View Rule

View EO 12866 Meetings

Printer-Friendly Version Download RIN Data in XML

HHS/FDA

RIN: 0910-AG30

Publication ID: Fall 2010

Title: Sunlamp Products; Proposed Amendment to the Performance Standard
Abstract: The Food and Drug Aministration's (FDA's) Center for Devices and Radiological Health (CDRH) intends to amend its standard for sunlamp products (21 CFR 1040.20). The sunlamp standard was promulgated in 1979, and FDA has not issued any amendments since 1985. CDRH issued two Policy Letters in 1985 and 1986, outlining FDA policy and providing a recommended exposure schedule. In 1999, FDA published an advanced notice of proposed rulemaking (ANPRM) that sought input on several proposed changes to the FDA performance standard for sunlamp products. The agency received 27 comments to the ANPRM. A summary is available on request. FDA plans to update the performance standard for sunlamp products to improve safety, reflect new scientific information, and work towards harmonization with international standards. FDA scientists have participated in amendments to the International Electrotechnical Commission's (IEC) international standard, IEC 60335-2-27, over the past 10 years. There are many elements of the IEC standard which FDA is considering adopting in our standard. Adopting specific elements of the IEC 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
Legal Authority: Not Yet Determined

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	09/00/2011

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
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