NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) | PAR 21 317

Opportunity Information: Apply for PAR 21 317

The NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), Funding Opportunity Number PAR-21-317, is a National Institutes of Health discretionary funding opportunity designed to support behavioral and social intervention clinical trials focused on dental, oral, or craniofacial health. The core goal is to move promising behavior change interventions from a structured planning period into full clinical trial execution, with the expectation that applicants will build a rigorous, feasible study and then carry it out if pre-specified milestones are achieved. Because this is a cooperative agreement, awardees should expect substantial scientific and programmatic involvement from NIH compared with a traditional research grant.

This opportunity uses a phased UG3/UH3 structure submitted as one combined application. The first phase (UG3) is a milestone-driven planning period that can last up to 2 years. It is intended to reduce the risk of launching an underprepared clinical trial by funding both scientific and operational groundwork. Transition to the second phase (UH3) is not automatic; only projects that meet the required feasibility and scientific milestones during UG3 are allowed to move forward. If the milestones are met, the award can transition into the UH3 implementation phase, which can support up to 5 additional years to conduct the clinical trial and related research activities.

During the UG3 planning phase, the FOA supports scientific planning activities that help confirm the intervention and trial approach are workable in the real world. This can include small-scale data collection to test feasibility and acceptability of the intervention and study procedures, such as whether participants find the content acceptable, whether the proposed delivery method (in-person, remote, digital, community-based, clinic-based, etc.) is practical, and whether data collection workflows are realistic. It can also include early testing of intervention training processes and fidelity monitoring, meaning the project can pilot how staff will be trained to deliver the intervention consistently and how the study will verify the intervention is delivered as intended.

The UG3 phase also requires substantial operational planning. At a minimum, applicants are expected to use this period to produce the final clinical protocol, an intervention manual (or an equivalent set of standardized intervention materials), and a functional data management system along with tools for data and quality management. Projects also need to establish safety monitoring and operational oversight plans, along with detailed recruitment and retention strategies and other essential trial documents. In practice, this means the UG3 phase is where the trial is fully engineered so that, if milestones are achieved, the project can shift into implementation without major redesign.

The UH3 phase funds the actual execution of the clinical trial and supports investigator-initiated behavioral and social intervention research across the full translational spectrum. The FOA explicitly allows studies ranging from early mechanistic work and intervention development (often described as Stages 0/I) through later-stage implementation research and cost-effectiveness research (Stages IV/V). That scope indicates NIDCR is open to supporting trials that test how and why an intervention works, trials that refine intervention delivery, and trials that evaluate real-world adoption, scalability, and value, as long as the focus remains on behavioral or social interventions tied to dental, oral, or craniofacial conditions.

Eligibility is broad and includes many types of domestic applicants, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other organizations as allowed under NIH rules. The FOA also highlights additional eligible applicants, including 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth signals an intent to encourage strong community, clinical, and public health partnerships, which is often essential for recruitment and sustained behavior change interventions.

Administratively, the activity category is Health and the CFDA number listed is 93.121. The funding instrument is a cooperative agreement, reinforcing that awardees should be prepared for active coordination with NIH staff and adherence to agreed-upon milestones and oversight expectations. The original closing date provided is January 7, 2025, and the FOA was created on September 1, 2021. The award ceiling and expected number of awards are not specified in the source data provided, which typically means applicants must rely on the FOA text and NIH institute guidance for budget expectations and should design budgets that match the scope of the UG3 planning work and the UH3 trial implementation work.

Overall, this FOA supports a structured path to launching and completing behavioral and social intervention clinical trials in oral health: first proving the trial is ready and feasible through required UG3 milestones and deliverables, then conducting the full trial under UH3 funding if those milestones are successfully achieved.

• 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 2021-09-01.
• Applicants must submit their applications by 2025-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 21 317

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