Notice of Intent to Sole Source

The Food and Drug Administration has issued a Notice of Intent to Sole Source for consultative and technical support services related to the Center for Veterinary Medicine's existing adverse event reporting system, specifically the Pharmacovigilance (PV) Works VET platform. This special notice was posted on September 29, 2025, with a due date of October 6, 2025. The FDA requires specialized support to advance their priority initiative of developing a streamlined, consolidated enterprise-wide adverse event monitoring system. The work involves the PV Works suite of tools, which CVM currently uses for receiving and evaluating animal drug adverse events reports for both approved and unapproved animal drugs. The opportunity falls under the Software Publishers NAICS category and IT and Telecom Business Application/Application Development Software as a Service PSC category.

The sole source procurement is justified because the PV Works VET suite is proprietary software owned by the original equipment manufacturer Ennov, doing business as Assured Information Systems (AIS), making the required code and specialized knowledge unique to this vendor. Contractors interested in this opportunity must respond by October 6, 2025, and the work scope includes validation of systems analysis documentation, mapping, data extraction, and migration support services. The procurement specifically targets the proprietary nature of the existing system, which limits competition to the original manufacturer due to the specialized technical requirements. This initiative supports FDA's broader adverse event monitoring directive and requires intimate knowledge of the existing PV Works platform architecture. The sole source approach ensures continuity and technical compatibility with the current system while advancing the agency's enterprise-wide monitoring capabilities.