One Hundred Thirteenth Congress of the United States of America
1st Session
Begun and held at the City of Washington on Thursday, the third day of January, two thousand and thirteen
S. 330
AN ACT
To amend the Public Health Service Act to establish safeguards and standards of quality for research and transplantation of organs infected with human immunodeficiency virus (HIV).
Short title
This Act may be cited as the
HIV Organ Policy Equity
Act
.
Amendments to the Public Health Service Act
Standards of quality for the acquisition and transportation of donated organs
Organ Procurement and Transplantation Network
Section 372(b) of the Public Health Service Act (42 U.S.C. 274(b)) is amended—
in paragraph (2)(E), by striking ,
including standards for preventing the acquisition of organs that are infected
with the etiologic agent for acquired immune deficiency syndrome
;
and
by adding at the end the following:
Clarification
In adopting and using standards of quality
under paragraph (2)(E), the Organ Procurement and Transplantation Network may
adopt and use such standards with respect to organs infected with human
immunodeficiency virus (in this paragraph referred to as HIV
),
provided that any such standards ensure that organs infected with HIV may be
transplanted only into individuals who—
are infected with HIV before receiving such organ; and
are participating in clinical research approved by an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of section 377E; or
if the Secretary has determined under section 377E(c) that participation in such clinical research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the standards and regulations under section 377E(c).
.
Conforming amendment
Section 371(b)(3)(C) of the Public Health
Service Act (42 U.S.C. 273(b)(3)(C); relating to organ procurement
organizations) is amended by striking including arranging for testing
with respect to preventing the acquisition of organs that are infected with the
etiologic agent for acquired immune deficiency syndrome
and inserting
including arranging for testing with respect to identifying organs that
are infected with human immunodeficiency virus (HIV)
.
Technical amendments
Section 371(b)(1) of the Public Health Service Act (42 U.S.C. 273(b)(1)) is amended by—
striking subparagraph (E);
redesignating subparagraphs (F) and (G) as subparagraphs (E) and (F), respectively;
striking (H) has a director
and inserting (G) has a director
; and
in subparagraph (H)—
in clause (i) (V), by striking
paragraph (2)(G)
and inserting paragraph (3)(G)
;
and
in clause (ii), by striking
paragraph (2)
and inserting paragraph (3)
.
Publication of research guidelines
Part H of title III of the Public Health Service Act (42 U.S.C. 273 et seq.) is amended by inserting after section 377D the following:
Criteria, standards, and regulations with respect to organs infected with HIV
In general
Not later than 2 years after the date of
the enactment of the HIV Organ Policy Equity
Act, 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.
Corresponding changes to standards and regulations applicable to research
Not later than 2 years after the date of the enactment of the HIV Organ Policy Equity Act, 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 372(b)(2)(E); and
the Secretary shall revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations).
Revision of standards and regulations generally
Not later than 4 years after the date of the enactment of the HIV Organ Policy Equity Act, and annually thereafter, the Secretary, 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 372(b)(2)(E) 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 372(b)(2)(E) 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 372 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).
.
Conforming amendment to title 18 of the United States Code
Section 1122(a) of title 18, United States
Code, is amended by inserting or in accordance with all applicable
guidelines and regulations made by the Secretary of Health and Human Services
under section 377E of the Public Health Service Act
after
research or testing
.
Speaker of the House of Representatives
Vice President of the United States and President of the Senate