93484 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 

and IMmb meeting the standards in 

204.2.0. 

* * * * * 

507 Mailer Services 

* * * * * 

5.0 Package Intercept 

* * * * * 

5.3 Adding Extra Services 

[Revise the third sentence in the 

introductory text of 5.3 to read as 

follows:] 

* * * The relabeled item will be 

assigned a new barcode applicable to 

the extra service purchased.* * * 

* * * * * 

600 Basic Standards for All Mailing 

Services 

601 Mailability 

1.0 General Standards 

* * * * * 

1.2 Overweight Items or Oversize 

Items 

* * * * * 

1.2.3 Fee 

[Revise the text of 1.2.3 to read as 

follows:] 

Except for an overweight or oversize 

item discovered and picked up at the 

same facility where it was entered, the 

overweight/oversize item fee of $200 

will be assessed and must be paid before 

release of the item. The $200 overweight 

or oversize item fee may be paid by any 

authorized retail payment method or 

through PostalOne!. 

* * * * * 

604 Postage Payment Methods and 

Refunds 

* * * * * 

9.0 Exchanges and Refunds 

* * * * * 

9.2 Postage and Fee Refunds 

* * * * * 

9.2.4 Postage and Fee Refunds Not 

Available 

Refunds are not made for the 

following: 

* * * * * 

[Revise 9.2.4 by adding an item j to 

read as follows:] 

j. For the Package Intercept per-piece 

fee once the USPS successfully 

intercepts the mailpiece (507.5.2) or the 

Live Animal and Perishable Handling 

fee once the piece is entered in the 

network. 

* * * * * 

609 Filing Indemnity Claims for Loss 

or Damage 

1.0 General Filing Instructions 

* * * * * 

1.2.2 Eligibilty 

Eligibility for mailers to submit claims 

using the Bulk Indemnity Claims feature 

is based on the following: 

* * * * * 

[Revise the text of item b to read as 

follows:] 

b. IMpb and IMmb compliance 

history. 

* * * * * 

1.3 Who May File 

A claim may be filed by: 

* * * * * 

[Revise the text of item c to read as 

follows:] 

c. Only the account holder, for USPS 

Returns packages that are insured as 

identified by the account holder’s 

mailer identification (MID) and the 

applicable STC for insurance imbedded 

into the IMpb and IMmb on the label, 

and for which the account holder has 

provided electronic data that supports 

the value of the merchandise being 

returned (see 503.4.3.1a). 

* * * * * 

700 Special Standards 

* * * * * 

705 Advanced Preparation and 

Special Postage Payment Systems 

* * * * * 

18.0 Priority Mail Express Open and 

Distribute and Priority Mail Open and 

Distribute 

* * * * * 

18.5 Preparation 

* * * * * 

18.5.7 Address Label Service Barcode 

Requirement 

[Revise first and third through fifth 

sentences in the introductory text of 

18.5.7 to read as follows:] 

An electronic service barcode must 

include an Intelligent Mail package 

barcode (IMpb) and Intelligent Mail 

matrix barcode (IMmb) (eVS approved 

mailers) symbology for Priority Mail 

Express Open and Distribute, and the 

IMpb and IMmb symbology for Priority 

Mail Open and Distribute in the address 

label.* * * * * * Priority Mail Express 

Open and Distribute IMpb and IMmb 

labels must include service type code 

‘‘723.’’ For Priority Mail Open and 

Distribute, the IMpb and IMmb must 

include service type code ‘‘123.’’ The 

human-readable text ‘‘USPS SCAN ON 

ARRIVAL’’ must appear above the IMpb 

barcode.* * * 

* * * * * 

[Add an IMmb in the address block to 

the left of the delivery address to the 

label graphics in Exhibits 18.5.8 through 

18.5.12.] 

* * * * * 

Index 

* * * * * 

I 

* * * * * 

Intelligent Mail 

* * * * * 

[Revise the ‘‘Intelligent Mail’’ entry by 

alphabetically adding the following:] 

matrix barcode, 204.2.0 

* * * * * 

Notice 123 (Price List) 

[Revise competitive prices as 

applicable.] 

* * * * * 

Colleen Hibbert-Kapler, 

Attorney, Ethics and Legal Compliance. 

[FR Doc. 2024–27463 Filed 11–26–24; 8:45 am] 

BILLING CODE 7710–12–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: Final rule. 

SUMMARY: The Department of Health and 

Human Services (HHS) amends 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 

kidneys 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 determines 

that participation in such clinical 

research should no longer be a 

requirement for transplantation of 

kidneys and livers from donors with 

HIV to recipients with HIV. This final 

rule serves as publication of the 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 93485 

1Federal Register. Organ Procurement and 

Transplantation: Implementation of the HIV Organ 

Policy Equity (HOPE) Act. 80 FR 26464 (May 8, 

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

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

2Federal Register. Final Human 

Immunodeficiency Virus (HIV) Organ Policy Equity 

(HOPE) Act Safeguards and Research Criteria for 

Transplantation of Organs Infected With HIV. 80 FR 

73785 (Nov. 25, 2015). https:// 

www.federalregister.gov/documents/2015/11/25/ 

2015-30172/final-human-immunodeficiency-virushiv-organ-policy-equity-hope-act-safeguards-andresearch-criteria. 

Secretary’s determination and amends 

the regulations to reflect this 

determination. This final rule also 

serves as publication of the Secretary’s 

direction to the Organ Procurement and 

Transplantation Network (OPTN) to 

adopt and use standards of quality with 

respect to kidneys and livers from 

donors with HIV to ensure that HOPE 

Act kidney and liver transplants are 

subject to OPTN policies that are 

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: This rule is effective November 

27, 2024. 

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

On September 12, 2024, HHS

published a notice of proposed 

rulemaking (NPRM) in the Federal 

Register (89 FR 74174) proposing both 

that the Secretary of HHS determine that 

participation in clinical research should 

no longer be required for transplantation 

of kidneys and livers from donors with 

HIV to recipients with HIV, and that the 

HHS regulations at 42 CFR part 121 

implementing the HOPE Act be 

amended consistent with this proposed 

determination. The NPRM provided for 

a 30-day comment period, and HHS 

received 56 comments raising a variety 

of issues. HHS has carefully considered 

all comments in developing this rule, as 

outlined in section III, below, and 

presents a summary of all significant 

comments and Departmental responses. 

II. Background

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 CFR part 

121. The OPTN is also charged with

developing policies on many subjects

related to organ donation, procurement,

and transplantation, which include

establishing standards of quality

pertaining to organs procured for use in 

transplantation. 42 U.S.C. 274(b)(2)(E). 

B. HOPE Act Requirements and

Implementation

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 scientific 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 26464.1 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 

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, the 

National Institutes of Health (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 

73785.2

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 

antiretroviral therapy (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. 

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 


ddrumheller on DSK120RN23PROD with RULES1
93486 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 

3Organ 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. 

4Organ 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. 

5Organ 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. 

6Organ 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. 

7 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. 

methods of improving organ allocation) 

providing standards for transplant 

hospitals conducting HOPE Act 

transplants.3 The OPTN expanded the 

variance in 2019 to include all solid 

organs,4 and extended the variance 

through January 2026, to provide for the 

gathering of data and subsequent 

evaluation of the outcomes of HOPE Act 

transplants.5

C. Review of Research Results 

The Secretary, in conjunction with 

the OPTN, reviewed 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 

allowed 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.6 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 pilot studies evaluating HOPE Act 

kidney transplants and liver transplants, 

and the progress of two ongoing NIHfunded 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 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 found 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.7 Rates of 

opportunistic infections and infections 

requiring hospitalization post-transplant 

did not differ significantly across the 

study arms. Rejection 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 statistically significant. 

The insignificance of the result is due, 

in part, to the relatively small sample 

size. 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 higher 

rejection rates in HIV allografts. 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 merited further investigation. 

A separate pilot study 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 nonHOPE 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.) 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 93487 

8 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. 

9National 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. 

10National 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. 

11Stock 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. 

12Locke 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. 

13Cooper M. ‘‘OPTN Letter to Secretary Becerra 

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

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

14McCauley 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. 

15Chandran 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. 

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 increases 

among HOPE Act liver transplant 

recipients in mortality, cytomegalovirus 

(CMV) viremia, infectious 

hospitalizations, and cancer, were 

observed. 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.8

Ongoing Clinical Trials 

The OPTN further considered the 

progress of an NIH-funded study on 

HOPE Act kidney transplants that was 

ongoing at the time of the OPTN’s 

analysis. The NIH-funded U01 HOPE 

Act kidney transplant clinical trial was 

designed to analyze rejection and longterm outcomes of kidney transplantation 

for recipients with HIV. While the study 

was subsequently expanded, at the time 

of the OPTN’s consideration the study 

was designed to 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.9 The results from this clinical 

trial were published in October 2024 

and are described in section 3, 

‘‘Additional Research Results Published 

Subsequent to Issuance of the NPRM,’’ 

below. Of note, these investigators were 

awarded an expansion grant to evaluate 

longer-term outcomes in HOPE Act 

kidney transplants. 

Similarly, the OPTN considered the 

progress of an ongoing U01 HOPE Act 

liver transplant clinical trial 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,10 reaching 

target enrollment, and now is in the 

phase of patient follow-up. 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.11 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.12

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 

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.13 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.14 15

2. Additional Research Results 

Published Subsequent to the OPTN 

Assessment 

Prior to publication of the NPRM, the 

Secretary further considered additional 

research published providing more 

evidence for the safety of organ 

transplantation from donors with HIV to 

recipients with HIV. In general, this 

research demonstrates that the safety 

and outcomes of kidney and liver HOPE 

Act transplants are well established, 

with over 517 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, 


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93488 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 

16Werbel 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. 

17Motter 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. 

18Motter 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. 

19Motter 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. 

20 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. 

21Montefiore 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. 

22Hemmige 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. 

23C.M. Durand, A. Massie, S. Florman, T. Liang, 

M.M. Rana, R. Friedman-Moraco, A. Gilbert, P. 

Stock, S.A. Mehta, S. Mehta, V. Stosor, M.R. 

Pereira, M.I. Morris, J. Hand, S. Aslam, M. Malinis, 

G. Haidar, C.B. Small, C.A.Q. Santos, J. Schaenman, 

J. Baddley, D. Wojciechowski, E.A. Blumberg, K. 

Ranganna, O. Adebiyi, N. Elias, J.A. Castillo-Lugo, 

E. Giorgakis, S. Apewokin, D. Brown, D. Ostrander, 

Y. Eby, N. Desai, F. Naqvi, S. Bagnasco, N. Watson, 

E. Brittain, J. Odim, A.D. Redd, A.A.R. Tobian, and 

D.L. Segev, for the HOPE in Action Investigators. 

Safety of Kidney Transplantation from Donors with 

HIV. New England Journal of Medicine. 2024 Oct 

17; 391(15): 1390–1401. 

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 

organs from donors with HIV in 

recipients with HIV. Further, the study 

also found that there were no major 

differences in 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.16

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.17 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.18 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 end stage renal 

disease (ESRD) have higher mortality 

than people with ESRD who are not also 

living with HIV,19 in HHS’s view, this 

data illustrates the benefit of HOPE Act 

kidney transplants for this vulnerable 

population. 

The HOPE in Action Consortium also 

has published information 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.20

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 three heart 

transplants have been conducted, 

including one heart-kidney 

transplant.21 22 No HOPE Act transplants 

have been recorded among recipients in 

need of other organs. 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. Additional Research Results 

Published Subsequent to Issuance of the 

NPRM 

Since publication of the NPRM, 

results from a new, groundbreaking 

study were published in October 2024.23

In the largest prospective, observational, 

multicenter study to date, researchers 

compared transplantation of kidneys at 

26 U.S. centers from deceased donors 

with HIV and donors without HIV to 

recipients with HIV. The study enrolled 

408 transplantation candidates, of 

whom 198 received a kidney from a 

deceased donor; 99 received a kidney 

from a donor with HIV and 99 from a 

donor without HIV. This study was 

larger than the HOPE Act pilot study, 

described above, and was designed to 

assess whether kidney transplantation 

from donors with HIV to recipients with 

HIV would be noninferior to 

transplantation from donors without 

HIV. The study further assessed safety 

and post-transplantation complications. 

The primary outcome assessed was a 

safety outcome (a composite of death 

from any cause, graft loss, serious 

adverse event, HIV breakthrough 

infection, persistent failure of HIV 

treatment, or opportunistic infection) for 

noninferiority (margin for the upper 

bound of the 95% confidence interval, 

3.00). Researchers found an adjusted 

hazard ratio of 1.00 for the primary 

composite outcome, demonstrating 

noninferiority of kidney transplantation 

from donors with HIV as compared to 

kidney transplantation from donors 

without HIV. 

Secondary outcomes included overall 

survival, survival without graft loss, 

rejection, infection, cancer, and HIV 

superinfection. The following secondary 

outcomes were similar whether the 

donor had HIV or not: overall survival 

at 1 year (94% vs. 95%) and 3 years 

(85% vs. 87%), survival without graft 

loss at 1 year (93% vs. 90%) and 3 years 

(84% vs. 81%), and rejection at 1 year 

(13% vs. 21%) and 3 years (21% vs. 

24%). 

The incidence of serious adverse 

events, infections, and cancer was 

similar in all groups studied. Of note, 

the incidence of HIV breakthrough 

infection was approximately three times 

higher among HOPE Act transplants 

(incidence rate ratio, 3.14; 95% CI, 1.02 

to 9.63), which the researchers 

attributed to non-adherence to 

antiretroviral therapy. In all participants 

with HIV breakthrough infection, viral 

suppression was regained. A single case 

of potential HIV superinfection or dual 

infection occurred among the 58 

recipients in this group, without HIV 

breakthrough infection or clinical 

consequences. 


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Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 93489 

24HHS 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. 

Among the acknowledged limitations 

of this study are the lack of true 

randomization, which the authors note 

was not possible due to the U.S. 

national organ allocation process. The 

authors further note that study 

participants were equally eligible for a 

kidney from a donor with or a donor 

without HIV, and that study group 

assignment was determined according 

to whichever organ was available first. 

The study group whose donors did not 

have HIV served as a control group and 

included 27 donors who were treated as 

having HIV during allocation but did 

not; in the authors’ estimation, 

recipients of kidneys from these donors 

represent an ideal counterfactual control 

group. Immunosuppression and 

prophylaxis were heterogeneous; 

however, these factors were balanced 

between the two groups and reflect realworld practice, which the authors assert 

increases the generalizability of the 

study results. 

This study is an important addition to 

the evidence base for HOPE Act kidney 

transplants in that the finding that 

kidney transplantation from donors 

with HIV was noninferior to kidney 

transplantation from donors without 

HIV with respect to the primary safety 

outcome, and that the incidence of 

serious adverse events, infections, 

surgical or vascular complications, and 

cancer was similar in the two groups, 

supporting the safety of HOPE Act 

kidney transplants. 

4. HHS Advisory Committee on Blood 

and Tissue Safety and Availability 

Recommendations 

The Secretary also considered the 

HHS Advisory Committee on Blood and 

Tissue Safety and Availability 

(ACBTSA) recommendation that the 

Secretary eliminate research and IRB 

requirements for all HOPE Act 

transplants. The ACBTSA working 

group developing this recommendation 

considered the OPTN recommendation 

and the results of relevant scientific 

research. While the ACBTSA working 

group proposed that the full committee 

recommend that the Secretary eliminate 

research and IRB requirements for all 

HOPE Act transplants, the working 

group expressed concern about the 

elimination of research and IRB 

requirements for non-kidney and nonliver HOPE Act transplants,24 and 

whether there was sufficient data 

collected on other organs to justify a full 

adoption of 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. 

Upon review of the OPTN, ACBTSA 

and BOTSEC recommendations, and in 

consideration of the results of relevant 

scientific research, the Secretary 

proposed to determine that the research 

and IRB requirements for kidney and 

liver HOPE Act transplants are no 

longer warranted. The NPRM 

incorporated this approach, publishing 

the Secretary’s proposed determination 

for comment, and proposing regulatory 

changes to exempt HOPE Act kidney 

and liver transplants from research and 

IRB requirements. In an effort to avoid 

the use of stigmatizing language, the 

NPRM further proposed wording 

changes to references to persons, 

donors, and recipients with HIV, and 

organs from individuals with HIV. 

III. Discussion of Public Comment 

HHS received 56 comments from 

individuals and organizations involved 

in healthcare, organ transplantation, 

HIV advocacy, health equity, 

LGTBQIA+ health, and HOPE Act 

clinical research. The comments 

received expressed overwhelming 

support for the finalization of this rule. 

A total of 55 of the 56 commenters 

expressed support for the proposed rule. 

One commenter did not support the 

proposed rule. Additional consideration 

was given to comments that were 

expressed by multiple individuals and 

entities. HHS has considered all of the 

comments, and, in response to 

comments regarding the use of nonstigmatizing language, made changes to 

the final rule as suggested by 

commenters. 

Themes identified in many comments 

include that the proposed rule, if 

finalized, could reduce morbidity and 

mortality for people with HIV, reduce 

barriers to organ transplantation, 

increase organ utilization, reduce wait 

times for people on organ transplant 

wait lists, and reduce stigma and 

discrimination associated with HIV. 

One commenter indicated that, given 

that only 31 of the 250 transplant 

centers in the U.S. currently participate 

in HOPE Act clinical trials, access to 

these vital transplants is geographically 

limited: the proposed rule would 

encourage more transplant centers to 

offer HOPE Act transplants, enabling 

more equitable access to life-saving care 

for people with HIV across the country 

and helping to generate additional 

clinical data to enhance understanding 

and inform best practices in transplant 

care for people with HIV. In addition, 

numerous commenters noted that 

research has sufficiently demonstrated 

that HOPE Act kidney and liver 

transplants are both safe and effective. 

The NPRM specifically invited public 

comment on the future Secretarial 

direction to the OPTN to revise the 

standards of quality concerning kidneys 

and livers from donors with HIV. Some 

commenters provided specific 

suggestions for the Secretary’s direction, 

and other comments received appear 

relevant to HHS’s consideration as to 

the content of the direction to the 

OPTN. These comments are noted 

below in both the subheading 

discussing the comments specifically 

provided on the content of the direction 

to the OPTN, and the subheadings 

relating to the subject matter of the 

comment. HHS has considered these 

comments in the development of the 

Secretary’s direction to the OPTN, 

which is provided in section V, 

‘‘Implementation Considerations,’’ 

below. 

Multiple commenters also provided 

specific suggestions for the content of 

the revised NIH Research Criteria, and 

other comments received appear 

relevant to the content of the Research 

Criteria. These comments are noted 

below in both the subheading 

discussing the comments specifically 

provided on the Research Criteria, as 

well as in the subheadings relating to 

the subject matter of the comment when 

the commenter did not specifically 

reference the Research Criteria. All 

comments relating to the content of the 

revised Research Criteria were provided 

to NIH for consideration in the 

development of the revised Research 

Criteria. 

Detailed descriptions of comments on 

specific aspects of the NPRM preamble 

and the proposed regulation, and HHS’s 

responses to these comments, are 

provided below. 


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25Cooper M. ‘‘OPTN Letter to Secretary Becerra 

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

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

Removal of Research and IRB 

Requirements for All Organs 

Several commenters suggested that 

the Secretary should consider in this 

rule, or in a future rulemaking, the 

removal of research and IRB 

requirements for all HOPE Act organ 

transplants instead of removing research 

and IRB requirements only for kidney 

and liver transplants. Some of these 

commenters referenced the October 

2021 letter from the OPTN to the 

Secretary providing that the OPTN had 

not identified any patient safety 

concerns involving HOPE Act 

transplants and that no research 

protocols applicable to HOPE Act 

transplants had been stopped, paused, 

or substantially altered due to patient 

safety concerns.25 Many of these 

comments suggested that the available 

data was sufficient to prove the safety 

and efficacy of HOPE Act 

transplantation for all organ transplants, 

not only kidney and liver transplants. 

Others suggested that HHS should 

continue supporting research on HOPE 

Act transplants with the goal of 

generating sufficient evidence to make 

the case for a future Secretarial 

determination and rulemaking process 

that would remove the research and IRB 

requirements for all HOPE Act 

transplants. 

HHS response: In the process leading 

up to the development of the NPRM, the 

Secretary considered whether to 

eliminate research and IRB 

requirements for all HOPE Act 

transplants. As a part of this process, the 

Secretary considered the October 2021 

communication from the OPTN 

referenced by commenters, 

recommendations of advisory bodies, 

and research results and outcomes data 

on HOPE Act transplants. The vast 

majority of this data was generated from 

kidney and liver transplants, and, as 

discussed in the NPRM preamble, the 

Secretary notes the limited evidence 

demonstrating safety and efficacy of 

non-kidney and non-liver HOPE Act 

transplants. In order to lift the research 

and IRB requirements for HOPE Act 

transplants, the HOPE Act requires that 

the Secretary must determine that 

participation in clinical research is no 

longer warranted. 42 U.S.C. 

274(b)(3)(B)(ii). In the absence of 

research results and robust outcomes 

data 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. For this reason, the 

NPRM proposal to lift the research and 

IRB requirements only for HOPE Act 

kidney and liver transplants is 

incorporated in this final rule. As 

required by the HOPE Act, the Secretary 

will periodically review the results of 

additional scientific research relevant to 

transplants of organs other than kidneys 

and livers, and will reevaluate in the 

future whether the evidence is robust 

enough to demonstrate that other types 

of HOPE Act transplants need not be 

conducted in the research context. HHS 

makes no changes to the regulatory 

proposal in response to these comments. 

Language Regarding HIV 

Many commenters expressed support 

for the proposed revisions to the 

regulatory language used when 

referencing people, donors, and 

recipients with HIV. In general, 

commenters suggested that the proposed 

changes are more respectful, reflect a 

person-centered approach, and help to 

combat stigma associated with HIV. 

Others noted that these wording 

changes help to create a more inclusive 

healthcare environment. 

One commenter requested that the 

proposed modification to 42 CFR 121.6 

regarding references to donor organs be 

changed from ‘‘donor organ(s) with 

HIV’’ to ‘‘organ(s) from donors with 

HIV.’’ The commenter stated that, in 

their view, the term ‘‘organs from 

donors with HIV’’ is accurate and 

precise, stigma-reducing, and reflects a 

person-first approach in describing 

these donated organs. 

HHS response: HHS appreciates this 

feedback, and includes the regulatory 

revisions in this final rule as proposed 

with regard to references to people, 

donors, and recipients with HIV. 

Further, HHS concurs with the 

suggested revision provided by the 

commenter with respect to the 

references to donor organs, and has 

incorporated this suggested revision and 

other similar revisions in the final rule 

at 42 CFR 121.6(b)(1)(ii)(B) introductory 

text, (b)(1)(ii)(B)(1) and (2), and (b)(2). 

Ongoing Data Monitoring 

Multiple commenters expressed 

support for efforts to monitor outcomes 

of HOPE Act transplants, both for 

patient safety and to develop evidence 

for the safety and efficacy of HOPE Act 

transplants. 

Commenters addressing patient safety 

indicated that while the proposed rule 

may streamline the transplant process 

and increase the availability of organs, 

patient safety must be the top priority 

and rigorous safety standards must 

continue to apply. Several commenters 

noted that areas needing further 

attention, such as monitoring for 

rejection, malignancy, and infection, do 

not overshadow the overall favorable 

outcomes for HOPE Act kidney and 

liver transplants. Commenters 

emphasized the importance of 

continued monitoring of outcomes for 

these transplants by the OPTN, and that 

transparency and public communication 

of these outcomes are critical to 

maintaining trust and ensuring the 

ongoing success of HOPE Act transplant 

programs. Commenters indicated that 

application of the NIH Research Criteria 

has provided essential protections with 

regard to outcomes monitoring for 

HOPE Act kidney and liver transplants, 

and urged continued monitoring of 

HOPE Act transplants to ensure these 

protections are maintained. 

Other commenters expressed that data 

monitoring could help HOPE Act 

transplant recipients and HOPE Act 

living donors who may need to be 

monitored for the development of 

chronic or end-stage conditions. For 

example, one commenter noted that 

living kidney donors ‘‘are already at 

higher risk of kidney disease and will 

now only have one kidney.’’ 

Commenters addressing evidence 

development noted that monitoring and 

evaluation of HOPE Act transplants may 

help develop evidence that will inform 

future policy, including a potential 

future implementation of the HOPE Act 

to remove research and IRB 

requirements for all HOPE Act organ 

transplants. 

Several commenters indicated that 

current data monitoring requirements 

applicable to all organ transplants are 

sufficient. One commenter indicated 

that there is no reason to continue 

monitoring HOPE Act kidney and liver 

transplant outcomes above and beyond 

the baseline safety and outcomes 

monitoring for all organ transplants in 

the United States. One commenter 

indicated that the OPTN structure and 

outcome data collected are sufficient in 

their current state to provide oversight 

for all organs. Another commenter 

indicated comfort with appropriate 

oversight and data management by the 

organizations designated to oversee 

transplant services on a national level, 

which could include comprehensive 

reporting systems to track outcomes and 

address any issues promptly. The 

commenter further expressed an 

expectation that this information be 

made available to the public is a 

transparent manner. 

HHS response: HHS notes that the 

final rule does not affect existing data 


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Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 93491 

26Organ Procurement and Transplantation 

Network. OPTN Policies. Updated October 31, 

2024. https://optn.transplant.hrsa.gov/media/ 

eavh5bf3/optn_policies.pdf. 

27Organ Procurement and Transplantation 

Network. OPTN Policies. Updated October 31, 

2024. https://optn.transplant.hrsa.gov/media/ 

eavh5bf3/optn_policies.pdf. 

monitoring or evaluation requirements 

for HOPE Act transplants, as these are 

determined by OPTN policy and the 

NIH Research Criteria. HHS agrees that 

patient safety remains a paramount 

concern and that appropriate safety 

standards apply to protect organ donors 

and transplant recipients. Further, HHS 

expects to utilize data on HOPE Act 

transplant outcomes in its ongoing 

evaluation of the HOPE Act. These 

comments were provided to the NIH 

working group for consideration in the 

development of revisions to the 

Research Criteria. Further, HHS 

considered these comments in 

developing the Secretary’s direction to 

the OPTN to revise the OPTN standards 

of quality embodied in OPTN policy 

regarding organs from donors with HIV. 

HHS makes no changes to the regulatory 

proposal in response to these comments. 

Standards for Transplant Centers 

Performing HOPE Act Transplants 

Several commenters provided 

suggestions for transplant centers that 

are seeking to participate in HOPE Act 

transplants. One commenter requested 

that HHS evaluate all outstanding 

requests by transplant centers to 

participate in HOPE Act transplants, 

and approve qualifying transplant 

centers as soon as possible to both 

expand access to care and to generate 

additional data on the HOPE Act 

transplants they perform. The 

commenter further requested that HHS 

explore providing grants designed to 

build the capacity at transplant centers 

such that more transplant centers will 

be able to meet the minimum 

requirements necessary to become 

HOPE Act transplant centers. 

HHS response: Thank you for these 

suggestions. While no changes have 

been made to the regulatory proposal in 

response to these comments, HHS will 

consider these suggestions in the 

Department’s ongoing approach to 

implementation of the HOPE Act. 

Informed Consent and Autonomy of 

Transplant Recipients 

Some commenters expressed the 

desire that, if HHS finalizes the 

proposed rule, that HHS take steps to 

prioritize ethical considerations relevant 

to the autonomy of donors and 

recipients. In particular, commenters 

asked that transplant centers maintain 

meaningful processes to provide 

patients with the opportunity to provide 

informed consent, and that transplant 

candidates with HIV retain the option to 

elect a non-HOPE Act transplant instead 

of a HOPE Act transplant. 

HHS response: This rule does not 

affect existing OPTN policies that 

require that informed consent is 

obtained from all transplant candidates, 

including HOPE Act transplant 

candidates,26 or the informed consent 

policies or practices at hospitals 

providing clinical care to potential 

organ donors, OPOs, or individual 

transplant centers. HHS supports 

retaining the existing approach in OPTN 

policy that requires informed consent. 

Further, existing OPTN policies do 

not prohibit transplant candidates 

eligible for a HOPE Act transplant to 

choose a non-HOPE Act transplant.27

There are no revisions made in this rule 

that would force a transplant candidate 

to receive an organ from a donor with 

HIV. HHS supports retaining the 

existing approach in OPTN policy that 

permits transplant candidates eligible 

for a HOPE Act kidney or liver 

transplant to choose a non-HOPE Act 

kidney or liver transplant. 

HHS considered these comments in 

developing the Secretary’s direction to 

the OPTN to revise the OPTN standards 

of quality embodied in OPTN policy 

regarding organs from donors with HIV, 

as provided below in this preamble in 

the discussion of implementation 

considerations. HHS makes no changes 

to the regulatory proposal in response to 

these comments. 

Education 

Commenters expressed the desire for 

additional educational efforts regarding 

HOPE Act transplantation. Some 

commenters suggested that HRSA 

collaborate with the OPTN and work 

with OPOs to ensure that transplant 

centers are making compassionate 

efforts to seek authorization from 

potential kidney donors with HIV. 

Commenters further suggested that 

HRSA partner with the Centers for 

Medicare & Medicaid Services (CMS) to 

ensure that donor hospitals recognize 

every opportunity for organ donation for 

patients with an HIV-positive diagnosis 

and make referrals to the local OPO for 

an organ donation evaluation as 

mandated by the CMS Conditions of 

Participation. Other commenters asked 

for educational efforts aimed at people 

with HIV, healthcare professionals, 

students of health sciences, transplant 

centers, OPOs, and the public at large to 

increase awareness of the HOPE Act and 

opportunities to elect organ donation 

regardless of HIV status. 

HHS response: HHS is supportive of 

any and all efforts to increase awareness 

and education about HOPE Act 

transplants, opportunities for persons 

with HIV to participate as organ donors, 

and transplant candidates with HIV to 

receive a HOPE Act transplant. While 

HHS is not making any revisions to the 

regulatory proposal in response to these 

comments, HHS will consider 

additional educational efforts along the 

lines of those suggested by the 

commenters. 

NIH Research Criteria 

Several commenters provided specific 

suggestions for the content and 

development of the revised NIH 

Research Criteria: 

• Commenters requested the 

elimination of the current requirement 

that a transplant team perform at least 

five transplants within a four-year 

period between any donor and a 

recipient with HIV for all organs, as, in 

the commenters’ estimation, this 

requirement is not necessary for organs 

from donors with HIV to be used safely. 

• Commenters suggested that each 

transplant team should include 

infectious disease specialists with 

expertise in HIV care. 

• One commenter requested the 

elimination of the biopsy requirement. 

• One commenter noted that, in 

revising the Research Criteria, NIH 

should both maintain the strong patient 

safety record for HOPE Act transplants, 

while actively seeking to reduce 

burdens that may be slowing the 

establishment of non-kidney and nonliver HOPE Act transplant programs. 

• One commenter requested that NIH 

include people with HIV, HIV 

researchers, physicians, and healthcare 

providers in the process of developing 

revised Research Criteria, and indicated 

that these individuals can provide 

invaluable insights that can only come 

from lived experience. 

HHS response: HHS appreciates these 

suggestions, and agrees that these 

comments are relevant to the content of 

the NIH Research Criteria. These 

comments were provided to the NIH 

working group for consideration in the 

development of revisions to the 

Research Criteria. HHS makes no 

changes to the regulatory proposal in 

response to these comments. 

Secretarial Direction to the OPTN 

While multiple commenters provided 

suggestions that appear relevant to the 

Secretary’s future direction to the OPTN 

to revise the standards of quality 

concerning kidneys and livers from 

donors with HIV, only a few 

commenters specifically referenced the 


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content of the Secretarial direction and 

provided recommendations. One 

commenter indicated that they defer to 

health care professionals as to the 

content of such direction, and further 

urged HHS to make sure that the final 

OPTN policies do not create additional 

barriers or lead to unintended 

consequences that make it more difficult 

for individuals to access these organs. 

One commenter requested that the 

direction to the OPTN require intensive 

and multi-disciplinary counseling and 

discussions to be conducted with the 

solid organ recipient, with ongoing care 

before, during, and after the transplant, 

to ensure that solid organ recipients 

understand the complexities of the 

transplant procedure while also 

receiving the emotional and physical 

care they need throughout the entirety 

of the process. The commenter further 

noted the opportunity for the OPTN to 

define transplant program collaboration 

on a more formal basis, recommending 

that the structure of the transplant team 

include nephrologists and/or 

hepatologists, infectious diseases 

experts, and transplant pharmacy 

members, and that requirements be 

instituted for providing counseling or 

any specific transplant training 

recommendations for infectious disease 

experts. 

The commenters who provided views 

and suggestions that are relevant to the 

Secretary’s direction to the OPTN, while 

not specifically referencing the content 

of the Secretary’s direction, generally 

indicated that the current requirements 

applicable to all organ transplants are 

sufficient to appropriately ensure the 

safety of HOPE Act kidney and liver 

transplants conducted outside of the 

research context. One commenter 

indicated that there is no reason to 

impose special monitoring requirements 

for HOPE Act kidney and liver 

transplant outcomes, as appropriately 

protective standards are already 

included in the baseline safety and 

outcomes monitoring for all organ 

transplants in the United States. One 

commenter indicated that the OPTN 

structure and outcome data collected are 

sufficient in their current state to 

provide appropriate oversight for all 

organ transplants, regardless of whether 

the transplant involves organs from 

donors with HIV to recipients with HIV. 

Another commenter indicated comfort 

with appropriate oversight and data 

management by the organizations 

designated to oversee transplant 

services on a national level, indicating 

that such oversight may include 

stringent medical protocols, regular 

follow-ups, and comprehensive 

reporting systems to track outcomes and 

address any issues promptly. The 

commenter further expressed an 

expectation that safety and outcomes 

information be made available to the 

public is a transparent manner. 

One commenter noted that HHS 

stated in the NPRM that scientific 

evidence demonstrates that transplants 

of kidneys and livers from donors with 

HIV to recipients with HIV are safe and 

effective. Given this view, the 

commenter opined that the current 

clinical standards of care for non-HOPE 

Act organ transplants are sufficient to 

apply to transplants of all kidneys and 

livers, of any HIV serostatus. The 

commenter further expressed that 

additional scrutiny of transplants of 

kidneys and livers from donors with 

HIV to recipients with HIV could be 

viewed as discrimination against 

recipients with HIV who are willing to 

accept offers of an organ from a donor 

with HIV, and infringes on patient 

autonomy. The commenter noted that 

the OPTN already is responsible for 

safety and outcomes monitoring for 

transplants that involve donors or 

recipients with viruses other than HIV, 

including cytomegalovirus, Epstein-Barr 

virus, hepatitis B and C viruses, and 

severe acute respiratory syndrome 

coronavirus 2. 

HHS response: HHS appreciates all of 

the comments and suggestions regarding 

the content of the Secretary’s direction 

to the OPTN. HHS has carefully 

considered these comments in 

developing the Secretary’s direction to 

the OPTN to revise the OPTN standards 

of quality embodied in OPTN policy 

regarding organs from donors with HIV. 

As discussed below in section V, 

‘‘Implementation Considerations,’’ 

through publication of this final rule, 

the Secretary directs the OPTN to adopt 

and use standards of quality with 

respect to kidneys and livers from 

donors with HIV to ensure that HOPE 

Act kidney and liver transplants are 

subject to OPTN policies that, from the 

OPTN’s expertise, will not reduce the 

safety of HOPE Act kidney and liver 

transplants, provide appropriate 

oversight for these transplants, and 

require sufficient data collection and 

outcomes monitoring. 

Health Equity and Patient Experience 

Many comments positively noted the 

health equity component of the 

proposed rule and the potential impact 

to populations that are 

disproportionately impacted by HIV and 

end-stage chronic diseases. Several 

commenters requested that HHS 

consider the insights and experiences of 

HOPE Act patients in this and future 

rulemaking efforts. 

HHS response: We agree. HHS 

supports efforts to better address health 

equity in organ transplantation and 

believes this rule will help to increase 

access to care among populations that 

are disadvantaged. HHS also is 

supportive of efforts to incorporate 

patient experience into policy, and we 

have received, and considered, 

comments from HOPE Act patients 

during this rulemaking process, 

including a comment from a selfidentified living donor of a kidney used 

in a HOPE Act transplant. HHS makes 

no changes to the regulatory proposal in 

response to these comments. 

Approach to Patient Care 

Several commenters suggested 

changes to clinical care standards for 

HOPE Act transplant patients. One 

commenter requested that the 

Department encourage transplant 

centers to incorporate syndemic care 

approaches to address the complex 

needs of people with HIV. Syndemic 

care aims to provide more holistic 

service delivery to prevention and care, 

including by addressing the social 

determinants of health that allow for 

health conditions to cluster and interact. 

Several commenters requested that 

additional safety protocols be developed 

for transplant centers, such as postoperative care guidelines for HOPE Act 

transplant recipients. 

HHS response: HHS is supportive of 

efforts to incorporate syndemic care 

approaches within the organ 

transplantation domain. Regarding the 

establishment of additional safety 

protocols for transplant centers, 

currently safety protocols beyond those 

included in the NIH Research Criteria 

are determined by individual transplant 

centers. These comments were provided 

to the NIH working group for 

consideration in the development of 

revisions to the Research Criteria. 

Further, HHS considered these 

comments in developing the Secretary’s 

direction to the OPTN to revise the 

OPTN standards of quality embodied in 

OPTN policy regarding organs from 

donors with HIV, as provided below in 

the discussion of implementation 

considerations. HHS makes no changes 

to the regulatory proposal in response to 

these comments. 

Addressing Diverse Needs 

Several commenters requested that 

HHS consider the unique challenges of 

patients who are Black, Indigenous, and 

people of color and patients living in 

rural areas. A commenter indicated that 

post-transplant care is essential for 


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28Bowring, 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. 

positive patient outcomes and factors 

such as implicit bias in medical settings, 

socioeconomic disparities, and 

geographic limitations frequently hinder 

equitable access to post-transplant care, 

especially for people experiencing both 

geographic isolation and medical 

racism. Long travel distances to 

transplant centers and lacking local 

healthcare options can impede 

consistent follow-up care and 

medication compliance. 

HHS response: HHS is supportive of 

efforts to improve health equity in organ 

transplantation and believes this rule 

will contribute to improving access to 

care for patients who are Black, 

Indigenous, and people of color and 

patients living in rural areas by allowing 

HOPE Act kidney and liver transplants 

to be conducted at any transplant center 

in the United States. HHS makes no 

changes to the regulatory proposal in 

response to this comment. 

Standards for Transplant Candidates 

One commenter noted his opposition 

to lengthy sobriety requirements for 

liver transplant candidates. 

HHS response: Currently, sobriety 

requirements for transplant candidates 

are determined by individual transplant 

centers. This comment was provided to 

the NIH working group for 

consideration in the development of 

revisions to the Research Criteria. 

Further, HHS considered this comment 

in developing the Secretary’s direction 

to the OPTN to revise the OPTN 

standards of quality embodied in OPTN 

policy regarding organs from donors 

with HIV, as provided below in this 

preamble in the discussion of 

implementation considerations. HHS 

makes no changes to the regulatory 

proposal in response to this comment. 

Future Research on HOPE Act 

Transplants 

Multiple commenters expressed 

support for additional research 

evaluating the safety and efficacy of 

HOPE Act transplants. One commenter 

suggested that the experience of HOPE 

Act transplant patients should help 

inform the direction of future research 

on HOPE Act transplants. 

HHS response: HHS is supportive of 

additional research evaluating the safety 

and efficacy of HOPE Act transplants, 

and considering patient experiences in 

informing the direction of future 

research. While no changes are made to 

the regulatory proposal in response to 

these comments, HHS will consider 

these comments in further efforts to 

implement the HOPE Act. 

Beyond Scope 

Some commenters provided 

comments or made suggestions that are 

beyond the scope of the proposed rule. 

One commenter requested that HHS 

establish a program to provide technical 

assistance to state, local, and tribal 

health departments with the goal of 

adopting policies to prevent health 

information from being used in a 

criminal, civil, or immigration legal 

proceeding. 

One commenter noted that none of 

the other comments provided on the 

NPRM highlight that there will be a 

conflict between a majority of expressly 

prohibitive or potentially permissive 

State laws and expressly permissive 

Federal law when this proposed rule is 

finalized. The commenter indicated that 

State laws that are silent on or 

prohibitive of organ transplantation 

between people diagnosed with HIV can 

and do preclude performance of HOPE 

Act transplants within a given 

jurisdiction regardless of permissive 

Federal laws, and despite Congress and 

Federal regulators having the authority 

to preempt state and local health laws. 

Multiple commenters noted that State 

criminal laws that prohibit persons with 

HIV for donating or attempting to 

donate organs, blood, tissue, and other 

bodily fluids are a legal barrier to 

implementation of the HOPE Act. 

HHS response: As these comments are 

not within the scope of the proposed 

rule, these comments have not altered 

HHS’s proposed approach to lifting the 

research and IRB requirements for 

HOPE Act kidney and liver transplants. 

Opposition 

One commenter opposed the 

proposed rule, suggesting that organs 

from donors with HIV are not the same 

as organs from donors without HIV, and 

expressing concern regarding the 

transmission of HIV through organ 

transplantation to recipients without 

HIV. 

HHS response: HHS notes that there 

have been no reported cases of 

inadvertent HIV transmission resulting 

from HOPE Act transplants. Further, 

under the requirements of the HOPE 

Act, transplantation of organs from 

donors with HIV to recipients without 

HIV is prohibited. HHS makes no 

changes to the regulatory proposal in 

response to this comment. 

IV. Secretarial Determination 

The Secretary has reviewed the 

recommendations of the OPTN, the 

ACBTSA, and the BOTSEC on 

implementation of the HOPE Act, 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, and public comment received on 

the NPRM. 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 determines that 

participation in clinical research, and 

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 publication of this 

final rule, the Secretary is lifting the 

statutory research and IRB requirements 

for such transplants. 

HHS anticipates that the Secretary’s 

determination and publication of this 

final rule will increase access to kidney 

and liver transplants by allowing more 

transplant centers to perform HOPE Act 

kidney and liver transplants. 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 organspecific 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 by 

some as a barrier to participation in 

HOPE Act transplant programs, which 

may impact equity and access to organ 

transplantation throughout the United 

States.28 By eliminating the requirement 

that HOPE Act kidney and liver 

transplants are conducted in the 

research context, HHS expects that a 

larger number of transplant centers will 

be able to conduct such transplants. 

This rule 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. 

Further, HHS expects this rule will 

expand access to organ transplantation 

for all patients, regardless of their HIV 

status. When eligible for transplant, a 


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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 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.29 Every 10 minutes another 

person is added to the waiting list, and 

nearly 20 people die every day while 

waiting for a transplant.30 HHS expects 

that the Secretary’s determination and 

publication of this rule will improve 

access to kidney and liver transplants 

both by increasing the number of 

kidneys and livers available for 

transplant, and by allowing more 

transplant centers to perform HOPE Act 

kidney and liver transplants. This 

anticipated positive result is consistent 

with the Department’s commitment to 

reducing the number of persons on the 

organ transplant waiting list. 

V. Implementation Considerations 

A. 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). 

NIH, in consultation with HRSA and the 

OPTN, and including the input of other 

relevant Federal stakeholders, formed a 

working group to develop revised NIH 

Research Criteria. The NIH 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 this rule removes HOPE Act kidney 

and liver transplants from the research 

context, it is necessary that the revised 

NIH Research Criteria appropriately 

address non-kidney and non-liver HOPE 

Act transplantation. 

Further, HHS recognizes the revised 

NIH Research Criteria should reflect 

advances in research in the time since 

HOPE Act transplants began, including 

the current needs of various entities 

involved in non-kidney and non-liver 

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. 

HHS has considered the comments 

submitted in response to the NPRM that 

are relevant to the revised NIH Research 

Criteria, as summarized in the 

discussion of public comment in section 

III, supra. These comments have been 

provided to NIH for consideration in 

developing the revised NIH Research 

Criteria. HHS will publish updated 

Research Criteria in the Federal Register 

for public comment. 

B. Secretary’s Direction To Revise OPTN 

Policies 

As part of the implementation of the 

Secretary’s determination that 

participation in clinical research as a 

requirement for transplants of kidneys 

and livers from persons with HIV is no 

longer warranted, 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). 

In the NPRM preceding publication of 

this final rule, HHS specifically sought 

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 

welcomed 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. 

As described in the discussion of 

public comment in section III, supra, 

HHS received multiple comments 

relating to HHS’s consideration as to the 

direction to the OPTN. The vast 

majority of commenters agreed that 

scientific evidence clearly demonstrates 

that HOPE Act kidney and liver 

transplants are safe and effective. Many 

of those commenters indicated that the 

current requirements applicable to all 

organ transplants are sufficient to 

appropriately ensure the continued 

safety of HOPE Act kidney and liver 

transplants conducted outside of the 

research context. HHS has carefully 

considered all comments received in the 

development of the Secretary’s direction 

to the OPTN. 

Through publication of this final rule, 

the Secretary directs the OPTN to adopt 

and use standards of quality with 

respect to kidneys and livers from 

donors with HIV to ensure that HOPE 

Act kidney and liver transplants are 

subject to OPTN policies that are 

consistent with 42 U.S.C. 274, and from 

the OPTN’s expertise, will not reduce 

the safety of HOPE Act kidney and liver 

transplants, provide appropriate 

oversight for these transplants, and 

require sufficient data collection and 

outcomes monitoring. 

In consideration of the public 

comments received, HHS notes that it 

may be appropriate for the OPTN to 

determine that current OPTN policies 

that are generally applicable to kidney 

and liver transplants provide 

appropriate safety and oversight 

standards for HOPE Act kidney and 

liver transplants. Alternatively, the 

OPTN may choose to revise OPTN 

policies to provide additional standards 

for HOPE Act kidney and liver 

transplants. 

This rule provides the Secretary’s 

determination that that participation in 

clinical research as a requirement for 

transplants of kidneys and livers from 

persons with HIV is no longer 

warranted; revises 42 CFR 121.6 to 

reflect the removal of the statutory 

research and IRB requirements for 

HOPE Act kidney and liver transplants; 

and directs the OPTN to revise its 

standards of quality with respect to 

kidneys and livers from donors with 

HIV consistent with 42 U.S.C. 274 and 

in a way that ensures the changes will 

not reduce the safety of organ 

transplantation policies as required by 

the HOPE Act. The final 

implementation step is for the OPTN to 

adopt and use standards of quality as 

directed by the Secretary to reflect that 

HOPE Act kidney and liver transplants 

no longer are subject to research and 

IRB requirements. 

As was stated in the NPRM, HHS 

expects that the OPTN will 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 this 

final rule. As publication of this final 

rule has obviated current OPTN policies 

requiring HOPE Act kidney and liver 

transplants to be conducted in 

accordance with research and IRB 

requirements, HHS encourages the 

OPTN to act expeditiously to revise 

these policies. This will allow 

transplant centers that had not 


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31Centers 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. 

32Organ Procurement and Transplantation 

Network. Dashboard and metrics. https://

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

2024. 

33Organ Procurement and Transplantation 

Network (OPTN)/Scientific Registry of Transplant 

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

Accessed November 2024. https://

srtr.transplant.hrsa.gov/ADR/ 

Chapter?name=Liver&year=2022. 

34Organ Procurement and Transplantation 

Network. Dashboard and metrics. https://

optn.transplant.hrsa.gov/data/dashboards-metrics/. 

Accessed November 2024. 

35Organ 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. 

36Motter 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. 

previously been performing HOPE Act 

kidney and liver transplants in the 

research context to begin performing 

HOPE Act kidney and liver transplants 

in accordance with the revised OPTN 

policies. 

VI. Final Rule Requirements 

A. Removal of Research and IRB 

Requirements for HOPE Act Kidney and 

Liver Transplants 

Consistent with the Secretary’s 

determination under the HOPE Act, this 

rule revises 42 CFR 121.6 to reflect the 

removal of the statutory research and 

IRB requirements for kidney and liver 

HOPE Act transplants. Section 

121.6(b)(1)(ii)(B) provides that 

participation in clinical research is no 

longer warranted for the following 

categories of transplants: 

• Transplant of a kidney from a donor 

with HIV; and 

• Transplant of a liver from a donor 

with HIV. 

In implementation, this means that 

HOPE Act kidney and liver transplants 

will no longer be required to be 

conducted as research, and instead will 

be conducted in accordance with OPTN 

policies applicable to HOPE Act kidney 

and liver transplants. As noted above, 

the OPTN may decide that OPTN 

policies that generally apply to kidney 

and liver transplants are appropriate to 

apply to HOPE Act kidney and liver 

transplants, or may create different 

policies for HOPE Act kidney and liver 

transplants. 

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 revises all current references 

in 42 CFR 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, 

‘‘organs from donors with HIV’’ and 

specifically ‘‘kidneys from donors with 

HIV’’ and ‘‘livers from donors with 

HIV.’’ Further, HHS revises the current 

reference in 42 CFR 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.31 These changed 

regulatory references are to avoid 

stigmatizing language, and do not 

change the groups of people referenced 

in 42 CFR 121.6. 

VII. Effective Date 

HHS finds that there is good cause for 

this rule to be effective upon 

publication in accordance with 5 U.S.C. 

553(d)(3) of the Administrative 

Procedure Act and 5 U.S.C. 808(2) of the 

Congressional Review Act. 

The waiting list for kidney transplant 

in the U.S. currently exceeds 88,700 

candidates.32 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.33 Most transplant candidates 

wait years for a kidney transplant, often 

requiring dialysis or other interventions. 

In addition, thousands of Americans 

suffer from conditions requiring liver 

transplant. As of November 8, 2024, 

13,170 candidates were added to the 

waiting list in 2024.34 In 2022, more 

than 1,031 liver patients died while 

awaiting transplant, according to the 

OPTN/SRTR Annual Data Report.35

HHS expects that this final rule will 

have the effect of decreasing the time all 

candidates for kidney and liver 

transplants spend on the waiting list, 

regardless of their HIV status. As 

described in section IV, above, a 

transplant candidate with HIV may 

choose to receive a HOPE Act kidney or 

liver transplant if an organ from a donor 

with HIV becomes available, or may 

choose to wait for an organ from a donor 

without HIV. Research has 

demonstrated that candidates with HIV 

who accept a HOPE Act kidney 

transplant spend significantly less time 

awaiting transplant than candidates on 

the waiting list for an kidney from a 

donor without HIV. A 2023 study found 

that median wait time for a HOPE Act 

kidney transplant was 10.8 months 

compared to 60.8 months—a 3.3-fold 

higher rate of transplant compared to 

non-HOPE Act transplants.36 When 

candidates with HIV choose a HOPE Act 

transplant, this data suggests that this 

will decrease the time they spent on the 

waiting list. Additionally, this will have 

the effect of allowing a candidate further 

down the waiting list to receive the next 

available organ from a donor who does 

not have HIV, both reducing the time 

that candidate spends waiting for a 

transplant and decreasing the time all 

other candidates spend on the waiting 

list. 

Moreover, HHS expects that this final 

rule also will increase access to organ 

transplantation. Thirty-one transplant 

centers are qualified to perform HOPE 

Act kidney and liver transplants as 

research in conformance with the 

requirements of the NIH Research 

Criteria, while 250 transplant centers 

operate nationwide. As, pursuant to this 

rule, HOPE Act kidney and liver 

transplants no longer need to be 

conducted as research, it can be 

reasonably expected that more 

transplant centers than in the past will 

be able to offer HOPE Act kidney and 

liver transplants to appropriate 

candidates on the transplant center’s 

waiting list. It also is reasonable to 

expect that if a greater number of 

transplant centers will be able to offer 

HOPE Act transplants, this will allow 

more candidates with HIV on the 

waiting list to receive HOPE Act kidney 

and liver transplants. 

Lastly, HHS believes that a delayed 

effective date is unnecessary to afford 

affected parties a reasonable time to 

adjust practices in accordance with this 

rule. From the economic analysis of 

impacts, provided below in section IX, 

this final rule will have a minimal direct 

impact on affected entities with regard 

to preparing for implementation. The 

direct effect of this final rule on 

transplant centers is considered to be 

limited to the time spent by transplant 

centers to read and understand the final 

rule, educate their staff on the content 

of this final rule, and review and update 


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internal policies. This rule does not 

impose obligations on transplant 

centers, and rather increases available 

flexibilities in that transplant centers are 

no longer required to conduct HOPE Act 

kidney and liver transplants in the 

research context. Further, as described 

above in section V(B), the final 

implementation step for HOPE Act 

kidney and liver transplants to begin 

occurring outside of the research 

context is for the OPTN to revise its 

policies to reflect that HOPE Act kidney 

and liver transplants no longer are 

subject to research and IRB 

requirements. HHS is encouraging the 

OPTN to act expeditiously to revise 

these policies, and it is likely that 

transplant centers will educate their 

staff and review and update internal 

policies relevant to the content of this 

final rule after the OPTN has published 

its revised policies for HOPE Act kidney 

and liver transplants. Transplant centers 

do not have any obligations stemming 

from this rule until the OPTN revises its 

policies. In light of this context, a 

delayed effective date for this rule is 

unnecessary for implementation 

purposes. 

Given that, and the expected positive 

effects on time candidates spend on the 

waiting list and the increase in access to 

HOPE Act transplants resulting from 

this rule, pursuant to 5 U.S.C. 553(d)(3) 

and 5 U.S.C. 808(2) HHS finds that there 

is good cause for this rule to be effective 

upon publication. 

VIII. Paperwork Reduction Act of 1995 

This rule does 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 (OMB). The current data 

collection requirements in the OPTN 

final rule approved by 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). 

IX. Final Economic Analysis of Impacts 

We have examined the impacts of the 

final 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 

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. The 

regulatory impact analysis indicates, 

and OIRA has determined, that the final 

rule is a significant regulatory action 

under Executive Order 12866, section 

3(f)(1), and that it meets the criteria set 

forth in 5 U.S.C. 804(2) under the 

Congressional Review Act. 

The Regulatory Flexibility Act (RFA) 

requires agencies to consider the impact 

of their regulatory proposals on small 

entities. Because the impacts on kidney 

and liver transplants are small relative 

to the number of transplants performed 

annually, and because the economic 

impacts on affected small entities are 

small relative to the average payroll of 

firms in the smallest enterprise size 

category, HHS certifies that the final 

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 final 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, in the aggregate, or by the 

private sector. Each agency issuing a 

final rule with relevant effects over that 

threshold must also seek input from 

State, local, and tribal governments. The 

current threshold after adjustment for 

inflation using the Implicit Price 

Deflator for the Gross Domestic Product 

is $183 million, reported in 2023 

dollars. The final rule will not result in 

an unfunded mandate in any year that 

meets or exceeds this amount. 

The final rule removes the current 

research and IRB requirements for the 

transplantation of kidneys and livers 

from donors with HIV. We have 

assessed the likely impacts of the final 

rule, and report in the regulatory impact 

analysis (RIA) several sources of 

monetized, quantified, and unquantified 

benefits, costs, or transfers. Most of the 

monetized or quantified impacts relate 

to the incremental increases in the 

number of kidney and liver transplants 

that will be performed annually as a 

result of the final rule. 

We report monetized benefits from 

increases in life expectancy for both 

kidney and liver transplant recipients; 

and for kidney transplant recipients, we 

also report monetized benefits from 

quality-of-life improvements and time 

savings from fewer kidney dialysis 

visits. We also anticipate quality-of-life 

improvements for liver transplant 

recipients, and quantify the number of 

people affected who might experience 

those benefits. We also identify several 

sources of unquantified benefits, which 

could potentially be quantified through 

additional research or data, including 

time savings for caregivers, and cost 

savings for transplant centers from 

removing the research and institutional 

review board requirements. We also 

identify difficult-to-quantify benefits 

associated with revising vocabulary and 

phrases that some people find 

stigmatizing through adoption of 

language that is intended be respectful 

of people living with HIV, and living 

and deceased donors with HIV. These 

changes may result in people living 

with HIV experiencing more inclusive 

interactions when accessing healthcare, 

generating additional benefits beyond 

the increases in life expectancy and 

improvements in quality of life from 

improved access to liver and kidney 

transplantation. 

We report monetized costs from 

increases in medical expenditures 

associated with organ transplantation; 

for kidney transplants, we report net 

costs that account for reductions in 

medical expenditures associated with 

kidney dialysis. We report this shift in 

expenditures from kidney dialysis to 

kidney transplantation as a monetized 

transfer. We also monetize the 

opportunity costs of the time spent by 

transplant centers reading and 

understanding the final rule, reviewing 

policies and procedures, and training 

staff. 

Table 1 summarizes our estimates of 

the benefits, costs, and transfers of the 

final rule, annualizing impacts over a 

10-year analytic time horizon covering 

2025 through 2034 using a 2 percent 

real discount rate, and reporting all 


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Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 93497 

monetary estimates in constant 2023 

dollars. Annualized benefits range from 

$381 million to $858 million, with a 

primary estimate of $612 million; costs 

range from $73 million to $92 million, 

with a primary estimate of $83 million; 

and transfers range from $24 million to 

$37 million, with a primary estimate of 

$30 million. Table 1 also reports our 

estimates of the annualized net benefits 

of the final rule, which range from $301 

million to $772 million, with a primary 

estimate of $530 million. The RIA 

concludes that the monetized net 

benefits, combined with the quantified, 

but non-monetized, and unquantified 

impacts, indicate that the final rule is 

highly likely to generate net benefits to 

society. This finding is further 

supported through additional 

quantitative assessments of uncertainty 

and sensitivity analyses contained in 

the RIA. The full RIA is available in the 

docket for this final rule at https://

www.regulations.gov/docket/HRSA2024-0001/document. 

TABLE 1—SUMMARY OF IMPACTS OF THE FINAL 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.

$612 $381 $858 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-monetized, 

benefits.

72 64 81 People affected .... 2 2025–2034 Improved quality of life for liver transplant 

recipients. 

Unquantified benefits ...... .................... .................... .................... ............................... .................... 2025–2034 Time savings for caregivers; cost savings 

for transplant centers from removing 

the research and institutional review 

board requirements; difficult-to-quantify 

benefits associated with stigma-reducing terminology. 

COSTS 

Annualized monetized 

costs.

83 73 92 2023 ..................... 2 2025–2034 Medical expenditures associated with 

transplantation; time spent by transplant centers to read and understand 

the final rule, review policies and procedures, and train staff. 

TRANSFERS 

Annualized monetized 

transfers.

30 24 37 2023 ..................... 2 2025–2034 Shift in expenditures from kidney dialysis 

to kidney transplantation. 

NET BENEFITS 

Annualized monetized 

net benefits.

530 301 772 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. 

List of Subjects in 42 CFR Part 121 

Health care, Hospitals, Organ 

transplantation, Reporting and 

recordkeeping requirements, Transplant 

centers. 

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 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, 371–377, 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 

transplantation of organs from donors 

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 kidney from a 

donor with HIV; and 

(2) Transplant of a liver from a donor 

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 organs from donors 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. 


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I I I 
93498 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Rules and Regulations 

(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 transplantation of 

organs from donors with HIV, the OPTN 

shall adopt and use standards of quality 

with respect to organs from donors 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. 

* * * * * 

Dated: November 19, 2024. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2024–27410 Filed 11–26–24; 8:45 am] 

BILLING CODE 4150–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

45 CFR Part 412 

RIN 0970–AD10 

Investigations of Child Abuse and 

Neglect Rule 

AGENCY: Office of Refugee Resettlement 

(ORR), Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS). 

ACTION: Interim final rule with comment 

period (IFR). 

SUMMARY: This IFR describes how ORR 

shall investigate and substantiate 

allegations of child abuse and neglect 

occurring in certain ORR care provider 

facilities, and maintain a registry of 

perpetrators relating to certain sustained 

allegations. 

DATES: This IFR is effective December 

27, 2024. Comments on this IFR must be 

received on or before January 27, 2025. 

ADDRESSES: You may send comments, 

identified by [docket number and/or 

Regulatory Information Number (RIN)], 

by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Email: UCPolicy-RegulatoryAffairs@

acf.hhs.gov. Include [docket number 

and/or RIN] in the subject line of the 

message. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this 

rulemaking. For detailed instructions on 

submitting comments and additional 

information on the rulemaking process, 

see the ‘‘Public Participation’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

FOR FURTHER INFORMATION CONTACT: 

Toby Biswas, Director of Policy, 

Division of Unaccompanied Children 

Policy, Unaccompanied Children 

Bureau, Office of Refugee Resettlement, 

Administration for Children and 

Families, Department of Health and 

Human Services, Washington, DC, (202) 

205–4440 or UCPolicyRegulatoryAffairs@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Public Participation 

A. Submitting Comments 

B. Viewing Comments and Documents 

C. Privacy Act 

II. Table of Abbreviations 

III. Executive Summary 

IV. Background and Purpose 

A. Background and History 

B. Authority 

C. Basis and Scope of Regulatory Action 

D. Severability 

V. Discussion of Elements of the Interim 

Final Rule 

VI. Good Cause for Issuing This IFR 

VII. Collection of Information Requirements 

VIII. Regulatory Impact Analysis 

A. Economic Analysis 

B. Regulatory Flexibility Analysis 

C. Unfunded Mandates Reform Act 

D. Executive Order 13132: Federalism 

E. Executive Order 12988: Civil Justice 

Reform 

IX. Assessment of Federal Regulation and 

Policies on Families 

I. Public Participation 

ORR encourages all interested parties 

to participate in this rulemaking by 

submitting written comments, views, 

and data on any or all aspects of this 

interim final rule. ORR also invites 

comments that relate to the economic, 

environmental, or federalism effects that 

might result from this interim final rule. 

ORR will review all comments received, 

but ORR will only post comments that 

address the topic of the interim final 

rule. All comments ORR posts to 

https://www.regulations.gov will 

include any personal or commercial 

information you provide. 

A. Submitting Comments 

Comments that will provide the most 

assistance to ORR will reference a 

specific portion of the interim final rule, 

explain the reason for any 

recommended change, and include data, 

information, or authority that support 

such recommended change. If you 

submit comments, please indicate the 

specific section of this document to 

which each comment applies and 

provide a reason for each suggestion or 

recommendation. You may submit your 

comments and materials online or by 

email, but please use only one of these 

means. If you submit a comment online 

via https://www.regulations.gov, it will 

be considered received when it is 

received at the Docket Management 

Facility. 

Instructions: To submit your 

comments online, go to https://

www.regulations.gov and insert 

‘‘XXXX–XXXX–XXXX’’ in the ‘‘Search’’ 

box. Click on the ‘‘Comment Now!’’ box 

and input your comment in the text box 

provided. Click the ‘‘Continue’’ box, and 

if you are satisfied with your comment, 

follow the prompts to submit it. 

For additional information, please 

read the ‘‘Privacy and Security Notice’’ 

that is available via the link in the footer 

of https://www.regulations.gov. 

ORR will consider all comments and 

materials received during the comment 

period and may change this rule based 

on your comments. 

B. Viewing Comments and Documents 

Docket: To view posted comments, as 

well as documents mentioned in this 

preamble as being available in the 

docket, go to https://

www.regulations.gov and insert 

‘‘XXXX–XXXX–XXXX’’ in the ‘‘Search’’ 

box. Click on the ‘‘Open Docket Folder,’’ 

and you can click on ‘‘View Comment’’ 

or ‘‘View All’’ under the ‘‘Comments’’ 

section of the page. Individuals without 

internet access can make alternate 

arrangements for viewing comments and 

documents related to this rulemaking by 

contacting ORR through the FOR

FURTHER INFORMATION CONTACT section 

above. You may sign up for email alerts 

on the online docket to be notified when 

comments are posted, or a final rule is 

published. 

C. Privacy Act 

As stated in the Submitting 

Comments section above, please be 

aware that anyone can search the 

electronic form of comments received 

into any dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). 

II. Table of Abbreviations 

ACF—Administration for Children and 

Families 

ALJ—Administrative Law Judge 

CAPTA—Child Abuse Prevention and 

Treatment Act 

CWT—ORR’s Child Welfare Team 

DAB—HHS Departmental Appeals Board 

DOJ—U.S. Department of Justice 

EIF—Emergency or Influx Facility 

FBI—Federal Bureau of Investigation 

FSA—Flores Settlement Agreement 

HHS—U.S. Department of Health and Human 

Services 


ddrumheller on DSK120RN23PROD with RULES1