Request for Information (RFI) Advanced Mass Spectrometry Systems FDA-RFI-75F40126Q00041

U.S. Food and Drug Administration Request for Information (RFI) FOR: Advanced Mass Spectrometry Systems GENERAL INFORMATION The U.S. Food and Drug Administration (FDA) issues this Request for Information (RFI) as a means of conducting market research pursuant to Federal Acquisition Regulation (FAR) Part 10. The purpose of this RFI is to obtain technical and business information from potential vendors capable of providing laboratory supplies in support of FDA laboratories. Information collected through this RFI will be used to: Assess market capability to meet FDA requirements Determine vendor interest Inform future acquisition planning This RFI is for informational purposes only and does not constitute a solicitation. Responses are voluntary. The Government will not reimburse costs incurred in responding. Failure to respond does not preclude participation in any future solicitation. All responses become Government property and will not be returned. Do not submit proprietary, classified, or sensitive information. The FDA does not intend to award a contract or conduct discussions based on this RFI; however, FDA reserves the right to request clarification or additional information. INSTRUCTIONS Responses shall not exceed 20 pages (excluding graphics, tables, contracts, and GSA schedules). Each page must identify the respondent s name and page number. Provide objective, comprehensive responses demonstrating capability. Failure to respond to any question may be interpreted as inability to meet requirements. Response Due Date/Time: 2 February 2026; 10:00 AM ESTEmail responses to: Warren Jackson; warren.jackson@fda.hhs.gov Subject Line: FDA-RFI-75F40126Q00041 Spectrometry SystemsBACKGROUND The Food and Drug Administration (FDA) operates multiple regulatory and forensic laboratories that require advanced analytical instrumentation to support its public health mission. FDA laboratories conduct targeted and non-targeted chemical analyses of foods, drugs, dietary supplements, medical products, tobacco products, and related commodities to ensure compliance with federal law. FDA has identified current and anticipated needs for the acquisition of advanced mass spectrometry systems, including: LC-MS/MS Systems (Linear Ion Trap) NFCC High-Resolution Mass Spectrometry - System Irvine Triple Quadrupole ICP-MS with HPLC NFCC and Irvine LC-MS/MS Systems (Triple Quadrupole) SJNLMP Liquid Chromatography Systems (LC/UHPLC/HPLC) These systems support activities such as detection and quantitation of drugs of abuse, synthetic opioids, adulterants, undeclared pharmaceutical ingredients, toxic elements, elemental speciation, nitrosamines, and complex fraud investigations. FDA is conducting this RFI to better understand current market capabilities, technology maturity, service models, and vendor experience related to these instrument classes. NAICS CODE (Anticipated) 334516 Analytical Laboratory Instruments 541380 Testing Laboratories (support services, as applicable) QUESTIONS FOR INDUSTRY RESPONSE 1.Corporate Profile Provide the following information: Provide the following information: Organization name Unique Entity ID (UEI) CAGE code Company website Primary point of contact (name, title) Telephone number Email address Business size standard (e.g., small, large) GSA Multiple Award Schedule (MAS) contract number 2.Draft SOW Review Identify any questions, concerns, or recommended updates to the draft Statement of Work (SOW) andattachments. Identify assumptions used in preparing your response. Identify the NAICS code you believe best aligns with the SOW. 3.GSA Schedule Information Provide a copy of the applicable GSA MAS schedule. Identify current and future option periods. State the schedule expiration date. 4.Vendor Capabilities and Experience Describe experience providing LC-MS/MS, HRMS, QQQ-ICP-MS, and/or UHPLC/UHF-QQQ systems tofederal or regulated laboratories. Identify which instrument platforms your company supports (OEM or authorized reseller). Provide 2 3 examples of federal contracts or commercial deployments with similar scope, includinginstallation, validation, and lifecycle support. Describe experience supporting regulatory laboratories operating under cGMP, cGLP, ISO/IEC 17025, ISO9001, and 21 CFR Part 11 requirements. Describe processes for installation qualification (IQ), operational qualification (OQ), and performanceverification (PV). Describe technical support model, including response times, escalation, and access to OEM-trained serviceengineers. Describe experience providing operator training and ongoing technical support. Describe capability to support multiple FDA laboratory locations under a single contract vehicle. 5.Product Information and Compliance Describe compliance with applicable quality and regulatory requirements (e.g., ISO/IEC 17025, ISO 9001, 21 CFR Part 11, cGMP/cGLP, USP where applicable). Describe data integrity, audit trail, and electronic records/electronic signature capabilities. Describe processes for managing non-conforming equipment, corrective actions, and returns. 6.Pricing and Discounts Describe pricing structures for capital equipment, software licenses, service plans, and consumables. Identify availability of GSA MAS pricing or other federal contract vehicles. Describe factors influencing discounts for multi-instrument or multi-site purchases. 7.Order Fulfillment and Logistics Describe typical manufacturing lead times for each instrument class. Describe delivery, inside installation, and site preparation coordination processes. Describe logistics experience supporting installations across all U.S. regions and territories. Identify factors that may impact delivery or installation timelines and mitigation strategies. 8.Socioeconomic Status Identify applicable socioeconomic categories (e.g., small business, 8(a), HUBZone, SDVOSB, WOSB) forthe identified NAICS codes. 9.Sustainability and Green Procurement Describe energy efficiency, waste reduction, and environmentally preferable design features of proposed systems. Describe sustainable packaging and shipping practices. ATTACHMENTS 1.Combine SOW (5) Spectrometry Systems