COMBINED SYNOPSIS-SOLICITATION OMAS-FDA-NCTR-2026-132591.docx

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 FAR 12.102(b) and FAR 12.201-1.

2. Description of Requirement FDA NCTR requires continued commercial maintenance and support services for the Government's existing Pristima® Pre-Clinical Data Management System.

The requirement includes manufacturer-authorized:

· Software maintenance;

· Technical support;

· Installation assistance;

· Software updates;

· Software upgrades; and

· Vulnerability patches necessary to maintain the Government's existing Pristima® implementation.

Xybion Corporation is the proprietary developer and manufacturer of the Pristima® Pre-Clinical Data Management System. Market research confirmed that Xybion Corporation is the exclusive provider of the required manufacturer-authorized maintenance and support. No authorized reseller, support partner, affiliate, or other third-party source was identified as authorized or capable of providing the required maintenance, software updates, upgrades, vulnerability patches, installation assistance, and technical support for the Government's existing Pristima® implementation.

Continued manufacturer-authorized maintenance and support are required to maintain compatibility with the Government's existing implementation, preserve continuity of operations, and support FDA NCTR's preclinical research mission.

The detailed technical requirements are contained in the attached [INSERT FINAL REQUIREMENTS DOCUMENT TITLE], which is incorporated into this RFQ.

3. Line Items and Pricing Schedule The quoter shall provide a Firm-Fixed-Price for the base period and each option period.

Total Evaluated Price – Base and All Options

If separately priced optional on-site maintenance visits are included in the final requirements document, separate optional CLINs shall be established before issuance.

4. Period of Performance The contemplated purchase order will include one 12-month base period and four 12-month option periods:

Base Period: September 1, 2026 – August 31, 2027 Option Period One: September 1, 2027 – August 31, 2028 Option Period Two: September 1, 2028 – August 31, 2029 Option Period Three: September 1, 2029 – August 31, 2030 Option Period Four: September 1, 2030 – August 31, 2031 Exercise of any option is solely at the discretion of the Government and is subject to the applicable terms and clauses incorporated into the resulting purchase order.

5. Place of Performance and Acceptance Services are expected to be performed primarily remotely.

If on-site services are required and authorized by the Government, performance will occur at:

FDA National Center for Toxicological Research (NCTR) Jefferson Laboratories 3900 NCTR Road Jefferson, AR 72079 Contractor personnel shall comply with applicable FDA security and facility-access requirements during authorized on-site performance.

Inspection and acceptance will be performed by the Government in accordance with the requirements and terms of the resulting purchase order.

6. Quotation Instructions The quotation shall provide sufficient information for the Government to determine that the proposed services satisfy the requirements of this RFQ and the attached requirements document.

At a minimum, the quotation shall include:

· Legal business name, address, UEI, and point of contact;

· Firm-Fixed-Price for the base period and each option period;

· Total price for the base period and all option periods;

· Confirmation that the quoted services meet the Government's technical requirements;

· Confirmation that the quoter can provide the required manufacturer-authorized maintenance and support for the Government's existing Pristima® implementation;

· Identification of any assumptions applicable to the quotation. Exceptions or deviations from the Government's commercial terms and conditions are not permitted unless expressly authorized by the solicitation or accepted in writing by the Contracting Officer; and

· Supporting commercial pricing information requested by the Contracting Officer for purposes of determining price reasonableness.

The Government may request clarifications or additional information as necessary to evaluate the quotation.

SAM.gov Registration Requirement: The quoter must be registered and have an active registration in the System for Award Management (SAM.gov) at the time the quotation is submitted and must maintain an active registration through award and during performance, as applicable. The quotation shall include the Unique Entity Identifier (UEI) associated with the quoter's active SAM.gov registration.

Acceptance of Government Commercial Terms and Conditions: By submitting a quotation in response to this solicitation, the quoter acknowledges and accepts the Government's commercial terms and conditions, including all applicable provisions and clauses incorporated into this solicitation and the resulting Purchase Order. Submission of a quotation constitutes the quoter's agreement to perform in accordance with those terms and conditions. Any contractor commercial terms or conditions that conflict with, supplement, or otherwise modify the Government's terms and conditions shall not apply unless expressly accepted in writing by the Contracting Officer and incorporated into the resulting Purchase Order.

7. Basis for Award The Government intends to issue a Firm-Fixed-Price purchase order to Xybion Corporation on a sole-source basis, subject to the quotation meeting the Government's requirements and the Contracting Officer determining the proposed price to be fair and reasonable.

The quotation will be evaluated for:

Technical Capability: The quoted services must meet the Government's requirements for manufacturer-authorized maintenance and support of the existing Pristima® implementation.

Price: The Contracting Officer will evaluate the quoted price and determine whether it is fair and reasonable in accordance with FAR 12.204.

Past Performance: The Government may consider available past performance information relevant to the quoter's ability to successfully perform the requirement.

8. Solicitation Provisions The following provisions are incorporated by reference and apply to this solicitation:

FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial Services FAR 52.204-7, System for Award Management—Registration (if applicable based on prescription) FAR 52.217-5, Evaluation of Options FAR 52.240-90, Security Prohibitions and Exclusions Representations and Certifications (if applicable based on prescription) Additional provisions prescribed for this acquisition shall be incorporated by reference or full text, as applicable.

Addendum to FAR 52.212-1 Quotations shall be submitted electronically in accordance with the instructions contained in this solicitation. The quotation shall include the quoter's legal business name, UEI, point of contact, Firm-Fixed-Price for the base period and each option period, total evaluated price, and confirmation that the quoted services meet the technical requirements of the solicitation.

The quoter shall identify any assumptions applicable to its quotation. By submitting a quotation, the quoter acknowledges and accepts the Government's commercial terms and conditions incorporated into this solicitation. Exceptions or deviations from the Government's commercial terms and conditions are not permitted unless expressly authorized by this solicitation or accepted in writing by the Contracting Officer.

FAR 52.217-5 – Evaluation of Options The Government will evaluate quotations for award purposes in accordance with FAR 52.217-5, Evaluation of Options. The total evaluated price will include the price of the base period and all option periods. Evaluation of the options does not obligate the Government to exercise any option.

9. Contract Terms and Conditions Any resulting award will be a Firm-Fixed-Price commercial purchase order and will be subject to the applicable Government commercial terms and conditions.

The following clauses are incorporated by reference with the same force and effect as if set forth in full text:

FAR 52.212-4, Terms and Conditions—Commercial Products and Commercial Services FAR 52.217-9, Option to Extend the Term of the Contract FAR 52.222-90, Addressing DEI Discrimination by Federal Contractors (APR 2026) HHSAR 352.232-71, Electronic Submission of Payment Requests Additional FAR/RFO, HHSAR, and agency-specific clauses prescribed for this acquisition shall be incorporated by reference or full text, as applicable.

FAR 52.217-9 – Option to Extend the Term of the Contract The Government may extend the term of the resulting Purchase Order by written notice to the Contractor within 5 days before the Purchase Order expires, provided that the Government gives the Contractor preliminary written notice of its intent to extend at least 15 days before the Purchase Order expires. The preliminary notice does not commit the Government to an extension.

If the Government exercises an option, the extended Purchase Order shall include the terms of FAR 52.217-9.

The total duration of the Purchase Order, including all options exercised under this clause, shall not exceed 60 months.

Electronic Submission of Payment Requests In accordance with HHSAR 352.232-71, the Contractor shall submit payment requests electronically through the Department of the Treasury Invoice Processing Platform (IPP), unless otherwise authorized in writing by the Contracting Officer.

Contractor Commercial Terms and Software Licensing Any commercial software license, maintenance agreement, End User License Agreement (EULA), Terms of Service (TOS), or similar Contractor commercial terms applicable to this acquisition shall be submitted with the quotation for Government review.

Such terms shall apply only to the extent expressly accepted in writing by the Contracting Officer and incorporated into the resulting Purchase Order, and only to the extent consistent with applicable Federal law and Government contract terms.

The resulting Purchase Order will be governed by the Government terms and conditions incorporated therein. By submitting a quotation in response to this solicitation, the quoter acknowledges and accepts the Government's commercial terms and conditions. Contractor commercial terms shall apply only to the extent expressly accepted in writing by the Contracting Officer and incorporated into the resulting Purchase Order.

The order of precedence and treatment of unauthorized obligations, including inconsistent EULA or TOS provisions, shall be governed by FAR 52.212-4.

10. SAM.gov Registration The quoter must be registered and have an active registration in the System for Award Management (SAM.gov) at the time the quotation is submitted and must maintain an active registration through award and during performance, as applicable. The quotation shall identify the Unique Entity Identifier (UEI) associated with the quoter's active SAM.gov registration.

11. Submission of Quotation Quotations shall be submitted electronically to:

Jesse Weidow Contracting Officer Department of Health and Human Services Office of Mission Acquisition Solutions Jesse.Weidow@hhs.gov Quotation Due Date: 08/21/2026 Quotation Due Time: 4:00 PM Eastern Time The email subject line shall identify the solicitation number OMAS-FDA-NCTR-2026-132591 and: Pristima® Pre-Clinical Data Management System Maintenance and Support The Government will consider quotations and other responses timely received in accordance with the solicitation terms.

12. Responses from Other Responsible Sources The Government intends to award this requirement to Xybion Corporation on a sole-source basis. However, responsible sources may respond to this Combined Synopsis/Solicitation in accordance with the submission instructions above.

Any source other than Xybion Corporation responding to this solicitation must provide sufficient information demonstrating that it is authorized and capable of providing manufacturer-authorized maintenance and support for the Government's existing Pristima® implementation, including the required software maintenance, updates, upgrades, vulnerability patches, installation assistance, and technical support.

The Government will consider all timely responses received before proceeding with award.

13. Questions Questions concerning this Combined Synopsis/Solicitation shall be submitted electronically to:

Jesse Weidow Contracting Officer Jesse.Weidow@hhs.gov Questions shall reference the solicitation number and acquisition title.