Accelerating Access to Critical Therapies for als Reauthorization act of 2026

Text in the Record

Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the bill

[[Page H4653]]

(H.R. 8205) 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, as amended. The Clerk read the title of the bill. The text of the bill is as follows:

H.R. 8205

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026''.

SEC. 2. REAUTHORIZATION OF ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS ACT.

(a) In General.--Section 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 Research.--Section 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''.

SEC. 3. IMPROVEMENTS TO PROGRAM FOR GRANTS FOR RESEARCH ON THERAPIES FOR ALS.

(a) Renewal of Grants for Research on Therapies for ALS Review.--Section 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 review.--In 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 Data.--Section 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 Definition.-- Section 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.''.

SEC. 4. FDA RARE NEURODEGENERATIVE DISEASE ACTION PLAN.

Showing the first 12 paragraphs. The full remarks are in the Record.

Read the full remarks in the Record (opens in a new tab)