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HHS Postpones Decision on Repealing SUNSET Final Rule

March 4, 2022

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

The Department of Health and Human Services (HHS) issued a final rule on March 3 pushing back the effective date of the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) regulation by six months.

The SUNSET regulation, which was published in the Federal Register on Jan. 19, 2021 (86 Fed. Reg. 5694) on the final day of the previous administration, provides that all regulations issued by HHS (subject to specific exceptions) 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.

In issuing the final rule (87 Fed. Reg. 12399), HHS explained that the department had decided to postpone the effective date rather than to withdraw or repeal the rule entirely as required by “the interests of justice.” This delay gives HHS an opportunity to review both the comments and related judicial filings from a lawsuit asserting that the SUNSET rule must be overturned because the issuance of the final rule violated the Administrative Procedures Act (County of Santa Clara v. HHS). The effective date of the SUNSET rule, which had previously been postponed to March 22, is now Sept. 22.

The AAMC submitted comments in response to the department’s Oct. 29, 2021, proposal to withdraw or repeal the final rule, and strongly urged the administration to take such an action [refer to Washington Highlights, Jan. 7]. Previously, the AAMC had submitted a response to the HHS’s initial request for comments on the SUNSET proposed rule (85 Fed. Reg. 70096), urging withdrawal of the entire proposed rule prior to it being finalized [refer to Washington Highlights, Dec 11, 2020].

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