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

SOURCES SOUGHT NOTICE No. 75N98026R00175 Title: Biobanking, Laboratory Analytics, and Associated Informatics Services for NIH Biorepositories Agency: National Institutes of Health (NIH) Description This is a SOURCES SOUGHT NOTICE. This is NOT a solicitation for proposals, proposal of abstracts or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources and (2) whether commercial 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. 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 capability statements from businesses, and subcontractors regarding their abilities to continue the work of 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. 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-end and back-end), supporting existing features and providing updates/improvements as requested, potentially including: Synchronizing sample availability data with a public- or investigator-facing sample explorer tool to streamline discovery of related data and biospecimens across repositories Showcase published research and provide lay summaries Advertise repository resources For existing resources, support all currently available features, with updates and improvements as requested Where in scope, develop outreach tools (e.g., an integrated chatbot or public-facing portal) to help users locate biomaterials/data and discover related resources across repositories Develop or maintain backend infrastructure (e.g., server maintenance, microservices, relational databases such as PostgreSQL) and front-end website design/UI-UX. Maintain Authority to Operate (ATO) and require security documentation to keep systems compliant with applicable FISMA-level and other NIH requirements. Maintain, update, and develop Application Programming Interfaces (APIs) and cyberinfrastructure for secure, interoperable data exchange. Capabilities for homomorphic encryption and distributed learning. Demonstrate experience and technical expertise to address all aspects of informatics requirements listed above. K. Collaboration & Governance Establish a strong collaborative relationship with the NIH Data Centers, study teams, and Institutes/Centers to enable modifications as the studies evolve. Serve as a co-signatory of the Specimen/Material Transfer Agreements developed by the funding Institute/Center. Be eligible to receive a Certificate of Confidentiality, adhering to requirements for protecting sensitive participant information as set forth in 45 CFR Part 75.303(a), NIHGPS Chapter 8.3 and 15.2.1, and subsection 301(d) of the Public Health Service Act (see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html). Comply…