CDER Priority Analysis

The CDER Priority Analysis Master Indefinite Delivery/Indefinite Quantity (IDIQ) contract, awarded by the Food and Drug Administration's Center for Drug Evaluation and Research, provides comprehensive technical assistance across multiple quantitative and qualitative analytical disciplines. The contract's primary purpose is to support the FDA's ability to develop and apply rigorous methodological approaches in evaluating drug-related research, regulatory processes, and public health impacts. Specifically, the vehicle enables technical support drawn from decision science, risk analysis, social science, health outcomes research, health systems research, and health economics to enhance the agency's analytical capabilities.

The task orders under this IDIQ consistently focus on supporting FDA regulatory and research initiatives, with contract values typically ranging from $38,587 to $1,965,088 and performance periods spanning approximately 12-24 months. Two primary prime contractors, Eastern Research Group (ERG) and Booz Allen Hamilton, have been the predominant awardees, executing task orders across various areas including drug development communication assessments, combination product reviews, opioid policy modeling, patient experience data analysis, and regulatory decision-making support. All task orders have been firm fixed price or labor hour contracts with no specific small business set-aside designations, and performance locations have included Massachusetts and Virginia. The contract supports critical FDA program areas such as Prescription Drug User Fee Act (PDUFA) assessments, benefit-risk framework evaluations, and demographic data collection for regulatory research.