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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations This rule is one component of the Departments broader regulatory reform initiative. The rule is designed to ensure accountability, fairness of how the Department uses guidance, proper use of guidance documents, and opportunities for third parties to be heard, and to safeguard the important principles underlying the United States administrative law system.

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A. Scope 45 CFR 1.1
The requirements established pursuant to this rule in 1.2b and 1.6
through 1.9 apply to civil enforcement actions by any component of the Department. Sections 1.3 through 1.5 as well as the definitions in 1.2 that were added through the Good Guidance Practices final rule at 85 FR 78770 Dec.
7, 2020, and that we will recodify in this rule at 1.2a will continue to apply to all guidance documents until FDA amends its good guidance practices regulation to be consistent with the HHS
Good Guidance Practices rule, at which point 1.2a and 1.3 through 1.5 shall apply to all divisions of HHS except FDA.
Nothing in this rule shall apply:
To any action that pertains to foreign or military affairs, or to a national security or homeland security function of the United States other than procurement actions and actions involving the import or export of nondefense articles and services;
To any action related to a criminal investigation or prosecution, including undercover operations, or any civil enforcement action or related investigation by the Department of Justice, including any action related to a civil investigative demand under 18
U.S.C. 1968;
To any action related to detention, seizure, or destruction of counterfeit goods, pirated goods, or other goods that infringe intellectual property rights;
To any investigation of misconduct by an agency employee or any disciplinary, corrective, or employment action taken against an agency employee; or In any other circumstance or proceeding to which application of this order, or any part of this order, would, in the judgment of the Secretary of HHS, undermine the national security.
B. Definitions 45 CFR 1.2
The definitions section at 45 CFR 1.2
is amended to include the following definitions at paragraph b.
Civil Enforcement Action HHS defines civil enforcement action to mean an action with legal consequence taken by the Department
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based on an alleged violation of the law.
Such actions include administrative enforcement 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 or denials/withdrawals of approval, claims authorizations, responses to citizen petitions, food or color additive petitions, or public health notifications.
Legal Consequence HHS defines legal consequence as 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. The meaning of this term is informed by the Supreme Courts discussion in U.S. Army Corps of Engineers v. Hawkes Co., 136 S. Ct.
1807, 181316 2016, and includes, for example, agency letters or orders establishing or increasing the probability of liability for regulated parties in a subsequent enforcement action, Ipsen Biopharmaceuticals, Inc.
v. Azar, 943 F.3d 953, 956 D.C. Cir.
2019; Rhea Lana, Inc. v. Dept of Labor, 824 F.3d 1023, 1030 D.C. Cir. 2016. It does not include a warning letter or other communication, such as one describing inspectional observations, that pursuant to agency policy is intended to provide notice to a regulated party and elicit voluntary compliance. Such warning letters and inspectional observations have no immediate regulatory implications for the entity, are an interim step in the agencys compliance communications with an entity, and are not final agency action that has legal consequences for a party. See Orton Motor, Inc. v. HHS, 884
F.3d 1205, 1215 D.C. Cir. 2018;
Holistic Candlers & Consumers Assn v.
FDA, 664 F.3d 940 D.C. Cir. 2012; see also Hi-Tech Pharm., Inc. v. Hahn, Civ.
No. 191268RBW, 2020 WL 3498588, 5 D.D.C. June 29, 2020; Lystn, LLC v.
FDA, No. 19cv1943PABKLM, 2020
WL 248962, 5 D. Colo. Jan. 16, 2020;
Cody Labs., Inc. v. Sebelius, No. 10CV
00147ABJ, 2010 WL 3119279, 11 D.
Wyo. July 26, 2010, affd, 446 F. Appx 964, 969 10th Cir. 2011; Gomperts v.
Azar, No. 1:19cv00345DCN, 2020
WL 3963864, 45 D. Idaho July 13, 2020.

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Unfair Surprise HHS defines unfair surprise to mean 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, or the initiation of litigation by HHS
following a very lengthy period of conspicuous inaction, in other words deliberate inaction, suggesting the agency previously had a different interpretation. Christopher v.
SmithKline Beecham Corp., 567 U.S.
142, 156 2012. However, an agency does not create unfair surprise when it proceeds with a new interpretation that it established in notice-and-comment rulemaking. See Martin v. Occupational Safety & Health Review Commn, 499
U.S. 144, 158 1991 identifying adequacy of notice to regulated parties as one factor relevant to the reasonableness of the agencys interpretation.
The definitions currently at 45 CFR
1.2 will be moved into a new paragraph a. All definitions at paragraph a apply to all components of HHS until FDA amends its good guidance practices regulation, at which point the definitions at 45 CFR 1.2a shall apply to all divisions of HHS except FDA. The definitions at 1.2b will apply to all components of the Department, including FDA.
C. Proper Department Reliance on Guidance Documents 45 CFR 1.6
This rule reiterates the application of certain existing legal principles to HHSs use of guidance documents:
When the Department takes a civil enforcement action or otherwise 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.
HHS may not use guidance documents to impose binding requirements or prohibitions on persons outside of the executive branch except as authorized by law or expressly incorporated into a contract. Noncompliance with a standard or practice that is not in a statute or regulation and announced solely in a guidance document may not be treated as itself a violation of applicable statutes or regulations, unless expressly authorized by statute.
This rule also explains the appropriate circumstances when the Department may use a guidance document in civil enforcement actions.
The Department may use a guidance document to explain the legal applicability of a statute or regulation
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