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

National Institutes of Health

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. 360b

Funding
Estimated total program funding: $40,000,000
Category
Health & Medical
Status
OPEN
Deadline
11/11/2026

About

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.

Applicant types

Grants.gov eligibility code 00Grants.gov eligibility code 01Grants.gov eligibility code 02Grants.gov eligibility code 04Grants.gov eligibility code 05Grants.gov eligibility code 06Grants.gov eligibility code 07Grants.gov eligibility code 08Grants.gov eligibility code 11Grants.gov eligibility code 12Grants.gov eligibility code 13Grants.gov eligibility code 20Grants.gov eligibility code 22Grants.gov eligibility code 23Grants.gov eligibility code 25
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Notice-specific evidence check

What an applicant must verify for Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

Applicant evidence

  • Applicant type: State governments
  • Applicant type: County governments
  • Applicant type: City or township governments
  • Applicant type: Special district governments
  • Applicant type: Independent school districts
  • Applicant type: Public and state-controlled institutions of higher education
  • Applicant type: Federally recognized tribal governments
  • Applicant type: Public housing authorities and Indian housing authorities

Opportunity boundaries

  • Recorded funding: Estimated total program funding: $40,000,000
  • Recorded deadline: November 11, 2026; confirm time zone and submission system.
  • Recorded focus: Health
Before investing in an application, connect every eligibility claim, required registration, submission component and deadline to the current official notice. Open the recorded official source →

Application checklist

How to apply for Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

The steps below turn the recorded grant fields into a pre-submission check. They do not replace the current Notice of Funding Opportunity or its amendments.

Recorded eligibility

  • • Applicant types: Grants.gov eligibility code 00, Grants.gov eligibility code 01, Grants.gov eligibility code 02, Grants.gov eligibility code 04, Grants.gov eligibility code 05, Grants.gov eligibility code 06.
  • • Geographic scope is not structured in this record.
  • • Notice summary: 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.

Focus areas: HL

Recorded deadline

November 10, 2026 — confirm the time zone and submission system

A missing or rolling date is not permission to assume an open application window.

  1. 1. Confirm fitMatch your applicant type, location, project scope and any cost-share or registration rule to the official notice.
  2. 2. Read the noticeCollect the current guidelines, amendments, budget rules, required attachments and submission instructions.
  3. 3. Check timingRecord the deadline time zone, internal review date and any earlier registration or portal cut-off.
  4. 4. Submit thereUse the official application route and save the confirmation or submission reference.

Official sources

Recorded source: https://www.grants.gov/xml-extract

Open official notice →

Last directory verification: Sep 13, 2026.