The National Institute of Dental and Craniofacial Research (NIDCR) has issued a funding opportunity for the Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3). This opportunity supports rigorous clinical trials addressing behavioral and biopsychosocial interventions relevant to dental, oral, and craniofacial health, as well as related medical and mental health conditions. Projects must involve a planning phase (UG3) and a subsequent implementation phase (UH3), to be submitted as a single application. This opportunity excludes trials involving FDA-regulated drugs, devices, or biologics.

Applicants can propose interventions for diverse populations and a broad range of conditions, such as craniofacial abnormalities, oral hygiene promotion, periodontal diseases, or conditions with comorbid systemic effects like diabetes or arthritis. Innovative methods, including telehealth, mobile health, or sequential randomized designs, are encouraged. Outcomes may focus on improving patient care, advancing practitioner techniques, or enhancing health system delivery. The NOFO prioritizes projects promoting equity in treatment outcomes and addressing disparities in oral health conditions affecting women.

Applications must include comprehensive goals and hypotheses for both phases, with specific aims and milestones. The UG3 phase, funded for up to one year, supports planning and preparatory activities, including tool development, protocol finalization, and regulatory documentation. Transition to the UH3 phase depends on administrative review and funding availability. The UH3 phase can last up to five years and encompasses clinical trial execution, data collection, and analysis.

Eligible applicants include higher education institutions, nonprofits, small businesses, and local governments. Foreign organizations are not eligible to apply, but foreign components of U.S. organizations are permitted. Applicants proposing budgets exceeding $500,000 in direct costs for any year must notify NIDCR at least eight weeks prior to submission. A data management and sharing plan is mandatory.

Key dates include an earliest submission date of January 7, 2025, and the first application deadline on February 7, 2025, with subsequent deadlines following a cyclical schedule. Applications must be submitted electronically through Grants.gov or other approved systems. Late or incomplete submissions will not be reviewed.

The review process evaluates scientific merit, including the significance of the research, rigor of the approach, feasibility, and investigator expertise. Applications must address protections for human subjects, resource sharing, and data safety. Successful applicants must comply with NIH policies on data sharing, reporting, and study oversight.

NIDCR encourages early consultation with program staff to ensure alignment with NOFO goals and policies. Contacts for scientific, review, and financial inquiries are listed in the announcement for assistance throughout the application process. This NOFO reflects NIDCR’s commitment to advancing research that improves oral and systemic health outcomes through innovative and evidence-based interventions.