National Dental Practice-Based Research Network Clinical Trial or Observational Study Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Optional) | PAR 20 306

Opportunity Information: Apply for PAR 20 306

The National Dental Practice-Based Research Network Clinical Trial or Observational Study Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Optional) is an NIH funding opportunity (PAR-20-306; CFDA 93.121) designed to support real-world dental research carried out through the National Dental Practice-Based Research Network (National Dental PBRN). The FOA invites applications proposing either clinical trials or large clinical observational studies that can be conducted in everyday practice settings using the Network. The goal is to move beyond small, tightly controlled studies and instead generate evidence that is practical, generalizable, and directly relevant to routine dental care, with research being executed through a milestone-driven, two-phase cooperative agreement structure.

This announcement uses the UG3/UH3 mechanism, which is built around a planning-to-implementation pathway. The UG3 phase supports planning activities needed to get a complex multi-site study ready to launch, such as finalizing the protocol, confirming feasibility within Network practices, putting operational systems in place (recruitment workflows, data capture, training), securing regulatory approvals, and meeting other predefined milestones. If those milestones are successfully met and NIH agrees the project is ready, the award can transition to the UH3 phase to support full study implementation. Because it is a cooperative agreement, NIH staff are expected to have substantial involvement compared to a standard grant, often including collaborative oversight of milestones, progress, and study execution to help ensure the project stays aligned with the Network model and can be completed effectively.

The FOA is categorized as discretionary funding and falls under the health activity area. It is open to a wide range of applicant organizations, reflecting the intent to bring together academic, clinical, community, governmental, and other partners who can run large, practice-embedded dental studies. Eligible applicants include state, county, city or township 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; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA explicitly notes additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Indian/Native American tribal governments other than federally recognized, regional organizations, Tribally Controlled Colleges and Universities (TCCUs), eligible federal government agencies, and U.S. territories or possessions.

At the same time, the opportunity places important limits on foreign involvement. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning certain parts of the work can involve foreign collaboration when it meets NIH policy definitions and is appropriately justified, even though the applicant organization itself must be domestic and the core project structure must fit within the stated eligibility rules.

Operationally, this FOA is centered on studies conducted through the National Dental PBRN, which emphasizes research embedded in routine care settings and often relies on participating dental practices to recruit patients, deliver interventions when applicable, and collect standardized clinical data. The “clinical trial optional” label signals that applicants may propose either a clinical trial or a large observational study, as long as it fits the Network environment and can be managed through the milestone-based UG3 to UH3 progression. The original closing date listed for this opportunity was 2023-09-07, and the FOA record shows a creation date of 2020-10-08. The award ceiling and expected number of awards are not specified in the provided source data, indicating applicants would need to refer to the full FOA text or NIH guidance for budget expectations, allowable costs, and any limits or typical award sizes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "National Dental Practice-Based Research Network Clinical Trial or Observational Study Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Optional)" 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 2020-10-08.
• Applicants must submit their applications by 2023-09-07. (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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