Limited Competition for the Continuation or Revision of Multisite Clinical Trial Clinical Coordinating Center (Collaborative UH3 Clinical Trial Optional) | PAR 21 117

Opportunity Information: Apply for PAR 21 117

This grant opportunity (PAR-21-117) from the National Institutes of Health, through the National Center for Complementary and Integrative Health (NCCIH), is a limited-competition cooperative agreement aimed at supporting the continuation or modification of multisite clinical trials that NCCIH is already funding. It is not meant to launch brand-new, unrelated trials. Instead, it focuses on two main scenarios: (1) a competing renewal to continue operating a Clinical Coordinating Center (CCC) for an ongoing NCCIH-supported clinical trial, or (2) a competitive revision to add an ancillary study to an ongoing NCCIH-supported clinical trial when there is a strong scientific reason to do so.

A key purpose of the announcement is to allow trials that are already underway to successfully finish their work when circumstances justify additional support. NCCIH will consider extensions when a trial needs more time to complete core trial activities, or when a longer follow-up period is clearly justified to measure longer-term outcomes that cannot be captured within the original timeline. In parallel, NCCIH will also consider competitive revisions when investigators can make a compelling case that adding an ancillary study will substantially increase the scientific value of the parent trial. The expectation is that these additions are well-integrated with the existing study, feasible within the trial infrastructure, and justified by clear research questions rather than being exploratory add-ons.

The CCC is positioned as the operational and scientific hub for the clinical trial. Applications are expected to present the trial's design logic and scientific rationale, along with a complete operational plan that shows how the study will be executed across sites. The CCC is typically responsible for high-level project management, coordinating multisite operations, developing and implementing participant recruitment and retention strategies, tracking progress against performance milestones, and ensuring the trial is conducted rigorously and consistently across locations. The CCC is also expected to play a leading role in communicating and disseminating results, reflecting NIH expectations for transparency, timely reporting, and responsible publication practices.

Because multisite trials often require both a Clinical Coordinating Center and a Data Coordinating Center (DCC), the FOA emphasizes coordination between these components. If both a DCC and a CCC are needed to complete the ongoing trial, NCCIH expects the applications to be submitted at the same time so they can be considered together. This signals that NCCIH is looking for an integrated management, data, and oversight structure where operational coordination and data/statistical coordination are aligned, with clear delineation of responsibilities and strong communication channels between the CCC and DCC teams.

Another important practical feature is that applicants are strongly encouraged to communicate early with the appropriate NCCIH Scientific/Research contact connected to the ongoing trial before submitting a competing renewal or competitive revision under this FOA. That pre-submission contact is meant to reduce misalignment on scope, confirm fit with NCCIH expectations for the specific parent trial, and clarify whether the proposed extension or ancillary work is appropriate for this mechanism and timeline.

In terms of eligibility, the FOA is broad and includes many U.S.-based organizational types that commonly apply for NIH funding, such as state and local governments, public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses), and small businesses, as well as federally recognized tribal governments and other tribal organizations. It also explicitly notes additional eligible applicant categories often highlighted by NIH, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander serving institutions, along with faith-based and community-based organizations and eligible federal agencies.

At the same time, the FOA draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as applicants. However, foreign components (as defined in NIH policy) are allowed, meaning a U.S. applicant organization may include certain foreign elements in the project when permitted under NIH rules and justified scientifically, even though foreign institutions themselves cannot serve as the applicant organization for this particular opportunity.

Administratively, this is a discretionary funding opportunity using the cooperative agreement instrument, which typically implies substantial NIH programmatic involvement compared to a standard grant. The activity category is health, and the CFDA number listed is 93.213. The listed award ceiling is $500,000, and the original closing date provided is 2023-09-27. Overall, the announcement is designed to help NCCIH-supported multisite clinical trials reach completion successfully or expand in carefully justified ways, with the CCC serving as the central engine for trial coordination, execution, and results dissemination.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for the Continuation or Revision of Multisite Clinical Trial Clinical Coordinating Center (Collaborative 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): 93.213.
• This funding opportunity was created on 2021-02-01.
• Applicants must submit their applications by 2023-09-27. (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 $500,000.00 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 21 117

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