Funding Opportunities

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small clinical studies for recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Activities supported in this program include regulatory activities to obtain an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. Only Significant Risk (SR) clinical studies that will require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants, will be supported by this NOFO. 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.