Translational Neural Devices (R61/R33 - Clinical Trial Optional)
Open Posted
- Opportunity number
- PAR-25-053
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- Special District Governments
- Tribal Governments (Federally Recognized)
- For Profit Organizations
- Tribal Organizations (Not Federally Recognized)
- Other
- Small Businesses
- Public or Indian Housing Auth.
- 501(c)(3) Nonprofits
- City/Township Governments
- Higher Education Inst. (Public)
- County Governments
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- State Governments
- Independent School Districts
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health is soliciting applications for Translational Neural Devices (R61/R33 – Clinical Trial Optional), a milestone-driven cooperative agreement program supporting therapeutic and diagnostic device development for nervous and neuromuscular system disorders, with applications due January 28, 2027.
Eligible applicants include 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, small businesses, higher education institutions (public and private), state and local governments, tribal governments and organizations, special district governments, public or Indian housing authorities, independent school districts, Alaska Native and Native Hawaiian serving institutions, Hispanic-serving institutions, historically Black colleges and universities, Asian American Native American Pacific Islander serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-domestic entities.
Supported activities include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation, obtaining an Investigational Device Exemption (IDE) for a Significant Risk study or Institutional Review Board (IRB) approval for a Non-Significant Risk study, and a subsequent small clinical study. The clinical study must provide information about device function or final design that cannot be practically obtained through additional non-clinical assessments due to device novelty or intended use.
This is a milestone-driven program requiring participation of NIH program staff in negotiating the final project plan before award and monitoring research progress. The opportunity is funded under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), administered by the National Institute of Neurological Disorders and Stroke.
Synopsis
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.
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.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-053-Full-Announcement.html | HTML file | |
| PKG00288441.pdf |
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