Opportunity Information: Apply for RFA EB 22 001

The BRAIN Initiative: Transformative Brain Non-invasive Imaging Technology Development (UG3/UH3 Clinical Trial Not Allowed) opportunity (RFA EB 22 001) is a National Institutes of Health (NIH) funding announcement that supports team-based projects aimed at creating and proving out genuinely new, non-invasive brain imaging technologies. The central purpose is to push beyond incremental improvements and develop tools that could meaningfully change how researchers measure and map brain function and brain connectivity, with the longer-term goal of enabling new kinds of neuroscience questions to be answered. The FOA emphasizes technology development that moves from an early, promising concept to a working, validated prototype rather than purely exploratory or descriptive research.

This award uses a two-phase, milestone-driven cooperative agreement mechanism (UG3/UH3). The first phase (UG3) is designed for feasibility: applicants are expected to demonstrate that the underlying concept can work in practice and that key technical risks are addressed. By the end of UG3, the project should have clear evidence that the approach is viable, along with concrete deliverables that justify advancing to the second phase. The second phase (UH3) focuses on completing the development into a functional prototype and then validating that prototype through in vivo imaging of brain function and/or connectivity in animals or humans. The announcement is explicit that applicants should present a realistic development plan, with a timeline and measurable, tangible milestones that allow progress to be tracked and go/no-go decisions to be made between phases.

A defining feature of this FOA is its emphasis on coordinated, networked science. Funded projects are expected to become part of the BRAIN Non-Invasive Imaging Consortium, meaning awardees will not work in isolation but will be integrated into a broader, collaborative effort focused on non-invasive imaging of brain function and connectivity. Because the funding instrument is a cooperative agreement, NIH is likely to have substantial programmatic involvement compared to a standard grant, with coordination, shared goals, and alignment with consortium activities being an important part of how projects are managed and how success is measured.

The “Clinical Trial Not Allowed” designation means the proposed work cannot include clinical trials as defined by NIH policy. While the technology can be validated in humans in vivo (as the FOA anticipates), the study design must remain outside the boundaries of a clinical trial, which generally involves prospectively assigning human participants to interventions to evaluate effects on health-related outcomes. In practice, this typically steers applicants toward engineering development and performance validation, and toward human testing that is observational or focused on demonstrating technical function rather than testing clinical efficacy.

In terms of who can apply, eligibility is broad and includes many organization types: state, county, city, and special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, tribal governments other than federally recognized, and non-U.S. (foreign) organizations. This breadth reflects the program’s interest in drawing strong multidisciplinary teams from academia, industry, nonprofit research groups, and diverse institutions to tackle high-risk technical challenges.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement instrument type. It falls under activity categories spanning education and health, among others, and is associated with multiple CFDA numbers (93.173, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting the cross-cutting NIH institutes and programs that can be involved in BRAIN-related funding. The FOA was created on 2022-07-11, and the original closing date listed is 2023-01-12. The provided source data does not specify an award ceiling or the expected number of awards in the excerpt, so applicants would typically consult the full FOA for budget guidance, project period structure, and the anticipated scale of the program.

Overall, the opportunity is best understood as a structured, milestone-based push to translate ambitious, non-invasive neuroimaging ideas into working prototypes that can be demonstrated in living systems, with the added expectation that awardees will participate in a coordinated consortium aimed at accelerating progress in brain function and connectivity imaging.

  • The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Transformative Brain Non-invasive Imaging Technology Development (UG3/UH3 Clinical Trial Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
  • This funding opportunity was created on 2022-07-11.
  • Applicants must submit their applications by 2023-01-12. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • 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 EB 22 001

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Frequently Asked Questions (FAQ)

What is the funding opportunity called?

The opportunity is titled "The BRAIN Initiative: Transformative Brain Non-invasive Imaging Technology Development (UG3/UH3 Clinical Trial Not Allowed)" and is associated with the NIH funding announcement RFA EB 22 001.

Who is offering this grant?

This is a National Institutes of Health (NIH) funding announcement under the BRAIN Initiative.

What is the main purpose of this FOA?

The central purpose is to support team-based projects that create and prove out genuinely new, non-invasive brain imaging technologies. The goal is to move beyond incremental improvements and develop tools that could materially change how brain function and brain connectivity are measured and mapped, enabling new neuroscience questions to be addressed.

What kinds of projects are a good fit for this announcement?

Projects focused on technology development that can progress from an early but promising concept to a working, validated prototype. The emphasis is on development and proof-of-concept leading into prototype completion and validation, rather than purely exploratory, descriptive, or observational research without a clear technology development trajectory.

What does "non-invasive brain imaging technology" mean in the context of this FOA?

Based on the description provided, the FOA is focused on technologies intended to image brain function and/or brain connectivity without invasive procedures, with the expectation that the technology can ultimately be demonstrated through in vivo imaging in animals or humans.

Is this grant focused on incremental improvements to existing imaging tools?

No. A core theme of the FOA is pushing beyond incremental improvements. The intent is to foster transformative approaches that can meaningfully shift the state of the art in non-invasive imaging of brain function and connectivity.

What mechanism does this funding opportunity use?

This opportunity uses a two-phase, milestone-driven cooperative agreement mechanism: UG3 (first phase) and UH3 (second phase).

How does the UG3 phase differ from the UH3 phase?

The UG3 phase is focused on feasibility. Applicants are expected to demonstrate that the underlying concept can work in practice and that key technical risks are addressed. The UH3 phase focuses on completing development into a functional prototype and validating that prototype through in vivo imaging of brain function and/or connectivity in animals or humans.

What is expected by the end of the UG3 phase?

By the end of UG3, the project is expected to provide clear evidence that the approach is viable and to produce concrete deliverables that justify advancing to the UH3 phase.

What happens during the UH3 phase?

During UH3, the project is expected to complete development into a functional prototype and then validate that prototype with in vivo imaging of brain function and/or connectivity in animals or humans.

Does the FOA require specific milestones?

Yes. The FOA emphasizes a realistic development plan with a timeline and measurable, tangible milestones. These milestones are intended to allow progress tracking and to support go/no-go decisions between phases.

What does "milestone-driven" mean here?

It means the project should define measurable deliverables and performance targets over time, so that progress can be assessed objectively. The milestones support decision-making about whether the project should advance from the UG3 feasibility stage to the UH3 prototype development and validation stage.

What does it mean that this is a cooperative agreement?

Because the instrument is a cooperative agreement, NIH is expected to have substantial programmatic involvement compared to a standard grant. This can include coordination, alignment with shared goals, and active involvement related to consortium activities and overall program direction.

Are awardees expected to collaborate with other funded teams?

Yes. Funded projects are expected to become part of the BRAIN Non-Invasive Imaging Consortium, which emphasizes coordinated, networked science. Awardees are expected to integrate into a broader collaborative effort rather than operate in isolation.

What is the BRAIN Non-Invasive Imaging Consortium?

It is the collaborative, networked framework described in the FOA for projects funded under this program. The consortium focus is on accelerating progress in non-invasive imaging of brain function and connectivity through coordination and shared efforts among awardees.

Does this FOA allow clinical trials?

No. The FOA is designated "Clinical Trial Not Allowed," meaning the proposed work cannot include clinical trials as defined by NIH policy.

Can projects include in vivo testing in humans if clinical trials are not allowed?

Yes. The description indicates that the technology can be validated in humans in vivo, but the study design must remain outside the NIH definition of a clinical trial. Human testing should be oriented toward demonstrating technical function and performance validation rather than testing clinical efficacy through prospectively assigned interventions and health-related outcomes.

What is the practical implication of "Clinical Trial Not Allowed" for study design?

Based on the provided description, it generally steers applicants toward engineering development and performance validation, including human testing that is observational or otherwise focused on technical validation rather than evaluating effects on health-related outcomes via prospectively assigned interventions.

Is animal testing allowed or expected?

The FOA anticipates prototype validation through in vivo imaging in animals or humans, so animal validation is within scope as described.

What types of organizations are eligible to apply?

Eligibility is broad and includes, among others: state, county, city, and special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities.

Are minority-serving and specialized institutions mentioned as eligible?

Yes. The FOA highlights eligibility for institutions and organizations such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs), among others.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly listed among eligible applicants in the provided information.

Are non-U.S. (foreign) organizations eligible?

Yes. Non-U.S. (foreign) organizations are included in the list of eligible entities in the provided information.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among eligible applicants in the provided information.

What kind of work is NIH trying to encourage with this FOA?

The FOA is positioned as a structured push to translate ambitious non-invasive neuroimaging concepts into working prototypes demonstrated in living systems, with a focus on technologies that can change the way brain function and connectivity are measured and mapped.

What is the funding type/category for this opportunity?

The opportunity is categorized as discretionary funding and uses a cooperative agreement instrument type.

What activity areas does this opportunity fall under?

The listing notes activity categories spanning education and health, among others, as described in the provided information.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with multiple CFDA numbers: 93.173, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.

When was this FOA created?

The FOA was created on 2022-07-11.

What is the closing date shown in the provided information?

The original closing date listed in the provided excerpt is 2023-01-12.

Does the excerpt specify the award ceiling or number of awards?

No. The provided source data excerpt does not specify an award ceiling or the expected number of awards.

Where should applicants look for budget guidance and project period details?

The excerpt indicates applicants would typically consult the full FOA for budget guidance, project period structure, and the anticipated scale of the program.

What is a key takeaway about how success is measured in this program?

Success is strongly tied to meeting measurable, tangible milestones, demonstrating feasibility in UG3, delivering a functional prototype in UH3, validating it in vivo (animals or humans), and participating effectively in the coordinated consortium effort with NIH programmatic involvement.

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