93616 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 

providing conference, meeting, or 

seminars services are required to 

provide specific information to HHS as 

stated in the HHS Acquisition 

Regulation. 

The Agency is requesting a 3-year 

extension to collect this information 

from public or private businesses. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

Business (Contractor) ...................... 1,067 1 1 1,067 

Total ........................................... ........................................................... 1,067 1 1 1,067 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2024–27806 Filed 11–26–24; 8:45 am] 

BILLING CODE 4150–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute, National Institutes of Health; 

Notice of Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Sickle Cell Disease 

Advisory Committee. 

The meeting will be held as a virtual 

meeting and open to the public, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. The meeting 

can be accessed from the NIH Videocast 

at the following link: https://

videocast.nih.gov/watch=55419. 

Name of Committee: Sickle Cell Disease 

Advisory Committee. 

Date: January 14, 2025. 

Time: 10:00 a.m. to 3:00 p.m. 

Agenda: NHLBI Sickle Cell Disease 

Program Updates and Long Term Follow-up 

of Participants undergoing gene therapy for 

SCD. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Contact Person: julie.panepinto@nih.gov. 

Meeting Format: Virtual Meeting. 

Any member of the public interested in 

presenting oral comments to the committee 

may notify the Contact Person listed on this 

notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations may submit 

a letter of intent, a brief description of the 

organization represented, and a short 

description of the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, presentations 

may be limited to five minutes. Both printed 

and electronic copies are requested for the 

record. In addition, any interested person 

may file written comments with the 

committee by forwarding their statement to 

the Contact Person listed on this notice. The 

statement should include the name, address, 

telephone number and when applicable, the 

business or professional affiliation of the 

interested person. 

Information is also available on the 

Institute’s/Center’s home page: https://

www.nhlbi.nih.gov/advisory-and-peerreview-committees/nhlbi-sickle-cell-diseaseadvisory-committee where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: November 22, 2024. 

Bruce A. George, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–27878 Filed 11–26–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Draft Revised Human 

Immunodeficiency Virus (HIV) Organ 

Policy Equity Act Safeguards and 

Research Criteria for Transplantation 

of Organs Infected With HIV 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Request for comments. 

SUMMARY: The HOPE Act requires the 

Secretary of Health and Human Services 

(the Secretary) to develop and publish 

criteria for research involving the 

transplantation of organs from donors 

with HIV to recipients with HIV. In 

2015, the National Institutes of Health 

(NIH), and the U.S. Department of 

Health and Human Services (HHS) 

published research criteria applicable to 

such transplants, which have been in 

effect for all transplants involving 

organs from donors with HIV as 

authorized by the HOPE Act. As 

amended in an HHS final rule published 

elsewhere in this issue of the Federal 

Register, the Secretary determined that 

participation in clinical research should 

no longer be a requirement for the 

transplantation of kidneys and livers 

from donors with HIV to recipients with 

HIV and amended the HHS regulations 

governing the operation of the Organ 

Procurement and Transplantation 

Network (OPTN) to reflect this 

determination. As a result, HOPE Act 

transplants involving kidneys and livers 

from donors with HIV no longer need to 

comply with the research criteria. Given 

this regulatory change, NIH proposes to 

delete aspects of the research criteria 

that are specific to kidney and liver 

transplantation. NIH proposes 

additional changes to the research 

criteria based on its review of scientific 

evidence and in consideration of prior 

public feedback concerning the criteria, 

including comments provided in the 

recent rulemaking procedure that 

modified the OPTN regulations. NIH 

invites the public to submit comments 

regarding the proposed changes to the 

research criteria. 

DATES: To ensure that comments will be 

considered, comments must be received 

no later than 5 p.m. on December 12, 

2024. 

ADDRESSES: Comments may be 

submitted by any of the following 

methods: 

• Email: HOPEAct@mail.nih.gov. 

• Fax: 301–451–5671. 

• Regular Mail: Dr. Jonah Odim, 5601 

Fishers Lane, Room 6B21, MSC 9827, 

Bethesda, MD 20892–9827. 

• Hand Delivery, Overnight Mail, 

FedEx, and UPS: Dr. Jonah Odim, 5601 

Fishers Lane, Room 6B21, MSC 9827, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Jonah Odim, Chief Clinical 

Transplantation Section, 

Transplantation Branch, 5601 Fishers 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 93617 

1Centers 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. 

Lane, Room 6B21, MSC 9827, Rockville, 

MD 20892–9827; by email at odimj@

niaid.nih.gov; by telephone at (301) 

828–7220. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. HHS Oversight of Organ Allocation 

and Transplantation 

HHS 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 OPTN is a network of transplant 

centers, organ procurement 

organizations, and other providers who 

work collectively to develop, 

implement, and monitor organ 

allocation policy and performance of the 

organ transplant system. The OPTN is 

also charged with developing policies 

on many subjects related to organ 

donation and transplantation, which 

include establishing standards of quality 

pertaining to organs procured for use in 

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

B. HOPE Act Requirements and 

Implementation 

The enactment of the HOPE Act in 

2013, Public Law 113–51, eliminated 

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 institutional review 

board (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). 

C. Research Criteria for HOPE Act 

Transplants 

In 2015, NIH published proposed 

research criteria for HOPE Act 

transplants in the Federal Register and 

solicited public comment. 80 FR 34912 

(June 18, 2015). After consideration of 

public comments received, NIH 

published the ‘‘Final Human 

Immunodeficiency Virus (HIV) Organ 

Policy Equity (HOPE) Act Safeguards 

and Research Criteria for 

Transplantation of Organs Infected With 

HIV’’ (‘‘2015 Research Criteria’’). 80 FR 

73785 (November 25, 2015). The goals 

of the 2015 Research Criteria were to 

ensure that research using organs from 

donors with HIV was conducted under 

conditions protecting the safety of 

research participants and the public and 

that the results of this research provide 

a basis for evaluating the safety of 

transplants of organs from donors with 

HIV in recipients with HIV. 80 FR 

73785. 

1. Proposed Changes to the 2015 

Research Criteria 

NIH is now proposing changes to the 

2015 Research Criteria to reflect the 

Secretary’s determination, published by 

regulation on November 27, 2024, that 

HOPE Act kidney and liver transplants 

are no longer required to be conducted 

as research subject to the 2015 Research 

Criteria and to continue to further the 

goals shared in 2015 with respect to 

HOPE Act transplants of other organs 

from donors with HIV that remain 

subject to the Research Criteria. NIH 

proposes to remove requirements from 

the Research Criteria applicable to 

HOPE Act kidney and liver transplants. 

NIH also proposes other changes to 

the 2015 NIH Research Criteria for 

conducting HOPE Act transplants of 

organs other than kidneys and livers 

(primarily heart and lung transplants) in 

IRB-approved research. The proposed 

changes are intended to accelerate 

research, ensure research participant 

safety, and maintain stakeholder 

confidence in clinical research 

conducted under the HOPE Act. Notable 

revisions include the elimination of (i) 

the transplant program experience 

requirement of five organ-specific 

transplants of organs from a donor 

without HIV in a recipient with HIV 

conducted over 4 years; (ii) mandated 

pre-implant biopsies; and (iii) the 

requirement for HIV independent 

advocates for living donors with HIV 

and recipients with HIV. Other organs 

(including multi visceral organs such as 

small intestine, stomach, liver, pancreas 

and colon) and multi organ transplants 

(e.g., heart-kidney) must comply with 

the revised Research Criteria for 

inclusion of any non-kidney or nonliver organs from donors with HIV and 

subject to IRB approval. 

2. Consideration of Public Comment 

Received on the HOPE Act NPRM 

In proposing these changes, NIH has 

considered the public participation in 

the HOPE Act rulemaking process 

through which the Secretary’s 

determination was made. In response to 

the September 21, 2024, notice of 

proposed rulemaking that proposed the 

Secretary’s determination with respect 

to HOPE Act kidney and liver 

transplants, 89 FR 74174, HHS received 

multiple comments that were relevant to 

the NIH Research Criteria, and some 

comments provided specific suggestions 

for the content of the revised NIH 

Research Criteria. All comments relating 

to the content of the revised Research 

Criteria were provided to NIH for 

consideration in the development of the 

proposed revised Research Criteria that 

appear later in this document. NIH has 

considered these comments and 

proposes changes to the Research 

Criteria responsive to specific comments 

received, as described here. 

• Several commenters noted that 

referring to organs ‘‘infected with HIV’’ 

or ‘‘HIV positive organs’’ may be 

stigmatizing, and one commenter 

requested that references to ‘‘organs 

with HIV’’ be revised to ‘‘organ(s) from 

donors with HIV.’’ The commenters 

indicated a strong preference for the use 

of stigma-reducing, and person-first 

language. In response to these 

comments, NIH proposes to revise 

references in the Research Criteria to 

refer to donors with HIV, recipients 

with HIV, and organs from donors with 

HIV. This is consistent with the Centers 

for Disease Control and Prevention’s 

(CDC) Stigma Language Guide 1 and 

with language adopted in the final rule. 

• Commenters also 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 


ddrumheller on DSK120RN23PROD with NOTICES1
93618 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 

2Organ 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. 

3Cooper M. ‘‘OPTN Letter to Secretary Becerra on 

the HOPE Act.’’ 2021 Oct 29. https://

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

4HHS 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. 

requirement is not necessary for organs 

from donors with HIV to be used safely. 

In response to these comments and 

based on its review of the evidence, NIH 

proposes to remove this requirement 

from the proposed revised Research 

Criteria. 

• Commenters suggested that each 

transplant team should include 

infectious disease specialists with 

expertise in HIV care. In response to 

these comments and based on its review 

of the evidence, NIH proposes that this 

requirement of the 2015 NIH Research 

Criteria be retained in the revised 

Research Criteria. 

• One commenter requested the 

elimination of the biopsy requirement. 

In response to this comment and based 

on its review of the evidence, NIH 

proposes to eliminate the requirement 

for a pre-implantation biopsy. 

• One commenter noted that, in 

revising the Research Criteria, NIH 

should 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. In 

response to this comment and based on 

its review of the evidence, NIH believes 

that the proposed revisions to the 

Research Criteria appropriately strike 

this balance. 

NIH’s rationale for these specific 

proposed revisions to the Research 

Criteria is provided in more detail in 

Section III, below. 

The Secretary delegated to the 

Director, NIH, the responsibility to 

revise the 2015 Research Criteria. The 

proposed revised Research Criteria 

proposed below were developed by NIH 

staff in collaboration with 

representatives of the Centers for 

Disease Control and Prevention, the 

Food and Drug Administration, the 

Health Resources and Services 

Administration, and the Office of the 

Assistant Secretary for Health. 

If adopted as proposed, it is 

anticipated that the revised Research 

Criteria would expand access to 

transplantation for recipients with HIV, 

provide benefits to organ donors; ensure 

safety of ongoing HOPE Act transplants 

of organs other than kidneys and livers; 

and provide for the systematic 

collection of safety and efficacy data 

related to transplants of hearts, lungs, 

and other organs from donors with HIV 

in recipients with HIV. 

3. Other Considerations 

(a) Research Results—Heart and Lung 

Transplants in Recipients With HIV 

As the Secretary has decided that 

HOPE Act transplants of organs other 

than kidneys and livers should remain 

subject to the Research Criteria until 

additional scientific research 

demonstrates the safety and efficacy of 

such transplants, NIH wishes to 

highlight the current state of the science 

with regard to transplantation of hearts 

and lungs from donors without HIV in 

recipients with HIV. The early outcomes 

data for such transplants may provide a 

foundation for future HOPE Act thoracic 

organ transplants (Koval 2018, 2019; 

Madan 2019). For example, in a 

retrospective analysis utilizing the 

OPTN database to compare outcomes of 

75 heart transplant recipients with HIV 

to those of 29,848 heart transplant 

recipients without HIV, survival rates 

were similar across the comparator 

groups, while rejection rates were 

approximately 2-fold higher in 

recipients with HIV (38.7% vs. 17.7%, 

respectively) (Doberne 2021). Similar 

findings were reported in studies based 

on the International Society for Heart 

and Lung Transplantation (ISHLT) and 

Scientific Registry of Transplant 

Recipients (SRTR) databases (Wairmu 

2021; Storm 2024; Madan 2019). Fewer 

transplants of lungs from donors 

without HIV in recipients with HIV 

have been reported (Koval 2019; Kern 

2014; Rouzaud 2022). 

NIH recognizes that additional 

research in this area will advance the 

state of the relevant science, and the 

results of such research will increase the 

evidence basis needed to support any 

future determination by the Secretary 

that participation in clinical research is 

no longer a requirement for transplants 

of hearts or lungs from donors with HIV 

in recipients with HIV. 

(b) Education Regarding the HOPE Act 

While no related proposals are 

included in the proposed revision to the 

2015 Research Criteria, NIH further 

notes that expanding awareness and 

continuing education of potential organ 

donors, transplant centers, organ 

procurement organizations (OPOs), 

healthcare providers, and people living 

with HIV will be important to fully 

realize the medical and societal benefits 

envisioned under the HOPE Act. 

Success in these endeavors will expand 

the supply of quality donor HIV organs, 

enhance transplant access, improve 

quality of life, and increase longevity for 

potential transplant recipients with HIV. 

Reducing longstanding stigma and 

increasing access to organ 

transplantation will be particularly 

important for communities 

disproportionately impacted by HIV 

(https://www.hiv.gov/hiv-basics/ 

overview/about-hiv-and-aids/who-is-atrisk-for-hiv). 

(D) Secretary’s Review of Research 

Results 

As stated above, the HOPE Act 

requires that the Secretary, in 

conjunction with the OPTN, 

periodically review the results of 

scientific research to determine whether 

the results warrant revision to the OPTN 

standards of quality with respect to 

organs from donors with HIV and the 

safety of transplanting an organ from a 

donor with a particular strain of HIV 

into a recipient with a different strain of 

HIV. 42 U.S.C. 274f–5(c)(1). This review 

allows the Secretary to determine if the 

safety and efficacy of HOPE Act 

transplants are comparable to nonHOPE Act transplants and, if warranted, 

to further determine whether such 

transplants may be conducted outside of 

a research setting. 

Past procedures for this review are 

described in detail in the final rule 

amending the OPTN regulation. Past 

reviews involved deliberations by 

bodies that provided recommendations 

to the Secretary, including the OPTN 

(which solicited and considered public 

comments) 2 3 the HHS Advisory 

Committee on Blood and Tissue Safety 

and Availability (ACBTSA) 4 and 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. 

The recommendations of the OPTN, 

ASBTSA, and BOTSEC, as well as 

subsequent research results, were 

considered in the Secretary’s decision as 

to whether participation in clinical 

research, as a requirement for certain 

types of transplants of organs from 

donors with HIV, is no longer 

warranted. 

Although not incorporated into the 

2015 Research Criteria or the proposed 

revised criteria, HHS intends to conduct 

a regular review of such scientific 

research to enable evidence-based 

recommendations, including any 

changes to the Research Criteria, and 

any determinations on transitioning 

additional HOPE Act organ transplants 

to medical practice and standard-of-care 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 93619 

(i.e., removing the clinical research and 

IRB requirements for such transplants) if 

appropriate in the future. NIH seeks 

public comment on this approach, and 

on the procedures through which this 

review should be conducted. 

II. Instructions for Submitting 

Comments 

Comments are invited on the 

proposed changes to the 2015 Research 

Criteria. 

Please note that, during the 

rulemaking process resulting in the HHS 

final rule published elsewhere in this 

issue of the Federal Register, HHS 

received and considered public 

comments regarding whether HOPE Act 

kidney and liver transplants from 

donors with HIV should continue to be 

required to be conducted in accordance 

with the 2015 Research Criteria. After 

consideration of public comments 

received, the Secretary determined that 

participation in clinical research will no 

longer be a requirement for HOPE Act 

kidney and liver transplants from 

donors with HIV. 

Further, in making the determination 

regarding HOPE Act kidney and liver 

transplants, the Secretary expressed the 

view in the notice of proposed 

rulemaking published on September 12, 

2024, 89 FR 74174, that the current 

research and IRB requirements should 

be maintained for HOPE Act transplants 

of all other organs, considering the lack 

of data on outcomes for HOPE Act organ 

transplants other than kidney or liver 

transplants. This decision was affirmed 

in the HHS final rule published 

elsewhere in this issue of the Federal 

Register. 

Because the Secretary’s determination 

regarding HOPE Act kidney and liver 

transplants, and the Secretary’s decision 

that other HOPE Act organ transplants 

should remain subject to the Research 

Criteria, resulted from full notice and 

comment rulemaking procedures, NIH 

views comments concerning the 

Secretary’s determination or decision to 

be outside the scope of this solicitation 

and such comments will not be 

considered. Specifically, related 

comments will not be considered with 

respect to these proposed changes to the 

2015 Research Criteria: (1) eliminating 

the requirement that transplants 

involving kidneys and livers from 

donors with HIV comply with the NIH 

Research Criteria; (2) retaining the 

requirement that transplants involving 

all other organs (other than kidneys and 

livers) from donors with HIV comply 

with the NIH Research Criteria; and (3) 

removal of criteria specific to the 

transplantation of kidneys and livers. 

Do not include personal information 

in submitted comments that you do not 

want to be publicly disclosed. 

III. Proposed Revision to the 2015 

Research Criteria 

The proposed revision to the 2015 

Research Criteria is as follows: 

Proposed Revised Human 

Immunodeficiency Virus (HIV) Organ 

Policy Equity (HOPE) Act Safeguards 

and Research Criteria for 

Transplantation of Organs From Donors 

With HIV 

Table of Contents 

Abbreviations 

Definitions 

Proposed Revised Hope Act Safeguards and 

Research Criteria 

Table 1. Revised Final Human 

Immunodeficiency Virus (HIV) Organ 

Policy Equity (HOPE) Act Safeguards 

and Research Criteria for Transplantation 

of Organs With HIV 

REFERENCES 

ABBREVIATIONS

AIDS ......................................................... Acquired Immunodeficiency Syndrome. 

ART .......................................................... Antiretroviral Therapy. 

CD4 .......................................................... Cluster of Differentiation 4. 

D¥ ........................................................... Donor Human Immunodeficiency Virus negative. 

D+ ............................................................ Donor Human Immunodeficiency Virus positive. 

HBV .......................................................... Hepatitis B virus. 

HCT/Ps .................................................... Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). 

HCV ......................................................... Hepatitis C virus. 

HIV ........................................................... Human Immunodeficiency Virus. 

HIV¥ ....................................................... Human Immunodeficiency Virus negative (using serology and/or nucleic acid testing using FDA-licensed, approved or 

cleared devices). 

HIV+ ......................................................... Human Immunodeficiency Virus positive (using serology and/or nucleic acid testing using FDA-licensed, approved or 

cleared devices). 

HOPE Act ................................................ HIV Organ Policy Equity Act. 

HRSA ....................................................... Health Resources and Services Administration. 

IRB ........................................................... Institutional review board. 

NIH ........................................................... National Institutes of Health. 

NPRM ...................................................... Notice of proposed rule making. 

OI ............................................................. Opportunistic infection. 

OPO ......................................................... Organ procurement organization. 

PML .......................................................... Progressive multifocal leukoencephalopathy. 

R¥ ........................................................... Recipient HIV negative. 

R+ ............................................................ Recipient HIV positive. 

RNA ......................................................... Ribonucleic acid. 

SOPs ........................................................ Standard operating procedures. 

DEFINITIONS

Antiretroviral therapy (ART) resistance ... When an HIV strain develops drug resistance and/or genetic mutations associated with drug resistance. 

HIV superinfection ................................... Systemic HIV superinfection is defined as the detection of HIV viral sequences that phylogenetically cluster with the donor’s viral population at two or more time points in circulating blood cells, plasma, or recipient tissues other than the 

allograft. 

Suppressed viral load .............................. HIV RNA below 50 copies per mL with current technology at the time of publication of this research criteria document. 

The 2015 Research Criteria are 

outlined in six broad categories (Donor 

Eligibility, Recipient Eligibility, 

Transplant Hospital Criteria, Organ 

Procurement Organization (OPO) 

Responsibilities, Prevention of 

Inadvertent Transmission of HIV, and 

Study Design/Required Data Elements 

and Outcome Measures). Table 1 

summarizes the proposed new HOPE 

Act Research Criteria in each category 


ddrumheller on DSK120RN23PROD with NOTICES1
93620 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 

and compares them to the 2015 NIH 

Research Criteria. 

TABLE 1—PROPOSED REVISED HUMAN IMMUNODEFICIENCY VIRUS (HIV) ORGAN POLICY EQUITY (HOPE) ACT

SAFEGUARDS AND RESEARCH CRITERIA FOR TRANSPLANTATION OF ORGANS FROM DONORS WITH HIV 1

Category Previous criteria 

Proposed revised criteria 

(No longer pertains to kidney and liver transplants 5) 

Donor Eligibility: 

All deceased donors with HIV ...... No evidence of invasive opportunistic complications of HIV infection.No evidence of invasive opportunistic complications of HIV infection. 

Pre-implant donor organ biopsy .............................. There is no requirement for a pre-implantation biopsy.* 

Viral load: no requirement ....................................... Viral load: no requirement. 

Deceased donor with known history of HIV and prior 

antiretroviral therapy (ART).

The study team must describe the anticipated 

post-transplant antiretroviral regimen(s) to be 

prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable, and 

effective.

The study team must describe the anticipated 

post-transplant antiretroviral regimen(s) to be 

prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable, and 

effective. 

Living donor with HIV .................... Well-controlled HIV infection defined as: 

• Cluster of Differentiation 4 (CD4) + T-cell count 

≥500/μL for the 6-month period before donation 

• HIV–1 ribonucleic acid (RNA) <50 copies/mL 

• No evidence of invasive opportunistic complications of HIV infection 

Pre-implant donor organ biopsy 

Thoracic Organs Exception: The living donor 

standards are not relevant for thoracic organ 

transplant except in the rare instances of living 

donor lung transplant or ‘‘domino’’ heart transplant. In such circumstances, the deceased 

donor eligibility criteria should be followed. 

Other Organs: If a living donor with HIV donates 

another type or organ (other than kidney and 

liver), the deceased donor eligibility criteria 

should be followed.* 

Recipient Eligibility: CD4+ T-cell count ≥200/μL (kidney) .......................

CD4+ T-cell count ≥100 μL (liver) within 16 weeks 

prior to transplant and no history of opportunistic 

infection (OI); or ≥200 μL if history of OI is 

present.

CD4+ T-cell count: no minimum threshold when all 

other recipient eligibility criteria are met.* 

HIV–1 RNA <50 copies/mL and on a stable 

antiretroviral regimen.

HIV–1 RNA <50 copies/mL and on a stable 

antiretroviral regimen. 

No evidence of active opportunistic complications 

of HIV infection.

No evidence of active opportunistic complications 

of HIV infection. 

No history of primary central nervous system 

(CNS) lymphoma or progressive multifocal 

leukoencephalopathy (PML).

No history of primary central nervous system 

(CNS) lymphoma or progressive multifocal 

leukoencephalopathy (PML). 

Transplant Hospital Criteria ................. Transplant hospital with established program for 

care of subjects with HIV.

Transplant hospital with established program for 

care of patients with HIV. 

HIV program expertise on the transplant team ...... HIV program expertise on the transplant team. 

Organ-specific experience with transplants of organs from donors without HIV to recipients with 

HIV (5 D-/R+ transplant cases over 4 years).

There is no longer a center specific case experience requirement with transplants of organs 

from donors without HIV to recipients with HIV.* 

Transplant patients with organs from donors 

with HIV must be managed with a multidisciplinary team before, during, and after transplant. 

The multidisciplinary team must include transplant surgeons, physicians, HIV specialists, 

nurses, social workers, and pharmacists capable of therapeutic drug monitoring to minimize 

drug-drug interactions. 

Standard operating procedures (SOPs) and training for the organ procurement, implanting/operative, and postoperative care teams for handling 

subjects with HIV, and organs and tissues from 

individuals with HIV.

Standard operating procedures (SOPs) and training for the organ procurement, implanting/operative, and postoperative care teams for handling 

HIV-infected subjects with HIV, and organs and 

tissues from individuals with HIV. 

IRB-approved research protocol for transplantation 

of organs from donors with HIV in recipients 

with HIV.

IRB-approved research protocol for transplantation 

of organs from donors with HIV in recipients 

with HIV for the applicable organs.* 

Institutional biohazard plan outlining measures to 

prevent and manage inadvertent exposure to 

and/or transmission of HIV.

Institutional biohazard plan outlining measures to 

prevent and manage inadvertent exposure to 

and/or transmission of HIV. 

Provide each living donor with HIV and recipient 

with HIV with an ‘‘independent advocate’’.

There is no longer a requirement to provide an 

HIV independent advocate beyond standard site 

practices.* 

Policies and SOPs governing the necessary 

knowledge, experience, skills, and training for 

independent advocates.

Policies and SOPs governing the necessary 

knowledge, experience, skills, and training for 

independent advocates. 


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Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 93621 

TABLE 1—PROPOSED REVISED HUMAN IMMUNODEFICIENCY VIRUS (HIV) ORGAN POLICY EQUITY (HOPE) ACT

SAFEGUARDS AND RESEARCH CRITERIA FOR TRANSPLANTATION OF ORGANS FROM DONORS WITH HIV 1—Continued 

Category Previous criteria 

Proposed revised criteria 

(No longer pertains to kidney and liver transplants 5) 

OPO Responsibilities ........................... SOPs and staff training procedures for working 

with deceased donors with HIV and their families in pertinent history taking; medical chart abstraction; the consent process; and handling 

blood, tissues, organs, and biospecimens.

SOPs and staff training procedures for working 

with deceased donors with HIV and their families in pertinent history taking; medical chart abstraction; the consent process; and handling 

blood, tissues, organs, and biospecimens. 

Biohazard plan to prevent and manage HIV exposure and/or transmission.Biohazard plan to prevent and manage HIV exposure and/or transmission. 

Prevention of Inadvertent Transmission of HIV.Each participating Transplant Program and OPO 

shall develop an institutional biohazard plan for 

handling organs from HIV-positive donors that is 

designed to prevent and/or manage inadvertent 

transmission or exposure to HIV.

Each participating Transplant Program and OPO 

shall develop an institutional biohazard plan for 

handling organs from HIV-positive donors that is 

designed to prevent and/or manage inadvertent 

transmission or exposure to HIV. 

Procedures must be in place to ensure that 

human cells, tissues, and cellular and tissuebased products (HCT/Ps) are not recovered 

from donors with HIV for implantation, transplantation, infusion, or transfer into a human recipient; however, HCT/Ps from a donor determined 

to be ineligible may be made available for nonclinical purposes.

Procedures must be in place to ensure that 

human cells, tissues, and cellular and tissuebased products (HCT/Ps) are not recovered 

from donors with HIV for implantation, transplantation, infusion, or transfer into a human recipient; however, HCT/Ps from a donor determined 

to be ineligible may be made available for nonclinical purposes. 

Required Data Elements and Outcome 

Measures ** 

Wait List Candidates ............................ HIV status ................................................................ HIV status. 

CD4+ T-cell counts ................................................. CD4+ T-cell counts. 

Co-infection (hepatitis C virus [HCV], hepatitis B 

virus [HBV]).

Co-infection: 

• Hepatitis C (HCV RNA). 

• Hepatitis B (HBV deoxyribonucleic acid, 

HBV antibody). 

• Cytomegalovirus (CMV immunoglobulin G 

[IgG]).* 

HIV viral load ........................................................... HIV viral load. 

ART resistance ........................................................ ART resistance. 

Removal from wait list (death or other reason) ...... Removal from wait list (death or other reason). 

Time on wait list ...................................................... Time on wait list. 

Renal dysfunction.* 

Liver dysfunction.* 

Indication for transplant.* 

Use of mechanical circulatory devices.* 

Use of extracorporeal membrane oxygenation, 

intra-aortic balloon pump, ventricular assist device.* 

Donors (all) ........................................... Type (Living or deceased) ...................................... Type Donation after Brain Death vs. Donation 

after Circulatory Death vs. Living Donor.* 

HIV status (new diagnosis of HIV, or known diagnosis of HIV).HIV status (new diagnosis of HIV, or known diagnosis of HIV). 

CD4+ T-cell count ................................................... CD4+ T-cell count. 

Co-infection (HCV, HBV) ........................................ Co-infection (HCV, HBV). 

HIV viral load ........................................................... HIV viral load. 

ART resistance ........................................................ ART resistance. 

Ex-vivo perfusion.* 

• Duration. 

• Warm and cold ischemia time. 

Normothermic regional perfusion.* 

• Duration. 

• Warm and cold ischemia time. 

Living Donors ....................................... Progression to renal insufficiency in kidney donors 

Progression to hepatic insufficiency in liver donors 

These data elements no longer apply since kidney 

or liver donation from a living donor with HIV no 

longer falls under the Research Criteria except 

that these data elements apply to simultaneous 

multiple organ transplants. 

Change in ART regimen as a result of organ dysfunction.Change in ART regimen as a result of organ dysfunction. 

Progression to acquired immunodeficiency syndrome (AIDS).Progression to AIDS. 

Failure to suppress viral replication (persistent HIV 

viremia).

Failure to suppress viral replication (persistent HIV 

viremia). 

Death ....................................................................... Death. 

Transplant Recipients .......................... Rejection rate (annual up to 5 years) ..................... Rejection rate (annual through 5 years). 

Progression to AIDS ............................................... Progression to AIDS. 


ddrumheller on DSK120RN23PROD with NOTICES1
93622 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 

5Consistent with the final rule amending the 

OPTN regulations, transplants using kidneys and 

livers from donors with HIV no longer need to 

comply with the HOPE Act research criteria. When 

multiple organs from donors with HIV are 

implanted simultaneously (e.g., dual heart-kidney 

or dual lung-kidney), the Research Criteria apply to 

such multiple organ transplants if the transplant of 

any of the organs are subject to the revised Research 

Criteria. For example, while a kidney transplant 

from a donor with HIV no longer is required to be 

conducted in accordance with the Research Criteria, 

a dual heart-kidney or dual lung-kidney transplant 

with organs from donors with HIV is required to be 

conducted in accordance with the Research Criteria 

and in accordance with an IRB-approved research 

protocol. A dual liver-kidney transplant with from 

donors with HIV is not required to be conducted in 

accordance with the Research Criteria, as neither 

liver transplants nor kidney transplants from 

donors with HIV are required to be conducted as 

research. 

TABLE 1—PROPOSED REVISED HUMAN IMMUNODEFICIENCY VIRUS (HIV) ORGAN POLICY EQUITY (HOPE) ACT

SAFEGUARDS AND RESEARCH CRITERIA FOR TRANSPLANTATION OF ORGANS FROM DONORS WITH HIV 1—Continued 

Category Previous criteria 

Proposed revised criteria 

(No longer pertains to kidney and liver transplants 5) 

New OI .................................................................... New OI. 

Failure to suppress viral replication (persistent HIV 

viremia).

Failure to suppress viral replication (persistent HIV 

viremia). 

HIV-associated organ failure ................................... HIV-associated organ failure. 

Malignancy .............................................................. Malignancy. 

Graft failure ............................................................. Graft failure. 

Mismatched ART resistance versus donor ............. Mismatched ART resistance versus donor. 

Death ....................................................................... Death. 

Type of rejection (antibody mediated versus cellular rejection).* 

Chronic heart allograft vasculopathy.* 

Chronic lung allograft dysfunction.* 

Hospitalized infections.* 

Estimated glomerular filtration rate.* 

HIV superinfection.* 

Re-transplantation.* 

Simultaneous multiple organ transplants. 

* Denotes a revision of the 2015 Research Criteria. 

** The previous category of outcome measures (from the original 2015 Research Criteria) is modified to also include data elements. 

A summary of the proposed revisions 

in each category of the Research Criteria 

is provided below. 

Donor Eligibility 

The only change proposed by NIH to 

this category applies to all deceased 

donors with HIV. NIH proposes 

removing the requirement for a preimplantation donor organ biopsy. 

Although pre-implantation biopsies for 

kidneys and livers have occurred 

regularly, pre-implant donor heart and 

lung biopsies are not routinely 

performed. Likewise, donor biopsies for 

other organs are not routine. Given that 

kidney and liver transplants are no 

longer subject to the NIH research 

criteria, NIH proposes removing the 

requirement for pre-implantation 

biopsies. Any pre-implant biopsies 

obtained, as part of future IRB-approved 

research protocols, should be stored in 

accordance with local institutional 

requirements and the federal regulations 

applicable to slides, tissues, and blocks, 

if applicable. 42 CFR 493.1105 (https:// 

www.ecfr.gov/current/title-42/chapterIV/subchapter-G/part-493/subpart-J/ 

section-493.1105). 

With respect to living donors with 

HIV, the 2015 NIH Research Criteria 

defined a well-controlled HIV infection 

and required pre-implant donor organ 

biopsies. The last living lobar lung 

transplant procedure in the U.S. was 

performed in 2013. NIH proposes 

removing this element as not relevant 

for heart and lung transplantation 

except in the rare instances of living 

donor lung transplant or ‘‘domino’’ 

heart transplants. In such 

circumstances, NIH proposes that the 

deceased donor eligibility criteria apply. 

If another type of organ is donated by 

a living donor with HIV, NIH proposes 

that the deceased donor eligibility 

criteria apply. 

Recipient Eligibility 

The only change proposed in this 

category concerns CD4+ T-cell counts. 

The 2015 NIH Research Criteria 

imposed requirements with respect to 

the CD4+ T-cell counts specific to livers 

and kidneys. Given that kidney and 

liver transplants are no longer required 

to comply with the research criteria, 

NIH proposes no minimum threshold 

CD4+ T-cell counts for other organs 

when all other eligibility criteria are 

met. 

Transplant Hospital 

NIH proposes several changes to this 

category. The requirement for prior 

experience with transplantation of 

organs from donors without HIV in 

recipients with HIV. The 2015 NIH 

Research Criteria required experience 

with five transplants over the four 

preceding years involving organs from 

donors without HIV transplanted into 

recipients with HIV. NIH proposes 

removing this requirement, which was 

perceived by many as burdensome and 

a barrier to entry to transplant hospitals 

wishing to perform HOPE Act 

transplants. To maximize favorable 

outcomes and effectively prevent and 

manage adverse events, NIH proposes 

that all patients with transplants 

involving donors with HIV be managed 

by multidisciplinary teams before, 

during, and after transplantation. NIH 

proposes specific members of this 

multidisciplinary team. 

NIH proposes removing the 

requirement that each living donor with 

HIV and each transplant recipient with 

HIV be provided with an HIVindependent advocate. NIH proposes 

instead that standard site practices 

apply. Based on a decade of HOPE Act 

clinical experience, stakeholder surveys 

have indicated that a requirement for an 

independent advocate is widely 

perceived as a redundant layer of 

consent and a potential barrier for some 

HIV patients who would otherwise 

benefit from an HIV donor transplant. 

The NIH notes that per current OPTN 

policy and guidance, all living donors, 

including those with HIV, have an 

independent advocate. NIH’s proposed 

change to the 2015 Research Criteria 

will not alter that. 


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Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 93623 

Organ Procurement Organization (OPO) 

Responsibilities 

NIH does not propose changes to this 

category. 

Prevention of Inadvertent Transmission 

of HIV 

NIH does not propose changes to this 

category. 

Required Outcome Measures and Data 

Elements 

The 2015 Research Criteria referenced 

required outcome measures. NIH 

proposes using the more precise 

‘‘Required Data Elements and Outcome 

Measures.’’ NIH notes that data on these 

existing and proposed outcome 

measures is collected by the OPTN as 

specified by the Secretary. NIH does not 

intend to propose data collection 

requirements beyond those collected by 

the OPTN. 

Waitlist Candidates: NIH proposes 

adding several data elements for waitlist 

candidates. NIH proposes adding 

cytomegalovirus (CMV immunoglobulin 

G [IgG]) as a required outcome measure 

for co-infection. NIH also proposes 

adding additional data elements and 

outcome measures: renal dysfunction, 

liver dysfunction, indication for 

transplant, use of mechanical 

circulatory devices, and use of 

extracorporeal membrane oxygenation, 

intra-aortic balloon pump, and 

ventricular assist device. 

Donors (All): First, NIH proposes 

adding additional elements related to 

the type of deceased donation: after 

brain death (DBD) or after circulatory 

death (DCD) given the increasing use of 

the latter technique in the U.S. In 

addition, NIH proposes the following 

data elements for all donors (if 

applicable): ex-vivo perfusion and 

normothermic regional perfusion 

including durations of warm and cold 

ischemia. 

Living Donors: The 2015 NIH 

Research Criteria included as required 

outcome measures progression to renal 

insufficiency in kidney living donors. 

Because kidney and liver transplants are 

no longer subject to the research criteria, 

NIH plans to retain these outcomes only 

where applicable (e.g., for deceased 

donor heart-living donor kidney 

transplants, deceased donor heart-living 

donor liver transplants, and for other 

organs subject to the research criteria). 

Transplant Recipients: NIH proposes 

adding several additional data elements 

and outcome measures to those 

included for transplant recipients in the 

2015 NIH Research Criteria. NIH 

proposes adding the following outcome 

measures: type of rejection (antibodymediated versus cellular rejection), 

chronic allograft vasculopathy (heart), 

chronic lung allograft dysfunction 

(lung), hospital infections, estimated 

glomerular filtration rate (heart and 

lung), HIV superinfection, graft failure 

(heart and lung), re-transplantation, and 

simultaneous multiple organ 

transplants. 

While not proposed as a requirement 

of the Research Criteria, NIH proposes 

to provide the following 

recommendation regarding patient 

management: NIH recommends that 

transplant programs and healthcare 

providers follow current and updated 

practice management guidelines. For 

specific guidance, transplant programs 

and healthcare providers should consult 

vaccination guidance (https://

www.cdc.gov/acip-recs/hcp/vaccinespecific/index.html) and expert 

guidance for the management of patients 

with HIV pre-, during-, and posttransplant summarized in: 

Transplantation in people with HIV 

(https://clinicalinfo.hiv.gov/en/ 

guidelines/hiv-clinical-guidelines-adultand-adolescent-arv/whats-new). 

References 

1. Department of Health and Human Services 

(DHHS). Human Immunodeficiency 

Virus (HIV) Organ Policy Equity (HOPE) 

Act Safeguards and Research Criteria for 

Transplantation of Organs Infected With 

HIV. 80 FR 34912. June 18, 2015. 

2. Doberne J.W., et al. (2021). Heart 

transplantation survival outcomes of HIV 

positive and negative recipients. Annals 

of Thoracic Surgery, 111:1465–71. 

3. Durand C., et al. (2024). Safety of kidney 

transplantation from donors with HIV 

infection. N Engl J Med, 391:1390–401. 

4. HIV Organ Policy Equity (HOPE) Act of 

2013. Public Law 113–51. 

5. Kern, R., Seethamraju, H., Blanc, P., Sinha, 

N., Loebe, M., Golden, J., et al. (2014). 

Lung Transplantation in HIV 

Seropositive Patients. Chest, 145(3 

Suppl), 642A. 

6. Koval C., et al. (2018). Heart and lung 

transplantation outcomes in HIV-positive 

recipients. 

7. Koval, C.E., Farr, M., Krisl, J., Haidar, G., 

Pereira, M.R., Shrestha, N., Malinis, 

M.F., Mueller, N.J., Hannan, M.M., 

Grossi, P., & Huprikar, S. (2019). Heart or 

lung transplant outcomes in HIVinfected recipients. The Journal of heart 

and lung transplantation: the official 

publication of the International Society 

for Heart Transplantation, 38(12), 1296– 

1305. https://doi.org/10.1016/ 

j.healun.2019.09.011. 

8. Madan S., et al, (2019). Outcomes of heart 

transplantation in patients with human 

immunodeficiency virus. Am J 

Transplant. 19:1529–35. 

9. Rouzaud C., et al., (2022). Lung 

transplantation in HIV-positive patients: 

a European retrospective cohort study. 

Eur Respir J. 60(1):2200189. 

10. Storm, K., & Durand, C.M. (2024). 

Overcoming barriers and stigma: new 

frontiers in solid organ transplantation 

for people with HIV. Clinical 

microbiology reviews, 37(1), e0011122. 

https://doi.org/10.1128/cmr.00111-22. 

11. Wairimu, F., Ward, N.C., Liu, Y., & 

Dwivedi, G. (2021). Cardiac 

Transplantation in HIV-Positive Patients: 

A Narrative Review. Journal of acquired 

immune deficiency syndromes (1999), 

87(2), 763–768. https://doi.org/10.1097/ 

QAI.0000000000002647. 

Dated: November 21, 2024. 

Lawrence A. Tabak, 

Principal Deputy Director, National Institutes 

of Health. 

[FR Doc. 2024–27733 Filed 11–26–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Comprehensive Partnerships to Advance 

Cancer Health Equity (CPACHE). 

Date: January 16, 2025. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W108, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Clifford W. Schweinfest, 

Ph.D., Scientific Review Officer, Special 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W108, 

Rockville, Maryland 20850, 240–276–6343, 

schweinfestcw@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Informatics 

Technologies for Cancer Research. 

Date: January 29, 2025. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


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