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. 


ddrumheller on DSK120RN23PROD with NOTICES1
93624 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Notices 

Address: National Cancer Institute at 

Shady Grove, 9609 Medical Center Drive, 

Room 7W106, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Eduardo Emilio Chufan, 

Ph.D., Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W106, Rockville, Maryland 

20850, 240–276–7975, chufanee@

mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Review of Research Projects in Physical 

Sciences Oncology. 

Date: January 31, 2025. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute at 

Shady Grove, 9609 Medical Center Drive, 

Room 7W640, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Saejeong J. Kim, Ph.D., 

Scientific Review Officer, Special Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W640, Rockville, 

Maryland 20850, 240–276–7684, 

saejeong.kim@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Outstanding Investigator Award (R35). 

Date: February 6–7, 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 

7W104, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: David G. Ransom, Ph.D., 

Chief, Scientific Review Officer, Special 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W104, 

Rockville, Maryland 20850, 240–276–6351, 

david.ransom@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–3: NCI 

Clinical and Translational Cancer Research. 

Date: February 6–7, 2025. 

Time: 9:30 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W612, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Prashant Sharma, Ph.D., 

Scientific Review Officer, Special Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W612, Rockville, 

Maryland 20850, 240–275–6351, 

prashant.sharma@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–7: NCI 

Clinical and Translational Cancer Research. 

Date: February 12, 2025. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute at 

Shady Grove, 9609 Medical Center Drive, 

Room 7W640, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Saejeong J. Kim, Ph.D., 

Scientific Review Officer, Special Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W640, Rockville, 

Maryland 20850, 240–276–7684, 

saejeong.kim@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI IMAT 

Biospecimen Special Emphasis Panel. 

Date: February 13, 2025. 

Time: 10:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W236, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Shuli Xia, Ph.D., Scientific 

Review Officer, Research Technology and 

Contract Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W236, Rockville, Maryland 20850, 

240–276–5256, shuli.xia@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–11: 

NCI Clinical and Translational Cancer 

Research. 

Date: February 18, 2025. 

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

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W606, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Bruce Daniel Hissong, 

Ph.D., Scientific Review Officer, Resource 

and Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W606, Rockville, Maryland 20850, 

240–276–7752, bruce.hissong@nih.gov. 

Name of Committee: National Cancer 

Institute, Initial Review Group; Transition to 

Independence Study Section (I). 

Date: February 26–27, 2025. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Place: National Cancer Institute at 

Shady Grove, 9609 Medical Center Drive, 

Room 7W602, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Delia Tang, M.D., 

Scientific Review Officer, Resources and 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W602, Rockville, Maryland 20850, 

240–276–6456, tangd@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Research specialist Award (R50). 

Date: February 27, 2025. 

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

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute at 

Shady Grove, 9609 Medical Center Drive, 

Room 7W242, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Zhiqiang Zou, M.D., Ph.D., 

Scientific Review Officer, Special Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W242, Rockville, 

Maryland 20850, 240–276–6372, zouzhiq@

mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–2: NCI 

Clinical and Translational Cancer Research. 

Date: March 6, 2025. 

Time: 10:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Cancer Institute at 

Shady Grove, 9609 Medical Center Drive, 

Room 7W242, Rockville, Maryland 20850. 

Meeting Format: Virtual Meeting. 

Contact Person: Zhiqiang Zou, M.D., Ph.D., 

Scientific Review Officer, Special Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W242, Rockville, 

Maryland 20850, 240–276–6372, zouzhiq@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: November 22, 2024. 

Miguelina Perez, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2024–27877 Filed 11–26–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Environmental Health Sciences Council. 

The meeting will be open to the 

public as indicated below, 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 NIEHS 

Videocast at the following link: https:// 

www.niehs.nih.gov/news/webcasts/ 

index.cfm. 

The meeting will be closed to the 

public in accordance with the 


ddrumheller on DSK120RN23PROD with NOTICES1