HHS Proposal May Simplify Guidance For Regulated Entities

Law360 (September 16, 2020, 3:05 PM EDT) -- With relatively little fanfare, the U.S. Department of Health and Human Services issued a notice of proposed rulemaking regarding good guidance practices on Aug. 20.[1]

As explained further below, this rulemaking is a response to Executive Order 13891 and proposes to establish clarity regarding how the department and its agencies, except for the U.S. Food and Drug Administration,[2] will issue subregulatory guidance documents and how the public can engage with the department in this process.

The stated purpose of the proposed rule is "to increase accountability, improve the fairness of guidance issued by the Department, guard against unlawful regulation through guidance,...

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