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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
Department has reviewed this rule and has determined that it imposes no new collections of information.
List of Subjects in 45 CFR Part 1
Guidance, Government employess.
For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR Part I
as set forth below:
PART 1TRANSPARENCY AND
FAIRNESS IN CIVIL ADMINISTRATIVE
ENFORCEMENT AND ADJUDICATION
1. The authority citation for part 1
continues to read as follows:

Authority: 42 U.S.C. 1302, 5 U.S.C. 301, 551 et seq.

2. Section 1.1 is revised to read as follows:

1.1

Scope.

Sections 1.2a and 1.3 through 1.5 of this part shall apply to guidance documents issued by all components of the Department, until the Secretary amends the Food and Drug Administrations good guidance regulations at 21 CFR 10.115 to bring them into conformance with the requirements of this part, at which point, such amended regulations shall apply to the Food and Drug Administration, and 1.2a and 1.3
through 1.5 shall apply to all divisions of the Department except the Food and Drug Administration. Sections 1.2b and 1.6 through 1.9 of this part shall apply to all components of the Department.
3. Section 1.2 is amended by designating the existing text as paragraph a followed by the alphabetical ordered definitions, revising newly designated paragraph a introductory text, and adding paragraph b.
The revision and addition read as follows:

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1.2

Definitions.

a The following definitions apply to all components of the Department until the Secretary amends the Food and Drug Administrations good guidance regulations at 21 CFR 10.115 to bring them into conformance with the requirements of 1.3 through 1.5 of this part:

b The following definitions apply to all components of the Department:
Civil enforcement action means an action with legal consequence taken by the Department based on an alleged violation of the law. Such actions include administrative enforcement
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proceedings and enforcement adjudication which is the administrative process undertaken by any component of the Department to resolve the legal rights and obligations of specific parties with regard to a particular enforcement issue pending before it but do not include actions taken in the normal course of the Departments regulatory communications or decision-making, for example, decisions on product applications such as approvals, denials, or withdrawals of approval, claims authorizations, citizen petitions, food or color additive petitions, or public health notifications.
Legal consequence means the result of an action that directly or indirectly affects substantive legal rights or obligations, including by subjecting a regulated party to potential liability in an enforcement action. This includes agency letters or orders establishing greater liability for regulated parties in a subsequent enforcement action, but excludes communications that have no immediate regulatory implications for a person or entity, such as letters e.g., warning letters or inspectional observations that serve as an interim step in the agencys compliance communications with a person or entity or that are intended to encourage voluntary compliance.
Unfair surprise means a lack of reasonable certainty or fair warning, from the perspective of a reasonably prudent member of regulated industry, of what a legal standard administered by an agency requires.
4. Section 1.6 is added to read as follows:
1.6 Proper Department reliance on guidance documents.

a Overview. A civil enforcement action must have an appropriate legal basis. When the Department takes a civil enforcement action or makes a determination based on an alleged violation of law that has legal consequence for a person or state, it must allege or establish the violation of law by applying statutes or regulations.
b Limitations on the use of guidance documents. 1 The Department may not use guidance documents to impose binding requirements or prohibitions on persons outside the executive branch except as expressly authorized by law or as expressly incorporated into a contract.
2 The Department may not treat noncompliance with a standard or practice announced solely in a guidance document as itself a violation of applicable statutes or regulations except as expressly authorized by law.

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3 If the Department uses a guidance document to explain the legal applicability of a statute or regulation, that document can do no more, with respect to prohibition of conduct, than articulate the Departments understanding of how a statute or regulation applies to particular circumstances.
4 The Department may cite to a guidance document in a civil enforcement action only if it has notified the public of such document in advance through publication, in the Departments guidance repository, as described in 1.4.
5. Section 1.7 is added to read as follows:
1.7 Fairness and notice in civil enforcement actions and administrative inspections.

a When the Department takes a civil enforcement action, the Department may only apply standards or practices that have been publicly stated in a manner that would not cause unfair surprise.
b The Department must avoid unfair surprise when it imposes penalties and whenever it adjudges past conduct to have violated the law.
c The Department shall only conduct civil administrative inspections according to published rules of agency procedure.
6. Section 1.8 is added to read as follows:
1.8 Fairness and notice in jurisdictional determinations.

a If the Department relies on a decision in an agency adjudication, administrative order, or agency document to assert a new or expanded claim of jurisdiction e.g., a claim to regulate a new subject matter or a new basis for liability, or a relinquishment of a claim of jurisdiction, the Department must give fair notice by publishing the initial decision before the conduct over which jurisdiction is sought occurs. It must publish the initial decision in full or by citation, if publicly available, in the Federal Register or the Departments guidance repository described in 1.4.
A claim of jurisdiction is not new or expanded simply because it involves a new or novel set of facts so long as it is based on an established principle of general applicability.
b If the Department intends to rely on a document arising out of litigation other than a publicly published opinion of an adjudicator, such as a brief, a consent decree, or a settlement agreement, to establish jurisdiction in future civil enforcement actions
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