Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

119 HR 8205 EH: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 U.S. House of Representatives 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. IB 119th CONGRESS2d Session H. R. 8205

IN THE HOUSE OF REPRESENTATIVES AN ACT To amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes.

1.Short titleThis Act may be cited as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.

2.Reauthorization of Accelerating Access to Critical Therapies for ALS Act (a)In generalSection 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking 2026 and inserting 2031. (b)Grants for ALS researchSection 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking 2026 and inserting 2031.

3.Improvements to program for grants for research on therapies for ALS (a)Renewal of grants for research on therapies for ALS reviewSection 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following: (4)Renewal of grants for research on therapies for ALS reviewIn reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall request from the manufacturer or sponsor, and assess, the enrollment, safety, and any available efficacy data relating to the investigational drug in the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.. (b)Reporting safety dataSection 2(c) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended— (1)in paragraph (2)(B), by striking and at the end; (2)in paragraph (3), by striking the period at the end and inserting ; and; and (3)by adding at the end the following: (4)the entity seeking such grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to the phase 3 trial to the grant-making institution, in addition to complying with the safety reporting requirements under section 312.32 of title 21, Code of Federal Regulations (or any successor regulations).. (c)Clarifying participating clinical trial definitionSection 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following: (4)The term phase 3, with respect to a clinical trial, includes a phase 2/3 combined trial that begins enrollment within a timeframe, determined by the Secretary through the terms and conditions of the grant awarded under this section..

4.FDA rare neurodegenerative disease action planSection 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended— (1)in the section heading, by striking ALS and other rare neurodegenerative disease action plan and inserting FDA rare neurodegenerative disease action plan; and (2)by adding at the end the following: (c)FDA rare neurodegenerative disease action plan (1)In generalNot later than 18 months after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration an action plan that includes a description of the actions that the Food and Drug Administration intends to take during the 5-year period following publication of the action plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a). (2)ReportNot later than 5 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that describes the actions taken by the Food and Drug Administration under the action plan published under paragraph (1) and the extent to which such action plan meets the requirements specified in paragraph (1).. Passed the House of Representatives July 22, 2026.Kevin F. McCumber,Clerk.

119 HR 8205 IH: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 U.S. House of Representatives 2026-04-06 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. I119th CONGRESS2d SessionH. R. 8205IN THE HOUSE OF REPRESENTATIVESApril 6, 2026Mr. Quigley (for himself and Mr. Calvert) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes.

1.Short titleThis Act may be cited as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.

2.Reauthorization of Accelerating Access to Critical Therapies for ALS Act (a)In generalSection 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking 2026 and inserting 2031. (b)Grants for ALS researchSection 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking 2026 and inserting 2031. (c)Sense of CongressThe Committee on Energy and Commerce of the House of Representatives expresses support for directly appropriating funds to carry out each section of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79).

3.Improvements to program for grants for research on therapies for ALS (a)Clinical trial status reviewSection 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following: (4)Clinical trial status review (A)In generalIn reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall assess the status of a clinical trial carried out for such drug with respect to data on enrollment of patients in such clinical trial. (B)Interim clinical trial dataTo enable the Secretary to make the assessment under subparagraph (A) with respect to an investigational drug, the Secretary shall request that the manufacturer of the investigational drug share interim clinical trial data with respect to such drug with the Secretary. . (b)Clarifying participating clinical trial definitionSection 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following: (4) The term phase 3, with respect to a clinical trial, includes a phase 2/3 combined trial and a planned phase 3 clinical trial that is not yet enrolling participants. .

4.Report on ALS and other rare neurodegenerative disease action plansSection 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended by adding at the end the following: (c)Report on ALS and other rare neurodegenerative disease action plansNot later than one year after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that contains— (1)an updated action plan, including— (A)a description of the actions the Food and Drug Administration intends to take during the 5-year period following publication of the plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a); (B)a description of the resources necessary to implement each section of the plan within such 5-year period; and (C)specific approaches the Commissioner will take to improve coordination of implementation of the plan with rare neurodegenerative disease communities that are not specifically ALS communities; and (2)with respect to the Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) published by the Food and Drug Administration on June 23, 2022 (referred to in this section as the 2022 Action Plan), a description of— (A)the actions taken by the Food and Drug Administration under the 2022 Action Plan; (B)the effect of the implementation of the 2022 Action Plan on the development of therapies and regulatory consideration of therapies for ALS and other rare neurodegenerative diseases; (C)any programs and initiatives that established or carried out as part of the implementation of the 2022 Action Plan; and (D)the extent to which the 2022 Action Plan was implemented with respect to rare neurodegenerative diseases that are not amyotrophic lateral sclerosis..

5.GAO reportNot later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the analyses and data described in section 6 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) (as in effect on the date of enactment of this Act).

117 HR 8205 PCS: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 U.S. House of Representatives 2026-07-23 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. IICalendar No. 466119th CONGRESS2d SessionH. R. 8205IN THE SENATE OF THE UNITED STATESJuly 23, 2026 Received; read twice and placed on the calendarAN ACTTo amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes.1.Short titleThis Act may be cited as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.2.Reauthorization of Accelerating Access to Critical Therapies for ALS Act(a)In generalSection 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking 2026 and inserting 2031.(b)Grants for ALS researchSection 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking 2026 and inserting 2031.3.Improvements to program for grants for research on therapies for ALS(a)Renewal of grants for research on therapies for ALS reviewSection 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:(4)Renewal of grants for research on therapies for ALS reviewIn reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall request from the manufacturer or sponsor, and assess, the enrollment, safety, and any available efficacy data relating to the investigational drug in the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis..(b)Reporting safety dataSection 2(c) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended—(1)in paragraph (2)(B), by striking and at the end; (2)in paragraph (3), by striking the period at the end and inserting ; and; and (3)by adding at the end the following:(4)the entity seeking such grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to the phase 3 trial to the grant-making institution, in addition to complying with the safety reporting requirements under section 312.32 of title 21, Code of Federal Regulations (or any successor regulations)..(c)Clarifying participating clinical trial definitionSection 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:(4)The term phase 3, with respect to a clinical trial, includes a phase 2/3 combined trial that begins enrollment within a timeframe, determined by the Secretary through the terms and conditions of the grant awarded under this section..4.FDA rare neurodegenerative disease action planSection 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended—(1)in the section heading, by striking ALS and other rare neurodegenerative disease action plan and inserting FDA rare neurodegenerative disease action plan; and(2)by adding at the end the following:(c)FDA rare neurodegenerative disease action plan(1)In generalNot later than 18 months after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration an action plan that includes a description of the actions that the Food and Drug Administration intends to take during the 5-year period following publication of the action plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a).(2)ReportNot later than 5 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that describes the actions taken by the Food and Drug Administration under the action plan published under paragraph (1) and the extent to which such action plan meets the requirements specified in paragraph (1)..Passed the House of Representatives July 22, 2026.Kevin F. McCumber,Clerk.July 23, 2026Received; read twice and placed on the calendar

117 HR 8205 RH: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 U.S. House of Representatives 2026-07-09 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. IBUnion Calendar No. 637119th CONGRESS2d SessionH. R. 8205[Report No. 119–733]IN THE HOUSE OF REPRESENTATIVESApril 6, 2026Mr. Quigley (for himself and Mr. Calvert) introduced the following bill; which was referred to the Committee on Energy and CommerceJuly 9, 2026Additional sponsors: Mr. Fitzpatrick, Ms. Schakowsky, Mr. McCaul, Mr. Auchincloss, Mr. DesJarlais, Ms. Craig, Mr. Valadao, Mr. Crow, Mr. Thompson of Pennsylvania, Ms. Moore of Wisconsin, Mr. Hurd of Colorado, Mr. Schneider, Mr. Joyce of Ohio, Mr. Veasey, Ms. Salazar, Ms. Bonamici, Mr. Bilirakis, Mr. Sherman, Mr. Garbarino, Mr. Lynch, Mr. Bacon, Mr. Cohen, Mr. Sessions, Mr. Smith of Washington, Mr. Obernolte, Ms. Dean of Pennsylvania, Mr. Cole, Mrs. Foushee, Mr. Rutherford, Ms. Sewell, Mr. Wilson of South Carolina, Mr. Davis of Illinois, Mr. Aderholt, Mr. Torres of New York, Mr. Mann, Ms. Norton, Mr. Van Drew, Mr. Krishnamoorthi, Mr. Alford, Ms. Underwood, Mr. LaLota, Ms. Schrier, Mrs. Kim, Ms. Matsui, Mr. Edwards, Mrs. Dingell, Mr. Walberg, Ms. Tlaib, Mr. Weber of Texas, Mr. Thompson of California, Mr. Bost, Mr. Tonko, Mrs. Bice, Ms. DelBene, Mr. Diaz-Balart, Mr. Correa, Mr. LaHood, Mr. Kennedy of New York, Mr. Womack, Mr. Whitesides, Mr. Rouzer, Mr. Bishop, Ms. Letlow, Ms. Kelly of Illinois, Mr. Amodei of Nevada, Mr. Gottheimer, Mr. Moore of North Carolina, Mr. Cleaver, Mr. Carter of Texas, Mr. Stanton, Mr. Wittman, Mr. Vindman, Mr. Guest, Ms. Bynum, Mrs. Miller of West Virginia, Mrs. Hayes, Mr. Latimer, Mr. Davis of North Carolina, Ms. McBride, Mr. Riley of New York, Mr. Conaway, Ms. Stansbury, Ms. Ross, Ms. Pingree, Mr. Himes, Mrs. Watson Coleman, Mr. Casten, Mr. Landsman, Mrs. Grijalva, Ms. Mejia, Mr. Larson of Connecticut, Mr. Sorensen, Mr. Peters, Mr. Jackson of Illinois, Ms. Adams, Ms. Budzinski, Mrs. Beatty, Mr. Magaziner, Ms. Kaptur, Mr. Carter of Louisiana, Mr. Suozzi, and Ms. ScanlonJuly 9, 2026Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printedStrike out all after the enacting clause and insert the part printed in italicFor text of introduced bill, see copy of bill as introduced on April 6, 2026A BILLTo amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes.1.Short titleThis Act may be cited as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.2.Reauthorization of Accelerating Access to Critical Therapies for ALS Act(a)In generalSection 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking 2026 and inserting 2031.(b)Grants for ALS researchSection 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking 2026 and inserting 2031.3.Improvements to program for grants for research on therapies for ALS(a)Renewal of grants for research on therapies for ALS reviewSection 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:(4)Renewal of grants for research on therapies for ALS reviewIn reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall request from the manufacturer or sponsor, and assess, the enrollment, safety, and any available efficacy data relating to the investigational drug in the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis..(b)Reporting safety dataSection 2(c) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended—(1)in paragraph (2)(B), by striking and at the end; (2)in paragraph (3), by striking the period at the end and inserting ; and; and (3)by adding at the end the following:(4)the entity seeking such grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to the phase 3 trial to the grant-making institution, in addition to complying with the safety reporting requirements under section 312.32 of title 21, Code of Federal Regulations (or any successor regulations)..(c)Clarifying participating clinical trial definitionSection 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:(4)The term phase 3, with respect to a clinical trial, includes a phase 2/3 combined trial that begins enrollment within a timeframe, determined by the Secretary through the terms and conditions of the grant awarded under this section..4.FDA rare neurodegenerative disease action planSection 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended—(1)in the section heading, by striking ALS and other rare neurodegenerative disease action plan and inserting FDA rare neurodegenerative disease action plan; and(2)by adding at the end the following:(c)FDA rare neurodegenerative disease action plan(1)In generalNot later than 18 months after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration an action plan that includes a description of the actions that the Food and Drug Administration intends to take during the 5-year period following publication of the action plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a).(2)ReportNot later than 5 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that describes the actions taken by the Food and Drug Administration under the action plan published under paragraph (1) and the extent to which such action plan meets the requirements specified in paragraph (1)..July 9, 2026Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed