CBER Biologics Effectiveness and Safety - Initiative #3 (BEST 3)

Obtain new data sources including administrative claims data or claims and EHR data with access to complete medical chart information, provided directly from primary sources such as an insurer, payer or provider to support the Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Contractor must provide FDA with: distributed-type access to large-scale, United States (US) health care data covering tens of millions of patients; adjudicated administrative claims data but data sources may also include EHR using a distributed data network which may use a common data model (CDM) (potentially OMOP CDM) (data sources will provide longitudinal health care data for participating patients); access to full medical charts of patients whose health care data are available for review, abstraction, and adjudication in the context of biologic products surveillance activities; contractor must be a provider and primary source of the data such as health insurer, payer or provider.