Economic Studies of FDA Regulations

The Food and Drug Administration's (FDA) Office of Planning Economics Staff Master Indefinite Delivery/Indefinite Quantity (IDIQ) contract supports comprehensive economic assessments of FDA regulatory actions. This contract provides specialized research and analytical services designed to produce high-visibility economic studies that can withstand rigorous scientific and technical review by diverse audiences, including government agencies, Congress, professional economists, and the scientific community. The vehicle enables the FDA to rapidly acquire specialized economic research capabilities, with contractors providing timely data gathering, analysis, and direct research involving regulated entities across various industry sectors.

The contract has been predominantly utilized by Eastern Research Group Inc. (ERG) and Research Triangle Institute (RTI) International, who have executed task orders ranging from $55,000 to $500,879 with typical durations of 6-24 months. Representative task orders have included industry profile studies (medical gas, food sampling, pharmaceutical manufacturing), economic impact analyses for proposed regulations, consumer behavior modeling, and compliance cost assessments across sectors like cosmetics, healthcare technology, and drug manufacturing. All task orders have been awarded on a firm fixed-price basis, with no specific small business set-aside designations. The contract supports the FDA's broader regulatory assessment and economic analysis mission, drawing from a wide range of industry and regulatory research methodologies to inform federal policy and regulatory decision-making.