Limited Competition: Biospecimen Banks to support NCI National Clinical Trials Network (NCTN)(U24 Clinical Trial Not Allowed) | RFA CA 20 002

Opportunity Information: Apply for RFA CA 20 002

The grant opportunity titled "Limited Competition: Biospecimen Banks to support NCI National Clinical Trials Network (NCTN) (U24 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-CA-20-002) is a National Cancer Institute (NCI) cooperative agreement meant to renew support for a small number of established biospecimen banks that serve major NCI-funded clinical trial programs. It is set up as a limited competition renewal, meaning it is aimed at continuing the work of existing, designated biobanks rather than launching brand-new banks from scratch. The overarching purpose is to ensure that NCI clinical trials, especially later-stage treatment trials, have reliable, high-quality biospecimen infrastructure that can keep pace with modern biomarker science and data standards.

At the center of the announcement is the expectation that funded NCTN Biobanks will collect, process, store, and distribute well-annotated human cancer specimens from patients enrolled in NCI-supported trials. The primary trial ecosystem served is the NCI National Clinical Trials Network (NCTN), particularly NCI-funded Phase II and Phase III studies and other NCI clinical treatment trials overseen through the Cancer Therapy Evaluation Program within the Division of Cancer Treatment and Diagnosis. In practical terms, the biobanks are expected to function as the operational backbone for specimen handling across multi-site trials, ensuring that tissues and other human specimens are managed using consistent, state-of-the-art procedures and that the specimen inventory is continuously maintained, current, and traceable.

A defining feature of the program is that the specimens are not just stored; they must be connected to strong clinical annotation. The FOA emphasizes distributing biospecimens to qualified investigators together with high-quality clinical data, including details such as treatment received and patient outcomes. This linkage is essential because it enables research that can discover, test, and validate biomarkers for cancer diagnosis, prognosis, and prediction of response to therapy. In other words, the biobanks are intended to make specimens maximally useful for translational and clinical research by pairing physical samples with the clinical context needed to interpret them.

The announcement also lays out an embedded collaboration model. Each NCTN Biobank must be formally associated with one specific NCTN Group and must be endorsed by that group’s leadership for the biobank role. This requirement is meant to ensure clear lines of responsibility and close integration with the cooperative group system that designs and runs trials. In addition, the biobanks are expected to work closely with NCTN Groups, the Groups’ Statistical and Data Management Centers, and affiliated institutions so that specimen operations align with trial workflows, data capture, and governance. Because this is a cooperative agreement (U24), NCI is positioned to have substantial programmatic involvement, typically translating into shared expectations around standards, coordination, and performance.

Beyond NCTN treatment trials, the FOA explicitly extends the biobanks’ responsibilities to support the NCI Community Oncology Research Program (NCORP), specifically cancer control and prevention trials managed through the Division of Cancer Prevention. This indicates the banks are expected to handle a broader portfolio than purely therapeutic studies, including biospecimen banking and longer-term storage needs that arise in prevention and control research conducted across community-based oncology settings.

Administratively, the opportunity is offered by the U.S. Department of Health and Human Services through the National Institutes of Health, National Cancer Institute. It uses the cooperative agreement funding instrument and is categorized under education and health (CFDA 93.394). Eligible applicants are public and state-controlled institutions of higher education, reflecting the expectation that awardees have the institutional infrastructure, compliance environment, and operational maturity required for large-scale biobanking tied to national clinical trials. The posted award ceiling is $3,000,000, and NCI anticipated making about five awards under this announcement. The FOA was created on October 24, 2019, with an original closing date of December 17, 2019.

Overall, this FOA is designed to keep the national clinical trials enterprise supplied with consistently handled, well-documented biospecimens and the associated clinical data necessary for modern oncology biomarker research. It prioritizes operational excellence (collection through distribution), tight integration with NCTN cooperative groups and their data centers, and service to both treatment-focused NCTN studies and prevention/control-focused NCORP trials, with the end goal of accelerating clinically meaningful biomarker development and validation.

• The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Limited Competition: Biospecimen Banks to support NCI National Clinical Trials Network (NCTN)(U24 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): 93.394.
• This funding opportunity was created on Oct 24, 2019.
• Applicants must submit their applications by Dec 17, 2019. (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 $3,000,000.00 in funding.
• The number of recipients for this funding is limited to 5 candidate(s).
• Eligible applicants include: Public and State controlled institutions of higher education.

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