Posted opportunity — confirm at source
Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
National Institutes of Health · RFA-NS-26-001
See source for award amount
2026-11-10-00-00-00
Confirm exact timezone in the announcement.Independent school districts, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, Special district governments, Native American tribal governments (Federally recognized), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Public and State controlled institutions of higher education, City or township governments, County governments, For profit organizations other than small businesses, State governments, Others (see text field entitled "Additional Information on Eligibility" for clarification), Native American tribal organizations (other than Federally recognized tribal governments), Public housing authorities/Indian housing authorities, Small businesses
Geographic eligibility and all attachment-specific conditions require review of the original announcement.
Eligibility details
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.
Matching funds & resources
Source matching-funds field: Not Required.
Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.
About this opportunity
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.
Funding geography: Not specified — review source. A funder’s address does not establish eligibility.
Review original source ↗Funding instrument: Cooperative Agreement. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.
Source fields and evidence
id: 360400
Source ↗ · id
opportunityNumber: RFA-NS-26-001
Source ↗ · opportunityNumber
opportunityTitle: Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Source ↗ · opportunityTitle
revision: 2
Source ↗ · revision
agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
Source ↗ · agencyDetails
owningAgencyCode: HHS-NIH11
Source ↗ · owningAgencyCode
cfdas: [{"id":430755,"opportunityId":360400,"cfdaNumber":"93.853","programTitle":"Extramural Research Programs in the Neurosciences and Neurological Disorders"},{"id":433090,"opportunityId":360400}]
Source ↗ · cfdas
applicantTypes: [{"id":"05","description":"Independent school districts"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"20","description":"Private institutions of higher education"},{"id":"04","description":"Special district governments"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"02","description":"City or township governments"},{"id":"01","description":"County governments"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"00","description":"State governments"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"23","description":"Small businesses"}]
Source ↗ · applicantTypes
applicantEligibilityDesc: 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.
Source ↗ · applicantEligibilityDesc
fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
Source ↗ · fundingInstruments
fundingActivityCategories: [{"id":"HL","description":"Health"}]
Source ↗ · fundingActivityCategories
awardFloor: none
Source ↗ · awardFloor
awardCeiling: none
Source ↗ · awardCeiling
responseDate: Nov 10, 2026 12:00:00 AM EST
Source ↗ · responseDate
responseDateStr: 2026-11-10-00-00-00
Source ↗ · responseDateStr
costSharing: false
Source ↗ · costSharing
lastUpdatedDate: May 04, 2026 11:56:35 AM EDT
Source ↗ · lastUpdatedDate
status: posted
Source ↗ · oppHits[id=360400].oppStatus
Build your funding pipeline.
Save opportunities, filter by fit, and export your deadlines with membership.
View plans from $49/month ↗