3.0.0 2141 2023-03-22T18:49:23Z 2023-03-22T18:49:23Z Senate S S 2014-03-13 113 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2014-09-17T17:41:44Z Markup by 2014-09-17T15:24:58Z Referred to 2014-03-13T22:26:22Z Sunscreen Innovation Act 113 4250 HR 2014-07-29 Received in the Senate. Identical bill CRS Related bill House 2014-11-26 Became Public Law No: 113-195. President E40000 2 House floor actions 2014-11-26 Became Public Law No: 113-195. BecameLaw 36000 9 Library of Congress 2014-11-26 Signed by President. President E30000 2 House floor actions 2014-11-26 Signed by President. BecameLaw 36000 9 Library of Congress 2014-11-19 Presented to President. Floor E20000 2 House floor actions 2014-11-19 Presented to President. President 28000 9 Library of Congress 2014-11-13 17:50:27 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2014-11-13 17:50:25 On passage Passed without objection. (text: CR H7959-7964) Floor H37100 2 House floor actions 2014-11-13 17:50:25 Passed/agreed to in House: On passage Passed without objection.(text: CR H7959-7964) Floor 8000 9 Library of Congress 2014-11-13 17:49:04 Considered by unanimous consent. (consideration: CR H7959-7964) Floor H30000 2 House floor actions 2014-11-13 17:49:03 Mr. Latta asked unanimous consent to take from the Speaker's table and consider. Floor H30200 2 House floor actions 2014-09-18 14:55:32 Held at the desk. Floor H15000 2 House floor actions 2014-09-18 13:30:53 Received in the House. Floor H14000 2 House floor actions 2014-09-18 Senate Message on Senate action sent to the House. Floor 2014-09-17 Senate Passed Senate with an amendment by Unanimous Consent. (consideration: CR S5715-5720; text as passed Senate: CR S5715-5720) Floor 2014-09-17 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S5715-5720; text as passed Senate: CR S5715-5720) Floor 17000 9 Library of Congress 2014-09-17 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 568. Calendars 2014-09-17 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute. Without written report. Committee 2014-09-17 Committee on Health, Education, Labor, and Pensions. Reported by Senator Harkin with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2014-09-17 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2014-03-13 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2014-03-13 Introduced in Senate IntroReferral 10000 9 Library of Congress R000122 Sen. Reed, Jack [D-RI] John Reed D RI F. N I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA 2014-03-13 True C001088 Sen. Coons, Christopher A. [D-DE] Christopher Coons D DE A. 2014-04-07 False B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2014-04-08 False C000174 Sen. Carper, Thomas R. [D-DE] Thomas Carper D DE R. 2014-04-11 False P000449 Sen. Portman, Rob [R-OH] Rob Portman R OH 2014-04-11 False A000368 Sen. Ayotte, Kelly [R-NH] Kelly Ayotte R NH 2014-04-29 False R000307 Sen. Roberts, Pat [R-KS] PAT ROBERTS R KS 2014-05-08 False K000360 Sen. Kirk, Mark Steven [R-IL] MARK KIRK R IL STEVEN 2014-05-08 False W000817 Sen. Warren, Elizabeth [D-MA] Elizabeth Warren D MA A. 2014-05-21 False M000355 Sen. McConnell, Mitch [R-KY] Mitch McConnell R KY 2014-05-21 False L000550 Sen. Landrieu, Mary L. [D-LA] MARY LANDRIEU D LA 2014-06-02 False P000603 Sen. Paul, Rand [R-KY] Rand Paul R KY 2014-06-24 False S001184 Sen. Scott, Tim [R-SC] Tim Scott R SC 2014-07-08 False S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. 2014-07-29 False H001049 Sen. Hagan, Kay R. [D-NC] Kay Hagan D NC R. 2014-07-31 False H000206 Sen. Harkin, Tom [D-IA] THOMAS HARKIN D IA RICHARD 2014-09-17 False A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN 2014-09-17 False B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze 2014-09-17 False B001288 Sen. Booker, Cory A. [D-NJ] Cory Booker D NJ 2014-09-17 False Public Law 113-195 Health Congressional oversight Consumer affairs Drug safety, medical device, and laboratory regulation Health promotion and preventive care Musculoskeletal and skin diseases Health 00 2014-03-13 Introduced in Senate 2014-07-11T19:17:04Z 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.

]]> 35 2014-09-17 Passed Senate amended 2014-10-31T12:59:25Z 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.

]]> 81 2014-11-13 Passed House without amendment 2014-11-18T19:16:02Z (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.

]]> 49 2014-11-26 Public Law 2014-12-05T18:01:06Z (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.

]]> Sunscreen Innovation Act Display Title Sunscreen Innovation Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients and for other purposes. Introduced in Senate IS Short Titles as Introduced Sunscreen Innovation Act Short Titles as Passed House Sunscreen Innovation Act H House Short Titles as Passed Senate Sunscreen Innovation Act S Senate Short Titles as Enacted Sunscreen Innovation Act Enrolled Bill https://www.govinfo.gov/content/pkg/BILLS-113s2141enr/xml/BILLS-113s2141enr.xml Reported to Senate 2014-09-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s2141rs/xml/BILLS-113s2141rs.xml Engrossed in Senate 2014-09-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s2141es/xml/BILLS-113s2141es.xml Introduced in Senate 2014-03-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s2141is/xml/BILLS-113s2141is.xml 2014-11-27T04:59:59Z https://www.govinfo.gov/content/pkg/PLAW-113publ195/uslm/PLAW-113publ195.xml Public Law 2014-11-26 Became Public Law No: 113-195. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.