Procurement and Installation of Mass Spectrometer
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), on behalf of CDER/OPQ/OPQR, has issued a Sources Sought Notice for the Procurement and Installation of a Mass Spectrometer system. This market research aims to identify vendors capable of providing a high-resolution mass spectrometer with Ultra-High-Performance Liquid Chromatography (UHPLC) capabilities to support the Office of Pharmaceutical Quality Research – St. Louis (OPQR – St. Louis). Responses are due by April 6, 2026.
Purpose & Scope
The FDA requires this equipment to characterize drug substances and drug products for potential nitrosamine impurities, small molecules, and macromolecules, thereby aiding domestic drug manufacturing. The system will be used for identifying nitrosamine drug substance related impurities (NDSRIs) and comprehensive biotherapeutic characterization at the Saint Louis, MO facility.
Key Requirements
- One high-resolution mass spectrometer system with UHPLC capabilities.
- Extended mass range up to m/z 12,000 for large biomolecule analysis.
- Fast and sensitive electron-based fragmentation (ETD/EThcD) and enhanced sensitivity/dynamic range with eDR scan mode.
- Includes delivery, installation, qualification, and instrument familiarization.
- Contractor must demonstrate proper operation and performance upon installation and qualification.
Contract & Timeline
- Opportunity Type: Sources Sought (Market Research)
- Set-Aside: Total Small Business Set-Aside (FAR 19.5)
- Anticipated Contract Period: 12 months from award, with an optional 1-year annual preventive maintenance agreement (total 2 years Period of Performance).
- Delivery: Within 180 days after award.
- Installation & Qualification: Within 90 days after delivery.
- Training & Familiarization: During qualification or within 60 days after installation.
- Warranty Start: Upon completion of IQ/OQ.
Submission Requirements
Interested vendors must provide:
- Company name, address, Cage Code, and UEI.
- Recommended NAICS code (specifically for Mass Spectrometers).
- Company size and socio-economic status.
- Any GSA Schedule or other government-wide contract information.
- Domestic manufacturing status.
- Technical specifications for the proposed solution.
Submission Instructions
- Responses Due: April 6, 2026, by 4:00 PM ET.
- Submit via Email: Reagan.davis@fda.hhs.gov
- Subject Line: Sources Sought Notice Number: SSN_CDER-2026-131687 – Mass Spectrometer
Important Note
This is for market research purposes only and is not a solicitation. No contract will be awarded from this announcement, and no reimbursement will be provided for costs associated with providing information. Proprietary information should not be submitted.