To embed, copy and paste the code into your website or blog: The US Department of Health and Human Services (HHS) issued a Final Rule on January 12, 2021 on Transparency and Fairness in Civil Administrative Enforcement Actions that amends 45 CFR Part I to set forth rules for appropriate reliance on guidance documents and requirements to give fair notice of relevant agency positions before taking a civil enforcement action that relies on any such position. The regulations purport to update HHS processes to ensure it operates with transparency and fairness so that regulated parties receive fair notice of laws and regulations to which they are subject and have an opportunity to contest an HHS determination prior to the agency taking any action with a legal consequence.