SUPPLEMENTARY INFORMATION:

On May 9, 2025, President Donald J. Trump issued E.O. 14294, Fighting Overcriminalization in Federal Regulations;90 FR 20363 (published May 14, 2025). Section 7 of E.O. 14294 provides that within 45 days of the E.O., and in consultation with the Attorney General, each agency should publish guidance in the Federal Register describing its plan to address regulations that impose criminal liability.

Consistent with that requirement, HHS advises the public that by May 9, 2026, the Department, in consultation with the Attorney General, will provide to the Director of the Office of Management and Budget a report containing: (1) a list of all criminal regulatory offenses ^[1] enforceable by the Department or the Department of Justice (DOJ); and (2) for each such criminal regulatory offense, the range of potential criminal penalties for a violation and the applicable mens rea ^[2] for the criminal regulatory offense.

This notice also announces a general policy, subject to appropriate exceptions and to the extent consistent with law, that when HHS is deciding whether to refer alleged violations of criminal regulatory offenses to DOJ, officers and employees of HHS should consider, among other factors:

• the harm or risk of harm, pecuniary or otherwise, caused by the alleged offense;
• the potential gain to the putative defendant that could result from the offense;
• whether the putative defendant held specialized knowledge, expertise, or was licensed in an industry related to the rule or regulation at issue; and
• evidence, if any is available, of the putative defendant's general awareness of the unlawfulness of his conduct as well as his knowledge or lack thereof of the regulation at issue.

This general policy is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, ( printed page 26823) or entities, its officers, employees, or agents, or any other person.

90 FR 26822