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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
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 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

Timetable:

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 Email: ctpregulations@fda.hhs.gov