Notice ID: 75F40125Q00090
This program will support the development of novel bioinformatics tools and Artificial Intelligence (AI) tools, Next Generation Sequencing (NGS) based genetic and epigenetic data analysis methodologies, reference databases and real-world datasets for improvement of regulatory processes, preparedness and response. This program will close knowledge gaps, develop regulatory guidance and regulatory review processes to prepare for countermeasures against emerging diseases and to mitigate against epidemic possibilities. This program will also enhance the FDA ARGOS database, which is a repository that contains quality controlled and curated genomic sequence data to support research and regulatory decisions. This evolving database is a tool for in-silico (computer simulation) performance validation. Use of FDA-ARGOS genomes for in-silico data analysis can potentially reduce the testing burden on industry for ID-NGS devices and prepare and respond to the next outbreak.
The goal of this contract is to provide FDA regulators with analytical tools and genetic and epigenetic datasets, which are an invaluable resource for advancing regulatory science, regulatory guidance and sponsor use with the goal of preparedness and response enhancement.
It is anticipated an Indefinite Delivery, Indefinite Quantity (IDIQ) with an ordering period of 5 years. Actual duration of orders will be specified in each individual order. Contract task orders will be FFP and T&M.
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