BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3) | RFA NS 16 009

Opportunity Information: Apply for RFA NS 16 009

The NIH BRAIN Initiative funding opportunity "Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3)" (RFA-NS-16-009) is a cooperative agreement program aimed at pushing promising invasive neurotechnology from late-stage translation into first-in-human style clinical evaluation. The central focus is on devices that can either record from the human central nervous system, modulate activity through stimulation, or do both, with the broader goals of improving treatments for nervous system disorders and enabling deeper understanding of how the human brain works. Rather than supporting early exploratory concepts, the FOA is geared toward teams that are ready to build and test a clinical prototype and generate the kind of evidence needed to lock down a final device design and prepare for larger clinical trials and, eventually, market pathways.

The award is structured as a phased UG3/UH3 mechanism. The UG3 phase supports the major preparatory work needed to reach a regulatory and ethical green light for human use, specifically either submitting an Investigational Device Exemption (IDE) to FDA for a Significant Risk (SR) study or obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study. In practical terms, this phase is where applicants are expected to complete critical non-clinical and pre-study activities such as non-clinical safety and performance testing, design verification and validation, finalizing the clinical prototype implementation approach, and assembling the documentation package required for the relevant regulatory path. The UH3 phase then supports conducting a single small clinical study, commonly described as an Early Feasibility Study, intended to answer targeted questions about device function and/or the final design.

A key point of this FOA is the purpose of the small clinical study: it is not meant to be a large efficacy trial or a broad pivotal study. Instead, it should produce highly specific human data that materially informs the device's design decisions, safety profile, functional performance, usability, and feasibility in the intended clinical context. NIH emphasizes that the study should provide information that cannot realistically be obtained through additional bench testing or animal studies, often because the device is novel, interacts with human neuroanatomy or physiology in a way that cannot be replicated elsewhere, or is intended for use conditions that are uniquely human. The expectation is that, by the end of the project, the device design may be close to "final" in the sense that it has undergone much of the non-clinical testing that typically precedes more advanced clinical trials and eventual regulatory submissions.

The types of activities explicitly supported include implementing clinical prototype devices, performing non-clinical safety and efficacy testing needed for risk assessment, completing design verification and validation work (often including manufacturing controls, reliability testing, biocompatibility considerations, and performance specifications), pursuing the appropriate regulatory approvals (IDE submission for SR studies or IRB approval for NSR studies), and then carrying out one small clinical study. Because this is a cooperative agreement, NIH involvement is expected to be more hands-on than with standard grants, with substantial programmatic engagement and coordination typical of U-series awards, especially where regulatory strategy, milestone-driven progress, and go/no-go decisions are central to the project.

Eligibility is broad across U.S.-based organizations and includes many common applicant types such as state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. It also includes tribal governments (federally recognized) and other tribal organizations. The FOA highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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 institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined under NIH policy are allowed, meaning certain limited foreign collaborations can be part of an otherwise eligible U.S.-led application.

Administratively, the opportunity is listed under NIH as the sponsoring agency, categorized as a discretionary opportunity using the cooperative agreement funding instrument. The activity falls within education, health, income security, and social services categories and spans multiple CFDA numbers (93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting participation across different NIH institutes and BRAIN-relevant program areas. The original closing date was April 26, 2016, and the listed award ceiling is $2,000,000, indicating the program was designed to support substantial late-stage development and early clinical evaluation work that typically requires robust resources, specialized testing, and regulatory preparation.

Overall, this FOA is best understood as a bridge between advanced device development and a tightly scoped first clinical deployment. It is designed for projects where the technical concept is already mature enough to justify human testing, the regulatory strategy is credible, and the proposed small clinical study can generate decisive human evidence that de-risks the technology and supports the next steps toward larger trials and eventual clinical adoption.

• 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)" 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 2015-09-17.
• Applicants must submit their applications by 2016-04-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
• 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 16 009

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