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HHS/FDA

RIN: 0910-AG30

Publication ID: Fall 2013

Title: Sunlamp Products; Proposed Amendment to the Performance Standard
Abstract: FDA plans to update 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 would 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: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 1040.20    21 CFR 1002
Legal Authority: Not Yet Determined

Legal Deadline:  None

Timetable: Action Date FR Cite NPRM  03/00/2014

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
Agency Contact: Karen Fikes Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring, MD 20993 Phone:240 402-7911 Email: karen.fikes@fda.hhs.gov