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

Opportunity Information: Apply for PAR 25 202

Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed) is an NIH funding opportunity from the National Institute of General Medical Sciences (NIGMS) designed to back early, exploratory technology development projects. The focus is on establishing feasibility and generating proof-of-concept data for new or improved technologies that align with the NIGMS mission and could ultimately enable or transform biomedical research. This mechanism is aimed at ideas that are still at a formative stage, where the central goal is to demonstrate that a concept can work and is worth pursuing further, rather than to deliver a fully mature product or a late-stage validated system. Projects are expected to be high-risk and/or highly novel, with a clear rationale for why the approach is innovative and why, if successful, it could have substantial downstream impact.

This opportunity uses the NIH R21 grant mechanism and is explicitly labeled "Clinical Trial Not Allowed," meaning applicants must not propose clinical trials under this NOFO. The intent is technology development research, not human-subjects interventional testing characteristic of clinical trials. Applicants should therefore frame work around tool creation, platform development, prototyping, or method innovation that can be validated through appropriate bench, computational, preclinical, or other non-clinical-trial approaches, depending on the technology and its intended biomedical research use.

Eligibility is broad and covers a wide range of U.S.-based organizations and governmental entities. Eligible applicants include 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. The NOFO also highlights additional eligible applicant 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, reinforcing that a diverse set of organizational types can compete.

At the same time, the NOFO is clear about restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which typically means a U.S. applicant organization may include certain well-justified foreign activities or collaborations as a component of the project, provided they meet NIH policy requirements and are appropriately documented.

Administratively, this is a discretionary grant opportunity in the health funding activity category, listed under CFDA 93.859, and issued by the National Institutes of Health. The funding opportunity number is PAR-25-202, and the opportunity lists an original closing date of January 7, 2028. An award ceiling is not specified in the provided source data, and the expected number of awards is also not stated, so applicants would typically consult the full NOFO text and NIH policy for standard R21 budget expectations, project period limits, and review considerations.

In practical terms, competitive applications under this NOFO generally need to articulate a compelling unmet need or capability gap in biomedical research, explain why current technologies are insufficient, and present a credible plan to build and test a new technological approach with clear feasibility milestones. Since the emphasis is proof of concept, reviewers will be looking for strong conceptual innovation paired with a realistic experimental strategy to de-risk the idea and generate decisive evidence that the technology can work and can be advanced in subsequent funding stages if initial feasibility is demonstrated.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - 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): 93.859.
• This funding opportunity was created on 2024-11-14.
• Applicants must submit their applications by 2028-01-07.
• 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 PAR 25 202

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