NIDCR Drug, Biologic, Device and/or Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) | PAR 25 057

Opportunity Information: Apply for PAR 25 057

The NIDCR Drug, Biologic, Device and/or Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) is an NIH funding opportunity (PAR-25-057) designed to support the full lifecycle of an intervention-focused clinical trial that fits squarely within the National Institute of Dental and Craniofacial Research (NIDCR) mission. The emphasis is on studies that test a drug, biologic, device, and/or procedure relevant to dental, oral, and craniofacial health. This program uses a phased UG3/UH3 structure, meaning applicants are expected to first complete a planning and start-up phase and then transition into an implementation phase, rather than proposing a trial that launches immediately at full scale.

The award mechanism is a cooperative agreement, which is different from a standard research grant because NIH (through NIDCR) typically has substantial programmatic involvement during the project. In practice, this usually means more active coordination with NIH staff around key scientific, operational, and oversight milestones, especially for the transition from the planning phase (UG3) to the implementation phase (UH3). The “Clinical Trial Required” designation signals that applications must include a clinical trial; this is not a planning grant in the abstract, but a funding path intended to move an intervention trial from readiness work into actual execution.

The UG3 phase is intended to support the concrete planning activities needed to ensure the trial is genuinely ready to enroll participants and run reliably. While the posting does not list specific milestones, UG3 phases in NIH UG3/UH3 programs commonly focus on finalizing the protocol and statistical analysis plan, completing site selection and readiness activities, setting up data and safety monitoring processes, establishing study operations and quality management plans, preparing case report forms and data systems, ensuring regulatory and ethics approvals are on track, and confirming feasibility elements such as recruitment pipelines, staffing, training, and intervention supply or device logistics. The UH3 phase supports the actual conduct of the trial once prespecified “go/no-go” criteria are met, including participant enrollment, intervention delivery, follow-up, data collection, monitoring, and analysis aligned with the approved protocol.

Eligibility is broad and includes many types of U.S.-based organizations and governments. 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; nonprofit organizations (with or without 501(c)(3) status, other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as tribal organizations that are not federally recognized tribal governments. The announcement also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions.

A key restriction is that non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, “foreign components” as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant organization may include certain foreign involvement or performance sites under NIH’s foreign component rules, as long as the applicant itself is domestic and compliant with the stated restrictions.

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. It falls under the health funding activity category and lists CFDA number 93.121. The sponsoring agency is the National Institutes of Health. The opportunity record shows a creation date of 2024-10-23, and an original closing date of 2028-01-06, indicating a multi-year window in which applications may be accepted according to the opportunity’s submission schedule. The posting does not specify an award ceiling or expected number of awards in the provided text, so prospective applicants would need to consult the full NIH funding opportunity announcement for budget limits, project period details, key dates (including standard receipt dates), and any NIDCR-specific expectations for trial design, milestone structure, and cooperative agreement terms.

Overall, this program is best suited for teams that are ready to run a rigorously designed dental, oral, or craniofacial intervention trial but need structured support to complete the final planning, infrastructure build-out, and readiness checks before launching full implementation. The UG3/UH3 structure is meant to reduce the risk of trial delays and failures by requiring clear early progress and feasibility before the study moves into the more resource-intensive clinical trial execution phase.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Drug, Biologic, Device and/or Procedure 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 2024-10-23.
• Applicants must submit their applications by 2028-01-06.
• 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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