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Pristima® Pre-Clinical Data Management System Maintenance and Support

ID: OMAS-FDA-NCTR-2026-132591 • Type: Synopsis Solicitation • Match:  95%
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Description

Background
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 to procure maintenance and support services for the Pristima® Pre-Clinical Data Management System. This acquisition aims to ensure continued operational capability and support for FDA NCTR's preclinical research mission. The contract will be awarded on a sole-source basis to Xybion Corporation, the proprietary developer of the Pristima® system.

Work Details
The contractor will provide manufacturer-authorized maintenance and support services for the existing Pristima® Pre-Clinical Data Management System, which includes:

- Software maintenance
- Technical support
- Installation assistance
- Software updates
- Software upgrades
- Vulnerability patches necessary to maintain the existing implementation.

The requirement emphasizes that Xybion Corporation is the exclusive provider capable of delivering these services, ensuring compatibility with the current system and continuity of operations.

Period of Performance
The contract will include one 12-month base period from September 1, 2026, to August 31, 2027, followed by four optional 12-month periods extending through August 31, 2031.

Place of Performance
Services are expected to be performed primarily remotely. If on-site services are required, they will occur at the FDA National Center for Toxicological Research (NCTR) in Jefferson, Arkansas.

Bidder Requirements
Bidders must demonstrate that they can provide manufacturer-authorized maintenance and support for the existing Pristima® implementation.

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.

Overview

Agency
HHS Office of the Assistant Secretary for Administration (ASA) [HHS]
Response Deadline
Due in 8 Days
Posted
Set Aside
None
NAICS
513210 - Software Publishers
PSC
DA10 - IT And Telecom - Business Application/Application Development Software As A Service
Place of Performance
Jefferson, AR 72079 United States
Source
Open
Current SBA Size Standard
$47 Million
Pricing
Fixed Price
Est. Level of Competition
Sole Source
Est. Value Range
Experimental
$75,000 - $250,000 (AI estimate)
On 8/12/26 HHS Office of the Assistant Secretary for Administration issued Synopsis Solicitation OMAS-FDA-NCTR-2026-132591 for Pristima® Pre-Clinical Data Management System Maintenance and Support due 8/21/26. The opportunity was issued full & open with NAICS 513210 and PSC DA10.
Primary Contact
Name
Jesse Weidow   Profile
Email
jesse.weidow@hhs.gov
Phone
None

Secondary Contact

Name
Laura Grey   Profile
Email
laura.grey@hhs.gov
Phone
None

Documents

Posted documents for Synopsis Solicitation OMAS-FDA-NCTR-2026-132591

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > OFFICE OF THE ASSISTANT SECRETARY FOR ADMINISTRATION (ASA) > PROGRAM SUPPORT CENTER ACQ MGMT SVC
FPDS Organization Code
7570-00233
Source Organization Code
100188100
Last Updated
Last Updated By
jesse.weidow@hhs.gov
Archive Date