FDA RFP: Economic Studies of FDA Regulations IDIQ

Notice ID: AmendedRFP121020

The Government intends to make award to no more than three (3) awardees as a multiple award Indefinite Delivery, Indefinite Quantity (IDIQ) contract with a five (5) year ordering.

The Economics Staff of the FDA’s Office of Policy, Legislation, and International Affairs (OPLIA) 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 (OMB), 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.

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.

Estimating Effects of Potential Regulatory Actions

The Agency’s planned regulatory agenda includes numerous potential regulations that would have economic consequences. The FDA requires data and models that can be used to estimate the effects likely to be associated with many different policies and provisions that could become regulations. These effects include the distribution of behavioral changes of consumers and producers in response to potential agency actions and the changes in risk that would result.

Analyses and Evaluations to Be Performed by the Contractor

• Conduct baseline assessment of industry characteristics, including, but not limited to, estimating employment levels, profits, prices, competitive structure, domestic and foreign location, and industry practices (or performance), including all international effects. The baseline should include projected changes over time.
• Develop methods and collect data to estimate the economic costs of existing or potential regulatory actions. FDA regulations may alter the expected use of a product, as well as result in higher costs of manufacture or distribution. Each component of these costs shall be identified, defined, and quantified, with all data compiled and sorted to facilitate statistical analyses.
• Develop methods and collect data to estimate the reduction in risk attributable to existing or potential regulatory actions and assess any potentially offsetting increases in risk …

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