BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3) | RFA NS 17 006

Opportunity Information: Apply for RFA NS 17 006

This NIH BRAIN Initiative funding opportunity (RFA-NS-17-006) supports small, focused clinical studies designed to push forward next-generation invasive devices that can record from and/or stimulate the human central nervous system. The core goal is practical: generate the critical human data needed to answer key questions about how a device performs and what its final design should be, so that the technology can move toward larger clinical trials and, ultimately, regulatory clearance or approval. The FOA is aimed at situations where additional bench testing or animal work cannot realistically provide the needed answers because the device is novel, the intended use is new, or the most important uncertainties only show up in humans.

The clinical work envisioned is early-stage and tightly scoped, similar in spirit to an Early Feasibility Study. Projects may involve acute or short-term procedures that an Institutional Review Board (IRB) determines are Non-Significant Risk (NSR), or they may involve Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, including studies with chronic implants. Regardless of risk category, the study is expected to be structured around specific, decision-driving questions about device function, safety, usability, performance, or design features. In other words, the clinical study is not meant to be a broad efficacy trial; it is meant to produce the kind of targeted evidence that directly informs whether the device works as intended in humans and what needs to change before moving forward.

A key theme is device translation. The FOA emphasizes that the "final device design" emerging from this stage may already require extensive non-clinical testing as part of the pathway toward advanced trials and eventual market authorization, and the supported clinical study should complement that trajectory by filling in the human-specific unknowns. The expectation is that applicants will justify why the information they are seeking cannot be obtained practically through additional non-clinical assessments, and why a small human study is the right next step for de-risking the technology and locking down design decisions.

The funding mechanism is a cooperative agreement (UH3), which typically means NIH staff will have substantial involvement during the project period compared with a standard grant. While the summary text does not list award sizes or number of awards, it clearly frames the scope around a small clinical study with concrete endpoints tied to device design and function. The program sits within NIH and is associated with multiple CFDA numbers (93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting the multi-institute nature of BRAIN-related and neuroscience device work.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Foreign eligibility is limited. Non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components as defined in the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain foreign collaborations or elements if they meet NIH definitions and requirements.

Key dates provided in the source include a creation date of 2016-09-28 and an original closing date of 2017-10-18. The opportunity is categorized as discretionary funding, and the activity area is listed under education, health, income security, and social services, consistent with NIH biomedical research and clinical translation priorities.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3)" 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 2016-09-28.
• Applicants must submit their applications by 2017-10-18. (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 17 006

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