The National Institute of Dental and Craniofacial Research (NIDCR) is offering this grant to accelerate the clinical translation of novel dental, oral, and craniofacial (DOC) biomaterials. This initiative seeks applications for developing, testing, and implementing advanced data-driven tools designed to overcome critical challenges in research and development cycles, which often cause delays in regulatory approval and human use. The grant encourages applicants to leverage the FDA-CDRH’s Medical Device Development Tools (MDDT) Program framework. Its purpose is to de-risk potential safety and effectiveness uncertainties through robust preclinical characterization, support FDA MDDT qualification, foster multi-domain collaborations, and establish a pipeline of robust, FDA-qualified tools, building confidence in data-driven technologies for biomaterials innovation.
Opportunity ID: 342915
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DE-23-006 |
| Funding Opportunity Title: | Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R61/R33 – Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.121 — Oral Diseases and Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Aug 02, 2022 |
| Last Updated Date: | Aug 02, 2022 |
| Original Closing Date for Applications: | Nov 09, 2022 |
| Current Closing Date for Applications: | Nov 09, 2022 |
| Archive Date: | Dec 15, 2022 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $750,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Small businesses For profit organizations other than small businesses State governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The goal of this FOA is to solicit applications to accelerate development, testing and implementation of advanced data-driven tools specifically designed to overcome critical problems affecting research and development (R and D) cycles that might contribute to delays in regulatory approval and human use of novel biomaterials for dental, oral, and craniofacial (DOC) applications. It is part of a suite of FOAs that encourage applicants to leverage the FDA-CDRHs Medical Device Development Tools (MDDT) Program framework as an innovative and important pathway to ensure that outcomes of funded studies yield practical and validated tools that are qualified by FDA to support a particular context-of-use. The overall objectives are to: 1) accelerate R and D cycles of biomaterials for DOC applications by de-risking potential safety and effectiveness 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 and empower workforce development at the intersection of data-driven technologies and biomaterial science in dentistry; 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 FDA. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-23-006.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 342915 Full Announcement-RFA-DE-23-006 -> RFA-DE-23-006-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or after January 25, 2022 | PKG00276255 | Oct 10, 2022 | Nov 09, 2022 | View |
Package 1
Mandatory forms
342915 RR_SF424_5_0-5.0.pdf
342915 PHS398_CoverPageSupplement_5_0-5.0.pdf
342915 RR_OtherProjectInfo_1_4-1.4.pdf
342915 PerformanceSite_4_0-4.0.pdf
342915 RR_KeyPersonExpanded_4_0-4.0.pdf
342915 RR_Budget_3_0-3.0.pdf
342915 PHS398_ResearchPlan_4_0-4.0.pdf
342915 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
342915 RR_SubawardBudget30_3_0-3.0.pdf
342915 PHS_AssignmentRequestForm_3_0-3.0.pdf
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