NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) | PAR 21 160

Opportunity Information: Apply for PAR 21 160

The NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), PAR-21-160, is a National Institutes of Health (NIH) funding opportunity designed to support investigator-initiated clinical trials that fit within the mission of the National Institute of Dental and Craniofacial Research (NIDCR). The core idea is to fund trials in two linked stages under a cooperative agreement mechanism, meaning NIH/NIDCR staff are expected to have substantial involvement during the project (for example, through ongoing coordination, milestone tracking, and programmatic stewardship) rather than operating as a purely hands-off grant.

This FOA uses a phased UG3/UH3 structure. The first phase (UG3) provides up to one year of support specifically for milestone-driven planning and feasibility work. In practical terms, this phase is meant to de-risk the trial before major resources are committed. Applicants are expected to use the UG3 period to finalize the key building blocks needed for a successful trial, such as the protocol and manual of procedures, clinical site readiness, recruitment and retention strategies, staffing and training plans, data management systems, safety monitoring plans, regulatory and IRB approvals as applicable, and clear operational benchmarks that demonstrate the trial is ready to launch.

Transition to the second phase (UH3) is not automatic. Only projects that meet the prespecified UG3 scientific milestones and feasibility requirements are eligible to move forward. If those milestones are achieved, the award can transition to the UH3 implementation phase for up to five additional years. The UH3 phase funds the actual conduct of one investigator-initiated clinical trial, including activities like participant enrollment, intervention delivery, follow-up assessments, data collection, monitoring, and analysis consistent with the approved trial plan. Because the UG3 and UH3 are connected, applicants must submit them together as a single, integrated application, with the planning and implementation components aligned and with clear go/no-go criteria for the phase transition.

Eligible applicants are broad and include many types of U.S.-based organizations and governments: state, county, city/township, and 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 (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where noted in the eligibility categories); for-profit organizations (other than small businesses); small businesses; and other entities that meet NIH eligibility rules. The FOA also explicitly highlights additional eligible applicant categories, 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, tribal governments other than federally recognized, and U.S. territories or possessions.

Foreign participation is restricted. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined in the NIH Grants Policy Statement) are not allowed. In effect, the applicant organization and the work supported under this FOA must be structured as domestic U.S. efforts without foreign components.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. It falls under the health funding activity category and is associated with CFDA 93.121. The sponsoring agency is NIH, with NIDCR as the relevant institute. The opportunity was created on March 4, 2021, and the listed original closing date is January 8, 2025. The FOA does not provide an award ceiling in the provided summary, and the expected number of awards is not specified in the provided data.

Overall, this program is aimed at well-developed clinical trial concepts that still need a structured, accountable planning runway before full execution. Applicants are expected to propose a rigorous, feasible trial and to define concrete, measurable milestones for the UG3 year that demonstrate readiness to enroll participants and run the study at scale during the UH3 phase.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR 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 2021-03-04.
• Applicants must submit their applications by 2025-01-08. (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 21 160

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