NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3) - Clinical Trial Required | PAR 18 547

Opportunity Information: Apply for PAR 18 547

The NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3) is an NIH funding opportunity designed specifically to help research teams move a clinical trial from a well-developed idea into a fully executed study. It uses a phased structure, meaning applicants propose both the planning work and the trial itself in one combined application, but funding is released in stages. The award starts with a short, milestone-driven planning period (the UG3 phase) lasting about one year, and only projects that clearly meet predefined feasibility and readiness milestones are allowed to transition into the longer implementation period (the UH3 phase), which can support up to five additional years of clinical trial conduct. This structure is meant to reduce the risk of launching trials that are not operationally ready, while still giving strong teams a clear pathway to full support once they have the essentials in place.

During the UG3 planning phase, the focus is on building everything needed to run a high-quality clinical trial rather than generating new early evidence about whether the intervention works. The FOA is explicit that UG3 is not intended for collecting preliminary efficacy data, such as animal studies or human observational data meant to strengthen the scientific rationale for the trial. Instead, the UG3 year is used to finalize the study team and produce the core operational and scientific documents and systems required before enrolling participants under the UH3 phase. Typical UG3-supported deliverables include a finalized clinical protocol, a Clinical Investigators Brochure (or equivalent documentation when appropriate), the data management system and related tools for data capture, quality control, and quality management, and the full set of oversight and operational plans. This includes safety monitoring and operational oversight plans, recruitment and retention strategies, and other essential trial materials such as a Manual of Procedures that standardizes how the study will be run across staff and sites. The FOA also allows, but does not require, evaluation of the potential participant pool during UG3, including assessing whether individuals are likely to meet eligibility criteria for the later trial, which can help confirm feasibility of enrollment targets.

If the UG3 milestones are achieved and NIH determines the project is ready, the award can transition to the UH3 phase. The UH3 phase supports the actual conduct of one investigator-initiated clinical trial. The trial is intended to evaluate the safety and/or efficacy of an intervention, and the announcement leaves room for various kinds of interventions so long as the study is a true clinical trial and aligns with NIDCR priorities (NIDCR is the National Institute of Dental and Craniofacial Research). Because this is a cooperative agreement rather than a standard grant, applicants should expect substantial programmatic involvement from NIH staff, with an emphasis on milestone tracking, performance oversight, and collaborative management to ensure the trial stays on schedule and meets agreed-upon objectives.

Eligibility is broad across U.S.-based organizations and includes many government, academic, nonprofit, and private-sector entities. Eligible applicants listed include state, county, and local governments; special districts; 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; for-profit organizations (other than small businesses) as well as small businesses; and federally recognized Native American tribal governments and certain tribal organizations. The FOA also highlights additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, the opportunity is restricted to domestic applicants: non-U.S. (foreign) organizations are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them in its Grants Policy Statement) are not allowed under this announcement.

Administratively, the opportunity is issued by the National Institutes of Health under a discretionary funding category and uses the Cooperative Agreement mechanism. The funding opportunity number is PAR-18-547, and the CFDA number is 93.121. The source information provided lists an original closing date of March 5, 2021, and an award ceiling of $400,000 (as presented in the dataset), though applicants typically confirm current budget rules and any updates directly in the full FOA and related NIH policy notices. Overall, the core purpose of this FOA is to fund clinical trials in a disciplined way: first paying for the concrete planning work needed to ensure a trial is truly ready to launch, then funding full implementation only when feasibility and operational readiness have been convincingly demonstrated.

• 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 2017-12-21.
• Applicants must submit their applications by 2021-03-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $400,000.00 in funding.
• 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 18 547

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