Title: Hive 2.0: Expansion of FDA ARGOS (database for Reference Grade micrObial Sequences) Agency: U.S. Food and Drug Administration (FDA) Notice Type: Presolicitation: Cost Reimbursement The U.S. Food and Drug Administration (FDA) intends to modify, on a sole source basis (in accordance with FAR 6.103-1), contract #75F40125C00095 with DNA HIVE, 3909 Fox Valley Drive, Rockville, MD 20853. The North American Industry Classification System (NAICS) code is 541714- Research and Development in Biotechnology (except Nanobiotechnology). The modification will not alter the existing period of performance established under the contract. Under this sole source modification, the contractor shall provide research and development services (including, but not limited to, biological and bioinformatic research) to expand the current repository of genetic sequence information under the ARGOS database. As such, this modification does not add new tasks, but rather expands on current tasks, specifically: Aim-1: Deployment, configuration, launch ARGOS instance running on a newer version of H2O Aim-2: Develop, adopt, and deploy AI and NGS Bioinformatics tools for: Aim-2.1: evaluation of epigenetic based pathogen detection diagnostics products for Lyme disease. Aim-2.2: assembly of new virus genomes for ARGOS using bulk public health sequencing datasets Aim-2.3: evaluation of emerging pathogens. Aim-2.4: predictive toxicology. Aim-2.5: evaluation of food import safety. Aim-2.6: on-, of-target evaluation of gene editing products. Aim-2.7: evaluation of biologics manufacturing consistency. Aim-2.8: evaluation of efficacy of attenuated vaccine and life viral products. Aim-3: Deliver regulatory grade high-quality reference datasets. Aim-3.1: Continuing to support FDA-ARGOS project with pathogen reference datasets. Aim-3.2: Continuing to support epigenetic biomarker datasets for FDA. Aim-4: Integrate FDA into ARPA-H FEAST network to provide RWD access. Aim-5: Provide system installation, maintenance, user documentation and operation manuals and appropriate video materials for the entire system This expansion is intended to increase the number of sequences and organisms that are validated in the ARGOS system, which will concurrently result in a marked increase in the utility of the ARGOS database, and enable interagency partners to have resources to support their individual research goals, including development of medical countermeasures to protect the American public. Nature of the acquisition and proposed unique qualifications of the contractor(s). DNA HIVE is currently under contract to conduct all of the tasks and deliverables envisioned under this acquisition, vis a vis performance of FDA contract, 75F40125C00095, was awarded in 2025 via the FDA Broad Agency Announcement (FDA BAA) program, following submission and review of their proposal under the BAA evaluation process. The concept, primary methodology, hypotheses, and anticipated outcomes constitute the intellectu…