BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required) | RFA NS 18 021

Opportunity Information: Apply for RFA NS 18 021

This NIH BRAIN Initiative funding opportunity (RFA-NS-18-021) supports the development and early clinical testing of next-generation invasive devices that can record from and/or modulate activity in the human central nervous system. The goal is strongly translational: projects should advance devices that can both deepen scientific understanding of the human brain and move toward treating neurological or neuropsychiatric disorders. The FOA is built around taking a device from an advanced prototype stage through the key regulatory and clinical steps needed to demonstrate that it can function as intended in people, especially when critical questions cannot be answered well through additional benchtop work or animal studies because the device or use case is genuinely novel.

The mechanism is a UG3/UH3 cooperative agreement, meaning NIH is expected to have substantial involvement and the project is structured in phases. In the earlier phase, investigators are supported to do the work required to reach an appropriate regulatory and ethics “green light” for a first-in-human or similarly early clinical evaluation. That includes preparing and submitting an Investigational Device Exemption (IDE) application to FDA for a Significant Risk (SR) study, or alternatively obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study when an IDE is not required. Once those milestones are met, the later phase supports the execution of a single small clinical trial, often described as an Early Feasibility Study. The expectation is that this trial is not a large pivotal study; instead, it should generate targeted data that answers a small set of decisive questions about safety, usability, performance, and design choices that will shape the final device configuration.

The clinical trial component is central and required. NIH is looking for studies that will clarify the function or final design of the device and help position it for later-stage clinical trials and eventual market clearance or approval. In practical terms, the work may include implementing clinical prototype devices, completing non-clinical safety and efficacy testing that is still needed, and carrying out design verification and validation activities. The trial is expected to produce information that is difficult or impossible to obtain through nonclinical testing alone, such as human-specific performance characteristics, interface stability, stimulation/recording effects in the intended anatomical context, or workflow and surgical considerations that only become clear in clinical use.

A notable feature of this program is its connection to the BRAIN Initiative Public-Private Partnership Program (BRAIN PPP). Through memoranda of understanding with device manufacturers, the PPP is intended to make advanced devices available for clinical research, including capabilities that may not yet be market approved but are suitable for carefully controlled clinical investigation. The FOA suggests that, in many cases, existing safety and utility data from these partner devices may be sufficient to support new IRB NSR determinations or FDA IDE approval without requiring extensive additional nonclinical testing, which is meant to speed responsible translation into early human studies. Applicants are directed to the BRAIN PPP website for details on participating companies and available technologies.

Eligibility is broad and includes many U.S.-based organization types: state, local, and tribal governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit entities (including small businesses, but not limited to them); independent school districts; special district governments; and public housing authorities/Indian housing authorities. The FOA also explicitly highlights a wide range of institutional categories such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, and U.S. territories or possessions. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, but foreign components are allowed as defined in the NIH Grants Policy Statement, meaning certain project activities may be conducted abroad under NIH rules even though the applicant organization must be domestic.

Administratively, the opportunity is run by the National Institutes of Health and uses the cooperative agreement funding instrument. It is listed under multiple CFDA numbers associated with NIH neuroscience and mental health programs (including 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867). The original posting dates to December 21, 2017, and the original closing date shown is February 22, 2021. Overall, the FOA is designed for teams that can integrate engineering, clinical neurology/neurosurgery, human subjects protections, and regulatory strategy to produce an actionable early clinical dataset that meaningfully de-risks a next-generation invasive neural interface or neuromodulation device.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2017-12-21.
• Applicants must submit their applications by 2021-02-22. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA NS 18 021

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