[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Pages 33021-33025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10764]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AQ65


Transplant Procedures With Live Donors and Related Care and 
Services

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) adopts as final, with 
changes, a proposed rule amending its medical regulations to implement 
legislation providing it stand-alone authority to provide procedures to 
remove a solid organ or bone marrow from a live donor for 
transplantation into a veteran and to furnish the live donor care or 
services before and after the procedure required in connection with the 
veteran's transplantation procedure. This rulemaking implements the 
mandates of section 153 of the VA MISSION Act of 2018.

DATES: This rule is effective July 1, 2022.

FOR FURTHER INFORMATION CONTACT: Mani Murugavel, DNP, NE-BC, CSSGB, RN, 
National Director, Clinical Services, National Surgery Office (11SURG), 
Veterans Health Administration, 810 Vermont Avenue NW, Washington, DC 
20420, (202) 461-7130. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register (FR) on March 24, 2021, (86 FR 15628), VA proposed to amend 
its medical regulations to implement its authority to provide 
procedures to remove a solid organ or bone marrow from a live donor for 
transplantation into a veteran and to furnish the live donor care or 
services before and after the procedure. VA provided a 60-day comment 
period, which ended on May 24, 2021. Six comments were received.

Comments

    The six comments were generally supportive of the proposed rule, 
and we thank the commenters for their comments. Of those six comments, 
four included substantive feedback, which is discussed below.
    One commenter opined that live donors should be further 
compensated. This commenter suggested VA cover additional expenses that 
are deemed necessary and for which live donors submit documentation, as 
there are ``other factors such as emotional effects that donors 
sometime[s] experience'' due to the transplant procedure. However, this 
commenter did not specify the types of additional expenses VA should 
cover.
    As explained in the proposed rule, VA will cover for the live donor 
hospital care and medical services prior to the surgical removal of the 
solid organ, part of a solid organ, or bone marrow; the surgical 
procedure to remove a solid organ, part of a solid organ, or bone 
marrow, and related care; and follow-up care which varies based on the 
type of donation. Additionally, VA will cover travel costs, including 
temporary lodging as VA determines to be needed. While VA acknowledges 
that live donors may incur additional expenses, VA believes the 
services and expenses covered under this rulemaking are reasonable 
under section 1788 of title 38, United States (U.S.C.), are consistent 
with how VA has administered the transplant program to date, and 
recognize the sacrifices that live donors make. While VA understands 
the commenter's support and rationale for expanding upon the additional 
expenses covered by VA, VA is not making any changes based on this 
comment.
    To the extent that this commenter further suggested that live 
donors should be compensated for their donation, by law, VA may not 
knowingly acquire, receive, or otherwise transfer any human organ for 
valuable consideration for use in human transplantation if the transfer 
affects interstate commerce. 42 U.S.C. 274e(a). For purposes of this 
statute, the term ``valuable consideration'' ``does not include the 
reasonable payments associated with the removal, transportation, 
implantation, processing, preservation, quality control, and storage of 
a human organ or the expenses of travel, housing, and lost wages 
incurred by the donor of a human organ in connection with the donation 
of the organ.'' Section 274e(c)(2). Although this prohibition does not 
apply to a ``human organ paired donation,'' (see last sentence of 
section 274e(a)), that is not to say that compensation is available in 
these cases, because the term ``human organ paired donation,'' as 
defined in section 274e(c)(4), clearly bars valuable consideration from 
being provided for the organ in subparagraph (c)(4)(F). Thus, 
furnishing compensation for a human organ is legally barred. In 
addition, a host of ethical questions are raised by such a proposal. 
Transplant programs participating in the Organ Procurement 
Transplantation Network (OPTN) are authorized, however, to provide 
reimbursement for incidental non-medical expenses of donors. See 42 
U.S.C. 274f, as implemented by Sec.  121.14 of title 42, Code of 
Federal Regulations (CFR). This authority is discretionary, and while 
VA voluntarily participates and complies with OPTN requirements and is 
an OPTN-designated transplant program, VA will cover only the non-
medical costs we have identified, as these types of non-medical costs 
are directly integral to the donor's transplant episode. In addition, 
this aligns with how very limited non-medical care benefits, or 
financial incentives, exist for other VA beneficiaries. Nonetheless, VA 
will undertake additional review and analysis to determine whether non-
medical expenses other than those already covered under this rulemaking 
should be covered to encourage greater

[[Page 33022]]

donor participation. If VA determines additional non-medical expenses 
such as incidental non-medical costs described in 42 CFR 121.14 should 
also be covered, it will propose to do so in a separate future 
rulemaking.
    VA therefore makes no changes based on this comment.
    Another commenter stated that it was unclear whether the definition 
of kidney paired donation, in 38 CFR 17.395(b), included living donor 
chains, and suggested VA modify this definition to explicitly cover 
living donor chains. As explained in OPTN policies, a living (or live) 
donor chain is an approach in which a live donor without an intended 
recipient donates an organ, which is matched with a recipient. See 
OPTN, Policy 1: Administrations Rules and Definitions, and Policy 13: 
Kidney Paired Donation. U.S. Department of Health and Human Services, 
Health Resources and Services Administration. Retrieved from: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/optn_policies.pdf (Accessed: 25 October 2021). That recipient's 
prospective live donor then donates an organ that can be matched with 
another recipient. Id. A chain of donations then occurs that allows for 
the donation and receipt of compatible organs. Id. Currently, live 
donor chains are widely used for the donation and receipt of kidneys.
    The definition of kidney paired donation in Sec.  17.395(b) is 
consistent with OPTN's definition of kidney paired donation. However, 
it does not specifically address live donor chains nor does it prohibit 
live donor chains. For the purposes of this rulemaking, VA clarifies 
that live donor chains are permitted, and interpreted to be included, 
under VA's definition of kidney paired donation. Based on this comment, 
VA is adding a note to the definition of kidney paired donation to 
state that for purposes of this section, kidney paired donation 
includes live donor chains. VA is also adding a definition for live 
donor chain to mean a set of kidney paired donation matches that begins 
with a donation of a kidney from a live donor without an intended 
recipient. Such live donor donates a kidney for transplantation into 
the intended recipient of a prospective live donor. The prospective 
live donor then donates a kidney for transplantation into a recipient 
other than the intended recipient. A chain continues to allow donation 
and receipt of compatible kidneys. VA makes no further changes based on 
this comment.
    One commenter suggested that VA revise its rule to specify that VA 
bone marrow programs follow standards of care and patient safety issued 
by the nation's bone marrow registry, as they opined that it is 
critical VA and non-VA bone marrow programs align. This commenter noted 
that National Marrow Donor Program (NMDP) network members are held to 
standards of care and safety for bone marrow transplant similar to OPTN 
members.
    As an initial matter, NMDP manages a bone marrow registry in which 
donors unrelated to the transplant recipient can voluntarily register 
to donate their bone marrow (including stem cells). These donations are 
then stored and managed by NMDP. While medical hospitals and facilities 
can become NMDP-contracted bone marrow donor centers, which are subject 
to NMDP Donor Center participation standards, VA does not have any such 
bone marrow donor centers as part of its bone marrow transplantation 
program. Instead, VA contracts with NMDP to obtain bone marrow for 
transplantation when a bone marrow match is identified (through NMDP's 
registry) for a veteran recipient. VA also may obtain bone marrow 
directly from live donors who are identified by VA as a match for the 
veteran recipient.
    To the extent that this commenter is suggesting VA revise the rule 
to specify that VA's bone marrow program follows standards of care and 
patient safety issued by NMDP for live donors of bone marrow, NMDP 
maintains standards for bone marrow donor centers, specifically related 
to the bone marrow donor. Because VA does not operate NMDP-contracted 
bone marrow donor centers, related NMDP standards do not apply to VA. 
When VA procures bone marrow including stem cells from NMDP for 
transplantation into a veteran recipient, VA does not directly interact 
with the bone marrow donor and thus any standards about donor care 
would be inapplicable, particularly as VA would not know the identity 
of the live donor. Therefore, NDMP donor center participation standards 
do not apply to VA's bone marrow transplantation program because VA 
does not operate such donor centers. As noted earlier, VA may obtain 
bone marrow directly from live donors (for example, family members of 
the veteran) who are identified by VA as a match for the veteran 
recipient; however, such donations do not fall under NMDP standards for 
donor centers. VA believes the current language in the regulation 
regarding care for bone marrow donors is sufficient, particularly as it 
is consistent with VA current policy and practices. VA does not make 
any changes to the regulation based on this comment.
    NMDP also maintains standards, including data reporting, relating 
to the unrelated allogeneic bone marrow transplant procedure. VA 
voluntarily complies with such standards. To the extent that this 
commenter is suggesting VA revise the rule to specify that VA's bone 
marrow program follows standards of care and patient safety issued by 
NMDP for transplant recipients, VA considers this outside the scope of 
the rulemaking as this relates to transplant recipients, not live 
donors. VA makes no changes to the regulation based on this comment.
    That same commenter also suggested the rule be revised to specify 
that data reporting requirements for bone marrow transplant be 
submitted to the Stem Cell Therapeutic Outcomes Database (SCTOD), as 
that ``database allows analysis of program use, center-specific 
outcomes, size of donor registry and cord blood inventory, and patient 
access to hematopoietic cell transplantations, and per the Stem Cell 
Therapeutic and Research Act of 2005, VA would share outcomes data with 
the SCTOD.''
    VA voluntarily complies with the Foundation for the Accreditation 
of Cellular Therapy (FACT) standards for direct allogeneic live donor 
care and data reporting requirements. These include submission of 
direct allogeneic stem cell transplant data to the SCTOD. However, VA 
considers this part of the comment beyond the scope of the rulemaking 
as these reporting requirements for bone marrow transplant mainly 
concern the engraftment and recipient, and not the live donor, and this 
comment does not pertain to the care and services available to live 
donors under VA's transplant program. VA believes that this is more 
appropriate for internal VA policy than regulation since it concerns 
internal VA requirements. To the extent that this commenter is 
suggesting non-VA providers performing bone marrow transplants under 
VA's transplant program comply with these same data reporting 
requirements, this is beyond the scope of this rulemaking and would be 
more appropriate for inclusion in agreements VA enters into with these 
non-VA providers. VA is making no changes based on this comment.
    One commenter stated that OPTN requires that transplant programs 
only use living donor organs recovered from OPTN approved living donor 
recovery hospitals and noted that when VA enters into agreements with 
non-VA facilities for organ transplants, it should ensure that these 
non-VA facilities are approved for recovery of organs from living 
donors if the recovery will occur in such facilities. This commenter

[[Page 33023]]

suggested VA consider clarifying in the final rule the minimum 
requirements for these non-VA facilities that recover organs from 
living donors. Relatedly, this commenter recommended the rule be 
``explicit about requirements for outcomes reporting, compliance 
monitoring, and other considerations between bone marrow and solid 
organ transplant, given their distinct contractual relationships with 
the federal government.''
    With regards to the comment that VA should ensure that non-VA 
facilities with which VA enters into agreements for bone marrow or 
solid organ transplants are approved by OPTN, VA considers this part of 
the comment beyond the scope of the rulemaking since it does not 
pertain to the care and services available to live donors under VA's 
transplant program. The qualifications that VA requires non-VA 
facilities providing such services to possess is a separate matter that 
will be addressed by VA in the context of its acquisitions.
    In the agreements VA would enter into with non-VA facilities for 
organ transplants, VA would ensure that the appropriate requirements, 
such as those requirements for outcomes reporting, compliance 
monitoring, and other requirements or considerations, are included in 
such agreements. This information is commonly set forth in agreements 
rather than regulations, especially to permit flexibility, as 
requirements are subject to change. Additionally, the purpose of this 
rulemaking is to regulate the care and services available to living 
donors before and after the procedure required in connection with a 
veteran's transplantation procedure; not to regulate the requirements 
for reporting, monitoring, or other similar requirements with which 
non-VA providers must comply.
    VA is making no changes based on this comment.

Technical Changes Not Based on Comments

    VA makes two technical changes not based on comments. Both 
technical changes are made to 38 CFR 17.395(g), which states the 
limitations on VA obligations in kidney paired donations. The first 
change is to replace the term, care, with the term, hospital care, in 
the introductory paragraph of Sec.  17.395(g). The second change is to 
replace the term, services, with the term, medical services, in the 
introductory paragraph of Sec.  17.395(g). These technical changes 
clarify the specific type of care and services referenced in Sec.  
17.395(g) and are consistent with how these terms are used in paragraph 
(c) of Sec.  17.395. These technical changes will also avoid potential 
confusion with the terms, non-hospital care and non-medical services, 
which appear in paragraph (d) of Sec.  17.395.
    Based on the rationale set forth in the proposed rule and in this 
final rule, VA is adopting the proposed rule with changes as noted.

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
The Office of Information and Regulatory Affairs has determined that 
this rule is not a significant regulatory action under Executive Order 
12866. The Regulatory Impact Analysis associated with this rulemaking 
can be found as a supporting document at www.regulations.gov.

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-
612). VA has determined that this rule will not have a significant 
impact on a substantial number of small entities because the final rule 
does not directly regulate or impose costs on small entities and any 
effects would be indirect. Therefore, pursuant to 5 U.S.C. 605(b), the 
initial and final regulatory flexibility analysis requirements of 5 
U.S.C. 603 and 604 do not apply.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This final rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

Paperwork Reduction Act

    This final rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Assistance Listing

    The Assistance Listing numbers and titles for the programs affected 
by this document are 64.009, Veterans Medical Care Benefits; 64.029, 
Purchased Care Program; 64.047, VHA Primary Care; 64.042, 64. 045, VHA 
Ancillary Outpatient Services; 64.042, VHA Inpatient Surgery; 64.040, 
VHA Inpatient Medicine; 64.041,VHA Outpatient Specialty Care; 64.035, 
Veterans Transportation Program.

Congressional Review Act

    Pursuant to Subtitle E of the Small Business Regulatory Enforcement 
Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 
801 et seq.), the Office of Information and Regulatory Affairs 
designated this rule as not a major rule, as defined by 5 U.S.C. 
804(2).

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs-health, Grant programs-veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved this 
document on March 7, 2022, and authorized the undersigned to sign and 
submit the document to the Office of the Federal Register for 
publication electronically as an official document of the Department of 
Veterans Affairs.

Consuela Benjamin,
Regulation Development Coordinator, Office of Regulation Policy & 
Management, Office of General Counsel, Department of Veterans Affairs.

    For the reasons stated in the preamble, the Department of Veterans 
Affairs amends 38 CFR part 17 as set forth below:

PART 17--MEDICAL

0
1. The general authority citation for part 17 continues and an 
authority

[[Page 33024]]

citation for Sec.  17.395 is added in numerical order to read as 
follows:

    Authority: 38 U.S.C. 501 and as noted in specific sections.
* * * * *
    Section 17.395 is also issued under 38 U.S.C. 1788.

0
2. Add an undesignated center heading and Sec.  17.395 to read as 
follows:

Hospital Care, Medical Services, and Other Services for Live Donors


Sec.  17.395  Transplant procedures with live donors, and related 
services.

    (a) Scope. This section provides for medical and non-medical care 
and services of persons who volunteer to donate a solid organ, part of 
a solid organ, or bone marrow for transplantation into an eligible 
veteran transplant candidate, irrespective of a donor's eligibility to 
receive VA health care for any reason other than to donate a solid 
organ, part of a solid organ, or bone marrow. It prescribes the type, 
timing, and duration of hospital care and medical services VA provides, 
including medical care or services purchased by agreement from a non-VA 
facility. It also provides for non-medical care and services essential 
to the prospective live donor's or live donor's participation and for 
VA reimbursement for that care and services. The section does not 
provide for eligible veteran transplant candidates' VA medical 
benefits.
    (b) Definitions. For purposes of this section:
    Initial prospective live donor means an intended recipient's 
prospective live donor who volunteers to donate a kidney to a recipient 
other than the intended recipient through kidney paired donation.
    Intended recipient means the transplant candidate who VA identifies 
to receive a live donor's solid organ, part of a solid organ, or bone 
marrow.
    Kidney paired donation means one prospective live donor's voluntary 
donation of a kidney for transplantation into a recipient other than an 
intended recipient, paired with the transplantation into the intended 
recipient of a compatible kidney from a different live donor. Note: For 
purposes of this section, kidney paired donation includes live donor 
chains.
    Live donor means an individual who is:
    (i) Medically suitable for donation;
    (ii) Is a compatible match to an identified veteran transplant 
candidate; and
    (iii) Has provided informed consent to undergo elective removal of 
one solid organ, part of a solid organ, or of bone marrow.
    Live donor chain means a set of kidney paired donation matches that 
begins with a donation of a kidney from a live donor without an 
intended recipient. Such live donor donates a kidney for 
transplantation into the intended recipient of a prospective live 
donor. The prospective live donor then donates a kidney for 
transplantation into a recipient other than the intended recipient. A 
chain continues to allow donation and receipt of compatible kidneys.

Live Donor Follow-Up Means

    (i) For live donors of a solid organ or part of a solid organ, the 
collection of clinically relevant post-donation live donor data and the 
provision of recommended clinical laboratory tests and evaluations 
consistent with Organ Procurement and Transplantation Network policy, 
and the provision of direct medical care required to address reasonably 
foreseeable donor health complications resulting directly from the 
donation procedure.
    (ii) For live donors of bone marrow, the provision of direct 
medical care required to address reasonably foreseeable donor health 
complications resulting directly from the donation procedure.
    Prospective live donor means a person who has volunteered to donate 
a solid organ, part of a solid organ, or bone marrow to an intended 
recipient, and who has agreed to participate in any activity VA deems 
necessary to carry out the intended recipient's transplant procedure.
    Transplant candidate means an enrolled veteran or a veteran 
otherwise eligible for VA's medical benefits package who VA determines 
has a medical need for a solid organ, part of a solid organ, or bone 
marrow transplant.
    Transplant recipient means a transplant candidate who has undergone 
transplantation and received a solid organ, part of a solid organ, or 
bone marrow from a live donor.
    (c) Hospital care and medical services. To obtain a solid organ, 
part of a solid organ, or bone marrow for a VA transplant candidate, VA 
may provide the following hospital care and medical services to a 
prospective live donor or live donor:
    (1) Before removal of a solid organ, part of a solid organ, or bone 
marrow, VA will provide examinations, tests, and studies necessary to 
qualify a prospective live donor to donate a solid organ, part of a 
solid organ, or bone marrow.
    (2) During removal of a solid organ, part of a solid organ, or bone 
marrow, VA will provide the surgical procedure to remove a solid organ, 
part of a solid organ, or bone marrow from the living donor whose solid 
organ, part of a solid organ, or bone marrow will be transplanted into 
an intended recipient.
    (3) After removal of a solid organ or part of a solid organ, VA 
will provide all hospital care, medical services, and other services 
which are necessary and appropriate to live donor follow-up as defined 
in paragraph (b) of this section for a period not less than that which 
the Organ Procurement and Transplantation Network prescribes or 
recommends or for a period of 2 years, whichever is greater.
    (4) After bone marrow removal, VA will provide direct medical care 
required to address reasonably foreseeable live donor health 
complications resulting directly from the bone marrow donation 
procedure for a period not greater than 2 years.
    (5) A prospective live donor who is also a veteran enrolled in VA's 
health care system may receive care and services authorized in 
paragraphs (c)(1) and (2) only under this section. A live donor who is 
also a veteran enrolled in VA's health care system may opt to receive 
the care and services authorized under paragraph (c)(3) or (4) under 
either the medical benefits package codified at Sec.  17.38 or under 
this section, but not both at the same time.
    (d) Non-hospital care and non-medical services. If VA determines 
the prospective live donor's or the live donor's presence or proximity 
is necessary, VA will reimburse the travel costs of the prospective 
live donor or live donor, including one needed attendant or support 
person, at the rates provided in Sec.  70.30 of this chapter, without 
the deductibles required by Sec.  70.31 of this chapter, for:
    (1) Travel between the prospective live donor's or live donor's 
residence and the site of hospital care or medical services authorized 
in paragraph (c) of this section; and
    (2) Temporary lodging:
    (i) While the live donor is hospitalized for the organ removal 
procedure; or
    (ii) While the prospective live donor's or live donor's 
participation in the live donor program requires the prospective live 
donor's or live donor's presence away from home at least overnight and 
the prospective live donor's or live donor's presence or proximity is 
determined necessary by VA.
    (e) Use of non-VA facilities and non-VA service providers. (1) If 
and only if VA and a non-VA facility or non-VA

[[Page 33025]]

service provider have an agreement governed by 38 U.S.C. 8153 or any 
other applicable authority in title 38, United States Code, a non-VA 
facility may provide--
    (i) A surgical procedure and care and services described in 
paragraph (c) of this section; or
    (ii) Non-hospital care or non-medical services described and 
otherwise reimbursable under paragraph (d) of this section.
    (2) The prospective live donor or live donor is eligible for 
hospital care and medical services, or travel services, at a non-VA 
facility solely for the procedure, care, and services described in 
paragraphs (c) and (d) of this section as governed by an agreement 
described in paragraph (e)(1) of this section.
    (f) Participation terminated without completion of the intended 
recipient's transplantation procedure. (1) VA will provide the 
prospective live donor or live donor the care and services described in 
this section for any VA-authorized participation in the intended 
recipient's organ or bone marrow transplantation process even if the 
transplantation procedure for which the prospective live donor or live 
donor volunteered to donate a solid organ, part of a solid organ, or 
bone marrow is not completed.
    (2) A prospective live donor or a live donor may withdraw his or 
her informed consent at any time and for any reason. In the case of 
revocation of consent, VA will pay all the costs authorized under this 
section for the prospective live donor or live donor up until when the 
donor revokes consent and ends his or her participation.
    (g) Limitation on VA obligation in kidney paired donations. In 
kidney paired donations, VA's obligation to provide any procedure, 
hospital care, or medical services under this section extends:
    (1) To the initial prospective live donor who elects to participate 
in a kidney paired donation matching program, but only for the 
examinations, tests, and studies described in paragraph (c)(1) of this 
section for a prospective live donor before kidney removal.
    (2) To the live donor whose kidney the intended recipient will 
receive or has received but only for the services described in 
paragraphs (c)(2) and (3) of this section.

[FR Doc. 2022-10764 Filed 5-31-22; 8:45 am]
BILLING CODE 8320-01-P