NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) | PAR 25 188

Opportunity Information: Apply for PAR 25 188

The NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), Funding Opportunity Number PAR-25-188, is a National Institutes of Health (NIH) discretionary funding opportunity that supports the planning and execution of behavioral and social intervention clinical trials focused on dental, oral, and craniofacial health. The goal is to move behavior-change interventions from concept to a well-run clinical trial, with an emphasis on careful upfront planning, clear milestones, and demonstrated feasibility before large-scale implementation begins. The funding mechanism is a cooperative agreement, which generally means NIH program staff are expected to have substantial scientific or programmatic involvement during the project compared with a standard grant.

This opportunity uses a phased UG3/UH3 structure that is designed to reduce risk and improve trial readiness. The first phase (UG3) is a milestone-driven planning period of up to two years. If the project meets prespecified scientific milestones and feasibility benchmarks during UG3, it can transition to the second phase (UH3), which supports full clinical trial implementation for up to five additional years. Importantly, applicants submit a single, combined UG3/UH3 application from the start; the UH3 phase is not a separate later application, but it is conditional on successfully completing the UG3 phase requirements.

During the UG3 planning phase, the NOFO allows both scientific and operational planning activities. On the scientific side, UG3 funds can be used for small-scale data collection intended to confirm feasibility and acceptability of the intervention and the study procedures. Examples include testing whether participants find the intervention content acceptable, whether the proposed delivery method works in the intended setting (such as clinic-based delivery, community delivery, telehealth, or digital tools), whether data collection procedures are workable, and whether the team can train interventionists and monitor fidelity reliably. On the operational side, UG3 is expected to produce the core infrastructure needed to run a rigorous trial, including the final clinical protocol, an intervention manual (or equivalent documentation), data management systems and tools for data and quality management, safety monitoring and operational oversight plans, and concrete recruitment and retention strategies along with other essential trial documents.

The UH3 implementation phase supports the actual conduct of investigator-initiated behavioral or social intervention research across the full spectrum of intervention development and testing. The NOFO explicitly notes support for studies ranging from early mechanistic and intervention development work (often described as Stage 0/I) through later-stage implementation and cost-effectiveness research (Stages IV/V). In practical terms, this means UH3 funds can support not only efficacy- or effectiveness-style trials, but also studies that examine how interventions work, how to implement them in real-world systems, and what they cost relative to their benefits, so long as the trial is grounded in dental, oral, or craniofacial health priorities and the project meets the required milestones to advance from UG3 to UH3.

Eligible applicants are broad and include many types of U.S.-based organizations and governmental units. Eligible entities include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; and small businesses. The NOFO also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, certain federal agencies, regional organizations, and U.S. territories or possessions. Foreign organizations are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible, which limits the work to domestic U.S. organizational structures and components.

Key administrative details included in the source information are that the sponsoring agency is NIH (through NIDCR), the CFDA number is 93.121, and the original closing date listed is 2028-01-06. The award ceiling shown in the source data is $500,000 (noting that NIH awards can sometimes vary based on institute policies, project scope, and specific budget instructions in the full announcement). Overall, this NOFO is geared toward teams that can propose a well-justified behavioral or social intervention trial in oral health, lay out measurable go/no-go milestones for the UG3 planning period, and demonstrate that they can stand up the protocol, systems, and operational capacity needed to run a high-quality clinical trial in the UH3 phase.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
• This funding opportunity was created on 2024-12-02.
• Applicants must submit their applications by 2028-01-06.
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 188

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: