Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R61/R33 - Clinical Trial Not Allowed) | RFA DE 23 006

Opportunity Information: Apply for RFA DE 23 006

The NIH funding opportunity titled "Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R61/R33 - Clinical Trial Not Allowed)" focuses on speeding up how new biomaterials for dental, oral, and craniofacial (DOC) uses move from the lab into real-world clinical adoption. The core idea is that biomaterials development often gets bogged down by long, expensive research and development cycles, especially when there are unresolved questions about safety, performance, reliability, and how those findings will translate to humans. This FOA aims to reduce those bottlenecks by supporting the creation and validation of advanced data-driven tools that can produce stronger, more predictive preclinical evidence earlier in the pipeline, which in turn can reduce uncertainty and help avoid delays later when developers are preparing for regulatory review.

A defining feature of this opportunity is its alignment with the FDA Center for Devices and Radiological Health (CDRH) Medical Device Development Tools (MDDT) Program. Applicants are encouraged to frame their projects around the MDDT concept of producing practical tools that can be qualified by the FDA for a specific context of use. In plain terms, the program is not just looking for interesting algorithms or exploratory modeling; it is looking for tools that are engineered, tested, and validated in a way that makes them credible for decision-making in medical device development and, importantly, in regulatory interactions. The expectation is that the funded work will generate tools that are robust enough, and validated enough, to support a defined role in evaluating DOC biomaterials, such as improving characterization, predicting performance, standardizing analysis, or strengthening evidence packages that would be used in future regulatory submissions.

The FOA lays out four major objectives. First, it seeks to accelerate DOC biomaterials R and D cycles by "de-risking" safety and effectiveness concerns. That typically means using better, more predictive preclinical characterization methods so that potential issues are identified and addressed earlier, before time and money are invested in less informative studies. Second, it supports the technical development and validation work needed for the FDA MDDT qualification pathway, meaning applicants should think in terms of tool readiness, performance evaluation, reproducibility, and clearly documented validation plans tied to a specific context of use. Third, it emphasizes multi-domain collaboration and workforce development, reflecting the reality that meaningful data-driven tool development often requires teams that span biomaterials science, dentistry, computational modeling, machine learning, statistics, software engineering, and regulatory science. Fourth, it aims to build confidence in data-driven approaches for biomaterials innovation by creating a pipeline of well-validated, FDA-qualified tools that others can adopt, rather than one-off bespoke methods that are difficult to reproduce or generalize.

This is an R61/R33 funding mechanism, which is typically structured as a phased award. The R61 phase generally supports early, milestone-driven development and feasibility work, while the R33 phase supports more advanced development and validation once predefined milestones are met. The "Clinical Trial Not Allowed" designation indicates that the funded activities must remain in the preclinical and tool-development realm rather than enrolling human participants in clinical trials. The emphasis, instead, is on building tools that can make preclinical testing and evidence-generation more predictive, more standardized, and more efficient, thereby positioning future biomaterials and devices for smoother clinical translation and regulatory progress.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. It also explicitly includes various mission-driven and capacity-building institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as eligible federal agencies, faith-based or community-based organizations, and U.S. territories or possessions. At the same time, the FOA states that non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" as defined in NIH policy are allowed, which generally means a U.S.-based applicant can include certain well-justified foreign activities or collaborations under NIH rules without the foreign organization being the primary applicant.

Administratively, the opportunity is a discretionary grant in the health funding category under CFDA 93.121, offered by the National Institutes of Health. The opportunity number is RFA-DE-23-006, and the original closing date listed is 2022-11-09. The listed award ceiling is $750,000, indicating the maximum funding level anticipated per award under the announcement as presented in the source data. Overall, the program is best understood as a targeted push to turn data-driven methods into credible, validated development tools for DOC biomaterials, with a strong preference for projects designed from the start to produce outputs that are usable in real development and regulatory contexts rather than remaining purely academic demonstrations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R61/R33 - 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 2022-08-02.
• Applicants must submit their applications by 2022-11-09. (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 $750,000.00 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 23 006

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: