Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Open Posted
- Opportunity number
- RFA-NS-26-001
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Small Businesses
- Tribal Governments (Federally Recognized)
- Higher Education Inst. (Private)
- For Profit Organizations
- County Governments
- Tribal Organizations (Not Federally Recognized)
- State Governments
- Special District Governments
- Independent School Districts
- Public or Indian Housing Auth.
- Other
- Higher Education Inst. (Public)
- Non-501(c)(3) Nonprofits
- 501(c)(3) Nonprofits
- City/Township Governments
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Neurological Disorders and Stroke (NINDS) is soliciting applications for scientific research utilizing expanded access data for investigational drugs or biological products targeting intermediate-size populations of amyotrophic lateral sclerosis (ALS) patients ineligible for ongoing clinical trials, with an application due date of November 10, 2026. Eligible applicants are restricted to clinical trial sites that participate in phase 2/3 or phase 3 efficacy clinical trials sponsored by U.S.-based small business concerns holding FDA-designated investigational new drug (IND) applications for ALS therapeutics; foreign organizations and non-domestic components of U.S. organizations are not eligible.
NINDS intends to commit up to $40 million per fiscal year to fund approximately four new awards for a maximum project period of four years. The funding mechanism is a U01 Cooperative Agreement and requires a clinical trial. Awards will support investigational drug costs, biospecimen collection and banking through BioSEND or NHCDR, clinical site research expenses, personnel effort, and participant travel. A Data Management and Sharing Plan is mandatory, with data expected to be submitted to the ALS Knowledge Portal.
Applications must comply with detailed requirements including research strategy that does not interfere with ongoing trials, use of common data elements, stakeholder engagement, data safety monitoring, and submission of FDA documentation demonstrating "may proceed" authorization. Review will be conducted by the Center for Scientific Review and the National Advisory Neurological Disorders and Stroke Council, with substantial NINDS programmatic involvement including protocol oversight, adverse event monitoring, site visits, and steering committee participation. The Assistance Listing number is 93.853.
Synopsis
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.
Eligibility
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.
Files
| File | Type | Posted |
|---|---|---|
| PKG00292631.pdf | ||
| RFA-NS-26-001-Full-Announcement.html | HTML file |
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