News & Analysis as of

Notice and Comment Regulatory Requirements Department of Health and Human Services (HHS)

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

Alston & Bird

Trump Administration Changes Seek to Avoid Notice and Comment Hurdles

Alston & Bird on

Our Health Care and Health Care Litigation Groups examine a policy move by the Department of Health and Human Services (HHS) that will allow the department to forgo notice and comment procedures for many of its regulations....more

Morgan Lewis

HHS Rescinds Policy Extending Notice and Comment Rulemaking Procedures to Rules for Grants, Public Benefits, and Contracts

Morgan Lewis on

Effective March 3, 2025, the US Department of Health and Human Services (HHS) rescinded its long-standing policy that had waived a statutory exemption under the Administrative Procedure Act (APA) from notice and comment...more

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