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.Apply for PAR 21 317
- 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.
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is the NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), Funding Opportunity Number (FOA) PAR-21-317. It is a National Institutes of Health (NIH) discretionary funding opportunity that supports behavioral and social intervention clinical trials focused on dental, oral, or craniofacial health.
Which NIH institute is offering it?
The opportunity is offered by NIDCR, the National Institute of Dental and Craniofacial Research.
What types of studies does the FOA support?
The FOA supports behavioral and social intervention clinical trials tied to dental, oral, or craniofacial conditions or outcomes. It is intended to move promising behavior change interventions from a structured planning period into full clinical trial execution, assuming pre-specified milestones are met.
Is a clinical trial required?
Yes. The mechanism name includes "Clinical Trial Required," and the opportunity is designed specifically to support clinical trials of behavioral and social interventions.
What is the overall purpose of the UG3/UH3 phased structure?
The phased structure is designed to reduce the risk of launching an underprepared clinical trial. The UG3 phase funds milestone-driven planning and feasibility work. Only projects that meet required milestones can transition to the UH3 phase, which funds the full trial implementation.
Do applicants submit two separate applications for UG3 and UH3?
No. The UG3 and UH3 phases are submitted as one combined application under a single UG3/UH3 structure.
How long can the UG3 planning phase last?
The UG3 planning phase can last up to 2 years.
How long can the UH3 implementation phase last?
If the project transitions successfully from UG3, the UH3 implementation phase can support up to 5 additional years to conduct the clinical trial and related research activities.
Is transition from UG3 to UH3 automatic once UG3 is awarded?
No. Transition is not automatic. Only projects that meet the required feasibility and scientific milestones during the UG3 phase are allowed to move forward to UH3 implementation.
What kinds of activities are supported during the UG3 planning phase?
The UG3 phase supports scientific and operational planning activities intended to confirm that the intervention and trial approach are workable in real-world settings. This can include small-scale data collection to test feasibility and acceptability of the intervention and study procedures.
What does "feasibility and acceptability" mean in this context?
Based on the description provided, feasibility and acceptability may include whether participants find the intervention content acceptable, whether the proposed delivery method is practical, and whether data collection workflows are realistic and workable.
Are different intervention delivery methods allowed?
Yes. The FOA description explicitly mentions delivery methods such as in-person, remote, digital, community-based, and clinic-based approaches, indicating that multiple delivery formats may be appropriate depending on the intervention and setting.
Can UG3 activities include piloting training and fidelity monitoring?
Yes. The UG3 phase can include early testing of intervention training processes and fidelity monitoring, such as piloting how staff will be trained to deliver the intervention consistently and how the study will verify the intervention is delivered as intended.
What key deliverables are expected by the end of the UG3 phase?
At a minimum, applicants are expected to produce: (1) the final clinical protocol, (2) an intervention manual or equivalent standardized intervention materials, and (3) a functional data management system with tools for data and quality management.
What operational plans are expected during UG3?
The UG3 phase requires substantial operational planning, including establishing safety monitoring and operational oversight plans, developing detailed recruitment and retention strategies, and preparing other essential trial documents so the trial can shift into implementation without major redesign if milestones are achieved.
What does the UH3 phase fund?
The UH3 phase funds the actual execution of the clinical trial and supports investigator-initiated behavioral and social intervention research activities associated with conducting the trial.
What is meant by "across the full translational spectrum" for this FOA?
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). This indicates support for trials that test how and why an intervention works, refine intervention delivery, or evaluate real-world adoption, scalability, and value, as long as the focus remains on behavioral or social interventions tied to dental, oral, or craniofacial health.
What makes this a cooperative agreement, and what should awardees expect?
The funding instrument is a cooperative agreement, which means awardees should expect substantial scientific and programmatic involvement from NIH compared with a traditional research grant. Awardees should be prepared for active coordination with NIH staff and for adherence to agreed-upon milestones and oversight expectations.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic applicants, including 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.
Are specific institution types and community organizations highlighted as eligible?
Yes. The FOA highlights additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).
Are non-U.S. (foreign) organizations eligible?
Yes. The information provided explicitly lists non-U.S. entities (foreign organizations) among the highlighted eligible applicants.
What is the activity category for this opportunity?
The activity category is listed as Health.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.121.
What is the Funding Opportunity Number (FOA number)?
The FOA number is PAR-21-317.
When was the FOA created?
The FOA was created on September 1, 2021.
What is the closing date listed for this opportunity?
The original closing date provided is January 7, 2025.
Is there an award ceiling listed?
No award ceiling is specified in the information provided.
Is the expected number of awards listed?
No. The expected number of awards is not specified in the information provided.
How should applicants think about budgeting if award amounts are not specified?
Based on the information provided, applicants should design budgets that match the scope of the UG3 planning work and the UH3 clinical trial implementation work, and should rely on the FOA text and NIH institute guidance for budget expectations.
What is the core goal of this FOA in practical terms?
The core goal is to provide a structured path to launching and completing behavioral and social intervention clinical trials in oral health: first demonstrating trial readiness through UG3 milestones and required deliverables, then conducting the full trial under UH3 support if milestones are achieved.
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