Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
About
The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products as described in section 561 of the Federal Food, Drug, and Cosmetic Act (21 U. S. C. 360bbb). These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS.
The Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) grant is a federal funding opportunity designed to support scientific research utilizing expanded access data for investigational drugs and biological products targeting patients with ALS. This program is specifically intended for clinical trial sites that are part of phase 2/3 or phase 3 efficacy clinical trials sponsored by small business concerns serving as FDA-designated sponsors. The grant supports research focused on prevention, diagnosis, mitigation, treatment, or cure of ALS for intermediate-sized patient populations who do not qualify for ongoing clinical trials. Eligible organizations can conduct research that leverages expanded access programs under Section 561 of the Federal Food, Drug, and Cosmetic Act. This opportunity is ideal for small business-sponsored clinical trial sites seeking to advance ALS treatment research and generate pivotal data supporting marketing applications. Organizations interested in this funding should review the complete Notice of Funding Opportunity (NOFO) for detailed eligibility requirements and application procedures. The application deadline is November 10, 2026.
Funding Facts
● Applications openDeadline
November 10, 2026
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Not specified
Deadline
2026-11-10
Grant Type
federal
Application Cycle
Annual (Deadline: November 10, 2026)
Best For
Clinical trial sites participating in phase 2/3 or phase 3 efficacy trials sponsored by small business concerns as FDA-designated sponsors
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Eligible applicants must be clinical trial sites that participate in a phase 2/3 or phase 3 efficacy clinical trial (designed to provide pivotal data to support a marketing application) supported by a small business concern that is the FDA-designated sponsor of a drug or biological product which is
Frequently Asked Questions
Who is eligible for Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)?
Eligible applicants must be clinical trial sites that participate in a phase 2/3 or phase 3 efficacy clinical trial supported by a small business concern that is the FDA-designated sponsor of a drug or biological product. For complete eligibility details, refer to Section III of the Notice of Funding Opportunity (NOFO) on the official funding agency website.
How much funding does Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) provide?
Specific funding amounts are not listed in the current available information. Contact the funding agency directly or review the full NOFO for details on award amounts and budget requirements.
How do I apply for Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)?
Applications should be submitted according to the procedures outlined in the Notice of Funding Opportunity (NOFO). The application deadline is November 10, 2026. For detailed submission instructions, application forms, and technical requirements, visit the official funding agency website and review the complete NOFO.
What can Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) funding be used for?
Funding supports the conduct of scientific research utilizing data from expanded access programs for investigational drugs or biological products. Research must focus on prevention, diagnosis, mitigation, treatment, or cure of ALS for intermediate-sized patient populations not eligible for ongoing clinical trials. Research must align with expanded access provisions under Section 561 of the Federal Food, Drug, and Cosmetic Act.
Last updated: July 5, 2026