BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) | RFA NS 24 016

Opportunity Information: Apply for RFA NS 24 016

The BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) funding opportunity (RFA-NS-24-016) is a National Institutes of Health (NIH) cooperative agreement aimed at moving cutting-edge human CNS neurotechnology closer to real clinical use. It is a reissue of RFA-NS-21-023 and focuses on translational work and small clinical studies that advance therapeutic and diagnostic devices for neurological and neuromuscular disorders. In practical terms, the program is designed for teams developing next-generation devices that can record from, stimulate, or otherwise modulate the human central nervous system, and who need targeted support to bridge the gap between promising prototypes and early human evaluation.

The FOA supports a specific set of late-stage development activities that commonly block progress in neural device translation. Fundable work includes building and implementing clinical prototype devices; completing non-clinical safety and efficacy studies; performing design verification and validation testing; and carrying out the regulatory steps needed to begin human research, including obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study when required. After those steps, the program can also support a subsequent small clinical study. The clinical component is framed as purposeful and tightly justified: it should generate essential information about device function, performance, or final design choices that cannot realistically be obtained through additional bench testing or animal studies, often because the device is novel or because its intended use must be evaluated in the human context.

This opportunity uses the UG3/UH3 phased cooperative agreement structure. The UG3 phase generally covers the earlier, preparatory, and translational milestones (such as finalizing the clinical prototype, completing key preclinical testing, and preparing regulatory submissions). If those predefined milestones are met, projects can transition to the UH3 phase, which can include the small clinical study and any remaining activities needed to demonstrate the device in humans. Because it is a milestone-driven cooperative agreement, NIH program staff play an active role compared with a standard research grant. Applicants should expect NIH involvement in negotiating the final project plan before award, setting or refining milestones, and monitoring progress throughout the project. This structure is meant to keep projects focused on clear deliverables and readiness for the next translational step, rather than open-ended exploratory research.

Eligibility is broad across the public, private, and nonprofit landscape, reflecting the reality that neurodevice development often requires academia-industry-clinical partnerships. Eligible applicants include state and local governments, public and private institutions of higher education, independent school districts, special district governments, federally recognized Native American tribal governments, tribal organizations that are not federally recognized, public housing/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), and small businesses. The FOA also explicitly calls out additional eligible institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. U.S. territories or possessions are included as eligible applicants.

At the same time, the announcement draws firm boundaries around non-U.S. participation. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, are allowed, meaning certain project elements may be conducted abroad when appropriately justified and structured under NIH policy, even though the primary applicant organization must be U.S.-based and the project cannot be organized as a non-U.S. component of a U.S. organization.

Administrative details in the source data indicate this is a discretionary funding opportunity from NIH using a cooperative agreement mechanism, with activity areas tied to health and related social services categories. The CFDA (assistance listing) numbers associated with this opportunity include 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, and 93.867, reflecting involvement across multiple NIH institutes or programs that support neuroscience, neurological disorders, and technology development. The opportunity record lists an original closing date of 2027-01-28 and a creation date of 2024-03-20. An award ceiling and expected number of awards are not specified in the provided data, so applicants typically need to rely on the full FOA and NIH communications for budget expectations and competition scale.

Overall, this FOA is best understood as a translation-and-early-clinical bridge for advanced neural devices: it is not primarily for basic discovery science, and it is not aimed at large pivotal clinical trials. Instead, it targets teams who can define concrete development milestones, carry out rigorous non-clinical verification and safety work, navigate IDE and other regulatory requirements for significant risk devices when applicable, and run a carefully scoped clinical study to answer the key remaining questions that only human testing can resolve.

• 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 Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)" 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 2024-03-20.
• Applicants must submit their applications by 2027-01-28.
• 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 24 016

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