HHS Issues SUNSET Rule 

Situation Report | January 11, 2021

The U.S. Department of Health and Human Services (HHS) has issued a final rule — called the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) — requiring HHS to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA).

RFA-applicable regulations will expire if the Department does not assess and, if required, review them in a timely manner.

All HHS regulations, with certain exceptions will be subject to a two-step review. First, HHS will assess whether the regulations have a significant economic impact on a substantial number of small entities, the standard set out under the RFA. If a rule qualifies for review under the RFA, it will undergo a more detailed review that will consider: 1) the continued need for the rule; 2) complaints about it; 3) the rule’s complexity; 4) the extent to which it duplicates or conflicts with other rules; and 5) whether technological, economic, and legal changes favor amending or rescinding the rule.

Certain regulations are exempt, including certain Food and Drug Administration (FDA) regulations, regulations that are jointly issued with other agencies, certain military or foreign affairs regulations and others.

More information is here.