Translational Neural Devices (R61/R33 - Clinical Trial Optional) (PAR-24-151)

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of low risk therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study (R61 phase), as well as a subsequent small clinical study (R33 phase). 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 utilizes an Exploratory/Developmental Phased Award and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Transition from the R61 to the R33 phase is contingent upon the successful completion of proposed milestones.  

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 Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.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.