This grant supports small clinical trials to advance next-generation invasive devices for recording and modulating the human central nervous system. The core aim is to treat CNS disorders and enhance brain understanding. Studies, from acute to chronic implants (potentially requiring FDA IDE), must yield critical data on device function or design unobtainable through non-clinical means. As part of the BRAIN Public-Private Partnership, this opportunity facilitates access to novel devices from manufacturers. Existing safety data is generally expected to suffice for IRB or FDA approvals, accelerating the development of innovative neural technologies.
Opportunity ID: 333414
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-21-024 |
| Funding Opportunity Title: | BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (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: | $1,500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| 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 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 a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information 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. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices’ existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-024.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 333414 Full Announcement-RFA-NS-21-024 -> RFA-NS-21-024-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 | PKG00267010 | Jun 01, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270599 | Nov 22, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278473 | Nov 15, 2022 | Feb 20, 2024 | View |
Package 1
Mandatory forms
333414 RR_SF424_2_0-2.0.pdf
333414 PHS398_CoverPageSupplement_5_0-5.0.pdf
333414 RR_OtherProjectInfo_1_4-1.4.pdf
333414 PerformanceSite_2_0-2.0.pdf
333414 RR_KeyPersonExpanded_2_0-2.0.pdf
333414 RR_Budget_1_4-1.4.pdf
333414 PHS398_ResearchPlan_4_0-4.0.pdf
333414 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
333414 RR_SubawardBudget30_1_4-1.4.pdf
333414 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
333414 RR_SF424_5_0-5.0.pdf
333414 PHS398_CoverPageSupplement_5_0-5.0.pdf
333414 RR_OtherProjectInfo_1_4-1.4.pdf
333414 PerformanceSite_4_0-4.0.pdf
333414 RR_KeyPersonExpanded_4_0-4.0.pdf
333414 RR_Budget_3_0-3.0.pdf
333414 PHS398_ResearchPlan_4_0-4.0.pdf
333414 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
333414 RR_SubawardBudget30_3_0-3.0.pdf
333414 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
333414 RR_SF424_5_0-5.0.pdf
333414 PHS398_CoverPageSupplement_5_0-5.0.pdf
333414 RR_OtherProjectInfo_1_4-1.4.pdf
333414 PerformanceSite_4_0-4.0.pdf
333414 RR_KeyPersonExpanded_4_0-4.0.pdf
333414 RR_Budget_3_0-3.0.pdf
333414 PHS398_ResearchPlan_5_0-5.0.pdf
333414 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
333414 RR_SubawardBudget30_3_0-3.0.pdf
333414 PHS_AssignmentRequestForm_3_0-3.0.pdf
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