Title 42, The Public Health and WelfareRelease 119-110

§274f–5 Criteria, Standards, and Regulations with Respect to Organs Infected with Hiv

Title 42 › CHAPTER 6A — PUBLIC HEALTH SERVICE › SUBCHAPTER II — GENERAL POWERS AND DUTIES › Part H — Organ Transplants › § 274f–5

Last updated Sep 23, 2026|Official source

Summary

Require the Secretary of Health and Human Services to write and publish rules within 2 years after November 21, 2013 for doing research that transplants organs from donors who have HIV into people who already have HIV. Within the same 2 years, the Organ Procurement and Transplantation Network (OPTN) must update its quality standards, and the Secretary must update federal regulation 42 C.F.R. 121.6 if needed so the research can happen. Within 4 years after November 21, 2013, and every year after, the Secretary and OPTN must review new research to see if the standards should change, especially about safety when donor and recipient have different HIV strains. If changes are needed, the Secretary must tell OPTN to revise the standards in a way that does not reduce transplant safety and must update regulation 121.6 at the same time.

Full Legal Text

Title 42, §274f–5

The Public Health and Welfare, Source: USLM XML via OLRC

(a)In general

Not later than 2 years after November 21, 2013, the Secretary shall develop and publish criteria for the conduct of research relating to transplantation of organs from donors infected with human immunodeficiency virus (in this section referred to as “HIV”) into individuals who are infected with HIV before receiving such organ.

(b)Corresponding changes to standards and regulations applicable to research

Not later than 2 years after November 21, 2013, to the extent determined by the Secretary to be necessary to allow the conduct of research in accordance with the criteria developed under subsection (a)—

(1)the Organ Procurement and Transplantation Network shall revise the standards of quality adopted under section 274(b)(2)(E) of this title; and

(2)the Secretary shall revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations).

(c)Revision of standards and regulations generally

Not later than 4 years after November 21, 2013, and annually thereafter, the Secretary, shall—

(1)review the results of scientific research in conjunction with the Organ Procurement and Transplantation Network to determine whether the results warrant revision of the standards of quality adopted under section 274(b)(2)(E) of this title with respect to donated organs infected with HIV and with respect to the safety of transplanting an organ with a particular strain of HIV into a recipient with a different strain of HIV;

(2)if the Secretary determines under paragraph (1) that such results warrant revision of the standards of quality adopted under section 274(b)(2)(E) of this title with respect to donated organs infected with HIV and with respect to transplanting an organ with a particular strain of HIV into a recipient with a different strain of HIV, direct the Organ Procurement and Transplantation Network to revise such standards, consistent with section 274 of this title and in a way that ensures the changes will not reduce the safety of organ transplantation; and

(3)in conjunction with any revision of such standards under paragraph (2), revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations).

Reference

Citations & Metadata

Citation

42 U.S.C. § 274f–5

Title 42, The Public Health and Welfare

Last Updated

Sep 23, 2026

Release point: 119-110