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HHS/FDA RIN: 0910-AG30 Publication ID: Fall 2016 
Title: Sunlamp Products; Amendment to the Performance Standard 

FDA is updating the performance standard for sunlamp products to improve safety, reflect new scientific information, and work towards harmonization with international standards. For example, incorporating specific elements of the International Electrotechnical Commission's standard by reference will allow the Agency to take advantage of the expertise of the international committees involved in the modernization of the international standard, and, thus, save Agency resources. FDA also plans to include changes to the required warning label.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
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   
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
Action Date FR Cite
NPRM  12/22/2015  80 FR 79505   
NPRM Comment Period End  03/21/2016 
Final Action  11/00/2016 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
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