RIN Data
| HHS/FDA | RIN: 0910-AH14 | Publication ID: Fall 2016 |
| Title: General and Plastic Surgery Devices: Sunlamp Products | |
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Abstract:
This rule would apply device restrictions to sunlamp products. The incidence of skin cancer, including melanoma, has been increasing, and a large number of skin cancer cases are attributable to the use of sunlamp products. The devices may cause about 400,000 cases of skin cancer per year, and 6,000 of which are melanoma. Beginning sunlamp product use at young ages, as well as frequently using sunlamp products, both increase the risk of developing skin cancers and other illnesses, and sustaining other injuries. Even infrequent use, particularly at younger ages, can significantly increase these risks. Sunlamp products incorporate ultraviolet (UV) lamps and include devices such as UV tanning beds and booths. People who use sunlamp products are at increased risk of developing skin cancer and other illnesses, and sustaining injuries. |
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| Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: Yes | Unfunded Mandates: No |
| CFR Citation: 21 CFR 878.4635 | |
| Legal Authority: 21 U.S.C. 360j(e) | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: State |
| Small Entities Affected: Businesses | Federalism: Yes |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: Yes | |
| Related RINs: Related to 0910-AG30 | |
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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 |
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