This Funding Opportunity Announcement (FOA) seeks to accelerate the clinical translation of novel biomaterials for dental, oral, and craniofacial (DOC) applications through development and implementation of advanced data-driven tools designed to overcome critical bottlenecks in research and development (R&D) cycles that lead to delays in regulatory evaluations and translation to human use.
Donor Name: National Institutes of Health
State: All States
County: All Counties
Territory: Commonwealth of Puerto Rico, U.S. Virgin Islands, Guam, American Samoa, and Commonwealth of the Northern Mariana Islands
Type of Grant: Grant
Deadline: 09/09/2022
Size of the Grant: $750,000
Grant Duration: 3 years
Details:
This FOA seeks to accelerate the clinical translation of novel biomaterials for DOC applications through implementation of advanced data-driven tools specifically designed to overcome critical bottlenecks in R&D cycles that lead to delays in regulatory evaluations and translation to human use. This initiative leverages the FDA-CDRH’s Medical Device Development Tools (MDDT) program framework. Successful applications will integrate the FDA’s MDDT qualification process and related requirements into their research plan. Awardees will need to work closely with FDA’s MDDT Program to achieve FDA qualification of their proposed data-driven tool. The program goals include: 1) accelerate R&D cycles of biomaterials for DOC applications by de-risking potential safety and efficacious uncertainties through robust and predictive preclinical characterization; 2) support technical developments and validation activities needed to satisfy the FDA MDDT qualification process for proposed data-driven tools; 3) promote multi-domain collaborations between biomedical engineers, material scientists, software engineers, chemists, dentists, clinicians, biostatisticians, data analysts, biologists, and other relevant experts in academia and industry; and 4) build confidence in the use of data-driven technologies in biomaterials’ innovation by establishing pipelines of robust and validated tools that are qualified by the FDA.
Research Objectives
Research that encourages multi-domain investigators to collaborate in the development, customization, and validation of data-driven technologies and tools is expected to accelerate the R&D of novel DOC biomaterials. This initiative provides an opportunity to bridge knowledge and technology gaps to enhance capacity building and workforce development in data-driven technologies applied to biomaterials in alignment with the U. S. Department of Health and Human Services (HHS) AI Strategy and the NIH Office of Data Science Strategy. The following outcomes are expected from this initiative:
- Bring advanced data-driven technologies and computational material science to the forefront in R&D of DOC biomaterials.
- Yield significant reductions in the cost and time of regulatory approvals and in the clinical translation of safe and efficacious DOC biomaterials with improved clinical performance.
- Drive multi-domain collaborations and empower workforce development at the intersection of emerging data-driven and biomaterial science in DOC applications.
- Minimize use of laboratory animals and model organisms.
- Lead to new innovations in DOC biomaterials.
- Enhance the quality and efficiency of device evaluation and the FDA regulatory review process.
Funding Information
- Application budgets in the R61 phase are limited to $200,000 in direct costs per year. Application budgets in the R33 phase should not exceed $750,000 in direct costs per year.
- The total project period may not exceed one year for the R61 phase and three years for the R33 phase.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations.
For more information, visit Grants.gov.
