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HHS Publishes Final SUNSET Rule With New Exemptions and Timelines | Hogan Lovells

To embed, copy and paste the code into your website or blog: 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

Will the New Congress Reverse Any Midnight Rules? | Insights

Share 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.

Healthcare Policy Outlook with a Democratic-Controlled Senate | Holland & Knight LLP

Highlights The victories by Democrats Raphael Warnock and Jon Ossoff in the Georgia runoff elections for the U.S. Senate mean that incoming majority leader Chuck Schumer (D-N.Y.) will preside over the narrowest possible majority in the Senate under which Vice President Kamala Harris would provide the tie-breaking vote. The House and the Senate s narrow margins make it unlikely that broad sweeping proposals advanced by progressive Democrats but not supported by their more moderate colleagues will be able to pass. However, control of the Senate should significantly impact the prospects for President Biden s healthcare agenda. This Holland & Knight alert provides an updated assessment of healthcare policy activities likely to see action in the new 117th Congress and the Biden Administration in the wake of the Georgia runoff elections and based on additional information coming out of the Biden-Harris team.

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