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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 Administrati
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With the outcome of last week’s Georgia Senate runoff elections producing a 50-50 Senate ratio and giving Senate Democrats majority status, there is renewed interest in the Congressional Review Act (CRA) (5 U.S.C. 801 et seq.). Under the CRA, a new Congress can act within its first 75 days of legislative session to reverse “major rules” promulgated by federal agencies during the last 60 legislative days of the previous Congress.
In 2017, Congress used the CRA to pass “resolutions of disapproval” and nullify 16 different federal regulations promulgated in the last months of the Obama Administration. Under the statute, CRA resolutions are considered under expedited procedures and not subject to Senate filibuster rules. This means a simple majority – including all 50 Democratic (and left-leaning independent) senators plus incoming Vice President Kamala Harris breaking a tie if necessary – could pass such a resolution of disapproval in the new Senate.
HHS Finalizes Unprecedented Regulatory Reform through Retrospective Review
Today, the Department of Health and Human Services issued a final rule to further democratic values of accountability and transparency. Specifically, the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule requires the Department to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA), which requires regular review of significant regulations. If a given regulation is subject to the RFA, the Department must review the regulation every ten years to determine whether the regulation is still needed and whether it is having appropriate impacts. Regulations will expire if the Department does not assess and, if required, review them in a timely manner.
HHS Secretary Alex Azar (Photo by Tasos Katopodis/Getty Images)
The U.S. Department of Health and Human Services on Friday released a final rule requiring the agency to review its regulations once every ten years.
If a regulation is not reviewed, it may expire, said HHS.
The Securing Updated and Necessary Statutory Evaluations Timely, or SUNSET, rule, means that rules that are issued by an HHS component that are more than ten years old will need to be reviewed within five years. By terminating burdensome regulations unless their necessity is publicly demonstrated to the American people, our SUNSET rule will prove the boldest and most significant regulatory reform effort ever undertaken by the federal government,” said HHS Chief of Staff Brian Harrison.