(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 researchNot 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 generallyNot later than 4 years after November 21, 2013, and annually thereafter, the Secretary,[1] 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).
(July 1, 1944, ch. 373, title III, § 377E, as added Pub. L. 113–51, § 2(b), Nov. 21, 2013, 127 Stat. 580.)