74174 Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules 

5The July 14, 2022, local effective version of the 

last sentence of Rule 3D .0535(f) contains a change 

that incorporates a reference to regulations not 

approved into the SIP. If EPA takes final action to 

approve the November 28, 2022, SIP revision, the 

Agency will update the SIP table at 40 CFR 

52.1770(c) to reflect the retention of the September 

14, 1998, version of the aforementioned sentence. 

6 If EPA takes final action to approve the 

November 28, 2022, SIP revision, the SIP-approved 

version of Rule 3D .0535(c) will read, ‘‘(Paragraph 

(c) is not included in Forsyth County’s portion of 

the State Implementation Plan.),’’ and the SIPapproved version of .0535(g) will read, ‘‘(Paragraph 

(g) is not included in Forsyth County’s portion of 

the State Implementation Plan.).’’ The Agency 

would update the SIP table at 40 CFR 52.1770(c) to 

reflect this fact. 

sentence of Rule 3D .0535(f),5 and in 

Rule 3D .0535(c) and (g), is proposing to 

incorporate only the statements that 

each paragraph ‘‘is not included in 

Forsyth County’s portion of the State 

Implementation Plan.’’ 6 EPA has made 

and will continue to make these 

materials generally available through 

www.regulations.gov and at the EPA 

Region 4 office (please contact the 

person identified in the FOR FURTHER

INFORMATION CONTACT section of this 

preamble for more information). 

V. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve State choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely approves State law as meeting 

Federal requirements and does not 

impose additional requirements beyond 

those imposed by State law. For that 

reason, this proposed action: 

• Is not a significant regulatory action 

subject to review by the Office of 

Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 14094 (88 FR 

21879, April 11, 2023); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not subject to Executive Order 

13045 (62 FR 19885, April 23, 1997) 

because it approves a State program; 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); and 

• Is not subject to requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA. 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where EPA or an 

Indian Tribe has demonstrated that a 

Tribe has jurisdiction. In those areas of 

Indian country, the rule does not have 

Tribal implications and will not impose 

substantial direct costs on Tribal 

governments or preempt Tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

Executive Order 12898 (Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations, 59 FR 7629, 

February 16, 1994) directs Federal 

agencies to identify and address 

‘‘disproportionately high and adverse 

human health or environmental effects’’ 

of their actions on minority populations 

and low-income populations to the 

greatest extent practicable and 

permitted by law. EPA defines 

environmental justice (EJ) as ‘‘the fair 

treatment and meaningful involvement 

of all people regardless of race, color, 

national origin, or income with respect 

to the development, implementation, 

and enforcement of environmental laws, 

regulations, and policies.’’ EPA further 

defines the term fair treatment to mean 

that ‘‘no group of people should bear a 

disproportionate burden of 

environmental harms and risks, 

including those resulting from the 

negative environmental consequences of 

industrial, governmental, and 

commercial operations or programs and 

policies.’’ 

The FCEAP did not evaluate EJ 

considerations as part of its SIP 

submittal; the CAA and applicable 

implementing regulations neither 

prohibit nor require such an evaluation. 

EPA did not perform an EJ analysis and 

did not consider EJ in this proposed 

action. Due to the nature of the 

proposed action being taken here, this 

proposed action is expected to have a 

neutral to positive impact on the air 

quality of the affected area. 

Consideration of EJ is not required as 

part of this proposed action, and there 

is no information in the record 

inconsistent with the stated goal of E.O. 

12898 of achieving environmental 

justice for communities with EJ 

concerns. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: September 6, 2024. 

Jeaneanne Gettle, 

Acting Regional Administrator, Region 4. 

[FR Doc. 2024–20666 Filed 9–11–24; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules 74175 

1Werbel WA, Durand CM. Solid Organ 

Transplantation in HIV-Infected Recipients: 

History, Progress, and Frontiers. Curr HIV/AIDS 

Rep. 2019 Jun;16(3):191–203. 

2Muller E, Barday Z, Mendelson M, Kahn D. HIVPositive to HIV-Positive Kidney Transplantation— 

Results at 3 to 5 Years. New England Journal of 

Medicine. 2015 Feb 12;372(7):613–620. 

3Botha 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. 

4Federal Register. Organ Procurement and 

Transplantation: Implementation of the HIV Organ 

Policy Equity (HOPE) Act. 2015 May:80 FR 26464. 

https://www.federalregister.gov/documents/2015/ 

05/08/2015-11048/organ-procurement-andtransplantation-implementation-of-the-hiv-organpolicy-equity-act. 

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: 

https://www.regulations.gov. 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 www.regulations.gov [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 donation@hrsa.gov; 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 https://www.regulations.gov, 

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 

https://www.regulations.gov. 

Docket: For access to the docket and 

to read background documents or 

comments received, go to https://

regulations.gov, 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

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. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74176 Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules 

5Federal 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. https://www.federalregister.gov/ 

documents/2015/11/25/2015-30172/final-humanimmunodeficiency-virus-hiv-organ-policy-equityhope-act-safeguards-and-research-criteria. 

6HIV.gov. Opportunistic Infections: HIV 

Treatment Overview. https://www.hiv.gov/hivbasics/staying-in-hiv-care/other-related-healthissues/opportunistic-infections. Accessed Apr 2024. 

7Organ 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: 

https://optn.transplant.hrsa.gov/media/1872/dtac_

policynotice_hope_201606.pdf. 

8Organ Procurement and Transplantation 

Network. Policy Notice: Modify HOPE Act Variance 

to Include Other Organs. 2019 Jun 10: https://

optn.transplant.hrsa.gov/media/3000/dtac_

policynotice_201906.pdf. 

9Organ Procurement and Transplantation 

Network. Policy Notice: Extend HIV Organ Policy 

Equity (HOPE) Act Variance. 2021 Dec 6: https:// 

optn.transplant.hrsa.gov/media/t1sdej22/policynotice_dtac_hope_variance.pdf. 

10Organ Procurement and Transplantation 

Network. Public Comment Proposal: Modify the 

HOPE Act Variance to Include Other Organs. 2019 

Jan 22: https://optn.transplant.hrsa.gov/media/ 

2800/dtac_publiccomment_20190122.pdf. 

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. 

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. 

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+ Tcell 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. 

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

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 nonHOPE 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. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules 74177 

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. 

13National 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. https:// 

reporter.nih.gov/search/kcWJ0GeT8kigjO2_LU8R2g/ 

project-details/10848468. 

14National Institutes of Health RePORT. Hope In 

Action: A Clinical Trial of HIV-to-HIV Liver 

Transplantation. Project No. 5U01AI138897–05. 

Accessed 21 May 2024. https://reporter.nih.gov/ 

project-details/10459319. 

15Stock 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. 

16Locke 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. 

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. 

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 coinfections 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

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 longterm 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 nonHOPE 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

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 antiT-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

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 


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17Cooper M. ‘‘OPTN Letter to Secretary Becerra 

on the HOPE Act.’’ 2021 Oct 29. https://

optn.transplant.hrsa.gov/media/ueyjdfnd/hope-actletter.pdf. 

18McCauley J. ‘‘Fifty Sixth ACBTSA Meeting, 

Written Public Comment—November 17, 2022 

Meeting.’’ 2022 Nov 8. https://

optn.transplant.hrsa.gov/media/hwgncda2/optnexecutive-committee_acbtsa-letter.pdf. 

19Chandran 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. 

20Werbel 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, FriedmanMoraco 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. 

21Motter 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. 

22Motter 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. 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. 

25Montefiore News Releases. World’s First HIVPositive to HIV-Positive Heart Transplant 

Performed at Montefiore Health System. 2022 Jul 

22. https://www.montefiore.org/ 

body.cfm?id=1738&action=detail&ref=2194 

26Hemmige 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. 

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 abovedescribed 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

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

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 nonHOPE 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. 

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 posttransplant.24

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. 

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 


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27HHS Advisory Committee on Blood and Tissue 

Safety and Availability. 2022. Fifty-Sixth ACBTSA 

Meeting November 17, 2022—Meeting Summary. 

https://www.hhs.gov/oidp/advisory-committee/ 

blood-tissue-safety-availability/meeting-summary/ 

2022-11-17/index.html. 

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. 

30Motter 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. 

31Cooper M. ‘‘OPTN Letter to Secretary Becerra 

on the HOPE Act.’’ 2021 Oct 29. https:// 

optn.transplant.hrsa.gov/media/ueyjdfnd/hope-actletter.pdf. 

32Organ Procurement and Transplantation 

Network (OPTN)/Scientific Registry of Transplant 

Recipients (SRTR). 2022. ‘‘Annual Data Report: 

Kidney.’’ Accessed May 2024. https://

srtr.transplant.hrsa.gov/annual_reports/2022/ 

Kidney.aspx. 

33Locke 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 HIVinfected Patients. Ann Surg. 2017 Mar;265(3):604– 

608. 

34Motter 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. 

35Organ Procurement and Transplantation 

Network (OPTN)/Scientific Registry of Transplant 

Recipients (SRTR). 2022. ‘‘Annual Data Report: 

Liver.’’ Accessed May 2024. https://

srtr.transplant.hrsa.gov/annual_reports/2022/ 

Liver.aspx. 

36Ragni 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. 

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. 

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 nonliver HOPE Act transplants,27 and 

whether there was sufficient data 

collected on other organs to justify a full 

adoption the OPTN’s recommendation. 

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

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. 

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 HIVpositive 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. 

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

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

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

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 


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38McCauley J. ‘‘Fifty Sixth ACBTSA Meeting, 

Written Public Comment—November 17, 2022 

Meeting.’’ 2022 Nov 8. https://

optn.transplant.hrsa.gov/media/hwgncda2/optnexecutive-committee_acbtsa-letter.pdf. 

39Bowring, 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. 

40National Institute of Diabetes and Digestive and 

Kidney Diseases. n.d. Kidney Disease Statistics for 

the United States. Accessed February 2024. https:// 

www.niddk.nih.gov/health-information/healthstatistics/kidney-disease. 

41U.S. Department of Health and Human 

Services. Office of Minority Health: Organ Donation 

and African Americans. https://

minorityhealth.hhs.gov/organ-donation-andafrican-americans. Accessed 2/27/2024. 

42El-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. 

43Siminoff LA, Burant CJ, Ibrahim SA. Racial 

disparities in preferences and perceptions regarding 

organ donation. J Gen Intern Med. 2006 

Sep;21(9):995–1000. 

44Centers for Disease Control and Prevention. 

Estimated HIV incidence and prevalence in the 

United States, 2017–2021. HIV Surveillance 

Supplemental Report, 2023; 28 (No.3). https://

www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2023. 

45 Ibid. 

46Centers for Disease Control and Prevention. 

Estimated HIV incidence and prevalence in the 

United States, 2017–2021. HIV Surveillance 

Supplemental Report, 2023; 28 (No.3). https://

www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2023. 

47Wilk 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. 

48Centers for Disease Control and Prevention. 

Surveillance Supplemental Report, 2023, 2003 

May;28(No.3). https://www.cdc.gov/hiv/library/ 

reports/hiv-surveillance.html. 

49Purcell 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. 

50Centers for Disease Control and Prevention. 

HIV Surveillance Report, 2021; vol. 34. https://

www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2023. 

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. 

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. 

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

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

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

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 


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51Organ Procurement and Transplantation 

Network. 2024. Dashboard and metrics. Accessed 

February 2024. https://insights.unos.org/OPTNmetrics/. 52Health Resources and Services Administration. 

Organ Donation Statistics. Accessed February 2024. 

https://www.organdonor.gov/learn/organ-donationstatistics. 53National Institute of Diabetes and Digestive and 

Kidney Diseases. n.d. Kidney Disease Statistics for 

the United States. Accessed February 2024. https:// 

www.niddk.nih.gov/health-information/healthstatistics/kidney-disease. 

54National Institute of Diabetes and Digestive and 

Kidney Diseases. n.d. Kidney Disease Statistics for 

the United States. Accessed Feb 2024. https://

www.niddk.nih.gov/health-information/healthstatistics/kidney-disease. 

55 Ibid. 

56Organ Procurement and Transplantation 

Network. Dashboard and metrics. https://

insights.unos.org/OPTN-metrics/. Accessed Feb 

2024. 

57Organ Procurement and Transplantation 

Network (OPTN)/Scientific Registry of Transplant 

Recipients (SRTR). 2021. ‘‘Annual Data Report.’’ 

Accessed Feb 2024. https://srtr.transplant.hrsa.gov/ 

annual_reports/2021_ADR_Preview.aspx. 

58National Institute of Diabetes and Digestive and 

Kidney Diseases. n.d. Kidney Disease Statistics for 

the United States. Accessed Feb 2024. https://

www.niddk.nih.gov/health-information/healthstatistics/kidney-disease. 

59United Network for Organ Sharing (UNOS). 

February 14, 2024. A decade of record increases in 

liver transplant. Accessed Feb 2024. https://

unos.org/news/in-focus/a-decade-of-recordincreases-in-liver-transplant/. 

60Organ Procurement and Transplantation 

Network. Dashboard and metrics. https://

insights.unos.org/OPTN-metrics/. Accessed Feb 

2024. 

61Organ Procurement and Transplantation 

Network (OPTN)/Scientific Registry of Transplant 

Recipients (SRTR). 2021. ‘‘Annual Data Report.’’ 

Accessed February 2024. https://

srtr.transplant.hrsa.gov/annual_reports/2021_ADR_

Preview.aspx. 

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. 

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 lifechanging 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

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

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74182 Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules 

62Centers for Disease Control and Prevention. 

Let’s Stop HIV Together: Stigma Language Guide. 

https://www.cdc.gov/stophivtogether/hiv-stigma/ 

ways-to-stop.html. Accessed 2/23/2024. 

63HHS Advisory Committee on Blood and Tissue 

Safety and Availability. 2022. Fifty-Sixth ACBTSA 

Meeting November 17, 2022—Meeting Summary. 

64 79th Presidential Advisory Council on HIV/ 

AIDS (PACHA) Full Council Meeting |12.06.23 | Part 

4. Uploaded by U.S. Department of Health and 

Human Services. 2023 Dec 14. https:// 

www.youtube.com/watch?v=oHM3ygWpMek. 

65HHS Presidential Advisory Council on HIV/ 

AIDS (PACHA). Seventy-Ninth PACHA Meeting 

December 6, 2023—Meeting Summary. 2023 Dec 6. 

https://files.hiv.gov/s3fs-public/2024-03/PACHADec-2023-meeting-summary-final.pdf. 

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 § 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 

§ 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 § 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 § 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

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 § 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

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 nongovernmental organizations involved in 

HIV advocacy, organizations 

representing entities involved in organ 

transplantation, associations 

representing transplant surgeons, 

nephrologists, HIV clinicians, 

epidemiologists, and many more 

individuals. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules 74183 

66U.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.’’ https://www.whitehouse.gov/wp-content/ 

uploads/2021/01/2018_2019_2020-OMB-CostBenefit-Report.pdf. 

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. 

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 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Dollar year 

or unit 

Discount 

rate 

(%) 

Time 

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 nonmonetized, benefits.147 129 166 People affected .... 2 2025–2034 Improved quality of life for 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 benefits.$746 $412 $1,101 2023 ..................... 2 2025–2034 

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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74184 Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules 

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 

■ 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. 

■ 2. In § 121.6, revise paragraph (b) to 

read as follows: 

§ 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 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1 and 64 

[GN Docket No. 24–213; MD Docket No. 10– 

234; FCC 24–85; FR ID 240720] 

Improving the Effectiveness of the 

Robocall Mitigation Database; 

Amendment of CORES Registration 

System 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) proposes and seeks 

comment on procedural measures that 

would require Robocall Mitigation 

Database filers to take additional steps 

to ensure the accuracy of submitted 

information, potential technical 

solutions for validating data, 

accountability measures to ensure and 

improve the overall quality of 

submissions in the Robocall Mitigation 

Database, and generally invites 

comment on any other procedural steps 

the Commission could require to 

increase the effectiveness of the 

Robocall Mitigation Database as a 

compliance and consumer protection 

tool. 

DATES: Comments are due on or before 

October 15, 2024, and reply comments 

are due on or before November 12, 2024. 

ADDRESSES: Pursuant to §§ 1.415 and 

1.419 of the Commission’s rules, 47 CFR 

1.415, 1.419, interested parties may file 

comments and reply comments on or 

before the dates indicated above. 

Comments may be filed using the 

Commission’s Electronic Comment 

Filing System (ECFS). See Electronic 

Filing of Documents in Rulemaking 

Proceedings, 63 FR 24121 (1998). 

• Electronic Filers: Comments may be 

filed electronically using the internet by 

accessing ECFS: https://www.fcc.gov/ 

ecfs/. 

• Paper Filers: Parties who choose to 

file by paper must file an original and 

one copy of each filing. 

• Filings can be sent by commercial 

overnight courier, or by first-class or 

overnight U.S. Postal Service mail. All 

filings must be addressed to the 

Commission’s Secretary, Office of the 

Secretary, Federal Communications 

Commission. 

• Hand-delivered or messengerdelivered paper filings for the 

Commission’s Secretary are accepted 

between 8 a.m. and 4 p.m. by the FCC’s 

mailing contractor at 9050 Junction 

Drive, Annapolis Junction, MD 20701. 

All hand deliveries must be held 

together with rubber bands or fasteners. 

Any envelopes and boxes must be 

disposed of before entering the building. 

• Commercial courier deliveries (any 

deliveries not by the U.S. Postal Service) 

must be sent to 9050 Junction Drive, 

Annapolis Junction, MD 20701. 

• Filings sent by U.S. Postal Service 

First-Class Mail, Priority Mail, and 

Priority Mail Express must be sent to 45 

L Street NE, Washington, DC 20554. 

Accessible Formats. To request 

materials in accessible formats for 

people with disabilities (Braille, large 

print, electronic files, audio format), 

send an email to fcc504@fcc.gov or call 

the Consumer & Governmental Affairs 

Bureau at 202–418–0530 (voice). 

FOR FURTHER INFORMATION CONTACT: For 

further information about the Notice of 

Proposed Rulemaking (NPRM), contact 

Erik Beith, Attorney Advisor, 

Competition Policy Division, Wireline 

Competition Bureau, at Erik.Beith@

fcc.gov. For additional information 

concerning the Paperwork Reduction 

Act proposed information collection 

requirements contained in this 

document, send an email to PRA@

fcc.gov or contact Nicole Ongele at (202) 

418–2991. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s NPRM in 

GN Docket No. 24–213, MD Docket No. 

10–234, released on August 8, 2024. The 

complete text of this document is 

available for download at https://

docs.fcc.gov/public/attachments/FCC24-85A1.pdf. 

Paperwork Reduction Act: The NPRM 

may contain proposed new and revised 

information collection requirements. 

The Commission, as part of its 

continuing effort to reduce paperwork 

burdens, invites the general public and 

the Office of Management and Budget 

(OMB) to comment on the information 

collection requirements contained in 

this document, as required by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13. In addition, 

pursuant to the Small Business 

Paperwork Relief Act of 2002, Public 

Law 107–198, see 44 U.S.C. 3506(c)(4), 


ddrumheller on DSK120RN23PROD with PROPOSALS1