106548 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

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 has added 

several additional data elements and 

outcome measures to those included for 

transplant recipients in the 2015 

Research Criteria. NIH has added the 

following outcome measures: type of 

rejection (antibody mediated 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 included as a requirement 

of the Research Criteria, NIH has 

included 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: December 20, 2024. 

Lawrence A. Tabak, 

Principal Deputy Director, National Institutes 

of Health. 

[FR Doc. 2024–31265 Filed 12–27–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 

Institute of General Medical Sciences 

Special Emphasis Panel Review of 

Centers of Biomedical Research 

Excellence (COBRE) Phase IIITranslational Centers (P30) 

Applications 

Date: March 18–19, 2025 

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

Agenda: To review and evaluate grant 

applications 

Address: National Institutes of Health, 

National Institute of General Medical 

Sciences, Natcher Building, 45 Center 

Drive, Bethesda, Maryland 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Manas 

Chattopadhyay, Ph.D., Scientific Review 

Officer, Office of Scientific Review, 

National Institute of General Medical 

Sciences, National Institutes of Health, 

45 Center Drive, Room 3AN12N, 

Bethesda, Maryland 20892, 301–827– 

5320, manasc@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: December 19, 2024. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–30873 Filed 12–27–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Secretary; Notice of 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting of Interagency 

Autism Coordinating Committee. 

The meeting will be virtually held 

and is open to public viewing. The 

connection information and how to 

access the meeting will be available on 

the IACC website https://iacc.hhs.gov/ 

meetings/iacc-meetings/2025/summaryof-advances/january14/. Advanced 

registration is recommended. 

Individuals wishing to participate 

virtually that need special assistance or 

other reasonable accommodations 

should submit a request to the Contact 

Person listed on this notice at least 

seven (7) business days prior to the 

meeting. 

The purpose of the IACC meeting is 

to discuss the committee’s nominations 

of articles for the 2024 IACC Summary 

of Advances in Autism Research report. 

The final report will summarize the top 

20 advances in autism biomedical and 

services research, as selected by the 

IACC. 

Name of Committee: Interagency Autism 

Coordinating Committee 2024 IACC 

Summary of Advances in Autism Research. 

Date: January 14, 2025. 

Time: 2:00 p.m. to 4:00 p.m. 


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