Key Dates
NOT-DE-22-011 - Notice of Intent to Publish a Funding Opportunity Announcement for Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (Fast-Track – R44 Clinical Trial Not Allowed)
NOT-DE-22-009- Notice of Intent to Publish a Funding Opportunity Announcement for Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R61/R33 Clinical Trial Not Allowed)
National Institute of Dental and Craniofacial Research (NIDCR)
The National Institute of Dental and Craniofacial Research (NIDCR) intends to promote a new initiative by publishing Funding Opportunity Announcements (FOAs) to solicit applications for research on “Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials”.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOAs are expected to be published in Summer 2022, with an expected application due date in Fall 2022.
These FOAs will utilize the R42, R44 and R61/R33 Clinical Trial Not Allowed activity code.
This Notice encourages investigators with expertise and insights into ways 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 to begin to consider applying for this new FOA.
In addition, collaborative investigations combining expertise in biomedical engineering, material science, software engineering, chemistry, dentistry, medicine, biostatististics, data analysis, biology, and other relevant areas from academia and industry will be encouraged and these investigators should also begin considering applying for this FOA.
Among the areas of research encouraged in this initiative arethe acceleration of R&D cycles and the regulatory evaluation of novel and/or repurposed biomaterial formulations with unique functional properties optimized for the restoration, repair, or replacement of DOC tissues.This initiative promotes NIDCR’s collaboration with FDA’s Medical Device Development Tools (MDDT) program established by the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools for use in evaluating medical devices subject to regulation by FDA/CDRH. The framework of FDA's MDDT program will be leveraged by this initiative as an innovative and important roadmap to guide the development of data-driven tools that are qualified by the FDA for a specific Context of Use (CoU).
An MDDT is a method, material, or measurement used to assess the efficacy, safety, and performance of a medical device. MDDTs can accelerate the device development process by providing developers with measurements and tools qualified by FDA that do not need to be re-evaluated within the CoU, which helps streamline/speed device development and FDA regulatory decision-making. Applicants should refer to FDA Guidance on MDDT Program for more details on the MDDT qualification process. Applicants are expected to adhere to the FDA’s MDDT qualification process as they work towards producing an FDA qualified MDDT.
TBD
TBD
Application budgets in the R42 phase I are limited to $200,000 in direct costs per year. Application budgets in the R42 phase I must not exceed $750,000 in direct costs per year.
TBD
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Please direct all inquiries to:
Orlando Lopez, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-402-4243
Email: [email protected]
and Human Services (HHS)
