S 4472 — Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

360ee(C) note)in isthe amendedmatter preceding paragraph (1), as so redesignated, by addingstriking the period at the end theand following:inserting ``including--'';

``(4)(D) Theby termamending `phaseparagraph 3',(1), withas respectso redesignated, to aread clinicalas trial,follows: includes a phase 2/3 combined trial and a planned phase 3 clinical trial that is not yet enrolling participants.''.

``(1) a description of how data generated through the proposed expanded access grant will be used to support research or development related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis;'';

(E) in paragraph (2), as so redesignated-- (i) by striking ``Noninterference with clinical trials--'' and all that follows through ``shall include'';

(ii) by striking ``program'' and inserting ``grant'';

and (iii) by striking the period at the end and inserting ``;

and'';

and (F) by adding at the end the following:

``(3) an assurance that such entity will promptly report to the Secretary available safety data from any ongoing clinical trial of the investigational drug as set forth in the terms and conditions of the grant.'';

(3) in subsection (c)-- (A) by redesignating subparagraphs (A) and (B) of paragraph (2) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;

(B) by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively, and adjusting the margins accordingly;

(C) in subparagraph (C), as so redesignated, by striking the period at the end and inserting ``;

and'';

(D) in the matter preceding subparagraph (A), as so redesignated, by striking ``this section, confirm that--'' and inserting the following:

``this section-- ``(1) confirm that--'';

and (E) by adding at the end the following:

``(2) in the case of a renewal of such a grant, request from the sponsor of the investigational new drug application involved, and assess, the enrollment, safety, and any available efficacy data of the drug related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.'';

(4) in subsection (d)(1), by striking ``request described in subsection (a)'' and inserting ``grant'';

and (5) in subsection (e)-- (A) in paragraph (2), by inserting ``, and that begins enrollment within a timeframe as determined by the Secretary through the terms and conditions of the grant'' before the period at the end;

and (B) by adding at the end the following:

``(4) The term `phase 3 clinical trial' includes a phase 2/ combined trial and a planned phase 3 clinical trial that is not yet enrolling participants.''.

360aa note) is amendedamended-- (1) in the section heading, by addingstriking at``als theand endother'' theand following:inserting ``fda'';

``(c)(2) Reportin onsubsection ALS(a), andin Otherthe Rarematter Neurodegenerativepreceding Diseaseparagraph Action(1)-- Plans.--Not(A) by inserting ``and not later than one1 year after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026,2026 the Commissioner of Food and Drugsevery shall5 publishyears onthereafter,'' theafter website``this ofAct,''; 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)and a(B) descriptionby ofinserting the``develop, resourcesor necessaryupdate, toas implementapplicable, eachand'' sectionbefore of``publish theon''; plan within such 5-year period;

and(3) ``(C)in specificsubsection approaches(b)-- the(A) Commissionerin will take to improve coordination of implementation of the planmatter withpreceding rareparagraph neurodegenerative(1), diseaseby communitiesstriking that``initial''; are not specifically ALS communities;

and(B) ``(2)in withparagraph respect(2)-- to(i) 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 thissubparagraph section(A), as the `2022 Action Plan'), a description of-- ``(A) the actions taken by theinserting Food``of andrelevant Druginvestigational Administrationnew underdrug theapplications'' 2022after Action``sponsors''; Plan;

``(B)(ii) thein effectsubparagraph of(C) theby implementationinserting of``for the 2022prevention, Actiondiagnosis, Planmitigation, ontreatment, theor developmentcure of therapiesrare andneurodegenerative regulatorydiseases'' considerationbefore ofthe therapiessemicolon; for ALS and other rare neurodegenerative diseases;

``(C) any programs and initiatives(iii) thatin establishedsubparagraph or(D), carriedby outstriking as``; part of the implementation of the Action Plan;

and'' and ``(D)inserting thea extentsemicolon; to which the 2022 Action Plan was implemented with respect to rare neurodegenerative diseases that are not amyotrophic lateral sclerosis.''.

(C) in paragraph (3), by striking the period at the end and inserting ``;

and'';

and (D) by adding at the end the following:

``(4) for each action plan published after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, include a description of-- ``(A) previous actions taken by the Food and Drug Administration to implement the previous action plan published under subsection (a);

``(B) any other planned actions to implement such action plan;

and ``(C) any barriers to implementing such action plan and related recommendations, which may include an estimate of resources necessary to address such barriers.''.

GAOREPORTS. REPORT.

Section 6 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79) is amended,amended-- (1) in the matterheading, preceding paragraph (1)-- (1) by striking ``4``gao yearsreport'' after the date of the enactment of this Act'' and inserting ``5``reports''; years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026'';

and (2) by insertingstriking ``,``Not withlater respectthan'' toand theinserting 10-year period starting on the datefollowing: of enactment of this Act'' after ``containing''.

<all>``(a) GAO Report.--Not later than'';

(3) in the matter preceding paragraph (1) of subsection (a), as so designated, by striking ``this Act'' and inserting ``the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026'';

and (4) by adding at the end the following:

``(b) HHS Report.--Not later than 4 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Secretary of Health and Human Services shall, in a manner that does not duplicate the information described in the action plan published pursuant to section 4, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the effectiveness of the activities carried out under sections 2, 3, and 5 and making recommendations to improve such activities.''.

SEC.

6.

TECHNICAL AMENDMENTS.

Section 3 of the Accelerating Access to Critical Therapies for ALS Act (42 U.S.C.

280g-7b) is amended-- (1) in subsection (a), in the matter preceding paragraph (1), by striking ``amytrophic'' and inserting ``amyotrophic'';

and (2) in subsection (b)(3)(A)(iii), by striking ``rational''.

Calendar No.

461 119th CONGRESS 2d Session S.

4472 _______________________________________________________________________ A BILL 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.

_______________________________________________________________________ July 16, 2026 Reported with an amendment