HHS seeks to repeal Trump-era rules on guidance documents, enforcement procedures

Regulatory NewsRegulatory News | 21 October 2021 |  By 

US Department of Health and Human Services (HHS) officials are proposing to repeal two rules issued in the final days of the Trump Administration, calling them a “burden” and “inconsistent with the policies and goals of the current Administration.”
In a proposed rule issued on 20 October 2021, HHS outlined plans to roll back a final rule on guidance document procedures and another on civil administrative enforcement and adjudication procedures. The two final rules stemmed from executive orders issued by the Trump Administration in October 2019. In January 2021, President Biden revoked both of the executive orders that served as the basis for these rules and directed federal agencies to rescind any rules and policies associated with them. (RELATED: Biden’s day one regulatory freeze, Regulatory Focus 21 January 2021)
“Both rules created a single set of procedures for guidance documents and civil enforcement for the entire Department, which we believe is contrary to the efficient and effective administration of the wide array of programs by the Department, given the diversity of those programs,” HHS officials wrote in the Federal Register.
HHS added that both the guidance document rule and the enforcement rule would have a disproportionate impact on underserved communities because “they make it harder for agencies to take action to protect public health or remove bad actors from the market, which in turn harms those who need HHS services the most.”
Guidance procedures
The “Department of Health and Human Services Good Guidance Practices” rule was originally proposed in August 2020 with the stated goal of increasing accountability and improving fairness. As originally proposed, the rule required that all guidance documents issued by HHS include a statement that the guidance “does not have the force and effect of law and is not binding unless specifically incorporated into a contract.” The rule would have increased the procedures for significant guidance documents, including requiring the HHS Secretary to approve them and requiring that they be submitted to the Office of Information and Regulatory Affairs for review. The proposal also called for the creation of a guidance document repository and noted that if guidance documents were not in the repository, they would be considered rescinded. The proposed rule also included procedures that would allow the public to petition to withdraw or modify guidance documents.
Originally the guidance document proposal was not meant to apply to the Food and Drug Administration (FDA), which already has its own rules for issuing guidance documents. However, the final rule, issued in December 2020, included the FDA as part of the guidance changes. The final rule also added a requirement that the HHS Secretary approve all non-significant guidance documents if they were related to a priority policy matter, had the potential to create serious inconsistency, or would interfere with the action of another HHS agency.
HHS said it is now seeking to repeal the guidance procedures rule because it would delay or prevent the issuance of guidance documents, imposes inflexible requirements on HHS agencies, and conflicts with the FDA’s existing good guidance practices. If the agency finalizes plans to repeal the guidance procedures rule, the action would not change existing law on the non-binding effect of guidance documents, HHS noted.
Enforcement procedures
The “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions” was issued in January 2021 as a final rule without public comment. The rule included a requirement that HHS “avoid unfair surprise” by only applying civil enforcement standards that have been publicly stated, publishing decisions about new or expanded claims of jurisdiction in the Federal Register or the guidance repository and providing parties with written notice of its determinations and an opportunity to respond before taking civil enforcement action.
HHS said it is seeking to repeal the civil enforcement rule because it would create unnecessary obstacles to agency actions, conflicts with current HHS processes, and would divert critical resources.
“Slower and fewer enforcement actions could not only leave more bad actors in the market, but could embolden them, ultimately undermining the public interest,” HHS wrote in the Federal Register.
Federal Register notice


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