The U.S. Department of Health and Human Services (HHS) analyzes the benefits, costs, and other impacts of significant proposed and final rulemakings, consistent with the requirements of several executive orders and statutes. HHS develops these analyses according to Circular A-4, technical guidance published by the U.S. Office of Management and Budget (OMB) covering all Federal agencies, and the HHS Guidelines for Regulatory Impact Analysis, developed and maintained by the Office of the Assistant Secretary for Planning and Evaluation (ASPE).
This website includes links to current HHS and OMB guidance, and additional resources related to the Regulatory Flexibility Act.
HHS Guidance on Regulatory Analysis
- Guidelines for Regulatory Impact Analysis (2016). The HHS Guidelines are complementary to Circular A-4, addressing issues commonly addressed when analyzing HHS regulations.
- Updating Value per Statistical Life (VSL) Estimates for Inflation and Changes in Real Income (2021). This appendix to the HHS Guidelines provides background information on VSL, which HHS applies in analyses of regulations that impact mortality risks. The appendix discusses a criteria-driven literature review commissioned by ASPE that identified values that are suitable for use in its regulatory impact analyses, and contains technical guidance on applying the estimates and the process for updating these values.
- Addressing International Effects (2021). This supplement to the HHS Guidelines extends its brief discussion of addressing international effects to provide more detailed information on conducting such assessments.
- Standard Values for Regulatory Analysis (2024). Each year, ASPE updates its default recommendations for several key inputs commonly used in HHS regulatory impact analyses. This data point reports current estimates of the value per statistical life and other parameters used to value changes in mortality risks, life expectancy, non-fatal health effects, and changes in time use, for use in analyses developed in 2024.
- Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices (2017). This report examines the conceptual framework and general approach for valuing changes in time use.
- Estimating Medical Costs for Regulatory Benefit-Cost Analysis: Conceptual Framework and Best Practices (2017). This report provides analytic considerations related to estimating the medical costs of illness.
- Addressing Uncertainty in Regulatory Impact Analysis (2021). This white paper expands on a discussion in the HHS Guidelines 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.
- Valuing COVID-19 Mortality and Morbidity Risk Reductions (2021). This report developed an approach to monetize mortality and morbidity risks associated with COVID-19, recommending estimates of the value per statistical case (VSC) that varied by case severity. Current COVID-19 VSC estimates are available in the Standard Values for Regulatory Analysis data point.
OMB Guidance and Resources
- OMB Circular A-4, Regulatory Analysis (2023) contains technical guidance to Federal agencies on the development of regulatory analysis.
- Appendix for OMB Circular No. A-4 (2023) and Current and Historical Estimates of the Social Rate of Time Preference (2023) provide additional information on the approach to discounting.
- Explanation and Response to Public Input (2023) provides explanations of OMB’s decisions that are reflected in the revisions to Circular A-4, as well as responses to public comments and peer reviewers’ reports on the draft revisions. A Preamble, published with a proposed revised Circular A-4, provides additional information about the context and process OMB used to revise the guidance.
- OMB topic-specific guidance, supplementing Circular A-4:
- Regulatory Matters contains additional resources related to the interagency review process managed by OMB’s Office of Information and Regulatory Affairs (OIRA) and the Executive Orders and statutes governing regulatory review.
- Guidance specific to several monetary thresholds:
- OMB Guidance on Compliance with the Congressional Review Act (2024) describes OIRA’s major determination process under the Congressional Review Act (CRA), noting that its requirements apply if “any undiscounted benefit, cost, or transfer estimate is at least $100 million in at least one year.”
- OIRA memo on implementing Executive Order 14094 highlights the importance of “the word ‘or’ in… ‘benefits, costs, or transfers,” noting that comparisons to the monetary threshold are performed separately for each estimate when determining significance under Executive Order 12866.
- OIRA Reports to Congress on the Benefits and Costs of Federal Regulation and Agency Compliance with the Unfunded Mandates Reform Act.
- Modernizing Regulatory Review summarizes recent efforts in response to the President’s January 20, 2021 memo of the same name.
- Frontiers of Benefit-Cost Analysis contains the inaugural 2023 and 2024 annual reports from the National Science and Technology Council’s Subcommittee on Frontiers of Benefit-Cost Analysis. This subcommittee is a technical community of practice where Federal agencies can: share knowledge and expertise on advancing benefit-cost analysis; aid each other in accessing new data, methods, and expertise; and identify areas where additional research, including by non-governmental actors, could meaningfully advance agency capacity to quantify or monetize costs and benefits.
Guidance and Resources Related to the Regulatory Flexibility Act
- HHS Guidance on Proper Consideration of Small Entities in Rulemakings (2003). This guidance discusses considerations related to analysis of regulatory actions under the Regulatory Flexibility Act (RFA). This guidance defines “substantial number” and “significant economic impact” in the context of RFA and identifies default numeric thresholds for use in certification analysis, which helps agencies to determine whether an initial and final regulatory flexibility analysis is required.
- U.S. Small Business Administration, Office of Advocacy. A Guide For Government Agencies: How To Comply With The Regulatory Flexibility Act (2017). The HHS Guidelines direct analysts to this guidance document when preparing analyses under the Regulatory Flexibility Act.
- U.S. Small Business Administration. Table of Size Standards (2023) contains industry-specific size standards, which are usually stated in number of employees or average annual receipts, representing the largest size that a business may be to remain classified as a small business.
- U.S. Census Bureau. Statistics of U.S. Businesses (SUSB). 2021 SUSB Annual Data Tables by Establishment Industry include the number of firms, number of establishments, employment, and annual payroll for most U.S. business establishments. The data are tabulated by employment size, which is convenient for comparing the potential economic impacts of a rule to the average annual revenue of firms by various firm-size categories.