Combined Synopsis/Solicitation & Notice of Intent to Sole Source: Purchase of a Factory-Certified Refurbished HUMIMIC Starter Kit Control Unit

The Food and Drug Administration Office of Acquisition and Grant Services seeks a factory-certified refurbished HUMIMIC Starter Kit Control Unit (Product Code D01-B, Serial Number 68517 or OEM-designated equivalent) directly from manufacturer TissUse GmbH, with quotes due August 1, 2026 at 1:00 PM Central Time. This is a sole-source procurement under FAR 12.102(a); TissUse GmbH is the Original Equipment Manufacturer and sole patent-holder of the HUMIMIC technology platform, and no other source possesses the proprietary software source codes, diagnostic calibration fixtures, or engineering data necessary for factory recertification and maintenance.

Delivery to FDA/CBER, 10903 New Hampshire Avenue, Building 52/72, Room 3248, Silver Spring, Maryland must be completed within 60 calendar days after order receipt under Delivered Duty Paid (DDP) Incoterms. The procurement includes mandatory OEM factory recertification and technical services, one OEM-configured HUMIMIC Starter M2.SSD replacement part with proprietary system firmware, and shared on-site travel and service expenses covering both the newly acquired unit and an existing FDA operational unit. The NAICS code is 334516, Analytical Laboratory Instrument Manufacturing; PSC is 6640, Laboratory Equipment and Supplies. Small business size standard is 1,000 employees. The contract type is firm-fixed-price commercial product. Quoters must submit prices for all four line items and hold prices firm through September 30, 2026. The comprehensive one-year manufacturer warranty, operations and maintenance manuals, detailed service reports, and phone and email technical support are included at no additional cost. Payment is due Net 30 days after government acceptance. Quoters must submit quotes by email to Suzanne Martella at suzanne.martella@fda.hhs.gov; all document submissions must not contain macros or executable files, and invoices must be submitted electronically through the Department of Treasury Invoice Processing Platform.