Limited Competition: Biospecimen Banks to support NCI National Clinical Trials Network Biospecimen Banks (NCTN Biobanks) and the NCI Early-Phase and Experimental Clinical Trials Biospecimen Bank (EET Biobank) (U24 Clinical Trial Not Allowed)

Through this limited competition Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications to support continuation of the two distinct biospecimen banking resources: • The National Clinical Trials Network (NCTN) Biospecimen Banks (NCTN Biobanks) support the NCI-funded NCTN and the Community Oncology Research Program (NCORP), and • The Early-Phase and Experimental Clinical Trials Biospecimen Bank (EET Biobank) support the Experimental Therapeutics Clinical Trials Network (ETCTN) and NCI-supported other early phase and experimental clinical trials. The objective is to maintain these robust national resources for continuing the collection, processing, storage, and distribution of high-quality, clinically annotated human biospecimens. The goal of these resources is to ensure availability of biospecimens from participants in NCI-funded clinical trials focused on treatment, prevention, and cancer control studies to enable translational cancer research. NCTN Biobanks support the biobanking operations of the NCTN funded through the Cancer Therapy Evaluation Program (CTEP) and NCORP funded through the Division of Cancer Prevention (DCP). The clinical trials conducted through NCTN and NCORP enroll thousands of patients with adult and childhood cancers each year. NCTN Biobank operations aim to facilitate hypothesis-driven biomarker development and validation, secondary research studies, and broader scientific discovery. Biospecimens collected through harmonized protocols and long-term follow-up across large multi-site clinical trials provide valuable resources for studying disease mechanisms, therapeutic response, and clinical outcomes in different types of cancers. This NOFO will also support the continuation of the EET Biobank, a dedicated resource with a primary focus on meeting the biospecimen banking needs of the ETCTN and other early-phase and experimental clinical trials involving investigational new drugs (INDs). Biospecimens collected from the early phase clinical trials enable validated biomarker assay development, pharmacokinetic and pharmacodynamic studies, investigation of drug action and resistance mechanisms, improved patient stratification, and broader scientific discovery. Unlike the NCTN Biobank, the EET Biobank bridges basic science and clinical applications that enable acceleration of NCI’s IND...

Other Eligible ApplicantsFor the NCTN Biobanks: Eligibility is limited to an institution/entity that is a recipient of an existing NCTN biobank of human biospecimens from NCI clinical trials funded under RFA-CA-20-002. For the EET Biobank: Eligibility is limited to the institution/entity that is a recipient of an existing EET biobank of human biospecimens from NCI clinical trials funded under RFA-CA-20-003.

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; 2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...