The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. All projects will have two phases. The program will utilize a cooperative agreement mechanism to support nonclinical testing (the initial UG3 phase) to support the filing of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical study (UH3 phase). The small clinical study should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical study is expected to provide information that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical study. 

Potential applicants should note that companion to this FOA is an X02 pre-application (PAR-15-345), for researchers wishing to partner with corporate manufacturers of latest- or next-generation devices to take advantage of their existing safety and utility data for FDA or IRB approval of new clinical research studies.  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 IRB NSR or FDA IDE approval without need for significant additional non-clinical data. 

For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/. 

Though not required, PAR-15-345 encourages X02 pre-applications from those investigators interested in collaborating with a device manufacturer through the BRAIN PPP. The X02 pre-applications will be evaluated by a panel of outside experts for scientific and technical merit. Investigators whose X02 pre-applications are judged to be meritorious will be notified of the opportunity to submit an application under RFA-NS-16-009 (UG3/UH3) or RFA-NS-16-010 (UH3), and will be provided contact information to work with the relevant manufacturer to develop full applications. 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-16-009 or RFA-16-010 without an X02 pre-application.