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safety risks subject to Executive Order the population the program is meant to D. Section 59.7 What criteria will the 13045 (62 FR 19885, April 23, 1997); serve. The Department proposes to Department of Health and Human • Is not a significant regulatory action revise the 2019 rules by readopting the Services use to decide which family subject to Executive Order 13211 (66 FR planning services projects to fund and in 2000 regulations, with several what amount? 28355, May 22, 2001); modifications needed to strengthen the • E. Section 59.10 Confidentiality Is not subject to requirements of program and ensure access to equitable, F. Section 59.12 What other HHS section 12(d) of the National affordable, client-centered, quality regulations apply to grants under this Technology Transfer and Advancement services for all clients, subpart? Act of 1995 (15 U.S.C. 272 note) because especially for low-income clients. V. Regulatory Impact Analyses A. Introduction application of those requirements would DATES: To ensure consideration, B. Summary of Costs, Benefits, and be inconsistent with the CAA; and comments must be received by May 17, • Does not provide EPA with the Transfers 2021. discretionary authority to address, as C. Preliminary Economic Analysis of ADDRESSES: You may submit comments, Impacts appropriate, disproportionate human a. Background health or environmental effects, using identified by Regulatory Information Number 0937–AA11, by any of the b. Market Failure or Social Purpose practicable and legally permissible Requiring Federal Regulatory Action methods, under Executive Order 12898 following methods: • c. Purpose of the Proposed Rule (59 FR 7629, February 16, 1994). Federal eRulemaking Portal: http:// d. Baseline Conditions and Impacts In addition, this proposed www.regulations.gov. Enter the above Attributable to the Proposed Rule rulemaking, the District’s regional haze docket ID number in the ‘‘Enter e. Further Discussion of Distributional state implementation plan for the Keyword or ID’’ field and click on Effects second implementation period and ‘‘Search.’’ On the next web page, click f. Uncertainty and Sensitivity Analysis on ‘‘Submit a Comment’’ and follow the g. Analysis of Regulatory Alternatives to correction for the RACT rule for major the Proposed Rule stationary sources of NO , does not instructions. X • VI. Environmental Impact have tribal implications as specified by Mail or Hand Delivery [For paper, VII. Paperwork Reduction Act Executive Order 13175 (65 FR 67249, disk, or CD–ROM submissions] to: Attn: November 9, 2000), because the SIP is Title X Rulemaking, Office of I. Statutory Background not approved to apply in Indian country Population Affairs, Office of the Title X of the Public Health Service located in the State, and EPA notes that Assistant Secretary for Health, U.S. Act (PHS Act or the Act) (42 U.S.C. 300 it will not impose substantial direct Department of Health and Human through 300a–6) was enacted in 1970 by costs on tribal governments or preempt Services, 200 Independence Avenue Public Law 91–572 as a means of tribal law. SW, Washington, DC 20201. Comments, ‘‘making comprehensive voluntary including any personally identifiable or family planning services readily List of Subjects in 40 CFR Part 52 confidential businesses information, available to all persons desiring such Environmental protection, Air received prior to the close of the services.’’ 1 Section 1001 of the Act (42 pollution control, Incorporation by comment period will be posted without U.S.C. 300(a)), as amended, authorizes reference, Nitrogen dioxide, Ozone, change to http://www.regulations.gov. the Secretary of Health and Human Particulate matter, Sulfur oxides. While the Department welcomes Services ‘‘to make grants to and enter Dated: April 5, 2021. comments on any aspect of the into contracts with public or nonprofit Diana Esher, regulations, we particularly welcome private entities to assist in the comments concerning how the current Acting Regional Administrator, Region III. establishment and operation of regulations have impacted the public’s [FR Doc. 2021–07334 Filed 4–14–21; 8:45 am] voluntary family planning projects health or how this proposal to revise which shall offer a broad range of BILLING CODE 6560–50–P them will promote public health and aid acceptable and effective family planning in the program’s fundamental mission to methods and services (including natural DEPARTMENT OF HEALTH AND offer a broad range of effective family family planning methods, HUMAN SERVICES planning methods with priority given to services, and services for adolescents).’’ clients from low-income families. Section 1006 of the Act (42 U.S.C. 300a– 42 CFR Part 59 FOR FURTHER INFORMATION CONTACT: 4) ensures that priority of services is given to clients from low-income RIN 0937–AA11 Alicia Richmond Scott, Office of Population Affairs, Office of the families and authorizes the Secretary to Ensuring Access to Equitable, Assistant Secretary for Health, promulgate regulations governing the Affordable, Client-Centered, Quality Department of Health and Human program. Family Planning Services Services, 200 Independence Avenue Enacted as part of the original Title X SW, Washington, DC 20201; telephone: legislation, Section 1008 of the Act (42 AGENCY: Office of the Secretary, U.S. 240–453–2800; email: Alicia.richmond@ U.S.C. 300a–6) directs that ‘‘None of the Department of Health and Human hhs.gov. funds appropriated under this title shall Services (HHS). SUPPLEMENTARY INFORMATION: be used in programs where is ACTION: Proposed rule. a method of family planning.’’ The I. Statutory Background Conference Report accompanying the SUMMARY: The Office of Population II. Regulatory and Litigation Background III. Public Health Impact as a Result of the legislation described the intent of this Affairs (OPA), in the Office of the provision as follows: Assistant Secretary for Health, proposes 2019 Rules and Reason for This Proposal to revise the rules issued on March 4, IV. Proposed Rules It is, and has been, the intent of both A. Section 59.2 Definitions 2019, establishing standards for Houses that funds authorized under this B. Section 59.5 What requirements must legislation be used only to support compliance by family planning services be met by a family planning project? projects authorized by Title X of the C. Section 59.6 What procedures apply to 1 Public Law 91–572 (‘‘The Family Planning Public Health Service Act. Those rules ensure the suitability of informational Services and Population Research Act of 1970’’), have undermined the public health of and educational material? section 2(1).

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preventive family planning services, Id. Since FY 1998, Congress has for Family Planning Services at 13 population research, infertility services and included a rider in HHS’s annual (1981). other related medical, information, and appropriations act that provides that In 1988, reacting in large part to a educational activities. The conferees have directive from President Reagan, the adopted the language contained in section ‘‘[n]one of the funds appropriated in 1008, which prohibits the use of such funds this Act may be made available to any Department changed course. 53 FR 2922 for abortion, in order to make clear this entity under Title X of the PHS Act (Feb. 2, 1988). Regulations promulgated intent. unless the applicant for the award then—commonly called the ‘‘gag H.R. Rep. No 91–1667, at 8–9 (1970) certifies to the Secretary that it rule’’—prohibited the discussion of or (Conf. Rep.). This requirement has been encourages family participation in the referral for abortion. The regulations reiterated by later Congresses through decision of minors to seek family also required grantees to maintain strict annual appropriations provisos that planning services.’’ 6 See, e.g., physical and financial separation state: ‘‘[A]mounts provided to said Consolidated Appropriations Act, 2021, between Title X projects and abortion [voluntary family planning] projects Public Law 116–260, Div. H, sec. 207, related activities, to be determined by under such title shall not be expended 134 Stat. 1182, 1590. The same the ‘‘facts and circumstances’’ of each for .’’ See, e.g., Consolidated appropriations rider also requires that grantee. Additionally, the regulations Appropriations Act, 2021, Public Law such an applicant certify to the prohibited lobbying, education, dues- 116–260, Div. H, 134 Stat 1182, 1570. Secretary that it ‘‘provides counseling to paying, or any other activities which Since 1970 when Title X was first minors on how to resist attempts to could be interpreted to encourage or enacted, Congress has amended the law coerce minors into engaging in sexual promote abortion as a method of family several times both through changes to activities.’’ Id. And, since FY 1999, in a planning. the Title X statute itself and through separate rider, Congress has required The 1988 regulations were yearly appropriations riders. For that, ‘‘[n]otwithstanding any other immediately subject to multiple example, in 1975, Congress amended provision of law, no provider of services lawsuits and ultimately upheld by the Title X to include ‘‘natural family under Title X of the PHS Act shall be Supreme Court in Rust v. Sullivan, 500 planning methods’’ as part of the broad exempt from any State law requiring U.S. 173 (1991). In Rust, the Supreme range of family planning methods to be notification or the reporting of child Court held that section 1008 was offered by Title X projects.2 PHS Act abuse, child molestation, sexual abuse, ‘‘ambiguous’’ and ‘‘at no time did 1001(a) (42 U.S.C. 300(a)). In 1978, rape, or incest.’’ 7 See, e.g., Consolidated Congress directly address the issues of Congress amended Title X to codify Appropriations Act, 2021, Public Law abortion counseling, referral or HHS past practice by specifically 116–260, Div. H, sec. 208, 134 Stat. advocacy.’’ Id at 185. The Court was requiring that Title X projects include 1182, 1590 (2021). nearly unanimous on this point. ‘‘services for adolescents.’’ 3 PHS Act Blackmun dissenting at 207; O‘Connor 9 1001(a) (42 U.S.C. 300(a)). The Act was II. Regulatory and Litigation Dissenting at 223. Given the lack of again amended in 1981 to provide that Background clarity regarding section 1008, the Court ‘‘[t]o the extent practicable, entities deferred to the Secretary’s construction The Department first promulgated of the statute as ‘‘reasonable’’ under which receive grants or contracts under regulations for the Title X program in this subsection shall encourage family Chevron U.S.A. v. NRDC, 467 U.S. 837 1971 but did not directly address (1984). participation in projects under this section 1008. 36 FR 18465 (Sept. 15, subsection.’’ 4 PHS Act sec. 1001(a) (42 The Court also upheld the regulations 1971). With experience, the Department against constitutional attack under the U.S.C. 300(a)). interpreted section 1008 to prohibit Congress has also imposed additional Fifth and First Amendments. Following grantees 8 from promoting or requirements through annual recent precedent, the Court held that the encouraging abortion as a method of appropriations riders. For example, Government could constitutionally family planning in any way and to since Fiscal Year (FY) 1996, the annual subsidize some activities over others Title X appropriation includes the require that Title X activities be separate and that plaintiffs were still free to proviso that ‘‘all counseling and distinct from any abortion pursue abortion related activities and activities. 53 FR 2922, 2923 (Feb. 2, shall be nondirective.’’ 5 See, e.g., speech ‘‘when they are not acting under 1988) (describing the Department’s Consolidated Appropriations Act, 2021, the auspices of the Title X project.’’ Id. interpretation in the early years of the Public Law 116–260, Div. H, 134 Stat at 199. program). In 1981, the Department built 1182, 1570 (2021). Also since FY 1996, On November 5, 1991, responding to upon this experience and issued the Title X appropriation has directed widespread concerns over the guidelines directing grantees to provide that Title X funds ‘‘shall not be regulation’s overreach into the doctor- ‘‘nondirective counseling’’ to pregnant expended for any activity (including the patient relationship, President Bush clients ‘‘upon request’’ including: (1) publication or distribution of literature) issued a directive to the Department to and delivery; (2) infant that in any way tends to promote public allow for open communications care, , or ; and (3) support or opposition to any legislative between doctors and patients for all pregnancy termination. Counseling proposal or candidate for public office.’’ aspects of their medical condition. See included ‘‘referral upon request.’’ OPA, Nat’l Family Planning & Reprod. Health 2 Public Law 94–63. Program Guidelines for Project Grants Ass’n v. Sullivan, 979 F.2d 227 (D.C. Cir 3 Public Law 95–613. The amendment reflected 1992). However, the Department did not Congress’ intent to place ‘‘a special emphasis on 6 Departments of Labor, Health and Human engage in rulemaking to carry out the preventing unwanted among sexually Services, and Education, and Related Agencies directive, as required by the active adolescents.’’ S. Rep. No 822, 95th Cong, 2d Appropriations Act, 1998, Public Law 105–78, sec. sess. 24 (1978). 212, 111 Stat. 1467, 1495 (1997). Administrative Procedure Act. 4 Omnibus Budget Reconciliation Act of 1981, 7 Department of Health and Human Services Therefore, the D.C. Court of Appeals Public Law 97–35, sec. 931(b)(1), 95 Stat. 357, 570 Appropriations Act, 1999, Public Law 105–277, (1981). Title II, sec. 219, 112 Stat. 2681, 2681–363 (1998). 9 Justice Stevens, the only Justice to find the 5 Omnibus Consolidated Rescissions and 8 For purposes of this notice of proposed § 1008 unambiguous, believed it ‘‘plainly’’ Appropriations Act, 1996, Public Law 104–134, rulemaking, the terms ‘‘grantee’’ and ‘‘recipient’’ are foreclosed the Secretary’s regulations. Stevens Title II, 110 Stat.1321, 1321–221 (1996). used interchangeably. dissent at 221.

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upheld a lower court injunction believing any referral to a prenatal or 1988 rule, as well re-codifying the prohibiting the directives from taking other provider when not requested lobbying restrictions. Additionally, the effect. Id. would raise real questions of coercion. rule added requirements on grantees Almost immediately after taking The rule also incorporated referrals as a and subrecipients regarding compliance office, President Clinton issued a ‘‘logical and appropriate outcome’’ of with state reporting laws, as well as memorandum to the Secretary of HHS, nondirective counseling and consistent expanded application and record- directing suspension of the ‘‘gag rule’’ with the requirement that the project keeping requirements. And, with and commencement of new rulemaking provide referrals for any medical respect to minors, the 2019 rule regarding the Title X program. 58 FR services not provided by the project [42 required providers to document what 7455 (Feb. 5, 1993). The Department CFR 59.5(b)(1)]. Id. 41274. For two specific actions were taken to encourage suspended the 1988 regulations and decades after these rules were finalized family participation. adopted compliance standards (and nearly three decades after they had As to nondirective counseling and predating the 1988 rules on an interim been in place following the 1988 rule’s referral for abortion, in recognition of basis. 58 FR 7462 (Feb. 5, 1993). The suspension in 1993), Title X faced no the Congressional direction for Department also sought comment on litigation or controversy over these nondirective counseling on abortion in adopting as final the rules and guidance regulations.10 yearly appropriations riders, the 2019 in effect prior to the 1988 rules. 58 FR In 2018, under a new Administration, rule allowed, but did not require, 7464 (Feb. 5, 1993). In response to this the Department proposed new rules counseling by grantees, limited to proposed rulemaking, the Department again. 83 FR 25502 (June 1, 2018). These physicians and advanced care received 146 comments, and finalized rules largely mirrored the 1988 providers. Id. at 7744. However, the new Title X rules in July of 2000. 65 FR regulations and were finalized in 2019. Department believed that the abortion 41270 (July 3, 2000). On that same day, 84 FR 7714 (March 24, 2019). The referral requirement was inconsistent the Department published Department promulgated the 2019 rules with section 1008 and that, though interpretations relating to the statutory because of its stated view, at that time, permissible for nearly the entire history requirement that no funds appropriated that they represented the best of the program, such referrals must be under Title X of the Public Health interpretation of the statute and prohibited. Id. Service Act be used in programs in provided the most appropriate guidance which abortion is a method of family Litigation over the 2019 rule for compliance with the statutory immediately ensued. The Department planning. 65 FR 41281 (July 3, 2000). provisions, including section 1008. The new rules rescinded the 1988 was sued by 23 states, every major While pointing to no direct violations of medical organization, Title X grantee rules prohibiting counseling and referral Title X, associated laws, or the 2000 for abortion. They also eliminated the organizations, and individual grantees. regulations, the Department believed the The suits were lodged in multiple provisions requiring strict physical and 2000 regulations ‘‘fostered an financial separation between Title X district courts and alleged a variety of environment of ambiguity surrounding claims under the Administrative projects and abortion related activities, appropriate Title X activities.’’ Id. at while still requiring that abortion and Procedure Act, the Affordable Care Act, 7721. Therefore, ‘‘bright line rules’’ and the Constitution. The rule was Title X activities are separated by more would ameliorate any confusion by than ‘‘mere bookkeeping.’’ 65 FR 41270, ultimately upheld by an en banc Court grantees and the public. 41271. Section 59.10 concerning of Appeals for the Ninth Circuit and The Department also cited several enjoined (only as to the state of lobbying restrictions was also repealed, conscience protection laws enacted by while still adhering to long established Maryland) by a district court in Congress to support the changes to the Maryland in a decision upheld by the en interpretations of the statute forbidding 2000 regulations. These laws prohibit promotion of abortion through advocacy banc Court of Appeals for the Fourth public health service grantees from activities. Id. at 41277. Finally, the Circuit. Both court of appeals decisions requiring individuals to assist in the Department codified the 1981 guidance were issued over substantial dissents. performance of health service activities requiring, upon request of the pregnant against their religious beliefs or In California v. Azar, 950 F.3d 1067 patient, nondirective counseling and convictions, 42 U.S.C. 300a-7(d), and (9th Cir. 2020), the Ninth Circuit relied referral, regarding any option requested: prohibit discrimination against both heavily on Rust in upholding the rule. ‘‘(1) prenatal care and delivery; (2) individual and institutional providers A majority of the en banc panel found infant care, foster care, or adoption; and for their refusal to provide, cover, or that the Department ‘‘could’’ interpret (3) pregnancy termination.’’ Id. at 41279 refer for abortions. Consolidated section 1008 as it did in the 2019 rule, [42 CFR 59.5(a)(5) (2000 reg)]. Appropriations Act, 2021, Public Law and nothing in subsequent legislation In promulgating the 2000 regulations, prevented this reading. Id. at 1085. The the Department concluded that revoking 116–260, Div. H, sec. 507(d) (2020), Consolidated Appropriations Act, 2021, Ninth Circuit upheld the rule against an the 1988 regulations was within its arbitrary and capricious challenge, administrative discretion and that there Public Law 116–260, Div. H, sec. 507(d) (2020). The Department concluded in stating, ‘‘that the new policy is was no evidence the ‘‘gag rule’’ would— permissible under the statute, that there or could—work in practice. The 2019 that the 2000 regulations, if enforced against objecting grantees, are good reasons for it, and that the Department concluded experience had agency believes it to be better.’’ Id. at taught that the rules and policies would be inconsistent with these statutory protections and dissuade 1097 (emphasis in original). Conversely, previous to the 1988 regulations had a majority of the Fourth Circuit found been accepted by grantees and enabled otherwise qualified providers from applying for Title X funds. the Department’s 2019 rule arbitrary and the program to operate successfully capricious. Mayor of Baltimore v. Azar, during virtually its entire history. The 2019 rules also re-imposed the physical separation provisions of the 973 F.3d 258 (4th Cir. 2020). The Fourth Additionally, the Department relied on Circuit also held the 2019 rule violated the direction from Congress in 11 10 As discussed below, the 2000 rule also fully the non-directive mandate. appropriations riders beginning in 1996 recognized the statutory conscience right of (Pub. L. 104–134), requiring that ‘‘all individual providers to object to counseling and 11 Both the Ninth and Fourth Circuits also came pregnancy counseling be nondirective,’’ referral for abortions. Id. At 41274, 41275. to opposite results on the validity of the rule under

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Losing parties in both cases sought grantees served 844,083 fewer clients as decreased by 256,523 for chlamydia, by review from the Supreme Court in compared to the previous year, prior to 625,802 for gonorrhea, and by 77,524 for October of 2020. The Court granted the change in the regulations. syphilis. Furthermore, 71,145 fewer certiorari on February 22, 2021, Specifically, 3,939,749 clients were individuals who were pregnant or consolidating the cases. No. 20–429. On served in 2018; 3,095,666 clients were sought pregnancy were served. As a March 12, 2021, the parties stipulated to served in 2019, an approximately 22 result of the dramatic decline in Title X dismiss the cases under Supreme Court percent decrease.13 • services provided, the 2019 Final Rule Rule 46.1. Low-income, uninsured, and racial undermined the mission of the Title X and ethnic minorities’ access to Title X program by helping fewer individuals in III. Public Health Impact as a Result of family planning services has decreased, planning and spacing births, providing the 2019 Rules and Reason for this thereby contributing to the increase in Proposal health inequities and unmet health fewer preventive health services, and The 2019 rule split courts and judges needs within these populations. delivering fewer screenings for STIs. on its approach, its reasonableness, and Compared to 2018 Family Planning Adolescent services were also adversely the interpretation of subsequent Annual Report (FPAR) data prior to the affected. In 2019, 151,375 fewer legislative provisions. Still, no court implementation of the 2019 Final Rule, adolescent clients received family questioned the Supreme Court’s in 2019, 573,650 fewer clients under planning services and 256,523 fewer fundamental holding in Rust that 100 percent of the Federal poverty level women under the age of twenty-five section 1008 is ‘‘ambiguous.’’ And, (FPL); 139,801 fewer clients between were tested for chlamydia.16 while section 1008 may be ambiguous, 101 percent to 150 percent FPL; 65,735 The true impact of the 2019 Final the public health consequences of the fewer clients between 151 percent and Rule in terms of long-term sexual and previous Administration’s interpretation 200 percent FPL; and, 30,194 fewer negative sequelae in of the statute are not. The following clients between 201 percent to 250 the lives of hundreds of thousands of outlines the effects of the 2019 rule: percent FPL received Title X services. low-income clients and clients of color • The number of family planning This contradicts the purpose and intent is difficult to quantify. As a result of the services grantees has dropped of the Title X program, which is to decrease in clients able to receive Title precipitously, resulting in an adverse prioritize and increase family planning X services, it is estimated that the 2019 impact on the number of clients served. services to low-income clients. After the implementation of the 2019 Additionally, 324,776 fewer uninsured Final Rule may have led to up to 17 Title X Final Rule, 19 Title X grantees clients were served in 2019 compared to 181,477 unintended pregnancies. out of 90 total grantees, 231 2018. FPAR data also demonstrate that Unintended pregnancies increase the subrecipients, and 945 service sites in 2019 compared to 2018, 128,882 risk for poor maternal and infant immediately withdrew from the Title X fewer African Americans; 50,039 fewer outcomes. Individuals having a birth program. Overall, the Title X program Asians; 6,724 fewer American Indians/ following an are lost more than 1,000 service sites. Those Alaska Natives; 7,218 fewer Native less likely to have benefitted from service sites represented approximately Hawaiians/Pacific Islanders; and, preconception care, to have optimal one quarter of all Title X-funded sites in 269,569 fewer Hispanics/Latinos spacing between births, and to have 2019. Title X services are not currently received Title X services.14 been aware of their pregnancy early on, • available at all in six states (HI, ME, OR, Provision of critical family planning which in turn makes it less likely that UT, VT, and WA) and are only available and related preventive health services they would have received prenatal care 15 on a very limited basis in six additional has decreased dramatically. The early in pregnancy.18 19 The 2019 Final impact of the 2019 Final Rule has been states (AK, CT, MA, MN, NH, and NY). Rule likely also resulted in additional devastating to the hundreds of California, the single-largest Title X costs to taxpayers as a result of an project in the nation (before the 2019 thousands of Title X clients who have increase in unintended pregnancies, Final Rule) had 128, or 36 percent, of its lost access to critical family planning Title X service sites withdraw from the and related preventive health services due to service delivery gaps created by 16 (OPA, 2020). Family Planning Annual Report: program, leaving more than 700,000 2019 National Summary Report. Accessed on March patients without access to Title X- the 2019 Final Rule. More specifically, 9, 2021 from https://opa.hhs.gov/sites/default/files/ funded care. Similarly, in New York, the compared to 2018, 225,688 fewer clients 2020-09/title-x-fpar-2019-national-summary.pdf. number of Title X-funded service sites received oral contraceptives; 49,803 17 Estimating that of the 844,083 fewer clients dropped from 174 to just two, leaving fewer clients received hormonal served by Title X in 2019 compared to 2018, 21.5% more than 328,000 patients without implants; and 86,008 fewer clients of those clients could have experienced an received IUDs. Additionally, 90,386 and unintended pregnancy as a result of not receiving Title X-funded care. All Planned services. Formula taken from Guttmacher Institute Parenthood affiliates—which in 2015 188,920 fewer Papanicolaou (Pap) tests (2017). Unintended pregnancies prevented by had served 41 percent of all clients at and clinical breast exams respectively publicly funded family planning services: Summary Title X service sites—withdrew from were performed in 2019 compared to of results and estimation formula. Accessed on Title X due to the 2019 Final Rule.12 2018. Confidential human March 8, 2021 from https://www.guttmacher.org/ sites/default/files/pdfs/pubs/Guttmacher-Memo-on- The withdrawal of numerous grantees, immunodeficiency virus (HIV) tests Estimation-of-Unintended-Pregnancies-Prevented- subrecipients, and service sites decreased by 276,109. Sexually June-2017.pdf. adversely impacted the number of transmitted infection (STI) testing 18 Jessica D. Gipson, Michael A. Koenig, and clients served under the Title X Michelle J. Hindin. ‘‘The Effects of Unintended program. With the 2019 Final Rule only 13 (OPA, 2020). Family Planning Annual Report: Pregnancy on Infant, Child, and Parental Health: A being in place for five and a half 2019 National Summary Report. Accessed on March Review of the Literature.’’ Studies in family 9, 2021 from https://opa.hhs.gov/sites/default/files/ planning 39.1 (2008): 18–38. Web. months, the remaining 71 Title X 2020-09/title-x-fpar-2019-national-summary.pdf. 19 Power to Decide. Maternal and Infant Health 14 (OPA, 2020). Family Planning Annual Report: and the Benefits of in America. section 1554 of the Affordable Care Act [42 U.S.C. 2019 National Summary Report. Accessed on March Accessed on March 8, 2020 from https:// 18114]. 9, 2021 from https://opa.hhs.gov/sites/default/files/ powertodecide.org/sites/default/files/resources/ 12 (Kaiser Family Foundation, 2020). Current 2020-09/title-x-fpar-2019-national-summary.pdf. supporting-materials/getting-the-facts-straight- Status of the Title X Network and the Path Forward. 15 Ibid. chapter-3-maternal-infant-health.pdf.

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preterm and low-birthweight births, Providing Quality Family Planning The 2019 rule abandoned this client STIs, infertility, and cervical cancer.20 Services: Recommendations from centered approach over the objection of • OPA has been unable to secure new Centers for Disease Control and every major medical organization Title X grantees and service sites to Prevention and the US Office of without any countervailing public meet the unmet need for family Population Affairs (QFP),21 was health rationale. Moreover, the 2019 planning services. To meet the unmet published as a CDC Morbidity and rule required prenatal referral even over need for family planning services Mortality Weekly Report (MMWR) the objection of the patient. For the nationwide, in Fiscal Year 2019 OPA Recommendations and Reports. The reasons discussed above, that approach issued a competitive supplemental QFP, developed jointly by the Centers cannot be squared with well-accepted funding announcement to existing for Disease Control and Prevention public health principles. grantees. Fifty existing grantees were (CDC) and the HHS Office of Population • The 2019 Final Rule increased awarded $33.7 million to expand Title Affairs (OPA), provides compliance and oversight costs, with no X services. However, only 7 states (CO, recommendations for use by all discernible benefit. The 1988 rules DE, KY, ND, NM, NV, TX) had a reproductive health and primary care requiring strict physical and financial meaningful increase in the number of providers with patients who are in need separation requirements, were based, in Title X clinics in their states. of services related to preventing or for part, on two governmental reports In addition, OPA has been unable to achieving pregnancy. The QFP are finding minor compliance issues with find new grantees to fill most of the gaps scientific and evidence-based grantees and recommended only more the 2019 Final Rule created, including recommendations that integrate and fill specific guidance, not a substantial in the six states that lost all Title X- gaps in existing guidelines for the reworking of the regulations. See, e.g., funded services. To address gaps in the family planning settings. QFP Comp. Gen. Rep. No GAO/HARD–HRD– Title X service network and increase recommendations are based on a 82–106 (1982), at 14–15; 65 FR 41270, coverage, a new competitive funding rigorous, systematic, transparent review 41272. While those reports found some announcement was issued in Fiscal of the evidence and with input from a confusion among grantees around Year 2020 to provide services in broad range of clinical experts, OPA, section 1008, ‘‘GAO found no evidence unserved or underserved states and and CDC. The QFP references numerous that Title X funds had been used for communities. The number of other clinical guidelines that are abortions or to advise clients to have applications received was so low (8 published by Federal agencies, as well abortions.’’ More importantly, in the eligible applications received) that the as guidelines released by professional decades between 1993 and the 2019 resulting grant awards were for less than medical associations. rule, and as evidenced by the silence of the total amount of funding available These guidelines were developed over the 2019 final rule on this issue, legally (grant awards for $8.5 million with $20 a three-year period through the CDC’s required audits, regular site visits, and million available), and were only able to Division of Reproductive Health (DRH) other oversight of grantees have found no diversion of grant funds that would provide services in three states with no and OPA, in consultation with a wide justify the greatly increased compliance or limited Title X services at the time. range of experts and key stakeholders. and oversight costs the 2019 rule This demonstrated the negative effects These guidelines have been the of the 2019 Title X Final Rule on client required. undisputed standard in reproductive The 2019 rule’s separation access to needed family planning and healthcare ever since. QFP related preventive health services, requirements also claimed to be recommendations support all providers addressing questions of ‘‘fungibility’’ especially for the priority low-income in delivering quality family planning populations that Title X is mandated to and a concern that Title X funds might services and define family planning be ‘‘intentionally or unintentionally’’ serve. services within a broader context of The realization of a greater pool of co-mingling with activities not allowed preventive services, to improve health under the statute. 84 FR at 7716. As grantees, as predicted by the 2019 rule, outcomes for women, men, and their has not transpired over the course of noted, close oversight for decades under (future) children. the 2000 rules uncovered no two grant cycles. As discussed above, The client centered approach adopted OPA was unable to meaningfully misallocation of Title X funds by in the QFP requires pregnancy tests to grantees. Moreover, courts have long expand services nor was it able to find be ‘‘followed by a discussion of options new grantees to fill existing gaps. In since held that governments cannot and appropriate referrals.’’ Id. at 14 restrict access to funds for one activity fact, the 2019 Final Rule did not Further, counseling and referral are to increase the pool of grantees and was simply because it may ‘‘free up’’ funds be provided, ‘‘at the request of the for another activity. See Planned unable to generate interest in providing client,’’ in accordance with Title X services from organizations who Parenthood of Cent. & N. Arizona v. recommendations from professional Arizona, 718 F.2d 938, 945 (9th Cir had not previously been Title X medical organizations. Though formally grantees. This, coupled with the exodus 1983) (concluding ‘‘as a matter of law, adopted as a QFP recommendation in the freeing-up theory cannot justify of otherwise qualified grantees, 2014, appropriate referrals with subrecipients and service sites that left withdrawing all state funds from nondirective counseling have been the otherwise eligible entities merely the network due to their opposition to practice and implicit standard of care in the 2019 Final Rule, led to great because they engage in abortion-related Title X programs for essentially its activities disfavored by the state’’); see difficulty in awarding appropriated entire history, including in early also Agency for Int’l Dev. v. Alliance for funds as intended by Congress. guidelines and later when expressly • The 2019 Final Rule is contrary to Open Soc’y Int’l, Inc., 570 U.S. 205, 220 incorporated in the 2000 regulations. the CDC and OPA’s Quality Family (2013) (‘‘[I]f the Government’s argument Planning (QFP) Guidelines. In April [that fungibility is sufficient for 21 2014 (with updates in 2015 and 2017), CDC. Providing Quality Family Planning prohibition] were correct, League of Services—Recommendations from CDC and the Women Voters would have come out U.S. Office of Population Affairs. Accessed on 20 Kaiser Family Foundation. https://www.kff.org/ March 8, 2021 from https://opa.hhs.gov/grant- differently, and much of the reasoning womens-health-policy/issue-brief/data-note-impact- programs/title-x-service-grants/about-title-x-service- of Regan and Rust would have been of-new-title-x-regulations-on-network-participation/ grants/quality-family-planning. beside the point’’). Because of the 2019

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rule, appropriations that would 2019 rule is not in the best interest of interfere with beneficiaries’ access to otherwise be used to carry out the public health. the most accessible and qualified purposes of the Title X program, providers. These state restrictions are IV. Proposed Rules providing a broad range of family not always related to the subrecipients’ planning services to individuals For nearly 50 years without ability to effectively deliver Title X (including confidential services to interruption, Title X program grants services, but rather are sometimes based minors), are now being diverted to have been administered against the either on the non-Title X activities of increased infrastructure costs resulting backdrop of counseling and referral for the providers or because they are a from the separation requirement as well appropriate medical care, including certain type of provider. However, as the micro-level monitoring and referral for abortion. Family planning is providers with a reproductive health reporting now required of grantees. widely considered one of the most focus often provide a broader range of None of these burdensome additional important public health achievements of contraceptive methods on-site and requirements provide discernible the 20th Century.23 As the only Federal therefore may reduce additional barriers compliance benefits, particularly not to program exclusively dedicated to to accessing services. Moreover, denying public health. As many commenters and providing contraceptive services, Title X participation by family planning at least one court emphasized, the 2019 has been imperative to that success. providers that can provide effective rule was a solution in search of a For five decades, Title X family services has resulted in populations in problem, a solution whose severe public planning clinics have played a critical certain geographic areas being left health consequences caused much role in ensuring access to a broad range without Title X providers for an greater problems. of family planning and related extended period of time.25 And, while preventive health services for millions The Department also recognizes many otherwise qualified providers are of low-income or uninsured individuals willing and can provide effective Title Congress has passed several laws and others. 24 Over the 50 years of the protecting the conscience rights of X services, some lack the administrative Title X program, Title X clinics have capacity to directly apply for and providers, particularly in the area of served more than 190 million clients: abortion. For example, in promulgating manage a Title X grant. 182.2 million women, 8.1 million men, The Department believes that these the 2000 Title X rules, the Department comprising 139.5 million adults and state restrictions on subrecipient affirmed: ‘‘under 42 U.S.C. 300a–7(d), 50.8 million adolescents, across 50 eligibility unrelated to the ability to grantees may not require individual states, the District of Columbia, and deliver Title X services undermine the employees who have such objections [to eight U.S. territories and freely mission of the program to ensure widely abortion] to provide such counseling.’’ associated states. Title X providers available access to services by the most 65 FR 41270, 41274 (July 3, 2000). Since offered clients a broad range of effective qualified providers. Therefore, the 2005 Congress has also annually and medically safe contraceptive Department invites comment on ways in enacted an appropriations rider which methods approved by the U.S. Food and which it can ensure that Title X projects extends non-discrimination protections Drug Administration. Title X-funded do not undermine the program’s to other ‘‘health care entities’’ who sexually transmitted infection (STI) and mission by excluding otherwise refuse to counsel or refer for abortion. human immunodeficiency virus (HIV) qualified providers as subrecipients. See, e.g., Consolidated Appropriations screening services prevented In place of the 2019 Title X Act, 2021, Public Law 116–260, Div. H, transmission and adverse health regulations, the Department proposes to section 507(d) (2020). Under these consequences. Over the 50 years of the largely readopt the 2000 regulations (65 statutes, objecting providers or Title X Title X program, Title X clinics also FR 41270) with several revisions aimed grantees are not required to counsel or performed 34.1 million chlamydia tests, at ensuring access to equitable, refer for abortions.22 However, such 18.3 million HIV tests, 37 million affordable, client-centered, quality protections for objecting providers and Papanicolaou tests, and 42 million family planning services. Advancing grantees should not prohibit willing clinical breast exams. equity for all, including people of color providers and grantees from providing Given the previous success of the and others who have been historically information in accordance with the program, the large negative public underserved, marginalized, and ethical codes of major medical health consequences of maintaining the adversely affected by persistent poverty organizations. 2019 rules, the substantial compliance and inequality, is a priority for OPA and Ultimately, continued enforcement of costs for grantees, and the lack of the Title X program. By focusing on the 2019 rule raises the possibility of a tangible benefits, the Department advancing equity in the Title X program, two-tiered healthcare system in which proposes revoking the 2019 Title X we can create opportunities for the those with insurance and full access to regulations. As has been clearly borne improvement of communities that have healthcare receive full medical out by case law and history, the been historically underserved, which information and referrals, while low- Department has the discretion to make benefits everyone. Additionally, given income populations with fewer this determination and it is in the the success of the Providing Quality opportunities for care are relegated to interest of public health. Family Planning Services guidelines inferior access. Given that so many The Department is also concerned published in 2014,26 the Department is individuals depend on the Title X that some state policies restricting program as their primary source of eligible subrecipients unnecessarily 25 Carter, M.W., Gavin, L., Zapata, L.B., Bornstein, healthcare, this situation creates a M., Mautone-Smith, N., & Moskosky, S.B. (2016). widespread public health concern. The 23 Centers. for Disease Control & Prevention, Four aspects of the scope and quality of family Achievements in Public Health, 1900–1999: Family planning services in U.S. publicly funded health Planning, 48 Morbidity & Mortality Weekly Reports centers: Results from a survey of health center 22 This has been the consistent position of the No. 47, 1073–80 (Dec. 3, 1999), https:// administrators. Contraception. doi:10.1016/ Department since 2000. See 65 FR at 41274 (in www.cdc.gov/mmwr/preview/mmwrhtml/ j.contraception.2016.04.009. response to comments on individual objections to mm4847a1.htm. 26 CDC. Providing Quality Family Planning providing abortion counseling or referral, 24 OPA. Title X: Celebrating 50 Years of Title X Services—Recommendations from CDC and the Department stating: ‘‘under 42 U.S.C. 300a–7(d), Service Delivery. Accessed on March 8, 2021 from U.S. Office of Population Affairs. Accessed on grantees may not require individual employees who https://opa.hhs.gov/sites/default/files/2020-11/title- March 8, 2021 from https://opa.hhs.gov/grant- have such objections to provide such counseling.’’). x-50-years-infographic.pdf. Continued

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proposing to incorporate into Affairs,27 which has been used defined as a clinic or other location regulations several of the QFP’s historically by OPA when implementing where Title X services are provided to recommendations. Based on experience, the program prior to 2019. Under the clients. The Title X grantees and/or their the Department is also proposing some proposed regulations, ‘‘family planning subrecipients may have services sites. provisions it believes will make the services’’ are defined as including a The proposed definition of service site program function more effectively, broad range of medically approved will assist Title X grantees in more efficiently and consistently for all. contraceptive services, which includes accurately reporting data on their The Department proposes revising the FDA-approved contraceptive services subrecipient and service sites and will and natural family planning methods, 2019 Title X Final Rule through notice eliminate confusion in the OPA Title X for clients who want to prevent and comment rulemaking, by readopting clinic locator database. pregnancy and space births, pregnancy the 2000 regulations with revisions that All other proposed definitions are testing and counseling, assistance to will enhance the Title X program and its used by Federal Government agencies or achieve pregnancy, basic infertility family planning services, including major medical associations, and services, sexually transmitted infection include: family planning services provided using (STI) services, and other preconception Adolescent-friendly health services telemedicine, for the future. This will health services. are services that are accessible, remove the 2019 Final Rule The Department also proposes to add acceptable, equitable, appropriate and requirements for strict physical and definitions for terms used throughout effective for adolescents.35 financial separation, allow Title X the revised regulations to provide Client-centered care is respectful of, providers to provide nondirective clarity. The newly proposed definitions and responsive to, individual client options counseling, and allow Title X include adolescent-friendly health preferences, needs, and values; client providers to refer their patients for all services,28 client-centered care,29 health values guide all clinical decisions.36 family planning related services desired equity,30 inclusivity,31 quality 32 Culturally and linguistically by the client, including abortion healthcare, service site, and trauma- appropriate services are respectful of services. In addition, this will allow for informed.33 and responsive to the health beliefs, several revisions that are needed to The proposed definition for ‘‘service practices and needs of diverse strengthen the program and ensure site’’ is adapted from previous Title X patients.37 access to equitable, affordable, client- Family Planning Guidelines that Health equity is achieved when every centered, trauma-informed quality implemented the 2000 regulations, the person has the opportunity to attain family planning services for all clients, 2014 Program Requirements for Title X their full health potential and no one is especially for low-income clients. At the Funded Family Planning Projects disadvantaged from achieving this same time, the proposed rule will retain (hereafter ‘‘2014 Title X Program potential because of social position or 34 the longstanding prohibition on directly Requirements’’). ‘‘Service site’’ is other socially determined promoting or performing abortion that circumstances.38 follows from Section 1008’s text and 27 CDC. Providing Quality Family Planning Services—Recommendations from CDC and the Inclusivity ensures that all people are subsequent appropriations enactments. U.S. Office of Population Affairs. Accessed on fully included and can actively And as indicated above, individuals and March 8, 2021 from https://opa.hhs.gov/grant- participate in and benefit from family grantees with conscience objections will programs/title-x-service-grants/about-title-x-service- planning, including, but not limited to, not be required to follow the proposed grants/quality-family-planning. 28 World Health Organization. Quality individuals who belong to underserved rule’s requirements regarding abortion Assessment Guidebook. A guide to assessing health communities, such as Black, Latino, and counseling and referral. services for adolescent clients. Geneva, World Indigenous and Native American Health Organization, 2009. Accessed on March 8, persons, Asian Americans and Pacific For all the above reasons, the 2021 from https://apps.who.int/iris/handle/10665/ Department proposes to revise the 44240. Islanders and other persons of color; regulations that govern the Title X 29 CDC. Providing Quality Family Planning members of religious minorities; family planning services program by Services—Recommendations from CDC and the lesbian, gay, bisexual, transgender, and U.S. Office of Population Affairs. Accessed on queer (LGBTQ+) persons; persons with readopting the 2000 regulations (65 FR March 8, 2021 from https://opa.hhs.gov/grant- 41270), with several modifications. The programs/title-x-service-grants/about-title-x-service- disabilities; persons who live in rural proposed revisions to the 2000 grants/quality-family-planning. areas; and persons otherwise adversely regulations and rationale for each are 30 CDC. Health Equity. Accessed on March 12, affected by persistent poverty or listed below: 2021 from https://www.cdc.gov/chronicdisease/ inequality.39 healthequity/index.htm. 31 White House. Executive Order on Advancing A. Section 59.2 Definitions 35 Racial Equity and Support for Underserved World Health Organization. Quality Communities Through the Federal Government. Assessment Guidebook. A guide to assessing health The Department proposes to revise Accessed on March 8, 2021 from https:// services for adolescent clients. Geneva, World § 59.2 to include a modified definition www.whitehouse.gov/briefing-room/presidential- Health Organization, 2009. Accessed on March 8, of family planning. The definition of actions/2021/01/20/executive-order-advancing- 2021 from https://apps.who.int/iris/handle/10665/ racial-equity-and-support-for-underserved- 44240. family planning services included in the 36 CDC. Providing Quality Family Planning 2019 Final Rule did not align with the communities-through-the-federal-government/. 32 Institute of Medicine. Crossing the Quality Services—Recommendations from CDC and the widely accepted definition. The Chasm: A New Health System for the 21st Century. U.S. Office of Population Affairs. Accessed on definition of family planning services Accessed on March 8, 2021 from https:// March 8, 2021 from https://opa.hhs.gov/grant- www.ncbi.nlm.nih.gov/books/NBK222274/. programs/title-x-service-grants/about-title-x-service- should be consistent with the Title X grants/quality-family-planning. statutory requirements and reflect the 33 SAMHSA. SAMHSA’s Concept of Trauma and Guidance for a Trauma-Informed Approach. 37 Office of Minority Health. What is Cultural and widely-recognized definition that is Accessed on March 8, 2021 from https:// Linguistic Competence? Accessed on March 8, 2021 included in Providing Quality Family ncsacw.samhsa.gov/userfiles/files/SAMHSA_ from https://minorityhealth.hhs.gov/omh/ Planning Services: Recommendations of Trauma.pdf. browse.aspx?lvl=1&lvlid=6. 38 CDC and the U.S. Office of Population 34 OPA. 2014 Program Requirements for Title X CDC. Health Equity. Accessed on March 12, Funded Family Planning Projects. Accessed on 2021 from https://www.cdc.gov/chronicdisease/ March 8, 2021 from https:// healthequity/index.htm. programs/title-x-service-grants/about-title-x-service- www.nationalfamilyplanning.org/ 39 White House. Executive Order on Advancing grants/quality-family-planning. document.doc?id=1462. Racial Equity and Support for Underserved

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Quality healthcare is safe, effective, referral provided does not unduly limit regulations, and policies. These billing client-centered, timely, efficient, and client access to services, such as practices, which are widely accepted in equitable.40 excessive distance or travel time to the the Title X community, indicate that: (1) Trauma-informed is a program, referral location or referral to services Family income should be assessed organization, or system that realizes the that are cost-prohibitive for the client. before determining whether copayments widespread impact of trauma and While an organization that offers only a or additional fees are charged; and (2) understands potential paths for single method of family planning may insured clients whose family income is recovery; recognizes the signs and participate as part of a Title X project as at or below 250% FPL should not pay symptoms of trauma in clients, families, long as the entire project offers a broad more (in copayments or additional fees) staff, and others involved with the range of family planning services, than what they would otherwise pay system; and responds by fully offering only a single method of family when the schedule of discounts is integrating knowledge about trauma into planning could unduly limit Title X applied. These revisions address areas policies, procedures, and practices, and clients, especially low-income clients, of confusion for grantees prior to the seeks to actively resist re- by reducing access to a client’s method 2014 Title X Program Requirements that traumatization.41 of choice. The Department proposes were clarified in that document. The Department also proposes a revising the 2000 regulations to require The Department proposes adding technical corrections to § 59.2 to replace sites that do not offer the broad range of § 59.5(a)(9) to ensure grantee income ‘‘grantee’’ with ‘‘recipient’’ in the methods on-site to be able to provide verification policies align with the regulatory text to align with the way the clients with a referral to a provider who mission of Title X services being term is used in Federal and HHS does offer the client’s method of choice. prioritized for low-income clients. This regulations. In addition, the referral provided must addition aims to address an area of B. Section 59.5 What requirements be client-centered and not unduly limit common confusion among Title X must be met by a family planning access to the client’s method of choice. grantees, which has resulted, in some project? This revision will help to improve instances, in a burden being placed on access to client-centered services. low-income clients. First, a requirement The Department proposes revising The Department proposes to revise is added (using text from the previous § 59.5(a)(1) to define what constitutes a § 59.5(a)(3) so that family planning 2014 Title X Program Requirements) to broad range of acceptable and effective services are required to be client- indicate that grantees should take family planning methods and services. centered, culturally and linguistically reasonable measures to verify client The proposed revision revises the 2000 appropriate, inclusive, trauma- income. In addition, a new requirement regulations by removing the existing informed, and ensure equitable and is added to use client self-reported ambiguity and defining what constitutes quality service delivery consistent with income if the income cannot be verified a broad range of acceptable and effective nationally recognized standards of care. after reasonable attempts. Without this family planning methods and services. This revision to the 2000 regulations is additional statement, several Title X The revised definition of the broad aimed at increasing access and ensuring grantees have established policies to range of methods and services is aligned equity in all services provided, which is charge full price for services following with the definition used in practice/ especially important for the Title X unsuccessful attempts to verify income, policy guidance. Moreover, the same program that prioritizes services for even when the self-reported income is definition is included in CDC and low-income clients. Including within below 250% of the Federal poverty level OPA’s Recommendations for Providing the regulation a specific focus on (FPL) and would have otherwise Quality Family Planning Services.42 services that are client-centered, qualified for no or reduced cost services. This revision will result in increased culturally and linguistically This proposed revision will greatly equitable access to a broad range of appropriate, inclusive, trauma- improve accessibility and affordability family planning methods and services to informed, and ensure equitable and of services for low-income clients all Title X clients and more clarity in quality service delivery will result in consistently across all Title X grantees. defining those services. improved services provided to clients. The Department proposes adding The Department proposes revising These new terms are defined in the § 59.5(a)(12) to retain some, but not all, § 59.5(a)(1) to require service sites that proposed regulation under § 59.2, and language from the 2019 Final Rule on do not offer a broad range of family the added definitions were derived from notification or reporting of child abuse, planning methods and services on-site existing definitions in use by the child molestation, sexual abuse, rape, to provide clients with a referral for Federal Government or major medical incest, intimate partner violence or where they can access the broad range associations. human trafficking. The notification and and ensure, when feasible, that the The Department proposes revising reporting requirements are important for § 59.5(a)(8) to include widely accepted Title X providers as mandatory reporters Communities Through the Federal Government. practices on grant billing practices that under state laws and protect Title X Accessed on March 8, 2021 from https:// were included in previous Title X clients. In addition, this regulation www.whitehouse.gov/briefing-room/presidential- actions/2021/01/20/executive-order-advancing- Family Planning Guidelines. These formalizes requirements contained in an racial-equity-and-support-for-underserved- revisions incorporate language that was annual appropriations rider related to communities-through-the-federal-government/. included in the 2014 Title X Program Title X that Congress has included since 40 Institute of Medicine. Crossing the Quality Requirements. The 2014 Title X FY 1999, requiring that, Chasm: A New Health System for the 21st Century. Program Requirements were developed ‘‘[n]otwithstanding any other provision Accessed on March 8, 2021 from https:// www.ncbi.nlm.nih.gov/books/NBK222274/. to assist grantees in understanding and of law, no provider of services under 41 SAMHSA. SAMHSA’s Concept of Trauma and implementing the family planning Title X of the PHS Act shall be exempt Guidance for a Trauma-Informed Approach. services grants. The 2014 Title X from any State law requiring Accessed on March 8, 2021 from https:// Program Requirements described the notification or the reporting of child _ ncsacw.samhsa.gov/userfiles/files/SAMHSA various requirements applicable to the abuse, child molestation, sexual abuse, Trauma.pdf. 42 CDC (2014). Providing Quality Family Planning Title X program, as set out in the Title rape, or incest.’’ Services, Recommendations of CDC and the U.S. X statute and implementing regulations, The Department proposes adding Office of Population Affairs. MMWR, 63(4). and in other applicable Federal statutes, § 59.5(a)(13) to describe requirements

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related to subrecipient monitoring and C. Section 59.6 What procedures apply collect charges without jeopardizing reporting. This addition requires Title X to ensure the suitability of informational client confidentiality. The Department grantees to report on the subrecipients and educational material? believes that the Title X program will be and referral agencies involved in their The Department proposes deleting strengthened by including this Title X projects, and to provide their prior § 59.5(a)(11) related to the clarification within the revised 2000 plan for oversight and monitoring of Advisory Committee and consolidating regulations. their subrecipients in grantee reports. with § 59.6; and revising § 59.6 to clarify In addition, the Department proposes The regulation no longer requires intent and remove areas of confusion for adding a requirement that grantees must grantees to report detailed information grantees regarding the Advisory inform the client of any potential for about each subrecipient and referral Committee and other miscellaneous disclosure of their confidential health agency such as location and specific other provisions. The 2000 regulations information to policyholders where the expertise, which will reduce the included information about the policyholder is someone other than the increased reporting burden required by Information & Education Advisory client. Since state and local laws may the 2019 Final Rule. Committee in two sections vary across jurisdictions (e.g., some are The Department proposes revising (§§ 59.5(a)(11) and 59.6, which was likely to result in notification to the § 59.5(b)(1) to acknowledge that confusing to Title X grantees. The result policyholder that the client has received consultation for medical services related is that this revision consolidates all of services, others provide for an ‘‘opt out’’ to family planning can be provided by the Advisory Committee information in process whereby the client can elect that healthcare providers beyond the one place, under section § 59.6. such a notification will not be made), physician. The proposed revision In addition, the Department is this addition will ensure that the client acknowledges that consultation for proposing several minor revisions to understands the implications for using healthcare services related to family clarify that the regulation applies to their insurance and the options planning may be by a physician, but both print and electronic materials, that available for them to maintain may also be by other healthcare the upper limit on council members confidentiality. should be determined by the grantee, providers, including physician G. Section 59.11 Additional that the factors to be considered for assistants and nurse practitioners. Conditions The Department proposes revising broad representation on the Advisory § 59.5(b)(3)(iii) to reflect the desire to Committee match the definition of The Department proposes revising engage diverse individuals to make inclusivity earlier in the regulation, and § 59.11 to add ‘‘during’’ the period of services accessible. This revision adds that materials will be reviewed for the award to allow for imposition of language to clarify the intent at engaging medical accuracy, cultural and additional conditions, during the period diverse individuals to ensure access to linguistic appropriateness, and of award in addition to ‘‘prior to and at equitable, affordable, client-centered, inclusivity and to ensure they are the time of any award’’, under quality family planning services. trauma-informed. circumstances where recipient performance or organizational risk The Department proposes revising D. Section 59.7 What criteria will the change, e.g. if a recipient is failing to § 59.5(b)(8) to add language to the Department of Health and Human perform we may impose new conditions existing 2000 regulation text to include Services use to decide which family mid-award to require corrective action primary healthcare providers in the list planning services projects to fund and per 45 CFR 75.207. of referrals and to state that referrals are in what amount? to be to providers in close proximity The Department proposes enabling H. Section 59.12 What other HHS when feasible to the Title X site in order the Department to consider the ability of regulations apply to grants under this to promote access to services and the applicant to advance health equity subpart? provide a seamless continuum of care. when awarding grant funds. Advancing The Department proposed a technical The Department also proposes health equity is critical to the mission including several technical corrections correction to § 59.12 to update the of the Title X program. Adding this regulations that apply to 42 CFR part 59, to § 59.5. The technical correction additional criterion to the 2000 proposed in §§ 59.5(a)(4) and 59.6(b)(2) subpart A. The proposal includes a regulations brings the total number of reference to 45 CFR part 87 (‘‘Equal replaces the word ‘‘handicapped criteria from seven to eight. condition’’ with ‘‘disability’’ in both Treatment for Faith-based sections in order to avoid negative E. Section 59.8 How is a grant Organizations’’) on the list of connotations and correct outdated awarded? regulations that apply to the Title X family planning services program. terminology. The technical correction The Department proposes a technical proposed to § 59.5(a)(5) replaces the correction to revise § 59.8 to change V. Regulatory Impact Analyses word ‘‘women’’ with ‘‘client’’, and the ‘‘project period’’ to ‘‘anticipated period’’ A. Introduction technical correction proposed to since HHS is in the process of adopting § 59.5(a)(6) and (7) replaces the word revised definition and project period HHS has examined the impacts of the ‘‘persons’’ with ‘‘clients’’ to use will no longer be used. proposed rule under Executive Order inclusive language. The technical 12866 on Regulatory Planning and correction proposed to § 59.5(a)(11) F. Section 59.10 Confidentiality. Review, Executive Order 13563 on replaces the term ‘‘sub-grantees’’ with The Department proposes revising Improving Regulation and Regulatory ‘‘subrecipients’’. The technical § 59.10 to include a widely accepted Review, Executive Order 13132 on correction proposed to § 59.5(b)(3) practice related to client confidentiality. Federalism, the Regulatory Flexibility clarifies that focus of this section is on This proposed revision will add a Act (5 U.S.C. 601–612), and the community education, participation, widely accepted practice in the Title X Unfunded Mandates Reform Act of 1995 and engagement, and should not be community that had been previously (Pub. L. 104–4). Executive Orders 12866 confused with the Information and included in the 2014 Title X Program and 13563 direct HHS to assess all costs Education Advisory Committee Requirements, indicating that and benefits of available regulatory requirement under § 59.6. reasonable efforts must be made to alternatives and, when regulation is

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necessary, to select regulatory B. Summary of Costs, Benefits and Department of Health and Human approaches that maximize net benefits Transfers Services (HHS), Office of Population (including potential economic, This proposed rule would revise the Affairs (OPA), is the only Federal environmental, public health and safety, 2019 Final Rule by readopting the 2000 program dedicated solely to supporting and other advantages; distributive regulations, with several modifications, the delivery of family planning and impacts; and equity). HHS believes that and returning the program to the related preventive healthcare. The this proposed rule is not an compliance regime as it existed prior to program is designed to provide ‘‘a broad economically significant regulatory the 2019 rule’s implementation. The range of acceptable and effective family action as defined by Executive Order proposed approach would allow the planning methods and services 12866 because it would not result in Title X program grantees, subrecipients, (including natural family planning annual effects in excess of $100 million. and service sites to have a greater methods, infertility services, and services for adolescents)’’ with priority The Regulatory Flexibility Act impact on public health than under the current regulatory approach. given to persons from low-income requires HHS to analyze regulatory families. In addition to offering these options that would minimize any We predict that this proposed rule would increase the number of grantees methods and services on a voluntary significant impact of a rule on small receiving Title X funds. In turn, the and confidential basis, Title X-funded entities. The proposed rule, if finalized, additional service sites supported by service sites provide contraceptive would lessen administrative burdens for funding would result in additional education and counseling; breast and grantees of all sizes. Therefore, the clients served under the program. These cervical cancer screening; sexually Secretary certifies this proposed rule, if clients receive access to contraception, transmitted infections (STIs) and HIV finalized, would not have a significant public health screening including testing, referral, and prevention economic impact on a substantial clinical breast exams and Papanicolau education; and pregnancy diagnosis and number of small entities under the (Pap) testing, and testing for sexually counseling. The program is Regulatory Flexibility Act, 5 U.S.C. 605. transmitted infections. These services implemented through competitively Section 202 of the Unfunded result in a reduction in unintended awarded grants to state and local public Mandates Reform Act of 1995 pregnancy, earlier detection of breast health departments and family (Unfunded Mandates Act) (2 U.S.C. and cervical cancer, and earlier planning, community health, and other 1532) requires HHS to prepare a written detection of sexually transmitted private nonprofit agencies. In fiscal year statement, which includes an infections including chlamydia, 2021, the Title X program received approximately $286.5 million in assessment of anticipated costs and gonorrhea, syphilis, and human immunodeficiency virus (HIV). This discretionary Federal Title X funding. benefits, before proposing ‘‘any rule that On March 4, 2019, HHS published a screening and testing can result in includes any Federal mandate that may final rule to ‘‘prohibit family planning significant cost savings from earlier result in the expenditure by State, local, projects from using Title X funds to treatment and other interventions. This and tribal governments, in the aggregate, encourage, promote, provide, refer for, proposed rule would also increase the or by the private sector, of $100,000,000 or advocate for abortion as a method of diversity of grantees receiving funds, or more (adjusted annually for inflation) family planning; require assurances of including geographic diversity to states in any one year.’’ The current threshold compliance; eliminate the requirement that do not currently have a Title X after adjustment for inflation is $158 that Title X projects provide abortion grantee. million, using the most current (2020) counseling and referral; require physical The proposed rule would also focus Implicit Price Deflator for the Gross and financial separation of Title X grantees on providing services in a Domestic Product. This proposed rule activities from those which are manner that is client-centered, would not result in an expenditure in prohibited under section 1008; provide culturally and linguistically any year that meets or exceeds this clarification on the appropriate use of appropriate, inclusive, and trauma- amount. funds in regard to the building of informed; protects the dignity of the infrastructure, and require additional Executive Order 13132 establishes individual; and ensures equitable and reporting burden from grantees.’’ certain requirements that an agency quality service delivery. This focus is must meet when it promulgates a rule especially important for the Title X b. Market Failure or Social Purpose that imposes substantial direct program that prioritizes services for Requiring Federal Regulatory Action requirement costs on State and local low-income clients. The regulatory impact analysis governments or has federalism This regulatory impact analysis associated with the 2019 Final Rule implications. The proposed rule will not reports the activity occurring at Title X predicted that the additional restrictions have a significant impact on state funds funded sites to provide policymakers on grantees would result in ‘‘an as, by law, project grants must be with this information. However, the expanded number of entities interested funded with at least 90 percent Federal direct impact within the program does in participating in Title X.’’ Further, the funds. 42 U.S.C. 300a–4(a). The not account for services that continue to analysis suggested the 2019 Final Rule Department has determined that this be provided at sites not receiving Title would result in ‘‘enhanced patient proposed rule does not impose such X funding, filling the gap left by service and care.’’ Contrary to these costs or have any federalism providers that withdrew from the predictions, during the initial period of implications. The Department expects program following the restrictions the 2019 Final Rule’s implementation, that while some states may not support placed on funding included in the 2019 the policy appears to have had the the policies contained in this proposed Final Rule. opposite effect. As we describe in rule, many states and local health C. Preliminary Economic Analysis of greater detail in the Baseline Section, departments will support the policies Impacts the restrictions included in the 2019 contained in this proposed rule, and Final Rule are associated with a that it will increase participation by a. Background substantial reduction in the number of states (many of who dropped out under The Title X National Family Planning Title X grantees, subrecipients, and the 2019 rule). Program, administered by the U.S. service sites, resulting in a

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corresponding reduction in total clients readopting the 2000 regulations with regulatory approach, we develop an served. This is particularly troubling, several modifications. The proposed annual forecast of grantees, since the Title X program serves a low- approach would allow the Title X subrecipients, service sites, and total income population that is particularly program grantees, subrecipients, and clients served. The key inputs to our vulnerable to losing access to these service sites to have a greater impact on forecast are historical data on Title X services. This proposed rule is needed public health than under the current service grantees. For fiscal years 2016– to improve the functioning of regulatory approach. 2019, this information is summarized in Government and the effectiveness of the d. Baseline Conditions and Impacts the 2019 Title X Family Planning Title X program. Attributable to the Proposed Rule Annual Report. We supplement this c. Purpose of the Proposed Rule We adopt a baseline that assumes the information with unpublished This proposed rule would revise the requirements of the 2019 Final Rule preliminary estimates of the impact for regulations that govern the Title X remain in place over the period of our fiscal year 2020. Table D1 summarizes family planning services program by analysis. To characterize the real-world these data. revoking the 2019 Final Rule and impact of the Title X program under this

TABLE D1—TITLE X SERVICE GRANTEES

Year 2016 2017 2018 2019 2020

Grantees ...... 91 89 99 100 73 Subrecipients ...... 1,117 1,091 1,128 1,060 803 Service Sites...... 3,898 3,858 3,954 3,825 2,682 Clients Served...... 4,007,552 4,004,246 3,939,749 3,095,666 1,536,744 Source: Title X Family Planning Annual Report, 2019: Exhibit A–2a, and unpublished preliminary estimates for FY2020.

The data for fiscal years 2016–2019 figure as a lower-bound estimate, and oral contraceptives and IUDs, this was included all grantees, subrecipients, and 3.1 million clients as an upper-bound a 27% reduction; and for hormonal service sites operating at any time estimate of the annual program impact implants, a 21% reduction. These during the year. The adoption of the under the baseline. percentages are similar in magnitude to 2019 Title X Final Rule occurred mid- Table D2 summarizes our baseline the 21% reduction in clients served in year in 2019. Following this regulation, forecast for the same categories of 2019 compared to 2018. Additionally, 19 grantees, 231 subrecipients, and 945 historical data presented in Table D1. 90,386 and 188,920 fewer Pap tests and service sites withdrew from the Title X We adopt the current count for grantees, clinical breast exams, respectively, were program. The reduced number of subrecipients, and services sites. We performed in 2019 compared to 2018. grantees, subrecipients, services sites, assume these figures will be constant Confidential HIV tests decreased by and clients served observed in 2019 and over time horizon of this analysis. 276,109. Testing for sexually 2020 cannot be explained by a reduction transmitted infections (STIs) decreased in discretionary funding for the TABLE D2—BASELINE FORECAST OF by 256,523 for chlamydia, by 625,802 program, which has remained constant TITLE X SERVICES for gonorrhea, and by 77,524 for at $286.5 million throughout this time syphilis. Baseline forecast Annual period. Since the 2019 figure includes For our forecast of services provided clients served by these service sites for Grantees ...... 73 under our baseline scenario, we adopt about half of the year, adopting 3.1 Subrecipients ...... 803 the most recent percentage of clients million clients served as an annual Service Sites ...... 2,682 receiving each service in the 2019 Title forecast would likely overstate activity Clients Served ...... 2,512,066 X Family Planning Annual Report. For in the program under the current example, in 2019, about 23% of female regulations. Indeed, preliminary figures In addition to the reduction in clients received a clinical breast exam. for FY2020 indicate that only about 1.5 grantees, subrecipients, service sites, We assume the same share of clients million clients were served. However, and total client served, we note that six will be served by Title X for screening this figure likely represents an states currently have no Title X services, and sexually transmitted infection underestimate for a typical year of the including HI, ME, OR, UT, VT, and WA. testing. Table D3 reports our best program under the current regulations There are six additional states that have estimate of the annual services provided since services were likely disrupted by limited Title X services, including AK, under the baseline scenario. We 43 the ongoing public health emergency. CT, MA, MN, NH, and NY. describe these services in greater detail In line with the reduction in clients As our primary estimate, we adopt later in this Section. 2,512,066 clients served as the baseline served under the 2019 Final Rule, data also reveal a significant drop in services annual impact of Title X under the TABLE D3—BASELINE TITLE X CAN- policies of the 2019 Final Rule. This 2.5 provided For example, when comparing 2019 figures to 2018, 225,688 fewer CER SCREENING AND SEXUALLY million corresponds to the number of TRANSMITTED INFECTION TESTING clients served in 2019 among remaining clients received oral contraceptives; 49,803 fewer clients received hormonal grantees as of March 2021. For Year Annual comparison, this primary estimate implants; and 86,008 fewer clients received intrauterine devices (IUDs). For represents a 37% reduction in clients Clinical Breast Exams ...... 509,550 served compared to the average of Pap Tests ...... 443,087 43 clients served from 2016 to 2018. In the As noted earlier, seven states (CO, DE, KY, ND, Chlamydia Test ...... 1,266,508 NM, NV, TX) experienced a meaningful increase in Uncertainty and Sensitivity Analysis the number of Title X clinics after the 2019 Gonorrhea Test ...... 1,420,198 Section, we adopt the 1.5 million client regulatory change. Syphilis Test ...... 536,619

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TABLE D3—BASELINE TITLE X CAN- the data from fiscal years 2016–2018, open, with some operating at a lower CER SCREENING AND SEXUALLY the last three years of data that are capacity, than they did prior to the 2019 TRANSMITTED INFECTION TESTING— unaffected by the drops experienced Final Rule. It is also consistent with an Continued following the 2019 Final Rule. expectation that many of the grantees Specifically, we adopt the average and service sites that withdrew from the Year Annual across these three years as our long-run program would be able to rejoin if this estimates. These averages are 93 proposed rule were finalized. In year Confidential HIV Test ...... 777,536 grantees, 1,112 subrecipients, 3,903 one, following the effective date of the Source: Calculations based on Title X Fam- service sites, and about 4.0 million proposed rule, the number of clients ily Planning Annual Report, 2019: Exhibits 26 clients served. served would increase to about 3.2 and 29. To complete our forecast of the policy million. In year two, this number would We predict that the main effect of the scenario, we assume that it will take two increase again to about 4.0 million and proposed rule would be to return to years for program participation and remain there for the duration of our Title X program impact levels observed clients served to achieve the long-run analysis. These figures are presented in prior to the 2019 Final Rule. Our equilibrium estimates. This two-year Table D4. We acknowledge uncertainty estimates of the long-run equilibrium of phase-in is consistent with a scenario in in this estimate, and include a grantees, subrecipients, service sites, which most service sites that withdrew discussion in the Uncertainty and and total client served are informed by from the Title X program have remained Sensitivity Section, below.

TABLE D4—POLICY SCENARIO FORECAST OF TITLE X SERVICE GRANTEES

Year 2022 2023 2024 2025 2026

Grantees ...... 80 86 93 93 93 Subrecipients ...... 906 1,009 1,112 1,112 1,112 Service Sites...... 3,089 3,496 3,903 3,903 3,903 Clients Served...... 3,247,958 3,983,849 3,983,849 3,983,849 3,983,849

To characterize the effect of the two scenarios, which represents the net baseline scenario. Approximately 88% proposed rule, we compare the policy effect of the proposed rule. For example, of clients served in 2016–2018 are scenario forecast to the baseline forecast in year 1 after this rule is effective, the female, and we use this percentage to described in the previous section. Table number of clients served would be estimate the increase in clients served D5 reports the difference between these about 736,000 higher than under the by sex under the policy scenario.

TABLE D5—EFFECT OF THE PROPOSED RULE ON TITLE X SERVICES

Year 2022 2023 2024 2025 2026

Increase in Grantees ...... 7 13 20 20 20 Increase in Subrecipients ...... 103 206 309 309 309 Increase in Service Sites ...... 407 814 1,221 1,221 1,221 Increase in Clients Served ...... 735,892 1,471,783 1,471,783 1,471,783 1,471,783 Female ...... 648,996 1,297,992 1,297,992 1,297,992 1,297,992 Male ...... 86,896 173,791 173,791 173,791 173,791

Clients served under the Title X in greater detail in the Section on 1,000 women who are unable to access program experience outcomes that Distributional Effects. public family planning services. We include reducing unintended pregnancy To further explore the likely effect of apply this estimate of a reduction of 250 through greater access to contraception. the Title X program on unintended unintended pregnancies per 1,000 The averted unintended pregnancies pregnancy, we rely on existing contraception clients to the number of translate to a reduction in unplanned methodology for estimating number of additional female clients served under births, a reduction in abortions, and unintended pregnancies prevented each the Title X program who adopt any reduction in miscarriages. Also, Title X year among U.S. women who depend on method of contraception. clients receive cancer screenings and publicly funded family planning For year 1, we multiply 735,892 testing for sexually transmitted services.44 Among this subgroup of clients by 88% to yield 648,996 clients infections. These screenings and testing women who use any method of who are women. Among female clients, can identify treatable conditions, contraception, 46 in 1,000 women are approximately 14% indicate they are improving the quality of life and expected to experience an unintended not using a method of contraception, extending the lives of beneficiaries. In pregnancy. This figure can be compared according to figures in the 2019 Title X the case of sexually transmitted to 296 unintended pregnancies per Family Planning Annual Report. We infections, additional testing can reduce reduce the potential number of clients 44 Jennifer J. Frost and Lawrence B. Finer (2017). that would potentially reduce the the likelihood of further infections and Memo entitled ‘‘Unintended pregnancies prevented future infertility. This proposed rule by publicly funded family planning services: likelihood of an unintended pregnancy would expand service to Summary of results and estimation formula.’’ by 14% to yield 558,205 clients socioeconomically disadvantaged https://www.guttmacher.org/sites/default/files/ expected to benefit from a contraceptive pdfs/pubs/Guttmacher-Memo-on-Estimation-of- populations, most of whom are female, Unintended-Pregnancies-Prevented-June-2017.pdf. method. Approximately 47% of low income, and young. We discuss this Accessed on March 14, 2021. unintended pregnancies result in

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unplanned births, 34% in abortion, and 19% in a miscarriage.45

TABLE D6—EFFECT OF THE PROPOSED RULE ON TITLE X-ASSOCIATED CONTRACEPTION

Year 2022 2023 2024 2025 2026

Clients Served ...... 735,892 1,471,783 1,471,783 1,471,783 1,471,783 Women Served...... 648,996 1,297,992 1,297,992 1,297,992 1,297,992 Women Served Using Contraception ...... 558,205 1,116,411 1,116,411 1,116,411 1,116,411

Unintended and unplanned infections, including chlamydia, intraepithelial lesion (HSIL) 48 or higher, pregnancies increase the risk for poor gonorrhea, syphilis, and HIV. Table D6 indicating the presence of a more severe maternal and infant outcomes. Women presents the effect of the proposed rule condition. who give birth following an unintended on Title X-associated cervical and breast Clinical breast exams can identify or unplanned pregnancy are less likely cancer screenings. These figures are women requiring further evaluation of to have benefitted from preconception calculated by multiplying the number of an abnormal finding. Pap test (or pap care, to have optimal spacing between additional women served by the births, and to have been aware of their smear test) results can indicate viral program in each year by about 23% for infections that, when untreated, can pregnancy early on, which in turn clinical breast exams, of which 5% makes it less likely that they would turn into cervical cancer. The Pap test result in a referral for further evaluation; have received prenatal care early in results can also detect cervical cancer and 20% for Pap testing, of which 13% pregnancy.46 47 cells. At a population level, these Title X funding recipients also with a result of atypical squamous cells screenings save lives by helping women perform preventive health services such (ASC) that require further evaluation identify cancer earlier, and preventing as cervical and breast cancer screening, and possibly treatment, and 1% of other conditions from developing into and testing for sexually transmitted which have a high-grade squamous cancer.

TABLE D7—EFFECT OF THE PROPOSED RULE ON TITLE X-ASSOCIATED CERVICAL AND BREAST CANCER SCREENING ACTIVITIES

Year 2022 2023 2024 2025 2026

Clinical Breast Exams ...... 149,269 298,538 298,538 298,538 298,538 Referred ...... 7,463 14,927 14,927 14,927 14,927 Pap Tests...... 129,799 259,598 259,598 259,598 259,598 Tests with ASC or higher ...... 17,304 34,609 34,609 34,609 34,609 Tests with HSIL or higher ...... 195 391 391 391 391

Table D7 presents the effect of the that 49% of women are tested for these infections are the following: 61% proposed rule on Title X-associated chlamydia; 55% for gonorrhea; 19% for for chlamydia, 68% for gonorrhea, 39% testing for sexually transmitted syphilis; and 28% for HIV. Table D6 for syphilis, and 53% for HIV. infections among female clients. These presents the same information for men. are calculated by adopting estimates The share of male clients tested for

TABLE D8—ADDITIONAL WOMEN TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X

Year 2022 2023 2024 2025 2026

Chlamydia ...... 318,008 636,016 636,016 636,016 636,016 Gonorrhea ...... 356,948 713,895 713,895 713,895 713,895 Syphilis ...... 123,309 246,618 246,618 246,618 246,618 Confidential HIV...... 181,719 363,438 363,438 363,438 363,438

TABLE D9—ADDITIONAL MEN TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X

Year 2022 2023 2024 2025 2026

Chlamydia ...... 53,006 106,013 106,013 106,013 106,013 Gonorrhea ...... 59,089 118,178 118,178 118,178 118,178 Syphilis ...... 33,889 67,779 67,779 67,779 67,779

45 Jennifer J. Frost, Lori F. Frohwirth, Nakeisha 46 Jessica D. Gipson, Michael A. Koenig, and Accessed on March 8, 2020 from https:// Blades, Mia R. Zolna, Ayana Douglas-Hall, and Michelle J. Hindin. ‘‘The Effects of Unintended powertodecide.org/sites/default/files/resources/ Jonathan Bearak (2017). ‘‘Publicly Funded Pregnancy on Infant, Child, and Parental Health: A supporting-materials/getting-the-facts-straight- Contraceptive Services at U.S. Clinics, 2015. Review of the Literature.’’ Studies in family chapter-3-maternal-infant-health.pdf. https://www.guttmacher.org/sites/default/files/ planning 39.1 (2008): 18–38. Web. 48 HSIL is the abnormal growth of certain cells on report_pdf/publicly_funded_contraceptive_ 47 Power to Decide. Maternal and Infant Health services_2015_3.pdf. Accessed on March 14, 2021. and the Benefits of Birth Control in America. the surface of the cervix.

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TABLE D9—ADDITIONAL MEN TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X—Continued

Year 2022 2023 2024 2025 2026

Confidential HIV...... 46,055 92,109 92,109 92,109 92,109

Table D8 reports the total clients performed. If the proposed rule is education. Pre-exposure prophylaxis tested for sexually transmitted finalized, Title X would be associated (PrEP) has emerged as an effective HIV infections. These tests can identify with identifying an additional 873 prevention strategy for individuals who treatable conditions that can cause positive cases of HIV. In subsequent are most at risk, and the inclusion of discomfort, permanent damage to years, this number would increase to PrEP in the HIV prevention services reproductive systems including 1,745. Testing for these sexually provided at Title X sites is becoming an infertility, and in certain cases, death. transmitted infections can also reduce increasingly important method for The 2019 Title X Family Planning the likelihood that an individual will protecting individuals of all ages from Annual Report indicates confidential spread an infection. In addition to acquiring HIV. HIV testing identifies a positive case for testing, Title X-funded service sites also approximately 0.38% of all HIV tests provide HIV/AIDS prevention

TABLE D10—ADDITIONAL CLIENTS TESTED FOR SEXUALLY TRANSMITTED INFECTIONS UNDER TITLE X

Year 2022 2023 2024 2025 2026

Chlamydia ...... 371,014 742,029 742,029 742,029 742,029 Gonorrhea ...... 416,037 832,074 832,074 832,074 832,074 Syphilis ...... 157,199 314,397 314,397 314,397 314,397 Confidential HIV...... 227,774 455,547 455,547 455,547 455,547 Positive Test Results ...... 873 1,745 1,745 1,745 1,745

Services of the type provided under goals, achieve financial stability, and about two thirds of the estimated gains Title X likely result in reduced costs to maintain their mental and physical are due to increases in the incomes of taxpayers as a result of a reduction in health.’’ 50 These recent interviews are parents.52 A recent summary discusses unintended pregnancies, pre-term and consistent with the historical experience other impacts of access to family low-birthweight births, sexually of the importance of birth control. For planning services in the United States transmitted infections, infertility, and example, one econometric study and in other countries, which extends cervical cancer. This report 49 estimates identifies a causal relationship between beyond women and girls, to their that each dollar spent on these services the introduction and diffusion of the children and wider communities.53 results in a net Government saving of birth control pill and the increase in The calculations above represent $7.09. We do not replicate the women enrolling in professional degree observable metrics of the effect of the calculations, but note that they are programs and increasing the age at first Title X program, which is important for derived from cost savings associated marriage.51 Title X services help evaluating the direct effect of the with averting unintended pregnancy connect women with the free program. For this reason, the scope of and complications such as pre-term and contraception provided by the our analysis initially focuses on clients low birth-weight births. These cost Affordable Care Act, which allows them served and services provided by Title X savings are also derived from detecting to experience these and other positive facilities. To properly account for the and treating sexually transmitted outcomes associated with access to net effect of the proposed rule when infections that would have resulted in contraception. comparing the baseline scenario to the more serious outcomes, including Researchers have identified other policy scenario, we would need to infertility, cancer, and death. economic, social, and health impacts of assess the extent to which clients and In addition to the effects described increased access to family planning, services continue to be provided above, this proposed rule would also contraception, and treatment. For through other channels than Title X enhance the equity and dignity example, Bailey et al. (2019) finds ‘‘that funded sites without the proposed rule. associated with access to family children born after the introduction of As a general matter, the impacts of this Federal family planning programs were proposed rule may include: planning services provided by Title X. • A recent research brief summarized 7 percent less likely to live in poverty Transfers between grantees and interviews with 30 women sharing their and 12 percent less likely to live in would-be grantees within the Title X experiences with contraceptive access, households receiving public program; • other transfers (for example, if Title providing suggestive evidence that birth assistance.’’ They perform an additional X newly funds medical services that control has an important positive bounding analysis, which suggests that would, in the absence of the proposed impact on women’s lives. Interviewees 50 rule, be provided by charitable noted that birth control allowed women Rebecca Peters, Sarah Benetar, Brigette Courtot, and Sophia Yin (2019). ‘‘Birth Control is to ‘‘to pursue academic and professional Transformative.’’ Urban Institute. https:// 52 Bailey, Martha J., Olga Malkova, Zoe¨ M. www.urban.org/sites/default/files/publication/ McLaren (2019). ‘‘Does Access to Family Planning 49 Jennifer J. Frost, Adam Sonfield, Mia R. Zolna, 99912/birth_control_is_transformative_1.pdf. Increase Children’s Opportunities? Evidence from and Lawrence B. Finer (2014). ‘‘Return on Accessed April 6, 2021. the War on Poverty and the Early Years of Title X.’’ Investment: A fuller assessment of the benefits and 51 Goldin, Claudia and Lawrence F. Katz (2002). Journal of Human Resources 54:4 pp. 825–856. costs of the US publicly funded family planning ‘‘The power of the pill: Oral contraceptives and doi:10.3368/jhr.54.4.1216–8401R1. program’’ Milbank Quarterly 2014 Dec;92(4):696– women’s career and marriage decisions.’’ Journal of 53 Emily Sohn (2020). ‘‘Strengthening society 749. Political Economy 110(4): 730–770. with contraception.’’ Nature 588, S162–S164.

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organizations or other private payers); the Federal poverty level; 14% between f. Uncertainty and Sensitivity Analysis and 101% and 150%; 7% between 151% to • societal benefits and costs to the 200%; 3% between 201% and 250%; All of the major drivers of the extent that the volume or characteristics 7% over 250%; and 5% have an quantified effects of this analysis are (such as location, which determines unknown or unreported income level. dependent on our forecast of the travel costs) of medical services would Among program clients, 33% are baseline number of clients served. We differ with and without the proposed Hispanic or Latino of all races; 3% are acknowledge the uncertainty in this rule. Asian and Not Hispanic or Latino; 22% baseline and have performed a As noted earlier in this preamble, all are Black or African American and Not sensitivity analysis to quantify its affiliates—which, Hispanic or Latino; 32% are White and importance. For our primary baseline, in 2015, served 41 percent of all Not Hispanic or Latino; and 5% are we chose 2.5 million annual clients of contraceptive clients at Title X-funded Other or Unknown and Not Hispanic or Title X services, which corresponds to service sites—withdrew from Title X Latino; and 4% are Unknown or not the number of clients in fiscal year 2019 due to the 2019 Final Rule. However, a Reported. Furthermore, the Title X among remaining grantees. As a comparison of Planned Parenthood’s statutory directive requires Title X sensitivity analysis, we investigate the two most recent annual financial reports projects to provide services for effect of the proposed rule compared to indicates no subsequent decrease in the adolescents without required parental a baseline with 1.5 million clients, number of patients served and an consent. This makes Title X a critical increase, from 9.8 million to 10.4 corresponding to preliminary estimates source of sexual and reproductive for fiscal year 2020. For comparison, we million, in the number of services healthcare for young people. In 2019, 54 also looked at the effects using an upper provided per annum (pre-pandemic). 2% program clients were younger than Although such year-to-year comparisons bound of 3.1 million clients served, 15, and 8% were younger than 18. which is the reported figure for 2019, are simplistic and a focus on just one Additional information about the but which includes 19 grantees, 231 organization (even a prominent one, number and distribution of all family subrecipients, and 945 service sites that with extensive activities) has obvious planning clients by age and year are withdraw from the Title X program limitations, this evidence may suggest available in Exhibit A–3a of the 2019 that the Title X program impacts Title X Annual Report. The benefits of following the 2019 Final Rule. quantified elsewhere in this regulatory revoking the 2019 Final Rule would Table F1 presents the number of impact analysis may largely be likely accrue roughly in proportion with clients served under different associated with transfers. Although these income and race and ethnicity assumptions of the baseline. We also there are notable challenges with figures. The costs of revoking the 2019 recalculate the number of clients served quantifying the benefit, cost and transfer Final Rule would likely accrue for the proposed rule scenario for each impacts of the proposed rule, we request proportional to the income and other of the baseline assumptions. Since the comment that might facilitate demographics of the general public. number of clients served in the first year refinement of the analysis prior to regulatory finalization. This proposed rule would also likely is the midpoint between the baseline have important geographic effects. As and long-run equilibrium figure, the e. Further Discussion of Distributional described in greater detail in the number of clients served in fiscal year Effects Baseline Section, 6 States currently have 2022 under the proposed rule would be The Title X program is designed to no Title X services, and 6 additional lower for the lower-bound scenario than provide services with priority given to states have limited Title X services. This the primary baseline. Similarly, the persons from low-income families. proposed rule would likely result in number of clients served under the According to the most recent data, 64% restoration of services to individuals in proposed rule would be higher in the of clients have income under 101% of these States. upper-bound scenario.

TABLE F1—TITLE X CLIENTS SERVED UNDER DIFFERENT BASELINE ASSUMPTIONS

Proposed rule, Proposed rule, Year Baseline Baseline, LB Baseline, UB Proposed rule LB UB

2022 ...... 2,512,066 1,536,744 3,095,666 3,247,958 2,760,297 3,539,758 2023 ...... 2,512,066 1,536,744 3,095,666 3,983,849 3,983,849 3,983,849 2024 ...... 2,512,066 1,536,744 3,095,666 3,983,849 3,983,849 3,983,849 2025 ...... 2,512,066 1,536,744 3,095,666 3,983,849 3,983,849 3,983,849 2026 ...... 2,512,066 1,536,744 3,095,666 3,983,849 3,983,849 3,983,849

Table F2 calculates the effect of the horizon of our analysis, applying a 3% served in annualized terms under the proposed rule under different baseline and a 7% discount rate. Under the primary baseline scenario. Under the assumptions. These estimates are lower-bound baseline scenario, the upper-bound baseline scenario, the reported by year, as well as in present proposed rule would have about a 66% proposed rule would have about a 64% value and annualized for the 5-year time greater impact on the number of clients lesser impact.

54 Please see https:// 67/30/67305ea1-8da2-4cee-9191-19228c1d6f70/ motivating message. If funds are more efficiently www.plannedparenthood.org/uploads/filer_public/ 210219-annual-report-2019-2020-web-final.pdf. The gathered and distributed via a program such as Title 2e/da/2eda3f50-82aa-4ddb-acce-c2854c4ea80b/ latter report indicates that Planned Parenthood X than through such private campaigns, the 2018-2019_annual_report.pdf and https:// conducted a major fundraising campaign with the efficiency would represent a cost savings www.plannedparenthood.org/uploads/filer_public/ 2019 Title X regulatory changes as its key attributable to the proposed rule.

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TABLE F2—EFFECT OF THE PROPOSED RULE UNDER DIFFERENT BASELINE ASSUMPTIONS

Proposed rule, Proposed rule, Year Proposed rule LB UB

2022 ...... 735,892 1,223,553 444,092 2023 ...... 1,471,783 2,447,105 888,183 2024 ...... 1,471,783 2,447,105 888,183 2025 ...... 1,471,783 2,447,105 888,183 2026 ...... 1,471,783 2,447,105 888,183 PDV, 3% ...... 6,025,877 10,019,109 3,636,461 PDV, 7% ...... 5,346,852 8,890,107 3,226,687 Annualized, 3% ...... 1,315,778 2,187,718 794,038 Annualized, 7% ...... 1,304,047 2,168,214 786,959

As discussed earlier, we acknowledge large number of service sites have shut Therefore, as a second sensitivity uncertainty in how quickly the Title X down permanently, the assumption of a analysis, we present estimates that program will be able to restore service two-year phase in would likely result in adopt alternative assumptions about the to levels experienced prior to the drops an overestimate of the proposed rule’s length of time it will take to reach the associated with the 2019 Final Rule. effect over the time horizon of the long-run equilibrium estimates. Table Our primary analysis adopts a two-year analysis. Similarly, if a small number of F3 presents our primary estimates, phase for grantees, subrecipients, service sites have shut down, the based on a two-year phase in, estimates service sites, and clients served to reach analysis would tend to underestimate without a phase in, and estimates with our long-run equilibrium estimates. If a the effect of the proposed rule. a 3-year phase in assumption.

TABLE F3—TITLE X CLIENTS WITH DIFFERENT PHASE-IN ASSUMPTIONS

Proposed rule, Proposed rule, Year Baseline 2-year Proposed rule, 3-year phase in no phase in phase in

2022 ...... 2,512,066 3,247,958 3,983,849 3,002,660 2023 ...... 2,512,066 3,983,849 3,983,849 3,493,255 2024 ...... 2,512,066 3,983,849 3,983,849 3,983,849 2025 ...... 2,512,066 3,983,849 3,983,849 3,983,849 2026 ...... 2,512,066 3,983,849 3,983,849 3,983,849

Table H4 calculates the effect of the horizon of our analysis, applying a 3% higher. Assuming a 3-year phase in proposed rule with different phase-in and a 7% discount rate. Compared to yields annualized effects that are about assumptions. These estimates are our primary estimates, the assumption 12% lower than the primary estimates. reported by year, as well as in present of no phase in yields annualized effects value and annualized for the 5-year time of the proposed rule that are about 12%

TABLE F4—EFFECT OF THE PROPOSED RULE WITH DIFFERENT PHASE-IN ASSUMPTIONS

Proposed rule, Proposed rule, Year 2-year Proposed rule, 3-year phase in no phase in phase in

2022 ...... 735,892 1,471,783 490,594 2023 ...... 1,471,783 1,471,783 981,189 2024 ...... 1,471,783 1,471,783 1,471,783 2025 ...... 1,471,783 1,471,783 1,471,783 2026 ...... 1,471,783 1,471,783 1,471,783 PDV, 3% ...... 6,025,877 6,740,335 5,325,293 PDV, 7% ...... 5,346,852 6,034,601 4,689,098 Annualized, 3% ...... 1,315,778 1,471,783 1,162,802 Annualized, 7% ...... 1,304,047 1,471,783 1,143,627

g. Analysis of Regulatory Alternatives to grantees, subrecipients, service sites, suggests the compliance regime as it the Proposed Rule and clients served that we have existed prior to the 2019 Final Rule was observed under the 2019 Final Rule. effective. We analyzed two alternatives to the Second, we considered revising the VI. Environmental Impact approach under the proposed rule. We 2019 Final Rule by readopting many considered one option to maintain many elements of the 2000 regulations, but We have determined under 21 CFR elements of the 2019 Final Rule and to 25.30(k) that this action is of a type that adopting additional flexibilities for impose additional restrictions on does not individually or cumulatively grantees and reducing programmatic grantees. This approach would have a significant effect on the human exacerbate the trends of reduced Title X oversight. However, our experience environment. Therefore, neither an

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environmental assessment nor an regarding subrecipients and referral grantees and subrecipients, as environmental impact statement is agencies and individuals, including a represented in Title X FPAR data. The required. description of the extent of mean hourly wage (not including collaboration and a clear explanation of benefits and overhead) for these VII. Paperwork Reduction Act how the grantee would ensure adequate occupations is $69.86 per hour for the This proposed rule contains oversight and accountability. lawyer and $55.37 per hour for the information collection requirements Proposed § 59.5 would also require medical and health service manager. (ICRs) that are subject to review by the Title X grantees to provide appropriate The labor cost is $132,750 in the first Office of Management and Budget documentation or other assurance year (($69.86 × 1 + $55.37 × 1) × 1060 (OMB) under the Paperwork Reduction satisfactory to the Secretary that it has grantees and subrecipients). We Act of 1995. A description of these in place and has implemented a plan to estimate that the cost, in subsequent provisions is given in the following comply with all State and local laws years, would be $95,700 which would paragraphs with an estimate of the requiring notification or reporting of represent an annual allotment of 30 annual burden, summarized in Table 1. child abuse, child molestation, sexual minutes for the lawyer and one hour for To fairly evaluate whether an abuse, rape, incest, intimate partner the medical and health service manager information collection should be violence, and human trafficking. It (($69.86 × 0.5 + $55.37 × 1) × 1060 approved by OMB, section 3506(c)(2)(A) would also require Title X grantees to grantees and subrecipients). of the Paperwork Reduction Act of 1995 maintain records to demonstrate (PRA) requires that we solicit comment compliance with the requirements of The Department estimates that all on the following issues: § 59.5, and make continuation of recipients and subrecipients will review • The need for the information funding for Title X services contingent their organizational policies and collection and its usefulness in carrying upon demonstrating to the Secretary procedures or take other actions to self- out the proper functions of our agency. that the criteria have been met. assess compliance with applicable Title • The accuracy of our estimate of the Burden of Response: The Department X requirements each year, spending an information collection burden. is committed to leveraging existing average of 4 hours doing so. The labor • The quality, utility, and clarity of grant, contract, annual reporting, and cost is a function of a lawyer spending the information to be collected. other Departmental forms where an average of 2 hours and a medical and • Recommendations to minimize the possible, rather than creating additional, health service manager spending an information collection burden on the separate forms for recipients to sign. We average of 2 hours. The labor cost for affected public, including automated anticipate two separate burdens of self-assessing compliance, such as collection techniques. response: (1) Assurance of compliance; reviewing policies and procedures, is a We are soliciting public comment on and (2) documentation of compliance. total of $265,500 each year (($69.86 × 2 each of the required issues under The burden for the assurance of + $55.37 × 2) × 1060 grantees and section 3506(c)(2)(A) of the PRA. The compliance is the cost of grantee and/ subrecipients). collections of information required by or subrecipient staff time to (a) review The burden for the documentation of the proposed rule relate to § 59.5 (What the assurance language as well as the compliance is the cost of grantee and/ requirements must be met by a family underlying language related to stated or subrecipient staff time to (a) complete planning project?) and § 59.7 (What requirements; (b) to review grantee and/ reports regarding information related to criteria would the Department of Health or subrecipient policies and procedures subrecipients, referral agencies and and Human Services use to decide or to take other actions to assess grantee individuals involved in the grantee’s which family planning services projects and/or subrecipient compliance with Title X project. to fund and in what amounts?). the requirements to which the grantee Proposed § 59.4 would require Title X and/or subrecipient is required to assure The labor cost would include a grant applicants to describe how the compliance. medical and health services manager proposed project would satisfy the The labor cost would include a lawyer spending an average of two hours each regulatory requirements for the Title X spending an average of 1 hour reviewing year to complete reports regarding program in their applications. All other all assurances and a medical and health information related to subrecipients, reporting burden associated with grant service manager spending an average of and referral agencies and individuals applications is already approved via one hour reviewing and signing the involved in the grantee’s Title X project existing Grants.gov common forms. assurances at each grantee and at each grantee and subrecipient. The Proposed § 59.5 would require Title X subrecipient. We estimate the number of labor cost will be $117,400 each year providers to report, in grant applications grantees and subrecipients at 1060, ($55.37 × 2 hours × 1060 grantees and and in all required reports, information based on 2019 number of Title X subrecipients).

TABLE 1—PROPOSED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS OR BURDEN OF RESPONSE IN YEAR ONE/SUBSEQUENT YEARS FOLLOWING PUBLICATION OF THE FINAL RULE

Burden per Total annual Labor cost of Regulation burden OMB control Respondents Hourly rate response burden reporting No. responses ($) (hours) (hours) ($)

Assurance of Compliance ...... 0938-New 1060/1060 62.62/62.62 6/5.44 6360/5766 398,250/ 361,200 Documentation of Compliance ...... 0938-New 1060/1060 55.37/55.37 2/2 2120/2120 117,400/ 117,400

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TABLE 1—PROPOSED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS OR BURDEN OF RESPONSE IN YEAR ONE/SUBSEQUENT YEARS FOLLOWING PUBLICATION OF THE FINAL RULE—Continued

Burden per Total annual Labor cost of Regulation burden OMB control Respondents Hourly rate response burden reporting No. responses ($) (hours) (hours) ($)

Total cost ...... 516,650/ 478,600 Note: The Department asks for public comment on the proposed information collection including what additional benefits may be cited as a re- sult of this proposed rule. Comments regarding the collection of information proposed in this proposed rule must refer to the proposed rule by name and docket number, and must be submitted to both OMB and the Docket Management Facility where indicated under ADDRESSES by the date specified under DATES. When it issues a final rule, the Department plans to publish in the FEDERAL REGISTER the control numbers assigned by the Office of Management and Budget (OMB). Publication of the control numbers notifies the public that OMB has approved the final rule’s in- formation collection requirements under the Paperwork Reduction Act of 1995.

List of Subjects in 42 CFR Part 59 voluntary family planning projects. persons, Asian Americans and Pacific Birth control, Contraception, Family These projects shall consist of the Islanders and other persons of color; planning, Grant programs, Health educational, comprehensive medical, members of religious minorities; facilities, Title X. and social services necessary to aid lesbian, gay, bisexual, transgender, and individuals to determine freely the queer (LGBTQ+) persons; persons with Xavier Becerra, number and spacing of their children. disabilities; persons who live in rural Secretary, Department of Health and Human areas; and persons otherwise adversely Services. § 59.2 Definitions. affected by persistent poverty or As used in this subpart: inequality. PART 59—GRANTS FOR FAMILY Act means the Public Health Service PLANNING Low-income family means a family Act, as amended. whose total annual income does not For the reasons set out in the Adolescent-friendly health services exceed 100 percent of the most recent preamble, subpart A of part 59 of title are services that are accessible, Poverty Guidelines issued pursuant to 42, Code of Federal Regulations, is acceptable, equitable, appropriate and 42 U.S.C. 9902(2). ‘‘Low-income family’’ hereby proposed to be revised to read as effective for adolescents. also includes members of families follows: Client-centered care is respectful of, whose annual family income exceeds and responsive to, individual client this amount, but who, as determined by Subpart A—Project Grants for Family preferences, needs, and values; client Planning Services the project director, are unable, for good values guide all clinical decisions. reasons, to pay for family planning Sec. Culturally and linguistically services. For example, unemancipated 59.1 To what programs do the regulations appropriate services are respectful of in this subpart apply? minors who wish to receive services on and responsive to the health beliefs, a confidential basis must be considered 59.2 Definitions. practices and needs of diverse patients. 59.3 Who is eligible to apply for a family on the basis of their own resources. Family means a social unit composed planning services grant? Nonprofit, as applied to any private of one person, or two or more persons 59.4 How does one apply for a family agency, institution, or organization, living together, as a household. planning services grant? means that no part of the entity’s net 59.5 What requirements must be met by a Family planning services include a earnings benefit, or may lawfully family planning project? broad range of medically approved benefit, any private shareholder or 59.6 What procedures apply to assure the contraceptive services, which includes individual. suitability of informational and Food and Drug Administration (FDA)- educational material? approved contraceptive services and Quality healthcare is safe, effective, 59.7 What criteria will the Department of natural family planning methods, for client-centered, timely, efficient, and Health and Human Services use to clients who want to prevent pregnancy equitable. decide which family planning services Secretary means the Secretary of projects to fund and in what amount? and space births, pregnancy testing and 59.8 How is a grant awarded? counseling, assistance to achieve Health and Human Services and any 59.9 For what purposes may grant funds be pregnancy, basic infertility services, other officer or employee of the used? sexually transmitted infection (STI) Department of Health and Human 59.10 Confidentiality. services, and other preconception health Services to whom the authority 59.11 Additional conditions. services. involved has been delegated. 59.12 What other HHS regulations apply to Health equity is when every person Service site is a clinic or other grants under this subpart? has the opportunity to attain their full location where Title X services (under the Act) are provided to clients. Title X Subpart A—Project Grants for Family health potential and no one is recipients and/or their subrecipients Planning Services disadvantaged from achieving this potential because of social position or may have service sites. Authority: 42 U.S.C. 300a–4. other socially determined State includes, in addition to the circumstances. several States, the District of Columbia, § 59.1 To what programs do the Inclusivity ensures that all people are Guam, the Commonwealth of Puerto regulations in this subpart apply? fully included and can actively Rico, the Northern Mariana Islands, the The regulations of this subpart are participate in and benefit from family U.S. Virgin Islands, American Samoa, applicable to the award of grants under planning, including, but not limited to, the U.S. Outlaying Islands (Midway, section 1001 of the Public Health individuals who belong to underserved Wage, et al.), the Marshall Islands, the Service Act (42 U.S.C. 3200) to assist in communities, such as Black, Latino, and Federated State of Micronesia and the the establishment and operation of Indigenous and Native American Republic of Palau.

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Trauma-informed means a program, unduly limit the client’s access to their (8) Provide that charges will be made organization, or system that is trauma- method of choice. for services to clients other than those informed realizes the widespread (2) Provide services without from low-income families in accordance impact of trauma and understands subjecting individuals to any coercion with a schedule of discounts based on potential paths for recovery; recognizes to accept services or to employ or not ability to pay, except that charges to the signs and symptoms of trauma in to employ any particular methods of persons from families whose annual clients, families, staff, and others family planning. Acceptance of services income exceeds 250 percent of the involved with the system; and responds must be solely on a voluntary basis and levels set forth in the most recent by fully integrating knowledge about may not be made a prerequisite to Poverty Guidelines issued pursuant to trauma into policies, procedures, and eligibility for, or receipt of, any other 42 U.S.C. 9902(2) will be made in practices, and seeks to actively resist re- services, assistance from or accordance with a schedule of fees traumatization. participation in any other program of designed to recover the reasonable cost the applicant.1 of providing services. § 59.3 Who is eligible to apply for a family (3) Provide services in a manner that (i) Family income should be assessed planning services grant? is client-centered, culturally and before determining whether copayments Any public or nonprofit private entity linguistically appropriate, inclusive, or additional fees are charged. in a State may apply for a grant under and trauma-informed; protects the (ii) With regard to insured clients, this subpart. dignity of the individual; and ensures clients whose family income is at or below 250% Federal poverty line (FPL) § 59.4 How does one apply for a family equitable and quality service delivery planning services grant? consistent with nationally recognized should not pay more (in copayments or additional fees) than what they would (a) Application for a grant under this standards of care. otherwise pay when the schedule of subpart shall be made on an authorized (4) Provide services without regard of religion, race, color, national origin, discounts is applied. form. (9) Take reasonable measures to verify (b) An individual authorized to act for disability, age, sex, number of client income, without burdening the applicant and to assume on behalf pregnancies, or marital status. clients from low-income families. of the applicant the obligations imposed (5) Not provide abortion as a method of family planning. A project must: Recipients that have lawful access to by the terms and conditions of the grant, other valid means of income verification including the regulations of this (i) Offer pregnant clients the opportunity to be provided information because of the client’s participation in subpart, must sign the application. another program may use those data (c) The application shall contain— and counseling regarding each of the (1) A description, satisfactory to the following options: rather than re-verify income or rely Secretary, of the project and how it will (A) Prenatal care and delivery; solely on clients’ self-report. If a client’s meet the requirements of this subpart; (B) Infant care, foster care, or income cannot be verified after (2) A budget and justification of the adoption; and reasonable attempts to do so, charges are amount of grant funds requested; (C) Pregnancy termination. to be based on the client’s self-reported (3) A description of the standards and (ii) If requested to provide such income. qualifications which will be required for information and counseling, provide (10) If a third party (including a all personnel and for all facilities to be neutral, factual information and Government agency) is authorized or used by the project; and nondirective counseling on each of the legally obligated to pay for services, all (4) Such other pertinent information options, and referral upon request, reasonable efforts must be made to as the Secretary may require. except with respect to any option(s) obtain the third-party payment without about which the pregnant client application of any discounts. Where the § 59.5 What requirements must be met by indicates they do not wish to receive cost of services is to be reimbursed a family planning project? such information and counseling. under title XIX, XX, or XXI of the Social (a) Each project supported under this (6) Provide that priority in the Security Act, a written agreement with part must: provision of services will be given to the title XIX, XX, or XXI agency is (1) Provide a broad range of clients from low-income families. required. acceptable and effective medically (7) Provide that no charge will be (11)(i) Provide that if an application approved family planning methods made for services provided to any relates to consolidation of service areas (including natural family planning clients from a low-income family except or health resources or would otherwise methods) and services (including to the extent that payment will be made affect the operations of local or regional pregnancy testing and counseling, by a third party (including a entities, the applicant must document assistance to achieve pregnancy, basic Government agency) which is that these entities have been given, to infertility services, STI services, authorized to or is under legal the maximum feasible extent, an preconception health services, and obligation to pay this charge. opportunity to participate in the adolescent-friendly health services). If development of the application. Local an organization offers only a single 1 42 U.S.C. 300a–8 (Section 205 of Pub. L. 94–63) and regional entities include existing or method of family planning, it may states: ‘‘Any (1) officer or employee of the United potential subrecipients which have States, (2) officer or employee of any State, political participate as part of a project as long subdivision of a State, or any other entity, which previously provided or propose to as the entire project offers a broad range administers or supervises the administration of any provide family planning services to the of acceptable and effective medically program receiving Federal financial assistance, or area proposed to be served by the approved family planning methods and (3) person who receives, under any program applicant. receiving Federal assistance, compensation for services. Title X service sites that are services, who coerces or endeavors to coerce any (ii) Provide an opportunity for unable to provide clients with access to person to undergo an abortion or maximum participation by existing or a broad range of acceptable and effective procedure by threatening such person with the loss potential subrecipients in the ongoing medically approved family planning of, or disqualification for the receipt of, any benefit policy decision making of the project. or service under a program receiving Federal (12) Title X projects shall comply methods and services, must be able to financial assistance shall be fined not more than provide a referral to the client’s method $1,000 or imprisoned for not more than one year, with all State and local laws requiring of choice and the referral must not or both.’’ notification or reporting of child abuse,

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child molestation, sexual abuse, rape, (i) Achieve community understanding made available under the project by an incest, intimate partner violence or of the objectives of the program; Advisory Committee prior to their human trafficking (collectively, ‘‘State (ii) Inform the community of the distribution, to assure that the materials notification laws’’). Title X projects availability of services; and are suitable for the population or must provide appropriate (iii) Promote continued participation community to which they are to be documentation or other assurance in the project by diverse persons to made available and the purposes of Title satisfactory to the Secretary that it: whom family planning services may be X of the Act. The project shall not (i) Has in place and implements a beneficial to ensure access to equitable, disseminate any such materials which plan to comply with State notification affordable, client-centered, quality are not approved by the Advisory laws. family planning services. Committee. (ii) Provides timely and adequate (4) Provide for orientation and in- (b) The Advisory Committee referred annual training of all individuals service training for all project personnel. to in paragraph (a) of this section shall (whether or not they are employees) (5) Provide services without the be established as follows: serving clients for, or on behalf of, the imposition of any durational residency (1) Size. The Committee shall consist project regarding State notification laws; requirement or requirement that the of no fewer than five members and up policies and procedures of the Title X patient be referred by a physician. to as many members the recipient project and/or for providers with respect (6) Provide that family planning determines, except that this provision to notification and reporting of child medical services will be performed may be waived by the Secretary for good abuse, child molestation, sexual abuse, under the direction of a physician with cause shown. rape, incest, intimate partner violence special training or experience in family (2) Composition. The Committee shall and human trafficking; appropriate planning. include individuals broadly interventions, strategies, and referrals to (7) Provide that all services purchased representative of the population or improve the safety and current situation for project participants will be community for which the materials are of the patient; and compliance with authorized by the project director or his intended (in terms of demographic State notification laws. designee on the project staff. factors such as race, ethnicity, color, (13) Ensure transparency in the (8) Provide for coordination and use national origin, disability, sex, sexual delivery of services by reporting the of referrals and linkages with primary orientation, gender identity, age, marital following information in grant healthcare providers, other providers of status, income, geography, and applications and all required reports: healthcare services, local health and including but not limited to individuals (i) Subrecipients and agencies or welfare departments, hospitals, who belong to underserved individuals providing referral services voluntary agencies, and health services communities, such as Black, Latino, and and the services to be provided; projects supported by other Federal Indigenous and Native American (ii) Description of the extent of the programs, who are in close physical persons, Asian Americans and Pacific collaboration with subrecipients, proximity to the Title X site, when Islanders and other persons of color; referral agencies, and any individuals feasible, in order to promote access to members of religious minorities; providing referral services, in order to services and provide a seamless lesbian, gay, bisexual, transgender, and demonstrate a seamless continuum of continuum of care. queer (LGBTQ+) persons; persons with care for clients; and (9) Provide that if family planning disabilities; persons who live in rural (iii) Explanation of how the recipient services are provided by contract or areas; and persons otherwise adversely will ensure adequate oversight and other similar arrangements with actual affected by persistent poverty or accountability for quality and providers of services, services will be inequality). effectiveness of outcomes among provided in accordance with a plan (3) Function. In reviewing materials, subrecipients. which establishes rates and method of the Advisory Committee shall: (b) In addition to the requirements of payment for medical care. These (i) Consider the educational, cultural, paragraph (a) of this section, each payments must be made under and diverse backgrounds of individuals project must meet each of the following agreements with a schedule of rates and to whom the materials are addressed; requirements unless the Secretary payment procedures maintained by the (ii) Consider the standards of the determines that the project has recipient. The recipient must be population or community to be served established good cause for its omission. prepared to substantiate that these rates with respect to such materials; Each project must: are reasonable and necessary. (ii) Review the content of the material (1) Provide for medical services (10) Provide, to the maximum feasible to assure that the information is related to family planning (including extent, an opportunity for participation factually correct, medically accurate, consultation by a healthcare provider, in the development, implementation, culturally and linguistically examination, prescription, and and evaluation of the project by persons appropriate, inclusive, and trauma continuing supervision, laboratory broadly representative of all significant informed; examination, contraceptive supplies) elements of the population to be served, (iii) Determine whether the material is and necessary referral to other medical and by others in the community suitable for the population or facilities when medically indicated, and knowledgeable about the community’s community to which is to be made provide for the effective usage of needs for family planning services. available; and contraceptive devices and practices. (iv) Establish a written record of its (2) Provide for social services related § 59.6 What procedures apply to assure determinations. to family planning, including the suitability of informational and counseling, referral to and from other educational material (print and electronic)? § 59.7 What criteria will the Department of social and medical service agencies, and (a) A grant under this section may be Health and Human Services use to decide any ancillary services which may be made only upon assurance satisfactory which family planning services projects to necessary to facilitate clinic attendance. to the Secretary that the project shall fund and in what amount? (3) Provide for opportunities for provide for the review and approval of (a) Within the limits of funds community education, participation, informational and educational materials available for these purposes, the and engagement to: (print and electronic) developed or Secretary may award grants for the

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establishment and operation of those § 59.8 How is a grant awarded? § 59.10 Confidentiality. projects which will in the Department’s (a) The notice of grant award specifies All information as to personal facts judgment best promote the purposes of how long Department of Health and and circumstances obtained by the section 1001 of the Act, taking into Human Services (HHS) intends to project staff about individuals receiving account: support the project without requiring (1) The number of clients, and, in the project to recompete for funds. This services must be held confidential and particular, the number of low-income anticipated period will usually be for must not be disclosed without the clients to be served; three to five years. individual’s documented consent, (2) The extent to which family (b) Generally the grant will initially be except as may be necessary to provide planning services are needed locally; for one year and subsequent services to the patient or as required by (3) The ability of the applicant to continuation awards will also be for one law, with appropriate safeguards for advance health equity; year at a time. A recipient must submit confidentiality. Otherwise, information (4) The relative need of the applicant; a separate application to have the may be disclosed only in summary, (5) The capacity of the applicant to support continued for each subsequent statistical, or other form which does not make rapid and effective use of the year. Decisions regarding continuation identify particular individuals. Federal assistance; awards and the funding level of such Reasonable efforts to collect charges (6) The adequacy of the applicant’s awards will be made after consideration without jeopardizing client facilities and staff; of such factors as the recipient’s confidentiality must be made. Recipient (7) The relative availability of non- progress and management practices, and must inform the client of any potential Federal resources within the community the availability of funds. In all cases, to be served and the degree to which for disclosure of their confidential continuation awards require a health information to policyholders those resources are committed to the determination by HHS that continued project; and where the policyholder is someone funding is in the best interest of the other than the client. (8) The degree to which the project Government. plan adequately provides for the (c) Neither the approval of any § 59.11 Additional conditions. requirements set forth in these application nor the award of any grant regulations. commits or obligates the United States The Secretary may, with respect to (b) The Secretary shall determine the in any way to make any additional, any grant, impose additional conditions amount of any award on the basis of his supplemental, continuation, or other prior to, at the time of, or during any estimate of the sum necessary for the award with respect to any approved award, when in the Department’s performance of the project. No grant application or portion of an approved judgment these conditions are necessary may be made for less than 90 percent of application. to assure or protect advancement of the the project’s costs, as so estimated, approved program, the interests of unless the grant is to be made for a § 59.9 For what purpose may grant funds public health, or the proper use of grant be used? project which was supported, under funds. section 1001, for less than 90 percent of Any funds granted under this subpart its costs in fiscal year 1975. In that case, shall be expended solely for the purpose § 59.12 What other HHS regulations apply the grant shall not be for less than the for which the funds were granted in to grants under this subpart? percentage of costs covered by the grant accordance with the approved Attention is drawn to the following in fiscal year 1975. application and budget, the regulations (c) No grant may be made for an of this subpart, the terms and conditions the HHS regulations which apply to amount equal to 100 percent for the of the award, and the applicable cost grants under this subpart. These project’s estimated costs. principles prescribed in 45 CFR part 75. include:

TABLE 1 TO § 59.12

37 CFR part 401 ...... Rights to inventions made by nonprofit organizations and small business firms under Government grants, contracts, and cooperative agreements. 42 CFR part 50, subpart D ...... Public Health Service grant appeals procedure. 45 CFR part 16 ...... Procedures of the Departmental Grant Appeals Board. 45 CFR part 75 ...... Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards. 45 CFR part 80 ...... Nondiscrimination under programs receiving Federal assistance through the De- partment of Health and Human Services effectuation of Title VI of the Civil Rights Act of 1964. 45 CFR part 84 ...... Nondiscrimination on the basis of handicap in programs and activities receiving or benefitting from Federal financial assistance. 45 CFR part 87 ...... Equal treatment for faith-based organizations. 45 CFR part 91 ...... Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance.

VerDate Sep<11>2014 16:01 Apr 14, 2021 Jkt 253001 PO 00000 Frm 00045 Fmt 4702 Sfmt 9990 E:\FR\FM\15APP1.SGM 15APP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 86, No. 71 / Thursday, April 15, 2021 / Proposed Rules 19833

[FR Doc. 2021–07762 Filed 4–14–21; 8:45 am] I. General Information risk of transmitting COVID–19. Our BILLING CODE 4150–03–P 1. Submitting Classified Business Docket Center staff will continue to Information. Do not submit CBI to EPA provide remote customer service via website https://www.regulations.gov or email, phone, and webform. We ENVIRONMENTAL PROTECTION email. Clearly mark the part or all of the encourage the public to submit AGENCY information that you claim to be CBI. comments via https:// For CBI information in a disk or CD– www.regulations.gov/ or email, as there 48 CFR Parts 1532 and 1552 ROM that you mail to EPA, mark the may be a delay in processing mail and [EPA–HQ–OMS–2020–0389; FRL–10021–63– outside of the disk or CD–ROM as CBI, faxes. Hand deliveries and couriers may OMS] and then identify electronically within be received by scheduled appointment the disk or CD–ROM the specific only. For further information on EPA Environmental Protection Agency information that is claimed as CBI. In Docket Center services and the current Acquisition Regulation (EPAAR); addition to one complete version of the status, please visit us online at https:// Electronic Invoicing and the Invoice comment that includes information www.epa.gov/dockets. The EPA Processing Platform (IPP) claimed as CBI, a copy of the comment continues to carefully and continuously AGENCY: Environmental Protection that does not contain the information monitor information from the Centers Agency (EPA). claimed as CBI must be submitted for for Disease Control and Prevention inclusion in the public docket. (CDC), local area health departments, ACTION: Proposed rule. Information so marked will not be and our Federal partners so that we can SUMMARY: The Environmental Protection disclosed except in accordance with respond rapidly as conditions change Agency (EPA) is amending an existing procedures set forth in 40 CFR part 2. regarding COVID–19. 2. Tips for Preparing Your Comments. EPAAR clause to further address II. Background electronic invoicing at EPA via the When submitting comments, remember Invoice Processing Platform (IPP). to: • The EPA is amending an existing DATES: Comments must be received on Identify the rulemaking by docket EPAAR clause to further address or before June 14, 2021. number and other identifying electronic invoicing at EPA via the information (subject heading, Federal ADDRESSES: Submit your comments, Invoice Processing Platform (IPP). Register date and page number). identified by Docket ID No. EPA–HQ– Currently EPA has one clause that • Follow directions—The Agency OMS–2020–0389, at http:// addresses IPP, which is clause may ask you to respond to specific www.regulations.gov. Follow the online 1552.232–70, Submission of Invoices. questions or organize comments by instructions for submitting comments. Clause 1552.232–70 is written for cost- referencing a Code of Federal Once submitted, comments cannot be reimbursable and time-and-materials Regulations (CFR) Part or section edited or removed from Regulations.gov. number. contracts and orders where considerable The EPA may publish any comment • Explain why you agree or disagree, supporting documentation is required. received to its public docket. Do not suggest alternatives, and substitute Such documentation is necessary for submit electronically any information language for your requested changes. those types of contracts and orders but you consider to be Confidential • Describe any assumptions and is not necessary for other contract types, Business Information (CBI) or other provide any technical information and/ like firm-fixed-price (FFP). Therefore, information whose disclosure is or data that you used. the subject clause is being amended to restricted by statute. Multimedia • If you estimate potential costs or include other contract and order types submissions (audio, video, etc.) must be burdens, explain how you arrived at like FFP, when it is not suitable to use accompanied by a written comment. your estimate in sufficient detail to clause 1552.232–70 in its current form. The written comment is considered the allow for it to be reproduced. III. Proposed Rule official comment and should include • Provide specific examples to discussion of all points you wish to illustrate your concerns, and suggest The proposed rule amends EPA make. The EPA will generally not alternatives. Acquisition Regulation (EPAAR) part consider comments or comment • Explain your views as clearly as 1532, Contract Financing, by amending contents located outside of the primary possible, avoiding the use of profanity § 1532.908, Contract Clauses. EPAAR submission (i.e. on the web, cloud, or or personal threats. Subpart 1552.2, Texts of Provisions and other file sharing system). For • Make sure to submit your Clauses, is amended by modifying additional submission methods, the full comments by the comment period EPA public comment policy, EPAAR § 1552.232–70 and also deadline identified. changing the clause title, from information about CBI or multimedia 3. Instructions: All submissions submissions, and general guidance on Submission of Invoices to Additional received must include the Docket ID No. Instructions for Submission of making effective comments, please visit for this rulemaking. Comments received http://www2.epa.gov/dockets/ Electronic Invoices via the Invoice may be posted without change to Processing Platform (IPP). commenting-epa-dockets. https://;www.regulations.gov/, including FOR FURTHER INFORMATION CONTACT: any personal information provided. For 1. EPAAR § 1532.908 amends the Thomas Valentino, Policy, Training and detailed instructions on sending prescription for use of § 1552.232–70 by Oversight Division, Acquisition Policy comments and additional information adding a prescription for Alternate 2 and Training Branch (3802R), on the rulemaking process, see the use. Environmental Protection Agency, 1200 SUPPLEMENTARY INFORMATION section of 2. EPAAR § 1552.232–70, Submission Pennsylvania Ave. NW, Washington, DC this document. Out of an abundance of of Invoices, is changed to Additional 20460; telephone number: (202) 564– caution for members of the public and Instructions for Submission of 4522; email address: valentino.thomas@ our staff, the EPA Docket Center and Electronic Invoices via the Invoice epa.gov. Reading Room are closed to the public, Processing Platform (IPP), and adds an SUPPLEMENTARY INFORMATION: with limited exceptions, to reduce the Alternate 2.

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