HHS Withdraws SUNSET Final Rule

Federal Register notice: Health and Human Services is withdrawing a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) that was published 1/19/2021. The SUNSET final rule was scheduled to take effect 3/22/2021. However, on 3/9 a lawsuit was filed seeking to overturn the final rule, and HHS decided to postpone it during the judicial review. Under the rule, subject to certain exceptions, HHS regulations would expire at the end of (1) two calendar years after the year that the SUNSET rule first became effective, (2) 10 calendar years after the year of the regulation’s promulgation, or (3) 10 calendar years after the last year in which the department “assessed” and, if required, “reviewed” the regulation, whichever was latest. In addition, the final rule contained exemptions for a small set of certain FDA regulations. To view the notice, click here.