SAM #OMAS-FDA-NCTR-2026-132591

Pristima Pre-Clinical Data Management System Maintenance and Support (FDA NCTR)

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), is seeking firm-fixed-price maintenance and support services for the Pristima® Pre-Clinical Data Management System. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) - Office of Mission Acquisition Solutions (OMAS) - OEM and Vendor: - Xybion Corporation (sole-source, proprietary developer of Pristima®) - Products/Services Requested: - Maintenance and support services for the Pristima® Pre-Clinical Data Management System - Includes software maintenance, technical support, installation assistance, updates, upgrades, and vulnerability patches - Five-year contract structure: 12-month base period plus four 12-month option periods - Pricing requested for each period separately - No specific part numbers provided - Unique/Notable Requirements: - Sole-source procurement justified due to proprietary nature of Pristima® - No other OEMs or vendors are eligible - Services must cover all updates, upgrades, and security patches for the system

Description

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. 

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