Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (Fast-Track - R44 - Clinical Trial Not Allowed) | RFA DE 23 008

Opportunity Information: Apply for RFA DE 23 008

This funding opportunity (RFA-DE-23-008) is an NIH small business Fast-Track SBIR grant (R44) focused on speeding up the pathway from early-stage dental, oral, and craniofacial (DOC) biomaterials research to real-world clinical use. The central idea is that promising new biomaterials often get stuck in long, expensive R and D cycles because developers lack reliable, predictive ways to characterize safety and effectiveness before reaching human use, and because regulators need strong, standardized evidence that a tool or method is trustworthy for a clearly defined purpose. This FOA aims to close that gap by supporting the creation and validation of advanced, data-driven tools that can reduce uncertainty, improve decision-making in preclinical development, and ultimately shorten timelines to regulatory approval for DOC biomaterials.

A defining feature of the opportunity is its alignment with the FDA Center for Devices and Radiological Health (CDRH) Medical Device Development Tools (MDDT) Program. Rather than funding data science in the abstract, the FOA pushes applicants to build tools that can be qualified by the FDA for a specific "context of use," meaning a clearly described role the tool will play in device development or evaluation. The emphasis is on producing practical tools that regulators and developers can rely on, not just generating exploratory models or one-off analyses. In that sense, the award is designed to help companies produce validated, regulator-ready tools that can become part of the evidence pipeline for DOC biomaterials, increasing confidence among developers, reviewers, and future adopters.

The FOA lays out four main objectives. First, it seeks to accelerate DOC biomaterials R and D by "de-risking" key safety and effectiveness questions, largely through robust and predictive preclinical characterization. This points to tools that can better forecast how a biomaterial will behave, fail, degrade, interact with tissue, or trigger adverse responses, ideally earlier in development when changes are still feasible. Second, it supports the technical development and validation work needed for FDA MDDT qualification, which typically requires careful definition of the tool, the decision it informs, performance metrics, and evidence that it works reliably under the stated conditions. Third, it promotes multi-domain collaboration and workforce development at the intersection of data-driven technology and biomaterials science in dentistry, reflecting the reality that useful tools often require teams spanning biomaterials, computational modeling, statistics, machine learning, regulatory science, and clinical or translational expertise. Fourth, it aims to build broader confidence in data-driven approaches for biomaterials innovation by establishing a pipeline of tools that are not only built, but rigorously validated and qualified for use.

This is a Fast-Track R44 mechanism, meaning it is intended for small businesses and is structured to support a Phase I to Phase II progression in a single application, accelerating development compared to submitting separate phases. The FOA explicitly states "Clinical Trial Not Allowed," which signals that projects should not include clinical trials involving human participants. The work is expected to be preclinical and tool-focused, such as developing computational models, AI/ML-enabled assessment methods, standardized data pipelines, predictive assays, simulation frameworks, or other data-driven methods that help evaluate DOC biomaterials without moving into human testing under this award.

In terms of eligibility, the applicant organization must be a small business. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, "foreign components" as defined by NIH policy may be allowed in some cases, which typically means limited, well-justified elements of the work performed outside the U.S. under specific NIH rules, rather than the applicant organization itself being foreign. The opportunity sits within the NIH (CFDA 93.121) and falls under the health funding activity category.

Key administrative details included in the notice are the original closing date of November 9, 2022, and an award ceiling of $750,000. While the number of expected awards is not specified in the provided excerpt, the ceiling indicates the FOA is designed to fund substantial, development-and-validation work that moves beyond early proof-of-concept toward tool maturity consistent with FDA qualification expectations. Overall, the program is best understood as a translational, regulator-aware push to equip the DOC biomaterials field with validated, data-driven development tools that reduce uncertainty, improve preclinical predictiveness, and make it easier to bring safe and effective biomaterials to patients faster.

• 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 (Fast-Track - R44 - 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: Small businesses.

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