Clinical and Translational Science Award (U54 Clinical Trial Optional) | PAR 18 940

Opportunity Information: Apply for PAR 18 940

The Clinical and Translational Science Award (CTSA) Program funding opportunity, titled "Clinical and Translational Science Award (U54 Clinical Trial Optional)" (Funding Opportunity Number PAR 18-940), is a National Institutes of Health (NIH) discretionary grant competition that uses a cooperative agreement mechanism (U54). In practical terms, this means NIH expects substantial involvement with awardees during the project period, with shared responsibilities and coordinated oversight rather than a hands-off, investigator-only model. The opportunity sits in the health funding activity category (CFDA 93.350) and is designed to strengthen the national clinical and translational research infrastructure by supporting hubs that can move discoveries more efficiently from basic science into clinical application, health practice, and improved patient and community outcomes.

The central purpose of the FOA is to invite institutions to participate as part of the CTSA Program, which emphasizes high-quality translational science and clinical research at local, regional, and national levels. The CTSA model typically aims to make research faster, more rigorous, and more useful by improving methods and processes across the translational pipeline. This includes building and refining research capabilities that help investigators design better studies, recruit and retain participants more effectively, ensure high standards of ethics and regulatory compliance, manage and share data responsibly, and translate results into real-world health impact. A key theme of the announcement is innovation: applicants are expected not only to run strong programs, but also to foster new approaches to translational science, including improved research methods and systems that can be adopted broadly.

Beyond research support, the FOA also highlights training and career development as major program priorities. CTSA hubs are expected to help develop the translational science workforce by offering structured education, mentorship, and career pathways for investigators and research staff. This can involve supporting early-career researchers, providing skills development in clinical research operations and translational methodologies, and creating environments where multidisciplinary teams can form and thrive. The "Clinical Trial Optional" designation signals that proposing a clinical trial is not required for an application to be responsive, though clinical trials may be included if they align with the program goals and meet NIH requirements.

Eligibility is broad across U.S.-based organizations that can lead a major translational science enterprise. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, and nonprofit organizations both with and without 501(c)(3) status (as long as they are not institutions of higher education in those nonprofit categories). The FOA explicitly calls out additional eligible applicant types to encourage participation from institutions that serve historically underrepresented communities, 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), and Tribally Controlled Colleges and Universities (TCCUs). At the same time, the announcement is clear that non-U.S. entities (foreign institutions) cannot apply as the primary applicant, and non-U.S. components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed when defined and justified under the NIH Grants Policy Statement, which generally means a U.S. applicant may include certain well-defined international elements in the project if they are necessary and comply with NIH policy.

From an administrative standpoint, the FOA was created on September 27, 2018, and the original closing date listed is July 15, 2021. The posted source data does not specify an award ceiling or the expected number of awards, which often means applicants need to consult the full FOA text and any related notices to understand budget expectations, hub size assumptions, and NIH’s anticipated funding levels. Overall, this opportunity is best understood as a major NIH infrastructure and capacity-building program for institutions prepared to operate a collaborative translational science hub, advance innovative research practices, and train the next generation of clinical and translational researchers while coordinating closely with NIH under a cooperative agreement structure.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical and Translational Science Award (U54 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
• This funding opportunity was created on 2018-09-27.
• Applicants must submit their applications by 2021-07-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education, 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, Others.

Apply for PAR 18 940

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