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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations
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administrative burdens for grantees of all sizes. Therefore, the Secretary certifies that the final rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act, 5
U.S.C. 605.
Section 202 of the Unfunded Mandates Reform Act of 1995
Unfunded Mandates Act 2 U.S.C.
1532 requires the Department to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 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. This final rule will not result in an expenditure in any year that meets or exceeds this amount.
Executive Order 13132 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 final rule will not have a significant impact on state funds as, by law, project grants must be funded with at least 90 percent federal funds. 42 U.S.C. 300a4a. The Department has determined that this final rule does not impose such costs or have any federalism implications. The Department expects that while some states may not support the policies contained in this final rule, many states and local health departments will support the policies contained in this final rule, and that it will increase participation by states many of which withdrew as a result of the 2019 rule.
B. Summary of Costs, Benefits and Transfers This final rule will revise the regulations that govern the Title X
family planning services program by revoking the 2019 rule and readopting the 2000 regulations with several modifications. This approach will allow the Title X program grantees, subrecipients, and service sites to have a greater impact on public health than under the current regulatory approach.
We predict that this final rule will increase the number of grantees receiving Title X funds. In turn, the additional service sites supported by funding will result in additional clients served under the program. These clients receive access to contraception, and
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public health screening including clinical breast exams, Papanicolau Pap testing, and testing for STIs. These services result in improved family planning and birth spacing, earlier detection of breast and cervical cancer, and earlier detection of sexually transmitted infections including chlamydia, gonorrhea, syphilis, and human immunodeficiency virus HIV, all of which correlate to net savings for the government. This screening and testing can result in significant cost savings from earlier treatment and other interventions. This final rule will also increase the diversity of grantees receiving funds, including geographic diversity to states that do not currently have a Title X grantee.
The final rule will also focus grantees on providing services in a manner that is client-centered, culturally and linguistically appropriate, inclusive, and trauma-informed; protects the dignity of the individual; and ensures equitable and quality service delivery.
This focus is especially important for the Title X program that prioritizes services for low-income clients.
This regulatory impact analysis reports the activity occurring at Title Xfunded sites to provide policymakers with this information. However, the direct impact within the program does not account for services that continue to be provided at sites not receiving Title X funding, filling the gap left by providers that withdrew from the program following the restrictions placed on funding included in the 2019
rule.
C. Comments on the Preliminary Economic Analysis and Our Responses On April 15, 2021, the Department issued a proposed rule to revise regulations relating to the Title X
program. The Department prepared a preliminary regulatory impact analysis PRIA for the proposed rule. Many comments were outside the scope of this rule. The paragraphs below describe and respond to the comments received on the PRIA.
Summary of comments addressing the PRIA that were generally opposed to the rulemaking:
Several of the comments suggested that the Department used flawed data in its forecasts or failed to account for COVID19 in the PRIA. Several of the comments suggested that the Department does not have data to assess the effect of the 2019 rule, arguing that COVID19 is a complicating factor.
Several comments noted that clients served under the Title X program declined between 2009 and 2018, suggesting long-term trends can account
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for some of the reduction in clients served under the 2019 rule. Other comments noted that long-term demographics trends are responsible for the decline in services, such as rise in median household income, rise in individuals with private insurance, and more diverse options available in the healthcare market.
Several of the comments suggested that grantees withdrawing from the program may not have resulted in a decline in services, and that some services were continued with state and private funds. Several comments pointed out that some states saw an increase in clients after the 2019 rule.
One comment argued that, when one of two Ohio grantees left the program, the remaining grantee prevented a gap in coverage.
Responses to comments addressing the PRIA that were generally opposed to the rulemaking:
The primary estimate of the baseline Title X service grantees, subrecipients, service sites, and clients served are derived from calendar year 2019 figures, which predate COVID19. The PRIAs estimate of the likely effect of the proposed rule is to gradually return to the level of grantees, subrecipients, service sites, and clients that the program supported in calendar years 2016 to 2018, which also predates COVID19. COVID19 may complicate attempts to precisely estimate the magnitude of the effect of the 2019 rule on the Title X program, but prepandemic data from calendar year 2019
preceding COVID19 reveals a significant drop-off in grantees, subrecipients, service sites, and clients supported by the program, which are contrary to the predictions in the 2019
rule.13 The Department acknowledges the uncertainty in the forecast of the baseline scenario of no regulatory action by including a sensitivity analysis in the PRIA. The upper-bound forecast of 3,095,666 clients served annually by the Title X program under the baseline scenario of the 2019 rule is well below the approximately 4 million clients served during calendar years 2016 to 2018.
The Department disagrees with the suggestion that long-term trends drove the reduction in clients served under the 2019 rule. Between calendar years 13 If adjustment to the requirements of the 2019
rule took time for grantees and prospective new grantees and possibly continues to do so, then immediate post-issuance difficulties in obligating Title X funds could ease over the years, which would in turn lead to a trend back toward pre-2019
Title X service levels even in the analytic baseline.
However, the effects of the COVID19 pandemic would obscure, in the available data, whether such trends are present or absent.

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