Data / Federal grants / RFA-NS-28-009
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
National Institutes of Health (Department of Health and Human Services) expects to post this opportunity around March 1, 2027, with applications due around May 25, 2027.
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Key facts
- Opportunity number
- RFA-NS-28-009
- Status
- Forecast
- Posted
- September 23, 2026
- Closes
- May 25, 2027
- Cost sharing
- Not required
- Funding instrument
- Cooperative Agreement
- Category
- Health
- Assistance listing
- 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders
- Contact
- ALS Program · [email protected] · Please contact via email.
Who can apply
- City or township governments
- Private institutions of higher education
- Special district governments
- State governments
- Public and State controlled institutions of higher education
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- County governments
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Native American tribal organizations (other than Federally recognized tribal governments)
- Native American tribal governments (Federally recognized)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- For profit organizations other than small businesses
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 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 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.
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 City or township governments · All grants open to Private colleges and universities · All grants open to Special district governments · Everything closing in May 2027
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.