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.Apply for RFA NS 24 016
- 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.
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FAQs: BRAIN Initiative - Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) (RFA-NS-24-016)
What is this funding opportunity?
This is an NIH cooperative agreement funding opportunity titled "The BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)" (RFA-NS-24-016). It is designed to move cutting-edge human central nervous system (CNS) neurotechnology closer to real clinical use through late-stage translational work and, when appropriate, a small clinical study.
What is the main goal of the program?
The main goal is to help teams bridge the gap between promising neurotechnology prototypes and early human evaluation. The emphasis is on practical, milestone-driven activities that reduce common barriers to translation for therapeutic and diagnostic devices aimed at neurological and neuromuscular disorders.
Is this opportunity focused on basic research or translation?
It is focused on translation and early clinical readiness rather than open-ended, exploratory basic discovery science. The program targets concrete deliverables such as clinical prototypes, safety and performance evidence, regulatory readiness, and tightly scoped human evaluation when needed.
What kinds of devices are within scope?
Devices that can record from, stimulate, or otherwise modulate the human central nervous system are within scope. The opportunity is aimed at next-generation human CNS neurotechnology intended for therapeutic and/or diagnostic use in neurological and neuromuscular disorders.
What specific activities are supported before human testing?
The FOA supports late-stage development activities that often block progress in translation, including:
- Building and implementing clinical prototype devices
- Completing non-clinical safety and efficacy studies
- Design verification and validation testing
- Regulatory steps needed to begin human research (including IDE-related work for Significant Risk studies when required)
Does the FOA support clinical studies?
Yes. After key translational and regulatory steps are completed, the program can support a subsequent small clinical study. The clinical work is expected to be purposeful and tightly justified, generating essential information about device function, performance, or final design choices that cannot realistically be obtained through additional bench testing or animal studies.
Are large clinical trials supported under this FOA?
No. This opportunity is described as a translation-and-early-clinical bridge and is not aimed at large pivotal clinical trials.
What does "UG3/UH3 phased cooperative agreement" mean in this program?
This opportunity uses a phased structure:
- UG3 phase: Generally covers preparatory and translational milestones such as finalizing the clinical prototype, completing key preclinical testing, and preparing regulatory submissions.
- UH3 phase: If predefined milestones are met, the project can transition to UH3, which can include the small clinical study and any remaining activities needed to demonstrate the device in humans.
Is the transition from UG3 to UH3 automatic?
No. Transition to the UH3 phase is milestone-driven. Projects must meet predefined milestones during UG3 to be eligible to move forward into UH3.
What does "cooperative agreement" imply about NIH involvement?
Because this 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.
Why does the FOA emphasize milestones and deliverables?
The structure is intended to keep projects focused on clear deliverables and readiness for the next translational step, rather than open-ended exploratory research. Milestones help ensure that supported projects are progressing toward clinical prototype readiness, regulatory preparedness, and (when appropriate) informative early human evaluation.
When is a clinical study considered appropriate under this FOA?
A small clinical study is considered appropriate when it is tightly justified and is needed to generate essential information about device function, performance, or final design decisions that cannot realistically be answered by bench testing or animal studies, often because of device novelty or because intended use must be evaluated in the human context.
Does this FOA require an IDE?
The FOA supports regulatory steps needed to begin human research, including obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study when required. Whether an IDE is required depends on the study and risk determination, but the FOA explicitly includes IDE-related work for SR studies when applicable.
Who is eligible to apply?
Eligibility is broad across public, private, and nonprofit organizations. Eligible applicants include, among others:
- 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 (501(c)(3) and non-501(c)(3))
- For-profit organizations (including those other than small businesses)
- Small businesses
- Eligible federal agencies
- U.S. territories or possessions
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The FOA explicitly calls out additional eligible institution types such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, as well as faith-based or community-based organizations.
Can foreign (non-U.S.) organizations apply as the main applicant?
No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization.
Can a non-U.S. component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply as the applicant organization.
Are any international activities allowed at all?
Yes. Foreign components (as defined under the NIH Grants Policy Statement) are allowed. This means 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.
Is this FOA new or a reissue of an earlier announcement?
It is a reissue of RFA-NS-21-023.
What is the funding mechanism and agency?
The agency is the National Institutes of Health (NIH). The mechanism is a cooperative agreement, and the opportunity is described as a discretionary funding opportunity.
What are the Assistance Listing (CFDA) numbers associated with this opportunity?
The associated Assistance Listing numbers include 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, and 93.867.
What are the key dates provided?
The opportunity record lists a creation date of 2024-03-20 and an original closing date of 2027-01-28.
Is an award ceiling or expected number of awards provided?
No. In the provided information, an award ceiling and expected number of awards are not specified. Budget expectations and competition scale would typically require consulting the full FOA and NIH communications.
What types of project teams is this opportunity designed for?
It is designed for teams developing next-generation human CNS neurotechnology and seeking targeted support to bridge promising prototypes into early human evaluation. The broad eligibility reflects the need for academia-industry-clinical partnerships commonly required for neurodevice development and translation.
What is the overall "fit" of a strong project for this FOA?
A strong fit is a project that can define concrete development milestones, complete rigorous non-clinical verification and safety work, navigate key regulatory requirements (including IDE steps for Significant Risk studies when needed), and conduct a carefully scoped clinical study to answer key questions that only human testing can resolve.
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