Limited Competition for the Continuation of Multisite Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Optional) | PAR 21 116

Opportunity Information: Apply for PAR 21 116

The opportunity titled "Limited Competition for the Continuation of Multisite Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Optional)" (Funding Opportunity Number PAR-21-116) is a National Institutes of Health cooperative agreement meant to fund a competing renewal of an existing Data Coordinating Center (DCC) for an ongoing multisite clinical trial supported by the National Center for Complementary and Integrative Health (NCCIH). In plain terms, this is not aimed at launching a brand-new clinical trial. It is designed for situations where an NCCIH-supported trial is already underway and needs additional time and coordinating resources either to finish the remaining data collection or to extend follow-up long enough to properly measure longer-term outcomes.

A key feature of this FOA is the reason for the continuation: NCCIH will consider supporting an extension when there is a clear need for more time to complete the trial as originally planned, or when longer follow-up is strongly justified scientifically (for example, when meaningful clinical effects, durability of response, safety signals, relapse, or other outcomes are expected to emerge later). The renewal application must lay out a detailed and realistic plan to complete trial data collection and close out the study cleanly. The DCC is expected to provide the backbone functions that keep a multisite trial running in a coordinated, compliant, and analyzable way, including overall project coordination, administrative oversight related to data operations, robust data management, and biostatistical support.

Functionally, NCCIH is looking for a DCC renewal plan that demonstrates it can manage the full data lifecycle for the ongoing study: maintaining and refining data systems, overseeing data quality and completeness, ensuring consistent data collection across sites (if sites are still active), supporting timely monitoring and reporting, and carrying out the statistical work needed to support interim and final analyses. Because this is a cooperative agreement (U24), the relationship is more collaborative than a typical research grant, meaning NIH program staff generally have substantial involvement and expectations around coordination, performance, and deliverables.

The FOA also explains how the coordinating structure can be proposed depending on what remains to be done. If the trial still requires active clinical-site operations (for example, participant visits, site-based follow-up, or on-site procedures), then NCCIH allows two linked renewals to be submitted at the same time: one for the Data Coordinating Center (DCC) and a corresponding renewal for a Clinical Coordinating Center (CCC), if both are necessary to finish the work. On the other hand, if the remaining data collection and follow-up can be handled centrally without continued in-person site visits, then the applicant may submit only the DCC competing renewal, with the DCC taking on the remaining centralized follow-up and data tasks.

Eligibility is broad and spans 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; federally recognized tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations other than small businesses; small businesses; and other entities. The FOA explicitly highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply; however, foreign components as defined under the NIH Grants Policy Statement are allowed, which typically means a limited, justified portion of the work may be performed outside the U.S. under NIH rules while the applicant organization remains U.S.-based.

Administratively, this is a discretionary health funding opportunity under CFDA (now commonly referred to as Assistance Listing) 93.213. The award ceiling listed is $500,000, signaling the maximum amount expected per award under this announcement (actual budgets still need to be justified based on the remaining scope and the specific trial’s needs). The posting notes an original closing date of 2023-09-27 and a creation date of 2021-02-01, which is helpful context for timing, although applicants typically need to confirm current receipt dates and status in the live NIH/Grants.gov listing and any notices of special interest or updates.

Finally, NCCIH strongly encourages prospective applicants to contact the designated Scientific/Research contact for the specific ongoing clinical trial before submitting. That instruction matters because this FOA is a limited competition renewal tied to existing NCCIH-supported trials, and early communication helps confirm fit, clarify what remains in scope, align expectations about coordinating-center responsibilities, and ensure the renewal request is appropriate for the trial’s stage and needs. In short, the FOA is essentially a continuation mechanism for the data and statistical coordination infrastructure of an ongoing NCCIH multisite clinical trial, focused on completing high-quality data collection and follow-up so the study can reach defensible, publishable conclusions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of Multisite Clinical Trial Data Coordinating Center (Collaborative U24 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.

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