Informational Webinar for Applicants to NINDS ALS Expanded Access (U01) - May 2026

Post Webinar Materials

The Accelerating Access to Critical Therapies (ACT) for ALS Act was passed into law on December 23, 2021 (P.L. 117-79). Section 2 authorized a grant program for scientific research utilizing data from expanded access to investigational drugs for individuals who are not otherwise eligible for clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis (ALS). The statute limits the grant program to phase 3 clinical sites sponsored by a small business concern.

NIH released RFA-NS-26-001 to implement Section 2 of ACT for ALS. In the frequently asked questions (FAQs), we have pointed out the relevant sections of ACT for ALS that establish the requirements of this NIH grant program.

Eligibility Requirements: See ACT for ALS Sec. 2(e) for definition of participating entity and participating clinical trial, and Sec. 2(a) for expanded access New Drug Application (IND) authorization requirements.