This grant is for the purpose of accelerating the development, testing, and clinical translation of novel dental, oral, and craniofacial (DOC) biomaterials. It specifically targets overcoming critical research and development (R&D) delays and expediting regulatory approval by leveraging advanced data-driven tools. Applicants are encouraged to utilize the FDA Medical Device Development Tools (MDDT) Program framework to ensure practical and validated outcomes. Key objectives include de-risking safety and effectiveness uncertainties through robust preclinical characterization, supporting validation for FDA MDDT qualification, fostering multi-domain collaborations, and promoting workforce development in data-driven biomaterial science. The initiative aims to build confidence and establish pipelines of FDA-qualified tools for biomaterials innovation.
Opportunity ID: 342916
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DE-23-008 |
| Funding Opportunity Title: | Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (Fast-Track – R44 – 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: | Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: 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, may be allowed. See full announcement for additional details on eligibility. |
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-23-008.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 342916 Full Announcement-RFA-DE-23-008 -> RFA-DE-23-008-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 | PKG00276244 | Oct 10, 2022 | Nov 09, 2022 | View |
Package 1
Mandatory forms
342916 RR_SF424_5_0-5.0.pdf
342916 PHS398_CoverPageSupplement_5_0-5.0.pdf
342916 RR_OtherProjectInfo_1_4-1.4.pdf
342916 PerformanceSite_4_0-4.0.pdf
342916 RR_KeyPersonExpanded_4_0-4.0.pdf
342916 RR_Budget_3_0-3.0.pdf
342916 PHS398_ResearchPlan_4_0-4.0.pdf
342916 SBIR_STTR_Information_3_0-3.0.pdf
342916 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
342916 RR_SubawardBudget30_3_0-3.0.pdf
342916 PHS_AssignmentRequestForm_3_0-3.0.pdf
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