Pristima® Pre-Clinical Data Management System Maintenance and Support

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of Mission Acquisition Solutions COMBINED SYNOPSIS/SOLICITATION REQUEST FOR QUOTATION (RFQ) Pristima® Pre-Clinical Data Management System Maintenance and Support General Information Document Type: Combined Synopsis/Solicitation Solicitation Number: OMAS-FDA-NCTR-2026-132591 Posted Date: 08/12/2026 Response Date: 08/21/2026 Set-Aside: None NAICS Code: 513210 – Software Publishers PSC: DA10 – IT and Telecom – Business Application/Application Development Software as a Service Contract Type: Firm-Fixed-Price Contracting Office: Department of Health and Human Services Office of Mission Acquisition Solutions (OMAS) 1. Combined Synopsis/Solicitation This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR Part 12. This announcement constitutes the only solicitation. Quotations are being requested and a separate written solicitation will not be issued. Solicitation number OMAS-FDA-NCTR-2026-132591 is issued as a Request for Quotation (RFQ) for Pristima® Pre-Clinical Data Management System Maintenance and Support. This acquisition is not set aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at Acquisition.gov. The Department of Health and Human Services (HHS), Office of Mission Acquisition Solutions (OMAS), on behalf of the Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), intends to issue a Firm-Fixed-Price purchase order on a sole-source basis to Xybion Corporation : Xybion Corporation UEI: REENR8LT12K3 2000 Lenox Drive, Suite 101 Lawrenceville, NJ 08648-2314 The Government's decision to restrict competition is supported by an approved Sole Source Justification prepared pursuant to RFO FAR 12.102(b) and FAR 12.201-1 . See attachment for compelte details.