[Federal Register Volume 86, Number 71 (Thursday, April 15, 2021)]
[Proposed Rules]
[Pages 19812-19833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07762]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 59

RIN 0937-AA11


Ensuring Access to Equitable, Affordable, Client-Centered, 
Quality Family Planning Services

AGENCY: Office of the Secretary, U.S. Department of Health and Human 
Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Office of Population Affairs (OPA), in the Office of the 
Assistant Secretary for Health, proposes to revise the rules issued on 
March 4, 2019, establishing standards for compliance by family planning 
services projects authorized by Title X of the Public Health Service 
Act. Those rules have undermined the public health of the population 
the program is meant to serve. The Department proposes to revise the 
2019 rules by readopting the 2000 regulations, with several 
modifications needed to strengthen the program and ensure access to 
equitable, affordable, client-centered, quality family planning 
services for all clients, especially for low-income clients.

DATES: To ensure consideration, comments must be received by May 17, 
2021.

ADDRESSES: You may submit comments, identified by Regulatory 
Information Number 0937-AA11, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Enter the above docket ID number in the ``Enter Keyword or ID'' field 
and click on ``Search.'' On the next web page, click on ``Submit a 
Comment'' and follow the instructions.
     Mail or Hand Delivery [For paper, disk, or CD-ROM 
submissions] to: Attn: Title X Rulemaking, Office of Population 
Affairs, Office of the Assistant Secretary for Health, U.S. Department 
of Health and Human Services, 200 Independence Avenue SW, Washington, 
DC 20201. Comments, including any personally identifiable or 
confidential businesses information, received prior to the close of the 
comment period will be posted without change to http://www.regulations.gov.
    While the Department welcomes comments on any aspect of the 
regulations, we particularly welcome comments concerning how the 
current regulations have impacted the public's health or how this 
proposal to revise them will promote public health and aid in the 
program's fundamental mission to offer a broad range of effective 
family planning methods with priority given to clients from low-income 
families.

FOR FURTHER INFORMATION CONTACT: Alicia Richmond Scott, Office of 
Population Affairs, Office of the Assistant Secretary for Health, 
Department of Health and Human Services, 200 Independence Avenue SW, 
Washington, DC 20201; telephone: 240-453-2800; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Statutory Background
II. Regulatory and Litigation Background
III. Public Health Impact as a Result of the 2019 Rules and Reason 
for This Proposal
IV. Proposed Rules
    A. Section 59.2 Definitions
    B. Section 59.5 What requirements must be met by a family 
planning project?
    C. Section 59.6 What procedures apply to ensure the suitability 
of informational and educational material?
    D. Section 59.7 What criteria will the Department of Health and 
Human Services use to decide which family planning services projects 
to fund and in what amount?
    E. Section 59.10 Confidentiality
    F. Section 59.12 What other HHS regulations apply to grants 
under this subpart?
V. Regulatory Impact Analyses
    A. Introduction
    B. Summary of Costs, Benefits, and Transfers
    C. Preliminary Economic Analysis of Impacts
    a. Background
    b. Market Failure or Social Purpose Requiring Federal Regulatory 
Action
    c. Purpose of the Proposed Rule
    d. Baseline Conditions and Impacts Attributable to the Proposed 
Rule
    e. Further Discussion of Distributional Effects
    f. Uncertainty and Sensitivity Analysis
    g. Analysis of Regulatory Alternatives to the Proposed Rule
VI. Environmental Impact
VII. Paperwork Reduction Act

I. Statutory Background

    Title X of the Public Health Service Act (PHS Act or the Act) (42 
U.S.C. 300 through 300a-6) was enacted in 1970 by Public Law 91-572 as 
a means of ``making comprehensive voluntary family planning services 
readily available to all persons desiring such services.'' \1\ Section 
1001 of the Act (42 U.S.C. 300(a)), as amended, authorizes the 
Secretary of Health and Human Services ``to make grants to and enter 
into contracts with public or nonprofit private entities to assist in 
the establishment and operation of voluntary family planning projects 
which shall offer a broad range of acceptable and effective family 
planning methods and services (including natural family planning 
methods, infertility services, and services for adolescents).'' Section 
1006 of the Act (42 U.S.C. 300a-4) ensures that priority of services is 
given to clients from low-income families and authorizes the Secretary 
to promulgate regulations governing the program.
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    \1\ Public Law 91-572 (``The Family Planning Services and 
Population Research Act of 1970''), section 2(1).
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    Enacted as part of the original Title X legislation, Section 1008 
of the Act (42 U.S.C. 300a-6) directs that ``None of the funds 
appropriated under this title shall be used in programs where abortion 
is a method of family planning.'' The Conference Report accompanying 
the legislation described the intent of this provision as follows:

    It is, and has been, the intent of both Houses that funds 
authorized under this legislation be used only to support

[[Page 19813]]

preventive family planning services, population research, 
infertility services and other related medical, information, and 
educational activities. The conferees have adopted the language 
contained in section 1008, which prohibits the use of such funds for 
abortion, in order to make clear this intent.

H.R. Rep. No 91-1667, at 8-9 (1970) (Conf. Rep.). This requirement has 
been reiterated by later Congresses through annual appropriations 
provisos that state: ``[A]mounts provided to said [voluntary family 
planning] projects under such title shall not be expended for 
abortions.'' See, e.g., Consolidated Appropriations Act, 2021, Public 
Law 116-260, Div. H, 134 Stat 1182, 1570.
    Since 1970 when Title X was first enacted, Congress has amended the 
law several times both through changes to the Title X statute itself 
and through yearly appropriations riders. For example, in 1975, 
Congress amended Title X to include ``natural family planning methods'' 
as part of the broad range of family planning methods to be offered by 
Title X projects.\2\ PHS Act 1001(a) (42 U.S.C. 300(a)). In 1978, 
Congress amended Title X to codify HHS past practice by specifically 
requiring that Title X projects include ``services for adolescents.'' 
\3\ PHS Act 1001(a) (42 U.S.C. 300(a)). The Act was again amended in 
1981 to provide that ``[t]o the extent practicable, entities which 
receive grants or contracts under this subsection shall encourage 
family participation in projects under this subsection.'' \4\ PHS Act 
sec. 1001(a) (42 U.S.C. 300(a)).
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    \2\ Public Law 94-63.
    \3\ Public Law 95-613. The amendment reflected Congress' intent 
to place ``a special emphasis on preventing unwanted pregnancies 
among sexually active adolescents.'' S. Rep. No 822, 95th Cong, 2d 
sess. 24 (1978).
    \4\ Omnibus Budget Reconciliation Act of 1981, Public Law 97-35, 
sec. 931(b)(1), 95 Stat. 357, 570 (1981).
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    Congress has also imposed additional requirements through annual 
appropriations riders. For example, since Fiscal Year (FY) 1996, the 
annual Title X appropriation includes the proviso that ``all pregnancy 
counseling shall be nondirective.'' \5\ See, e.g., Consolidated 
Appropriations Act, 2021, Public Law 116-260, Div. H, 134 Stat 1182, 
1570 (2021). Also since FY 1996, the Title X appropriation has directed 
that Title X funds ``shall not be expended for any activity (including 
the publication or distribution of literature) that in any way tends to 
promote public support or opposition to any legislative proposal or 
candidate for public office.'' Id. Since FY 1998, Congress has included 
a rider in HHS's annual appropriations act that provides that ``[n]one 
of the funds appropriated in this Act may be made available to any 
entity under Title X of the PHS Act unless the applicant for the award 
certifies to the Secretary that it encourages family participation in 
the decision of minors to seek family planning services.'' \6\ See, 
e.g., Consolidated Appropriations Act, 2021, Public Law 116-260, Div. 
H, sec. 207, 134 Stat. 1182, 1590. The same appropriations rider also 
requires that such an applicant certify to the Secretary that it 
``provides counseling to minors on how to resist attempts to coerce 
minors into engaging in sexual activities.'' Id. And, since FY 1999, in 
a separate rider, Congress has required that, ``[n]otwithstanding any 
other provision of law, no provider of services under Title X of the 
PHS Act shall be exempt from any State law requiring notification or 
the reporting of child abuse, child molestation, sexual abuse, rape, or 
incest.'' \7\ See, e.g., Consolidated Appropriations Act, 2021, Public 
Law 116-260, Div. H, sec. 208, 134 Stat. 1182, 1590 (2021).
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    \5\ Omnibus Consolidated Rescissions and Appropriations Act, 
1996, Public Law 104-134, Title II, 110 Stat.1321, 1321-221 (1996).
    \6\ Departments of Labor, Health and Human Services, and 
Education, and Related Agencies Appropriations Act, 1998, Public Law 
105-78, sec. 212, 111 Stat. 1467, 1495 (1997).
    \7\ Department of Health and Human Services Appropriations Act, 
1999, Public Law 105-277, Title II, sec. 219, 112 Stat. 2681, 2681-
363 (1998).
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II. Regulatory and Litigation Background

    The Department first promulgated regulations for the Title X 
program in 1971 but did not directly address section 1008. 36 FR 18465 
(Sept. 15, 1971). With experience, the Department interpreted section 
1008 to prohibit grantees \8\ from promoting or encouraging abortion as 
a method of family planning in any way and to require that Title X 
activities be separate and distinct from any abortion activities. 53 FR 
2922, 2923 (Feb. 2, 1988) (describing the Department's interpretation 
in the early years of the program). In 1981, the Department built upon 
this experience and issued guidelines directing grantees to provide 
``nondirective counseling'' to pregnant clients ``upon request'' 
including: (1) Prenatal care and delivery; (2) infant care, foster 
care, or adoption; and (3) pregnancy termination. Counseling included 
``referral upon request.'' OPA, Program Guidelines for Project Grants 
for Family Planning Services at 13 (1981).
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    \8\ For purposes of this notice of proposed rulemaking, the 
terms ``grantee'' and ``recipient'' are used interchangeably.
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    In 1988, reacting in large part to a directive from President 
Reagan, the Department changed course. 53 FR 2922 (Feb. 2, 1988). 
Regulations promulgated then--commonly called the ``gag rule''--
prohibited the discussion of or referral for abortion. The regulations 
also required grantees to maintain strict physical and financial 
separation between Title X projects and abortion related activities, to 
be determined by the ``facts and circumstances'' of each grantee. 
Additionally, the regulations prohibited lobbying, education, dues-
paying, or any other activities which could be interpreted to encourage 
or promote abortion as a method of family planning.
    The 1988 regulations were immediately subject to multiple lawsuits 
and ultimately upheld by the Supreme Court in Rust v. Sullivan, 500 
U.S. 173 (1991). In Rust, the Supreme Court held that section 1008 was 
``ambiguous'' and ``at no time did Congress directly address the issues 
of abortion counseling, referral or advocacy.'' Id at 185. The Court 
was nearly unanimous on this point. Blackmun dissenting at 207; 
O`Connor Dissenting at 223.\9\ Given the lack of clarity regarding 
section 1008, the Court deferred to the Secretary's construction of the 
statute as ``reasonable'' under Chevron U.S.A. v. NRDC, 467 U.S. 837 
(1984).
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    \9\ Justice Stevens, the only Justice to find the Sec.  1008 
unambiguous, believed it ``plainly'' foreclosed the Secretary's 
regulations. Stevens dissent at 221.
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    The Court also upheld the regulations against constitutional attack 
under the Fifth and First Amendments. Following recent precedent, the 
Court held that the Government could constitutionally subsidize some 
activities over others and that plaintiffs were still free to pursue 
abortion related activities and speech ``when they are not acting under 
the auspices of the Title X project.'' Id. at 199.
    On November 5, 1991, responding to widespread concerns over the 
regulation's overreach into the doctor-patient relationship, President 
Bush issued a directive to the Department to allow for open 
communications between doctors and patients for all aspects of their 
medical condition. See Nat'l Family Planning & Reprod. Health Ass'n v. 
Sullivan, 979 F.2d 227 (D.C. Cir 1992). However, the Department did not 
engage in rulemaking to carry out the directive, as required by the 
Administrative Procedure Act. Therefore, the D.C. Court of Appeals

[[Page 19814]]

upheld a lower court injunction prohibiting the directives from taking 
effect. Id.
    Almost immediately after taking office, President Clinton issued a 
memorandum to the Secretary of HHS, directing suspension of the ``gag 
rule'' and commencement of new rulemaking regarding the Title X 
program. 58 FR 7455 (Feb. 5, 1993). The Department suspended the 1988 
regulations and adopted compliance standards predating the 1988 rules 
on an interim basis. 58 FR 7462 (Feb. 5, 1993). The Department also 
sought comment on adopting as final the rules and guidance in effect 
prior to the 1988 rules. 58 FR 7464 (Feb. 5, 1993). In response to this 
proposed rulemaking, the Department received 146 comments, and 
finalized new Title X rules in July of 2000. 65 FR 41270 (July 3, 
2000). On that same day, the Department published interpretations 
relating to the statutory requirement that no funds appropriated under 
Title X of the Public Health Service Act be used in programs in which 
abortion is a method of family planning. 65 FR 41281 (July 3, 2000).
    The new rules rescinded the 1988 rules prohibiting counseling and 
referral for abortion. They also eliminated the provisions requiring 
strict physical and financial separation between Title X projects and 
abortion related activities, while still requiring that abortion and 
Title X activities are separated by more than ``mere bookkeeping.'' 65 
FR 41270, 41271. Section 59.10 concerning lobbying restrictions was 
also repealed, while still adhering to long established interpretations 
of the statute forbidding promotion of abortion through advocacy 
activities. Id. at 41277. Finally, the Department codified the 1981 
guidance requiring, upon request of the pregnant patient, nondirective 
counseling and referral, regarding any option requested: ``(1) prenatal 
care and delivery; (2) infant care, foster care, or adoption; and (3) 
pregnancy termination.'' Id. at 41279 [42 CFR 59.5(a)(5) (2000 reg)].
    In promulgating the 2000 regulations, the Department concluded that 
revoking the 1988 regulations was within its administrative discretion 
and that there was no evidence the ``gag rule'' would--or could--work 
in practice. The Department concluded experience had taught that the 
rules and policies previous to the 1988 regulations had been accepted 
by grantees and enabled the program to operate successfully during 
virtually its entire history. Additionally, the Department relied on 
the direction from Congress in appropriations riders beginning in 1996 
(Pub. L. 104-134), requiring that ``all pregnancy counseling be 
nondirective,'' believing any referral to a prenatal or other provider 
when not requested would raise real questions of coercion. The rule 
also incorporated referrals as a ``logical and appropriate outcome'' of 
nondirective counseling and consistent with the requirement that the 
project provide referrals for any medical services not provided by the 
project [42 CFR 59.5(b)(1)]. Id. 41274. For two decades after these 
rules were finalized (and nearly three decades after they had been in 
place following the 1988 rule's suspension in 1993), Title X faced no 
litigation or controversy over these regulations.\10\
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    \10\ As discussed below, the 2000 rule also fully recognized the 
statutory conscience right of individual providers to object to 
counseling and referral for abortions. Id. At 41274, 41275.
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    In 2018, under a new Administration, the Department proposed new 
rules again. 83 FR 25502 (June 1, 2018). These rules largely mirrored 
the 1988 regulations and were finalized in 2019. 84 FR 7714 (March 24, 
2019). The Department promulgated the 2019 rules because of its stated 
view, at that time, that they represented the best interpretation of 
the statute and provided the most appropriate guidance for compliance 
with the statutory provisions, including section 1008. While pointing 
to no direct violations of Title X, associated laws, or the 2000 
regulations, the Department believed the 2000 regulations ``fostered an 
environment of ambiguity surrounding appropriate Title X activities.'' 
Id. at 7721. Therefore, ``bright line rules'' would ameliorate any 
confusion by grantees and the public.
    The Department also cited several conscience protection laws 
enacted by Congress to support the changes to the 2000 regulations. 
These laws prohibit public health service grantees from requiring 
individuals to assist in the performance of health service activities 
against their religious beliefs or convictions, 42 U.S.C. 300a-7(d), 
and prohibit discrimination against both individual and institutional 
providers for their refusal to provide, cover, or refer for abortions. 
Consolidated Appropriations Act, 2021, Public Law 116-260, Div. H, sec. 
507(d) (2020), Consolidated Appropriations Act, 2021, Public Law 116-
260, Div. H, sec. 507(d) (2020). The Department concluded in 2019 that 
the 2000 regulations, if enforced against objecting grantees, would be 
inconsistent with these statutory protections and dissuade otherwise 
qualified providers from applying for Title X funds.
    The 2019 rules also re-imposed the physical separation provisions 
of the 1988 rule, as well re-codifying the lobbying restrictions. 
Additionally, the rule added requirements on grantees and subrecipients 
regarding compliance with state reporting laws, as well as expanded 
application and record-keeping requirements. And, with respect to 
minors, the 2019 rule required providers to document what specific 
actions were taken to encourage family participation.
    As to nondirective counseling and referral for abortion, in 
recognition of the Congressional direction for nondirective counseling 
on abortion in yearly appropriations riders, the 2019 rule allowed, but 
did not require, counseling by grantees, limited to physicians and 
advanced care providers. Id. at 7744. However, the Department believed 
that the abortion referral requirement was inconsistent with section 
1008 and that, though permissible for nearly the entire history of the 
program, such referrals must be prohibited. Id.
    Litigation over the 2019 rule immediately ensued. The Department 
was sued by 23 states, every major medical organization, Title X 
grantee organizations, and individual grantees. The suits were lodged 
in multiple district courts and alleged a variety of claims under the 
Administrative Procedure Act, the Affordable Care Act, and the 
Constitution. The rule was ultimately upheld by an en banc Court of 
Appeals for the Ninth Circuit and enjoined (only as to the state of 
Maryland) by a district court in Maryland in a decision upheld by the 
en banc Court of Appeals for the Fourth Circuit. Both court of appeals 
decisions were issued over substantial dissents.
    In California v. Azar, 950 F.3d 1067 (9th Cir. 2020), the Ninth 
Circuit relied heavily on Rust in upholding the rule. A majority of the 
en banc panel found that the Department ``could'' interpret section 
1008 as it did in the 2019 rule, and nothing in subsequent legislation 
prevented this reading. Id. at 1085. The Ninth Circuit upheld the rule 
against an arbitrary and capricious challenge, stating, ``that the new 
policy is permissible under the statute, that there are good reasons 
for it, and that the agency believes it to be better.'' Id. at 1097 
(emphasis in original). Conversely, a majority of the Fourth Circuit 
found the Department's 2019 rule arbitrary and capricious. Mayor of 
Baltimore v. Azar, 973 F.3d 258 (4th Cir. 2020). The Fourth Circuit 
also held the 2019 rule violated the non-directive mandate.\11\
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    \11\ Both the Ninth and Fourth Circuits also came to opposite 
results on the validity of the rule under section 1554 of the 
Affordable Care Act [42 U.S.C. 18114].

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[[Page 19815]]

    Losing parties in both cases sought review from the Supreme Court 
in October of 2020. The Court granted certiorari on February 22, 2021, 
consolidating the cases. No. 20-429. On March 12, 2021, the parties 
stipulated to dismiss the cases under Supreme Court Rule 46.1.

III. Public Health Impact as a Result of the 2019 Rules and Reason for 
this Proposal

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

[[Page 19816]]

preterm and low-birthweight births, STIs, infertility, and cervical 
cancer.\20\
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    \18\ Jessica D. Gipson, Michael A. Koenig, and Michelle J. 
Hindin. ``The Effects of Unintended Pregnancy on Infant, Child, and 
Parental Health: A Review of the Literature.'' Studies in family 
planning 39.1 (2008): 18-38. Web.
    \19\ Power to Decide. Maternal and Infant Health and the 
Benefits of Birth Control in America. Accessed on March 8, 2020 from 
https://powertodecide.org/sites/default/files/resources/supporting-materials/getting-the-facts-straight-chapter-3-maternal-infant-health.pdf.
    \20\ Kaiser Family Foundation. https://www.kff.org/womens-health-policy/issue-brief/data-note-impact-of-new-title-x-regulations-on-network-participation/
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     OPA has been unable to secure new Title X grantees and 
service sites to meet the unmet need for family planning services. To 
meet the unmet need for family planning services nationwide, in Fiscal 
Year 2019 OPA issued a competitive supplemental funding announcement to 
existing grantees. Fifty existing grantees were awarded $33.7 million 
to expand Title X services. However, only 7 states (CO, DE, KY, ND, NM, 
NV, TX) had a meaningful increase in the number of Title X clinics in 
their states.
    In addition, OPA has been unable to find new grantees to fill most 
of the gaps the 2019 Final Rule created, including in the six states 
that lost all Title X-funded services. To address gaps in the Title X 
service network and increase coverage, a new competitive funding 
announcement was issued in Fiscal Year 2020 to provide services in 
unserved or underserved states and communities. The number of 
applications received was so low (8 eligible applications received) 
that the resulting grant awards were for less than the total amount of 
funding available (grant awards for $8.5 million with $20 million 
available), and were only able to provide services in three states with 
no or limited Title X services at the time. This demonstrated the 
negative effects of the 2019 Title X Final Rule on client access to 
needed family planning and related preventive health services, 
especially for the priority low-income populations that Title X is 
mandated to serve.
    The realization of a greater pool of grantees, as predicted by the 
2019 rule, has not transpired over the course of two grant cycles. As 
discussed above, OPA was unable to meaningfully expand services nor was 
it able to find new grantees to fill existing gaps. In fact, the 2019 
Final Rule did not increase the pool of grantees and was unable to 
generate interest in providing Title X services from organizations who 
had not previously been Title X grantees. This, coupled with the exodus 
of otherwise qualified grantees, subrecipients and service sites that 
left the network due to their opposition to the 2019 Final Rule, led to 
great difficulty in awarding appropriated funds as intended by 
Congress.
     The 2019 Final Rule is contrary to the CDC and OPA's 
Quality Family Planning (QFP) Guidelines. In April 2014 (with updates 
in 2015 and 2017), Providing Quality Family Planning Services: 
Recommendations from Centers for Disease Control and Prevention and the 
US Office of Population Affairs (QFP),\21\ was published as a CDC 
Morbidity and Mortality Weekly Report (MMWR) Recommendations and 
Reports. The QFP, developed jointly by the Centers for Disease Control 
and Prevention (CDC) and the HHS Office of Population Affairs (OPA), 
provides recommendations for use by all reproductive health and primary 
care providers with patients who are in need of services related to 
preventing or for achieving pregnancy. The QFP are scientific and 
evidence-based recommendations that integrate and fill gaps in existing 
guidelines for the family planning settings. QFP recommendations are 
based on a rigorous, systematic, transparent review of the evidence and 
with input from a broad range of clinical experts, OPA, and CDC. The 
QFP references numerous other clinical guidelines that are published by 
Federal agencies, as well as guidelines released by professional 
medical associations.
---------------------------------------------------------------------------

    \21\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs. 
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
---------------------------------------------------------------------------

    These guidelines were developed over a three-year period through 
the CDC's Division of Reproductive Health (DRH) and OPA, in 
consultation with a wide range of experts and key stakeholders. These 
guidelines have been the undisputed standard in reproductive healthcare 
ever since. QFP recommendations support all providers in delivering 
quality family planning services and define family planning services 
within a broader context of preventive services, to improve health 
outcomes for women, men, and their (future) children.
    The client centered approach adopted in the QFP requires pregnancy 
tests to be ``followed by a discussion of options and appropriate 
referrals.'' Id. at 14 Further, counseling and referral are to be 
provided, ``at the request of the client,'' in accordance with 
recommendations from professional medical organizations. Though 
formally adopted as a QFP recommendation in 2014, appropriate referrals 
with nondirective counseling have been the practice and implicit 
standard of care in Title X programs for essentially its entire 
history, including in early guidelines and later when expressly 
incorporated in the 2000 regulations.
    The 2019 rule abandoned this client centered approach over the 
objection of every major medical organization without any 
countervailing public health rationale. Moreover, the 2019 rule 
required prenatal referral even over the objection of the patient. For 
the reasons discussed above, that approach cannot be squared with well-
accepted public health principles.
     The 2019 Final Rule increased compliance and oversight 
costs, with no discernible benefit. The 1988 rules requiring strict 
physical and financial separation requirements, were based, in part, on 
two governmental reports finding minor compliance issues with grantees 
and recommended only more specific guidance, not a substantial 
reworking of the regulations. See, e.g., Comp. Gen. Rep. No GAO/HARD-
HRD-82-106 (1982), at 14-15; 65 FR 41270, 41272. While those reports 
found some confusion among grantees around section 1008, ``GAO found no 
evidence that Title X funds had been used for abortions or to advise 
clients to have abortions.'' More importantly, in the decades between 
1993 and the 2019 rule, and as evidenced by the silence of the 2019 
final rule on this issue, legally required audits, regular site visits, 
and other oversight of grantees have found no diversion of grant funds 
that would justify the greatly increased compliance and oversight costs 
the 2019 rule required.
    The 2019 rule's separation requirements also claimed to be 
addressing questions of ``fungibility'' and a concern that Title X 
funds might be ``intentionally or unintentionally'' co-mingling with 
activities not allowed under the statute. 84 FR at 7716. As noted, 
close oversight for decades under the 2000 rules uncovered no 
misallocation of Title X funds by grantees. Moreover, courts have long 
since held that governments cannot restrict access to funds for one 
activity simply because it may ``free up'' funds for another activity. 
See Planned Parenthood of Cent. & N. Arizona v. Arizona, 718 F.2d 938, 
945 (9th Cir 1983) (concluding ``as a matter of law, the freeing-up 
theory cannot justify withdrawing all state funds from otherwise 
eligible entities merely because they engage in abortion-related 
activities disfavored by the state''); see also Agency for Int'l Dev. 
v. Alliance for Open Soc'y Int'l, Inc., 570 U.S. 205, 220 (2013) 
(``[I]f the Government's argument [that fungibility is sufficient for 
prohibition] were correct, League of Women Voters would have come out 
differently, and much of the reasoning of Regan and Rust would have 
been beside the point''). Because of the 2019

[[Page 19817]]

rule, appropriations that would otherwise be used to carry out the 
purposes of the Title X program, providing a broad range of family 
planning services to individuals (including confidential services to 
minors), are now being diverted to increased infrastructure costs 
resulting from the separation requirement as well as the micro-level 
monitoring and reporting now required of grantees. None of these 
burdensome additional requirements provide discernible compliance 
benefits, particularly not to public health. As many commenters and at 
least one court emphasized, the 2019 rule was a solution in search of a 
problem, a solution whose severe public health consequences caused much 
greater problems.
    The Department also recognizes Congress has passed several laws 
protecting the conscience rights of providers, particularly in the area 
of abortion. For example, in promulgating the 2000 Title X rules, the 
Department affirmed: ``under 42 U.S.C. 300a-7(d), grantees may not 
require individual employees who have such objections [to abortion] to 
provide such counseling.'' 65 FR 41270, 41274 (July 3, 2000). Since 
2005 Congress has also annually enacted an appropriations rider which 
extends non-discrimination protections to other ``health care 
entities'' who refuse to counsel or refer for abortion. See, e.g., 
Consolidated Appropriations Act, 2021, Public Law 116-260, Div. H, 
section 507(d) (2020). Under these statutes, objecting providers or 
Title X grantees are not required to counsel or refer for 
abortions.\22\ However, such protections for objecting providers and 
grantees should not prohibit willing providers and grantees from 
providing information in accordance with the ethical codes of major 
medical organizations.
---------------------------------------------------------------------------

    \22\ This has been the consistent position of the Department 
since 2000. See 65 FR at 41274 (in response to comments on 
individual objections to providing abortion counseling or referral, 
Department stating: ``under 42 U.S.C. 300a-7(d), grantees may not 
require individual employees who have such objections to provide 
such counseling.'').
---------------------------------------------------------------------------

    Ultimately, continued enforcement of the 2019 rule raises the 
possibility of a two-tiered healthcare system in which those with 
insurance and full access to healthcare receive full medical 
information and referrals, while low-income populations with fewer 
opportunities for care are relegated to inferior access. Given that so 
many individuals depend on the Title X program as their primary source 
of healthcare, this situation creates a widespread public health 
concern. The 2019 rule is not in the best interest of public health.

IV. Proposed Rules

    For nearly 50 years without interruption, Title X program grants 
have been administered against the backdrop of counseling and referral 
for appropriate medical care, including referral for abortion. Family 
planning is widely considered one of the most important public health 
achievements of the 20th Century.\23\ As the only Federal program 
exclusively dedicated to providing contraceptive services, Title X has 
been imperative to that success.
---------------------------------------------------------------------------

    \23\ Centers. for Disease Control & Prevention, Achievements in 
Public Health, 1900-1999: Family Planning, 48 Morbidity & Mortality 
Weekly Reports No. 47, 1073-80 (Dec. 3, 1999), https://www.cdc.gov/mmwr/preview/mmwrhtml/mm4847a1.htm.
---------------------------------------------------------------------------

    For five decades, Title X family planning clinics have played a 
critical role in ensuring access to a broad range of family planning 
and related preventive health services for millions of low-income or 
uninsured individuals and others. \24\ Over the 50 years of the Title X 
program, Title X clinics have served more than 190 million clients: 
182.2 million women, 8.1 million men, comprising 139.5 million adults 
and 50.8 million adolescents, across 50 states, the District of 
Columbia, and eight U.S. territories and freely associated states. 
Title X providers offered clients a broad range of effective and 
medically safe contraceptive methods approved by the U.S. Food and Drug 
Administration. Title X-funded sexually transmitted infection (STI) and 
human immunodeficiency virus (HIV) screening services prevented 
transmission and adverse health consequences. Over the 50 years of the 
Title X program, Title X clinics also performed 34.1 million chlamydia 
tests, 18.3 million HIV tests, 37 million Papanicolaou tests, and 42 
million clinical breast exams.
---------------------------------------------------------------------------

    \24\ OPA. Title X: Celebrating 50 Years of Title X Service 
Delivery. Accessed on March 8, 2021 from https://opa.hhs.gov/sites/default/files/2020-11/title-x-50-years-infographic.pdf.
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    Given the previous success of the program, the large negative 
public health consequences of maintaining the 2019 rules, the 
substantial compliance costs for grantees, and the lack of tangible 
benefits, the Department proposes revoking the 2019 Title X 
regulations. As has been clearly borne out by case law and history, the 
Department has the discretion to make this determination and it is in 
the interest of public health.
    The Department is also concerned that some state policies 
restricting eligible subrecipients unnecessarily interfere with 
beneficiaries' access to the most accessible and qualified providers. 
These state restrictions are not always related to the subrecipients' 
ability to effectively deliver Title X services, but rather are 
sometimes based either on the non-Title X activities of the providers 
or because they are a certain type of provider. However, providers with 
a reproductive health focus often provide a broader range of 
contraceptive methods on-site and therefore may reduce additional 
barriers to accessing services. Moreover, denying participation by 
family planning providers that can provide effective services has 
resulted in populations in certain geographic areas being left without 
Title X providers for an extended period of time.\25\ And, while many 
otherwise qualified providers are willing and can provide effective 
Title X services, some lack the administrative capacity to directly 
apply for and manage a Title X grant.
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    \25\ Carter, M.W., Gavin, L., Zapata, L.B., Bornstein, M., 
Mautone-Smith, N., & Moskosky, S.B. (2016). Four aspects of the 
scope and quality of family planning services in U.S. publicly 
funded health centers: Results from a survey of health center 
administrators. Contraception. doi:10.1016/
j.contraception.2016.04.009.
---------------------------------------------------------------------------

    The Department believes that these state restrictions on 
subrecipient eligibility unrelated to the ability to deliver Title X 
services undermine the mission of the program to ensure widely 
available access to services by the most qualified providers. 
Therefore, the Department invites comment on ways in which it can 
ensure that Title X projects do not undermine the program's mission by 
excluding otherwise qualified providers as subrecipients.
    In place of the 2019 Title X regulations, the Department proposes 
to largely readopt the 2000 regulations (65 FR 41270) with several 
revisions aimed at ensuring access to equitable, affordable, client-
centered, quality family planning services. Advancing equity for all, 
including people of color and others who have been historically 
underserved, marginalized, and adversely affected by persistent poverty 
and inequality, is a priority for OPA and the Title X program. By 
focusing on advancing equity in the Title X program, we can create 
opportunities for the improvement of communities that have been 
historically underserved, which benefits everyone. Additionally, given 
the success of the Providing Quality Family Planning Services 
guidelines published in 2014,\26\ the Department is

[[Page 19818]]

proposing to incorporate into regulations several of the QFP's 
recommendations. Based on experience, the Department is also proposing 
some provisions it believes will make the program function more 
effectively, efficiently and consistently for all.
---------------------------------------------------------------------------

    \26\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs. 
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
---------------------------------------------------------------------------

    The Department proposes revising the 2019 Title X Final Rule 
through notice and comment rulemaking, by readopting the 2000 
regulations with revisions that will enhance the Title X program and 
its family planning services, including family planning services 
provided using telemedicine, for the future. This will remove the 2019 
Final Rule requirements for strict physical and financial separation, 
allow Title X providers to provide nondirective options counseling, and 
allow Title X providers to refer their patients for all family planning 
related services desired by the client, including abortion services. In 
addition, this will allow for several revisions that are needed to 
strengthen the program and ensure access to equitable, affordable, 
client-centered, trauma-informed quality family planning services for 
all clients, especially for low-income clients. At the same time, the 
proposed rule will retain the longstanding prohibition on directly 
promoting or performing abortion that follows from Section 1008's text 
and subsequent appropriations enactments. And as indicated above, 
individuals and grantees with conscience objections will not be 
required to follow the proposed rule's requirements regarding abortion 
counseling and referral.
    For all the above reasons, the Department proposes to revise the 
regulations that govern the Title X family planning services program by 
readopting the 2000 regulations (65 FR 41270), with several 
modifications. The proposed revisions to the 2000 regulations and 
rationale for each are listed below:

A. Section 59.2 Definitions

    The Department proposes to revise Sec.  59.2 to include a modified 
definition of family planning. The definition of family planning 
services included in the 2019 Final Rule did not align with the widely 
accepted definition. The definition of family planning services should 
be consistent with the Title X statutory requirements and reflect the 
widely-recognized definition that is included in Providing Quality 
Family Planning Services: Recommendations of CDC and the U.S. Office of 
Population Affairs,\27\ which has been used historically by OPA when 
implementing the program prior to 2019. Under the proposed regulations, 
``family planning services'' are defined as including a broad range of 
medically approved contraceptive services, which includes FDA-approved 
contraceptive services and natural family planning methods, for clients 
who want to prevent pregnancy and space births, pregnancy testing and 
counseling, assistance to achieve pregnancy, basic infertility 
services, sexually transmitted infection (STI) services, and other 
preconception health services.
---------------------------------------------------------------------------

    \27\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs. 
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
---------------------------------------------------------------------------

    The Department also proposes to add definitions for terms used 
throughout the revised regulations to provide clarity. The newly 
proposed definitions include adolescent-friendly health services,\28\ 
client-centered care,\29\ health equity,\30\ inclusivity,\31\ quality 
\32\ healthcare, service site, and trauma-informed.\33\
---------------------------------------------------------------------------

    \28\ World Health Organization. Quality Assessment Guidebook. A 
guide to assessing health services for adolescent clients. Geneva, 
World Health Organization, 2009. Accessed on March 8, 2021 from 
https://apps.who.int/iris/handle/10665/44240.
    \29\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs. 
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
    \30\ CDC. Health Equity. Accessed on March 12, 2021 from https://www.cdc.gov/chronicdisease/healthequity/index.htm.
    \31\ White House. Executive Order on Advancing Racial Equity and 
Support for Underserved Communities Through the Federal Government. 
Accessed on March 8, 2021 from https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
    \32\ Institute of Medicine. Crossing the Quality Chasm: A New 
Health System for the 21st Century. Accessed on March 8, 2021 from 
https://www.ncbi.nlm.nih.gov/books/NBK222274/.
    \33\ SAMHSA. SAMHSA's Concept of Trauma and Guidance for a 
Trauma-Informed Approach. Accessed on March 8, 2021 from https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma.pdf.
---------------------------------------------------------------------------

    The proposed definition for ``service site'' is adapted from 
previous Title X Family Planning Guidelines that implemented the 2000 
regulations, the 2014 Program Requirements for Title X Funded Family 
Planning Projects (hereafter ``2014 Title X Program 
Requirements'').\34\ ``Service site'' is defined as a clinic or other 
location where Title X services are provided to clients. The Title X 
grantees and/or their subrecipients may have services sites. The 
proposed definition of service site will assist Title X grantees in 
more accurately reporting data on their subrecipient and service sites 
and will eliminate confusion in the OPA Title X clinic locator 
database.
---------------------------------------------------------------------------

    \34\ OPA. 2014 Program Requirements for Title X Funded Family 
Planning Projects. Accessed on March 8, 2021 from https://www.nationalfamilyplanning.org/document.doc?id=1462.
---------------------------------------------------------------------------

    All other proposed definitions are used by Federal Government 
agencies or major medical associations, and include:
    Adolescent-friendly health services are services that are 
accessible, acceptable, equitable, appropriate and effective for 
adolescents.\35\
---------------------------------------------------------------------------

    \35\ World Health Organization. Quality Assessment Guidebook. A 
guide to assessing health services for adolescent clients. Geneva, 
World Health Organization, 2009. Accessed on March 8, 2021 from 
https://apps.who.int/iris/handle/10665/44240.
---------------------------------------------------------------------------

    Client-centered care is respectful of, and responsive to, 
individual client preferences, needs, and values; client values guide 
all clinical decisions.\36\
---------------------------------------------------------------------------

    \36\ CDC. Providing Quality Family Planning Services--
Recommendations from CDC and the U.S. Office of Population Affairs. 
Accessed on March 8, 2021 from https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/quality-family-planning.
---------------------------------------------------------------------------

    Culturally and linguistically appropriate services are respectful 
of and responsive to the health beliefs, practices and needs of diverse 
patients.\37\
---------------------------------------------------------------------------

    \37\ Office of Minority Health. What is Cultural and Linguistic 
Competence? Accessed on March 8, 2021 from https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=1&lvlid=6.
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    Health equity is achieved when every person has the opportunity to 
attain their full health potential and no one is disadvantaged from 
achieving this potential because of social position or other socially 
determined circumstances.\38\
---------------------------------------------------------------------------

    \38\ CDC. Health Equity. Accessed on March 12, 2021 from https://www.cdc.gov/chronicdisease/healthequity/index.htm.
---------------------------------------------------------------------------

    Inclusivity ensures that all people are fully included and can 
actively participate in and benefit from family planning, including, 
but not limited to, individuals who belong to underserved communities, 
such as Black, Latino, and Indigenous and Native American persons, 
Asian Americans and Pacific Islanders and other persons of color; 
members of religious minorities; lesbian, gay, bisexual, transgender, 
and queer (LGBTQ+) persons; persons with disabilities; persons who live 
in rural areas; and persons otherwise adversely affected by persistent 
poverty or inequality.\39\
---------------------------------------------------------------------------

    \39\ White House. Executive Order on Advancing Racial Equity and 
Support for Underserved Communities Through the Federal Government. 
Accessed on March 8, 2021 from https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.

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[[Page 19819]]

    Quality healthcare is safe, effective, client-centered, timely, 
efficient, and equitable.\40\
---------------------------------------------------------------------------

    \40\ Institute of Medicine. Crossing the Quality Chasm: A New 
Health System for the 21st Century. Accessed on March 8, 2021 from 
https://www.ncbi.nlm.nih.gov/books/NBK222274/.
---------------------------------------------------------------------------

    Trauma-informed is a program, organization, or system that realizes 
the widespread impact of trauma and understands potential paths for 
recovery; recognizes the signs and symptoms of trauma in clients, 
families, staff, and others involved with the system; and responds by 
fully integrating knowledge about trauma into policies, procedures, and 
practices, and seeks to actively resist re-traumatization.\41\
---------------------------------------------------------------------------

    \41\ SAMHSA. SAMHSA's Concept of Trauma and Guidance for a 
Trauma-Informed Approach. Accessed on March 8, 2021 from https://ncsacw.samhsa.gov/userfiles/files/SAMHSA_Trauma.pdf.
---------------------------------------------------------------------------

    The Department also proposes a technical corrections to Sec.  59.2 
to replace ``grantee'' with ``recipient'' in the regulatory text to 
align with the way the term is used in Federal and HHS regulations.

B. Section 59.5 What requirements must be met by a family planning 
project?

    The Department proposes revising Sec.  59.5(a)(1) to define what 
constitutes a broad range of acceptable and effective family planning 
methods and services. The proposed revision revises the 2000 
regulations by removing the existing ambiguity and defining what 
constitutes a broad range of acceptable and effective family planning 
methods and services. The revised definition of the broad range of 
methods and services is aligned with the definition used in practice/
policy guidance. Moreover, the same definition is included in CDC and 
OPA's Recommendations for Providing Quality Family Planning 
Services.\42\ This revision will result in increased equitable access 
to a broad range of family planning methods and services to all Title X 
clients and more clarity in defining those services.
---------------------------------------------------------------------------

    \42\ CDC (2014). Providing Quality Family Planning Services, 
Recommendations of CDC and the U.S. Office of Population Affairs. 
MMWR, 63(4).
---------------------------------------------------------------------------

    The Department proposes revising Sec.  59.5(a)(1) to require 
service sites that do not offer a broad range of family planning 
methods and services on-site to provide clients with a referral for 
where they can access the broad range and ensure, when feasible, that 
the referral provided does not unduly limit client access to services, 
such as excessive distance or travel time to the referral location or 
referral to services that are cost-prohibitive for the client. While an 
organization that offers only a single method of family planning may 
participate as part of a Title X project as long as the entire project 
offers a broad range of family planning services, offering only a 
single method of family planning could unduly limit Title X clients, 
especially low-income clients, by reducing access to a client's method 
of choice. The Department proposes revising the 2000 regulations to 
require sites that do not offer the broad range of methods on-site to 
be able to provide clients with a referral to a provider who does offer 
the client's method of choice. In addition, the referral provided must 
be client-centered and not unduly limit access to the client's method 
of choice. This revision will help to improve access to client-centered 
services.
    The Department proposes to revise Sec.  59.5(a)(3) so that family 
planning services are required to be client-centered, culturally and 
linguistically appropriate, inclusive, trauma-informed, and ensure 
equitable and quality service delivery consistent with nationally 
recognized standards of care. This revision to the 2000 regulations is 
aimed at increasing access and ensuring equity in all services 
provided, which is especially important for the Title X program that 
prioritizes services for low-income clients. Including within the 
regulation a specific focus on services that are client-centered, 
culturally and linguistically appropriate, inclusive, trauma-informed, 
and ensure equitable and quality service delivery will result in 
improved services provided to clients. These new terms are defined in 
the proposed regulation under Sec.  59.2, and the added definitions 
were derived from existing definitions in use by the Federal Government 
or major medical associations.
    The Department proposes revising Sec.  59.5(a)(8) to include widely 
accepted practices on grant billing practices that were included in 
previous Title X Family Planning Guidelines. These revisions 
incorporate language that was included in the 2014 Title X Program 
Requirements. The 2014 Title X Program Requirements were developed to 
assist grantees in understanding and implementing the family planning 
services grants. The 2014 Title X Program Requirements described the 
various requirements applicable to the Title X program, as set out in 
the Title X statute and implementing regulations, and in other 
applicable Federal statutes, regulations, and policies. These billing 
practices, which are widely accepted in the Title X community, indicate 
that: (1) Family income should be assessed before determining whether 
copayments or additional fees are charged; and (2) insured clients 
whose family income is at or below 250% FPL should not pay more (in 
copayments or additional fees) than what they would otherwise pay when 
the schedule of discounts is applied. These revisions address areas of 
confusion for grantees prior to the 2014 Title X Program Requirements 
that were clarified in that document.
    The Department proposes adding Sec.  59.5(a)(9) to ensure grantee 
income verification policies align with the mission of Title X services 
being prioritized for low-income clients. This addition aims to address 
an area of common confusion among Title X grantees, which has resulted, 
in some instances, in a burden being placed on low-income clients. 
First, a requirement is added (using text from the previous 2014 Title 
X Program Requirements) to indicate that grantees should take 
reasonable measures to verify client income. In addition, a new 
requirement is added to use client self-reported income if the income 
cannot be verified after reasonable attempts. Without this additional 
statement, several Title X grantees have established policies to charge 
full price for services following unsuccessful attempts to verify 
income, even when the self-reported income is below 250% of the Federal 
poverty level (FPL) and would have otherwise qualified for no or 
reduced cost services. This proposed revision will greatly improve 
accessibility and affordability of services for low-income clients 
consistently across all Title X grantees.
    The Department proposes adding Sec.  59.5(a)(12) to retain some, 
but not all, language from the 2019 Final Rule on notification or 
reporting of child abuse, child molestation, sexual abuse, rape, 
incest, intimate partner violence or human trafficking. The 
notification and reporting requirements are important for Title X 
providers as mandatory reporters under state laws and protect Title X 
clients. In addition, this regulation formalizes requirements contained 
in an annual appropriations rider related to Title X that Congress has 
included since FY 1999, requiring that, ``[n]otwithstanding any other 
provision of law, no provider of services under Title X of the PHS Act 
shall be exempt from any State law requiring notification or the 
reporting of child abuse, child molestation, sexual abuse, rape, or 
incest.''
    The Department proposes adding Sec.  59.5(a)(13) to describe 
requirements

[[Page 19820]]

related to subrecipient monitoring and reporting. This addition 
requires Title X grantees to report on the subrecipients and referral 
agencies involved in their Title X projects, and to provide their plan 
for oversight and monitoring of their subrecipients in grantee reports. 
The regulation no longer requires grantees to report detailed 
information about each subrecipient and referral agency such as 
location and specific expertise, which will reduce the increased 
reporting burden required by the 2019 Final Rule.
    The Department proposes revising Sec.  59.5(b)(1) to acknowledge 
that consultation for medical services related to family planning can 
be provided by healthcare providers beyond the physician. The proposed 
revision acknowledges that consultation for healthcare services related 
to family planning may be by a physician, but may also be by other 
healthcare providers, including physician assistants and nurse 
practitioners.
    The Department proposes revising Sec.  59.5(b)(3)(iii) to reflect 
the desire to engage diverse individuals to make services accessible. 
This revision adds language to clarify the intent at engaging diverse 
individuals to ensure access to equitable, affordable, client-centered, 
quality family planning services.
    The Department proposes revising Sec.  59.5(b)(8) to add language 
to the existing 2000 regulation text to include primary healthcare 
providers in the list of referrals and to state that referrals are to 
be to providers in close proximity when feasible to the Title X site in 
order to promote access to services and provide a seamless continuum of 
care.
    The Department also proposes including several technical 
corrections to Sec.  59.5. The technical correction proposed in 
Sec. Sec.  59.5(a)(4) and 59.6(b)(2) replaces the word ``handicapped 
condition'' with ``disability'' in both sections in order to avoid 
negative connotations and correct outdated terminology. The technical 
correction proposed to Sec.  59.5(a)(5) replaces the word ``women'' 
with ``client'', and the technical correction proposed to Sec.  
59.5(a)(6) and (7) replaces the word ``persons'' with ``clients'' to 
use inclusive language. The technical correction proposed to Sec.  
59.5(a)(11) replaces the term ``sub-grantees'' with ``subrecipients''. 
The technical correction proposed to Sec.  59.5(b)(3) clarifies that 
focus of this section is on community education, participation, and 
engagement, and should not be confused with the Information and 
Education Advisory Committee requirement under Sec.  59.6.

C. Section 59.6 What procedures apply to ensure the suitability of 
informational and educational material?

    The Department proposes deleting prior Sec.  59.5(a)(11) related to 
the Advisory Committee and consolidating with Sec.  59.6; and revising 
Sec.  59.6 to clarify intent and remove areas of confusion for grantees 
regarding the Advisory Committee and other miscellaneous other 
provisions. The 2000 regulations included information about the 
Information & Education Advisory Committee in two sections (Sec. Sec.  
59.5(a)(11) and 59.6, which was confusing to Title X grantees. The 
result is that this revision consolidates all of the Advisory Committee 
information in one place, under section Sec.  59.6.
    In addition, the Department is proposing several minor revisions to 
clarify that the regulation applies to both print and electronic 
materials, that the upper limit on council members should be determined 
by the grantee, that the factors to be considered for broad 
representation on the Advisory Committee match the definition of 
inclusivity earlier in the regulation, and that materials will be 
reviewed for medical accuracy, cultural and linguistic appropriateness, 
and inclusivity and to ensure they are trauma-informed.

D. Section 59.7 What criteria will the Department of Health and Human 
Services use to decide which family planning services projects to fund 
and in what amount?

    The Department proposes enabling the Department to consider the 
ability of the applicant to advance health equity when awarding grant 
funds. Advancing health equity is critical to the mission of the Title 
X program. Adding this additional criterion to the 2000 regulations 
brings the total number of criteria from seven to eight.

E. Section 59.8 How is a grant awarded?

    The Department proposes a technical correction to revise Sec.  59.8 
to change ``project period'' to ``anticipated period'' since HHS is in 
the process of adopting revised definition and project period will no 
longer be used.

F. Section 59.10 Confidentiality.

    The Department proposes revising Sec.  59.10 to include a widely 
accepted practice related to client confidentiality. This proposed 
revision will add a widely accepted practice in the Title X community 
that had been previously included in the 2014 Title X Program 
Requirements, indicating that reasonable efforts must be made to 
collect charges without jeopardizing client confidentiality. The 
Department believes that the Title X program will be strengthened by 
including this clarification within the revised 2000 regulations.
    In addition, the Department proposes adding a requirement that 
grantees must inform the client of any potential for disclosure of 
their confidential health information to policyholders where the 
policyholder is someone other than the client. Since state and local 
laws may vary across jurisdictions (e.g., some are likely to result in 
notification to the policyholder that the client has received services, 
others provide for an ``opt out'' process whereby the client can elect 
that such a notification will not be made), this addition will ensure 
that the client understands the implications for using their insurance 
and the options available for them to maintain confidentiality.

G. Section 59.11 Additional Conditions

    The Department proposes revising Sec.  59.11 to add ``during'' the 
period of the award to allow for imposition of additional conditions, 
during the period of award in addition to ``prior to and at the time of 
any award'', under circumstances where recipient performance or 
organizational risk change, e.g. if a recipient is failing to perform 
we may impose new conditions mid-award to require corrective action per 
45 CFR 75.207.

H. Section 59.12 What other HHS regulations apply to grants under this 
subpart?

    The Department proposed a technical correction to Sec.  59.12 to 
update the regulations that apply to 42 CFR part 59, subpart A. The 
proposal includes a reference to 45 CFR part 87 (``Equal Treatment for 
Faith-based Organizations'') on the list of regulations that apply to 
the Title X family planning services program.

V. Regulatory Impact Analyses

A. Introduction

    HHS has examined the impacts of the proposed rule under Executive 
Order 12866 on Regulatory Planning and Review, Executive Order 13563 on 
Improving Regulation and Regulatory Review, Executive Order 13132 on 
Federalism, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 
12866 and 13563 direct HHS to assess all costs and benefits of 
available regulatory alternatives and, when regulation is

[[Page 19821]]

necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). HHS believes 
that this proposed rule is not an economically significant regulatory 
action as defined by Executive Order 12866 because it would not result 
in annual effects in excess of $100 million.
    The Regulatory Flexibility Act requires HHS to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. The proposed rule, if finalized, would lessen administrative 
burdens for grantees of all sizes. Therefore, the Secretary certifies 
this proposed rule, if finalized, would not have a significant economic 
impact on a substantial number of small entities under the Regulatory 
Flexibility Act, 5 U.S.C. 605.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded 
Mandates Act) (2 U.S.C. 1532) requires HHS to prepare a written 
statement, which includes an assessment of anticipated costs and 
benefits, before proposing ``any rule that includes any Federal mandate 
that may result in the expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $158 
million, using the most current (2020) Implicit Price Deflator for the 
Gross Domestic Product. This proposed rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct requirement costs on State and local governments or has 
federalism implications. The proposed rule will not have a significant 
impact on state funds as, by law, project grants must be funded with at 
least 90 percent Federal funds. 42 U.S.C. 300a-4(a). The Department has 
determined that this proposed rule does not impose such costs or have 
any federalism implications. The Department expects that while some 
states may not support the policies contained in this proposed rule, 
many states and local health departments will support the policies 
contained in this proposed rule, and that it will increase 
participation by states (many of who dropped out under the 2019 rule).

B. Summary of Costs, Benefits and Transfers

    This proposed rule would revise the 2019 Final Rule by readopting 
the 2000 regulations, with several modifications, and returning the 
program to the compliance regime as it existed prior to the 2019 rule's 
implementation. The proposed approach would allow the Title X program 
grantees, subrecipients, and service sites to have a greater impact on 
public health than under the current regulatory approach.
    We predict that this proposed rule would increase the number of 
grantees receiving Title X funds. In turn, the additional service sites 
supported by funding would result in additional clients served under 
the program. These clients receive access to contraception, public 
health screening including clinical breast exams and Papanicolau (Pap) 
testing, and testing for sexually transmitted infections. These 
services result in a reduction in unintended pregnancy, earlier 
detection of breast and cervical cancer, and earlier detection of 
sexually transmitted infections including chlamydia, gonorrhea, 
syphilis, and human immunodeficiency virus (HIV). This screening and 
testing can result in significant cost savings from earlier treatment 
and other interventions. This proposed rule would also increase the 
diversity of grantees receiving funds, including geographic diversity 
to states that do not currently have a Title X grantee.
    The proposed rule would also focus grantees on providing services 
in a manner that is client-centered, culturally and linguistically 
appropriate, inclusive, and trauma-informed; protects the dignity of 
the individual; and ensures equitable and quality service delivery. 
This focus is especially important for the Title X program that 
prioritizes services for low-income clients.
    This regulatory impact analysis reports the activity occurring at 
Title X funded sites to provide policymakers with this information. 
However, the direct impact within the program does not account for 
services that continue to be provided at sites not receiving Title X 
funding, filling the gap left by providers that withdrew from the 
program following the restrictions placed on funding included in the 
2019 Final Rule.

C. Preliminary Economic Analysis of Impacts

a. Background
    The Title X National Family Planning Program, administered by the 
U.S. Department of Health and Human Services (HHS), Office of 
Population Affairs (OPA), is the only Federal program dedicated solely 
to supporting the delivery of family planning and related preventive 
healthcare. The program is designed to provide ``a broad range of 
acceptable and effective family planning methods and services 
(including natural family planning methods, infertility services, and 
services for adolescents)'' with priority given to persons from low-
income families. In addition to offering these methods and services on 
a voluntary and confidential basis, Title X-funded service sites 
provide contraceptive education and counseling; breast and cervical 
cancer screening; sexually transmitted infections (STIs) and HIV 
testing, referral, and prevention education; and pregnancy diagnosis 
and counseling. The program is implemented through competitively 
awarded grants to state and local public health departments and family 
planning, community health, and other private nonprofit agencies. In 
fiscal year 2021, the Title X program received approximately $286.5 
million in discretionary Federal Title X funding.
    On March 4, 2019, HHS published a final rule to ``prohibit family 
planning projects from using Title X funds to encourage, promote, 
provide, refer for, or advocate for abortion as a method of family 
planning; require assurances of compliance; eliminate the requirement 
that Title X projects provide abortion counseling and referral; require 
physical and financial separation of Title X activities from those 
which are prohibited under section 1008; provide clarification on the 
appropriate use of funds in regard to the building of infrastructure, 
and require additional reporting burden from grantees.''
b. Market Failure or Social Purpose Requiring Federal Regulatory Action
    The regulatory impact analysis associated with the 2019 Final Rule 
predicted that the additional restrictions on grantees would result in 
``an expanded number of entities interested in participating in Title 
X.'' Further, the analysis suggested the 2019 Final Rule would result 
in ``enhanced patient service and care.'' Contrary to these 
predictions, during the initial period of the 2019 Final Rule's 
implementation, the policy appears to have had the opposite effect. As 
we describe in greater detail in the Baseline Section, the restrictions 
included in the 2019 Final Rule are associated with a substantial 
reduction in the number of Title X grantees, subrecipients, and service 
sites, resulting in a

[[Page 19822]]

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

                                       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 included all grantees, 
subrecipients, and service sites operating at any time during the year. 
The adoption of the 2019 Title X Final Rule occurred mid-year in 2019. 
Following this regulation, 19 grantees, 231 subrecipients, and 945 
service sites withdrew from the Title X program. The reduced number of 
grantees, subrecipients, services sites, and clients served observed in 
2019 and 2020 cannot be explained by a reduction in discretionary 
funding for the program, which has remained constant at $286.5 million 
throughout this time period. Since the 2019 figure includes clients 
served by these service sites for about half of the year, adopting 3.1 
million clients served as an annual forecast would likely overstate 
activity in the program under the current regulations. Indeed, 
preliminary figures for FY2020 indicate that only about 1.5 million 
clients were served. However, this figure likely represents an 
underestimate for a typical year of the program under the current 
regulations since services were likely disrupted by the ongoing public 
health emergency.
    As our primary estimate, we adopt 2,512,066 clients served as the 
baseline annual impact of Title X under the policies of the 2019 Final 
Rule. This 2.5 million corresponds to the number of clients served in 
2019 among remaining grantees as of March 2021. For comparison, this 
primary estimate represents a 37% reduction in clients served compared 
to the average of clients served from 2016 to 2018. In the Uncertainty 
and Sensitivity Analysis Section, we adopt the 1.5 million client 
figure as a lower-bound estimate, and 3.1 million clients as an upper-
bound estimate of the annual program impact under the baseline.
    Table D2 summarizes our baseline forecast for the same categories 
of historical data presented in Table D1. We adopt the current count 
for grantees, subrecipients, and services sites. We assume these 
figures will be constant over time horizon of this analysis.

             Table D2--Baseline Forecast of Title X Services
------------------------------------------------------------------------
                    Baseline forecast                         Annual
------------------------------------------------------------------------
Grantees................................................              73
Subrecipients...........................................             803
Service Sites...........................................           2,682
Clients Served..........................................       2,512,066
------------------------------------------------------------------------

    In addition to the reduction in grantees, subrecipients, service 
sites, and total client served, we note that six states currently have 
no Title X services, including HI, ME, OR, UT, VT, and WA. There are 
six additional states that have limited Title X services, including AK, 
CT, MA, MN, NH, and NY.\43\
---------------------------------------------------------------------------

    \43\ As noted earlier, seven states (CO, DE, KY, ND, NM, NV, TX) 
experienced a meaningful increase in the number of Title X clinics 
after the 2019 regulatory change.
---------------------------------------------------------------------------

    In line with the reduction in clients served under the 2019 Final 
Rule, data also reveal a significant drop in services provided For 
example, when comparing 2019 figures to 2018, 225,688 fewer clients 
received oral contraceptives; 49,803 fewer clients received hormonal 
implants; and 86,008 fewer clients received intrauterine devices 
(IUDs). For oral contraceptives and IUDs, this was a 27% reduction; and 
for hormonal implants, a 21% reduction. These percentages are similar 
in magnitude to the 21% reduction in clients served in 2019 compared to 
2018. Additionally, 90,386 and 188,920 fewer Pap tests and clinical 
breast exams, respectively, were performed in 2019 compared to 2018. 
Confidential HIV tests decreased by 276,109. Testing for sexually 
transmitted infections (STIs) decreased by 256,523 for chlamydia, by 
625,802 for gonorrhea, and by 77,524 for syphilis.
    For our forecast of services provided under our baseline scenario, 
we adopt the most recent percentage of clients receiving each service 
in the 2019 Title X Family Planning Annual Report. For example, in 
2019, about 23% of female clients received a clinical breast exam. We 
assume the same share of clients will be served by Title X for 
screening and sexually transmitted infection testing. Table D3 reports 
our best estimate of the annual services provided under the baseline 
scenario. We describe these services in greater detail later in this 
Section.

  Table D3--Baseline Title X Cancer Screening and Sexually Transmitted
                            Infection Testing
------------------------------------------------------------------------
                          Year                                Annual
------------------------------------------------------------------------
Clinical Breast Exams...................................         509,550
Pap Tests...............................................         443,087
Chlamydia Test..........................................       1,266,508
Gonorrhea Test..........................................       1,420,198
Syphilis Test...........................................         536,619

[[Page 19823]]

 
Confidential HIV Test...................................         777,536
------------------------------------------------------------------------
Source: Calculations based on Title X Family Planning Annual Report,
  2019: Exhibits 26 and 29.

    We predict that the main effect of the proposed rule would be to 
return to Title X program impact levels observed prior to the 2019 
Final Rule. Our estimates of the long-run equilibrium of grantees, 
subrecipients, service sites, and total client served are informed by 
the data from fiscal years 2016-2018, the last three years of data that 
are unaffected by the drops experienced following the 2019 Final Rule. 
Specifically, we adopt the average across these three years as our 
long-run estimates. These averages are 93 grantees, 1,112 
subrecipients, 3,903 service sites, and about 4.0 million clients 
served.
    To complete our forecast of the policy scenario, we assume that it 
will take two years for program participation and clients served to 
achieve the long-run equilibrium estimates. This two-year phase-in is 
consistent with a scenario in which most service sites that withdrew 
from the Title X program have remained open, with some operating at a 
lower capacity, than they did prior to the 2019 Final Rule. It is also 
consistent with an expectation that many of the grantees and service 
sites that withdrew from the program would be able to rejoin if this 
proposed rule were finalized. In year one, following the effective date 
of the proposed rule, the number of clients served would increase to 
about 3.2 million. In year two, this number would increase again to 
about 4.0 million and remain there for the duration of our analysis. 
These figures are presented in Table D4. We acknowledge uncertainty in 
this estimate, and include a discussion in the Uncertainty and 
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 proposed rule, we compare the 
policy scenario forecast to the baseline forecast described in the 
previous section. Table D5 reports the difference between these two 
scenarios, which represents the net effect of the proposed rule. For 
example, in year 1 after this rule is effective, the number of clients 
served would be about 736,000 higher than under the baseline scenario. 
Approximately 88% of clients served in 2016-2018 are female, and we use 
this percentage to estimate the increase in clients served 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 program experience outcomes that 
include reducing unintended pregnancy through greater access to 
contraception. The averted unintended pregnancies translate to a 
reduction in unplanned births, a reduction in abortions, and reduction 
in miscarriages. Also, Title X clients receive cancer screenings and 
testing for sexually transmitted infections. These screenings and 
testing can identify treatable conditions, improving the quality of 
life and extending the lives of beneficiaries. In the case of sexually 
transmitted infections, additional testing can reduce the likelihood of 
further infections and future infertility. This proposed rule would 
expand service to socioeconomically disadvantaged populations, most of 
whom are female, low income, and young. We discuss this in greater 
detail in the Section on Distributional Effects.
    To further explore the likely effect of the Title X program on 
unintended pregnancy, we rely on existing methodology for estimating 
number of unintended pregnancies prevented each year among U.S. women 
who depend on publicly funded family planning services.\44\ Among this 
subgroup of women who use any method of contraception, 46 in 1,000 
women are expected to experience an unintended pregnancy. This figure 
can be compared to 296 unintended pregnancies per 1,000 women who are 
unable to access public family planning services. We apply this 
estimate of a reduction of 250 unintended pregnancies per 1,000 
contraception clients to the number of additional female clients served 
under the Title X program who adopt any method of contraception.
---------------------------------------------------------------------------

    \44\ Jennifer J. Frost and Lawrence B. Finer (2017). Memo 
entitled ``Unintended pregnancies prevented by publicly funded 
family planning services: Summary of results and estimation 
formula.'' https://www.guttmacher.org/sites/default/files/pdfs/pubs/Guttmacher-Memo-on-Estimation-of-Unintended-Pregnancies-Prevented-June-2017.pdf. Accessed on March 14, 2021.
---------------------------------------------------------------------------

    For year 1, we multiply 735,892 clients by 88% to yield 648,996 
clients who are women. Among female clients, approximately 14% indicate 
they are not using a method of contraception, according to figures in 
the 2019 Title X Family Planning Annual Report. We reduce the potential 
number of clients that would potentially reduce the likelihood of an 
unintended pregnancy by 14% to yield 558,205 clients expected to 
benefit from a contraceptive method. Approximately 47% of unintended 
pregnancies result in

[[Page 19824]]

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

    \45\ Jennifer J. Frost, Lori F. Frohwirth, Nakeisha Blades, Mia 
R. Zolna, Ayana Douglas-Hall, and Jonathan Bearak (2017). ``Publicly 
Funded Contraceptive Services at U.S. Clinics, 2015. https://www.guttmacher.org/sites/default/files/report_pdf/publicly_funded_contraceptive_services_2015_3.pdf. Accessed on March 
14, 2021.

                    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 pregnancies increase the risk for poor 
maternal and infant outcomes. Women who give birth following an 
unintended or unplanned pregnancy are less likely to have benefitted 
from preconception care, to have optimal spacing between births, and to 
have been aware of their pregnancy early on, which in turn makes it 
less likely that they would have received prenatal care early in 
pregnancy.46 47
---------------------------------------------------------------------------

    \46\ Jessica D. Gipson, Michael A. Koenig, and Michelle J. 
Hindin. ``The Effects of Unintended Pregnancy on Infant, Child, and 
Parental Health: A Review of the Literature.'' Studies in family 
planning 39.1 (2008): 18-38. Web.
    \47\ Power to Decide. Maternal and Infant Health and the 
Benefits of Birth Control in America. Accessed on March 8, 2020 from 
https://powertodecide.org/sites/default/files/resources/supporting-materials/getting-the-facts-straight-chapter-3-maternal-infant-health.pdf.
---------------------------------------------------------------------------

    Title X funding recipients also perform preventive health services 
such as cervical and breast cancer screening, and testing for sexually 
transmitted infections, including chlamydia, gonorrhea, syphilis, and 
HIV. Table D6 presents the effect of the proposed rule on Title X-
associated cervical and breast cancer screenings. These figures are 
calculated by multiplying the number of additional women served by the 
program in each year by about 23% for clinical breast exams, of which 
5% result in a referral for further evaluation; and 20% for Pap 
testing, of which 13% with a result of atypical squamous cells (ASC) 
that require further evaluation and possibly treatment, and 1% of which 
have a high-grade squamous intraepithelial lesion (HSIL) \48\ or 
higher, indicating the presence of a more severe condition.
---------------------------------------------------------------------------

    \48\ HSIL is the abnormal growth of certain cells on the surface 
of the cervix.
---------------------------------------------------------------------------

    Clinical breast exams can identify women requiring further 
evaluation of an abnormal finding. Pap test (or pap smear test) results 
can indicate viral infections that, when untreated, can turn into 
cervical cancer. The Pap test results can also detect cervical cancer 
cells. At a population level, these screenings save lives by helping 
women identify cancer earlier, and preventing other conditions from 
developing into 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 proposed rule on Title X-
associated testing for sexually transmitted infections among female 
clients. These are calculated by adopting estimates that 49% of women 
are tested for chlamydia; 55% for gonorrhea; 19% for syphilis; and 28% 
for HIV. Table D6 presents the same information for men. The share of 
male clients tested for these infections are the following: 61% for 
chlamydia, 68% for gonorrhea, 39% for syphilis, and 53% for HIV.

               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

[[Page 19825]]

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

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

             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 Title X likely result in 
reduced costs to taxpayers as a result of a reduction in unintended 
pregnancies, pre-term and low-birthweight births, sexually transmitted 
infections, infertility, and cervical cancer. This report \49\ 
estimates that each dollar spent on these services results in a net 
Government saving of $7.09. We do not replicate the calculations, but 
note that they are derived from cost savings associated with averting 
unintended pregnancy and complications such as pre-term and low birth-
weight births. These cost savings are also derived from detecting and 
treating sexually transmitted infections that would have resulted in 
more serious outcomes, including infertility, cancer, and death.
---------------------------------------------------------------------------

    \49\ Jennifer J. Frost, Adam Sonfield, Mia R. Zolna, and 
Lawrence B. Finer (2014). ``Return on Investment: A fuller 
assessment of the benefits and costs of the US publicly funded 
family planning program'' Milbank Quarterly 2014 Dec;92(4):696-749.
---------------------------------------------------------------------------

    In addition to the effects described above, this proposed rule 
would also enhance the equity and dignity associated with access to 
family planning services provided by Title X. A recent research brief 
summarized interviews with 30 women sharing their experiences with 
contraceptive access, providing suggestive evidence that birth control 
has an important positive impact on women's lives. Interviewees noted 
that birth control allowed women to ``to pursue academic and 
professional goals, achieve financial stability, and maintain their 
mental and physical health.'' \50\ These recent interviews are 
consistent with the historical experience of the importance of birth 
control. For example, one econometric study identifies a causal 
relationship between the introduction and diffusion of the birth 
control pill and the increase in women enrolling in professional degree 
programs and increasing the age at first marriage.\51\ Title X services 
help connect women with the free contraception provided by the 
Affordable Care Act, which allows them to experience these and other 
positive outcomes associated with access to contraception.
---------------------------------------------------------------------------

    \50\ Rebecca Peters, Sarah Benetar, Brigette Courtot, and Sophia 
Yin (2019). ``Birth Control is Transformative.'' Urban Institute. 
https://www.urban.org/sites/default/files/publication/99912/birth_control_is_transformative_1.pdf. Accessed April 6, 2021.
    \51\ Goldin, Claudia and Lawrence F. Katz (2002). ``The power of 
the pill: Oral contraceptives and women's career and marriage 
decisions.'' Journal of Political Economy 110(4): 730-770.
---------------------------------------------------------------------------

    Researchers have identified other economic, social, and health 
impacts of increased access to family planning, contraception, and 
treatment. For example, Bailey et al. (2019) finds ``that children born 
after the introduction of Federal family planning programs were 7 
percent less likely to live in poverty and 12 percent less likely to 
live in households receiving public assistance.'' They perform an 
additional bounding analysis, which suggests that about two thirds of 
the estimated gains are due to increases in the incomes of parents.\52\ 
A recent summary discusses other impacts of access to family planning 
services in the United States and in other countries, which extends 
beyond women and girls, to their children and wider communities.\53\
---------------------------------------------------------------------------

    \52\ Bailey, Martha J., Olga Malkova, Zo[euml] M. McLaren 
(2019). ``Does Access to Family Planning Increase Children's 
Opportunities? Evidence from the War on Poverty and the Early Years 
of Title X.'' Journal of Human Resources 54:4 pp. 825-856. 
doi:10.3368/jhr.54.4.1216-8401R1.
    \53\ Emily Sohn (2020). ``Strengthening society with 
contraception.'' Nature 588, S162-S164.
---------------------------------------------------------------------------

    The calculations above represent observable metrics of the effect 
of the Title X program, which is important for evaluating the direct 
effect of the program. For this reason, the scope of our analysis 
initially focuses on clients served and services provided by Title X 
facilities. To properly account for the net effect of the proposed rule 
when comparing the baseline scenario to the policy scenario, we would 
need to assess the extent to which clients and services continue to be 
provided through other channels than Title X funded sites without the 
proposed rule. As a general matter, the impacts of this proposed rule 
may include:
     Transfers between grantees and would-be grantees within 
the Title X program;
     other transfers (for example, if Title X newly funds 
medical services that would, in the absence of the proposed rule, be 
provided by charitable

[[Page 19826]]

organizations or other private payers); and
     societal benefits and costs to the extent that the volume 
or characteristics (such as location, which determines travel costs) of 
medical services would differ with and without the proposed rule.
    As noted earlier in this preamble, all Planned Parenthood 
affiliates--which, in 2015, served 41 percent of all contraceptive 
clients at Title X-funded service sites--withdrew from Title X due to 
the 2019 Final Rule. However, a comparison of Planned Parenthood's two 
most recent annual financial reports indicates no subsequent decrease 
in the number of patients served and an increase, from 9.8 million to 
10.4 million, in the number of services provided per annum (pre-
pandemic).\54\ Although such year-to-year comparisons are simplistic 
and a focus on just one organization (even a prominent one, with 
extensive activities) has obvious limitations, this evidence may 
suggest that the Title X program impacts quantified elsewhere in this 
regulatory impact analysis may largely be associated with transfers. 
Although there are notable challenges with quantifying the benefit, 
cost and transfer impacts of the proposed rule, we request comment that 
might facilitate refinement of the analysis prior to regulatory 
finalization.
---------------------------------------------------------------------------

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

e. Further Discussion of Distributional Effects
    The Title X program is designed to provide services with priority 
given to persons from low-income families. According to the most recent 
data, 64% of clients have income under 101% of the Federal poverty 
level; 14% between 101% and 150%; 7% between 151% to 200%; 3% between 
201% and 250%; 7% over 250%; and 5% have an unknown or unreported 
income level. Among program clients, 33% are Hispanic or Latino of all 
races; 3% are Asian and Not Hispanic or Latino; 22% are Black or 
African American and Not Hispanic or Latino; 32% are White and Not 
Hispanic or Latino; and 5% are Other or Unknown and Not Hispanic or 
Latino; and 4% are Unknown or not Reported. Furthermore, the Title X 
statutory directive requires Title X projects to provide services for 
adolescents without required parental consent. This makes Title X a 
critical source of sexual and reproductive healthcare for young people. 
In 2019, 2% program clients were younger than 15, and 8% were younger 
than 18. Additional information about the number and distribution of 
all family planning clients by age and year are available in Exhibit A-
3a of the 2019 Title X Annual Report. The benefits of revoking the 2019 
Final Rule would likely accrue roughly in proportion with these income 
and race and ethnicity figures. The costs of revoking the 2019 Final 
Rule would likely accrue proportional to the income and other 
demographics of the general public.
    This proposed rule would also likely have important geographic 
effects. As described in greater detail in the Baseline Section, 6 
States currently have no Title X services, and 6 additional states have 
limited Title X services. This proposed rule would likely result in 
restoration of services to individuals in these States.
f. Uncertainty and Sensitivity Analysis
    All of the major drivers of the quantified effects of this analysis 
are dependent on our forecast of the baseline number of clients served. 
We acknowledge the uncertainty in this baseline and have performed a 
sensitivity analysis to quantify its importance. For our primary 
baseline, we chose 2.5 million annual clients of Title X services, 
which corresponds to the number of clients in fiscal year 2019 among 
remaining grantees. As a sensitivity analysis, we investigate the 
effect of the proposed rule compared to a baseline with 1.5 million 
clients, corresponding to preliminary estimates for fiscal year 2020. 
For comparison, we also looked at the effects using an upper bound of 
3.1 million clients served, which is the reported figure for 2019, but 
which includes 19 grantees, 231 subrecipients, and 945 service sites 
that withdraw from the Title X program following the 2019 Final Rule.
    Table F1 presents the number of clients served under different 
assumptions of the baseline. We also recalculate the number of clients 
served for the proposed rule scenario for each of the baseline 
assumptions. Since the number of clients served in the first year is 
the midpoint between the baseline and long-run equilibrium figure, the 
number of clients served in fiscal year 2022 under the proposed rule 
would be lower for the lower-bound scenario than the primary baseline. 
Similarly, the number of clients served under the proposed rule would 
be higher in the 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 proposed rule under different 
baseline assumptions. These estimates are reported by year, as well as 
in present value and annualized for the 5-year time horizon of our 
analysis, applying a 3% and a 7% discount rate. Under the lower-bound 
baseline scenario, the proposed rule would have about a 66% greater 
impact on the number of clients served in annualized terms under the 
primary baseline scenario. Under the upper-bound baseline scenario, the 
proposed rule would have about a 64% lesser impact.

[[Page 19827]]



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

                          Table F3--Title X Clients With Different Phase-In Assumptions
----------------------------------------------------------------------------------------------------------------
                                                                  Proposed rule,                  Proposed rule,
                      Year                           Baseline      2-year  phase  Proposed rule,   3-year  phase
                                                                        in          no phase in         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 proposed rule with different 
phase-in assumptions. These estimates are reported by year, as well as 
in present value and annualized for the 5-year time horizon of our 
analysis, applying a 3% and a 7% discount rate. Compared to our primary 
estimates, the assumption of no phase in yields annualized effects of 
the proposed rule that are about 12% higher. Assuming a 3-year phase in 
yields annualized effects that are about 12% lower than the primary 
estimates.

                    Table F4--Effect of the Proposed Rule With Different Phase-In Assumptions
----------------------------------------------------------------------------------------------------------------
                                                                  Proposed rule,                  Proposed rule,
                              Year                                 2-year  phase  Proposed rule,   3-year  phase
                                                                        in          no phase in         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 the Proposed Rule
    We analyzed two alternatives to the approach under the proposed 
rule. We considered one option to maintain many elements of the 2019 
Final Rule and to impose additional restrictions on grantees. This 
approach would exacerbate the trends of reduced Title X grantees, 
subrecipients, service sites, and clients served that we have observed 
under the 2019 Final Rule. Second, we considered revising the 2019 
Final Rule by readopting many elements of the 2000 regulations, but 
adopting additional flexibilities for grantees and reducing 
programmatic oversight. However, our experience suggests the compliance 
regime as it existed prior to the 2019 Final Rule was effective.

VI. Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an

[[Page 19828]]

environmental assessment nor an environmental impact statement is 
required.

VII. Paperwork Reduction Act

    This proposed rule contains information collection requirements 
(ICRs) that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995. A description 
of these provisions is given in the following paragraphs with an 
estimate of the annual burden, summarized in Table 1. To fairly 
evaluate whether an information collection should be approved by OMB, 
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (PRA) 
requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of the required issues 
under section 3506(c)(2)(A) of the PRA. The collections of information 
required by the proposed rule relate to Sec.  59.5 (What requirements 
must be met by a family planning project?) and Sec.  59.7 (What 
criteria would the Department of Health and Human Services use to 
decide which family planning services projects to fund and in what 
amounts?).
    Proposed Sec.  59.4 would require Title X grant applicants to 
describe how the proposed project would satisfy the regulatory 
requirements for the Title X program in their applications. All other 
reporting burden associated with grant applications is already approved 
via existing Grants.gov common forms.
    Proposed Sec.  59.5 would require Title X providers to report, in 
grant applications and in all required reports, information regarding 
subrecipients and referral agencies and individuals, including a 
description of the extent of collaboration and a clear explanation of 
how the grantee would ensure adequate oversight and accountability.
    Proposed Sec.  59.5 would also require Title X grantees to provide 
appropriate documentation or other assurance satisfactory to the 
Secretary that it has in place and has implemented a plan to comply 
with all State and local laws requiring notification or reporting of 
child abuse, child molestation, sexual abuse, rape, incest, intimate 
partner violence, and human trafficking. It would also require Title X 
grantees to maintain records to demonstrate compliance with the 
requirements of Sec.  59.5, and make continuation of funding for Title 
X services contingent upon demonstrating to the Secretary that the 
criteria have been met.
    Burden of Response: The Department is committed to leveraging 
existing grant, contract, annual reporting, and other Departmental 
forms where possible, rather than creating additional, separate forms 
for recipients to sign. We anticipate two separate burdens of response: 
(1) Assurance of compliance; and (2) documentation of compliance. The 
burden for the assurance of compliance is the cost of grantee and/or 
subrecipient staff time to (a) review the assurance language as well as 
the underlying language related to stated requirements; (b) to review 
grantee and/or subrecipient policies and procedures or to take other 
actions to assess grantee and/or subrecipient compliance with the 
requirements to which the grantee and/or subrecipient is required to 
assure compliance.
    The labor cost would include a lawyer spending an average of 1 hour 
reviewing all assurances and a medical and health service manager 
spending an average of one hour reviewing and signing the assurances at 
each grantee and subrecipient. We estimate the number of grantees and 
subrecipients at 1060, based on 2019 number of Title X grantees and 
subrecipients, as represented in Title X FPAR data. The mean hourly 
wage (not including benefits and overhead) for these occupations is 
$69.86 per hour for the lawyer and $55.37 per hour for the medical and 
health service manager. The labor cost is $132,750 in the first year 
(($69.86 x 1 + $55.37 x 1) x 1060 grantees and subrecipients). We 
estimate that the cost, in subsequent years, would be $95,700 which 
would represent an annual allotment of 30 minutes for the lawyer and 
one hour for the medical and health service manager (($69.86 x 0.5 + 
$55.37 x 1) x 1060 grantees and subrecipients).
    The Department estimates that all recipients and subrecipients will 
review their organizational policies and procedures or take other 
actions to self-assess compliance with applicable Title X requirements 
each year, spending an average of 4 hours doing so. The labor cost is a 
function of a lawyer spending an average of 2 hours and a medical and 
health service manager spending an average of 2 hours. The labor cost 
for self-assessing compliance, such as reviewing policies and 
procedures, is a total of $265,500 each year (($69.86 x 2 + $55.37 x 2) 
x 1060 grantees and subrecipients).
    The burden for the documentation of compliance is the cost of 
grantee and/or subrecipient staff time to (a) complete reports 
regarding information related to subrecipients, referral agencies and 
individuals involved in the grantee's Title X project.
    The labor cost would include a medical and health services manager 
spending an average of two hours each year to complete reports 
regarding information related to subrecipients, and referral agencies 
and individuals involved in the grantee's Title X project at each 
grantee and subrecipient. The labor cost will be $117,400 each year 
($55.37 x 2 hours x 1060 grantees and 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
                    Regulation burden                       OMB control     Respondents     Hourly rate      response         burden       Labor cost of
                                                                No.          responses          ($)           (hours)         (hours)     reporting  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                         -----------------------------------------------------------------------------------------------

[[Page 19829]]

 
    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 result 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 information collection requirements under the
  Paperwork Reduction Act of 1995.

List of Subjects in 42 CFR Part 59

    Birth control, Contraception, Family planning, Grant programs, 
Health facilities, Title X.

Xavier Becerra,
Secretary, Department of Health and Human Services.

PART 59--GRANTS FOR FAMILY PLANNING

    For the reasons set out in the preamble, subpart A of part 59 of 
title 42, Code of Federal Regulations, is hereby proposed to be revised 
to read as follows:
Subpart A--Project Grants for Family Planning Services
Sec.
59.1 To what programs do the regulations in this subpart apply?
59.2 Definitions.
59.3 Who is eligible to apply for a family planning services grant?
59.4 How does one apply for a family planning services grant?
59.5 What requirements must be met by a family planning project?
59.6 What procedures apply to assure the suitability of 
informational and educational material?
59.7 What criteria will the Department of Health and Human Services 
use to decide which family planning services projects to fund and in 
what amount?
59.8 How is a grant awarded?
59.9 For what purposes may grant funds be used?
59.10 Confidentiality.
59.11 Additional conditions.
59.12 What other HHS regulations apply to grants under this subpart?

Subpart A--Project Grants for Family Planning Services

    Authority: 42 U.S.C. 300a-4.


Sec.  59.1   To what programs do the regulations in this subpart apply?

    The regulations of this subpart are applicable to the award of 
grants under section 1001 of the Public Health Service Act (42 U.S.C. 
3200) to assist in the establishment and operation of voluntary family 
planning projects. These projects shall consist of the educational, 
comprehensive medical, and social services necessary to aid individuals 
to determine freely the number and spacing of their children.


Sec.  59.2  Definitions.

    As used in this subpart:
    Act means the Public Health Service Act, as amended.
    Adolescent-friendly health services are services that are 
accessible, acceptable, equitable, appropriate and effective for 
adolescents.
    Client-centered care is respectful of, and responsive to, 
individual client preferences, needs, and values; client values guide 
all clinical decisions.
    Culturally and linguistically appropriate services are respectful 
of and responsive to the health beliefs, practices and needs of diverse 
patients.
    Family means a social unit composed of one person, or two or more 
persons living together, as a household.
    Family planning services include a broad range of medically 
approved contraceptive services, which includes Food and Drug 
Administration (FDA)-approved contraceptive services and natural family 
planning methods, for clients who want to prevent pregnancy and space 
births, pregnancy testing and counseling, assistance to achieve 
pregnancy, basic infertility services, sexually transmitted infection 
(STI) services, and other preconception health services.
    Health equity is when every person has the opportunity to attain 
their full health potential and no one is disadvantaged from achieving 
this potential because of social position or other socially determined 
circumstances.
    Inclusivity ensures that all people are fully included and can 
actively participate in and benefit from family planning, including, 
but not limited to, individuals who belong to underserved communities, 
such as Black, Latino, and Indigenous and Native American persons, 
Asian Americans and Pacific Islanders and other persons of color; 
members of religious minorities; lesbian, gay, bisexual, transgender, 
and queer (LGBTQ+) persons; persons with disabilities; persons who live 
in rural areas; and persons otherwise adversely affected by persistent 
poverty or inequality.
    Low-income family means a family whose total annual income does not 
exceed 100 percent of the most recent Poverty Guidelines issued 
pursuant to 42 U.S.C. 9902(2). ``Low-income family'' also includes 
members of families whose annual family income exceeds this amount, but 
who, as determined by the project director, are unable, for good 
reasons, to pay for family planning services. For example, 
unemancipated minors who wish to receive services on a confidential 
basis must be considered on the basis of their own resources.
    Nonprofit, as applied to any private agency, institution, or 
organization, means that no part of the entity's net earnings benefit, 
or may lawfully benefit, any private shareholder or individual.
    Quality healthcare is safe, effective, client-centered, timely, 
efficient, and equitable.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    Service site is a clinic or other location where Title X services 
(under the Act) are provided to clients. Title X recipients and/or 
their subrecipients may have service sites.
    State includes, in addition to the several States, the District of 
Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana 
Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlaying 
Islands (Midway, Wage, et al.), the Marshall Islands, the Federated 
State of Micronesia and the Republic of Palau.

[[Page 19830]]

    Trauma-informed means a program, organization, or system that is 
trauma-informed realizes the widespread impact of trauma and 
understands potential paths for recovery; recognizes the signs and 
symptoms of trauma in clients, families, staff, and others involved 
with the system; and responds by fully integrating knowledge about 
trauma into policies, procedures, and practices, and seeks to actively 
resist re-traumatization.


Sec.  59.3  Who is eligible to apply for a family planning services 
grant?

    Any public or nonprofit private entity in a State may apply for a 
grant under this subpart.


Sec.  59.4  How does one apply for a family planning services grant?

    (a) Application for a grant under this subpart shall be made on an 
authorized form.
    (b) An individual authorized to act for the applicant and to assume 
on behalf of the applicant the obligations imposed by the terms and 
conditions of the grant, including the regulations of this subpart, 
must sign the application.
    (c) The application shall contain--
    (1) A description, satisfactory to the Secretary, of the project 
and how it will meet the requirements of this subpart;
    (2) A budget and justification of the amount of grant funds 
requested;
    (3) A description of the standards and qualifications which will be 
required for all personnel and for all facilities to be used by the 
project; and
    (4) Such other pertinent information as the Secretary may require.


Sec.  59.5  What requirements must be met by a family planning project?

    (a) Each project supported under this part must:
    (1) Provide a broad range of acceptable and effective medically 
approved family planning methods (including natural family planning 
methods) and services (including pregnancy testing and counseling, 
assistance to achieve pregnancy, basic infertility services, STI 
services, preconception health services, and adolescent-friendly health 
services). If an organization offers only a single method of family 
planning, it may participate as part of a project as long as the entire 
project offers a broad range of acceptable and effective medically 
approved family planning methods and services. Title X service sites 
that are unable to provide clients with access to a broad range of 
acceptable and effective medically approved family planning methods and 
services, must be able to provide a referral to the client's method of 
choice and the referral must not unduly limit the client's access to 
their method of choice.
    (2) Provide services without subjecting individuals to any coercion 
to accept services or to employ or not to employ any particular methods 
of family planning. Acceptance of services must be solely on a 
voluntary basis and may not be made a prerequisite to eligibility for, 
or receipt of, any other services, assistance from or participation in 
any other program of the applicant.\1\
---------------------------------------------------------------------------

    \1\ 42 U.S.C. 300a-8 (Section 205 of Pub. L. 94-63) states: 
``Any (1) officer or employee of the United States, (2) officer or 
employee of any State, political subdivision of a State, or any 
other entity, which administers or supervises the administration of 
any program receiving Federal financial assistance, or (3) person 
who receives, under any program receiving Federal assistance, 
compensation for services, who coerces or endeavors to coerce any 
person to undergo an abortion or sterilization procedure by 
threatening such person with the loss of, or disqualification for 
the receipt of, any benefit or service under a program receiving 
Federal financial assistance shall be fined not more than $1,000 or 
imprisoned for not more than one year, or both.''
---------------------------------------------------------------------------

    (3) Provide services in a manner that is client-centered, 
culturally and linguistically appropriate, inclusive, and trauma-
informed; protects the dignity of the individual; and ensures equitable 
and quality service delivery consistent with nationally recognized 
standards of care.
    (4) Provide services without regard of religion, race, color, 
national origin, disability, age, sex, number of pregnancies, or 
marital status.
    (5) Not provide abortion as a method of family planning. A project 
must:
    (i) Offer pregnant clients the opportunity to be provided 
information and counseling regarding each of the following options:
    (A) Prenatal care and delivery;
    (B) Infant care, foster care, or adoption; and
    (C) Pregnancy termination.
    (ii) If requested to provide such information and counseling, 
provide neutral, factual information and nondirective counseling on 
each of the options, and referral upon request, except with respect to 
any option(s) about which the pregnant client indicates they do not 
wish to receive such information and counseling.
    (6) Provide that priority in the provision of services will be 
given to clients from low-income families.
    (7) Provide that no charge will be made for services provided to 
any clients from a low-income family except to the extent that payment 
will be made by a third party (including a Government agency) which is 
authorized to or is under legal obligation to pay this charge.
    (8) Provide that charges will be made for services to clients other 
than those from low-income families in accordance with a schedule of 
discounts based on ability to pay, except that charges to persons from 
families whose annual income exceeds 250 percent of the levels set 
forth in the most recent Poverty Guidelines issued pursuant to 42 
U.S.C. 9902(2) will be made in accordance with a schedule of fees 
designed to recover the reasonable cost of providing services.
    (i) Family income should be assessed before determining whether 
copayments or additional fees are charged.
    (ii) With regard to insured clients, clients whose family income is 
at or below 250% Federal poverty line (FPL) should not pay more (in 
copayments or additional fees) than what they would otherwise pay when 
the schedule of discounts is applied.
    (9) Take reasonable measures to verify client income, without 
burdening clients from low-income families. Recipients that have lawful 
access to other valid means of income verification because of the 
client's participation in another program may use those data rather 
than re-verify income or rely solely on clients' self-report. If a 
client's income cannot be verified after reasonable attempts to do so, 
charges are to be based on the client's self-reported income.
    (10) If a third party (including a Government agency) is authorized 
or legally obligated to pay for services, all reasonable efforts must 
be made to obtain the third-party payment without application of any 
discounts. Where the cost of services is to be reimbursed under title 
XIX, XX, or XXI of the Social Security Act, a written agreement with 
the title XIX, XX, or XXI agency is required.
    (11)(i) Provide that if an application relates to consolidation of 
service areas or health resources or would otherwise affect the 
operations of local or regional entities, the applicant must document 
that these entities have been given, to the maximum feasible extent, an 
opportunity to participate in the development of the application. Local 
and regional entities include existing or potential subrecipients which 
have previously provided or propose to provide family planning services 
to the area proposed to be served by the applicant.
    (ii) Provide an opportunity for maximum participation by existing 
or potential subrecipients in the ongoing policy decision making of the 
project.
    (12) Title X projects shall comply with all State and local laws 
requiring notification or reporting of child abuse,

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child molestation, sexual abuse, rape, incest, intimate partner 
violence or human trafficking (collectively, ``State notification 
laws''). Title X projects must provide appropriate documentation or 
other assurance satisfactory to the Secretary that it:
    (i) Has in place and implements a plan to comply with State 
notification laws.
    (ii) Provides timely and adequate annual training of all 
individuals (whether or not they are employees) serving clients for, or 
on behalf of, the project regarding State notification laws; policies 
and procedures of the Title X project and/or for providers with respect 
to notification and reporting of child abuse, child molestation, sexual 
abuse, rape, incest, intimate partner violence and human trafficking; 
appropriate interventions, strategies, and referrals to improve the 
safety and current situation of the patient; and compliance with State 
notification laws.
    (13) Ensure transparency in the delivery of services by reporting 
the following information in grant applications and all required 
reports:
    (i) Subrecipients and agencies or individuals providing referral 
services and the services to be provided;
    (ii) Description of the extent of the collaboration with 
subrecipients, referral agencies, and any individuals providing 
referral services, in order to demonstrate a seamless continuum of care 
for clients; and
    (iii) Explanation of how the recipient will ensure adequate 
oversight and accountability for quality and effectiveness of outcomes 
among subrecipients.
    (b) In addition to the requirements of paragraph (a) of this 
section, each project must meet each of the following requirements 
unless the Secretary determines that the project has established good 
cause for its omission. Each project must:
    (1) Provide for medical services related to family planning 
(including consultation by a healthcare provider, examination, 
prescription, and continuing supervision, laboratory examination, 
contraceptive supplies) and necessary referral to other medical 
facilities when medically indicated, and provide for the effective 
usage of contraceptive devices and practices.
    (2) Provide for social services related to family planning, 
including counseling, referral to and from other social and medical 
service agencies, and any ancillary services which may be necessary to 
facilitate clinic attendance.
    (3) Provide for opportunities for community education, 
participation, and engagement to:
    (i) Achieve community understanding of the objectives of the 
program;
    (ii) Inform the community of the availability of services; and
    (iii) Promote continued participation in the project by diverse 
persons to whom family planning services may be beneficial to ensure 
access to equitable, affordable, client-centered, quality family 
planning services.
    (4) Provide for orientation and in-service training for all project 
personnel.
    (5) Provide services without the imposition of any durational 
residency requirement or requirement that the patient be referred by a 
physician.
    (6) Provide that family planning medical services will be performed 
under the direction of a physician with special training or experience 
in family planning.
    (7) Provide that all services purchased for project participants 
will be authorized by the project director or his designee on the 
project staff.
    (8) Provide for coordination and use of referrals and linkages with 
primary healthcare providers, other providers of healthcare services, 
local health and welfare departments, hospitals, voluntary agencies, 
and health services projects supported by other Federal programs, who 
are in close physical proximity to the Title X site, when feasible, in 
order to promote access to services and provide a seamless continuum of 
care.
    (9) Provide that if family planning services are provided by 
contract or other similar arrangements with actual providers of 
services, services will be provided in accordance with a plan which 
establishes rates and method of payment for medical care. These 
payments must be made under agreements with a schedule of rates and 
payment procedures maintained by the recipient. The recipient must be 
prepared to substantiate that these rates are reasonable and necessary.
    (10) Provide, to the maximum feasible extent, an opportunity for 
participation in the development, implementation, and evaluation of the 
project by persons broadly representative of all significant elements 
of the population to be served, and by others in the community 
knowledgeable about the community's needs for family planning services.


Sec.  59.6  What procedures apply to assure the suitability of 
informational and educational material (print and electronic)?

    (a) A grant under this section may be made only upon assurance 
satisfactory to the Secretary that the project shall provide for the 
review and approval of informational and educational materials (print 
and electronic) developed or made available under the project by an 
Advisory Committee prior to their distribution, to assure that the 
materials are suitable for the population or community to which they 
are to be made available and the purposes of Title X of the Act. The 
project shall not disseminate any such materials which are not approved 
by the Advisory Committee.
    (b) The Advisory Committee referred to in paragraph (a) of this 
section shall be established as follows:
    (1) Size. The Committee shall consist of no fewer than five members 
and up to as many members the recipient determines, except that this 
provision may be waived by the Secretary for good cause shown.
    (2) Composition. The Committee shall include individuals broadly 
representative of the population or community for which the materials 
are intended (in terms of demographic factors such as race, ethnicity, 
color, national origin, disability, sex, sexual orientation, gender 
identity, age, marital status, income, geography, and including but not 
limited to individuals who belong to underserved communities, such as 
Black, Latino, and Indigenous and Native American persons, Asian 
Americans and Pacific Islanders and other persons of color; members of 
religious minorities; lesbian, gay, bisexual, transgender, and queer 
(LGBTQ+) persons; persons with disabilities; persons who live in rural 
areas; and persons otherwise adversely affected by persistent poverty 
or inequality).
    (3) Function. In reviewing materials, the Advisory Committee shall:
    (i) Consider the educational, cultural, and diverse backgrounds of 
individuals to whom the materials are addressed;
    (ii) Consider the standards of the population or community to be 
served with respect to such materials;
    (ii) Review the content of the material to assure that the 
information is factually correct, medically accurate, culturally and 
linguistically appropriate, inclusive, and trauma informed;
    (iii) Determine whether the material is suitable for the population 
or community to which is to be made available; and
    (iv) Establish a written record of its determinations.


Sec.  59.7   What criteria will the Department of Health and Human 
Services use to decide which family planning services projects to fund 
and in what amount?

    (a) Within the limits of funds available for these purposes, the 
Secretary may award grants for the

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establishment and operation of those projects which will in the 
Department's judgment best promote the purposes of section 1001 of the 
Act, taking into account:
    (1) The number of clients, and, in particular, the number of low-
income clients to be served;
    (2) The extent to which family planning services are needed 
locally;
    (3) The ability of the applicant to advance health equity;
    (4) The relative need of the applicant;
    (5) The capacity of the applicant to make rapid and effective use 
of the Federal assistance;
    (6) The adequacy of the applicant's facilities and staff;
    (7) The relative availability of non-Federal resources within the 
community to be served and the degree to which those resources are 
committed to the project; and
    (8) The degree to which the project plan adequately provides for 
the requirements set forth in these regulations.
    (b) The Secretary shall determine the amount of any award on the 
basis of his estimate of the sum necessary for the performance of the 
project. No grant may be made for less than 90 percent of the project's 
costs, as so estimated, unless the grant is to be made for a project 
which was supported, under section 1001, for less than 90 percent of 
its costs in fiscal year 1975. In that case, the grant shall not be for 
less than the percentage of costs covered by the grant in fiscal year 
1975.
    (c) No grant may be made for an amount equal to 100 percent for the 
project's estimated costs.


Sec.  59.8   How is a grant awarded?

    (a) The notice of grant award specifies how long Department of 
Health and Human Services (HHS) intends to support the project without 
requiring the project to recompete for funds. This anticipated period 
will usually be for three to five years.
    (b) Generally the grant will initially be for one year and 
subsequent continuation awards will also be for one year at a time. A 
recipient must submit a separate application to have the support 
continued for each subsequent year. Decisions regarding continuation 
awards and the funding level of such awards will be made after 
consideration of such factors as the recipient's progress and 
management practices, and the availability of funds. In all cases, 
continuation awards require a determination by HHS that continued 
funding is in the best interest of the Government.
    (c) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.


Sec.  59.9   For what purpose may grant funds be used?

    Any funds granted under this subpart shall be expended solely for 
the purpose for which the funds were granted in accordance with the 
approved application and budget, the regulations of this subpart, the 
terms and conditions of the award, and the applicable cost principles 
prescribed in 45 CFR part 75.


Sec.  59.10   Confidentiality.

    All information as to personal facts and circumstances obtained by 
the project staff about individuals receiving services must be held 
confidential and must not be disclosed without the individual's 
documented consent, except as may be necessary to provide services to 
the patient or as required by law, with appropriate safeguards for 
confidentiality. Otherwise, information may be disclosed only in 
summary, statistical, or other form which does not identify particular 
individuals. Reasonable efforts to collect charges without jeopardizing 
client confidentiality must be made. Recipient must inform the client 
of any potential for disclosure of their confidential health 
information to policyholders where the policyholder is someone other 
than the client.


Sec.  59.11   Additional conditions.

    The Secretary may, with respect to any grant, impose additional 
conditions prior to, at the time of, or during any award, when in the 
Department's judgment these conditions are necessary to assure or 
protect advancement of the approved program, the interests of public 
health, or the proper use of grant funds.


Sec.  59.12   What other HHS regulations apply to grants under this 
subpart?

    Attention is drawn to the following the HHS regulations which apply 
to grants under this subpart. These include:

                         Table 1 to Sec.   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
                                          Department 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.
------------------------------------------------------------------------


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[FR Doc. 2021-07762 Filed 4-14-21; 8:45 am]
BILLING CODE 4150-03-P