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Regulatory Analysis

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

OMB Guidance and Resources

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.