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In January 2021, the Department of Health and Human Services (“HHS”) finalized its SUNSET Rule. Section 610 of the Regulatory Flexibility Act (“RFA”) requires agencies to have a written plan to review their significant regulations every ten years to determine their impact on small entities (and to determine whether the regulations should be amended or rescinded based on the findings of the review). Because HHS found it was not reviewing all its significant regulations, it issued the SUNSET Rule to better incentivize review. Under the SUNSET Rule, all HHS regulations must be assessed every ten years to determine whether they are significant under the RFA and if they are, the review called for by the RFA must be performed. If the assessment or review of a regulation is not conducted every ten years, the regulation would expire.

Critics of the rule argue that committing HHS to reassessing the economic impacts of many of the department’s existing regulations is a large undertaking and it establishes an extreme penalty for noncompliance. Last fall, HHS issued a notice of proposed rulemaking to rescind the SUNSET Rule, and reports suggest a final repeal may be near. This webinar discussed the SUNSET rule, the effort to repeal it, and possible future actions in this area.


  • William Funk, Lewis & Clark Distinguished Professor of Law Emeritus, Lewis & Clark Law School
  • Jonah Hecht, Attorney, McGonigle; Former Deputy General Counsel, U.S. Department of Health and Human Services
  • [Moderator] Karen Harned, Executive Director, National Federation of Independent Small Business Legal Center

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As always, the Federalist Society takes no position on particular legal or public policy issues; all expressions of opinion are those of the speaker.