The NIH is offering this grant to advance the development of therapeutic and diagnostic devices specifically designed for disorders affecting the nervous or neuromuscular systems. This funding opportunity supports crucial translational activities and small clinical studies. Eligible activities include implementing clinical prototypes, conducting non-clinical safety and efficacy testing, performing design verification and validation, and securing regulatory approvals such as an Investigational Device Exemption (IDE) or Institutional Review Board (IRB) approval. A subsequent small clinical study is also supported, focusing on obtaining vital information about device function or design that is impractical to gather through non-clinical assessments due to the device’s novelty. This is a milestone-driven cooperative agreement involving active NIH program staff monitoring.
Opportunity ID: 356903
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-053 |
| Funding Opportunity Title: | Translational Neural Devices (R61/R33 – Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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: | Oct 30, 2024 |
| Last Updated Date: | Oct 30, 2024 |
| Original Closing Date for Applications: | Jan 28, 2027 |
| Current Closing Date for Applications: | Jan 28, 2027 |
| Archive Date: | Mar 05, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Special district governments Public housing authorities/Indian housing authorities Small businesses State governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) 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 and State controlled institutions of higher education For profit organizations other than small businesses Independent school districts |
| 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 Notice of Funding Opportunity (NOFO) 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 NOFO 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/pa-files/PAR-25-053.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 356903 Full Announcement-PAR-25-053 -> PAR-25-053-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 | PKG00288441 | Dec 28, 2024 | Jan 28, 2027 | View |
Package 1
Mandatory forms
356903 RR_SF424_5_0-5.0.pdf
356903 PHS398_CoverPageSupplement_5_0-5.0.pdf
356903 RR_OtherProjectInfo_1_4-1.4.pdf
356903 PerformanceSite_4_0-4.0.pdf
356903 RR_KeyPersonExpanded_4_0-4.0.pdf
356903 RR_Budget10_3_0-3.0.pdf
356903 PHS398_ResearchPlan_5_0-5.0.pdf
356903 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
356903 RR_SubawardBudget10_30_3_0-3.0.pdf
356903 PHS_AssignmentRequestForm_4_0-4.0.pdf
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