September 25, 2021

Volume XI, Number 268

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September 22, 2021

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HHS to Repeal SUNSET Rule

By way of background, on January 19, 2021, the Department of Health and Human Services (HHS) issued the final “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) rule which would have amended nearly all of the approximately 18,000 HHS regulations to add self-executing expiration dates.

Specifically, the final rule stated that “subject to certain [undefined] exceptions,” all regulations in Titles 21, 42, and 45 of the CFR would expire on the later of the following dates: (1) five years after the effective date of the rule [originally March 22, 2021 and later delayed to March 22, 2022], (2) ten years after the regulation’s promulgation, or (3) ten years after HHS assessed and (if required) reviewed the regulation to determine if the regulation should be rescinded or modified to minimize its impacts on small entities. And, because over 17,000 of HHS’s rules are more than five years old, to avoid expiration, the SUNSET rule would require the vast majority of these rules to be assessed in a time and resource intensive process within five years of the effective date of the rule. The rule was purportedly issued to “enhance the Department’s implementation of section 3(a) the Regulatory Flexibility Act (RFA),” which requires agencies to periodically review rules which have or will have a significant economic impact on a substantial number of small entities.

As we have previously blogged about, various entities filed a lawsuit alleging that, among other things, the SUNSET rule violated the RFA and the Administrative Procedure Act (APA).

On April 21, 2021, in response to the lawsuit, HHS stated in a stipulation seeking to stay the case (filed jointly with Plaintiffs) that it “anticipates issuing, in the coming months, a notice of proposed rulemaking repealing the SUNSET Rule.” Keller and Heckman will continue to report on any developments in the repeal of the SUNSET rule.

 

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 117
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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