Enabling Technologies to Accelerate Development of Oral Biodevices (R01 Clinical Trial Not Allowed) | PAR 20 233

Opportunity Information: Apply for PAR 20 233

The National Institutes of Health (NIH) funding opportunity "Enabling Technologies to Accelerate Development of Oral Biodevices (R01 Clinical Trial Not Allowed)" (PAR-20-233) supports research projects that tackle the major engineering and translational hurdles holding back next-generation intraoral biodevices. The core aim is to fund transformative, practical technology development that moves beyond basic concepts and results in working device platforms that are positioned for eventual clinical use. The announcement is focused on intraoral devices, meaning systems designed to operate in the mouth, where challenges like moisture, variable chemistry, mechanical wear, biofouling, patient comfort, and safety requirements can make reliable performance difficult. Applications are expected to address these real-world constraints with engineering innovations that materially improve feasibility, robustness, and readiness for clinical translation.

The FOA emphasizes technologies that advance precision medicine approaches in oral health and broader systemic health. In practice, this includes biodevices that can support more personalized detection, diagnosis, and treatment, as well as tools to measure patient functional status and enable clinical outcome assessments. The scope is intentionally broad, covering both new device development and substantial optimization of existing technologies, as long as the work meaningfully advances the state of the art and reduces barriers to translation. The agency is looking for projects that do not stop at proof-of-concept prototypes, but instead deliver functional biodevices and integrated technical approaches that have been thoroughly characterized in ways that support a specific intended clinical application.

A central technical theme is integration: applicants are encouraged to propose engineering approaches that combine electronic, physical, and biological systems into a single functional platform. That can include multifunctional sensing, biointerfaces, signal processing, power and data management, microfluidics, novel materials, surface engineering to reduce biofouling, safe and durable packaging, and strategies that allow devices to operate reliably in the intraoral environment. The intended outcome is a device or device-enabling system that is demonstrably safe and effective in preclinical testing for its intended use, with performance characterization rigorous enough to credibly support later-stage development steps on a clinical pathway.

Because oral biodevices sit at the intersection of engineering, dentistry, medicine, and often pharmacology and chemistry, the FOA strongly encourages interdisciplinary teams. Collaborative proposals that bridge expertise across engineering disciplines (such as electrical, mechanical, biomedical, and materials engineering), sensor development, chemistry, pharmacology, clinical dentistry, and medicine are aligned with the program goals. The announcement also explicitly encourages academia-industry collaboration, reflecting an interest in designs that can realistically be manufactured, validated, and advanced toward clinical adoption rather than remaining confined to laboratory demonstrations.

The award mechanism is an NIH R01 research project grant, and the FOA states "Clinical Trial Not Allowed," which means projects should not propose clinical trials as part of the application. The expectation is that work will remain in the engineering, development, and preclinical evaluation space, generating evidence of safety and performance without conducting human clinical trial activities under this award. From a planning standpoint, that places heavy emphasis on preclinical models, benchtop and simulated-use testing, biocompatibility and safety-relevant assessments, and validation approaches that can de-risk later clinical studies supported through other mechanisms.

Eligibility is broad across U.S.-based organizations and includes many government and nonprofit entities as well as higher education and industry participants. 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; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. At the same time, non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components are allowed as defined in the NIH Grants Policy Statement, which typically means discrete project elements may be carried out abroad under specific NIH rules while the applicant organization remains U.S.-based.

Administratively, this is a discretionary grant opportunity in the health funding category (CFDA 93.121) managed by NIH. The source data lists an original closing date of 2023-05-07 (with the FOA created on 2020-06-16), and applicants would typically need to confirm current submission windows and any reissued or updated announcements through NIH before preparing an application. Award ceiling and expected award counts are not specified in the provided source excerpt, so budget planning would normally follow standard NIH R01 expectations and the specific limits and guidance stated in the full FOA text.

Overall, the opportunity is best read as a push to move oral biodevice concepts into translationally credible, preclinically validated systems by solving the hardest integration and real-use engineering problems. Competitive applications will likely be those that define a clear intended clinical use case, propose an engineering plan that directly addresses intraoral constraints, and deliver a functional device or enabling platform with strong preclinical safety and performance evidence that positions the technology for the next stage of clinical translation.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Enabling Technologies to Accelerate Development of Oral Biodevices (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 2020-06-16.
• Applicants must submit their applications by 2023-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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