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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