Live Breaking News & Updates on Unprecedented Regulatory Reform|Page 1

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On 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The SUNSET Final Rule imposes new regulatory review and potential sunset (expiration) requirements for all regulations (subject to certain exceptions) issued by the Department and its various agencies, including the U.S. Food and Drug Administration (FDA). The Final Rule largely mirrors the Proposed Rule with two key changes: (a) the time period each agency has to review existing rules before they automatically sunset has been extended from two years to five years, and (b) additional regulations have been exempted from the rule, including FDA food standards of identify. The five-year period to review existing regulations would begin 60 days after the effective date of the Final Rule. The new Admini ....

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