Senior Advisor for Blood and Tissue Safety

0937-AA13 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0937 Office of Assistant Secretary for Health OASH 0900 Department of Health and Human Services HHS Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act

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.

]]> Economically Significant Previously Published in The Unified Agenda Completed Actions Yes No Not subject to, not significant 42 CFR 121.6 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 No NPRM 09/12/2024 89 FR 74174 NPRM Comment Period End 10/15/2024 Final Action 11/27/2024 89 FR 93484 Final Action Effective 11/27/2024 No No None No No No No James Berger Mr. Senior Advisor for Blood and Tissue Safety 0937 Office of Assistant Secretary for Health OASH 202 578-9237 james.berger@hhs.gov 1101 Wootton Parkway, Rockville MD 20852