The Economics Staff of the Food and Drug Administration’s (FDA) Office of Planning (OPl) has a requirement 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. 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.
The objective of this contract is to provide FDA with accurate information, data, and analytical models for use in assessments of the economic impacts of FDA actions or contemplated actions.
- Activities under the proposed contract shall include, but are not limited to, the following:
Methods – While the economic impact of certain FDA regulatory actions can be analyzed via established methods, other FDA initiatives will require novel analytical approaches to evaluate potential effects. For example, estimating the societal effects of initiatives to modernize FDA’s regulatory oversight of product safety and efficacy may require innovative approaches to collect or generate data, such as Internet panels, laboratory or field experiments, expert elicitations, contingent valuation, and data-based simulations.
- Baseline Measurement – The FDA needs data on the economic characteristics of regulated industries, so that changes in regulatory policies can be empirically examined. This data will include, for example, the number, size, and location (domestic or foreign) of firms and their employment, sales, and number of stock keeping units (labels). In some instances, industry profile studies require supporting documentation for OMB survey clearance procedures.
