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

id: 363926
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opportunityNumber: RFA-NS-28-009
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opportunityTitle: Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
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revision: 0
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agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
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owningAgencyCode: HHS-NIH11
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cfdas: [{"id":435479,"opportunityId":363926,"cfdaNumber":"93.853","programTitle":"Extramural Research Programs in the Neurosciences and Neurological Disorders"}]
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forecastDesc: <p>The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see&nbsp;<a href="https://www.fda.gov/news-events/expanded-access/expanded-access-categories-drugs-including-biologics">Expanded Access Categories for Drugs (Including Biologics)</a>). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. The scientific research goal(s) informed by these data could include the investigational drug's or biological product's effect on biomarkers related to the pathophysiology of ALS or target engagement, the collection of safety or outcome information, such as survival or other significant medical events (e.g., hospitalization or need for ventilatory support), or patient experience data that are not specifically tied to assessing efficacy.&nbsp;</p><p>Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop responsive projects.</p>
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applicantTypes: [{"id":"04","description":"Special district governments"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"13","description":"Nonprofits that do not have 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":"22","description":"For profit organizations other than small businesses"},{"id":"02","description":"City or township governments"},{"id":"01","description":"County governments"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"00","description":"State 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":"20","description":"Private institutions of higher education"},{"id":"23","description":"Small businesses"}]
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applicantEligibilityDesc: 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 establish substantial evidence of effectiveness in support of a marketing application) supported by a U.S. based 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.
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fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
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fundingActivityCategories: [{"id":"HL","description":"Health"}]
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costSharing: false
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lastUpdatedDate: Sep 23, 2026 10:34:20 AM EDT
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status: forecasted
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