Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

About this grant

The NINDS and Office of the Director, NIH intend to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research on 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 f Grant Number: RFA-NS-26-001. Expected awards: 4.

Eligibility requirements

All of the following criteria must be met:

• U.S. Territory or PossessionEligible 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, an

What the funding covers

• See official listing for award details
• Expected Number of Awards: 4
• Total Program Funding: $40M

How to apply

1. 1Check eligibility: Confirm your organization type (e.g., nonprofit, state government), project alignment, and deadlines from the opportunity synopsis.
2. 2Register: Create a Grants.gov account via Login.gov, complete SAM.gov and UEI registration, and authorize organization representatives (takes 2-4 weeks).
3. 3Prepare application: Select "Apply" to open Workspace, download forms (e.g., SF-424), complete offline/online with validation checks, and upload supporting docs like budgets and narratives.
4. 4Submit and track: Check package for errors, sign/submit via Authorized Organization Representative (AOR), and monitor status with your tracking number
5. 5Applications must be submitted through grants.gov
6. 6Grant Number: RFA-NS-26-001
7. 7Posted: 2025-08-28

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