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ACCEPTING APPLICATIONS · COOPERATIVE AGREEMENT

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

National Institutes of Health · Health

Accepting applications. The agency is taking applications now through Grants.gov.
Deadline
Nov 10, 2026 (17 days left)
Who can apply
Others
Award range
Not stated
Expected awards
4
Total program funding
$40 million
Your own money required
No cost sharing or matching required
Opportunity number
RFA-NS-26-001
Posted
May 4, 2026
Assistance listing
93.853

More on who can apply

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 the subject of an IND under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) to prevent, diagnose, mitigate, treat, or cure ALS. The definition of a small business concern

What it funds

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.

Open the official notice on Grants.gov ↗

What to do next

  1. Open the official notice on Grants.gov and download the full announcement (the NOFO) and any attachments.
  2. Check you can apply: the eligible applicants above, and any detail in the notice's eligibility section.
  3. Register your organization in SAM.gov (choose "all awards") and create a Grants.gov account; allow several weeks the first time.
  4. Apply through Grants.gov exactly as the notice says, before Nov 10, 2026. Late applications are usually not accepted.

New to this? Applying for a federal grant, step by step · Register to apply · How to read the notice · Write the narrative · Build the budget · Agency contact: NINDSALSMailbox@mail.nih.gov

From Grants.gov's official daily extract of Oct 25, 2026. The notice on Grants.gov and its attachments are what count. UX Contract is independent and not a government website.

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