Biobanking, Laboratory Analytics, and Associated Informatics Services for NIH Biorepositories

small disadvantaged businesses, and women-owned small businesses); (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) whether commercials sources and services are available in the marketplace. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code 541714 should not submit a response to this notice. This notice is issued to help determine the appropriate acquisition method including small business socioeconomic set aside possibilities and to determine the availability of commercial or non-commercial companies technically capable of meeting the Government's potential requirement. It is not construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Furthermore, it should be noted that any future solicitations that may be issued as a result of this notice, or in response to this requirement, may be issued using a different solicitation number from the one identified above. Purpose NIH is seeking information from qualified R&D firms, small businesses, and subcontractors regarding their capabilities to support the operation, consolidation, and/or recompete of one or more NIH-funded biorepositories for FY 2028, including at a minimum the NIDA Center for Genetic Studies (NCGS) and the NIH Brain Development Cohorts (NBDC) Biobank, which supports the Adolescent Brain Cognitive Development (ABCD) Study, and HEALthy Brain and Child Development (HBCD) Study. This notice also serves to determine the availability of all small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses) with the capability to perform this work. Background NIH currently supports over 20 biorepositories across 10+ Institutes and Centers, with each individual biorepository storing several thousands to over 3.5 million samples. NIH biorepositories have stored, analyzed, and distributed millions of samples of biomaterials to enable broad investigations into the myriad of biological and environmental factors that affect health, development, and disease. These repositories typically: Receive, process, store, and biosamples from a wide range of biospecimen types (e.g. blood/derivatives, fluids, DNA/RNA, hair, cell lines, iPSCs, teeth, fecal matter, birth specimens and other tissues such as brain and other organs) at various temperature and storage conditions (e.g. -80C, liquid nitrogen; fresh, frozen, paraffin-embedded, formalin-fixed) at scales ranging from tens of thousands to several million specimens. Serve dozens to hundreds of research studies across the United States and abroad. Enable broad, controlled-access biomaterial sharing to meet specific research objectives that further our knowledge of health Anticipate continued growth in biospecimen and data volume over the life of the award. Scope of Work & Required Capabilities Capable vendors should provide examples from current or previous projects when responding to capabilities. A. Sample Management and Storage Maintain secure, humidity- and temperature-controlled storage and tracking for at least 3,500,000 biospecimens in accordance with Best Practices, Clinical and Laboratory Standards, and Good Laboratory Practice (GLP; 21 CFR 58) with expert quality control and assurance procedures. Document the maximum capacity that could be achieved to expand storage beyond the minimum requested. Destroy samples per regulatory and consent requirements when no longer needed. College of American Pathologists (CAP) Biorepository Accreditation preferred. Maintain positive chain of custody and resolve data/sample discrepancies (missing data, incorrect information, misdirected samples) through issue tracking and resolution, coordinating with relevant receiving/data management teams (e.g. sites, site monitors, study staff). Receive de-identified clinical, diagnostic, environmental, and phenotypic data alongside biospecimens from funded grants/contracts. Centrally manage and cost-effectively distribute biosamples to qualified investigators approved through established access programs. Provide studies with collection kits and supplies, including barcoded tubes with human-readable labels. Provide research staff training for ordering supplies and collecting samples. B. Data Curation and Management Develop and maintain SOPs for sample receipt, storage, processing, QC, and distribution. Receive de-identified clinical, diagnostic, environmental, and phenotypic data associated with biospecimens from funded grants/contracts. Maintain an internal relational database (e.g., using persistent identifiers such as RRIDs) linked to associated data and participant and sample identifiers, with computerized inventory management and accurate tracking of sample and data location. Register and track biospecimens via an internal relational database with sample IDs (RRID) linked to participant IDs and associated data in the Contractor's auditable LIMS, with computerized inventory management and accurate tracking of sample/data location. Clean, standardize, and harmonize clinical data with cross-disorder phenotypic knowledge (e.g. different diagnostic systems or criteria, such as RDOC, DSM, ICD), incorporating data from electronic health records when applicable. Transfer data and sample IDs to controlled-access repositories or Data Centers (e.g., dbGAP, NBDC Data Hub or program specific data repositories). C. Laboratory and Analytic Capabilities Demonstrate laboratory expertise appropriate to the repository's sample types, which may include molecular biology techniques (e.g., DNA/RNA extraction, cell line transformation/immortalization), rigorous quality control, and tissue/cell culture (isolation, scale-up, and banking of primary cells). Provide CLIA-certification status. Provide laboratory capabilities for, but not limited to: metabolic, hematologic, and/or clinical assays high-throughput genotyping, sequencing, and gene-expression analysis Mass spectrometry for proteomics and metabolomics Advanced genomic and cellular techniques such as short- and long-range sequencing, chromatin capture, ChIP-seq, Cut-and-Tag, HiC generation of iPSC/neural stem cell lines CRISPR/Cas9 gene editing Analysis of RNA and DNA from Formalin-Fixed Parafin-Embedded tissue Provide scientific and technical expertise to evaluate and respond to researcher-submitted requests for biospecimen availability. Demonstrate that lead investigators and support staff have relevant experience in biobanking, LIMS, and database management Store and/or process histopathological tissue samples. Isolate, scale up, and bank primary cells from diverse tissue samples. D. Informatics Requirements and Cyberinfrastructure Develop, or manage and enhance (if already existing), a biorepository web portal (front-