FORECAST · COOPERATIVE AGREEMENT
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
- Expected deadline
- Not stated
- Who can apply
- Others
- Award range
- Not stated
- Expected awards
- Not stated
- Total program funding
- Not stated
- Your own money required
- No cost sharing or matching required
- Opportunity number
- RFA-NS-28-009
- Posted
- Sep 23, 2026
- Assistance listing
- 93.853
More on who can apply
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 establish substantial evidence of effectiveness in support of a marketing application) supported by a U.S. based 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 can be found in section 3(a) of th
What it funds
The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics)). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.
Open the official notice on Grants.gov ↗What to do next
- This is a forecast: the agency expects to post the full notice later. Open it on Grants.gov and subscribe there to be told when it posts.
- Get your SAM.gov registration ("all awards") and Grants.gov account active now; both take time.
- Use the forecast's award range and eligibility to decide whether to prepare.
- Watch for the notice; the dates here are estimates and can change.
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.