ValGenesis Subscription: VLMS SaaS Renewal - 40NU 10 RA

Closed Solicitation Posted

Solicitation number
RFQ-NIAID-25-2266489
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Maryland 20852, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institute of Allergy and Infectious Diseases (NIAID), part of the Department of Health and Human Services, is seeking to procure a ValGenesis Validation Lifecycle Management System (VLMS) Software-as-a-Service (SaaS) subscription renewal through solicitation RFQ-NIAID-25-2266489. The procurement is for the Office of Cyber Infrastructure and Computational Biology's Clinical Informatics Branch, which requires this digital validation software to support computer system validation for clinical systems and ensure regulatory compliance. This acquisition is being processed under Federal Acquisition Regulation Part 13 Simplified Acquisition Procedures and includes a brand name restriction limiting the procurement to ValGenesis products only. The evaluation will be conducted on a lowest price technically acceptable basis, with the government intending to award a firm fixed-price purchase order. Quotes are due by September 22, 2025, just seven days after the posting date of September 15, 2025.

This procurement does not include any small business set-aside designation despite falling under NAICS code 541511 (Custom Computer Programming Services) with a small business size standard of $34.0 million. ValGenesis is identified as the sole source provider, as the company pioneered this specific digital validation platform and has no resellers or alternative service providers available. The contract requires delivery within 15 days after receipt of order (ARO) to NIAID's facility located at 5601 Fishers Lane, Rockville, Maryland 20852. The Bill of Materials attachment specifies the exact subscription components needed for the 40NU 10 RA configuration. The justification documentation indicates this system will provide a 100% paperless, risk-based validation platform supporting data integrity and operational efficiency for NIAID's clinical research systems.

Notice text

This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and solicitation for commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-NIAID-25-2266489 and the solicitation is issued as a Request for Quotes (RFQ).

This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-05, Effective 08/07/2025. 

The North American Industry Classification System (NAICS) code for this procurement is 541511, Custom Computer Programming Services, with a small business size standard of $34.0M.

This requirement is being competed with a Brand Name restriction (see attachment) and without a small business set-aside.

The Office of Cyber Infrastructure and Computational Biology (OCICB) Clinical Informatics Branch of NIAID is seeking to procure ValGenesis Subscription: VLMS SaaS Renewal - 40NU 10 RA. See attachments.

Manufacturer:

Valgenesis

Product needed:

See BOM attached.

Delivery location:

NIAID

5601 Fishers Lane

Rockville, MD 20852

Delivery Date:

15 days ARO

* By submitting a quotation, you are accepting that all government terms and conditions set forth herein shall prevail over the award.

The government intends to award a firm fixed price purchase order to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein. The award will be based the lowest price technically acceptable. By submitting a quotation, you are accepting that all government terms and conditions set forth herein shall prevail over the award. The technical evaluation will be based on the following: technical capability to meet the requirements listed on the attachment, and then price.

The following FAR provisions apply to this acquisition:

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)

FAR 52.212-1 Instructions to Offerors Commercial Items (Sep 2023)

FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (May 2024)

Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) is updated in your SAM record)

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements – Representation (Jan 2017)

The following FAR contract clauses apply to this acquisition:

FAR 52.212-4 Contract Terms and Conditions Commercial Items (Nov 2023)

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (Nov 2023)

*The applicable subparagraphs of FAR52.212-5 are included in the attachment to this posting.

FAR 52.203-19 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (Jan 2017)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

FAR 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014)

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov).

Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax.

Offers may be e-mailed to Ms. Skye Duffner, (E-Mail/ skye.duffner@nih.gov 240-236-9582). Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f)

All responsible sources may submit an offer that will be considered by this Agency. 

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Ms. Skye Duffner at skye.duffner@nih.gov.

Files

File Type Posted
52.212-5 Jan 2025 Supplies.docx DOCX document
2_ValGenesis JA 2266489.docx DOCX document
2_ValGenesis BOM 2266489 (FY25).xlsx XLSX spreadsheet

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