The National Institute of Neurological Disorders and Stroke (NINDS) is offering a grant to support scientific research leveraging data from expanded access (EA) to investigational drugs for Amyotrophic Lateral Sclerosis (ALS). This grant aims to provide promising treatments to intermediate populations of ALS patients ineligible for standard clinical trials. The initiative seeks to gather crucial data without impeding ongoing clinical investigations necessary for market approval. Eligible applicants are clinical trial sites participating in a Phase 3 trial, where a U.S. small business concern is the FDA-designated sponsor of an ALS drug under an Investigational New Drug Application (IND).
Opportunity ID: 356553
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-25-024 |
| Funding Opportunity Title: | Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Sep 26, 2024 |
| Last Updated Date: | Sep 26, 2024 |
| Original Closing Date for Applications: | Jan 24, 2025 |
| Current Closing Date for Applications: | Jan 24, 2025 |
| Archive Date: | Mar 01, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Native American tribal governments (Federally recognized) State governments City or township governments Independent school districts Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County governments 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 For profit organizations other than small businesses Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical trials for the diagnosis, mitigation, treatment, or cure of ALS (“intermediate EA protocol for ALS”). Providing the investigational drug or biological product under an intermediate EA protocol for ALS must not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval, or otherwise compromise the potential development of medical products for the diagnosis, mitigation, treatment, or cure of ALS. Eligible applicants are clinical trial sites that participate in a phase 3 clinical trial supported by a United States (U.S.) small business concern (as defined in section 3(a) of the Small Business Act (15 U.S. C. 623(a)) that is also the U.S. Food and Drug Administration (FDA) designated sponsor of a drug or biological product for ALS that is the subject of an Investigational New Drug Application (IND). This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in May 2022 with an expected application due date in June 2022. This FOA will utilize the U01 activity code. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-024.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 356553 Full Announcement-RFA-NS-25-024 -> RFA-NS-25-024-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00287995 | Dec 24, 2024 | Jan 24, 2025 | View |
Package 1
Mandatory forms
356553 RR_SF424_5_0-5.0.pdf
356553 PHS398_CoverPageSupplement_5_0-5.0.pdf
356553 RR_OtherProjectInfo_1_4-1.4.pdf
356553 PerformanceSite_4_0-4.0.pdf
356553 RR_KeyPersonExpanded_4_0-4.0.pdf
356553 PHS398_ResearchPlan_5_0-5.0.pdf
356553 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
356553 RR_Budget_3_0-3.0.pdf
356553 RR_SubawardBudget30_3_0-3.0.pdf
356553 PHS398_ModularBudget_1_2-1.2.pdf
356553 PHS_AssignmentRequestForm_3_0-3.0.pdf
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