FDA Notice of Proposed Rulemaking: Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures

On October 20, the United States Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking that would, in relevant part, repeal a Trump Administration rule on, “Department of Health and Human Services Good Guidance Practices,” (GGP Rule) (Dec 7, 2020).  

 The GGP Rule required:

  • Each guidance document issued by HHS (and its sub-agencies and offices) to generally include certain information, including a statement that the guidance does not have the force and effect of law and is not binding unless specifically incorporated into a contract;
  • heightened procedures for “significant guidance documents,” including a period of notice and comment, a requirement for HHS Secretary (Secretary) approval on a non-delegable basis, and a requirement for submission to the Office of Information and Regulatory Affairs for review;
  • creation of a repository website for all guidance documents along with a provision stating that guidance documents not in the repository are not effective and will be considered rescinded; and
  • Procedures for the public to petition the HHS to withdraw or modify any particular guidance document.

HHS has taken a renewed and critical look at the GGP Rule and concluded the Rule frustrate HHS’s “ability to efficiently direct and operate in the interest of public health and are inconsistent with the policies and goals of the current Administration.”

Specifically, the GGP Rule created a single set of procedures for all of HHS, which is problematic for how HHS is optimally run. Various agencies and offices within HHS require different processes to be impactful.  HHS believes the imposition of these uniform requirements interferes with HHS agencies and offices established practices and disrupts relationships with stakeholders. It no longer makes sense to have a one-size-fits-all approach to guidance procedures because it may hinder the agencies’ abilities to efficiently address public health issues, including but not limited to public health emergencies.

Accordingly, HHS is proposing to repeal both rules in their entirety and remove 45 C.F.R. pt. 1. Comments are due on November 19, 2021. We will be monitoring the next steps and will provide a summary. If you have any questions about HHS’s proposal, please contact us.


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