CDER Priority Analysis

The Food and Drug Administration's Center for Drug Evaluation and Research established this Master IDIQ on August 3, 2015, to provide technical assistance in quantitative and qualitative decision-science, risk analysis, health outcomes research, health economics, and related analytic methods to support FDA's regulatory analysis and drug review processes. The vehicle's ordering period closed on August 19, 2020, making this vehicle inactive for new task-order placement as of that date.

The vehicle has issued 17 task orders with a combined potential value of $8.6 million, of which $8.4 million (98%) has been obligated. Ordering momentum peaked in 2020 with five orders before declining sharply; the final task order awarded in February 2021 assessed postmarket safety signal evaluation processes. Recent work includes benefit-risk framework implementation evaluation, patient experience data incorporation in regulatory decisions, opioid systems modeling policy tools, tobacco product manufacturing practices research, and PDUFA program assessments.

Competition is highly concentrated among two primes. Eastern Research Group Inc. holds 10 of 17 orders ($4.3 million combined potential value), while Booz Allen Hamilton Inc. holds 6 orders ($4.1 million). Westat, Inc. received one order valued at $170 thousand. All 17 task orders were unrestricted (no set-aside used). Customer concentration is absolute: all orders fund FDA CDER work exclusively.

Task-order values range widely, from $38.6 thousand to $1.97 million, with no clear pattern in duration or pricing type—awards used firm fixed price, labor hours, and time-and-materials pricing. No mega-orders exist relative to the vehicle's scale. All work is performed for FDA's center-level operations based on task-order descriptions, with no geographic concentration outside the FDA's administrative footprint.

The purpose of the Master IDIQ is to provide technical assistance in identifying, developing, enhancing, applying or evaluating a wide range of quantitative and qualitative methods drawn from decision science, risk analysis, social science, health outcomes research, health systems research, health economics and other analytic disciplines. These methods will be applied in a variety of projects to enable the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) to use more comprehensive and rigorous methods of analysis, measures of effectiveness, measures of quality, and measures of value and other impacts on consumers, on public health, healthcare, regulated industry and other stakeholders.