Notice of Intent to Award a Sole Source Contract.docx

Sole Source Notice Agency: The Food and Drug Administration (FDA) Posted Date: August 13, 2025 Response Date: August 28, 2025 Procurement Type: Sole Source NAICS Code: 541380 - TESTING LABORATORIES Contracting Office Address: Office of Acquisitions and Grants Services (OAGS) Authority: FAR Part 6 (i.e. 6.302-1, Only One Responsible Source) Subject: Notice of Intent to Award a Sole Source Contract – ASFV, EhV & MCP EhV BioTag Testing and LAMP assay development Description: The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to The University of Minnesota for ASFV, EhV & MCP EhV BioTag Testing and LAMP assay development, in accordance with the authority under FAR Part 6 (i.e. 6.302-1, Only One Responsible Source). This procurement is being conducted under simplified acquisition procedures in accordance with FAR Part 13. The NAICS Code for this action is 541380 – Testing Laboratories.

The primary objective of this requirement is to assist The Government in the validation of molecular assays to detect determine the viability of the ASFV in animal feed/food to support study 414.30. The level of the methods validated should provide regulatory scrutiny so the methods can be used immediately for regulatory emergencies.

The government expects the contractor to provide the services of generating the validation data to support the methods acceptance for regulatory use to support study 414.30. The data generated is expected to confirm the utility of the modeling system as well as the molecular methods for regulatory use. The expectations of the services are to assist the implementation of strict biosecurity measures, surveillance, and control measures to prevent and control ASF outbreaks and mitigate its public health and economic impact.

Responses:

Responses to this notice should be sent to Ryan Alexander at ryan.alexander@fda.hhs.gov by August 28, 2025.

This notice is not a request for competitive quotes. Any other firms desiring consideration must fully identify their interest and capability of meeting the requirements by submitting a capability statement. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government.

Contracting Office Point of Contact:

Ryan Alexander Contract Specialist Email: ryan.alexander@fda.hhs.gov

Ian Weiss Contracting Officer Email: ian.weiss@fda.hhs.gov

Intended Awardee:

The University of Minnesota 230 Heller Hall, 271 19th Ave. S., Minneapolis, MN 55455