PAR-25-053: Translational Neural Devices (R61/R33)
This NOFO supports milestone-driven R61/R33 projects to advance low-risk therapeutic and diagnostic neural devices through non-clinical testing and a subsequent small clinical study. This chunk describes the R61/R33 grant mechanism, budget and project-period limits, eligible applicants, required registrations, and application restrictions.
Projects must focus on a condition that falls within the mission of NINDS. Projects proposing only a clinical phase are outside the scope of this funding opportunity. Applications must not include Basic research and studies of disease mechanisms. Applications must not include animal model development; all in vivo models must be well established, characterized, and available to the applicant. Applications must not include Significant Risk (SR) clinical studies or studies requiring an Investigational Device Exemption (IDE) from the FDA. Only new, resubmission, and revision application types are allowed for this NOFO. Applications may propose clinical trial(s) or may not propose clinical trial(s). Eligible applicant organizations include the listed higher-education institutions, nonprofit organizations, for-profit organizations, governments, tribal governments and organizations, federal eligible agencies, U.S. territories or possessions, school districts, public housing authorities, faith-based or community-based organizations, regional organizations, and non-domestic entities; foreign organizations and non-domestic components of U.S. organizations are eligible, and foreign components are allowed. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as a PD/PI may work with their organization to develop an application. Applicant organizations may submit more than one application only if each application is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time. Each application must focus on only one neurological disorder or disease, even if the device proposed for development could be used for more than one indication. Delayed onset trials are not responsive and will not be accepted.
Applications are due by 5:00 PM local time of the applicant organization on the listed application due dates.
Correct submission errors and submit any changed or corrected application to Grants.gov on or before the application due date and time.
Projects must focus on a condition that falls within the mission of NINDS.
Projects proposing only a clinical phase are outside the scope of this funding opportunity.
Applications must not include Basic research and studies of disease mechanisms.
Applications must not include animal model development; all in vivo models must be well established, characterized, and available to the applicant.
Applications must not include Significant Risk (SR) clinical studies or studies requiring an Investigational Device Exemption (IDE) from the FDA.
Only new, resubmission, and revision application types are allowed for this NOFO.
Applications may propose clinical trial(s) or may not propose clinical trial(s).
Eligible applicant organizations include the listed higher-education institutions, nonprofit organizations, for-profit organizations, governments, tribal governments and organizations, federal eligible agencies, U.S. territories or possessions, school districts, public housing authorities, faith-based or community-based organizations, regional organizations, and non-domestic entities; foreign organizations and non-domestic components of U.S. organizations are eligible, and foreign components are allowed.
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as a PD/PI may work with their organization to develop an application.
Applicant organizations may submit more than one application only if each application is scientifically distinct.
NIH will not accept duplicate or highly overlapping applications under review at the same time.
Each application must focus on only one neurological disorder or disease, even if the device proposed for development could be used for more than one indication.
Delayed onset trials are not responsive and will not be accepted.
| Name | Role | ||
|---|---|---|---|
| NINDS Program Staff | NIH Program Officers — negotiate final project plan before award and monitor research progress | — | — |