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HHS/OASH RIN: 0937-AA13 Publication ID: Spring 2024 
Title: ●Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act 
Abstract:

This proposed rule would amend 42 CFR 121.6 to remove clinical research and institutional review board (IRB) requirements for kidney and liver transplants of organs from people with human immunodeficiency virus (HIV). The proposed rule would continue to require that the Organ Procurement and Transplantation (OPTN) adopt and use standards of quality with respect to kidneys and livers donated by persons with HIV, consistent with the National Organ Transplant Act of 1984 and in a way that ensures the use of kidneys and livers from people with HIV will not reduce the safety of organ transplantation.

 
Agency: Department of Health and Human Services(HHS)  Priority: Section 3(f)(1) Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 121.6   
Legal Authority: secs. 215, 371 to 377, and 377E of the PHS Act (42 U.S.C. 216, 273 to 274d, 274f-5)    secs.1102, 1106, 1138 and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8, and 1395hh)    sec. 301 of the National Organ Transplant Act, as amended (42 U.S.C. 274e)    E.O. 13879, 84 FR 33817   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Mr. James Berger
Senior Advisor for Blood and Tissue Safety
Department of Health and Human Services
Office of Assistant Secretary for Health
1101 Wootton Parkway,
Rockville, MD 20852
Phone:202 578-9237
Email: james.berger@hhs.gov