BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3) | RFA NS 16 010

Opportunity Information: Apply for RFA NS 16 010

The BRAIN Initiative UH3 funding opportunity (RFA-NS-16-010) is a National Institutes of Health (NIH) cooperative agreement designed to push next-generation invasive neurotechnology into human testing through a small, tightly focused clinical study. The goal is to generate the specific, practical human data needed to advance implantable or invasive devices that can record from and/or modulate activity in the human central nervous system, with an eye toward both treating neurological or neuropsychiatric disorders and improving scientific understanding of human brain function. The program is aimed at situations where additional bench testing or animal work cannot realistically answer the remaining critical questions because the device, its intended use, or the relevant neurophysiology is too novel or too human-specific.

A key feature of this FOA is its emphasis on early, decision-enabling clinical evidence rather than large efficacy trials. The supported study is expected to answer “go/no-go” questions about device function and/or the final design configuration. In other words, investigators should use the clinical study to determine whether the device performs as intended in people, whether the signals are usable (for recording devices), whether stimulation or modulation has the desired effect (for neuromodulation devices), whether design changes are required, and what specifications should be locked for a later-stage version. The output is meant to inform the device’s final design in a way that sets up the remaining steps toward more advanced clinical trials and, ultimately, regulatory clearance or approval. The FOA explicitly anticipates that the “final” design coming out of this work may require most, if not all, of the standard non-clinical testing that typically precedes pivotal studies and commercialization, so the human study is framed as a critical bridge to that more formal development pathway.

The clinical studies contemplated here can range from acute or short-term procedures to longer-term implanted evaluations, depending on risk and regulatory requirements. On the lower-risk end, studies may involve acute or short-duration procedures that an Institutional Review Board (IRB) determines to be Non-Significant Risk (NSR). On the higher-risk end, the FOA also supports Significant Risk (SR) studies, including chronic implants, as long as the project follows the appropriate regulatory route, which may include obtaining an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). This makes the opportunity relevant both to teams testing invasive devices in constrained clinical contexts (for example, limited-duration recordings in an operating room setting) and to teams developing longer-term implanted systems that require more extensive oversight.

Because this is a cooperative agreement (UH3), NIH is positioned to have substantial programmatic involvement compared with a standard research grant. In practice, that usually means closer coordination with NIH program staff, clearer milestone-driven expectations, and a strong focus on generating actionable development data rather than exploratory aims that do not materially move the device forward. Applicants are expected to propose a small clinical study that is tightly matched to the unanswered questions that block the next development step, and to justify why those questions cannot be resolved through additional non-clinical evaluations.

The eligible applicant pool is broad and includes many types of U.S.-based organizations: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education when relevant); for-profit organizations other than small businesses; and small businesses. The FOA also calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, 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” may be allowed as defined by the NIH Grants Policy Statement, meaning limited international elements could potentially be included if they meet NIH policy requirements and are properly justified.

Administratively, the opportunity is listed under NIH with a discretionary funding category and uses the cooperative agreement mechanism. The posted award ceiling is $2,000,000. The original closing date shown in the source record is April 26, 2016, and the FOA creation date is September 17, 2015. The opportunity 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 its placement within NIH’s broader portfolio that can span different institutes and program areas relevant to neuroscience, neurological disorders, and technology development.

Overall, this FOA is best understood as a translational “last key question” clinical funding mechanism for invasive neural recording and neuromodulation technologies. It is meant for teams that are far enough along to responsibly enter human testing, have a clear regulatory and risk pathway (IRB NSR determination and/or FDA IDE when needed), and can define a small clinical study whose results will directly shape the device’s final design and readiness for subsequent, larger clinical trials and eventual market authorization.

• 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 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 16 010

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: