42 U.S.C. § 274f–5 — Criteria, standards, and regulations with respect to organs infected with HIV
submitted 82 years ago by Pub. L. 113-51 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 348 words · no verdicts yet
By late 2015, the Secretary had to publish criteria for research on transplanting HIV-infected organs into HIV-infected recipients, and update related standards and regulations to allow it. Starting in 2017 and every year after, the Secretary must review the science and revise standards if warranted, without reducing transplant safety.
(a) In general: Not later than 2 years after November 21, 2013, the Secretary* had to develop and publish criteria for conducting research on transplanting organs from HIV-infected donors into recipients already infected with HIV before the transplant.
(b) Corresponding changes to standards and regulations applicable to research: Not later than 2 years after November 21, 2013, to whatever extent the Secretary decided was needed to let this research happen under the (a) criteria: (1) the Organ* Procurement and Transplantation Network had to revise its quality standards adopted under section 274(b)(2)(E); and (2) the Secretary had to revise section 121.6 of title 42, Code of Federal Regulations (or its successor).
(c) Revision of standards and regulations generally: Not later than 4 years after November 21, 2013, and every year after that, the Secretary must: (1) review the scientific research results, with the Network, to see if they justify revising the quality standards under section 274(b)(2)(E) for HIV-infected organs and for transplanting an organ with one HIV strain into a recipient with a different strain; (2) if the results do justify revision, direct the Network to revise the standards, consistent with section 274 and in a way that does not reduce transplant safety; and (3) revise section 121.6 of title 42, Code of Federal Regulations (or its successor) to match any such revision.
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*.
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)—
the Organ Procurement and Transplantation Network shall revise the standards of quality adopted under section 274(b)(2)(E) of this title; and
the Secretary shall revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations).
Not later than 4 years after November 21, 2013, and annually thereafter, the Secretary,1 shall—
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;
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
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).
Source credit: (July 1, 1944, ch. 373, title III, § 377E, as added Pub. L. 113–51, § 2(b), Nov. 21, 2013, 127 Stat. 580.)
- 1944Enacted · Pub. L. 113-51 · 127 Stat. 580
A history note hasn’t been published yet. The record shows enactment by Pub. L. 113-51 on 1944-07-01.
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