SUPPLEMENTARY INFORMATION:

HHS published a notice of proposed rulemaking in the Federal Register on June 22, 2020 (85 FR 37414), with a sixty-day comment period, which closed on August 21, 2020. HHS did not receive any public comments.

HHS will remove the regulations appearing at 42 CFR part 136a. These regulations were promulgated as a final rule in 1987 and were intended to replace the regulations appearing in the CFR at 42 CFR part 136. The new regulations, however, were never implemented and have since been referred to as “suspended” in the Federal Register . In the intervening years, the IHS has continued to follow the regulations appearing at 42 CFR part 136, and the IHS does not propose to alter this practice. Instead, this final rule will remove the duplicative regulations at 42 CFR part 136a from the CFR. Given how much time has passed since these regulations were initially promulgated; the concern on the part of Congress regarding implementation of the regulations; and the confusion caused by having two sets of regulations addressing the same issue published in the CFR, the Agency will suspend the regulations at 42 CFR part 136a and will be deleted in their entirety. For access to background documents or posted comments, go to www.regulations.gov and search for Docket ID number IHS-FRDOC-0001.

Executive Orders 12866, 13563, and 14192

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

HHS submits that this final rule is not “economically significant” as measured by the $100 million threshold, and hence not a major rule under the Congressional Review Act. This rule has not been designated as a “significant regulatory action” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB). Executive Order 14192 requires that any new incremental costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least ten prior regulations.” This final rule is expected to be an Executive Order 14192 deregulatory action.

Regulatory Flexibility Act

This action will not have a significant economic impact on small entities such as Indian health programs. Therefore, the regulatory flexibility analysis provided for under the Regulatory Flexibility Act is not required.

Paperwork Reduction Act

This action does not affect any information collections.

Final Rule

91 FR 64302