HHS Rescinds Richardson Waiver and Signals Reduced Opportunity for Public Comment on Agency Action

Industry members and stakeholders who are regulated by HHS and its many subagencies, or who regularly participate in the rulemaking process, should take note.

Notice and Comment Rulemaking

Federal agencies like HHS publish rules and regulations for several reasons, including to implement or interpret statutes or to describe agency procedures. The Administrative Procedure Act (APA) establishes ground rules for agencies to follow during the rulemaking process to ensure the public can weigh in on the proposed agency policy or action. One type of rulemaking under Section 553 of the APA is informal rulemaking (otherwise known as “notice and comment rulemaking”).

Under the notice and comment process, agencies publish proposed rules in the Federal Register and invite stakeholders and the public to submit comments to the proposed rules. Comments often include additional data, opinions, support, or criticism related to the proposed rules. Once agencies close the comment period, agencies are required to consider all timely submitted comments before issuing a final rule. Federal agencies must respond to significant issues raised by public comments in the introduction or preamble to final rules.

Section 553 of the APA provides two statutory exceptions to notice and comment rulemaking:

• Section 553(a)(2): Agencies do not have to undergo notice and comment rulemaking for rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts.”
• Section 553(b)(3)(B): The good cause exception permits agencies to forgo notice and comment rulemaking when the process is “impracticable, unnecessary, or contrary to the public interest.”

The Richardson Waiver

In 1971, HHS adopted the Richardson Waiver, which waived the § 553(a)(2) exception and required HHS and its subagencies to conduct notice and comment rulemaking when promulgating rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts.” At the time, the HHS wanted “greater participation by the public in the formation of [agency] rules and regulations.” Furthermore, under the Richardson Waiver, HHS proclaimed to use the good cause exception sparingly.

The newly issued “Policy on Adhering to the Text of the Administrative Procedure Act” (2025 Policy) rescinds the Richardson Waiver and departs from HHS’ established notice and comment procedures that had been in effect for 50 years. Under the 2025 Policy, HHS subagencies are not required to adhere to notice and comment procedures for matters relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” unless HHS or its subagencies exercise their discretion to do so or are otherwise required by law.

Scope of the 2025 Policy

The 2025 Policy will impact the following subagencies and offices within HHS:

• Centers for Disease Control and Prevention
• Centers for Medicare & Medicaid Services
• US Food and Drug Administration
• National Institutes of Health
• Health Resources and Services Administration
• Indian Health Service
• Substance Abuse and Mental Health Services Administration
• Office of Inspector General
• Office for Civil Rights
• Office of the National Coordinator for Health Information Technology
• Office of the Secretary
• Administration for Children and Families
• Administration for Community Living
• Agency for Healthcare Research and Quality
• Agency for Toxic Substances and Disease Registry