The NIH Translational Neural Devices Grant Program aims to support translational activities and small clinical studies for the development of therapeutic and diagnostic devices targeting nervous or neuromuscular disorders. This grant facilitates the implementation of clinical prototype devices, safety testing, design validation, and obtaining necessary approvals for clinical studies. Researchers are encouraged to conduct small clinical trials to gather essential data on device functionality not achievable through non-clinical assessments. The grant operates on a milestone-driven cooperative agreement model, involving NIH program staff in project planning and monitoring. Deadline for application: Feb 20, 2024.
Opportunity ID: 333154
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-NS-21-021 |
| Funding Opportunity Title: | Translational Neural Devices (UG3/UH3 – Clinical Trial Optional) |
| 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: | Apr 28, 2021 |
| Last Updated Date: | Apr 28, 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: | $4,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities Special district governments State governments Small businesses Native American tribal governments (Federally recognized) Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) |
| 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. |
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 or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) 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-21-021.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 333154 Full Announcement-RFA-NS-21-021 -> RFA-NS-21-021-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 | PKG00266797 | Jun 01, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270468 | Nov 18, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278470 | Nov 15, 2022 | Feb 20, 2024 | View |
Package 1
Mandatory forms
333154 RR_SF424_2_0-2.0.pdf
333154 PHS398_CoverPageSupplement_5_0-5.0.pdf
333154 RR_OtherProjectInfo_1_4-1.4.pdf
333154 PerformanceSite_2_0-2.0.pdf
333154 RR_KeyPersonExpanded_2_0-2.0.pdf
333154 RR_Budget_1_4-1.4.pdf
333154 PHS398_ResearchPlan_4_0-4.0.pdf
333154 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
333154 RR_SubawardBudget30_1_4-1.4.pdf
333154 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
333154 RR_SF424_5_0-5.0.pdf
333154 PHS398_CoverPageSupplement_5_0-5.0.pdf
333154 RR_OtherProjectInfo_1_4-1.4.pdf
333154 PerformanceSite_4_0-4.0.pdf
333154 RR_KeyPersonExpanded_4_0-4.0.pdf
333154 RR_Budget_3_0-3.0.pdf
333154 PHS398_ResearchPlan_4_0-4.0.pdf
333154 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
333154 RR_SubawardBudget30_3_0-3.0.pdf
333154 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
333154 RR_SF424_5_0-5.0.pdf
333154 PHS398_CoverPageSupplement_5_0-5.0.pdf
333154 RR_OtherProjectInfo_1_4-1.4.pdf
333154 PerformanceSite_4_0-4.0.pdf
333154 RR_KeyPersonExpanded_4_0-4.0.pdf
333154 RR_Budget_3_0-3.0.pdf
333154 PHS398_ResearchPlan_5_0-5.0.pdf
333154 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
333154 RR_SubawardBudget30_3_0-3.0.pdf
333154 PHS_AssignmentRequestForm_3_0-3.0.pdf
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