HR 4250 113th Congress House Health Congressional oversight Consumer affairs Drug safety, medical device, and laboratory regulation Health promotion and preventive care Musculoskeletal and skin diseases

Sunscreen Innovation Act

Introduced: March 13, 2014 See on congress.gov

Everywhere this bill has been 17 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Jul 29, 2014

Received in the Senate.

Jul 28, 2014

Motion to reconsider laid on the table Agreed to without objection.

Jul 28, 2014

On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6928-6930)

Jul 28, 2014

Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H6928-6930)

Jul 28, 2014

DEBATE - The House proceeded with forty minutes of debate on H.R. 4250.

Jul 28, 2014

Considered under suspension of the rules. (consideration: CR H6928-6933)

Jul 28, 2014

Mr. Whitfield moved to suspend the rules and pass the bill, as amended.

Jul 24, 2014

Placed on the Union Calendar, Calendar No. 418.

Jul 24, 2014

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558.

Jul 15, 2014

Ordered to be Reported (Amended) by Voice Vote.

Jul 15, 2014

Committee Consideration and Mark-up Session Held.

Jul 14, 2014

Committee Consideration and Mark-up Session Held.

Jun 19, 2014

Forwarded by Subcommittee to Full Committee (Amended) by Unanimous Consent .

Jun 19, 2014

Subcommittee Consideration and Mark-up Session Held.

Mar 14, 2014

Referred to the Subcommittee on Health.

Mar 13, 2014

Referred to the House Committee on Energy and Commerce.

Mar 13, 2014

Introduced in House

Plain-English summary Congressional Research Service

(This measure has not been amended since it was reported to the House on July 24, 2014. The summary of that 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.

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.

What's happening now July 29, 2014

Received in the Senate.

Committees of jurisdiction 2