Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed) | PAR 25 202

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is the NIH "Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed)" funding opportunity from the National Institute of General Medical Sciences (NIGMS). It supports early, exploratory technology development projects intended to establish feasibility and generate proof-of-concept data for new or improved technologies that align with the NIGMS mission and could enable or transform biomedical research.

What is the goal of projects funded under this NOFO?

The central goal is to demonstrate that a technology concept can work and is worth pursuing further. The emphasis is on feasibility milestones and proof-of-concept evidence rather than delivering a fully mature product or a late-stage validated system.

What types of projects are a good fit?

Projects that focus on tool creation, platform development, prototyping, or method innovation that can be validated using appropriate non-clinical-trial approaches. The NOFO is aimed at ideas still at a formative stage, especially those that are high-risk and/or highly novel and could have substantial downstream impact if successful.

What does "high-risk and/or highly novel" mean in the context of this opportunity?

It refers to technology development efforts that involve significant uncertainty or a strong departure from existing approaches, paired with a clear rationale for why the approach is innovative and why success would meaningfully advance or transform biomedical research capabilities.

What grant mechanism is used?

This opportunity uses the NIH R21 grant mechanism.

Are clinical trials allowed under this opportunity?

No. The NOFO is explicitly labeled "Clinical Trial Not Allowed." Applicants must not propose clinical trials under this funding opportunity.

If clinical trials are not allowed, what kinds of validation approaches are appropriate?

The description points to validation through bench, computational, preclinical, or other non-clinical-trial approaches, depending on the technology and its intended biomedical research use.

Is the intent to fund technology development research or human-subjects interventional testing?

The intent is technology development research. Applications should avoid framing the work as human-subjects interventional testing characteristic of clinical trials.

Who is the sponsoring NIH institute for this opportunity?

The sponsoring institute is the National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health (NIH).

What should an application emphasize to be competitive?

Based on the provided description, competitive applications typically: (1) articulate a compelling unmet need or capability gap in biomedical research, (2) explain why current technologies are insufficient, and (3) present a credible plan to build and test a new technological approach with clear feasibility milestones. Reviewers are expected to look for strong conceptual innovation paired with a realistic experimental strategy to de-risk the idea and generate decisive proof-of-concept evidence.

Does this opportunity support fully mature products or late-stage validated systems?

No. The focus is on early feasibility and proof-of-concept for formative-stage ideas, not on delivering a fully mature product or a late-stage validated system.

What is the funding opportunity number?

The funding opportunity number is PAR-25-202.

What is the listed closing date?

The opportunity lists an original closing date of January 7, 2028.

What is the funding activity category?

It is described as a discretionary grant opportunity in the health funding activity category.

What CFDA number is associated with this opportunity?

The opportunity is listed under CFDA 93.859.

Which organizations are eligible to apply?

Eligibility is described as broad and includes many U.S.-based organizations and governmental entities, including: 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; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (when not an institution of higher education); for-profit organizations other than small businesses; small businesses; and other types of organizations as permitted.

Are specific institution types called out as eligible?

Yes. The NOFO highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); faith-based or community-based organizations; Hispanic-serving institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); regional organizations; eligible federal agencies; and U.S. territories or possessions.

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

No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply.

Can a U.S. organization apply if the project includes non-U.S. components of that U.S. organization?

No. The NOFO states that non-domestic components of U.S. organizations are not eligible to apply.

Are foreign components allowed at all?

Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. This generally means a U.S. applicant organization may include certain well-justified foreign activities or collaborations as part of the project, as long as they comply with NIH policy requirements and are appropriately documented.

Is an award ceiling provided in the information summarized here?

No. An award ceiling is not specified in the provided source data.

Is the expected number of awards stated in the information summarized here?

No. The expected number of awards is not stated in the provided source data.

Where should applicants look for standard R21 budget expectations, project period limits, and review considerations?

The summary indicates applicants would typically consult the full NOFO text and NIH policy for standard R21 budget expectations, project period limits, and review considerations.

What is the overall intended impact of funded technologies?

The intent is to enable or transform biomedical research by supporting new or improved technologies that align with the NIGMS mission and that, if successful, could have substantial downstream impact.