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

Frequently Asked Questions (FAQs)

What is the DOC-OoCs funding opportunity (RFA-DE-25-002)?

The Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs) opportunity (RFA-DE-25-002) is a National Institutes of Health (NIH) discretionary grant program. It supports early-stage, high-impact research to validate organs-on-a-chip (OoC) platforms for dental, oral, and craniofacial (DOC) research, especially for disease modeling and preclinical efficacy studies.

What grant mechanism does this opportunity use?

This opportunity uses the NIH R21 exploratory/developmental research grant mechanism. R21 projects are intended to be ambitious and innovative, while still producing clear proof-of-concept and validation results within a limited scope and budget.

Are clinical trials allowed under this funding opportunity?

No. The funding opportunity is designated as "Clinical Trial Not Allowed." Proposed work must stay in the preclinical and model-development/validation space and should not involve conducting a clinical trial.

What is the main purpose of this opportunity?

The core purpose is to push early-stage validation of DOC-relevant organs-on-a-chip systems and demonstrate that these microphysiological models are realistic, reproducible, and fit-for-purpose for studying disease mechanisms or evaluating potential interventions before moving into animal studies or later-stage development.

What types of research are encouraged?

The opportunity emphasizes validating and using OoC technologies for DOC research. Projects are expected to show that an OoC system can meaningfully represent DOC tissues and conditions, and then use that validated system to produce credible preclinical evidence (for example, by modeling disease features or predicting responses relevant to preclinical decision-making).

Is this opportunity focused on inventing entirely new OoC platforms?

Based on the provided description, the scientific focus is on validation and use of OoC technologies rather than broad, open-ended platform invention. Building or adapting chips may be part of the work, but the emphasis is on demonstrating DOC relevance and generating validation and proof-of-concept data.

What does "validation" mean in the context of this program?

Validation in this context refers to demonstrating that a DOC-relevant OoC model is realistic, reproducible, and fit-for-purpose. Applicants are expected to show the system can represent important aspects of DOC biology and can recapitulate disease features or predict responses in ways that support preclinical decision-making.

What are examples of DOC features an OoC model might mimic?

The opportunity description notes that OoC models may mimic key aspects of oral and craniofacial biology, such as interfaces, tissue architecture, mechanical forces, or microenvironmental cues, and then demonstrate that these features support credible disease modeling or preclinical efficacy evaluation.

What does "preclinical efficacy studies" mean here?

As described, preclinical efficacy studies in this program refer to using the validated OoC system to evaluate potential interventions before moving into animal studies or later-stage development. The emphasis is on OoC-based evidence generation rather than testing interventions in human clinical trials.

What is the award ceiling for this opportunity?

The opportunity lists an award ceiling of $275,000, which indicates a capped maximum amount available per award under the terms of this announcement.

How many awards will be made?

The number of expected awards is not specified in the provided information. As described, the structure is consistent with competitive NIH funding, where awards typically depend on application volume, merit review outcomes, and available funds.

What is the closing date for this opportunity?

The original closing date listed is 2024-11-19.

When was the opportunity record created?

The opportunity record shows a creation date of 2024-09-09.

What is the program category and assistance listing information provided?

Administratively, the program is categorized under Health and references CFDA 93.121. The offering type is a grant.

Who is eligible to apply (in general terms)?

Eligibility is broad for U.S.-based organizations and government entities. The eligible applicant types listed include various levels of government, higher education institutions (public and private), tribal governments and tribal organizations, nonprofits (with or without 501(c)(3) status, subject to the categorization note provided), for-profit organizations (other than small businesses), and small businesses.

Which government entities are eligible to apply?

The eligible government applicant types listed include state governments, county governments, city or township governments, special district governments, and independent school districts.

Are institutions of higher education eligible?

Yes. The eligible applicant list includes public and state-controlled institutions of higher education as well as private institutions of higher education.

Are tribal governments and tribal organizations eligible?

Yes. The eligible applicants include Native American tribal governments (federally recognized) and Native American tribal organizations other than federally recognized tribal governments.

Are nonprofits eligible to apply?

Yes. The eligible applicants include nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status, with the caveat in the provided text that eligibility applies "as long as they are not institutions of higher education when categorized that way."

Are for-profit organizations eligible to apply?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.

Are minority-serving institutions and other emphasized categories included in eligibility?

Yes. The announcement explicitly highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. The eligibility description explicitly includes faith-based or community-based organizations among the emphasized eligible applicant categories.

Are federal agencies eligible to apply?

Yes. The eligibility description includes eligible federal government agencies.

Are U.S. territories or possessions included in eligibility?

Yes. The eligibility description explicitly mentions U.S. territories or possessions.

Can a foreign (non-U.S.) organization apply as the primary applicant?

No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as applicant organizations under this opportunity.

Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are not eligible to apply as applicant organizations, based on the provided information.

Are foreign components allowed in any form?

Yes. Foreign components are allowed as defined in the NIH Grants Policy Statement. This means a U.S. applicant may be able to include certain foreign collaborations or elements if they meet NIH's definition and requirements for a foreign component, with appropriate justification and oversight.

How should applicants handle the "Clinical Trial Not Allowed" requirement when designing a project?

Applicants should frame aims, methods, and outcomes around OoC-based disease modeling and preclinical efficacy testing rather than clinical trial activities. Projects should avoid enrolling human participants into a clinical trial to test an intervention's effects on health outcomes.

What kind of outcomes is the program trying to produce?

Based on the description, the program is aiming for clear proof-of-concept and validation data showing that a DOC-relevant OoC model is credible and useful for studying disease mechanisms or evaluating interventions in a preclinical context.

What is the practical value the program is trying to support?

In practical terms, the opportunity is aimed at helping researchers demonstrate that an OoC model can support preclinical decision-making, including generating evidence that can inform whether and how to proceed to animal studies or later-stage development.