Tuesday, November 26, 2024

FDA Presolicitation: FY 2019 precisionFDA, Collaborative Omics Environment in the Cloud

Re: Solicitation Number: FDA-19-SOL-1208859

As part of the FDA’s effort to enable innovation in genomic testing, FDA is developing precisionFDA, an open-source, cloud-based regulatory science research space in which community members can share data, ideas and methods that advance the use of next generation sequencing (NGS) technology.

The beta-release of precisionFDA recently became operational. This IDIQ shall include the maintenance of the current operational system, as well as enhancements to that system through incremental task orders.

FDA requires the IT support services of contractors to maintain and improve the production version of precisionFDA system through the following objectives:

  • Maintain and continue the evolution of the online cloud-based production precisionFDA system that is backed by a FedRAMP moderate compliant genomic platform by providing (1) capabilities to advance genomic sequencing research and develop new NGS methods; and (2) flexibility to be adapted and improved, keeping the pace with the rapidly evolving NGS field.
  • NGS technologies for the FDA to advance regulatory science and develop regulatory tests.
  • A system that can expand to support multi-omics scientific capabilities. The current precisionFDA system is already being used to support challenges in addition to genomics (e.g., proteomics). The FDA envisions adding capabilities to support multi-omics sciences as those disciplines become better defined.

In order to meet these objectives, the Contractor shall provide a cloud-based genomics platform that has following:

  • Federal Risk and Authorization Management Program (FedRAMP) Moderate authorization for a cloud-based Platform as a Service (PaaS)
  • Facilitate private collaborations related to the tools and techniques used to analyze large genomics data sets
  • Provide the ability to analyze genomics data and test relevant tools and provides a library of reference data and comparative tools…

Task Areas that may be awarded through task orders from the IDIQ shall include Project Management, Increment Development, Operations and Maintenance, User Support, and Transition In and Out activities.

Read more here.

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Jackie Gilbert
Jackie Gilbert
Jackie Gilbert is a Content Analyst for FedHealthIT and Author of 'Anything but COVID-19' on the Daily Take Newsletter for G2Xchange Health and FedCiv.

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