Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 C
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 applicati
| Agency | National Institutes of Health |
|---|---|
| Status | Posted |
| Opportunity number | RFA-NS-26-001 |
| Posted date | 05/04/2026 |
| Application deadline | Nov 10, 2026 12:00:00 AM EST |
| Award ceiling | none |
| Award floor | none |
| Estimated total funding | 40,000,000 |
| Expected number of awards | 4 |
| 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. 35 |
| Assistance Listing (CFDA) | 93.853 |
| Description | 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. |
| Agency contact | NINDSALSMailbox@mail.nih.gov |
| Official listing | https://www.grants.gov/search-results-detail/360400 |