BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional) | RFA NS 21 024

Opportunity Information: Apply for RFA NS 21 024

The NIH BRAIN Initiative funding opportunity "Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)" (RFA-NS-21-024) is designed to push promising invasive neurotechnology from late-stage development into a focused, real-world clinical setting. The main aim is to support a small clinical trial that can generate the specific, high-value evidence needed to refine a device's function and finalize design decisions for technologies that record from and/or stimulate the human central nervous system. These studies are meant to help move devices toward treating neurological or psychiatric disorders and toward deeper understanding of human brain function, especially in situations where bench testing or animal work cannot realistically answer the remaining questions because the device or its intended use is genuinely novel.

The FOA is centered on early, tightly scoped human testing, such as an Early Feasibility Study, where the key deliverable is actionable information about how the device performs in people. The clinical study can take the form of acute or short-term procedures that an Institutional Review Board (IRB) determines are Non-Significant Risk (NSR). It can also support Significant Risk (SR) research, including studies involving chronic implants, as long as the project obtains an Investigational Device Exemption (IDE) from the FDA when required. In other words, the program is flexible about the risk category and trial format, but it is strict about the purpose: the study should answer concrete questions that directly influence device design, operational parameters, safety strategies, usability, recording quality, stimulation performance, or other core elements that determine whether the technology is ready for later-stage clinical trials and eventual market pathways.

A key theme in the announcement is that this is not meant to be "another" incremental study that could be done outside the clinic. NIH is looking for situations where the remaining uncertainties can only be resolved in humans. The expectation is that the trial will produce evidence that meaningfully shapes the final device configuration and reduces major unknowns before larger, more definitive trials. The "final design" referenced in the FOA is essentially the version that could proceed with most of the remaining non-clinical verification and validation already in place, aligning the project with the broader path toward advanced clinical trials and regulatory approval.

The FOA also ties into a larger BRAIN Initiative Public-Private Partnership Program (BRAIN PPP). Through this program, NIH has established Memoranda of Understanding with device manufacturers willing to provide access to invasive recording and modulation devices, including capabilities that may not yet be market approved but are suitable for well-controlled clinical research. The practical implication is that many applicants may be able to use industry-supplied devices with existing safety and utility data that can support either IRB NSR determinations or FDA IDE submissions without requiring a large additional package of non-clinical testing. This is meant to reduce barriers to getting high-potential devices into appropriately designed human studies while maintaining regulatory and ethical safeguards.

From an administrative standpoint, the award uses a cooperative agreement mechanism, meaning NIH is expected to have substantial involvement during the project rather than serving only as a passive funder. The agency listed is the National Institutes of Health, and the funding instrument type is a cooperative agreement. The award ceiling is listed at $1,500,000. The activity is categorized under areas spanning education, health, and social services, and it is associated with multiple CFDA numbers, reflecting participation across several NIH institutes and programs that align with neurotechnology, neurological disorders, and brain research.

Eligibility is broad across U.S.-based organizations and includes state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both with and without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA explicitly highlights additional eligible applicant 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 eligible federal agencies and faith-based or community-based organizations. U.S. territories or possessions are also included. At the same time, non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" as defined under NIH policy are allowed, which typically means limited, well-justified parts of the work may be conducted outside the U.S. under the umbrella of a U.S. applicant institution.

The opportunity’s original closing date is listed as February 20, 2024, and the FOA was created on May 7, 2021. Overall, this program is best understood as a translational bridge for invasive neural interface and neuromodulation technologies: it funds small, strategically designed clinical studies that are intended to de-risk and finalize next-generation devices by producing the kind of human data that cannot be credibly substituted by additional laboratory or animal testing.

• 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 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 2021-05-07.
• Applicants must submit their applications by 2024-02-20. (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 $1,500,000.00 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 21 024

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