Sunscreen Innovation Act

3.0.0 4250 2023-01-11T13:26:02Z 2023-01-11T13:26:02Z House H HR 2014-03-13 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. WHITFIELD:H.R. 4250.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3: The Congress shall havePower *** to regulate Commerce with foreign Nations, andamong the several States, and with the Indian Tribes.____________________[Page H2434]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2014-06-19T14:20:35Z Markup by 2014-06-19T14:20:23Z Referred to 2014-03-14T18:23:44Z Reported by 2014-07-24T22:16:43Z Markup by 2014-07-15T15:48:05Z Referred to 2014-03-13T14:04:15Z H. Rept. 113-558 Sunscreen Innovation Act 113 2141 S 2014-11-26 Became Public Law No: 113-195. Identical bill CRS Related bill House 2014-07-29 Senate Received in the Senate. IntroReferral 2014-07-28 17:52:45 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2014-07-28 17:52:43 On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6928-6930) Floor H37300 2 House floor actions 2014-07-28 17:52:43 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) Floor 8000 9 Library of Congress 2014-07-28 17:39:56 DEBATE - The House proceeded with forty minutes of debate on H.R. 4250. Floor H8D000 2 House floor actions 2014-07-28 17:39:53 Considered under suspension of the rules. (consideration: CR H6928-6933) Floor H30000 2 House floor actions 2014-07-28 17:39:34 Mr. Whitfield moved to suspend the rules and pass the bill, as amended. Floor H30300 2 House floor actions 2014-07-24 Placed on the Union Calendar, Calendar No. 418. Calendars H12410 2 House floor actions U00418 2014-07-24 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2014-07-24 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2014-07-15 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by Voice Vote. Committee 2014-07-15 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2014-07-14 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2014-06-19 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee (Amended) by Unanimous Consent . Committee 2014-06-19 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2014-03-14 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2014-03-13 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2014-03-13 Introduced in House IntroReferral Intro-H 9 Library of Congress 2014-03-13 Introduced in House IntroReferral 1000 9 Library of Congress W000413 Rep. Whitfield, Ed [R-KY-1] EDWARD WHITFIELD R KY 1 N D000355 Rep. Dingell, John D. [D-MI-12] JOHN DINGELL D MI D. 12 2014-03-13 True F000030 Rep. Farr, Sam [D-CA-20] SAM FARR D CA 20 2014-03-27 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2014-03-27 False T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2014-03-27 False S001187 Rep. Stivers, Steve [R-OH-15] Steve Stivers R OH 15 2014-03-27 False R000395 Rep. Rogers, Harold [R-KY-5] HAROLD ROGERS R KY 5 2014-03-27 False B001282 Rep. Barr, Andy [R-KY-6] Andy Barr R KY 6 2014-03-27 False F000445 Rep. Forbes, J. Randy [R-VA-4] J. Forbes R VA Randy 4 2014-04-07 False C001083 Rep. Carney, John C., Jr. [D-DE-At Large] John Carney D DE C. 0 2014-04-07 False L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2014-04-07 False E000291 Rep. Ellmers, Renee L. [R-NC-2] Renee Ellmers R NC L. 2 2014-04-07 False B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2014-04-10 False M000087 Rep. Maloney, Carolyn B. [D-NY-12] CAROLYN MALONEY D NY B. 12 2014-04-10 False G000567 Rep. Griffin, Tim [R-AR-2] Tim Griffin R AR 2 2014-04-10 False C001045 Rep. Crenshaw, Ander [R-FL-4] ANDER CRENSHAW R FL 4 2014-04-29 False L000575 Rep. Lankford, James [R-OK-5] James Lankford R OK 5 2014-04-29 False D000604 Rep. Dent, Charles W. [R-PA-15] Charles Dent R PA W. 15 2014-04-29 False R000583 Rep. Rooney, Thomas J. [R-FL-17] Thomas Rooney R FL J. 17 2014-04-29 False B001252 Rep. Barrow, John [D-GA-12] John Barrow D GA 12 2014-04-29 False K000220 Rep. Kingston, Jack [R-GA-1] JACK KINGSTON R GA 1 2014-04-29 False N000184 Rep. Noem, Kristi L. [R-SD-At Large] Kristi Noem R SD L. 0 2014-04-29 False L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2014-04-30 False G000560 Rep. Graves, Tom [R-GA-14] Tom Graves R GA 14 2014-05-01 False R000593 Rep. Ross, Dennis A. [R-FL-15] Dennis Ross R FL A. 15 2014-05-06 False B001242 Rep. Bishop, Timothy H. [D-NY-1] Timothy Bishop D NY H. 1 2014-05-06 False P000593 Rep. Perlmutter, Ed [D-CO-7] Ed Perlmutter D CO 7 2014-05-09 False M001151 Rep. Murphy, Tim [R-PA-18] Tim Murphy R PA 18 2014-05-22 False D000600 Rep. Diaz-Balart, Mario [R-FL-25] Mario Diaz-Balart R FL 25 2014-06-02 False J000292 Rep. Johnson, Bill [R-OH-6] Bill Johnson R OH 6 2014-06-02 False M001142 Rep. Matheson, Jim [D-UT-4] JIM MATHESON D UT 4 2014-06-02 False R000580 Rep. Roskam, Peter J. [R-IL-6] Peter Roskam R IL J. 6 2014-06-17 False F000459 Rep. Fleischmann, Charles J. "Chuck" [R-TN-3] Charles Fleischmann R TN J. "Chuck" 3 2014-07-08 False C000266 Rep. Chabot, Steve [R-OH-1] STEVE CHABOT R OH 1 2014-07-10 False R000586 Rep. Renacci, James B. [R-OH-16] James Renacci R OH B. 16 2014-07-15 False 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 House 2014-08-06T16:52:08Z 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.

]]>

17 2014-07-24 Reported to House with amendment(s) 2014-09-23T16:09:04Z 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.]]>

36 2014-07-28 Passed House amended 2014-09-23T16:09:31Z (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.

Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.

Sunscreen Innovation Act Display Title Sunscreen Innovation Act Official Title as Introduced 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 House IH Short Titles as Introduced Sunscreen Innovation Act Short Titles as Reported to House Sunscreen Innovation Act H House Short Titles as Passed House Sunscreen Innovation Act H House Received in Senate 2014-07-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr4250rds/xml/BILLS-113hr4250rds.xml Engrossed in House 2014-07-28T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr4250eh/xml/BILLS-113hr4250eh.xml Reported in House 2014-07-24T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr4250rh/xml/BILLS-113hr4250rh.xml Introduced in House 2014-03-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr4250ih/xml/BILLS-113hr4250ih.xml 2014-07-29 Received in the Senate. 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.