Inactive
Notice ID:75F40124R00002
The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologic...
The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics (BEST 3). The primary goal of this Contract is to 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. 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 shall 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. This requirement will be unrestricted, full and open competition. The associated North American Industry Classification System (NAICS) Code is 518210- Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services; Small Business Size Standard is $40 million. The FDA anticipates a multiple award Indefinite Delivery/Indefinite Quantity contract with an anticipated performance period of a 5-year ordering period. Vendors are encouraged to sign up on the Interested Vendors List to receive automated notification from SAM.gov when changes are made to the posting; however, contractors are responsible to monitor this website for further information concerning this procurement.
