Sunscreen Innovation Act

Bill: 113-s-2141
Sponsor: Sen. Reed, Jack [D-RI]
Introduced: 2014-03-13 in the Senate
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.
 
Require 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: 2014-09-17
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.
 
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. 

action_date: 2014-11-13
text: 

(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. 

action_date: 2014-11-26
text: 

(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. 


Legislative actions:
action_date: 2014-11-26
text: Became Public Law No: 113-195.
action_date: 2014-11-26
text: Became Public Law No: 113-195.
action_date: 2014-11-26
text: Signed by President.
action_date: 2014-11-26
text: Signed by President.
action_date: 2014-11-19
text: Presented to President.
action_date: 2014-11-19
text: Presented to President.
action_date: 2014-11-13
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2014-11-13
text: On passage Passed without objection. (text: CR H7959-7964)
action_date: 2014-11-13
text: Passed/agreed to in House: On passage Passed without objection.(text: CR H7959-7964)
action_date: 2014-11-13
text: Considered by unanimous consent. (consideration: CR H7959-7964)
action_date: 2014-11-13
text: Mr. Latta asked unanimous consent to take from the Speaker's table and consider.
action_date: 2014-09-18
text: Held at the desk.
action_date: 2014-09-18
text: Received in the House.
action_date: 2014-09-18
text: Message on Senate action sent to the House.
action_date: 2014-09-17
text: Passed Senate with an amendment by Unanimous Consent. (consideration: CR S5715-5720; text as passed Senate: CR S5715-5720)
action_date: 2014-09-17
text: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S5715-5720; text as passed Senate: CR S5715-5720)
action_date: 2014-09-17
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 568.
action_date: 2014-09-17
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute. Without written report.
action_date: 2014-09-17
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute. Without written report.
action_date: 2014-09-17
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2014-03-13
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2014-03-13
text: Introduced in Senate

Enacted as: number: 113-195