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

Key facts

Copied from the official Grants.gov record. Last verified October 29, 2026.

Program name

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

Issuing agency

National Institutes of Health (Department of Health and Human Services)

Opportunity number

RFA-NS-26-001

Funding type

Cooperative Agreement

Funding purpose

Health

Status

Open (posted)

Application deadline

Closes November 10, 2026(11 days left)

Published award range

Not published by the agency

Estimated total program funding

$40,000,000

Expected number of awards

4

Cost sharing or match required

No

Eligible applicants (official categories)

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

Relevant to

Businesses and NonprofitsHow we determined this: Grants.gov eligibility includes small businesses or for-profit organizations. Grants.gov eligibility includes nonprofit organizations.

Geographic restrictions

None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.

Assistance Listing (CFDA)

93.853

Official source

View on Grants.gov ↗

Application URL

www.grants.gov/search-results-detail/360400 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.

Source identifier

Grants.gov opportunity ID 360400 · Funding opportunity number RFA-NS-26-001

Posted

May 4, 2026 · Source last updated May 4, 2026

Last verified

October 29, 2026 (against Grants.gov)

Data completeness

92% of key fields published by the sourceNot published: published funding range.

Record confidence

highVerified against the official source; key fields present; no open issues.

Eligibility details (from the agency)

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.

Description (from the official listing)

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

ALS Program NINDSALSMailbox@mail.nih.gov
NINDSALSMailbox@mail.nih.gov