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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations These procedures regarding fair notice and an opportunity to respond would not apply where the agency, in its discretion, determines there is a serious threat to health, safety, or similar emergency, or where a statute specifically authorizes proceedings that are inconsistent with this section, including proceedings without a prior opportunity to be heard. Where such a threat arises and a statute does not specifically authorize proceedings without a prior opportunity to be heard, HHS would still provide an affected entity with an opportunity to be heard and a written response as soon as practicable. In this context, a serious threat means that, as reasonably determined by the Department, there is a non-negligible likelihood of the threat materializing.
We anticipate that the exception from 1.9 for actions taken in the context of threats to health, safety, or similar emergencies will apply broadly to public health agencies acting in furtherance of their missions. Actions will be considered to fall into this exception regardless of whether there is a showing of actual, imminent risk or harm, either to persons or animals. The agency has sole discretion to determine when an action falls into this exception.
An agency may invoke this exception regardless of whether agency action is taken reactively e.g., to address an unsafe item currently on the market or proactively e.g., to enforce regulations needed to protect public health prior to actual exposure by the public to unsafe items. Actions that fall into this exception include, for example, enforcing age restrictions or other controls around access to certain regulated products, enforcing manufacturer recordkeeping or reporting requirements, enforcing premarket requirements where there is an absence of or insufficient data concerning the product, protecting beneficiary data privacy or a federal healthcare program beneficiary from harm, and taking action to remove unapproved, misbranded, or adulterated human or animal products from the market.
Because of this exception, the procedures in 1.9 generally will not impact, for example, the administrative detention process for foods, drugs, devices, and tobacco products 21
U.S.C. 334g, h, the detention, refusal, and where authorized, destruction of imported products regulated by FDA 21 U.S.C. 381, disqualification 21 CFR parts 56, 58, 312, 511, 812, administrative detention, recall requests, import alerts, or other public notifications about food, drug,
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device, or tobacco products, or other actions related to investigating adulterated or misbranded products.
These procedures would also not apply to settlement negotiations between agencies and regulated parties, to notices of a prospective legal action, where a statute specifically precludes review of agency action, or to litigation before courts. Examples of situations where statutes specifically authorize differently structured proceedings include, but are not limited to, the hospital cost report appeals process 42
U.S.C. 1395oo, the individual benefit claims appeals process 42 U.S.C.
1395ff, and the process for the review of disallowances of Medicaid expenditures by the Secretary 42 U.S.C.
1316e. In such circumstances, the process and substantive standards governing review of claims arising under a relevant statute or regulation remain governed by those more specific procedures. The procedures would also not apply to any action related to a criminal investigation or prosecution, including undercover operations that may be used in a criminal investigation or prosecution, or any civil enforcement action either related to an investigation by the Department of Justice, or referred to the Department of Justice.
III. Rulemaking Analyses and Notices A. Executive Orders 12866 and 13563
Executive Order 12866, Regulatory Planning and Review, and Executive Order 13563, Improving Regulation and Regulatory Review, direct agencies to assess all costs and benefits of available regulatory alternatives and, if the regulation is necessary, to select regulatory approaches that maximize net benefits. The Department does not believe that this rulemaking is a significant regulatory action under these Executive Orders. This rule describes an update to the Departments current processes to ensure that it operates with transparency and fairness. The requirements in 45 CFR 1.6 through 1.9
relating to the proper use of guidance documents and fairness and notice in enforcement actions generally already exist in law. The requirements set forth in Section 6 of Executive Order 13892
and codified at 45 CFR 1.6 may exceed the requirements imposed by the Due Process clause of the Constitution and may impose a burden by delaying the time until HHS can take actions with legal consequence. However, this process will also offer important procedural safeguards and potentially reduce economic costs borne by regulated entities, which will have an opportunity to respond in writing before
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the Department takes an action that has potentially costly legal consequence.
The Department anticipates that the public, and, in particular, regulated parties, would benefit from greater efficiencies and more transparency in how the Department regulates, including facilitating smoother operations within HHS by clearly defining how guidance can be used.
B. Executive Order 13771
This final rule is neither a regulatory nor a deregulatory action under Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs, 82 FR 9339 Feb. 3, 2017, because this rule is estimated to impose no more than de minimis costs on regulated entities.
C. Regulatory Flexibility Act The Department has examined the economic implications of this rule as required by the Regulatory Flexibility Act RFA, 5 U.S.C. 601 et seq. The RFA
requires an agency to describe the impact of a rulemaking on small entities by providing an initial regulatory flexibility analysis, unless the agency expects that the rule will not have a significant impact on a substantial number of small entities, provides a factual basis for this determination, and proposes to certify the statement. 5
U.S.C. 603a, 605b. The Department considers a proposed or final rule to have a significant impact on a substantial number of small entities if it has at least a three percent impact on revenue on at least five percent of small entities. The Department anticipates that this rule will allow small entities to operate more efficiently, by increasing the transparency of government regulation. As a result, the Department has determined, and the Secretary certifies, that this final rule would not have a significant impact on the operations of a substantial number of small entities.
D. Executive Order 13132 Federalism Executive Order 13132, Federalism, establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments or has Federalism implications. The Department has determined that this final rule will not impose such costs or have any federalism implications.
E. Paperwork Reduction Act of 1995
In accordance with the Paperwork Reduction Act of 1995 and its implementing regulations, 44 U.S.C.
35013521; 5 CFR part 1320, the
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