Request for Information (RFI):  B.R.A.I.N. Initiative Public/Private Partnership to Accelerate Clinical Access to Next-Generation Stimulating/Recording Devices

Notice Number:

NOT-NS-14-054

Key Dates

Release Date: September 26, 2014
Response Date: November 21, 2014   

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 Drug Abuse (NIDA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Mental Health (NIMH)
National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Working Group recommended a new "streamlined path for developing, implementing and integrating new technologies for human neuroscience research, through cooperation of clinical and academic research teams and private companies in a pre-competitive space" in their landmark report to the Advisory Committee to the National Institutes of Health (NIH) Director titled "BRAIN 2025: A Scientific Vision".  Towards this end, the NIH is interested in developing public/private partnerships with manufacturers of novel 'significant risk' stimulating and/or recording devices to facilitate broad access to these devices to conduct clinical research.

The Investigational Device Exemptions (IDE) regulation (21 CFR 812) describes three types of devices studies: significant risk (SR), non-significant risk (NSR), and exempt studies. Clinical research utilizing SR devices for a new indication or to answer scientific questions require an Investigational Device Exemption (IDE) from the FDA. Moreover, devices available for sale often have expanded research capabilities that could be used to accelerate additional clinical research studies, but enabling those features would require a new IDE to ensure appropriate use in a controlled research setting.

Due to the complexity of the manufacturing requirements and the statutory requirements to market medical devices in the U.S., there may be a period of time between initial first-in-human demonstrations of a novel technology and the market approval or clearance required to legally market the device for widespread use.  Although the first-in-human studies may be sufficient to demonstrate the safety and utility of the technology to answer clinical research questions in a highly controlled environment, the additional time before market approval or clearance is primarily needed to conduct a Feasibility and Pivotal trial to demonstrate safety and effectiveness of a device for a specific intended use, typically in a statistically justified number of subjects.  These studies are also necessary to further understand potential safety risks when implanted at scale under more typical usage conditions to adequately evaluate the benefit/risk profile of the device.        

The NIH recognizes an opportunity to work with leading academics, clinical researchers, industry and the FDA to develop a streamlined path to provide clinical researchers widespread access to next-generation technologies that have already demonstrated safety in Early Feasibility/Proof-of-Concept clinical studies, as well as enabling capability to answer impactful research questions.  In particular, the NIH is interested in identifying manufacturers willing to share their pre-clinical safety and technical data to support new IDEs for clinical research for these devices.  It is anticipated enabled studies will include fundamental human neuroscience research, studies to better understand the mechanisms of action of existing therapies, as well as exploratory studies to demonstrate the therapeutic potential of these existing devices for small market indications.       

The purpose of this time-sensitive RFI, issued by the Institutes of the NIH BRAIN Initiative (http://www.nih.gov/science/brain/funding.htm), is to seek input from interested academic/clinical researchers, regulatory and other government agencies, and potential industry partners to identify key barriers and potential opportunities to grant earlier broad access to significant risk recording and/or stimulating medical devices for clinical research.  As the intent is to address the unique manufacturing and regulatory burden for SR implantable medical devices, the scope of the RFI is limited to invasive technologies that can stimulate and/or record from the brain, and for which first IDEs have already been obtained or could be obtained in the very near term. 

This RFI is intended to gather relevant information and identify interested parties to inform a follow-on workshop.  The RFI and workshop may lead to a subsequent funding opportunity announcement (FOA); however, this RFI should not be construed as a funding opportunity.

Information Requested

The NIH invites input from stakeholders including but not limited to researchers in academia and industry, healthcare professionals, patient advocates and advocacy organizations, scientific and professional organizations, federal agencies and other interested members of the public.  Small businesses with appropriate technologies are especially encouraged to provide input.  The NIH is interested in human neuroscience research, novel therapeutic approaches, and further understanding of the mechanisms of action of existing therapies, as well as interdisciplinary approaches that span these areas. Your input can include but is not limited to the following topics:

• New and/or ongoing challenges and opportunities for conducting clinical research utilizing significant risk medical devices (either pre-market approval, or using expanded research platforms for existing market approved devices)
• Opportunities and concerns for utilizing a public/private partnership structure including intellectual property, and common data standards for access and annotation
• Extent of industry contribution, which potentially could include free devices and technical support, access to pre-clinical data to support new IDEs, cost-sharing, and construction and maintenance of publically accessible data repositories
• Additional sources of data that could be obtained to supplement the limited opportunities available to utilize invasive recording/stimulating devices to maximize the value of these studies for the wider community

How to Submit a Response

To ensure consideration, responses must be received by November 21, 2014, and must be submitted electronically using the web-based format at http://braininitiative.nih.gov/rfi-brain-initiative.htm. The web format will provide confirmation of response submission, but respondents will not receive individualized feedback.

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential or sensitive information should not be included in your response. Comments may be compiled for discussion and may appear in related reports. Any personal identifiers (names, e-mail addresses, etc.) will be removed when responses are compiled.

This RFI is for informational and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States (US) Government, the NIH or the NINDS to provide support for any ideas submitted in response to it. Please note that the US Government, NIH and NINDS will not pay for the preparation of any information submitted, or for its use of that information.

Inquiries

Please direct all inquiries to:

Kip Ludwig, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: kip.ludwig@nih.gov