The BRAIN Initiative is offering this grant to support translational activities and small clinical studies, aimed at advancing next-generation invasive therapeutic and diagnostic devices for nervous or neuromuscular system disorders. Work encompasses implementing clinical prototypes, non-clinical safety/efficacy testing, design verification/validation, and obtaining an Investigational Device Exemption (IDE) for significant risk studies. A subsequent small clinical study is supported to gain device function or design insights impractical through non-clinical methods. This milestone-driven cooperative agreement involves NIH program staff in planning and monitoring.
Opportunity ID: 333402
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-21-023 |
| Funding Opportunity Title: | BRAIN Initiative: Next-Generation Invasive 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: | May 07, 2021 |
| Last Updated Date: | May 07, 2021 |
| Original Closing Date for Applications: | Feb 20, 2024 |
| Current Closing Date for Applications: | Feb 20, 2024 |
| Archive Date: | Mar 27, 2024 |
| Estimated Total Program Funding: | $10,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) County governments Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 State governments City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Special district governments Small businesses Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) |
| 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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 Funding Opportunity Announcement (FOA) 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: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-023.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 333402 Full Announcement-RFA-NS-21-023 -> RFA-NS-21-023-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster 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-F | Use for due dates on or before January 24, 2022 | PKG00267009 | Jun 01, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270489 | Nov 18, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278472 | Nov 15, 2022 | Feb 20, 2024 | View |
Package 1
Mandatory forms
333402 RR_SF424_2_0-2.0.pdf
333402 PHS398_CoverPageSupplement_5_0-5.0.pdf
333402 RR_OtherProjectInfo_1_4-1.4.pdf
333402 PerformanceSite_2_0-2.0.pdf
333402 RR_KeyPersonExpanded_2_0-2.0.pdf
333402 RR_Budget_1_4-1.4.pdf
333402 PHS398_ResearchPlan_4_0-4.0.pdf
333402 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
333402 RR_SubawardBudget30_1_4-1.4.pdf
333402 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
333402 RR_SF424_5_0-5.0.pdf
333402 PHS398_CoverPageSupplement_5_0-5.0.pdf
333402 RR_OtherProjectInfo_1_4-1.4.pdf
333402 PerformanceSite_4_0-4.0.pdf
333402 RR_KeyPersonExpanded_4_0-4.0.pdf
333402 RR_Budget_3_0-3.0.pdf
333402 PHS398_ResearchPlan_4_0-4.0.pdf
333402 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
333402 RR_SubawardBudget30_3_0-3.0.pdf
333402 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
333402 RR_SF424_5_0-5.0.pdf
333402 PHS398_CoverPageSupplement_5_0-5.0.pdf
333402 RR_OtherProjectInfo_1_4-1.4.pdf
333402 PerformanceSite_4_0-4.0.pdf
333402 RR_KeyPersonExpanded_4_0-4.0.pdf
333402 RR_Budget_3_0-3.0.pdf
333402 PHS398_ResearchPlan_5_0-5.0.pdf
333402 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
333402 RR_SubawardBudget30_3_0-3.0.pdf
333402 PHS_AssignmentRequestForm_3_0-3.0.pdf
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