Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs) (R01 Clinical Trial Not Allowed) | RFA DE 25 001

Opportunity Information: Apply for RFA DE 25 001

The National Institutes of Health is offering an R01 grant opportunity titled "Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs) (R01 Clinical Trial Not Allowed)" under Funding Opportunity Number RFA-DE-25-001 (CFDA 93.121). The purpose of the program is to support research projects that validate organ-on-a-chip (OoC) platforms specifically for dental, oral, and craniofacial (DOC) science. In practical terms, the emphasis is on demonstrating that a given OoC model is reliable and fit-for-purpose for DOC disease modeling and for pre-clinical efficacy studies, meaning it can be used to test interventions in a controlled, biologically relevant system before moving to animal studies or human trials. As an R01 mechanism, the funding is meant to support a substantial, hypothesis-driven or milestone-driven research project rather than a small pilot, and the "Clinical Trial Not Allowed" designation means applicants should not propose studies that meet NIH's definition of a clinical trial involving human participants assigned to an intervention to evaluate health-related biomedical or behavioral outcomes.

This opportunity sits at the intersection of microphysiological systems engineering and DOC translational research. The core idea is to move beyond proof-of-concept chip demonstrations and toward rigorous validation: showing that the chip can reproduce key aspects of DOC tissue biology and pathology, and that it can generate results that are reproducible, interpretable, and relevant for decision-making in preclinical pipelines. Projects responsive to this goal would typically involve demonstrating biological fidelity (for example, appropriate cell composition, tissue architecture, mechanical forces, barrier functions, vascular or immune interactions where relevant), establishing performance characteristics (repeatability across runs, robustness across operators or sites where feasible, stability over time), and showing that the model can capture disease phenotypes or treatment responses that matter for DOC conditions. Because the stated target use includes disease modeling and pre-clinical efficacy studies, strong applications would generally connect the technical platform to a clearly articulated context of use: what disease or condition is being modeled, what readouts will be used to judge success, and how the resulting data would be used to evaluate candidate therapeutics, biomaterials, devices, or other interventions relevant to dental, oral, or craniofacial health.

Eligibility is broad and includes many U.S.-based organization types commonly allowed on NIH grants. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private 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 with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses, along with other eligible entities. The opportunity also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. These callouts signal NIH's interest in broad participation across institution types, including organizations that serve underrepresented or historically excluded communities.

At the same time, there are clear restrictions related to foreign involvement. 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 in the NIH Grants Policy Statement, are allowed. In NIH terms, this typically means a U.S. applicant may include certain well-justified activities performed by a foreign institution or investigator as part of the overall project, provided those activities meet NIH requirements and are appropriately described, justified, and budgeted. The distinction matters for teams that want to collaborate internationally: the prime applicant must be eligible and domestic, but discrete foreign component work can be included when it adds unique scientific value.

Key administrative details from the source information include that the sponsoring agency is the National Institutes of Health, the funding instrument type is a grant, and the activity category is health. The original closing date listed is 2024-11-19. The listed award ceiling is $500,000, which typically indicates a maximum annual direct cost level or a limit associated with the announcement (applicants would still need to confirm how the ceiling is defined in the full announcement and NIH budget policy language). The expected number of awards is not provided in the supplied text, suggesting it may be unspecified or dependent on available funds and application quality.

Overall, this funding opportunity is aimed at pushing DOC-focused organ-on-a-chip systems from promising technology toward validated, decision-grade preclinical tools. Competitive proposals will generally be those that define a concrete DOC application, build in rigorous validation and benchmarking plans, and show how the chip will be used to model disease biology and evaluate candidate interventions in a way that can realistically improve the efficiency and relevance of preclinical research in dental, oral, and craniofacial health.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs) (R01 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): 93.121.
• This funding opportunity was created on 2024-09-09.
• Applicants must submit their applications by 2024-11-19. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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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