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General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products
This proposed rule will restrict use of sunlamp products to individuals age 18 and older, require users to sign a risk acknowledgement certification, and require the provision of user manuals.
Rule Summary: This proposed rule will restrict use of sunlamp products to individuals age 18 and older, require users to sign a risk acknowledgement certification, and require the provision of user manuals.
RIN: 0910-AH14
Agency: Department of Health and Human Services Food and Drug Administration
Date Proposed by Agency: 12/22/2015
Stage: Open Comment Period
Top Industry: Merchant Wholealers, Nondurable Goods
Restrictions: 27
Word Count: 12362
Costs Monetized: Yes
Benefits Monetized: Yes
TABLE DESCRIPTION FOR POTENTIAL MIDNIGHT REGULATIONS:
- Regulation Title: The official title of the rulemaking used by the issuing agency.
- RIN: Regulation Identifier Number—a unique tracking number assigned by the Regulatory Information Service Center to each regulation under development or review by an agency.
- Stage: Shows where the rulemaking is in the regulatory process. Stages include:
a. Open comment period: the proposed rule has been published in the Federal Register and the agency is taking public comments.
b. Closed comment period: the public comment period for a rulemaking is closed.
c. Pending final review: OIRA is reviewing what the agency intends to publish as the final regulation.
- Restrictions: The number of binding constraints or “restrictions” in the proposed regulation’s text. These are words that indicate an obligation to comply such as “shall” or “must.” Given the difficulty of measuring regulations, counting restrictions is one of the best ways to measure the size and scope of regulations. These numbers are obtained from using RegData.
- Top Industry: The industry likely to be most affected by the regulation. Obtained using RegData.
- Costs Monetized: Shows whether the agency provides a quantitative estimate of the costs associated with the rule.
- Benefits Monetized: Shows whether the agency provides a quantitative estimate of the benefits associated with the rule.