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HHS/FDA

RIN: 0910-AG30

Publication ID: Fall 2021

Title: Sunlamp Products; Amendment to the Performance Standard
Abstract: FDA is updating the performance standard for sunlamp products and ultraviolet lamps for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards. By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 1040.20 21 CFR 1002.1
Legal Authority: 21 U.S.C. 360ii 21 U.S.C. 360kk 21 U.S.C. 393 21 U.S.C. 371

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	12/22/2015	80 FR 79505
NPRM Comment Period End	03/21/2016
Final Rule	05/00/2022

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Local, State
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Related RINs: Related to 0910-AH14
Agency Contact: Ian Ostermiller Regulatory Counsel, Center for Devices and Radiological Health Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring, MD 20993 Phone:301 796-5678 Email: ian.ostermiller@fda.hhs.gov