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BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)

National Institutes of Health

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.

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-24-017 or this NOFO.

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..

For more information on the BRAIN PPP, see https://braininitiative.nih.gov/research/neural-recording-modulation/public-private-partnerships-program .

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

Deadlines:

Letter of Intent: 60 days prior to receipt date
Application Due Date(s): May 29, 2024; Jan 28, 2025; May 28, 2025; Sep 29, 2025; Jan 28, 2026; May 28, 2026; Sep 28, 2026; Jan 28, 2027

RFA-NS-24-016 Expiration Date January 29, 2027