Translational Neural Devices (R61/R33 - Clinical Trial Optional)
National Institutes of Health
Summary
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.
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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. | applicant types: Independent school districts; Public housing authorities/Indian housing authorities; Native American tribal organizations (other than Federally recognized tribal governments); Private institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Small businesses; County governments; City or township governments; State governments; Nonprofits that do not have 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; Special district governments; Native American tribal governments (Federally recognized)