Notice of Intent to Sole Source

The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), intends to procure consultative and technical support services for its Center for Veterinary Medicine’s (CVM) existing adverse event reporting system, known as the Pharmacovigilance (PV) Works VET platform. The objective of this procurement is to obtain deliverables that will aid in the development of a streamlined, consolidated enterprise-wide adverse event monitoring (AEM) system, which is a priority initiative for the FDA. The PV Works suite is crucial for the evaluation of animal drug adverse event reports, and the services required include validation of systems analysis documentation, mapping, and data extraction and migration support, all of which are unique to the proprietary software developed by Ennov, operating as Assured Information Systems (AIS). Interested parties can reach out to Narissa Charles at narissa.charles@fda.hhs.gov for further information regarding this opportunity.