Notice of Intent to Publish a Funding Opportunity Announcement for the BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH2/UH3)

Notice Number:

NOT-NS-15-008

Key Dates

Release Date: December 17, 2014

Estimated Publication Date of Announcement: January 2015

First Estimated Application Due Date: March 2015

Earliest Estimated Award Date: September 2015

Earliest Estimated Start Date: September 2015

Related Announcements

None

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The NIH BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations for responsive projects.

The FOA is expected to be published in January 2015 with an expected application due date in Spring 2015.

This FOA will utilize the UH2/UH3 mechanism to support non-clinical testing and a singular clinical study to advance next generation recording and/or stimulation devices to treat central nervous system disorders and better understand the human brain. The UH2 phase will support the non-clinical testing necessary to obtain necessary approvals for a small clinical study, and the UH3 phase will support the subsequent clinical study. A companion stand-alone UH3 FOA is also expected to be published in January, and will support projects that do not require additional non-clinical testing to obtain approval for the clinical study. The total duration of the UH2 and UH3 Phases combined may not exceed 5 years.

A summary of the planned FOA is provided below.

Research Initiative Details

This FOA is related to Section III of the BRAIN 2025 Report, and addresses the goal of developing 'innovative technologies to understand the human brain and treat its disorders'. The NIH recognizes that initial first-in-man studies are a key point in the development of innovative new clinical technologies. The leap from animal studies to humans is large, and initial clinical studies are often necessary to address critical scientific questions about the function of a device in human subjects and/or inform a final device design suitable for eventual FDA market approval. Initial demonstrations of novel device function in humans have become increasingly required to encourage the industry and venture capital investment necessary to develop a final safe, reliable, and efficacious device that can be manufactured at scale suitable for regulatory approval, yet at a price point sufficient for sustainable commercial market given insurance reimbursement.

The purpose of this FOA is to encourage applications to pursue translational and clinical studies to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support non-clinical testing necessary to enable the successful submission 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 the subsequent small clinical study (e.g., Early Feasibility Study). The 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.

All projects will have two phases, an UH2 and an UH3 phase. The initial UH2 phase will support nonclinical testing to support to the submission of an IDE for an SR study or to obtain IRB approval for an NSR clinical study. All projects will start at the UH2 phase, but the length of UH2 phase will depend on the maturity of the project at entry. Only those UH2 projects that have met specific criteria outlined in the FOA will be eligible for transition to the second UH3 phase after NIH administrative review. The UH3 phase will support the small clinical study. Clinical studies supported may consist of acute or short-term NSR studies, or SR studies such as chronic implants. Examples of the types of clinical studies that can be proposed include, but are not limited to:

• Optimization of the device design with respect to the human functional anatomy
• Identification of the most simple, reliable, and cost effective device configuration for more advanced clinical trials and eventual market approval
• Basic proof-of-concept testing in human subjects
• Studies of the key physiological variables that may impact the function of the device in humans
• Initial assessments of device safety, but only in conjunction with obtaining enabling data about device design or function.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Kip Ludwig, PhD,
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: brain-initiative-FY15-FOA@mail.nih.gov