This document is scheduled to be published in the Federal Register on 01/14/2021 and available online at federalregister.gov/d/2021-00592, and on govinfo.gov [Billing Code: 4150-26] DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 1 HHS-OS-2021-0001 RIN: 0991-AC18 Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions AGENCY: Office of the Secretary, Department of Health and Human Services. ACTION: Final rule. SUMMARY: The Department of Health and Human Services is issuing regulations promoting transparency and fairness in civil enforcement actions. These regulations will help to ensure that regulated parties receive fair notice of laws and regulations they are subject to, and have an opportunity to contest an agency determination prior to the agency taking an action that has a legal consequence. DATES: Effective January 12, 2021. FOR FURTHER INFORMATION CONTACT: Brenna Jenny, Department of Health and Human Services, 200 Independence, Avenue, S.W., Room 713F, Washington, D.C. 20201. Email:
[email protected]. Telephone: (202) 690- 7741. I. Statutory and Regulatory Background The primary legal authority supporting this rulemaking is 5 U.S.C. 301. That provision provides that the “head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property.” This statute authorizes an “agency to regulate its own affairs,” and issue rules, such as this one, that are “rules of agency organization[,] procedure or practice.” Chrysler Corp.