Last week, HHS issued a final rule setting expiration dates for regulations that are not retrospectively reviewed in a timely manner. The final rule requires HHS to review its regulations every 10 years to determine whether they are subject to the Regulatory Flexibility Act (RFA) and, if so, whether they comply with the RFA.
HHS has five years to review regulations that are ten years or older and may request a one-time, one-year extension. The RFA, a statute enacted in 1980, requires each agency to issue a plan for periodic review of regulations to assess whether they have a significant economic impact on a large number of small entities and to determine whether the regulations should be amended based on that assessment. In reviewing its regulations, an agency is tasked with considering a number of factors including duplication with other rules, the need for the regulations, public input, complexity of the regulations, and the length of time since the last assessment and review.
Certain regulations are exempt from the final rule including some Food and Drug Administration regulations, jointly issued regulations, procedural rules, and internal management regulations.
The new rule would apply to regulations found in Titles 21 (Food and Drugs), 42 (Public Health), and 45 (Public Welfare) of the Code of Federal Regulations subject to certain exceptions. If HHS does not review a regulation within the mandated time period, the regulation will expire at the later of: (1) five years after the final rule is effective; (2) ten years after the regulation is promulgated; or (3) ten years after the last required assessment and review. According to the rule, the sunset provisions are intended to incentivize HHS to perform more retrospective reviews of its regulations in a timely manner.
During the 60-day comment period, HHS received 532 comments from healthcare providers, industry trade organizations, members of Congress, and non-profit public interest groups. According to the final rule, a majority of commenters opposed the rule and about 25% of commenters asked HHS to withdraw the proposed rule. Those commenters opposing the rule highlighted in their comments the additional regulatory burden associated with the required regulatory review process and the possibility that the rule would negatively affect HHS’s ability to focus on administering current programs.
The rule will become effective 60 days after the publication date, which is after President-elect Joe Biden’s inauguration. It is uncertain whether the final rule’s implementation would be blocked by the incoming administration.
