Action Date FR Cite
NPRM  09/00/2019 
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:
Darin Achilles
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103,
Silver Spring, MD 20993
Phone:301 796-4040
Email: darin.achilles@fda.hhs.gov