Sunscreen Innovation Act

Bill: 113-hr-4250
Sponsor: Rep. Whitfield, Ed [R-KY-1]
Introduced: 2014-03-13 in the House
Policy area: Health
Subjects: Congressional oversight
Consumer affairs
Drug safety, medical device, and laboratory regulation
Health promotion and preventive care
Musculoskeletal and skin diseases

Summary:
action_date: 2014-03-13
text: 
Sunscreen Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreens.
 
Requires the Secretary of Health and Human Services (HHS) to review and determine whether OTC sunscreens are generally recognized as safe and effective and ensure that any sunscreens marketed in the United States are appropriately labeled.
 
Makes sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act. 
 
Establishes a framework for the review and approval by the Food and Drug Administration (FDA) of OTC sunscreens with new active ingredients. Sets forth time frame requirements for review. Requires applications for review to include safety and efficacy data as well as adverse drug experience information.
 
Directs the Secretary to report on the progress made in issuing timely decisions on the safety and effectiveness of OTC sunscreens.
 
Requires the Secretary to make determinations on the testing and labeling of aerosol sunscreens and on whether a sunscreen may contain a label indicating a sun protection factor (SPF) greater than 50.

action_date: 2014-07-24
text: 
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.
action_date: 2014-07-28
text: 

(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.

Legislative actions:
action_date: 2014-07-29
text: Received in the Senate.
action_date: 2014-07-28
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2014-07-28
text: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6928-6930)
action_date: 2014-07-28
text: 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)
action_date: 2014-07-28
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 4250.
action_date: 2014-07-28
text: Considered under suspension of the rules. (consideration: CR H6928-6933)
action_date: 2014-07-28
text: Mr. Whitfield moved to suspend the rules and pass the bill, as amended.
action_date: 2014-07-24
text: Placed on the Union Calendar, Calendar No. 418.
action_date: 2014-07-24
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558.
action_date: 2014-07-24
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558.
action_date: 2014-07-15
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2014-07-15
text: Committee Consideration and Mark-up Session Held.
action_date: 2014-07-14
text: Committee Consideration and Mark-up Session Held.
action_date: 2014-06-19
text: Forwarded by Subcommittee to Full Committee (Amended) by Unanimous Consent .
action_date: 2014-06-19
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2014-03-14
text: Referred to the Subcommittee on Health.
action_date: 2014-03-13
text: Referred to the House Committee on Energy and Commerce.
action_date: 2014-03-13
text: Introduced in House
action_date: 2014-03-13
text: Introduced in House