On September 17, 2015, NIH posted a Funding Opportunity Announcement (FOA) titled “BRAIN Initiative: Next Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System” http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-16-009.html. NIH anticipates providing $13.5 million per year to fund an estimated four to seven awards. The application due date is April 27, 2016.
The FOA involves developing and supporting pre-clinical testing necessary to enable initial clinical studies of implantable devices with recording and/or stimulation capabilities to advance clinical diagnostic or therapeutic applications.
The next step will be to do a small clinical study for the devices to provide information that can’t be obtained through additional nonclinical assessments due to the novelty of the device or its intended use.
As part of this FOA, the NIH BRAIN Public-Private Partnership Program (BRAIN PPP) www.braininitiative.nih.gov/BRAIN_PPP aims to develop partnerships between clinical investigators and manufacturers on the latest-generation stimulating and/or recording devices that are FDA-designated as Class III.
These partnerships will contribute to the effort to conduct clinical research on the central nervous system. NIH is interested in reducing barriers to negotiating partnerships to ensure that new clinical studies will help manufacturers demonstrate safety and utility of these devices.
NIH has signed Memoranda of Understanding (MOU) with device manufacturers to serve as the basis for this program. Each participating company will provide information on their devices and the support they are willing to provide to researchers.
Eligible applicants include higher education institutions, nonprofits, for-profits including small businesses, government, and others.