Notice of Intent to Sole Source: Vaccine Adverse Event Reporting System (VAERS) & Safety Monitoring Support

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)’s Office of Biostatistics and Pharmacovigilance (OPBV)’s Division of Pharmacovigilance (DPV) is responsible for monitoring the safety of vaccines and biologics once they are approved for use under a Biologic Licensing Application (BLA) or authorized for use under an Emergency Use Authorization (EUA).

The Contractor shall furnish the necessary services and qualified personnel needed to perform the Statement of Work.