HR.4250 - Sunscreen Innovation Act

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7/28/2014--Passed House amended. 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. 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.

Received In The Senate.
July 29th 2014 @ 12:00 AM

Motion To Reconsider Laid On The Table Agreed To Without Objection.
July 28th 2014 @ 5:52 PM

On Motion To Suspend The Rules And Pass The Bill, As Amended Agreed To By Voice Vote.
July 28th 2014 @ 5:52 PM

Debate - The House Proceeded With Forty Minutes Of Debate On H.r. 4250.
July 28th 2014 @ 5:39 PM

Considered Under Suspension Of The Rules.
July 28th 2014 @ 5:39 PM

Mr. Whitfield Moved To Suspend The Rules And Pass The Bill, As Amended.
July 28th 2014 @ 5:39 PM

Placed On The Union Calendar, Calendar No. 418.
July 24th 2014 @ 6:16 PM

Reported (amended) By The Committee On Energy And Commerce. H. Rept. 113-558.
July 24th 2014 @ 6:16 PM

Ordered To Be Reported (amended) By Voice Vote.
July 15th 2014 @ 12:00 AM

Committee Consideration And Mark-up Session Held.
July 15th 2014 @ 12:00 AM

Committee Consideration And Mark-up Session Held.
July 14th 2014 @ 12:00 AM

Forwarded By Subcommittee To Full Committee (amended) By Unanimous Consent .
June 19th 2014 @ 12:00 AM

Subcommittee Consideration And Mark-up Session Held.
June 19th 2014 @ 12:00 AM

Referred To The Subcommittee On Health.
March 14th 2014 @ 12:00 AM

Referred To The House Committee On Energy And Commerce.
March 13th 2014 @ 12:00 AM

H.R. 4250 – the Sunscreen Innovation Act, sponsored by Rep. Ed Whitfield (R-KY) would amend current law to provide a new process for reviewing the safety and effectiveness of nonprescription sunscreen.  

Erin Carson, Lead Analyst
Monday August 4th 2014

H.R. 4250 would expedite the Food and Drug Administration review process for new ingredients in non-prescription sunscreen that are “generally recognized as safe and effective.” The bill would also give this process transparency, and would require a number of reports to Congress on how the FDA is implementing the new procedures. The Sunscreen Innovation Act has bipartisan support in Congress, and H.R. 4250 passed the House of Representatives under suspension of the rules on July 28, 2014.

Erin Carson, Lead Analyst
Monday August 4th 2014
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