The purpose of this Funding Opportunity Announcement (FOA) 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 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, 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 FOA. 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 FOA 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.
Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to RFA-NS-21-024 or this FOA.
The BRAIN PPP includes agreements with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new FDA IDE and IRB approvals without need for significant additional non-clinical data. For more information on the BRAIN PPP, see https://braininitiative.nih.gov/brain-programs/public-private-partnerships
Deadlines:
- Letter of Intent: 60 days prior to receipt date
- Application Due Date(s): July 1, 2021; Oct 20, 2021; Feb 16, 2022; June 20, 2022; Oct 18, 2022; Feb 21, 2023; June 19, 2023; Oct 18, 2023; Feb 20, 2024
RFA-NS-21-023 Expiration Date February 21, 2024