Health Law Daily Rule requires HHS to review regulations in specific years, or regulations will expire
Monday, January 11, 2021

Rule requires HHS to review regulations in specific years, or regulations will expire

By Cathleen Calhoun, J.D.

With some exceptions, a review of HHS regulations must be done every 10 years, and some rules must be reviewed within 5 years, or they will no longer be valid.

The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule requires HHS to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA). If a regulation is found to be subject to review under the RFA, HHS is required to review the regulation every ten years and evaluate if the regulation is still needed and if it is having an impact that is appropriate. Most importantly, with some exceptions, regulations will expire if the assessments are not done and the regulations requiring review are not reviewed.

Review process. Regulations will be reviewed through a two-part process. First, through the process of assessing whether they have a significant economic impact on a substantial number of small entities, and, if the rule qualifies for review under the RFA. Second, a more in-depth review that will consider, as prescribed in the RFA:

  1. The continued need for the rule
  2. Complaints about the rule
  3. The rule’s complexity
  4. The extent to which the rule duplicates or conflicts with other rules
  5. Whether technological, economic, and legal changes favor amending or rescinding the rule

Timeline. If a rule is more than ten years old, it must be reviewed within five calendar years of the effective date of the SUNSET rule. The effective date of the SUNSET rule will be 60 days after it is published in the Federal Register. The rule has not yet been published in the Federal Register, but is expected to be published soon.

Exceptions. The SUNSET rule provides for exceptions. Specifically, the following regulations are exempt from the review process:

  • Certain Food and Drug Administration (FDA) device-specific, food standard, and over-the-counter drug specific regulations
  • Regulations that are jointly issued with other agencies
  • Regulations that legally cannot be rescinded
  • Regulations issued with respect to a military or foreign affairs function or addressed solely to internal management or personnel matters (two categories exempt from standard rulemaking requirements under the Administrative Procedure Act)

Regulations that have an impact on the regulations of other agencies will be reviewed in conjunction with those agencies.

Consequences. If a regulation is not reviewed within the timeframe required, it expires. However, if a review is published by an agency concluding that a regulation should be rescinded or amended, an agency will have two years to rescind or amend the rule.

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