Economic Studies of FDA Regulations

The Food and Drug Administration awarded this Master IDIQ on September 9, 2019, to provide economic assessments of FDA regulatory actions, but ordering closed on September 14, 2020, making this vehicle inactive for new task orders. The combined potential value across 12 task orders is $2.6 million, with $2.4 million already obligated (94% utilization).

Work contracted under the vehicle spans economic analyses of FDA-regulated industries, regulatory impacts, and compliance costs. Recent task orders include economic characterization of biologics and outsourcing facilities industries, traceability compliance cost studies supporting food safety modernization analysis, health equity research literature reviews, breakthrough therapy designation database metrics collection and analysis, and database modernization and data analytics support for FDA systems including the Data Analysis Search Host (DASH).

Competition is highly concentrated. Eastern Research Group Inc. holds 9 of 12 orders totaling $2 million in combined potential value, while Research Triangle Institute holds the remaining 3 orders valued at $571 thousand. All 12 task orders are unrestricted (no set-aside designation). Ordering is exclusively from FDA's Office of Planning and related components, with no multi-agency participation.

Task order values range from approximately $92 thousand to $510 thousand, with durations typically spanning 12 to 36 months. Pricing structures mix firm fixed price, time and materials, and labor hours. The most recent awards date to August 2023, with two orders extending through September 2025 and one through July 2026, indicating trailing activity despite the vehicle's closed ordering period.

Because the last-date-to-order passed in September 2020, this vehicle is not available for new task-order competition. Pursuit is viable only if your firm already holds a position as a subcontractor to Eastern Research Group Inc. or Research Triangle Institute on active orders, or if you are evaluating historical performance for recompete positioning on a successor IDIQ.

The Economics Staff of the Food and Drug Administration's (FDA) Office of Planning (OPl) has awarded a Master IDIQ to provide accurate and timely economic assessments of FDA regulatory actions. These analyses have high public visibility and, therefore, must withstand intense scientific and technical review and scrutiny by diverse audiences including the public, regulated entities, Government agencies such as the Department of Health and Human Services and the Office of Management and Budget, the U.S. Congress, professional economists, and the scientific and medical community.