Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R42 Fast-Track - Clinical Trial Not Allowed) | RFA DE 23 007

Opportunity Information: Apply for RFA DE 23 007

This funding opportunity, RFA-DE-23-007, is an NIH small business grant designed to speed up the path from lab research to real-world clinical use for new dental, oral, and craniofacial (DOC) biomaterials. The focus is not on funding the biomaterials themselves as products, but on building and validating advanced data-driven tools that make biomaterials development faster, more reliable, and less risky from a regulatory standpoint. The underlying problem the program is trying to solve is that promising DOC biomaterials can get stuck in long, expensive research and development cycles because it is difficult to predict safety and performance early on, and because the evidence packages needed for regulatory submissions can be inconsistent or time-consuming to generate. By investing in tools that improve prediction, standardization, and decision-making during preclinical development, NIH aims to reduce delays that ultimately slow down FDA clearance/approval and adoption in human care.

A key feature of the opportunity is its strong alignment with the FDA Center for Devices and Radiological Health (CDRH) Medical Device Development Tools (MDDT) Program. In practical terms, applicants are encouraged to design their tool development plans around the MDDT framework so that, by the end of the project, the tool is not just a research prototype but a well-characterized, validated, and regulator-ready resource with a clearly defined context of use. The intent is to produce tools that FDA can qualify for specific uses, which can then be used broadly by developers to support regulatory submissions. That emphasis on qualification and practical deployment is central here: success is measured by whether the funded work yields a tool that others can trust and reuse to support decisions about DOC biomaterials, not merely by publishing results.

The FOA lays out four major objectives. First, it aims to accelerate DOC biomaterials R and D by reducing uncertainty around safety and effectiveness through robust, predictive preclinical characterization. This points toward tools that can forecast how a material will behave in relevant biological environments, how it degrades, how it interacts with tissues, and how performance might change across manufacturing lots or patient conditions. Second, it supports the specific technical development and validation work needed to satisfy the FDA MDDT qualification process, which typically requires careful definition of the tool, its context of use, the evidentiary standards, and reproducible performance across datasets and sites where relevant. Third, it is intended to promote collaborations across domains and strengthen workforce capacity at the intersection of data science and biomaterials research in dentistry, meaning teams that blend biomaterials expertise with machine learning, computational modeling, imaging analytics, informatics, and rigorous validation/quality practices. Fourth, it aims to build confidence and momentum in the broader field by establishing a pipeline of FDA-qualified, validated data-driven tools that can be reused to improve biomaterials innovation, rather than forcing each company or lab to reinvent methods and validation approaches from scratch.

The mechanism is an R42 Fast-Track award, which is the Small Business Technology Transfer (STTR) format that combines Phase I and Phase II in a single application intended to move more quickly from feasibility to full development. The opportunity is explicitly labeled "Clinical Trial Not Allowed," meaning the work should stay in the preclinical and tool-validation space rather than enrolling human subjects in a clinical trial. The eligible applicant type is small businesses, consistent with the STTR/R42 structure, and the award ceiling listed in the source data is $750,000. The program is categorized under health (CFDA 93.121), is administered under the National Institutes of Health umbrella, and was created on 2022-08-02 with an original closing date of 2022-11-09.

Eligibility is restricted in ways that matter for company structuring and partnering. Non-U.S. (foreign) institutions are not eligible to apply as applicants, and non-U.S. components of U.S. organizations are also not eligible to apply. At the same time, the announcement notes that foreign components, as NIH defines them in its Grants Policy Statement, may be allowed in some cases, which usually refers to discrete parts of the project carried out outside the U.S. under specific justification and oversight rather than a foreign entity serving as the applicant. For teams considering international datasets, specialized testing, or unique expertise abroad, that nuance can be important, but the applicant organization itself must be U.S.-based and meet small business requirements.

Overall, this FOA is best understood as an effort to modernize and standardize how DOC biomaterials are evaluated before they ever reach humans, using computational and data-centric approaches that can be qualified under an FDA pathway. The program is trying to create a set of trustworthy, validated tools that improve prediction and reduce uncertainty, thereby lowering regulatory risk, shortening development timelines, and improving the odds that genuinely novel biomaterials can move efficiently from bench research into dental and craniofacial patient care.

• 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 (R42 Fast-Track - 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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