In 2016, the U.S. Department of Health and Human Services finalized its Guidelines for Regulatory Impact Analysis under the leadership of its Assistant Secretary for Planning Evaluation and Analytics Team. The Guidelines discuss strategies for characterizing the uncertainty in quantified effects as well as the potential impacts of non-quantified effects. They provide an overview of basic concepts, along with a summary discussion of different approaches and their complexity. This white paper expands on the discussion to provide a more detailed discussion of terminology, tools, and methods that may be used in uncertainty and sensitivity analyses conducted as part of the development of an RIA. It also provides a discussion of methods that may be used for communicating uncertainty to different stakeholder audiences and summarizes best practices for conducting these analyses. This white paper does not constitute new Guidelines.
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