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

(a) In general Section 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79Public Law 117-79View official source on GovInfo) 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. 360eU.S. Code — Title 21, Section 360eView official source on GovInfoe note) is amended by striking 2026 and inserting 2031.

(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. 360eU.S. Code — Title 21, Section 360eView official source on GovInfoe 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. 360eU.S. Code — Title 21, Section 360eView official source on GovInfoe 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. 360eU.S. Code — Title 21, Section 360eView official source on GovInfoe 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..

Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aU.S. Code — Title 21, Section 360aView official source on GovInfoa 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 general Not 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) Report Not 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)..