SUNSET Rule Effective Date Postponed

Federal Register notice: HHS is postponing, pending judicial review, the effective date of a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/22. However, on 3/9 a lawsuit was filed seeking to overturn the final rule, and HHS has decided to postpone it during the judicial review. Under the rule as proposed, 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) ten calendar years after the year of the regulation’s promulgation, or (3) ten 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 contains exemptions for a small set of certain FDA regulations. To view the notice, click here.