OCP/DARS Purchase of AB Sciex ZenoTOF 7600+ and 4500 QTrap liquid chromatographs-tandem mass spectrometers (LC-MS/MS)

The FDA's Office of Acquisitions and Grant Services is procuring two AB Sciex liquid chromatograph-tandem mass spectrometers (LC-MS/MS) - specifically a ZenoTOF 7600+ and a 4500 QTrap - along with associated accessories and installation services for their Division of Applied Regulatory Science (DARS). These instruments will replace existing outdated mass spectrometers and expand DARS's analytical capabilities for bioanalytical research, including pharmacokinetic studies, drug metabolism analysis, and investigations involving biologics and biosimilars. The procurement requires vendors to provide comprehensive documentation demonstrating how their proposed equipment meets technical specifications and include a trade-in value for an existing Waters Xevo TQ-XS instrument. The contract will be evaluated using a lowest-priced technically acceptable (LPTA) methodology, with proposals due by 3:00 p.m. Eastern Time on July 7, 2025. The contract period runs from September 1, 2025, to August 30, 2026, and includes provisions for one-year limited warranties, StatusScope Remote Monitoring Service, and preventative maintenance.

This procurement is designated as a small business set-aside under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a size standard of 1,000 employees. No current contractors or incumbents are identified in the solicitation documents. The contract value will be determined based on submitted quotes, with pricing required to be inclusive of shipping, handling, installation, and training services. The solicitation requires a single quantity each of the two specified mass spectrometer models, with comprehensive technical specifications that must be met by proposed equipment. Performance will take place in Silver Spring, Maryland, where the FDA's facilities are located. Proposals must be submitted electronically to Contract Specialist Hilda M. Aryeh in native MS Word, Excel, or PDF format, with strict requirements prohibiting the use of macros in submitted documents.