Data / Federal rules / 2024-20643
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act
The Health and Human Services Department published this proposed rule in the Federal Register on September 12, 2024. Comments closed on October 15, 2024.
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What the agency says
The Department of Health and Human Services (HHS) proposes to amend 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 kidney 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 proposes to determine that participation in such clinical research should no longer be a requirement for transplantation of HIV positive kidneys and livers from donors with HIV to recipients with HIV. This proposed rule serves as publication of the Secretary's proposed determination and proposes to amend the regulations to reflect this determination. Consistent with NOTA and current regulatory requirements, the Secretary's proposed determination and the proposed corresponding regulatory revision, if finalized, will necessitate that the Organ Procurement and Transplantation Network (OPTN) adopt and use standards of quality concerning kidneys and livers from donors with HIV, as directed by the Secretary, 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
- 2024-20643
- Type
- Proposed rule
- Action
- Notice of proposed rulemaking
- Agency
- Health and Human Services Department
- Published
- September 12, 2024
- Comments due
- October 15, 2024
- Dates
- Comments on this notice of proposed rulemaking should be received no later than October 15, 2024.
- Regulation ID (RIN)
- 0937-AA13
- Code of Federal Regulations
- 42 CFR 121
- Topics
- Health care; Hospitals; Reporting and recordkeeping requirements
- Pages
- 11
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 September 2024
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