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AusGrant
Federal Open GRANTS-GOV-360400

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

National Institutes of Health (NIH) · Competitive grant · Science & Technology

At a glance

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) is a federal competitive grant from National Institutes of Health for the science & technology sector. Funding: 40000000. Eligible applicants: Native American tribal organizations (other than Federally recognized tribal governments); City or township governments; County governments; For profit organizations other than small businesses; Special district governme. The application deadline is November 10, 2026. Apply via the official listing at www.grants.gov.

Amount
$40M total
Deadline
Nov 10, 2026
Type
Competitive
Status
Open

About this program

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.

Who can apply

Native American tribal organizations (other than Federally recognized tribal governments); City or township governments; County governments; For profit organizations other than small businesses; Special district governments; Public housing authorities/Indian housing authorities; Native American tribal governments (Federally recognized); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); Independent school districts; Public and State controlled institutions of higher education; Private institutions of higher education; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Small businesses; State governments. 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.

How to apply

Apply through Grants.gov using funding opportunity number RFA-NS-26-001. Register your organization (SAM.gov + Grants.gov) before the deadline, then submit the application package listed in the official notice.

Apply at official source