Posted April 22, 2025
Notice ID: FDA-SSN-75F40125Q00090
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.
Specific Tasks:
Task 1 – To develop bioinformatics tools for quality assessment of NGS datasets submitted for regulatory review and regulatory surveillance use.
Task 2 – To capture, annotate, assemble, and deposit additional pathogen reference genetic sequences into the ARGOS database.
Task 3 – To develop bioinformatics, AI, and machine learning (ML) tools to assess genetic and epigenetic biomarkers, epigenetic signature characteristics via epigenetic databases to model host-based disease and exposure detection.
Task 4 – To perform genetic and epigenetic regulatory science research that addresses regulatory knowledge gaps for review and guidance development.
Task 5 – To provide NGS bioinformatics, AI, and ML tools for evaluation of MCMs (including vaccines, biologics, therapeutics and diagnostics products).
Task 6 – To provide additional algorithm development, scientific computing, further database support and model development for regulatory evaluation of medical products supporting MCM preparedness against CBRN and emerging threats and emerging technologies including real world applications and data.
Task 7 – To provide bioinformatics, AI/ML tool adaptation, deployment and maintenance of software applications into high performance computing centers at the FDA.
Task 8 – To provide advice on optimization of computing resources used for bioinformatics, AI/ML and database regulatory pipelines.
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.
Posted January 22, 2054
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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