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

SOURCES SOUGHT NOTICE Title: Biobanking, Laboratory Analytics, and Associated Informatics Services for NIH Biorepositories Agency: National Institutes of Health (NIH) Description This is a SMALL BUSINESS 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 small business sources; (2) whether they are 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); (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-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 with all applicable human subjects protection, ethical, privacy, and data security regulations. Submission Requirements Interested organizations must demonstrate and document in a submitted capability statement extensive experience across the technical areas above, and include specific information on: Experience — An outline of previous similar projects, specifically the techniques employed in the areas described above. Personnel — Name and professional qualifications of personnel with specific experience in the work requested and knowledge of/experience in biomedical research. Facilities — Availability and description of facilities and equipment required to conduct this type of work. The Government will assess the appropriateness of professional and technical personnel classifications and consider any other specific and relevant information that would improve evaluation of respondents. Organizations should demonstrate capability to administer and coordinate interrelated tasks effectively and in a timely manner. Supporting documentation may include contracts in which the organization performed equivalent tasks (Government and commercial), references (names, titles, phone numbers, and other identifying information), and awards or commendations. An organization that does not have all the listed expertise, may respond by listing organizations with which they intend to collaborate or have as subcontractors to fulfill the requirements. Based on preliminary market research, the Government has determined that the requirements described herein do not meet the definition of a commercial product or commercial service as defined in RFO 2.101, and therefore, RFO Part 12 procedures are not applicable to this requirement. However, if a capable vendor believes that these services or products qualify as commercial under FAR 2.101, the vendor may submit a written justification for the Contracting Officer's consideration. Such submissions must be provided to the Contracting Officer no later than October 20, 2026 at 1:00 PM EST. All capability statements should include: Company name and address Point of contact SAM.gov Unique Entity Identifier (UEI) Phone/fax/email NAICS Code(s) Business size and status Capability information responsive to the requirements and qualifications identified in this notice Type(s) of business, if any (e.g., small, Veteran-owned, service-disabled Veteran-owned, women-owned, 8(a), Small Disadvantaged Business (SDB), Historically Underutilized Business Zone (HUBZone)) NAICS Code: 541714 — Research and Development in Biotechnology (except Nanobiotechnology). SBA size standard: 1,000 employees or fewer. Submission Instructions Capability statements must be submitted electronically to: Shaun Rostad, Contract Specialist Email: shaun.rostad@nih.gov Secondary Point of Contact: Joshua T. Lazarus, Contract Specialist Email: josh.lazarus@nih.gov Submissions are due NO LATER THAN 1:00 p.m. EST on October 20, 2026. The subject line must include the Small Business Sources Sought Number. NIDA will not accept paper or faxed capability statements. Disclaimer THIS IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement, nor does it constitute a solicitation or commitment by NIDA. The Government does not intend to award a contract based on responses under this announcement, nor otherwise pay for the preparation of any information submitted. Any proprietary information should be so marked. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Respondents should ensure their response is complete and sufficiently detailed to allow the Government to determine qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of information or provide feedback with respect to any information submitted. Based on the Government’s market research, it is the agency’s assessment that the services described herein do not appear to constitute commercial services as defined under RFO Subpart 2.1, and therefore, the agency does not currently intend to utilize RFO Part 12 Acquisition Procedures. However, if an interested party asserts that these services are in fact commercial in nature, it should respond to this requirement and provide supporting evidence demonstrating that the services meet the definition of commercial services as prescribed by the applicable regulations.