Sunscreen Innovation Act
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S 2141 — Sunscreen Innovation Act
Last action — Became Public Law No: 113-195.
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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✓In Committee
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✓Passed Senate
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✓Passed House
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✓To Executive
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6Enacted
This bill has been enacted into law. Introduced March 13, 2014. Enacted.
Summary
Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients. Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective. Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA). Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient. Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe. Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products. Allows the Secretary to amend a determination if additional information becomes available. (Sec. 3) Allows sponsors of eligible non-sunscreen OTC drug applications to request that the Secretary provide a framework for review of their application. Requires the Secretary to respond with framework options, including options that follow the review process set forth in this Act for sunscreen active ingredients. (Sec. 4) Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.
Bill Text
We don't have the full text on file for this bill yet.
Read S 2141 on the official United States source →Action History
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Became Public Law No: 113-195.
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Signed by President.
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Presented to President.
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Motion to reconsider laid on the table Agreed to without objection.
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On passage Passed without objection. (text: CR H7959-7964)
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Considered by unanimous consent. (consideration: CR H7959-7964)
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Mr. Latta asked unanimous consent to take from the Speaker's table and consider.
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Held at the desk.
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Received in the House.
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Message on Senate action sent to the House.
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Passed Senate with an amendment by Unanimous Consent. (consideration: CR S5715-5720; text as passed Senate: CR S5715-5720)
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 568.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute. Without written report.
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Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
- Jack Reed · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 0 co-sponsors · 546 not signed on
Sponsors (1)
Co-sponsors (0)
None.
Not signed on (546)
546 members have not signed on to this bill.
Show all 546 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Subjects
Frequently asked questions
- What does S 2141 do?
- Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients. Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective. Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA). Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient. Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe. Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products. Allows the Secretary to amend a determination if additional information becomes available. (Sec. 3) Allows sponsors of eligible non-sunscreen OTC drug applications to request that the Secretary provide a framework for review of their application. Requires the Secretary to respond with framework options, including options that follow the review process set forth in this Act for sunscreen active ingredients. (Sec. 4) Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.
- Who sponsors S 2141?
- S 2141 is sponsored by Jack Reed (D).
- What is the current status of S 2141?
- This bill has been enacted into law. Introduced March 13, 2014. Enacted.
- Where can I track S 2141?
- Track S 2141 free on One Click Politics — get push/email alerts when it moves.
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