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Comments to HHS on Proposed Repeal of Good Guidance Practices Rule

Policy Integrity submitted comments to the U.S. Department of Health & Human Services' (“HHS”) request for input on its proposed repeal of the Trump Administration’s Good Guidance Practices Rule (“GGP Rule”). The GGP Rule would have created heightened procedures for “significant guidance” documents, including a period of notice and comment, which HHS now recognizes would significantly delay expedient release of the guidance necessary to run its programs and protect public health, especially during the COVID-19 emergency. The GGP Rule also created a repository for all guidance along with a provision stating that guidance documents not in the repository are not effective and will be considered rescinded. As HHS now also recognizes, this provision could lead to accidental recession through human or technological error and create significant confusion for regulated entities and the public.

Policy Integrity’s comments make two key points. First, they explain why the GGP Rule is arbitrary and capricious, and HHS is justified in repealing it. In promulgating the rule, the Department ignored the rule’s costs, in the form of forgone health benefits, costs to regulated entities, and increased monitoring burdens on the public; and failed to justify the GGP Rule’s benefits beyond insufficient conclusory statements contradicted by the facts. Second, they explain how HHS can strengthen its repeal of the GGP Rule by taking note of the aggregate costs and benefits of repealing the GGP Rule, incorporating further information that clarifies the scope of the costs and benefits for repealing the GGP Rule when possible, and incorporating public comments on the GGP Rule into the record for the repeal if they inform its decisionmaking on the repeal.