Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed) | RFA AI 23 065

Opportunity Information: Apply for RFA AI 23 065

The Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed) funding opportunity (RFA-AI-23-065) is a National Institutes of Health (NIH) cooperative agreement designed to build and support multidisciplinary translational research centers that can move promising anti-infective ideas closer to real-world medical use. The overall aim is to accelerate the generation, validation, and advancement of medical countermeasures targeting specific high-priority bacterial or fungal pathogens identified in the NOFO, particularly organisms with known and emerging resistance to existing therapies. In practical terms, NIH is looking for center-style programs that combine expertise across fields (for example, microbiology, immunology, medicinal chemistry, pharmacology, diagnostics development, bioinformatics, and translational/clinical laboratory science) and can demonstrate a clear plan to push candidate countermeasures through rigorous preclinical and translational development steps, without conducting clinical trials under this mechanism.

This opportunity uses the U19 activity code and is explicitly labeled “Clinical Trial Not Allowed,” which means the supported work is intended to stay on the translational research side rather than funding human subject clinical trial activities. Applicants are expected to propose coordinated projects and shared resources that function like a cohesive center, not a set of loosely connected studies. The emphasis is on translational readiness: producing strong validation datasets, demonstrating feasibility, and addressing key development questions that typically stall medical countermeasure progress against antimicrobial-resistant threats. While the NOFO text referenced here does not list the organisms, it indicates that the target bacteria or fungi must be among those specified by the solicitation and must be relevant to resistance challenges.

Awards are made as cooperative agreements, which is important because it signals substantial programmatic involvement from NIH staff compared with a standard research grant. In cooperative agreements, the funding agency typically plays an active partnership role in areas like milestone setting, progress review, coordination across funded centers, data/resource sharing expectations, and alignment with broader program goals. The activity category is Health, and the associated CFDA number is 93.855, indicating it sits within NIH’s infectious disease and related biomedical research funding streams.

The program allows applications from a wide range of organization types, reflecting an interest in drawing in academic, nonprofit, government, and industry capabilities where they can best support translation. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as listed); for-profit organizations (other than small businesses); small businesses; and other entities. The NOFO also explicitly calls out additional eligible applicant categories such as 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); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal government agencies; regional organizations; U.S. territories or possessions; and non-U.S. entities (foreign organizations). This breadth suggests NIH is open to single institutions or consortia that can assemble the right mix of capabilities, including international partners when scientifically justified.

From a funding standpoint, the listed award ceiling is $5,000,000, indicating that NIH anticipates relatively large, center-scale budgets that can support multiple integrated components such as project cores, shared platforms, specialized assays, translational services, and coordinated management. The original application closing date provided is April 29, 2024, and the posting (creation) date is December 13, 2023. While the “Expected Awards” field is not populated in the provided text, the combination of a high ceiling and a cooperative agreement mechanism typically implies a competitive, selective program with a limited number of funded centers.

In summary, this CETR opportunity is geared toward teams that can operate as a true translational research center focused on antimicrobial-resistant bacterial or fungal threats named in the NOFO, producing actionable preclinical and translational outputs that de-risk and advance medical countermeasures. It is not meant for clinical trials, but rather for the integrated research and development work that bridges discovery and later-stage testing, supported through an NIH cooperative agreement with active NIH engagement and coordination.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2023-12-13.
• Applicants must submit their applications by 2024-04-29. (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 $5,000,000.00 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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