Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) | PAR 22 192

Opportunity Information: Apply for PAR 22 192

The PAR-22-192 funding opportunity from the National Institutes of Health supports the creation and operation of a Clinical Coordinating Center (CCC) to run an investigator-initiated, multi-site clinical trial that aligns with the mission of the National Heart, Lung, and Blood Institute (NHLBI). The trial must meet the NIH definition of a clinical trial and can take several forms, including efficacy trials, comparative effectiveness trials, pragmatic trials, and implementation research trials. In practical terms, this FOA is aimed at teams that already have a clear clinical trial concept and need to build the centralized leadership and operational infrastructure required to execute that trial across multiple sites with consistent procedures, high-quality oversight, and credible results.

A key feature of this opportunity is that it uses a cooperative agreement mechanism, meaning NHLBI will have substantial involvement in the project rather than acting only as a passive funder. It is also milestone-driven and uses a two-phase UG3/UH3 structure. The UG3 phase is typically used to complete startup and readiness activities (for example, finalizing key protocol and operational elements, preparing sites, and satisfying pre-specified milestones). The UH3 phase is intended for full trial implementation once the milestones are met. This design is meant to reduce risk by ensuring a trial is truly ready before large-scale implementation funding proceeds.

The CCC application is expected to do more than describe the clinical question. Applicants need to provide a persuasive scientific rationale for the trial and a detailed operational blueprint for how it will actually be carried out across sites. The FOA emphasizes core coordinating-center responsibilities such as project management; site coordination; training and support for participating sites; subject recruitment and retention strategies; quality management; tracking and meeting performance milestones; ensuring rigorous scientific conduct; and planning for dissemination of results. In other words, NHLBI is looking for applicants who can show they have both a strong trial concept and the hands-on, real-world management plan to deliver the study on time, on budget, and with high protocol fidelity.

This FOA is explicitly designed to run in parallel with a companion announcement for a Data Coordinating Center (DCC) (listed as PAR-22-NNN in the provided text). A major requirement is that both a CCC application and a collaborating DCC application must be submitted for the same due date for NHLBI to consider the package. That requirement signals that NHLBI expects a complete, integrated trial leadership structure: one component focused on clinical operations and site execution (CCC) and a complementary component focused on data management and related functions (DCC). The CCC application therefore needs to make clear how it will work with the DCC, including coordination plans, division of responsibilities, and communication pathways that support smooth trial operations.

The opportunity is broad in who may apply. Eligible applicants include many types of U.S. government entities (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses, along with Native American tribal governments (federally recognized) and other tribal organizations. The FOA also highlights additional eligible groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations. This wide eligibility reflects the reality that large, multi-site clinical trials often depend on partnerships across academic, healthcare, community, and public-sector settings.

Administratively, this is a discretionary health funding opportunity under NIH, using the cooperative agreement funding instrument. It is associated with CFDA numbers 93.233 and 93.837 through 93.840, which correspond to NIH/NHLBI-related research and program areas. The opportunity was created on 2022-07-12, and the listed closing date is 2025-09-11. The summary information provided does not specify an award ceiling or the expected number of awards, so applicants typically need to consult the full FOA text and any related NHLBI guidance for budget expectations, allowable costs, and any limits that may apply.

Finally, the FOA strongly encourages applicants to contact the relevant NIH scientific/research contact before submitting. For a complex cooperative agreement and a linked CCC/DCC submission requirement, early communication can help applicants confirm fit with NHLBI priorities, clarify expectations for the UG3-to-UH3 milestones, and avoid misalignment on trial scope, infrastructure, or readiness assumptions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative 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): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2022-07-12.
• Applicants must submit their applications by 2025-09-11. (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 22 192

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