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  • Washington Highlights

    AAMC Comments on Proposed Rule to Withdraw or Repeal SUNSET Final Rule

    Contacts

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel
    Daria Grayer, SA- Lead Specialist, Science Policy and Regulation
    Ivy Baer, Senior Director and Regulatory Counsel

    The AAMC submitted comments to the Department of Health and Human Services (HHS) on Dec. 22, 2021, in response to an Oct. 29, 2021, notice of proposed rulemaking (86 Fed. Reg. 59906) to withdraw or repeal the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule, which was published in the Federal Register on Jan. 19, 2021 (86 Fed. Reg. 5694). The SUNSET final rule provides that all regulations issued by the HHS (subject to specific exceptions) would expire at the end of 1) five calendar years after the effective date of the SUNSET final rule, 2) 10 calendar years after the regulation's promulgation, or 3) 10 calendar years after the last year in which the HHS assessed and/or reviewed a regulation.

    On Dec. 4, 2020, the AAMC submitted a response to the HHS’ initial request for comments on the SUNSET proposed rule, (85 Fed. Reg. 70096), urging withdrawal “due to serious concerns about the use of agency resources, the lack of content-based prioritization of rules for review, and the need for the regulated community to keep track of which rules are coming up for review, or which may be sunset without warning" [refer to Washington Highlights, Dec 11, 2021].

    Consistent with the AAMC’s earlier comments on the SUNSET proposed rule, the association strongly recommended that the rule be withdrawn in its entirety in response to the department’s Oct. 29, 2021, proposal to withdraw or repeal the final rule. The AAMC also agreed with the HHS’ reasoning that the final rule, “if implemented, would significantly alter the operations of HHS with considerable repercussions for a diverse array of stakeholders.” In its comments, the AAMC also raised the following concerns:

    • The SUNSET final rule is contrary to the Administrative Procedures Act and Regulatory Flexibility Act given the automatic expiration of regulations without a required notice and comment period.
    • The SUNSET final rule undermines the goals of executive order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government” (Jan. 25, 2021), given the deleterious impact of the expiration of critical regulations on the patients and populations that rely on those regulations for their care (e.g., children; elderly adults; people with disabilities; people of color; other groups who have been historically underserved, marginalized, and/or impacted by poverty) [refer to Washington Highlights, July 9, 2021].
    • The SUNSET final rule drastically miscalculated the time and resources needed to carry out the regulatory review process, relying on a flawed understanding of the resources needed to implement such massive agencywide changes.
    • The SUNSET final rule would have a tremendous impact on the department’s ability to monitor and respond to the ongoing COVID-19 public health emergency, reallocating significant resources away from the pandemic and jeopardizing other department priorities.