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Proposed Rule2024-20643

Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act

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Published

September 12, 2024

Issuing agencies

Health and Human Services Department

Abstract

The Department of Health and Human Services (HHS) proposes to amend the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove clinical research and institutional review board (IRB) requirements ("research and IRB requirements") for transplantation of kidney and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. As allowed by the HIV Organ Policy Equity (HOPE) Act, the Secretary of HHS proposes to determine that participation in such clinical research should no longer be a requirement for transplantation of HIV positive kidneys and livers from donors with HIV to recipients with HIV. This proposed rule serves as publication of the Secretary's proposed determination and proposes to amend the regulations to reflect this determination. Consistent with NOTA and current regulatory requirements, the Secretary's proposed determination and the proposed corresponding regulatory revision, if finalized, will necessitate that the Organ Procurement and Transplantation Network (OPTN) adopt and use standards of quality concerning kidneys and livers from donors with HIV, as directed by the Secretary, consistent with NOTA and in a way that ensures the revised requirements for transplantation of such organs will not reduce the safety of organ transplantation.

Full Text

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<title>Federal Register, Volume 89 Issue 177 (Thursday, September 12, 2024)</title>
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[Federal Register Volume 89, Number 177 (Thursday, September 12, 2024)]
[Proposed Rules]
[Pages 74174-74184]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20643]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 121

RIN 0937-AA13

Organ Procurement and Transplantation: Implementation of the HIV
Organ Policy Equity (HOPE) Act

AGENCY: Office of the Assistant Secretary for Health (OASH) and Health
Resources and Services Administration (HRSA), Department of Health and
Human Services (HHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Health and Human Services (HHS) proposes to
amend the regulations implementing the National Organ Transplant Act of
1984, as amended (NOTA), to remove clinical research and institutional
review board (IRB) requirements (``research and IRB requirements'') for
transplantation of kidney and livers from donors with human
immunodeficiency virus (HIV) to recipients with HIV. As allowed by the
HIV Organ Policy Equity (HOPE) Act, the Secretary of HHS proposes to
determine that participation in such clinical research should no longer
be a requirement for transplantation of HIV positive kidneys and livers
from donors with HIV to recipients with HIV. This proposed rule serves
as publication of the Secretary's proposed determination and proposes
to amend the regulations to reflect this determination. Consistent with
NOTA and current regulatory requirements, the Secretary's proposed
determination and the proposed corresponding regulatory revision, if
finalized, will necessitate that the Organ Procurement and
Transplantation Network (OPTN) adopt and use standards of quality
concerning kidneys and livers from donors with HIV, as

[[Page 74175]]

directed by the Secretary, consistent with NOTA and in a way that
ensures the revised requirements for transplantation of such organs
will not reduce the safety of organ transplantation.

DATES: Comments on this notice of proposed rulemaking should be
received no later than October 15, 2024.

ADDRESSES: You may send comments, identified by Document ID HRSA-2024-
0001, to the Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document.
In accordance with 5 U.S.C. 553(b)(4), a summary of this rulemaking
may be found in the docket for this rulemaking at <a href="http://www.regulations.gov">www.regulations.gov</a>
[Document ID HRSA-2024-0001].

FOR FURTHER INFORMATION CONTACT: Frank Holloman, Director, Division of
Transplantation, Health Systems Bureau, HRSA, 5600 Fishers Lane, Room
08W63, Rockville, MD 20857; by email at <a href="/cdn-cgi/l/email-protection#a1c5cecfc0d5c8cecfe1c9d3d2c08fc6ced7">[email&#160;protected]</a>; or by
telephone (301) 443-7577.

SUPPLEMENTARY INFORMATION:

I. Public Participation

All interested parties are invited to participate in this
rulemaking by submitting written comments and supportive data that
should be considered. HHS also invites comments that relate to the
economic, legal, environmental, or federalism effects that might result
from this proposed rule. Comments that will provide the most assistance
to HHS in finalizing the rule will reference a specific portion of the
proposed rule, explain the reason for any recommended change, and
include data, information, or authority that supports such recommended
change.
Instructions: If you submit a comment, you must include the agency
name and the Document ID HRSA-2024-0001 for this rulemaking. Regardless
of the method used for submitting comments or material, all submissions
will be posted, without change, to the Federal eRulemaking Portal at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, and will include any personal information
you provide. Therefore, submitting this information makes it public.
You may wish to consider limiting the amount of personal information
that you provide in any voluntary public comment submission you make to
HHS. HHS may withhold information provided in comments from public
viewing that it determines may impact the privacy of an individual or
is offensive. For additional information, please read the Privacy Act
notice that is available via the link in the footer of <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Docket: For access to the docket and to read background documents
or comments received, go to <a href="https://regulations.gov">https://regulations.gov</a>, referencing
Document ID HRSA-2024-0001. You may also sign up for email alerts on
the online docket to be notified when comments are posted or a final
rule is published.

II. Background and Purpose

A. HHS Oversight of Organ Allocation and Transplantation

Within HHS, HRSA is responsible for overseeing the operation of the
nation's OPTN, including assisting in the equitable allocation of donor
organs for transplantation. 42 U.S.C. 274(b)(2)(D). The allocation of
organs is guided by the OPTN in accordance with NOTA and with the HHS
regulations governing the operation of the OPTN in 42 Code of Federal
Regulations (CFR) part 121. The OPTN is also charged with developing
policies on many subjects related to organ donation and
transplantation, which include establishing standards of quality
pertaining to organs procured for use in transplantation. 42 U.S.C.
274(b)(2)(E). In addition to ensuring the efficient and effective
allocation of donor organs through the OPTN, HHS supports efforts to
increase the number of transplants performed in the United States.

B. HOPE Act Requirements and Implementation

In 1988, NOTA was amended to prohibit the transplantation of organs
from donors with HIV, referring to HIV as the etiologic agent for
acquired immunodeficiency virus or AIDS. Until 1997, a total of 32
kidney transplants were performed in recipients with HIV, all with
organs from donors without HIV.\1\ Advances in antiretroviral therapies
(ART) have now made it possible for individuals with HIV to live longer
and with fewer complications from the virus. Following the success of
pioneering transplants occurring outside the United States of organs
from donors with HIV to recipients with HIV,\2\ interest in developing
specialized HIV transplant programs grew domestically.\3\
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\1\ Werbel WA, Durand CM. Solid Organ Transplantation in HIV-
Infected Recipients: History, Progress, and Frontiers. Curr HIV/AIDS
Rep. 2019 Jun;16(3):191-203.
\2\ Muller E, Barday Z, Mendelson M, Kahn D. HIV-Positive to
HIV-Positive Kidney Transplantation--Results at 3 to 5 Years. New
England Journal of Medicine. 2015 Feb 12;372(7):613-620.
\3\ Botha J, Fabian J, Etheredge H, Conradie F, Tiemessen CT.
HIV and Solid Organ Transplantation: Where Are we Now. Curr HIV/AIDS
Rep. 2019 Oct;16(5):404-413.
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The enactment of the HOPE Act in 2013, Public Law 113-51, amended
NOTA to eliminate the prohibition in the United States on
transplantation of organs from persons with HIV, allowing
transplantation of these organs if certain requirements are satisfied.
Under the HOPE Act, organs from donors with HIV may be transplanted
only in recipients living with HIV prior to receiving such an organ. 42
U.S.C. 274(b)(3)(A). Further, the HOPE Act requires that transplants of
HIV-positive organs occur only in recipients with HIV who are
participating in IRB-approved research protocols that adhere to certain
criteria, standards, and regulations. 42 U.S.C. 274(b)(3)(B)(i).
However, the Secretary may lift the research and IRB requirements if
the Secretary has determined that participation in such clinical
research, as a requirement for such transplants, is no longer
warranted. 42 U.S.C. 274(b)(3)(B)(ii).
The HOPE Act outlines the process by which the Secretary may make
such a determination under 42 U.S.C. 274(b)(3)(B)(ii). Specifically,
the Secretary must routinely review the results of clinical research,
in conjunction with the OPTN, to determine whether the results warrant
revision of the OPTN standards of quality regarding organs from donors
with HIV. If the Secretary determines that those standards of quality
should be revised, the Secretary must direct the OPTN to revise the
standards. 42 U.S.C. 274f-5(c)(2). The Secretary is also required to
revise the regulatory provision implementing the HOPE Act, 42 CFR
121.6, upon determining that revisions to the OPTN standards of quality
are warranted. 42 U.S.C. 274f-5(c)(3).
HRSA published a final rule implementing the HOPE Act on May 8,
2015. 80 FR 26464.\4\ The 2015 rule amended 42 CFR 121.6 to permit
transplants of organs from donors with HIV in accordance with the HOPE
Act requirements.
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\4\ Federal Register. Organ Procurement and Transplantation:
Implementation of the HIV Organ Policy Equity (HOPE) Act. 2015
May:80 FR 26464. <a href="https://www.federalregister.gov/documents/2015/05/08/2015-11048/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-act">https://www.federalregister.gov/documents/2015/05/08/2015-11048/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-act</a>.
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The HOPE Act also directs the Secretary to develop and publish
criteria for the conduct of research relating to transplantation of
organs from donors with HIV into persons who

[[Page 74176]]

are living with HIV before receiving an HIV-positive organ. 42 U.S.C.
274f-5(a). Subsequent to publication of the 2015 rule implementing the
HOPE Act, NIH published the Final Human Immunodeficiency Virus (HIV)
Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for
Transplantation of Organs Infected With HIV, on November 25, 2015. 80
FR 73785.\5\ The NIH Research Criteria were developed by an HHS working
group of entities involved in organ transplantation, with input from
multiple stakeholders.
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\5\ Federal Register. Final Human Immunodeficiency Virus (HIV)
Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for
Transplantation of Organs Infected With HIV. 2015 Nov:80 FR 73785.
<a href="https://www.federalregister.gov/documents/2015/11/25/2015-30172/final-human-immunodeficiency-virus-hiv-organ-policy-equity-hope-act-safeguards-and-research-criteria">https://www.federalregister.gov/documents/2015/11/25/2015-30172/final-human-immunodeficiency-virus-hiv-organ-policy-equity-hope-act-safeguards-and-research-criteria</a>.
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In general, the NIH Research Criteria include safeguards designed
to protect both donors and recipients, as well as healthcare providers
at Organ Procurement Organizations (OPOs), and transplant centers.
Specifically, and in addition to the requirements in established OPTN
transplant policies, donors with HIV must not have evidence of
opportunistic infections and recipients must have a stable CD4+ T-cell
count and established HIV suppression and control on effective ART. The
study team must describe the anticipated effective HIV treatment plan
and ART regimen for patients receiving an organ with a potentially
different HIV strain. Antiretroviral drugs suppress viral replication;
however, HIV may develop resistance to a specific drug necessitating a
different medication regimen to maintain effectiveness.\6\ Transplant
hospitals conducting HOPE Act operations are required to have expertise
in transplants provided to recipients with HIV. OPOs are required to
have procedures in place to address working with families of deceased
donors who lived with HIV and a biohazard plan to address viral
exposure and potential transmission. Finally, the Research Criteria
establish uniform outcome measures that must be incorporated in the
research design so that data on HOPE Act transplants can be analyzed
consistently and data collection is harmonized to inform future
implementation of the HOPE Act.
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\6\ <a href="http://HIV.gov">HIV.gov</a>. Opportunistic Infections: HIV Treatment Overview.
<a href="https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/opportunistic-infections">https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/opportunistic-infections</a>. Accessed Apr 2024.
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Publication of both the final rule implementing the HOPE Act and
the NIH Research Criteria necessitated that the OPTN update its
standards of quality for HIV-positive organ transplants and coordinate
related OPTN policies. On November 21, 2015, the OPTN published an open
variance (an experimental policy that tests methods of improving organ
allocation) providing standards for transplant hospitals conducting
HOPE Act transplants.\7\ The OPTN expanded the variance in 2019 to
include all solid organs,\8\ and extended the variance through January
2026, to provide for the gathering of data and subsequent evaluation of
the outcomes of HOPE Act transplants.\9\
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\7\ Organ Procurement and Transplantation Network. Policy
Notice: Modifications to the Open Variance for the Recovery and
Transplantation of Organs from HIV Positive Donors. 2016 Sep 1:
<a href="https://optn.transplant.hrsa.gov/media/1872/dtac_policynotice_hope_201606.pdf">https://optn.transplant.hrsa.gov/media/1872/dtac_policynotice_hope_201606.pdf</a>.
\8\ Organ Procurement and Transplantation Network. Policy
Notice: Modify HOPE Act Variance to Include Other Organs. 2019 Jun
10: <a href="https://optn.transplant.hrsa.gov/media/3000/dtac_policynotice_201906.pdf">https://optn.transplant.hrsa.gov/media/3000/dtac_policynotice_201906.pdf</a>.
\9\ Organ Procurement and Transplantation Network. Policy
Notice: Extend HIV Organ Policy Equity (HOPE) Act Variance. 2021 Dec
6: <a href="https://optn.transplant.hrsa.gov/media/t1sdej22/policy-notice_dtac_hope_variance.pdf">https://optn.transplant.hrsa.gov/media/t1sdej22/policy-notice_dtac_hope_variance.pdf</a>.
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C. Review of Research Results

As stated above, the HOPE Act requires that the Secretary, in
conjunction with the OPTN, periodically review the results of
scientific research to determine whether the results warrant revision
to the OPTN standards of quality with respect to organs from donors
with HIV and the safety of transplanting an organ from a donor with a
particular strain of HIV into a recipient with a different strain of
HIV. 42 U.S.C. 274f-5(c)(1). This review allows the Secretary to
determine if the safety and efficacy of HOPE Act transplants are
comparable to non-HOPE Act transplants and, if warranted, to further
determine whether such transplants should be conducted outside of a
research setting.
1. OPTN Review and Recommendations
In 2018, the OPTN initiated a review of research results and data
relevant to HOPE Act transplants, forming a working group for this
purpose.\10\ The OPTN's assessment as to whether revision is warranted
for the OPTN standards of quality applicable to HOPE Act transplants
was based primarily on (1) the review of studies demonstrating the
safety and outcomes of organ transplantation in recipients with HIV and
(2) a recognition that the removal of the general research and IRB
requirements for HOPE Act transplants could expand access to organ
transplantation for all patients regardless of their HIV status. In
this context, safety is measured by accidental or inadvertent
transmission of HIV in the performance of HOPE Act transplants. (Of
note, there were no recorded accidental or inadvertent transmission
events in the data reviewed by the OPTN.) Outcomes are determined
primarily by transplant recipient or graft survival, compared to non-
HOPE Act transplants or transplant recipients without HIV. Measures
(e.g., CD4+ T-cell counts, ART resistance, and detectable HIV viral
loads) or variables such as opportunistic infections, HIV
superinfection, malignancy, rejection or graft failure may also factor
into comparative outcomes in the short and long term.
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\10\ Organ Procurement and Transplantation Network. Public
Comment Proposal: Modify the HOPE Act Variance to Include Other
Organs. 2019 Jan 22: <a href="https://optn.transplant.hrsa.gov/media/2800/dtac_publiccomment_20190122.pdf">https://optn.transplant.hrsa.gov/media/2800/dtac_publiccomment_20190122.pdf</a>.
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The OPTN used three primary sources of data to assess HOPE Act
transplants, each of which contributed to the recommendation the OPTN
provided to the Secretary: (1) the research results of two NIH-funded
pilot studies evaluating HOPE Act kidney transplants and liver
transplants, and the progress of two ongoing NIH-funded clinical trials
evaluating HOPE Act kidney transplants and liver transplants, (2) the
research results of an older clinical trial analyzing safety and
efficacy of kidney transplants in a small cohort of transplant
recipients with HIV, and (3) OPTN data on the outcomes of all HOPE Act
transplants.
Pilot Studies
A multicenter pilot study funded by NIH was launched in 2016 to
determine safety and efficacy of HOPE Act kidney transplants. The HOPE
In Action Consortium of 14 transplant centers conducting HOPE Act
kidney transplants which participated in the pilot study found that
there were no major differences between HOPE Act transplants of a
kidney from a donor with HIV to a recipient with HIV and non-HOPE Act
kidney transplants from a donor without HIV to a recipient with
HIV.\11\ While donors with HIV were more likely to have co-infections,
the study found that these were manageable in the larger clinical
context. Rejection

[[Page 74177]]

was common for the study participants in the first year after
transplant, occurring in 50 percent of recipients who received a kidney
from a donor with HIV and 29 percent of recipients who received a
kidney from a donor without HIV, but this result was not found to be
statistically significant. The insignificance of the result is due, in
part, to the relatively small sample size. In addition, the
investigators indicated that this result could be due to chance. This
finding is consistent with the earlier clinical trial of kidney
transplantation in recipients with HIV, discussed in the next
subsection of this preamble, which also found that rejection of such
transplants is common. The pilot study investigators noted that despite
rejection rates, 1-year renal function was excellent for both study
populations. Limitations of the pilot study include study size (75
transplants), which investigators attributed to the lower number of
HOPE Act transplants conducted than the projected potential. In
general, the study authors concluded that there is a survival benefit
of transplantation for kidneys from donors with HIV to recipients with
HIV, and that the availability of HOPE Act kidney transplants has the
potential to mitigate disparities for a vulnerable population that
faces lower access to transplant and higher waitlist mortality. The
investigators further concluded that the observed trend toward higher
rejection, albeit not statistically significant, for transplanted
organs from donors with HIV raises concerns that merited further
investigation.
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\11\ Durand CM, Zhang W, Brown DM, Yu S, Desai N, Redd AD,
Bagnasco SM, Naqvi FF, Seaman S, Doby BL, Ostrander D, Bowring MG,
Eby Y, Fernandez RE, Friedman-Moraco R, Turgeon N, Stock P, Chin-
Hong P, Mehta S, Stosor V, Small CB, Gupta G, Mehta SA, Wolfe CR,
Husson J, Gilbert A, Cooper M, Adebiyi O, Agarwal A, Muller E, Quinn
TC, Odim J, Huprikar S, Florman S, Massie AB, Tobian AAR, Segev DL;
HOPE in Action Investigators. A prospective multicenter pilot study
of HIV-positive deceased donor to HIV-positive recipient kidney
transplantation: HOPE in action. Am J Transplant. 2021
May;21(5):1754-1764.
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A separate pilot study funded by NIH and conducted by HOPE In
Action Consortium participants compared HOPE Act transplants of a liver
from a donor with HIV to a recipient with HIV and non-HOPE Act liver
transplants from a donor without HIV to a recipient with HIV, and found
that there were no differences in one-year graft survival, rejections,
HIV breakthrough or severe adverse events. While the recipients of HOPE
Act liver transplants presented with more opportunistic infections,
infectious hospitalizations, and cancer, compared to non-HOPE Act liver
transplants, the investigators determined that these findings warrant
further investigation and perhaps consideration of additional donor and
recipient infection and malignancy monitoring. In general, the
investigators concluded that the transplant outcomes were more
favorable compared to historical data on liver transplantation in
recipients with HIV, who are known to experience higher rates of
opportunistic infections and other complications. In addition, it was
noted that co-infections are more common among both donors and
recipients with HIV and confound the results. (Results of non-HOPE Act
transplants have confirmed that recipients with both HIV and a co-
infection have lower survival rates. Therefore, the presence of co-
infections could independently impact survival and other variables
measured by studies on HOPE Act transplants.) This pilot study was the
first multicenter prospective study reporting results of U.S.
transplants of livers from donors with HIV to recipients with HIV and
comparing outcomes according to donor HIV status in order to assess
attributable risk. The investigators recognized as a limitation that
the pilot study was relatively small (45 transplants), and noted that
the observed increases among HOPE Act liver transplant recipients in
mortality, cytomegalovirus (CMV) viremia, infectious hospitalizations,
and cancer. However, they note that these results should be considered
in light of the relatively high rate of mortality for recipients
awaiting liver transplant. For these patients, the benefit of
undergoing a HOPE Act liver transplant may outweigh the risks of living
with HIV and end stage liver disease.\12\
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\12\ Durand CM, Florman S, Motter JD, Brown D, Ostrander D, Yu
S, Liang T, Werbel WA, Cameron A, Ottmann S, Hamilton JP, Redd AD,
Bowring MG, Eby Y, Fernandez RE, Doby B, Labo N, Whitby D, Miley W,
Friedman-Moraco R, Turgeon N, Price JC, Chin-Hong P, Stock P, Stosor
V, Kirchner VA, Pruett T, Wojciechowski D, Elias N, Wolfe C, Quinn
TC, Odim J, Morsheimer M, Mehta SA, Rana MM, Huprikar S, Massie A,
Tobian AAR, Segev DL; HOPE in Action Investigators. HOPE in action:
A prospective multicenter pilot study of liver transplantation from
donors with HIV to recipients with HIV. Am J Transplant. 2022
Mar;22(3):853-864.
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Ongoing Clinical Trials
Two NIH-funded studies on kidney and liver HOPE Act transplants are
ongoing. The NIH-funded U01 HOPE Act kidney transplant clinical trial
is designed to analyze rejection and long-term outcomes of kidney
transplantation for recipients with HIV. The study will compare
outcomes of 100 HOPE Act kidney transplant recipients to 100 kidney
transplant recipients with HIV who received an HIV-negative organ at 15
transplant centers, adding to the cohort accrued from the pilot studies
discussed in the immediately preceding section of this preamble.\13\
Similarly, the U01 HOPE Act liver transplant clinical trial is designed
to compare outcomes between HOPE Act transplants and non-HOPE Act
transplants of livers from donors without HIV. The study has enrolled
40 individuals in each group over 3 years at 16 transplant centers.\14\
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\13\ National Institutes of Health RePORT. Kidney
Transplantation from Donors with HIV: Impact on Rejection and Long-
term Outcomes. Project No. 5U01AI177211-02. Accessed 21 May 2024.
<a href="https://reporter.nih.gov/search/kcWJ0GeT8kigjO2_LU8R2g/project-details/10848468">https://reporter.nih.gov/search/kcWJ0GeT8kigjO2_LU8R2g/project-details/10848468</a>.
\14\ National Institutes of Health RePORT. Hope In Action: A
Clinical Trial of HIV-to-HIV Liver Transplantation. Project No.
5U01AI138897-05. Accessed 21 May 2024. <a href="https://reporter.nih.gov/project-details/10459319">https://reporter.nih.gov/project-details/10459319</a>.
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Both U01 clinical trials have reached their target enrollments and
now in phases of final data analysis (kidney) and patient follow-up
(liver). The final results are not yet published.
Other Research Results
Prior to the initiation of the pilot studies and clinical trials
discussed previously, a clinical trial examined outcomes of 150 kidney
transplants in recipients with HIV conducted between November 2003 and
June 2009. The investigators found both recipient and graft survival
rates were high with no important increases in complications associated
with HIV.\15\ As noted in the description of the findings of the HOPE
Act kidney transplant pilot study described in the immediately
preceding subsection of this preamble, the investigators observed what
they described as ``unexpectedly higher'' rejection rates in the
transplant recipients with HIV participating in the study, compared
with kidney transplant recipients who are not living with HIV. This
higher rejection rate was blunted in transplant recipients that
received anti-T-cell antibody medication at the time of
transplantation. Studies of non-HOPE Act transplants have confirmed
that such immunosuppressive regimens can reduce the risk of rejection
for kidney transplant recipients with HIV.\16\
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\15\ Stock PG, Barin B, Murphy B, Hanto D, Diego JM, Light J,
Davis C, Blumberg E, Simon D, Subramanian A, Millis JM, Lyon GM,
Brayman K, Slakey D, Shapiro R, Melancon J, Jacobson JM, Stosor V,
Olson JL, Stablein DM, Roland ME. Outcomes of kidney transplantation
in HIV-infected recipients. N Engl J Med. 2010 Nov 18;363(21):2004-
14.
\16\ Locke JE, James NT, Mannon RB, Mehta SG, Pappas PG, Baddley
JW, Desai NM, Montgomery RA, Segev DL. Immunosuppression Regimen and
the Risk of Acute Rejection in HIV-Infected Kidney Transplant
Recipients. Transplantation. 2014 Feb 27;97(4):p 446-450.
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OPTN Data--HOPE Act Transplant Outcomes
Data from HOPE Act transplants is compiled by the OPTN on a
quarterly basis, including waitlist registrations and counts of HOPE
Act transplants, and is routinely reviewed. Prior to issuing its
recommendation to the Secretary, the OPTN reviewed data on over 300
patients included in the HOPE

[[Page 74178]]

Act research variance for which no case was halted, paused, or
substantially amended to address safety concerns.
OPTN Recommendations
Based on the assessment of the above-described research results and
data, in 2021 the OPTN recommended to the Secretary that the research
and IRB requirements of the HOPE Act be removed for all organs.\17\ The
OPTN specifically noted that in its review of the data safety
monitoring review board (DSMB) reports from five years of HOPE Act
transplants, with over 300 persons with HIV receiving HOPE Act
transplants, no DSMB identified patient safety concerns in HOPE Act
research. Further, there have been no reports made to the OPTN of
safety issues regarding HOPE Act transplants among OPO, hospital, or
transplant center personnel or in patients, in donor hospitals, or
transplant hospitals. The OPTN noted that it was the opinion of the
OPTN Safety Review Group that the research and IRB requirements for
HOPE Act transplants present a barrier to fully realizing the potential
of organ transplantation from donors with HIV to recipients with HIV,
as the research and IRB requirements limit access to such
transplants.18 19
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\17\ Cooper M. ``OPTN Letter to Secretary Becerra on the HOPE
Act.'' 2021 Oct 29. <a href="https://optn.transplant.hrsa.gov/media/ueyjdfnd/hope-act-letter.pdf">https://optn.transplant.hrsa.gov/media/ueyjdfnd/hope-act-letter.pdf</a>.
\18\ McCauley J. ``Fifty Sixth ACBTSA Meeting, Written Public
Comment--November 17, 2022 Meeting.'' 2022 Nov 8. <a href="https://optn.transplant.hrsa.gov/media/hwgncda2/optn-executive-committee_acbtsa-letter.pdf">https://optn.transplant.hrsa.gov/media/hwgncda2/optn-executive-committee_acbtsa-letter.pdf</a>.
\19\ Chandran S, Stock PG, Roll GR. Expanding Access to Organ
Transplant for People Living With HIV: Can Policy Catch Up to
Outcomes Data? Transplantation. 2024 Apr 1;108(4):874-883.
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2. Additional Research Results Published Subsequent to the OPTN
Assessment
Following the OPTN's review of research results and data relevant
to HOPE Act transplants and its recommendation to the Secretary,
additional research has since been published providing more evidence
for the safety of organ transplantation from donors with HIV to
recipients with HIV. In general, safety and outcomes of kidney and
liver HOPE Act transplants is well established with over 468 HOPE Act
kidney and liver transplants conducted to date.
One prospective study published in 2022, examined 92 HOPE Act
donors contributing 177 organs, which included 131 kidneys and 46
livers, to understand the characteristics of donors with HIV in terms
of clinical, immunologic, and virologic profiles to ensure the safety
of transplantation. Of these donors, 58 were donors with HIV and 34
were donors without HIV. For those donors with known HIV infection, 90
percent received ART treatment. The study concluded that although drug
resistant mutations (DRMs) were common, DRMs that could compromise the
effectiveness of certain ART were rare, reassuring the safety of using
donor organs with HIV in recipients with HIV. Further, the study also
found that there were no major differences comorbidities between
recipient groups that received an organ from a donor with HIV compared
to those that received an organ from a donor without HIV.\20\
---------------------------------------------------------------------------

\20\ Werbel WA, Brown DM, Kusemiju OT, Doby BL, Seaman SM, Redd
AD, Eby Y, Fernandez RE, Desai NM, Miller J, Bismut GA, Kirby CS,
Schmidt HA, Clarke WA, Seisa M, Petropoulos CJ, Quinn TC, Florman
SS, Huprikar S, Rana MM, Friedman-Moraco RJ, Mehta AK, Stock PG,
Price JC, Stosor V, Mehta SG, Gilbert AJ, Elias N, Morris MI, Mehta
SA, Small CB, Haidar G, Malinis M, Husson JS, Pereira MR, Gupta G,
Hand J, Kirchner VA, Agarwal A, Aslam S, Blumberg EA, Wolfe CR, Myer
K, Wood RP, Neidlinger N, Strell S, Shuck M, Wilkins H, Wadsworth M,
Motter JD, Odim J, Segev DL, Durand CM, Tobian AAR; HOPE in Action
Investigators. National Landscape of Human Immunodeficiency Virus-
Positive Deceased Organ Donors in the United States. Clin Infect
Dis. 2022 Jun 10;74(11):2010-2019.
---------------------------------------------------------------------------

In a March 2024 analysis of the impact of the HOPE Act on access to
kidney transplantation for recipients with HIV, the authors found 70
percent of HOPE Act recipients received a kidney transplant during the
4.5 year study period versus 43 percent of non-HOPE Act transplant
candidates at the same center.\21\ Furthermore, those who received
transplants in HOPE Act trials had shorter estimated wait times (median
10.3 months versus 60.8 months), and after adjusting for relevant
allocation factors including time on dialysis, kidney transplantation
was 3.3-fold higher for those who received an organ from a donor with
HIV.\22\ These findings suggest that the availability of kidneys from
donors with HIV increases access to transplantation among people with
HIV. Given that people with HIV who are living with ESRD have higher
mortality than people with ESRD who are not also living with HIV,\23\
in HHS's view, this data illustrates the benefit of HOPE Act kidneys
transplants for this vulnerable population.
---------------------------------------------------------------------------

\21\ Motter JD, Hussain S, Brown DM, Florman S, Rana MM,
Friedman-Moraco R, Gilbert AJ, Stock P, Mehta S, Mehta SA, Stosor V,
Elias N, Pereira MR, Haidar G, Malinis M, Morris MI, Hand J, Aslam
S, Schaenman JM, Baddley J, Small CB, Wojciechowski D, Santos CAQ,
Blumberg EA, Odim J, Apewokin SK, Giorgakis E, Bowring MG, Werbel
WA, Desai NM, Tobian AAR, Segev DL, Massie AB, Durand CM; HOPE in
Action Investigators. Wait Time Advantage for Transplant Candidates
With HIV Who Accept Kidneys From Donors With HIV Under the HOPE Act.
Transplantation. 2024 Mar 1;108(3):759-767.
\22\ Motter JD, et al, on behalf of the HOPE in Action
Investigators. Wait Time Advantage for Transplant Candidates With
HIV Who Accept Kidneys From Donors With HIV Under the HOPE Act.
Transplantation. 2024 Mar 1;108(3):759-767.
\23\ Ibid.
---------------------------------------------------------------------------

In addition to providing important evidence for the survival
benefit of organ transplantation for recipients with HIV, the HOPE in
Action Consortium has also published on the positive outcomes of living
HOPE Act kidney donors. In a case series of three transplants,
investigators reported that two of the three donors developed adverse
events, but findings suggested these were medically managed and that
HIV RNA copies and CD4+ T-cell counts were stable at two to four years
post-transplant.\24\
---------------------------------------------------------------------------

\24\ Durand CM, et al, on behalf of the HOPE in Action
Investigators. Living Kidney Donors with HIV: Experience and
Outcomes from a Case Series by the HOPE in Action Consortium. The
Lancet Regional Health Americas. 2023 Jul;24:100553.
---------------------------------------------------------------------------

There is significantly less data on non-kidney and non-liver HOPE
Act transplants. Since 2019, when the OPTN's HOPE Act policy was
expanded to include all solid organs, only three heart transplant
programs have received approval to perform HOPE Act transplants. To
date, just one heart transplant has been conducted (dual organ: heart-
kidney).25 26 No HOPE Act transplants have been recorded
among recipients in need of organs such as a lung, pancreas, islet, or
intestine. The lack of data makes it difficult to assess the safety and
outcomes of HOPE Act transplants other than kidney and liver HOPE Act
transplants.
---------------------------------------------------------------------------

\25\ Montefiore News Releases. World's First HIV-Positive to
HIV-Positive Heart Transplant Performed at Montefiore Health System.
2022 Jul 22. <a href="https://www.montefiore.org/body.cfm?id=1738&action=detail&ref=2194">https://www.montefiore.org/body.cfm?id=1738&action=detail&ref=2194</a>
\26\ Hemmige V, Saeed O, Puius YA, Azzi Y, Colovai A, Borgi J,
Goldstein DJ, Rahmanian M, Carlese A, Jorde UP, Patel S. HIV D+/R+
heart/kidney transplantation: First case report. J Heart Lung
Transplant. 2023 Mar;42(3):406-408.
---------------------------------------------------------------------------

3. HHS Advisory Committee on Blood and Tissue Safety and Availability
Recommendations
Following the OPTN recommendation to the Secretary in 2021, the HHS
Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA)
formed a Working Group to evaluate the recommendation from the OPTN.
After analyzing the OPTN recommendation, and receiving presentations on
data on HOPE Act kidney and liver transplants, and relevant research
results on heart transplants and lung transplants in recipients with
HIV, the ACBTSA HOPE Act working group recommended to the full
committee that the Secretary

[[Page 74179]]

eliminate research and IRB requirements for all HOPE Act transplants.
However, the working group expressed concern about the elimination of
research and IRB requirements for non-kidney and non-liver HOPE Act
transplants,\27\ and whether there was sufficient data collected on
other organs to justify a full adoption the OPTN's recommendation.
---------------------------------------------------------------------------

\27\ HHS Advisory Committee on Blood and Tissue Safety and
Availability. 2022. Fifty-Sixth ACBTSA Meeting November 17, 2022--
Meeting Summary. <a href="https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meeting-summary/2022-11-17/index.html">https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meeting-summary/2022-11-17/index.html</a>.
---------------------------------------------------------------------------

The ACBTSA subsequently recommended that the Secretary act to lift
the statutory research and IRB requirements for all HOPE Act
transplants and at the same time recommended that the Secretary direct
the OPTN to adopt, for HOPE Act transplants of organs other than
kidneys and livers, organ-specific policies imposing additional
requirements for the conduct of these transplants, including collecting
safety and outcomes data for transplant candidates and recipients of
such transplants through an IRB-approved research protocol.
These recommendations were later approved by the HHS Blood, Organ,
and Tissue Senior Executive Council (BOTSEC), an advisory forum for
senior leadership from HHS entities involved in blood, organ, and
tissue safety and availability.
4. HHS Secretary: Review
Upon review of the OPTN, ACBTSA and BOTSEC recommendations, and in
consideration of the results of relevant scientific research, the
Secretary believes that the research and IRB requirements for kidney
and liver HOPE Act transplants are no longer warranted.
The Secretary has been informed by the research results described
in this preamble from pilot studies, clinical trials, and case reports,
as well as OPTN outcomes data on all HOPE Act transplants and
additional data. Studies of kidney and liver HOPE Act transplants have
demonstrated survival benefit for transplant recipients with HIV,
compared to non-HOPE Act transplants, with few adverse
consequences.28 29 30 Additionally, the OPTN's letter to the
Secretary noted that in five years of HOPE Act transplants with over
300 HOPE Act transplant recipients with HIV, no patient safety concerns
were identified, and no HOPE Act research has been halted, paused, or
substantially amended to address recipient safety concerns.\31\
---------------------------------------------------------------------------

\28\ Durand CM, et al; HOPE in Action Investigators. A
prospective multicenter pilot study of HIV-positive deceased donor
to HIV-positive recipient kidney transplantation: HOPE in action. Am
J Transplant. 2021 May;21(5):1754-1764.
\29\ Durand CM, et al; HOPE in Action Investigators. HOPE in
action: A prospective multicenter pilot study of liver
transplantation from donors with HIV to recipients with HIV. Am J
Transplant. 2022 Mar;22(3):853-864.
\30\ Motter JD, et al; HOPE in Action Investigators. Wait Time
Advantage for Transplant Candidates With HIV Who Accept Kidneys From
Donors With HIV Under the HOPE Act. Transplantation. 2024 Mar
1;108(3):759-767.
\31\ Cooper M. ``OPTN Letter to Secretary Becerra on the HOPE
Act.'' 2021 Oct 29. <a href="https://optn.transplant.hrsa.gov/media/ueyjdfnd/hope-act-letter.pdf">https://optn.transplant.hrsa.gov/media/ueyjdfnd/hope-act-letter.pdf</a>.
---------------------------------------------------------------------------

The outcomes of HOPE Act transplants are considered in light of the
limitations of organ transplantation generally: that too few organs are
available for the thousands of patients awaiting transplants. The
pretransplant mortality rate for adults awaiting a kidney transplant
varies substantially across the country. The average is 5.4 deaths per
100 person years, but it is reported to be as high as 7.5 deaths per
100 person years as of the most recent OPTN/SRTR Annual Data
Report.\32\ This results in most transplant candidates waiting years
for a kidney transplant, often requiring dialysis or other
interventions.
---------------------------------------------------------------------------

\32\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2022. ``Annual
Data Report: Kidney.'' Accessed May 2024. <a href="https://srtr.transplant.hrsa.gov/annual_reports/2022/Kidney.aspx">https://srtr.transplant.hrsa.gov/annual_reports/2022/Kidney.aspx</a>.
---------------------------------------------------------------------------

It is well established that pretransplant kidney mortality rates
among candidates with HIV are higher than those without HIV. In one
study analyzing survival benefit of HIV-positive kidney transplantation
(i.e., non-HOPE Act transplants), mortality rates among transplant
candidates with HIV after one year were 8.7 deaths per 100 person years
compared to just 3.1 deaths per 100 person years among those that
received a kidney transplant.\33\ Therefore, it is hypothesized that
reduction in waitlist times may indeed result in lower mortality for
transplant candidates with HIV and end-stage diseases.
---------------------------------------------------------------------------

\33\ Locke JE, Gustafson S, Mehta S, Reed RD, Shelton B,
MacLennan PA, Durand C, Snyder J, Salkowski N, Massie A, Sawinski D,
Segev DL. Survival Benefit of Kidney Transplantation in HIV-infected
Patients. Ann Surg. 2017 Mar;265(3):604-608.
---------------------------------------------------------------------------

Research has demonstrated that recipients with HIV may reduce the
time on the kidney waitlist significantly if they are willing to accept
a HOPE Act transplant. As previously mentioned, one 2023 study found
that median wait time for a HOPE Act transplant was 10.8 months
compared to 60.8 months--a 3.3-fold higher rate of kidney transplant
compared to non-HOPE Act transplants.\34\
---------------------------------------------------------------------------

\34\ Motter JD, et al; HOPE in Action Investigators. Wait Time
Advantage for Transplant Candidates With HIV Who Accept Kidneys From
Donors With HIV Under the HOPE Act. Transplantation. 2024 Mar
1;108(3):759-767.
---------------------------------------------------------------------------

Significant progress has been made in the reduction of
pretransplant mortality for liver transplant candidates over the past
decade. Rates have declined from a high of 17.9 deaths per 100 person
years in 2014 to 12.3 deaths per 100 person years in 2022.\35\ Like
kidney transplant, research has also demonstrated the survival benefit
of organ transplantation for those with HIV and end-stage liver disease
when compared to transplant candidates without HIV.\36\
---------------------------------------------------------------------------

\35\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2022. ``Annual
Data Report: Liver.'' Accessed May 2024. <a href="https://srtr.transplant.hrsa.gov/annual_reports/2022/Liver.aspx">https://srtr.transplant.hrsa.gov/annual_reports/2022/Liver.aspx</a>.
\36\ Ragni MV, Eghtesad B, Schlesinger KW, Dvorchik I, Fung JJ.
Pretransplant survival is shorter in HIV-positive than HIV-negative
subjects with end-stage liver disease. Liver Transpl. 2005
Nov;11(11):1425-30.
---------------------------------------------------------------------------

It is also hypothesized that the expansion of kidney and liver HOPE
Act transplantation will also help to reduce stigma and health
disparities associated with HIV. Stigma and physician reluctance to
counsel potential transplant candidates with HIV on the benefits of
organ transplantation may contribute to the lower than projected counts
of HOPE Act transplants to date.\37\
---------------------------------------------------------------------------

\37\ Klitenic SB, Levan ML, Van Pilsum Rasmussen SE, Durand CM.
Science Over Stigma: Lessons and Future Direction of HIV-to-HIV
Transplantation. Curr Transplant Rep. 2021;8(4):314-323.
---------------------------------------------------------------------------

The Secretary also believes that the current research and IRB
requirements should be maintained for HOPE Act transplants of all other
organs, in light of the lack of data on outcomes for HOPE Act organ
transplants other than kidney or liver transplants. At the time the
ACBTSA developed its recommendations, no HOPE Act transplants outside
of kidneys, livers, and one dual heart-kidney transplant had been
performed, and data on heart, lung, pancreas, islet, intestine, or
other organ transplants from donors with HIV to recipients with HIV
that were conducted outside the U.S. is limited.
The HOPE Act requires that, for the statutory research and IRB
requirements to be lifted for HOPE Act transplants, the Secretary must
determine that participation in such clinical research, as a
requirement for these transplants, is no longer warranted. 42 U.S.C.
274 (b)(3)(B)(ii). In the absence of research results and robust
outcomes data

[[Page 74180]]

relevant to HOPE Act transplants of organs other than kidneys and
livers, the Secretary does not have sufficient information about
transplants of organs other than kidneys and livers on which to base
the statutorily required determination.
The Secretary acknowledges that the OPTN has argued that any
research and IRB requirements serve as a barrier to access for HOPE Act
transplant candidates and may perpetuate inequities in HOPE Act
transplant programs.\38\ We believe, however, that the proposed rule
balances the need to ensure the safety of HOPE Act transplants while
removing research and IRB requirements for HOPE Act kidney and liver
transplants in transplant programs that are well established and have
demonstrated both efficacy and safety.
---------------------------------------------------------------------------

\38\ McCauley J. ``Fifty Sixth ACBTSA Meeting, Written Public
Comment--November 17, 2022 Meeting.'' 2022 Nov 8. <a href="https://optn.transplant.hrsa.gov/media/hwgncda2/optn-executive-committee_acbtsa-letter.pdf">https://optn.transplant.hrsa.gov/media/hwgncda2/optn-executive-committee_acbtsa-letter.pdf</a>.
---------------------------------------------------------------------------

D. Diversity, Equity, Inclusion: Effects on Individuals in Need of
Transplant

Currently, only a limited number of centers can perform HOPE Act
transplants, because there are specific requirements stipulated by the
NIH Research Criteria for such transplant centers. These requirements
include expertise in HIV infection management, minimum organ-specific
transplant team experience of five transplants of organs from donors
without HIV to recipients with HIV over four years and an independent
advocate for both recipients with HIV and prospective living donors
with HIV. The requirements for centers conducting HOPE Act transplants
have been subject to critique and have been viewed as a barrier to
participation in HOPE Act transplant programs, which may impact equity
and access to organ transplantation throughout the United States.\39\
By eliminating the requirement that HOPE Act kidney and liver
transplants are conducted in the research context, it is anticipated
that a larger number of transplant centers will be able to conduct such
transplants. This proposal will enable more transplant centers to
transplant kidneys and livers donated by both living and deceased
donors with HIV, in recipients with HIV, thereby expanding
opportunities for people with HIV and end-stage diseases.
---------------------------------------------------------------------------

\39\ Bowring, M.G., Ruck, J.M., Bryski, M.G., Werbel, W.,
Tobian, A.A.R., Massie, A.B., Segev, D.L., & Durand, C.M. (2023).
Impact of expanding HOPE Act experience criteria on program
eligibility for transplantation from donors with human
immunodeficiency virus to recipients with human immunodeficiency
virus. American Journal of Transplantation, 23(6), 860-864.
---------------------------------------------------------------------------

Other factors, such as systemic racism, perpetuate long-standing
inequalities and inequities in health care access including organ
transplantation. People who identify as Black or African American are
four times more likely to develop ESRD compared to non-Hispanic White
people but are less likely to receive a kidney
transplant.40 41 These outcomes are not explained by
individual characteristics alone, suggesting that other factors, such
as lower socioeconomic status and poor clinical communication,
contribute to this inequity.42 43
---------------------------------------------------------------------------

\40\ National Institute of Diabetes and Digestive and Kidney
Diseases. n.d. Kidney Disease Statistics for the United States.
Accessed February 2024. <a href="https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease">https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease</a>.
\41\ U.S. Department of Health and Human Services. Office of
Minority Health: Organ Donation and African Americans. <a href="https://minorityhealth.hhs.gov/organ-donation-and-african-americans">https://minorityhealth.hhs.gov/organ-donation-and-african-americans</a>.
Accessed 2/27/2024.
\42\ El-Khoury B, Yang TC. Reviewing Racial Disparities in
Living Donor Kidney Transplantation: a Socioecological Approach. J
Racial Ethn Health Disparities. 2023 Mar 29:1-10.
\43\ Siminoff LA, Burant CJ, Ibrahim SA. Racial disparities in
preferences and perceptions regarding organ donation. J Gen Intern
Med. 2006 Sep;21(9):995-1000.
---------------------------------------------------------------------------

Separate from organ transplantation, HIV disproportionately affects
people of some racial and ethnic groups in the United States, such as
Black or African American and Hispanic or Latino populations.
Prevalence rates suggest these communities have higher rates of HIV
compared to White populations. For example, according to the Centers
for Disease Control and Prevention's (CDC) HIV Surveillance
Supplemental Report, 2023, people who identified as Black or African
American represented 12.4 percent of the population but 40.2 percent of
those with diagnosed HIV in 2021.\44\ In addition, people identified as
Hispanic or Latino represent 17.6 percent of the population but make up
23.8 percent of people with diagnosed HIV.\45\ Incidence rates also
confirm that new infections disproportionately affect Black or African
Americans (40 percent of new infections), and Hispanic or Latinos (29
percent of new infections), suggesting that prevention efforts are not
adequately reaching these populations.\46\ Higher prevalence and
incidence rates among communities over-represented in the HIV epidemic
suggest that these communities would also benefit from expanded access
to HOPE Act transplants. In fact, in one 2019 study of HOPE Act
deceased-donor characteristics, investigators found a higher proportion
of people who identify as Black or African American (72 percent) among
HOPE Act kidney transplant recipients than the percent of Black or
African Americans in the general population. Among recipient
characteristics of HOPE Act liver transplant recipients in the same
study, 23 percent identified as Black or African American.\47\
---------------------------------------------------------------------------

\44\ Centers for Disease Control and Prevention. Estimated HIV
incidence and prevalence in the United States, 2017-2021. HIV
Surveillance Supplemental Report, 2023; 28 (No.3). <a href="https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html">https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html</a>. Published May
2023.
\45\ Ibid.
\46\ Centers for Disease Control and Prevention. Estimated HIV
incidence and prevalence in the United States, 2017-2021. HIV
Surveillance Supplemental Report, 2023; 28 (No.3). <a href="https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html">https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html</a>. Published May
2023.
\47\ Wilk AR, Hunter RA, McBride MA, Klassen DK. National
landscape of HIV+ to HIV+ kidney and liver transplantation in the
United States. American Journal of Transplantation 2019;19(9):2594-
2605.
---------------------------------------------------------------------------

In addition to racial and ethnic diversity, gay, bisexual, and
other men who have sex with men (MSM) are the most affected group of
people with HIV, accounting for 66 percent of new infections in 2021
even though they only compose 2 percent of the
population.48 49 Lastly, people who identify as transgender
represent 2 percent of all new HIV diagnoses, exceeding the proportion
of people who identify as transgender in the general population.\50\
---------------------------------------------------------------------------

\48\ Centers for Disease Control and Prevention. Surveillance
Supplemental Report, 2023, 2003 May;28(No.3). <a href="https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html">https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html</a>.
\49\ Purcell DW, Johnson CH, Lansky A, et al. Estimating the
population size of men who have sex with men in the United States to
obtain HIV and syphilis rates. Open AIDS J 2012; 6:98-107.
\50\ Centers for Disease Control and Prevention. HIV
Surveillance Report, 2021; vol. 34. <a href="https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html">https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html</a>. Published May 2023.
---------------------------------------------------------------------------

In light of all of these considerations, HHS expects that this
proposed rule, if finalized, will assist in improving access to kidney
and liver transplants for recipients with HIV. This anticipated
positive result is consistent with the Department's commitment to
diversity, equity, and inclusion.
Further, this proposed rule to remove research and IRB requirements
for kidney and liver HOPE Act transplants would, if finalized, expand
access to organ transplantation for all patients, regardless of their
HIV status. When eligible for transplant, a person with HIV is added to
the waiting list. That patient may elect to receive an organ from a
donor with HIV, as a HOPE Act transplant, should it become available,
or may choose to wait for an organ from a donor who did not have HIV.
If the patient with HIV chooses the HOPE Act

[[Page 74181]]

transplant, this will allow another patient on the waiting list to
receive the next available organ from a donor who does not have HIV,
which would reduce the time spent waiting for a transplant. Of note,
patients who do not have HIV will not be offered an organ from a donor
who has HIV, as such transplants are not allowed under Federal law.
As of February 16, 2024, more than 103,000 men, women, and children
were on the national organ transplant waiting list.\51\ Every 10
minutes another person is added to the waiting list, and nearly 20
people die every day while waiting for a transplant.\52\ The current
approach to acquiring organs for transplantation relies on the altruism
of donors and their families.
---------------------------------------------------------------------------

\51\ Organ Procurement and Transplantation Network. 2024.
Dashboard and metrics. Accessed February 2024. <a href="https://insights.unos.org/OPTN-metrics/">https://insights.unos.org/OPTN-metrics/</a>.
\52\ Health Resources and Services Administration. Organ
Donation Statistics. Accessed February 2024. <a href="https://www.organdonor.gov/learn/organ-donation-statistics">https://www.organdonor.gov/learn/organ-donation-statistics</a>.
---------------------------------------------------------------------------

According to the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), more than 1 in 7 adults in the U.S. are
affected by kidney disease.\53\ Of those, more than 800,000 Americans
are living with end-stage renal disease (ESRD), a condition that often
requires renal dialysis or kidney transplant.\54\ Kidney transplants in
2023 set a new record, offering 27,332 ESRD patients and their families
a life-changing organ.\55\ Despite upward trends in the number of
kidney transplants conducted year over year, tens of thousands of
Americans remain on the waiting list, which currently exceeds 88,700
candidates.\56\ The 2022 OPTN/U.S. Scientific Registry of Transplant
Recipients (SRTR) Annual Data Report indicated that over the course of
a year more than 4,400 adults died while waiting for a kidney
transplant, and an additional 4,500 persons were removed from the
waiting list because they became too sick to receive a transplant.\57\
Furthermore, at least 562,000 Americans endure renal dialysis each
year, often while awaiting a kidney transplant.\58\
---------------------------------------------------------------------------

\53\ National Institute of Diabetes and Digestive and Kidney
Diseases. n.d. Kidney Disease Statistics for the United States.
Accessed February 2024. <a href="https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease">https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease</a>.
\54\ National Institute of Diabetes and Digestive and Kidney
Diseases. n.d. Kidney Disease Statistics for the United States.
Accessed Feb 2024. <a href="https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease">https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease</a>.
\55\ Ibid.
\56\ Organ Procurement and Transplantation Network. Dashboard
and metrics. <a href="https://insights.unos.org/OPTN-metrics/">https://insights.unos.org/OPTN-metrics/</a>. Accessed Feb
2024.
\57\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2021. ``Annual
Data Report.'' Accessed Feb 2024. <a href="https://srtr.transplant.hrsa.gov/annual_reports/2021_ADR_Preview.aspx">https://srtr.transplant.hrsa.gov/annual_reports/2021_ADR_Preview.aspx</a>.
\58\ National Institute of Diabetes and Digestive and Kidney
Diseases. n.d. Kidney Disease Statistics for the United States.
Accessed Feb 2024. <a href="https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease">https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease</a>.
---------------------------------------------------------------------------

In addition, thousands of Americans suffer from conditions
requiring liver transplant. In 2023, more than 10,660 liver transplants
were carried out with organs from both living and deceased donors,
setting an all-time record.\59\ As of February 16, 2024, 9,882
candidates remain on the waiting list, but additional registrations are
expected throughout the year.\60\ In 2021, more than 1,100 liver
patients died while awaiting transplant, according to the OPTN/SRTR
Annual Data Report.\61\
---------------------------------------------------------------------------

\59\ United Network for Organ Sharing (UNOS). February 14, 2024.
A decade of record increases in liver transplant. Accessed Feb 2024.
<a href="https://unos.org/news/in-focus/a-decade-of-record-increases-in-liver-transplant/">https://unos.org/news/in-focus/a-decade-of-record-increases-in-liver-transplant/</a>.
\60\ Organ Procurement and Transplantation Network. Dashboard
and metrics. <a href="https://insights.unos.org/OPTN-metrics/">https://insights.unos.org/OPTN-metrics/</a>. Accessed Feb
2024.
\61\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2021. ``Annual
Data Report.'' Accessed February 2024. <a href="https://srtr.transplant.hrsa.gov/annual_reports/2021_ADR_Preview.aspx">https://srtr.transplant.hrsa.gov/annual_reports/2021_ADR_Preview.aspx</a>.
---------------------------------------------------------------------------

As such, HHS believes regulatory changes designed to increase the
number of organs available for donation, such as those proposed in this
rule, could mitigate these outcomes. HHS is committed to reducing the
number of persons on the organ transplant waiting list by increasing
the number of organs made available for transplantation.

E. Implementation Considerations

1. NIH Research Criteria
The HOPE Act provides the Secretary with the discretion to
determine what research criteria should apply to HOPE Act transplants.
42 U.S.C. 274f-5(a). If this proposed rule is finalized, HHS
anticipates that NIH will, in consultation with HRSA and the OPTN, and
including the input of other relevant Federal stakeholders, revise and
publish updated Research Criteria in the Federal Register for public
comment later this year. The Research Criteria, as originally drafted,
include a strong focus on HOPE Act kidney and liver transplants, as
these are the most common types of HOPE Act transplants. As the current
Research Criteria will no longer be applicable to HOPE Act kidney and
liver transplants once the Secretary's determination is implemented,
much of the current criteria will no longer be relevant.
Further, HHS recognizes it will be appropriate to update the NIH
Research Criteria to reflect advances in research in the time since
HOPE Act transplants began. The research criteria should reflect the
current needs of various entities involved in HOPE Act transplants in
consideration of input from transplant centers, transplant surgeons,
OPOs, HIV clinicians, donors, recipients, HIV advocates, the OPTN, and
individuals affected by the HOPE Act.
2. Secretarial Direction To Revise OPTN Policies
Should this proposed rule be finalized, the Secretary must direct
the OPTN to update its policies to clarify that HOPE Act kidney and
liver transplants may be conducted in a way consistent with the
statutory requirements at 42 U.S.C. 274, and that ensures the revisions
to the policies will not reduce the safety of organ transplantation. 42
U.S.C. 274f-5(c)(2); 42 CFR 121.6(b)(3). Through this NPRM, HHS
specifically seeks public comment on the nature and content of the
Secretary's direction to the OPTN, including the level of specificity
in the direction and the extent of the OPTN's discretion in developing
the revised policies; what factors should be considered in assessing
whether the revised policies are consistent with 42 U.S.C. 274; and
what factors should be considered in assessing whether the revisions to
the OPTN policies will not reduce the safety of organ transplantation.
HHS further welcomes comment on any other aspects relating to the
Secretary's direction to the OPTN to revise its standards of quality as
required by the HOPE Act.
HHS expects that the OPTN would solicit public comment on a
proposed revision to relevant OPTN policies, and update the OPTN
policies containing standards of quality with respect to kidneys and
livers from donors with HIV, within 15 months from the publication of a
final rule.

F. Secretarial Determination

The Secretary has reviewed the recommendations of the OPTN, the
ACBTSA, and the BOTSEC on implementation of the HOPE Act, and the
results of research on HOPE Act transplants conducted to date as well
as results of other relevant research on organ transplants in
recipients with HIV. Pursuant to his authority under the HOPE Act, 42
U.S.C. 274(b)(3)(B)(ii), and consistent with the implementing
regulations at 42 CFR 121.6, the Secretary proposes to determine that
participation in clinical research, and

[[Page 74182]]

therefore adherence to research and IRB requirements, as a requirement
for transplants of kidneys and livers from persons with HIV, is no
longer warranted. Through this rulemaking, the Secretary proposes to
lift the statutory research and IRB requirements for such transplants.
Through this NPRM, HHS specifically seeks public comment on the
Secretary's proposed determination that participation in clinical
research, and application of the statutory research and IRB
requirements, as a requirement for transplants of kidneys and livers
from persons with HIV, is no longer warranted.

III. Discussion of the Proposed Rule

A. Removal of Research and IRB Requirements for HOPE Act Kidney and
Liver Transplants

Consistent with the Secretary's proposed determination under the
HOPE Act, this proposed rule, if finalized, will revise Sec. 121.6 of
the HHS regulations governing the OPTN to reflect the removal of the
statutory research and IRB requirements for kidney and liver HOPE Act
transplants.
HHS proposes to revise Sec. 121.6(b)(1)(ii)(B) to reflect the
Secretary's proposed determination that participation in clinical
research is no longer warranted for the following categories of
transplants:
(1) Transplant of a donor kidney with HIV; and
(2) Transplant of a donor liver with HIV.
In implementation, this proposal, if approved, would mean that HOPE
Act kidney and liver transplants will no longer be conducted as
research, and instead will be conducted in accordance with newly
adopted OPTN policies regarding kidneys and livers from donors with
HIV.

B. Revised Terminology: Persons With HIV

HHS is aware that previous language used in enacting and
implementing the HOPE Act contained vocabulary and phrases that some
people find stigmatizing--namely, references to ``infected with HIV''
when the regulatory language encompasses both living and deceased
donors with HIV, or recipients with HIV. For the references to both
living and deceased donors with HIV, HHS proposes to revise all current
references in Sec. 121.6(b) from ``individuals infected with human
immunodeficiency virus (HIV)'' and ``individuals infected with HIV'' to
``donors with HIV'' or, when discussing organs donated, ``donor organs
with HIV.'' Further, HHS proposes to revise the current reference in
Sec. 121.6(b)(1)(i) describing the allowable recipients of HOPE Act
transplants from individuals who are ``infected with HIV before
receiving such organ(s)'' to instead refer to individuals who are
``living with HIV before receiving such organ(s).'' This is consistent
with the Centers for Disease Control and Prevention's (CDC) Stigma
Language Guide.\62\
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\62\ Centers for Disease Control and Prevention. Let's Stop HIV
Together: Stigma Language Guide. <a href="https://www.cdc.gov/stophivtogether/hiv-stigma/ways-to-stop.html">https://www.cdc.gov/stophivtogether/hiv-stigma/ways-to-stop.html</a>. Accessed 2/23/2024.
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HHS is proposing these new regulatory references to ``donors with
HIV'' and ``living with HIV'' with the intent to be respectful, and not
to change the group of people referenced in the current Sec. 121.6.

V. Explanation of the 30-Day Public Comment Period

HHS is publishing this proposed rule with a 30-day public comment
period, as multiple opportunities for public input on the matters
addressed through this rulemaking already have been provided. HHS has
been collecting public commentary on the HOPE Act since the OPTN
provided its HOPE Act recommendations to Secretary Becerra in October
2021. ACBTSA heard a summary of the OPTN's consideration of the HOPE
Act soon after its December 1, 2021 public meeting. Following this
presentation, ACBTSA formed a working group to develop a recommendation
regarding the HOPE Act. During the ACBTSA's November 17, 2022 public
meeting, ACBTSA received written public comment on its proposed
recommendations to the Secretary regarding removing the research and
IRB requirements for kidney and liver HOPE Act transplantations.\63\
---------------------------------------------------------------------------

\63\ HHS Advisory Committee on Blood and Tissue Safety and
Availability. 2022. Fifty-Sixth ACBTSA Meeting November 17, 2022--
Meeting Summary.
---------------------------------------------------------------------------

HHS has actively engaged transplant surgeons, researchers,
advocates, donors, and recipients involved in organ transplantation in
the course of drafting a recommendation to the Secretary. The
Department has reviewed dozens of comments received in response to
discussions held by the ACBTSA, the BOTSEC and the Presidential
Advisory Council on HIV/AIDS (PACHA).64 65 The Department
understands that there is widespread support for the proposed
recommendation including the endorsement of at least 35 non-
governmental organizations involved in HIV advocacy, organizations
representing entities involved in organ transplantation, associations
representing transplant surgeons, nephrologists, HIV clinicians,
epidemiologists, and many more individuals.
---------------------------------------------------------------------------

\64\ 79th Presidential Advisory Council on HIV/AIDS (PACHA) Full
Council Meeting [verbar]12.06.23 [verbar] Part 4. Uploaded by U.S.
Department of Health and Human Services. 2023 Dec 14. <a href="https://www.youtube.com/watch?v=oHM3ygWpMek">https://www.youtube.com/watch?v=oHM3ygWpMek</a>.
\65\ HHS Presidential Advisory Council on HIV/AIDS (PACHA).
Seventy-Ninth PACHA Meeting December 6, 2023--Meeting Summary. 2023
Dec 6. <a href="https://files.hiv.gov/s3fs-public/2024-03/PACHA-Dec-2023-meeting-summary-final.pdf">https://files.hiv.gov/s3fs-public/2024-03/PACHA-Dec-2023-meeting-summary-final.pdf</a>.
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Given the multiple committees and policy mechanisms employed for
discussion of potential changes to requirements for HOPE Act
transplants, previous efforts to gather public commentary and the
considerable public health impact this proposed policy may have on
those in need of organ transplantation, HHS believes the 30-day public
comment period is sufficient and most expedient.

VI. Paperwork Reduction Act of 1995

This proposed rule, if finalized, would not impose any additional
information collection burden under the Paperwork Reduction Act and
does not contain any information collection requirements beyond those
already imposed by current regulations, which have been approved by the
Office of Management and Budget. The current data collection
requirements in the OPTN final rule approved by the OMB under the
Paperwork Reduction Act of 1995 are assigned control numbers OMB No.
0915-0157 (for organ donors, candidates, and recipients) and OMB No.
0915-0184 (for OPTN membership application data).

VII. Preliminary Economic Analysis of Impacts

We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act (5 U.S.C. 801, Pub. L. 104-121), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all
benefits, costs, and transfers 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, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866
section 3(f)(1) (as amended by Executive Order 14094) if they have an
annual effect on the economy of $200 million or more (adjusted every 3
years

[[Page 74183]]

by the Administrator of the Office of Information and Regulatory
Affairs (OIRA) for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or Tribal governments or
communities. This analysis indicates that this proposed rule is a
significant regulatory action under Executive Order 12866 section
3(f)(1).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the impacts are small relative to the number of organ
transplants performed annually, and because the costs are small
relative to the average payroll of firms in the smallest enterprise
size category, we propose to certify that the proposed rule will not
have a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (UMRA) generally requires
that each agency conduct a cost-benefit analysis, identify and consider
a reasonable number of regulatory alternatives, and select the least
costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule before promulgating any proposed or
final rule that includes a Federal mandate that may result in
expenditures of more than $100 million (adjusted for inflation) in at
least one year by State, local, and Tribal governments, or by the
private sector. Each agency must also seek input from State, local, and
Tribal governments.\66\ The current threshold after adjustment for
inflation using the Implicit Price Deflator for the Gross Domestic
Product is $183 million, reported in 2023 dollars. This proposed rule,
if finalized, would not result in an unfunded mandate in any year that
meets or exceeds this amount.
---------------------------------------------------------------------------

\66\ U.S. Office of Management and Budget, Office of Information
and Regulatory Affairs. ``2018, 2019, and 2020 Report to Congress on
the Benefits and Costs of Federal Regulations and Agency Compliance
with the Unfunded Mandates Reform Act.'' <a href="https://www.whitehouse.gov/wp-content/uploads/2021/01/2018_2019_2020-OMB-Cost-Benefit-Report.pdf">https://www.whitehouse.gov/wp-content/uploads/2021/01/2018_2019_2020-OMB-Cost-Benefit-Report.pdf</a>.
---------------------------------------------------------------------------

This proposed rule would, if finalized, remove the current research
and institutional review board (IRB) requirements for transplants of
human immunodeficiency virus (HIV)-positive kidneys and livers. This
would result in impacts related to changes in the number of kidney and
liver transplants performed annually. We monetize benefits associated
with increases in life expectancy for organ transplant recipients and,
for kidney transplant recipients, benefits associated with improved
quality of life and time savings from fewer kidney dialysis visits. We
monetize costs from medical expenditures associated with organ
transplantation; for kidney transplants, we report impacts that are net
of medical expenditures associated with kidney dialysis. We also
monetize costs associated with organ transplant centers reading and
understanding the rule, reviewing policies and procedures, and training
staff. We report the shift in expenditures associated with kidney
dialysis to expenditures associated with kidney transplantation
separately as transfers. We estimate that the annualized benefits over
a 10-year time horizon covering 2025 through 2034 would range from $561
million to $1.26 billion at a 2 percent discount rate, with a primary
estimate of $900 million. The annualized costs would range from $134
million to $174 million, with a primary estimate of $154 million. The
annualized transfers would range from $24 million to $39 million, with
a primary estimate of $31 million.

Table 1--Summary of Impacts of the Proposed Rule
[Millions of constant 2023 dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
Primary Low High Discount Time
Category estimate estimate estimate Dollar year or unit rate (%) horizon Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
BENEFITS:
Annualized monetized benefits... $900 $561 $1,261 2023........................ 2 2025-2034 Increased life expectancy
for organ transplant
recipients; improved
quality of life for kidney
transplant recipients; time
savings from fewer kidney
dialysis visits.
Annualized quantified, but non- 147 129 166 People affected............. 2 2025-2034 Improved quality of life for
monetized, benefits. liver transplant
recipients.
Unquantified benefits........... ......... ......... ......... ............................ ......... 2025-2034 Time savings for caregivers;
cost savings related to
removing the research and
institutional review board
requirements.
COSTS:
Annualized monetized costs...... $154 $134 $174 2023........................ 2 2025-2034 Net costs associated with
organ transplants; costs
associated with organ
transplant centers reading
and understanding the rule,
reviewing policies and
procedures, and training
staff.
TRANSFERS:
Annualized monetized transfers.. $31 $24 $39 2023........................ 2 2025-2034 Shift in expenditures
associated with kidney
dialysis to expenditures
associated with kidney
transplantation.
NET BENEFITS:
Annualized monetized net $746 $412 $1,101 2023........................ 2 2025-2034 ............................
benefits.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: primary, low, and high estimates correspond to the mean, 5th percentile, and 95th percentile of the outcomes of a Monte Carlo simulation.

We have developed a comprehensive preliminary economic analysis of
impacts that assesses the impacts of the proposed rule, which is
available in the docket for this proposed rule Document ID HRSA-2024-
0001.

List of Subjects in 42 CFR Part 121

Health care, Hospitals, Transplant centers, Organ transplantation,
Reporting and recordkeeping requirements.

[[Page 74184]]

Dated: September 6, 2024.
Xavier Becerra,
Secretary.

Accordingly, by the authority vested in me as the Secretary of
Health and Human Services, and for the reasons set forth in the
preamble, 42 CFR part 121 is proposed to be amended as follows:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

0
1. The authority citation for part 121 continues to read as follows:

Authority: Sections 215, 371-77, and 377E of the PHS Act (42
U.S.C. 216, 273-274d, 274f-5); sections 1102, 1106, 1138 and 1871 of
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8, and 1395hh);
section 301 of the National Organ Transplant Act, as amended (42
U.S.C. 274e); and E.O. 13879, 84 FR 33817.

0
2. In Sec. 121.6, revise paragraph (b) to read as follows:

Sec. 121.6 Organ procurement.

* * * * *
(b) HIV. (1) Organs from donors with human immunodeficiency virus
(HIV) may be transplanted only into individuals who--
(i) Are living with HIV before receiving such organ(s); and
(ii)(A) Are participating in clinical research approved by an
institutional review board, as defined in 45 CFR part 46, under the
research criteria published by the Secretary under subsection (a) of
section 377E of the Public Health Service Act, as amended; or
(B) The Secretary has published, through appropriate procedures, a
determination under section 377E(c) of the Public Health Service Act,
as amended, that participation in such clinical research, as a
requirement for transplants of donor organs with HIV, is no longer
warranted. The Secretary has determined that participation in such
clinical research is no longer warranted for the following categories
of transplants:
(1) Transplant of a donor kidney with HIV; and
(2) Transplant of a donor liver with HIV.
(2) Except as provided in paragraph (b)(3) of this section, the
OPTN shall adopt and use standards of quality with respect to donor
organs with HIV to the extent the Secretary determines necessary to
allow the conduct of research in accordance with the criteria described
in paragraph (b)(1)(ii)(A) of this section.
(3) If the Secretary has determined under paragraph (b)(1)(ii)(B)
of this section that participation in clinical research is no longer
warranted as a requirement for transplants of donor organs with HIV,
the OPTN shall adopt and use standards of quality with respect to donor
organs with HIV as directed by the Secretary, consistent with 42 U.S.C.
274, and in a way that ensures the changes will not reduce the safety
of organ transplantation.
* * * * *
[FR Doc. 2024-20643 Filed 9-11-24; 8:45 am]
BILLING CODE 4150-28-P

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