NIH Brain Development Cohorts Biobank

SOURCES SOUGHT NOTICE The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from business organizations to provide the Government a resource that can maintain the NIH Brain Development Cohorts (NBDC) Biobank, a repository to process, store, analyze, and distribute de-identified biological samples and related data from the Adolescent Brain Cognitive DevelopmentSM (ABCD) Study and HEALthy Brain and Child Development (HBCD) Study. Capable Vendors must demonstrate the experience and capability necessary to manage a large biobank containing over 550,000 samples, which would be transferred at the outset of the award, if other than the incumbent. Capable Vendors must demonstrate the ability to receive a volume of approximately 170,000 samples over the course of the contract. Sample and Data Management Demonstrate an ability to safely process, store, and track between 500,000-700,000 biospecimen samples from a wide range of biospecimen types (e.g. blood, serum, plasma, DNA, RNA, saliva, hair, urine, teeth, fecal matter, placenta, umbilical cord blood and tissue) at a variety of storage conditions, and perform expert quality control and assurance procedures; Provide 48 research sites across the country with collection kits including barcoded tubes with human readable labels for the collection of biospecimens which will be registered and tracked in the Contractor’s auditable Laboratory Information Management System (LIMS). Provide site coordinators and research staff with training for ordering supplies and collecting samples; Maintain positive chain of custody and resolve data/sample discrepancies (e.g. missing data, incorrect information, samples sent to the wrong location) through management and support of issue tracking and resolution. This involves coordination with sites, site monitors, study staff, and the respective receiving or data management teams at the Biobank. Centrally manage and effectively distribute biosamples in the repository to qualified investigators approved through the Biospecimens Access Programs in a cost-effective manner; Technical & Informatics Requirements Maintain and update databases linking phenotypic/genotypic information with participant and sample IDs; Manage and enhance the NBDC Biobank portal (both front-end and back-end) to support all currently available features and provide updates and improvements when requested. Requirements include, but are not limited to: Maintain and update existing databases to accurately reflect available samples, and synchronize this data with the Biospecimen Explorer front-end Provide for the ordering of kits and supplies for the ABCD and HBCD Study staff Support the Biospecimen Access Program features (e.g. Biospecimen Explorer, Availability Inquiry and Inquiry Dashboard, Resource Availability and Impact Reports) Maintain ATO and security documents to keep system compliant with FISMA-low and other NIH requirements; Maintain, update, and develop Application Programming Interfaces (APIs) and a cyberinfrastructure for secure, interoperable data exchange; Laboratory Requirements Lead investigators and support staff must demonstrate experience in biobanking, LIMS and database management. Additional technical requirements include experience to maintain and further develop all aspects of the NBDC Biobank Portal (e.g. backend logic and server maintenance, creating microservices and PostGreSQL databases, website design and UI/UX); Provide scientific and technical expertise to evaluate and offer feedback to researcher-submitted availability inquiries for ABCD and HBCD biosamples. If requested, provide Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory capabilities (either directly or through subcontracts) for performing metabolic, hematologic, and/or cutting-edge, high-throughput genotyping, sequencing, and gene-expression analyses as needed;  ensure scientific leads have appropriate technical experience; Collaboration & Governance Establish a strong collaborative relationship with the ABCD and HBCD Data Centers and study teams to enable modifications that may be required as the studies evolve; Be a co-signatory of the Specimen Transfer Agreement developed by NIDA; and Be eligible to receive a Certificate of Confidentiality, with adherence to requirements for protecting sensitive participant information as set forth in 45 CFR Part 75.303(a), NIHGPS Chapter 8.3 and15.2.1, and subsection 301(d) of the Public Health Service Act (see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html). Interested organizations must demonstrate and document in the submitted capability statement extensive experience in the technical areas listed above. Furthermore, organizations should include relevant and specific information on each of the following qualifications: 1) Experience: An outline of previous similar projects, specifically the techniques employe