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Jan2021

Update: This rule was filed for public inspection on Friday, January 15, 2020; it is scheduled for final publication on January 19, 2020. 

On November 4, 2020—immediately following Election Day in the United States—the US Department of Health and Human Services (HHS) published a proposed rule in the Federal Register. The proposed rule, titled Securing Updated and Necessary Statutory Evaluations Timelyimplements an automatic expiration date for all new HHS regulations of ten years after their initial promulgation. Before that ten-year period is up, HHS regulators may choose to initiate a process to evaluate the rule to assess its continued effectiveness and relevance (after confirming the rule’s “significant economic impact.”) If they do not, the rule simply expires. Notably, already-existing rules are subject to just a two-year window for evaluation after the promulgation of this new rule. 

HHS’ justification for this rule is that it constitutes compliance with the 1980 Regulatory Flexibility Actwhich called for reforms to the regulatory process that included “review [of] the continued need for existing rules.” Such review, HHS says, could help avoid the problem of outdated, irrelevant, or redundant regulation that no longer serves the needs of stakeholders. 

On December 3, 2020, PRIM&R submitted a comment to HHS offering our perspective on the rule’s potential impact, with specific regard to the research ethics and oversight communities. Despite the clear benefits of regular, retrospective review of regulations—which we believe is critical to a healthy and effective regulatory environment”—the rule’s attempt to enact it is hasty, blunt, and overly rigid. 

ten-year time window for review may be appropriate for some regulations, but for more sweeping or impactful regulations (or sets of interrelated regulations), that time window may be inadequate for a comprehensive review process. In PRIM&R’s comments, we cite the process of revising the Common Rule, which itself took nearly a decade from start to finish: 

“The process for revising the Common Rule took eight yearsand involved the input of thousands of stakeholders representing the regulated community and beyond. The proposed rule fails to account for the time and resources that may be required to conduct the iterative, stakeholder-engaged process of effective rulemaking for substantial and far-reaching regulations such as the Common Rule. 

One-size-fits-all review of regulations also fails to make best use of limited HHS resources. Given time and financial constraints, rational prioritization of review of regulations that merit it is vastly preferable to indiscriminate review of all regulations. Regulators’ time would be best spent reviewing those regulations thatfor instance, “apply to a domain that is quickly evolving, or because they have an outsized impact on the regulated community,” as opposed to reviewing strictly on the basis of the regulation’s age. 

The rule also does not contain an adequate mechanism for engaging with the public about regulations on the docket for review (or already undergoing review), instead leaving to the regulated community the responsibility of keeping track of soon-to-expire regulations and “reminding” regulators to review themCreating a website to do so, which the rules proposes as a fix to the acknowledged risk that “a Regulation could expire because the Department inadvertently did not Assess or Review it,” is woefully inadequate stakeholder engagement. Simply allowing the public to ask regulators to review rules, as noted in a Regulatory Review piece, overlooks, or at the very least undervalues, residual harms imposed on stakeholders, particularly small businesses and vulnerable populations—two groups that ordinarily lack the resources to keep up with an aggressive calendar for such sunsets or to lobby the agency to review them.  

In our submitted comments, PRIM&R also voiced concern about the unclear details surrounding what actually happens to an expired regulation. It is not clear whether the public will be notified how and when rules disappear, or whether there will be formal assessment of the impact of a regulations’ disappearing. Nor does the rule seem to require HHS to explain why it didn’t assess or review certain rules, or allow the public to weigh in on that decision. 

As we wrote in our comments, “eliminating regulations out of neglect is not an acceptable way to do rulemaking.” This rule represents an abdication of the responsibilities of regulators to carefully review the most important, timely rules in a manner that provides space for deep, sustained public engagement. As of the end of 2020, the rule has not yet been finalized, and we urge HHS to carefully reconsider it before it is. 

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