Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs) (R21 Clinical Trial Not Allowed) | RFA DE 25 002

Opportunity Information: Apply for RFA DE 25 002

The Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs) funding opportunity (RFA-DE-25-002) is a National Institutes of Health discretionary grant program that uses the R21 exploratory/developmental mechanism and does not allow clinical trials. Its core purpose is to push early-stage, high-impact work that validates organs-on-a-chip (OoC) platforms specifically for dental, oral, and craniofacial (DOC) research, with an emphasis on using these microphysiological systems for disease modeling and for pre-clinical efficacy studies. In practical terms, the opportunity is aimed at helping researchers demonstrate that a DOC-relevant OoC model is realistic, reproducible, and fit-for-purpose as a tool to study disease mechanisms or to evaluate potential interventions before moving into animal studies or later-stage development.

The scientific focus is on validation and use of OoC technologies rather than broad, open-ended platform invention. Applicants are expected to show how an OoC system can meaningfully represent DOC tissues and conditions, and then use that system to generate credible preclinical evidence. This can include building or adapting chips that mimic key aspects of oral and craniofacial biology (for example, interfaces, tissue architecture, mechanical forces, or microenvironmental cues) and then demonstrating that the model can recapitulate important disease features or predict responses in a way that supports preclinical decision-making. Because this is an R21, the intent is exploratory and developmental: projects should be ambitious and innovative, but also designed to produce clear proof-of-concept and validation data within the limited scope and budget typical of R21 awards.

Administratively, the program is categorized under Health (CFDA 93.121) and is offered as a grant. The opportunity lists an award ceiling of $275,000, signaling a capped maximum amount available per award under the terms of this announcement. The original closing date is 2024-11-19, and the opportunity record shows a creation date of 2024-09-09. While the number of expected awards is not specified in the provided source data, the structure is consistent with competitive NIH funding where awards depend on application volume, merit review outcomes, and available funds.

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, and city or township 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 (as long as they are not institutions of higher education when categorized that way); for-profit organizations (other than small businesses); and small businesses. The announcement also explicitly highlights additional eligible applicant categories often emphasized in federal funding, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, regional organizations, and U.S. territories or possessions. This structure reflects an intent to encourage participation from a wide range of institution types, including capacity-building and minority-serving institutions, as well as community-connected organizations that may contribute specialized expertise or infrastructure.

At the same time, the announcement draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may be able to include certain foreign collaborations or elements if they meet NIH’s definition and requirements for foreign components (for example, a defined portion of the project being performed outside the U.S. with appropriate justification and oversight), even though a foreign organization cannot serve as the primary applicant.

Finally, the “Clinical Trial Not Allowed” designation matters for project design. The work supported here is intended to remain in the preclinical and model-development/validation space rather than enrolling human participants into a clinical trial to test an intervention’s effects on health outcomes. Applicants need to frame aims, methods, and outcomes accordingly, focusing on OoC-based disease modeling and preclinical efficacy testing rather than clinical trial activities.

• 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) (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): 93.121.
• 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 $275,000.00 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.

Apply for RFA DE 25 002

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