Opportunity Information: Apply for PAR 21 197
The NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) is a National Institutes of Health (NIH) funding opportunity (PAR-21-197) designed to support the full lifecycle of behavioral and social intervention clinical trials in oral health and related areas covered by the National Institute of Dental and Craniofacial Research (NIDCR). The main goal is to fund projects that both plan and then carry out (implement) a clinical trial, using a two-phase, milestone-driven structure that reduces risk and ensures the study is truly ready to launch before large-scale resources are committed. Because this is labeled "Clinical Trial Required," applications must propose a clinical trial rather than an observational study or purely preparatory research.
The award uses a UG3/UH3 phased cooperative agreement model. In practical terms, the UG3 phase functions as the planning and start-up period, where the research team completes the critical steps needed to make the trial executable and scientifically solid. That typically includes finalizing the protocol, refining the behavioral or social intervention and its delivery methods, confirming recruitment and retention strategies, setting up data collection and management systems, training staff, ensuring regulatory and ethical approvals are on track, and demonstrating feasibility through clear readiness milestones. If those predefined milestones are met, the project can transition to the UH3 phase, which is the implementation stage where the clinical trial is actually conducted, participants are enrolled, interventions are delivered, outcomes are measured, and the study is managed through to completion. The phased approach is meant to prevent trials from stalling after award because of unresolved operational issues, while also giving well-prepared teams a clear pathway to proceed into full implementation.
This FOA is a cooperative agreement rather than a standard research project grant, which signals a more involved partnership with NIH/NIDCR during the life of the award. Cooperative agreements generally include substantial scientific or programmatic involvement from NIH staff, such as participating in oversight, monitoring progress toward milestones, and helping ensure that trial conduct aligns with NIH expectations for rigor, safety, and data quality. Applicants should expect that progress and milestone achievement will be closely tracked, and that the transition from UG3 to UH3 is contingent on meeting the agreed-upon benchmarks.
Eligibility is broad across many types of U.S.-based organizations. Eligible applicants include 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 Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, and U.S. territories or possessions. At the same time, the opportunity is clear about geographic and foreign involvement limits: non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed. In short, applications must be led and carried out entirely within eligible domestic settings.
From an administrative standpoint, this is an NIH discretionary funding opportunity in the health category, listed under CFDA 93.121, and the funding instrument type is a cooperative agreement. The original closing date provided is September 7, 2021, and the posting creation date is April 1, 2021. The award ceiling and expected number of awards are not specified in the provided data, which usually means applicants need to consult the full FOA text and NIH budget guidance for detailed constraints, limits, and expectations around the scope and scale of proposed work.
Overall, the opportunity is aimed at supporting well-justified behavioral and social intervention clinical trials with a strong readiness plan, clear milestones, and an implementation strategy that can succeed in real-world research settings. The UG3/UH3 format is especially relevant for complex interventions where careful planning, operational testing, and documented feasibility are essential before launching a full clinical trial, and the cooperative agreement structure emphasizes active coordination with NIDCR throughout both phases.Apply for PAR 21 197
- 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 2021-04-01.
- Applicants must submit their applications by 2021-09-07. (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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FAQs: NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) - PAR-21-197
What is this funding opportunity?
This opportunity is the NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), an NIH funding opportunity announcement (FOA) from the National Institute of Dental and Craniofacial Research (NIDCR). It is designed to support the full lifecycle of certain oral health-related behavioral and social intervention clinical trials, from planning through implementation, using a milestone-driven phased structure.
Which NIH institute is sponsoring this FOA?
The FOA is sponsored by the National Institute of Dental and Craniofacial Research (NIDCR), which is part of the National Institutes of Health (NIH).
What is the FOA number for this opportunity?
The FOA number provided is PAR-21-197.
What is the main purpose of the UG3/UH3 phased model?
The main purpose of the UG3/UH3 phased model is to reduce risk and improve trial readiness by funding an initial planning/start-up phase (UG3) with clear readiness milestones, and only allowing transition to the implementation phase (UH3) if the project demonstrates it is truly ready to launch and meet agreed-upon benchmarks.
What does "Clinical Trial Required" mean for applicants?
"Clinical Trial Required" means the application must propose a clinical trial. The opportunity is not intended for observational studies or projects that are purely preparatory research without a proposed clinical trial.
What happens during the UG3 phase?
The UG3 phase serves as the planning and start-up period. Typical UG3 activities include finalizing the clinical trial protocol, refining the behavioral or social intervention and how it will be delivered, confirming recruitment and retention strategies, setting up data collection and data management systems, training staff, ensuring regulatory and ethical approvals are on track, and demonstrating feasibility through predefined readiness milestones.
What happens during the UH3 phase?
The UH3 phase is the implementation stage. During UH3, the clinical trial is conducted: participants are enrolled, the intervention is delivered, outcomes are measured, and the study is managed through to completion.
Is transition from UG3 to UH3 automatic?
No. Transition from UG3 to UH3 is contingent on meeting predefined milestones and agreed-upon benchmarks that demonstrate readiness to proceed with full clinical trial implementation.
Why does this FOA use milestones?
The milestone-driven approach is intended to prevent trials from stalling after award due to unresolved operational issues. It ensures that key planning and readiness work is completed before large-scale implementation resources are committed.
What kind of award mechanism is this?
This opportunity uses a cooperative agreement mechanism, specifically the UG3/UH3 phased cooperative agreement model.
How is a cooperative agreement different from a standard research grant in this context?
A cooperative agreement indicates more involved partnership from NIH/NIDCR during the award. Based on the information provided, applicants should expect substantial scientific or programmatic involvement from NIH staff, including oversight, monitoring progress toward milestones, and helping ensure the trial aligns with NIH expectations for rigor, safety, and data quality.
What should applicants expect regarding NIH/NIDCR involvement?
Applicants should expect progress and milestone achievement to be closely tracked, with NIH/NIDCR participating in oversight and monitoring and taking an active role consistent with the cooperative agreement structure.
What types of projects is this opportunity intended to support?
The FOA is intended to support behavioral and social intervention clinical trials in oral health and related areas covered by NIDCR, particularly where careful planning, operational testing, and documented feasibility are important before launching a full trial.
Who is eligible to apply?
Eligibility is broad across many U.S.-based organization types. Eligible applicants include 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 Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofit organizations with or without 501(c)(3) status (with the noted limitation described in the provided eligibility list); for-profit organizations other than small businesses; and small businesses.
Are specific institution types explicitly highlighted as eligible?
Yes. The information provided explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, and U.S. territories or possessions.
Are non-U.S. (foreign) entities allowed to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Are non-domestic components of U.S. organizations allowed?
No. Non-domestic components of U.S. organizations are not eligible.
Are foreign components allowed under NIH definitions?
No. Foreign components (as defined by NIH in its Grants Policy Statement) are not allowed under this opportunity.
Does the work need to be conducted in domestic settings?
Yes. Based on the eligibility and foreign involvement restrictions described, applications must be led and carried out entirely within eligible domestic settings.
What is the CFDA number listed for this opportunity?
The opportunity is listed under CFDA 93.121.
What funding category and type is this described as?
It is described as an NIH discretionary funding opportunity in the health category, with the funding instrument type identified as a cooperative agreement.
What are the key dates provided?
The posting creation date provided is April 1, 2021, and the original closing date provided is September 7, 2021.
Is the award ceiling provided?
No. The award ceiling is not specified in the information provided.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the information provided.
Where should applicants look for budget limits, scope expectations, and other detailed constraints?
Because the award ceiling and expected number of awards are not specified in the provided data, applicants would typically need to consult the full FOA text and NIH budget guidance for detailed constraints, limits, and expectations related to budget and project scope.
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