Limited Competition: Biospecimen Bank to Support NCI Early-Phase and Experimental Clinical Trials (U24 Clinical Trials Not Allowed) | RFA CA 20 003

Opportunity Information: Apply for RFA CA 20 003

This limited-competition NIH/NCI funding opportunity (RFA-CA-20-003) supports a single, specialized effort to maintain and operate a high-quality biospecimen banking program for NCI-sponsored early-phase and experimental cancer clinical trials. The award mechanism is a U24 cooperative agreement, which means the funded organization would not simply receive money to run a project independently; it would carry out the work in close coordination with NCI staff, following agreed-upon milestones, policies, and operational expectations. Although the FOA uses the U24 activity code, it explicitly states that clinical trials are not allowed under this award. In practical terms, the purpose is infrastructure and operations that enable trials, not running trials themselves.

The core goal is to sustain and modernize the biobanking infrastructure that supports the Experimental Therapeutics Clinical Trials Network (ETCTN) and other NCI-supported early and experimental trials. These studies often rely on timely, standardized handling of patient-derived materials so that correlative science, biomarker analyses, pharmacodynamic studies, and other laboratory assessments can be performed reliably across multiple sites. The FOA emphasizes that the biobank must be capable of collecting, processing, and storing a wide range of human biospecimens from cancer patients enrolled in these NCI-funded studies, and then making those specimens available to qualified, NCI-approved investigators and laboratories when needed.

A major structural objective of the opportunity is to separate the biobanking function that currently serves ETCTN and similar early-phase trials from the existing National Clinical Trials Network (NCTN) Biobank. At the time of the announcement, the early-phase/experimental-trials biobanking capability existed as part of a broader biobank primarily serving the NCTN program. NCI’s intent under this FOA is to carve out that ETCTN-serving component and establish it as an independent operation through a separate U24 award. The resulting entity is referred to as the Early-Phase and Experimental Clinical Trials Biospecimen Bank, also called the EET Biobank. Even if the EET Biobank and the “parent” NCTN Biobank are physically housed within the same institution, the FOA expects them to function as distinct biobanks with separate leadership and operational independence. This independence is meant to reduce competing priorities, clarify governance and accountability, and ensure the early-phase and experimental trial community has dedicated, fit-for-purpose biospecimen support.

Operationally, the EET Biobank’s responsibilities extend beyond simple storage. The bank is expected to run end-to-end specimen operations that typically include coordinated specimen intake from participating clinical sites, standardized processing and preservation steps, long-term storage under controlled conditions, comprehensive documentation, and ongoing quality practices. A specific duty highlighted in the FOA is maintaining an up-to-date specimen inventory, meaning a robust tracking system that records what specimens exist, their condition and quantities, associated metadata, and their availability for approved uses. In addition, the biobank must support specimen distribution, supplying materials to qualified NCI-approved trial investigators and research laboratories in a controlled, documented manner consistent with study protocols, patient consent, and applicable regulatory and ethical requirements.

Eligibility is restricted, reflecting the “limited competition” nature of the announcement. The provided source data lists eligible applicants as public and state-controlled institutions of higher education, signaling that the competition is targeted rather than broadly open. The FOA also clearly excludes foreign participation: non-U.S. (non-domestic) entities cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. Applicants are directed to the full funding announcement for any additional eligibility constraints and details.

Key administrative details from the source information include the sponsoring agency (National Institutes of Health, with NCI as the driving program), the funding instrument (cooperative agreement), and the activity focus (education and health, aligned with CFDA number 93.394). The original application closing date was January 2, 2020, and the announcement was created on November 12, 2019. The award ceiling and expected number of awards were not specified in the provided extract, which is common in some FOAs where budgeting depends on the proposed scope and NCI program needs.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Limited Competition: Biospecimen Bank to Support NCI Early-Phase and Experimental Clinical Trials (U24 Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394.
• This funding opportunity was created on 2019-11-12.
• Applicants must submit their applications by 2020-01-02. (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.

Apply for RFA CA 20 003

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