PAR-21-160 NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

This Funding Opportunity Announcement (FOA) will support UG3/UH3 phased, cooperative agreement research applications to plan and implement clinical trials within the mission of the National Institute of Dental and Craniofacial Research (NIDCR). Studies appropriate for this FOA are those testing a drug, biologic, device, or procedure to improve dental, oral, or craniofacial diseases or conditions, including trials for any phase of testing for a Food and Drug Administration (FDA)-regulated product. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a clinical trial implementation phase (UH3) of up to five years. Progression to the UH3 phase is based on an administrative review and is dependent on success in meeting UG3 milestones, NIDCR program priorities, and availability of funds.

The UG3/UH3 application must be submitted as a single application with the final design of the UH3 clinical trial described in the application, following the instructions described in this FOA. The UG3 planning phase permits both scientific and operational planning activities, though the planning phase cannot be used to test for intervention safety or efficacy. The UH3 phase of the award will support the conduct of one investigator-initiated clinical trial. Applications designed to test behavior change interventions or those used as tools to understand mechanisms of behavior change will not be supported by this FOA.