Inactive

See attached solicitation files for (BEST) Initiative #3: Data Sources for Surveillance of Biologics 07/13/2020: Amendment A00001: See attached Amendment posting Questions and the FDA's answers to the... See attached solicitation files for (BEST) Initiative #3: Data Sources for Surveillance of Biologics 07/13/2020: Amendment A00001: See attached Amendment posting Questions and the FDA's answers to the questions for the BEST 3 initiative. The solicitation closing date is not extended.

Inactive

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: Data Processing, Hosting, and Related Services; the Small Business Size Standard is $35 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 FBO when changes are made to the posting; however, contractors are responsible to monitor this website for further information concerning this procurement. Interested Parties with comments, questions, etc., shall respond to Suzanne Martella at suzanne.martella@fda.hhs.gov