This NIH BRAIN Initiative grant encourages investigators to pursue translational activities and small clinical studies aimed at advancing the development of therapeutic and diagnostic devices for disorders affecting the nervous or neuromuscular systems. Supported activities encompass implementing clinical prototype devices, comprehensive non-clinical safety and efficacy testing, along with essential design verification and validation. The program also facilitates obtaining an Investigational Device Exemption (IDE) for significant risk studies, followed by a small clinical study. This clinical study is crucial for gathering information on device function or final design that is otherwise unattainable through non-clinical assessments due to the device’s novelty or specific intended use. This is a milestone-driven cooperative agreement, requiring NIH program staff participation in planning and monitoring.
Opportunity ID: 356981
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-25-021 |
| Funding Opportunity Title: | BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.173 — Research Related to Deafness and Communication Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 05, 2024 |
| Last Updated Date: | Nov 05, 2024 |
| Original Closing Date for Applications: | Sep 28, 2026 |
| Current Closing Date for Applications: | Sep 28, 2026 |
| Archive Date: | Nov 03, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Special district governments Independent school districts For profit organizations other than small businesses State governments County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) City or township governments Private 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 allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this announcement is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-021.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 356981 Full Announcement-RFA-NS-25-021 -> RFA-NS-25-021-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-I | Use for due dates on or after January 25, 2025 | PKG00288476 | Dec 28, 2024 | Sep 28, 2026 | View |
Package 1
Mandatory forms
356981 RR_SF424_5_0-5.0.pdf
356981 PHS398_CoverPageSupplement_5_0-5.0.pdf
356981 RR_OtherProjectInfo_1_4-1.4.pdf
356981 PerformanceSite_4_0-4.0.pdf
356981 RR_KeyPersonExpanded_4_0-4.0.pdf
356981 RR_Budget10_3_0-3.0.pdf
356981 PHS398_ResearchPlan_5_0-5.0.pdf
356981 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
356981 RR_SubawardBudget10_30_3_0-3.0.pdf
356981 PHS_AssignmentRequestForm_4_0-4.0.pdf
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