H.R. 1262: Give Kids a Chance Act of 2025
The Give Kids a Chance Act of 2025 is designed to improve the investigation and development of drugs specifically for pediatric cancers. Here’s an overview of the main features of the bill:
1. Pediatric Drug Research Enhancement
The bill allows for more comprehensive investigations into the use of existing and new drugs for treating pediatric cancers. This includes:
- Facilitating clinical trials to gather data on the effectiveness and safety of molecularly targeted cancer therapies in children.
- Requiring studies to be designed to produce meaningful data that can inform proper dosing and labeling for pediatric patients.
2. Accountability for Pediatric Studies
The legislation strengthens the accountability of pharmaceutical companies to complete pediatric study requirements. This includes:
- Implementing penalties for companies that do not fulfill their responsibilities regarding pediatric studies.
- Ensuring that enforcement actions can only be taken if the company is found to have acted without due diligence.
3. Reporting and Compliance
The bill mandates various reporting requirements, such as:
- The Secretary of Health and Human Services must report on compliance with the new pediatric study requirements.
- The Government Accountability Office (GAO) will study the effectiveness of these requirements and their impact on drug development for pediatric cancers.
4. Priority Review Vouchers
The legislation extends the existing system of priority review vouchers for treatments developed for rare pediatric diseases until September 30, 2029. This encourages pharmaceutical companies to invest in research and development for these treatments.
5. Limitations on Orphan Drug Exclusivity
It modifies the rules around orphan drug exclusivity, which traditionally grants exclusive rights for seven years. The new amendments prevent companies from claiming exclusivity for drugs that treat the same condition as an already approved drug but are intended for different uses or indications.
6. Program for Pediatric Studies
The bill establishes a specific program that allocates funds for conducting studies on drugs for pediatric populations, specifically designating $25 million per year from 2025 to 2027.
7. Organ Procurement and Transplantation Network Updates
Improvements to the existing Organ Procurement and Transplantation Network, focusing on the integration of technology to streamline organ transplants for pediatric patients, are also included.
8. Establishment of an Office for Abraham Accords
A new office within the Food and Drug Administration (FDA) will focus on enhancing collaboration and regulatory cooperation with countries that are part of the Abraham Accords. This includes sharing information and technical assistance related to drug approval processes.
9. Required Studies and Reporting
The bill mandates studies on the efficacy of priority review vouchers and progress toward regulatory compliance, aiming to improve outcomes for pediatric drug development.
Relevant Companies
- PFE (Pfizer Inc.): Potentially impacted due to its involvement in oncology research, including pediatric cancer treatments.
- NVS (Novartis AG): As a major player in pharmaceuticals with a focus on treatments for rare diseases, it may be affected by extended incentives under this bill.
- AMGN (Amgen Inc.): Might see implications for its studies and treatments relevant to pediatric cancers and rare diseases.
This is an AI-generated summary of the bill text. There may be mistakes.
Sponsors
223 bill sponsors
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TrackMichael T. McCaul
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TrackAlma S. Adams
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TrackMark Alford
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TrackRick W. Allen
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TrackYassamin Ansari
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TrackJake Auchincloss
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TrackDon Bacon
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TrackTroy Balderson
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TrackMichael Baumgartner
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TrackCliff Bentz
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TrackAmi Bera
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TrackStephanie I. Bice
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TrackGus M. Bilirakis
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TrackSanford D. Bishop, Jr.
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TrackSuzanne Bonamici
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TrackBrendan F. Boyle
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TrackRobert Bresnahan
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TrackShontel M. Brown
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TrackJulia Brownley
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TrackNikki Budzinski
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TrackTim Burchett
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TrackJanelle Bynum
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TrackKen Calvert
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TrackSalud O. Carbajal
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TrackMike Carey
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TrackTroy A. Carter
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TrackEd Case
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TrackSean Casten
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TrackKathy Castor
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TrackJoaquin Castro
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TrackSheila Cherfilus-McCormick
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TrackJuan Ciscomani
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TrackYvette D. Clarke
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TrackEmanuel Cleaver
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TrackBen Cline
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TrackSteve Cohen
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TrackTom Cole
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TrackHerbert Conaway
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TrackJ. Luis Correa
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TrackJim Costa
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TrackAngie Craig
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TrackDan Crenshaw
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TrackJason Crow
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TrackHenry Cuellar
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TrackSharice Davids
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TrackDonald G. Davis
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TrackMadeleine Dean
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TrackSuzan K. DelBene
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TrackChristopher R. Deluzio
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TrackMario Diaz-Balart
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TrackDebbie Dingell
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TrackChuck Edwards
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TrackAdriano Espaillat
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TrackDwight Evans
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TrackGabe Evans
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TrackCleo Fields
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TrackPat Fallon
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TrackShomari Figures
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TrackBrad Finstad
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TrackBrian K. Fitzpatrick
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TrackCharles J. "Chuck" Fleischmann
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TrackLizzie Fletcher
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TrackMike Flood
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TrackBill Foster
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TrackValerie P. Foushee
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TrackScott Franklin
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TrackMaxwell Frost
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TrackJohn Garamendi
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TrackAndrew R. Garbarino
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TrackRobert Garcia
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TrackLaura Gillen
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TrackCarlos A. Gimenez
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TrackVicente Gonzalez
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TrackJosh Gottheimer
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TrackSam Graves
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TrackAl Green
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TrackRaúl M. Grijalva
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TrackGlenn Grothman
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TrackAbraham Hamadeh
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TrackJosh Harder
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TrackDiana Harshbarger
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TrackJahana Hayes
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TrackClay Higgins
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TrackAshley Hinson
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TrackErin Houchin
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TrackChrissy Houlahan
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TrackBill Huizenga
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TrackJonathan L. Jackson
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TrackRonny Jackson
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TrackSara Jacobs
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TrackPramila Jayapal
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TrackJulie Johnson
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TrackJohn Joyce
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TrackMarcy Kaptur
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TrackWilliam R. Keating
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TrackRobin L. Kelly
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TrackMike Kelly
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TrackTimothy M. Kennedy
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TrackJennifer Kiggans
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TrackKevin Kiley
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TrackYoung Kim
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TrackRaja Krishnamoorthi
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TrackDarin LaHood
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TrackDoug LaMalfa
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TrackGreg Landsman
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TrackJohn B. Larson
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TrackGeorge Latimer
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TrackMichael Lawler
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TrackSummer L. Lee
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TrackTeresa Leger Fernandez
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TrackJulia Letlow
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TrackTed Lieu
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TrackBarry Loudermilk
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TrackAnna Paulina Luna
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TrackStephen F. Lynch
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TrackSeth Magaziner
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TrackNicole Malliotakis
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TrackTracey Mann
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TrackDoris O. Matsui
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TrackSarah McBride
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TrackApril McClain Delaney
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TrackJennifer L. McClellan
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TrackBetty McCollum
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TrackMorgan McGarvey
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TrackJames P. McGovern
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TrackJohn McGuire
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TrackLaMonica McIver
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TrackGrace Meng
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TrackMark Messmer
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TrackDaniel Meuser
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TrackMax L. Miller
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TrackMary E. Miller
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TrackCarol D. Miller
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TrackCory Mills
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TrackJohn R. Moolenaar
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TrackTim Moore
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TrackNathaniel Moran
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TrackJoseph D. Morelle
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TrackJared Moskowitz
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TrackSeth Moulton
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TrackJames C. Moylan
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TrackFrank J. Mrvan
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TrackKevin Mullin
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TrackJerrold Nadler
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TrackTroy E. Nehls
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TrackDan Newhouse
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TrackDonald Norcross
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TrackEleanor Holmes Norton
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TrackZachary Nunn
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TrackIlhan Omar
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TrackBurgess Owens
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TrackJimmy Panetta
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TrackScott H. Peters
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TrackBrittany Pettersen
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TrackAugust Pfluger
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TrackMark Pocan
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TrackMike Quigley
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TrackAumua Amata Coleman Radewagen
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TrackJosh Riley
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TrackDeborah K. Ross
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TrackDavid Rouzer
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TrackRaul Ruiz
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TrackMichael A. Rulli
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TrackMaria Elvira Salazar
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TrackAndrea Salinas
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TrackMary Gay Scanlon
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TrackJanice D. Schakowsky
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TrackDerek Schmidt
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TrackBradley Scott Schneider
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TrackHillary J. Scholten
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TrackKim Schrier
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TrackAustin Scott
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TrackPete Sessions
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TrackTerri A. Sewell
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TrackMikie Sherrill
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TrackJefferson Shreve
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TrackChristopher H. Smith
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TrackAdrian Smith
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TrackLloyd Smucker
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TrackEric Sorensen
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TrackDarren Soto
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TrackMelanie A. Stansbury
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TrackGreg Stanton
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TrackElise M. Stefanik
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TrackBryan Steil
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TrackW. Gregory Steube
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TrackMarilyn Strickland
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TrackSuhas Subramanyam
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TrackThomas R. Suozzi
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TrackEric Swalwell
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TrackEmilia Strong Sykes
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TrackMark Takano
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TrackDavid Taylor
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TrackClaudia Tenney
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TrackBennie G. Thompson
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TrackGlenn Thompson
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TrackDina Titus
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TrackJill N. Tokuda
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TrackPaul Tonko
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TrackRitchie Torres
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TrackLori Trahan
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TrackDerek Tran
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TrackMichael R. Turner
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TrackDavid G. Valadao
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TrackJefferson Van Drew
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TrackDerrick Van Orden
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TrackJuan Vargas
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TrackGabe Vasquez
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TrackMarc A. Veasey
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TrackEugene Vindman
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TrackTim Walberg
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TrackDebbie Wasserman Schultz
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TrackMaxine Waters
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TrackRandy K. Weber, Sr.
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TrackDaniel Webster
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TrackBruce Westerman
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TrackTony Wied
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TrackRoger Williams
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TrackFrederica S. Wilson
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TrackJoe Wilson
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TrackRobert J. Wittman
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TrackRudy Yakym III
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TrackRyan K. Zinke
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Actions
2 actions
| Date | Action |
|---|---|
| Feb. 12, 2025 | Introduced in House |
| Feb. 12, 2025 | Referred to the House Committee on Energy and Commerce. |
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