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The Department of Health and Human Services proposes to issue regulations governing the agency’s procedural safeguards to ensure that guidance documents are used appropriately in administrative enforcement actions, and protect the due process rights of individuals and regulated entities. These regulations will help to ensure that the agency, where feasible, fosters greater private-sector cooperation in enforcement and promotes information sharing with the private sector.

Statement of Need:

To provide regulated parties with greater transparency and fairness in administrative actions, and consistent with the requirements of Executive Order 13892 of October 9, 2019, Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication, 84 Fed. Reg. 55,239 (Oct. 15, 2019), HHS is proposing to issue regulations that set forth policies that promote transparency and fairness in civil enforcement and adjudication activity that would apply to all divisions of HHS.

Summary of the Legal Basis:

The Administrative Procedure Act (APA), 5 U.S.C.  551  et seq.,  requires that administrative policies affecting individual rights and obligations be promulgated pursuant to certain stated procedures so as to avoid the inherently arbitrary nature of unpublished  ad hoc  determinations.  Morton v. Ruiz,  415 U.S. 199, 232 (1974).  The Freedom of Information Act amended the APA to advance this goal, and generally requires that agencies publish in the Federal Register their substantive rules of general applicability, statements of general policy, and interpretations of law that are generally applicable.  5 U.S.C.  552(a)(1)(D).  Unless a party has actual and timely notice of the effect of a rule or policy, the Freedom of Information Act generally prohibits an agency from adversely affecting a party with a rule or policy that is required to be published in the Federal Register that is not so published.  5 U.S.C.  552(a)(1).

Alternatives:

The Agency will consider comments on our proposed implementation of transparency and fairness measures, including comments on additional changes not included in the proposed rule.

Anticipated Costs and Benefits:

This proposed regulation will offer important procedural safeguards and potentially reduce economic costs borne by regulated entities, which will now have an opportunity to respond in writing before the Department takes an action that has (potentially costly) legal consequence.  If this proposed rule is finalized, the Department anticipates that the public, and, in particular, regulated parties, would benefit from greater efficiencies and more transparency in how the Department regulates.