This is not a solicitation announcement.  This is a Sources Sought Notice (SSN) only. This SSN is issued solely for market research and planning purposes – it does not constitute a Request for Quotations (RFQ) or a promise to issue an RFQ in the future. Further, the SSN does not commit the Government to contract for any supply or service whatsoever. The FDA is not seeking proposals and will not accept any unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this SSN; all costs associated with responding to this SSN will be solely at the expense of the interested respondents. Not responding to this SSN does not preclude participation in any future RFP, if issued.  The purpose of this sources sought synopsis is to gain knowledge of potential qualified vendors to include large business sources, small business sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned Small Business, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) code.

Responses to this Sources Sought Notice will be used by the Government to make appropriate determinations about potential sources. 

Project Title: Research and Development of the FDA ARGOS System

Background/Overview:

Many infectious diseases have similar signs and symptoms, making it challenging for health care providers to identify the disease-causing agent. Clinical samples are often tested by multiple test methods to help reveal the particular microbe that is causing the infectious disease. The results of these test methods can help health care professionals determine the best treatment for patients. High-Throughput Sequencing (HTS) or Next Generation Sequencing (NGS) technology has the capability, as a single test, to accomplish what might have required several different tests in the past.

NGS technology may allow the diagnosis of infections without prior knowledge of disease(s) cause. NGS technology can potentially reveal the presence of all microorganisms in a patient sample. Using infectious disease NGS (ID-NGS) technology, each microbial pathogen may be identified by its unique genomic fingerprint. The vision of ID-NGS technology is to further improve patient care by delivering diagnostics which can help identify the microbial makeup in patient samples quickly and accurately.

https://www.fda.gov/medical-devices/science-and-research-medical-devices/database-reference-grade-microbial-sequences-fda-argos

The Office of Regulatory and Emerging Science (ORES) supports FDA’s public health emergency preparedness and response mission, including MCMs by advancing discovery and innovation in regulatory science research and training to develop the tools, standards, and approaches necessary to assess MCM safety, efficacy, quality, and performance.  ORES also helps translate cutting-edge science and technology into safe and effective MCMs and preparedness measures.

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.

Purpose:

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.

Instructions for Responses:

Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method.  Page limit: Maximum 15 pages (font size Times New Roman 11 or larger). In addition to responses to the below questions, each vendor responding to this SSN shall also fill out and provide responses to the Vendor Feedback Form, Attachment B, to this SSN.