Sponsor Deadline for Letters of Intent (requested): 60 days in advance of the full proposal deadline

Sponsor Deadlines for Full Proposals: July 1, 2021; October 20, 2021; February 18, 2022; June 20, 2022; October 18, 2022; February 21, 2023; June 19, 2023; October 18, 2023; February 20, 2024

FAS/SEAS/OSP Deadline: 5 business days prior to submission

Award Information: Application budgets are not limited but should rarely exceed $1M in direct costs per year for the UG3 phase and $1.5M in direct costs per year for the UH3 phase. The proposed project period for the UG3 phase must not exceed 4 years. The proposed project period for the UH3 phase must not exceed 4 years. The total duration of the UG3 and UH3 may not exceed 5 years. NIH anticipates providing $10M per year to fund an estimated 5 to 7 awards.

The purpose of this 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 Public-Private Partnership Program (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.

All projects must have two phases: UG3 and UH3. The UG3 phase will support non-clinical testing to obtain an IDE and IRB approval for an SR clinical study. All projects will start at the UG3 phase. The duration of the UG3 phase will depend on the maturity of the project at entry and can range from one to four years. Only those UG3 phase projects that have met specific criteria will transition to the UH3 phase after NIH administrative review. The UH3 phase will support a small clinical study and can last one to four years, however, the total project period (including both the UG3 and UH3 phases) must not exceed five years. 

Sponsor Deadline for Letters of Intent (requested): 30 days in advance of the full proposal deadline

Sponsor Deadlines for Full Proposals: July 1, 2021; October 20, 2021; February 18, 2022; June 20, 2022; October 18, 2022; February 21, 2023; June 19, 2023; October 18, 2023; February 20, 2024

FAS/SEAS/OSP Deadline: 5 business days prior to submission

Award Information: Application budgets are not limited but should rarely exceed $1.5M in direct costs per year. The total duration may not exceed 5 years. NIH anticipates providing $10M per year to fund an estimated 5 to 7 awards.

The purpose of this FOA is to encourage investigators to pursue first-in-human or early stage clinical studies for recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Only Significant Risk (SR) studies that 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 data to answer key questions about the function or final design of a device and 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 part of 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-21-023 or this FOA. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) 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.

This FOA utilizes a UH3 cooperative mechanism. As a cooperative agreement, this FOA supports milestone-driven projects and involves NIH program staff’s participation in negotiating the final milestone plan before award, monitoring the research progress, and making go/no-go decisions. The expectations of the program are in line with those of industry regarding the advancement of devices through the developmental and translational pipelines. As such, an inherent rate of attrition is possible within this program.