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

Federal funding opportunity RFA-NS-26-001 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes November 10, 2026

Program funding history

Synopsis

Who can apply

• Public housing authorities/Indian housing authorities
• Nonprofits having 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)
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• County governments
• State governments
• Native American tribal governments (Federally recognized)
• Private institutions of higher education
• Small businesses
• Independent school districts
• Public and State controlled institutions of higher education
• City or township governments
• Special district governments
• Native American tribal organizations (other than Federally recognized tribal governments)
• For profit organizations other than small businesses

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

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