Research and Development of the FDA ARGOS System

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 solicitation, 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. The Vendor Feedback Form is not included in the 15-page limit. A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions or the Vendor Feedback Form). The anticipated period of performance is to be negotiated. After review of the responses received, a formal solicitation may be published on SAM.gov. Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions: Is your business a small business under the NAICS code? Does your firm qualify as a Small Disadvantaged Business? If disadvantaged, specify if your firm is certified under Section 8(a) of the Small Business Act? Are you considered a certified HUBZone firm? Are you considered Woman-Owned or operated business? Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business? Included is a draft Statement of Objectives that is inclusive of the anticipated Task Areas (Attachment A). All interested parties can provide written opinions/questions on the draft Statement of Objectives. All opinions/questions expressed should focus on strengthening the draft Statement of Objectives Tasks to ensure industry understands and comprehends the government's requirements. Responses to this notice shall be submitted via e-mail to Nicholas Bisher, Contracting Officer (Nicholas.bisher@fda.hhs.gov), and Kimberly Pennix, Contract Specialist (kimberly.pennix@fda.hhs.gov), by May 2, 2025, at 2:00 pm EST. After a review of the received responses, a formal solicitation may be published on SAM.gov. No solicitation is currently available. This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this Sources Sought Notice will not be considered adequate responses to any potential solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. Ref. No. 75F40125Q00090. Attachments: Attachment A: Draft Statement of Objectives Attachment B: Vendor Feedback Form