In late October 2021, the United States Department of Health and Human Services (HHS) issued a proposed rule to repeal the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule that was published on January 19, 2021.
The SUNSET Final Rule
The SUNSET final rule was scheduled to take effect on March 22, 2021, but HHS issued an administrative delay of effective day that extended the effective date until March 22, 2022.
Under the SUNSET final rule, subject to certain exceptions, HHS regulations would expire and be considered ineffective: (1) five calendar years after the year that the SUNSET rule first becomes effective; (2) ten calendar years after the year of the regulation’s promulgation; or (3) ten calendar years after the last year in which HHS “assessed” and/or “reviewed” that regulation (whichever is later).
The final rule also required HHS to amend or rescind a regulation within a specified timeframe if necessitated by a detailed review or assessment of that regulation and requires that these reviews and assessments be posted both in the Federal Register and on the HHS website with an opportunity for public comment.
Proposal to Rescind
In the proposal to rescind the SUNSET rule, HHS claims that implementing the final rule would “significantly alter the operations of HHS with considerable repercussions for a diverse array of stakeholders” and result in an administrative burden on the Department and related agencies. Such an administrative burden would divert resources away from critical public health matters, including the COVID-19 pandemic.
HHS also notes that the final rule is “expansive in scope and impact, faced considerable opposition from stakeholders (and very little support), and lacked a public health or welfare rationale for expediting rulemaking.”
HHS also believes that the automatic expiration of its regulations holds the potential for public harm and that the sudden expiration of regulations would also potentially harm small entities by creating an undue and disproportionate burden. Additionally, HHS states that the definitions and exceptions in the final rule are ambiguous and risk the automatic expiration of many regulations.
In the proposed withdrawal, HHS opined that repealing the SUNSET final rule would result in cost savings for both HHS and the public based on that reduced administrative burden.
Request for Comments
While HHS believes that the SUNSET rule should be withdrawn in its entirety, it requests comments on whether it should consider modification of the final rule instead. Comments must be submitted to HHS no later than December 28, 2021. Electronic comments may be submitted through the Federal eRulemaking Portal, https://www.regulations.gov.