BEST Initiative - New and Innovative Methods for Automated Reporting

The Food and Drug Administration established this Master IDIQ on September 27, 2018, to develop automated adverse-event reporting and analysis methods for biologics under its Center for Biologics Evaluation and Research (CBER). The vehicle's ordering period closed on September 25, 2023—the vehicle is no longer active and accepts no new orders.

This vehicle is fully consumed and unlikely to yield future work. All four task orders awarded under the IDIQ have been completed or are in closeout; the most recent order finished on September 26, 2024. The combined potential value of $36.9 million has been fully obligated across those four delivery orders, with no remaining capacity. Ordering closed nearly three years ago with no extensions advertised.

International Business Machines Corporation is the sole prime contractor, holding all four task orders and 100 percent of combined potential value. FDA's CBER is the sole customer. All four orders were uncompetitive awards with no set-aside designation. Task-order values ranged from approximately $7.0 million to $14.6 million, all structured as time-and-materials arrangements with ceilings equal to obligated amounts. The orders were awarded annually from fiscal 2018 through 2022, suggesting steady-state FDA funding for this automated-reporting capability.

The work scope across all orders focused on developing natural language processing, artificial intelligence, and machine-learning methods to improve surveillance and automated adverse-event reporting for CBER-regulated biologic products. No successor vehicle is identified in the source material, and no task orders have been awarded since September 2022. Organizations seeking similar work with FDA would need to monitor for a new vehicle or pursue work through alternative contract mechanisms with CBER.

The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative: Development of New and Innovative Methods for Automated Reporting for CBER-Regulated Products. The primary goal of the contract is to develop new or improved automated adverse events data collection and analysis techniques by using methods such as natural language processing, artificial intelligence, machine learning and others to conduct more sophisticated surveillance and automated adverse event reporting for CBER-Regulated Products.