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Data / Federal rules / 2024-27410

Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act

The Health and Human Services Department published this final rule in the Federal Register on November 27, 2024. It took effect on November 27, 2024.

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What the agency says

The Department of Health and Human Services (HHS) amends the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove clinical research and institutional review board (IRB) requirements ("research and IRB requirements") for transplantation of kidneys and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. As allowed by the HIV Organ Policy Equity (HOPE) Act, the Secretary of HHS determines that participation in such clinical research should no longer be a requirement for transplantation of kidneys and livers from donors with HIV to recipients with HIV. This final rule serves as publication of the Secretary's determination and amends the regulations to reflect this determination. This final rule also serves as publication of the Secretary's direction to the Organ Procurement and Transplantation Network (OPTN) to adopt and use standards of quality with respect to kidneys and livers from donors with HIV to ensure that HOPE Act kidney and liver transplants are subject to OPTN policies that are consistent with NOTA, and in a way that ensures the revised requirements for transplantation of such organs will not reduce the safety of organ transplantation.

Key facts

Document number
2024-27410
Type
Final rule
Action
Final rule
Agency
Health and Human Services Department
Published
November 27, 2024
Takes effect
November 27, 2024
Dates
This rule is effective November 27, 2024.
Regulation ID (RIN)
0937-AA13
Code of Federal Regulations
42 CFR 121
Topics
Health care; Hospitals; Reporting and recordkeeping requirements
Pages
15

The document on federalregister.gov PDF

Other documents from the Health and Human Services Department

Everything from the Health and Human Services Department · Rules on health care · Rules on hospitals · Rules on reporting and recordkeeping requirements · Published in November 2024

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.