Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
National Institutes of Health · Opportunity number RFA-NS-26-001
Details summarized from the official notice as of Oct 16, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.
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Key facts
| Opportunity number | RFA-NS-26-001 |
|---|---|
| Agency | National Institutes of Health Department of Health and Human Services |
| Assistance listing (ALN, formerly CFDA) | 93.853 |
| Posted | May 4, 2026 |
| Deadline | Nov 10, 2026 |
| Expected number of awards | 4 |
| Estimated total program funding | $40,000,000 |
| Cost sharing or matching required | No |
| Funding type | Cooperative agreement |
| Category | Health |
| Last updated here | Oct 16, 2026 |
Summary from the notice
Who can apply
The official notice lists these applicant types as eligible:
- Small businesses
- Federally recognized tribal governments
- Private colleges and universities
- For-profit organizations other than small businesses
- County governments
- Other Native American tribal organizations
- State governments
- Special district governments
- Independent school districts
- Public and Indian housing authorities
- Others named in the notice (see the eligibility text)
- Public and state colleges and universities
- Nonprofits without 501(c)(3) status (other than colleges)
- Nonprofits with 501(c)(3) status (other than colleges)
- City or township governments
Who should take a closer look
- Small businesses
- Nonprofits
- Colleges and universities
- State governments
- Local governments
- Tribal governments and organizations
- Larger for-profit companies
Not listed as eligible
- Individuals
Unless the eligibility text in the notice names you, this opportunity is probably not for you.
Eligibility details from the notice
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 can be found in section 3(a) of the Small Business Act (15 U.S.C. 632(a)).Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Registrations you will likely need
Most applications submitted through Grants.gov need the following. Registration can take several weeks, so start early. The notice lists the exact requirements.
- SAM.gov registration for your organization, which also gives you a Unique Entity ID (UEI). Registration is free.
- A Login.gov account, which Grants.gov uses for sign-in.
- A Grants.gov applicant registration linked to your organization's UEI.
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