Economic Studies of FDA Regulations

The Food and Drug Administration awarded this Master IDIQ on March 27, 2014 to provide economic analyses of FDA regulatory actions, with ordering authority that closed on March 26, 2019. The vehicle is no longer active; the ordering period expired more than seven years ago and no new task orders can be placed.

The FDA's Economics Staff in the Office of Planning used this vehicle to fund rapid-turnaround economic impact assessments and industry surveys supporting rulemaking, post-market safety reporting, and compliance-cost characterization across FDA-regulated sectors including pharmaceuticals, medical devices, cosmetics, food, and outsourcing facilities. All 12 task orders issued under the vehicle carried firm-fixed-price or labor-hour pricing with no set-aside designation; scope ranged from targeted economic models predicting consumer behavior in response to warnings and labeling (the largest order, valued at $500,879) to industry profiling and compliance-cost surveys requiring direct contact with regulated entities.

Eastern Research Group Inc. dominated the vehicle, capturing 9 of 12 orders and $1.2 million of combined potential value (approximately 63% of the vehicle total). Research Triangle Institute held the remaining 3 orders and $725 thousand in potential value. The FDA was the sole customer across all awards. Task orders clustered between approximately $55,000 and $268,000 in ceiling value, with the exception of the $500,879 behavioral-response modeling study; all 12 orders have been obligated in full against the vehicle's $9 million shared ceiling. The vehicle exhibited steady ordering momentum from 2014 through 2018, with 2, 3, 2, 3, and 2 orders placed in those years respectively, before ordering authority lapsed in March 2019. The most recent award was in September 2018 for a medical gas industry profile and compliance-effort estimate, with an ultimate completion date of January 2020.

The Economics Staff of the Food and Drug Administration's (FDA) Office of Planning (OPl) has awarded a Master IDIQ for 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. The need of the Economics Staff for support by a contractor arises from the variety and complexity of the work, the need to have access to specialized resources to rapidly gather data to meet tight deadlines, and the need for research involving direct contact with regulated entities.