Sunscreen Innovation Act
Latest action. Became public lawWhat a bill becomes when enacted, numbered by Congress and order of enactment: Public Law 119-4 is the 4th law of the 119th Congress.Read the full definition (opens a new tab) No: 113-195.
(This measure has not been amended since it was reported to the Senate on September 17, 2014. The summary of the Senate passed version is repeated here.)
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.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Public Law" stage on November 26, 2014. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
This bill has been enacted. It is law.
The record's latest action, on November 26, 2014: Became Public Law No: 113-195.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
John Reed (D-RI) introduced it on March 13, 2014, and 19 members have since signed on as cosponsors.
They come from both major parties: 9 Democrats, 10 Republicans.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- SenatePassed
- HousePassed
- PresidentSigned into law