Center for Biologics Evaluation and Research (CBER), Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics   6

Background
The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) has a requirement for their Biologics Effectiveness and Safety (BEST) Initiative #3: Data Sources for Surveillance of Biologics. The contract is a multiple-award Indefinite-Delivery Indefinite-Quantity contract for severable and non-severable services.

Work Details
The Contractor shall perform work according to the Statement of Work, terms, conditions, requirements set forth in the contract. The requirement is to provide FDA with de-identified analytic study results from large-scale United States health care data of tens of millions of patients, including adjudicated administrative claims data and electronic health records using a distributed data network which may use a common data model.
The data sources shall provide longitudinal health care data for participating patients and provide 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.

Period of Performance
The period of performance for this IDIQ contract shall consist of five one-year ordering periods estimated to be from September 30, 2024, through September 29, 2029. Task Orders may be issued up to the final day of this contract inclusive of any extensions thereto, and the contract shall remain in force to allow for the completion of all Task Orders issued.

Place of Performance
The geographic location(s) where the work will be performed is not explicitly provided in the solicitation document.