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:
RFA-NS-21-023 Expiration Date February 21, 2024
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Applicants should rarely exceed $1,000,000 direct costs per year for the UG3 phase and $1,500,000 direct costs per year for the UH3 phase.
The duration of the UG3 phase cannot exceed 4 years and the total duration of the UG3/UH3 phases combined may not exceed 5 years.
