Testing laboratories

The Food and Drug Administration's Center for Veterinary Medicine is seeking validation services for molecular assays to detect the viability of African Swine Fever Virus (ASFV) in animal feed and food products. The procurement involves developing and validating molecular methods including BioGx, LAMP, and biosensor technologies to establish detection capabilities for ASFV viability that can be deployed during regulatory emergencies. Key contract requirements include conducting validation experiments in BSL-2 and BSL-3 laboratory facilities, submitting detailed validation protocols, generating experimental controls, and delivering comprehensive scientific reports with specific analytical sensitivity requirements. However, there appears to be conflicting information in the procurement documents, as one file indicates this is a total small business set-aside under NAICS code 541380 with quotes due September 5, 2025, while another document shows the FDA's intent to award a sole source contract to the University of Minnesota with responses due August 28, 2025. The evaluation will focus on selecting the best-suited contractor based on technical capabilities and compliance with safety and quality control standards.

The procurement documents show contradictory set-aside designations, with one indicating a total small business set-aside under the Testing Laboratories NAICS code 541380 (with a $47 million size standard), while another document reveals the government's intent to sole source the award to the University of Minnesota in Minneapolis. The base performance period is scheduled from October 15, 2025, to October 14, 2026, with work to be performed at the contractor's BSL-2 and BSL-3 facilities and delivery to the FDA/CVM facility in Laurel, Maryland. The contract will operate under simplified acquisition procedures as a firm-fixed price purchase order, though specific dollar values are not disclosed in the available documentation. The project supports study 414.30 and aims to generate validation data for implementing biosecurity measures, surveillance, and control strategies to prevent and mitigate African Swine Fever outbreaks. Interested parties have until August 28, 2025, to submit capability statements, with the government retaining discretion to determine whether to compete the requirement based on responses received.