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Federal Register / Vol. 86, No. 54 / Tuesday, March 23, 2021 / Rules and Regulations with tribal governments. Again, these same concerns were raised in the written comments on the SUNSET
proposed rule. Under Executive Order 13175, entitled Consultation and Coordination With Indian Tribal Governments, HHS is required, before any action is taken that will significantly affect Indian Tribes, to consult with Indian Tribes in the development of the proposed rule to the extent practicable and permitted by law.
65 FR 67249 Nov. 6, 2000. This required consultation is in recognition that Tribes should be afforded an opportunity to comment meaningfully on the rules impact. However, multiple comments from representatives of several Tribes and related groups explained that, despite the enormous impact that this rule, if implemented, would have on Tribes, HHS failed to consult with Tribal governments or even notify them regarding the proposal, contrary to procedures required under Executive Order 13175.
See, e.g., Comments from the: Saint Regis Mohawk Tribe; Chickahominy Indian Tribe; Jena Band of Choctaw Indians; Nez Perce Tribe; Affiliated Tribes of Northwest Indians; Mohegan Tribe of Connecticut; Tanana Chiefs Conference; Chippewa Cree Tribe of the Rocky Boys Reservation; Alaska Native Tribal Health Consortium; United South and Eastern Tribes Sovereignty Protection Fund; Northwest Portland Area Indian Health Board; Quinault Indian Nation; California Tribal Families Coalition; National Indian Child Welfare Association; Tribal Law and Policy Institute; Tribal Technical Advisory Group; Native American Rights Fund, and the National Congress of American Indians, available at https www.regulations.gov/document/
HHS-OS-2020-0012-0001/comment. In light of the allegations in the Complaint, we need to reconsider the conclusion in the SUNSET final rule that the rule does not significantly affect Indian Tribes or have Tribal implications. Accordingly, HHS requires additional time to review the SUNSET final rule in light of the pending litigation.
In publishing the SUNSET final rule, the Department previously took the position that the rule complies with the APA and that the comment period was adequate, among other things. The Departments conclusions rested on certain assumptions that the Complaint challenges. For example, the Department expressed a view that it has the resources to complete assessments and reviews and avoid expiration, thus avoiding many of the legal concerns related to automatic repeal of
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regulations. See, e.g., 86 FR 5694, 5705
The regulatory impact analysis in this final rule explains how HHS has the resources and personnel to perform the Assessments and Reviews called for by this final rule.; id. at 5710 HHS does not intend to allow a regulation to simply expire.; id. at 5711 HHS
believes that this final rule does not significantly affect Indian Tribes or have Tribal implications . . . HHS intends that all rules will be Assessed and if necessary Reviewed timely. Therefore, this final rule would have no direct impact on Indian Tribes; id. at 5714
The Department does not intend for any regulations to inadvertently sunset, and it is unlikely that any regulations with significant benefits would slip through the cracks.. However, the Complaint alleges that there is no realistic probability that the Department will be able to conduct the number of reviews required to prevent automatic rescission, based in part on the quantity of analyses that would be required in the first five years and the agencys past practices. Complaint, 8485. As noted above, the Department now believes that the RIA
developed for the SUNSET final rule may not have fully taken into account all of the resource implications of this rule and therefore misjudged the likely expiration of existing regulations, elevating the administrative law concerns and concerns about the adequacy of the RIA.
In addition, the Department previously took the view that a 30-day comment period was adequate.
However, the Complaint challenges the sufficiency of a 30-day comment period for complex rules, Complaint, 54, and the SUNSET rules unique breadth, affecting an extraordinarily large number of regulations, could add force to such claims. The Department also took the view that the lack of tribal consultation was mitigated by the fact that Tribes will be able to comment on regulations during the Assessment and Review processes, 86 FR at 5711, but, as noted above, HHS is reconsidering that conclusion in light of the claims raised in the Complaint.
The Complaint also alleges that Plaintiffs and others are immediately harmed by the SUNSET final rule. The Complaint alleges that the uncertainty resulting from its implementation impacts the entire healthcare sector, which accounts for nearly one-fifth of the U.S. economy and secures individual and community health for hundreds of millions of Americans, and that participants in every single industry the Department regulates, including Plaintiffs, must plan their
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futures and operations without knowing what regulations will govern their businesses in these notoriously complex regulatory arenas. See Complaint, 2, 95122. While HHS does not concede that Plaintiffs would establish irreparable harm in litigation, HHS
agrees that it is appropriate to postpone the effective date of the SUNSET final rule to preserve the status quo and to ensure that HHS has time to evaluate the rule before it takes effect to avoid the possibility of confusion among the regulated community.
In addition, given the scope of work and timeframes set forth in the SUNSET
final rule, the review required under the rule would divert the Departments resources from mission-critical endeavors for HHS agencies. For example, based on a count cited in the SUNSET final rule, under the timeline and definitions provided in the final rule, over 7,000 sections of the Code of Federal Regulations promulgated by the Food and Drug Administration FDA
are more than ten years old or would become more than ten years old during the first five years the rule would be in effect, representing over 95 percent of its current regulations. Unless one of the exemptions applied, these regulations would need to be assessed within five years and, if applicable, reviewed, or be subject to expiration. If the SUNSET
final rule were to become effective as scheduled on March 22, 2021, then, in order to meet these new obligations within the specified timeframe to avoid automatic expiration of its regulations, FDA and the Department would need to immediately divert resources toward assessment and review during the ongoing COVID19 public health emergency. In that event, FDAs reviews of medical product applications, fulfillment of user fee commitments, and actions to address urgent public health matters such as ongoing COVID
19 pandemic relief efforts, outbreaks of foodborne illness, inspections, recalls, and other public health priorities would be significantly impacted. This concentration of resources in conducting regulatory review pursuant to the SUNSET rule could prevent FDA
from modernizing its regulatory oversight more efficiently and addressing new regulatory needs. These considerations further support HHSs determination that justice requires a postponement of the SUNSET final rules effective date. See 5 U.S.C. 705.
The SUNSET final rule presents similar burdens for HHSs seven other Public Health Service agencies and three human services agencies, such as the Centers for Medicare & Medicaid Services CMS, with implications for
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