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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Section 3f 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 Presidents 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, and a significant regulatory action is subject to review by the Office of Management and Budget OMB. HRSA estimates that, on average, each health center would have needed to hire one additional full-time equivalent FTE
eligibility assistance worker at approximately $50,000 to support necessary additional administrative processes, totaling approximately $68,750,000 across health centers.
As stated in the RIA for the 2020 Rule, HRSA determined that the 2020 Rule was not economically significant, given that the administrative burden of $68.7
million described above fell below the economically significant threshold of $100 million. HRSA relies on that same analysis now, finding that rescission of that rule will have an economic impact of the same amount, $68,750,000, in administrative savings to health centers, and that such amount is below the economically significant threshold of $100 million. As Executive Order 13937

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remains in effect, HHS is exploring nonregulatory options for implementation.
HHS welcomed but did not receive comments on whether the proposed rescission of the 2020 Rule is a significant regulatory action under Section 3f of Executive Order 12866.
The Regulatory Flexibility Act RFA
The Regulatory Flexibility Act 5
U.S.C. 601 et seq. RFA and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require HHS to analyze options for regulatory relief of small businesses. If a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of the rule on small entities and analyze regulatory options that could lessen the impact of the rule. As we did in the Implementation of Executive Order on Access to Affordable LifeSaving Medications rule, HHS will use an RFA threshold of at least a 3 percent impact on at least 5 percent of small entities.
For purposes of the RFA, HHS
considers all health care providers to be small entities either by meeting the Small Business Administration SBA
size standard for a small business, or by being a nonprofit organization that is not dominant in its market. The current SBA size standard for health care providers ranges from annual receipts of $8 million to $41.5 million. As of September 31, 2020, the Health Center Program provides grant funding under section 330e of the Public Health Service Act to 1,315 organizations to provide health care to medically underserved communities. HHS has determined, and the Secretary certifies, that this rule will not have a significant impact on the operations of a substantial number of small health centers;
therefore, we are not preparing an analysis of impact for purposes of the RFA. HHS estimates the economic impact on small entities as a result of rescinding the 2020 Rule will be minimal. HHS welcomed but did not receive comments concerning the economic impact of the proposed rescission of the Implementation of Executive Order on Access to Affordable Life-Saving Medications rule on health centers for the purposes of the RFA.
Unfunded Mandates Reform Act Section 202a of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing any rule that includes any Federal mandate that may
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result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more adjusted annually for inflation in any one year. The current threshold after adjustment for inflation is $158 million, using the most current 2020 Implicit Price Deflator for the Gross Domestic Product. As stated in the RIA for the 2020 Rule, HRSA
determined that the administrative burden of $68.75 million described above fell below the Unfunded Mandates Reform Acts threshold of $158 million. HRSA relies on that same analysis now, finding that rescission of that rule will have an economic impact of the same amount, $68.75 million in administrative savings to health centers, and that such amount is below the threshold of $158 million.
Executive Order 13132Federalism HHS has reviewed this rule in accordance with Executive Order 13132
regarding federalism and has determined that it does not have federalism implications. This rule will not have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. This rule will not adversely affect the following family elements: Family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654c of the Treasury and General Government Appropriations Act of 1999.
Paperwork Reduction Act of 1995
The Paperwork Reduction Act of 1995
44 U.S.C. 3507d requires that OMB
approve all collections of information by a federal agency from the public before they can be implemented. This rule is projected to have no impact on current reporting and recordkeeping burden for health centers. This rule will result in no new reporting burdens.
HHS welcomed but did not receive comments that this rule would result in new reporting burdens for health centers.
Dated: September 28, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.

List of Subjects in 42 CFR Part 51c Grant programsHealth, Health care, Health facilities, Reporting and recordkeeping requirements.

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