Exploratory/Developmental Bioengineering Research Grants (EBRG) (R21 Clinical Trial Not Allowed) | PAR 25 346

Frequently Asked Questions (FAQs) - Exploratory/Developmental Bioengineering Research Grants (EBRG) (PAR-25-346)

What is PAR-25-346 (Exploratory/Developmental Bioengineering Research Grants, EBRG)?

PAR-25-346 is a National Institutes of Health (NIH) funding opportunity administered by the National Cancer Institute (NCI) to support early-stage, engineering-driven bioengineering projects. The program is focused on creating new tools, technologies, methods, and workflows (or making significant improvements to existing ones) that address concrete needs in biomedical research and cancer-related clinical contexts.

Which NIH grant mechanism does this opportunity use?

This opportunity uses the R21 mechanism, which is designed for exploratory and developmental work. The central expectation is to demonstrate feasibility and strong potential utility, rather than deliver a fully validated, late-stage product.

What kind of work is this program trying to fund?

NCI is looking for early-stage engineering innovation that solves practical bottlenecks. Projects may involve developing and testing new capabilities such as prototypes, instrumentation, computational methods, analytical systems, workflows, platforms, or other bioengineering solutions that could enable or accelerate later translational and clinical impact.

Is the focus limited to cancer?

The opportunity is administered by NCI and emphasizes cancer-related clinical contexts and biomedical research needs. Proposed work should align with NCI priorities and address needs relevant to biomedical and cancer research or cancer-related clinical environments.

Are clinical trials allowed under PAR-25-346?

No. Clinical trials are not allowed under this notice. Applicants should not propose studies that meet NIH's definition of a clinical trial, even if the work is clinically relevant.

What does "clinical trials not allowed" mean in practical terms?

It means the project should not include research activities that meet NIH's clinical trial definition. The intent is to develop and test tools, methods, prototypes, or infrastructure in ways that demonstrate feasibility without crossing into clinical trial design or execution.

If clinical trials are not allowed, can projects still be clinically relevant?

Yes. The notice explicitly allows clinically relevant engineering work, including improvements connected to clinical care delivery or clinical research infrastructure, as long as the proposed studies do not meet NIH's definition of a clinical trial.

What types of performance improvements does NCI care about?

NCI highlights practical performance measures such as quality, speed, efficacy, ease of use (operability), cost, and accessibility. Applications are expected to show how the proposed engineering advance could meaningfully improve one or more of these measures.

How broad is the scientific and technical scope?

The scope is broad. It can span basic biomedical research, pre-clinical research, clinical research infrastructure (without running a clinical trial), clinical care delivery improvements, and approaches that expand access to high-quality methods or services.

What makes an application a good fit for an R21 under this opportunity?

A good fit typically includes a clearly defined engineering problem, a plausible technical approach, and focused proof-of-concept aims or development milestones that convincingly demonstrate feasibility and reduce risk for later-stage development.

Does the program expect a fully validated product by the end of the award?

No. Because this is an R21 exploratory/developmental program, the emphasis is on feasibility and demonstrating strong potential utility, rather than delivering a fully validated, late-stage product.

What does the opportunity mean by "engineering-driven" projects?

Based on the notice description, "engineering-driven" means the project is centered on developing, building, improving, or substantially advancing a tool, technology, method, workflow, computational approach, or instrument that addresses a real biomedical or cancer-related need.

What kinds of outputs or deliverables are implied by the opportunity description?

The notice points to outputs like prototypes, new or improved workflows, computational methods, instrumentation, platforms, and other bioengineering solutions, along with feasibility data or proof-of-concept results showing the approach works and could be useful.

Does the opportunity prioritize incremental improvements or bigger leaps?

The description emphasizes creating or significantly improving tools, technologies, and methods, and notes that competitive applications will typically make a strong case that the engineering advance is not incremental.

What should applicants avoid when designing aims?

Applicants should avoid drifting into a clinical trial design. Aims should stay focused on engineering development and feasibility demonstrations rather than testing interventions in a way that meets NIH's clinical trial definition.

What is the funding activity category for this opportunity?

The opportunity is categorized as a discretionary grant program within the Education and Health funding activity category.

Which CFDA numbers are associated with this opportunity?

The opportunity is associated with multiple CFDA numbers: 93.121, 93.393, 93.394, 93.395, 93.396, and 93.399.

Is an award ceiling or expected number of awards provided?

Not in the provided information. The source data described does not specify an award ceiling or the expected number of awards.

How should applicants think about budget and scope given the information provided?

While specific budget limits are not stated in the provided description, applicants are advised to treat R21 budgets and scope as targeted to early development and feasibility demonstration rather than large-scale validation efforts.

When was this funding opportunity created?

The opportunity was created on December 11, 2024.

What is the original closing date listed for this opportunity?

The listing shows an original closing date of January 7, 2028, indicating a multi-year window during which applications may be accepted according to the notice's submission schedule.

Who is eligible to apply?

Eligibility is broad and includes many U.S. applicant types such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; small businesses; and other entities.

Are minority-serving institutions and community-based organizations eligible?

Yes. The notice explicitly highlights additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions; AANAPISIs; Hispanic-serving Institutions; HBCUs; TCCUs; and faith-based or community-based organizations.

Can federal agencies apply?

Yes. The notice includes eligible federal agencies among the eligible applicant categories.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly listed as eligible.

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

Yes. The notice states that non-U.S. (foreign) organizations are eligible.

Does broad eligibility mean any project topic is acceptable?

No. Even with broad eligibility, projects still need to align with NCI priorities, fit the early-stage R21 feasibility intent, and comply with NIH policies, including the restriction that clinical trials are not allowed.

What is the core goal reviewers are likely looking for based on the description?

Based on the description, the core goal is a credible demonstration that the proposed engineering concept works (feasibility) and that it has strong potential utility to materially improve how biomedical and cancer research or care-related processes are performed.

What are examples of measurable improvements an application might propose?

The description mentions measurable improvements such as faster processing, lower cost per sample, improved sensitivity, improved robustness, or improved usability, along with broader measures like quality, speed, efficacy, operability, cost, and accessibility.

What does it mean that this program is an "entry point" for high-impact bioengineering ideas?

It means the program is positioned to support ideas that are still formative but can be developed far enough to show proof-of-concept and practical promise, setting the stage for later-stage development and eventual translational or clinical impact.