Notice2025-11543
Guidance on Referrals for Potential Criminal Enforcement
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2025
Issuing agencies
Health and Human Services Department
Abstract
This notice describes the Department of Health and Human Services' (HHS or the Department) plans to address regulations that impose criminal liability under the recent Executive Order (E.O.) on Fighting Overcriminalization in Federal Regulations.
Full Text
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<title>Federal Register, Volume 90 Issue 119 (Tuesday, June 24, 2025)</title>
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[Federal Register Volume 90, Number 119 (Tuesday, June 24, 2025)]
[Notices]
[Pages 26822-26823]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11543]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Guidance on Referrals for Potential Criminal Enforcement
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: This notice describes the Department of Health and Human
Services' (HHS or the Department) plans to address regulations that
impose criminal liability under the recent Executive Order (E.O.) on
Fighting Overcriminalization in Federal Regulations.
FOR FURTHER INFORMATION CONTACT: Bob Foster, Deputy General Counsel,
(202) 260-3324, <a href="/cdn-cgi/l/email-protection#92e0fdf0f7e0e6bcf4fde1e6f7e0d2fafae1bcf5fde4"><span class="__cf_email__" data-cfemail="087a676a6d7a7c266e677b7c6d7a4860607b266f677e">[email protected]</span></a>.
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.
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\1\ ``Criminal regulatory offense'' means a Federal regulation
that is enforceable by a criminal penalty. E.O. 14294, sec. 3(b).
\2\ ``Mens rea'' means the state of mind that by law must be
proven to convict a particular defendant of a particular crime. E.O.
14294, sec. 3(c).
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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:
<bullet> the harm or risk of harm, pecuniary or otherwise, caused
by the alleged offense;
<bullet> the potential gain to the putative defendant that could
result from the offense;
<bullet> whether the putative defendant held specialized knowledge,
expertise, or was licensed in an industry related to the rule or
regulation at issue; and
<bullet> 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,
[[Page 26823]]
or entities, its officers, employees, or agents, or any other person.
Eric J. Osterhues,
Deputy General Counsel, U.S. Department of Health and Human Services.
[FR Doc. 2025-11543 Filed 6-23-25; 8:45 am]
BILLING CODE 4150-26-P
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</html>Indexed from Federal Register on June 24, 2025.
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