Data / Federal grants / RFA-NS-26-001
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
National Institutes of Health (Department of Health and Human Services) is accepting applications until November 10, 2026. It lists 4 awards expected, $40 million in total.
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Key facts
- Opportunity number
- RFA-NS-26-001
- Status
- Posted, open
- Posted
- May 4, 2026
- Closes
- November 10, 2026
- Expected awards
- 4
- Total funding
- $40,000,000
- Cost sharing
- Not required
- Funding instrument
- Cooperative Agreement
- Category
- Health
- Assistance listing
- 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders; None None
- Contact
- National Institutes of Health · [email protected] · 301-402-2541
Who can apply
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- Public housing authorities/Indian housing authorities
- City or township governments
- Special district governments
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- State governments
- Independent school districts
- For profit organizations other than small businesses
- Public and State controlled institutions of higher education
- County governments
- Native American tribal governments (Federally recognized)
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.
What the agency says
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.
Other open grants from the Department of Health and Human Services
| Opportunity | Status | Closes | Award ceiling | Total funding | Record |
|---|---|---|---|---|---|
| Long-term health outcomes of people living with spina bifida CDC-RFA-DD-26-0222 | Open | Oct 26 | $300,000 | $3,000,000 | grants.gov |
| GREGoRi Data Coordination and Outreach Center (U01, Clinical Trials Not Allowed) RFA-HG-27-011 | Open | Oct 30 | $1,250,000 | $2,000,000 | grants.gov |
| GREGoRi Innovation Projects (U01 Clinical Trial Optional) RFA-HG-27-013 | Open | Oct 30 | $500,000 | $7,500,000 | grants.gov |
| GREGoRi Technology Integration Center (U01, Clinical Trials Optional) RFA-HG-27-012 | Open | Oct 30 | $2,250,000 | $3,000,000 | grants.gov |
| HEAL Initiative: Whole Joint Health Program (R61/R33 Clinical Trial Required) PAR-27-045 | Open | Oct 30 | grants.gov | ||
| Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR-24-280 | Open | Nov 2 | grants.gov |
All grants open to Nonprofits (501(c)(3)) · All grants open to Private colleges and universities · All grants open to Public housing authorities/Indian housing authorities · Everything closing in November 2026
Read from the Grants.gov API, last updated 2026-10-23. The agency's notice on Grants.gov is the official record; check it before you apply.