[Congressional Record Volume 159, Number 86 (Monday, June 17, 2013)]
[Senate]
[Pages S4533-S4534]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
HIV ORGAN POLICY EQUITY ACT
Mr. KING. Madam President, I ask unanimous consent that the Senate
proceed to the immediate consideration of Calendar No. 75, S. 330.
The PRESIDING OFFICER. The clerk will report the bill by title.
The legislative clerk read as follows:
A bill (S. 330) to amend the Public Health Service Act to
establish safeguards and standards for research and
transplantation of organs infected with human
immunodeficiency virus (HIV).
There being no objection, the Senate proceeded to consider the
bill (S. 330) 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), which had been
reported from the Committee on Health, Education, Labor, and Pensions,
with an amendment to strike all after the enacting clause and insert in
lieu thereof the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``HIV Organ Policy Equity
Act''.
SEC. 2. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
(a) Standards of Quality for the Acquisition and
Transportation of Donated Organs.--
(1) Organ procurement and transplantation network.--Section
372(b) of the Public Health Service Act (42 U.S.C. 274(b)) is
amended--
(A) 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
(B) by adding at the end the following:
``(3) 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--
``(A) are infected with HIV before receiving such organ;
and
``(B)(i) 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
``(ii) 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).''.
(2) 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)''.
(3) Technical amendments.--Section 371(b)(1) of the Public
Health Service Act (42 U.S.C. 273(b)(1)) is amended by--
(A) striking subparagraph (E);
(B) redesignating subparagraphs (F) and (G) as
subparagraphs (E) and (F), respectively;
(C) striking ``(H) has a director'' and inserting ``(G) has
a director''; and
(D) in subparagraph (H)--
(i) in clause (i) (V), by striking ``paragraph (2)(G)'' and
inserting ``paragraph (3)(G)''; and
(ii) in clause (ii), by striking ``paragraph (2)'' and
inserting ``paragraph (3)''.
(b) 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:
``SEC. 377E. CRITERIA, STANDARDS, AND REGULATIONS WITH
RESPECT TO ORGANS INFECTED WITH HIV.
``(a) 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.
``(b) 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)--
``(1) the Organ Procurement and Transplantation Network
shall revise the standards of quality adopted under section
372(b)(2)(E); 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 the date of the enactment of the HIV
Organ Policy Equity Act, 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 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;
``(2) 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
``(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).''.
SEC. 3. CONFORMING AMENDMENT TO TITLE 18 OF THE UNITED STATES
CODE.
Section 1122 of title 18, United States Code, is amended by
adding at the end the following:
``(d) Exception.--An organ donation does not violate this
section if the donation is in accordance with all applicable
criteria and regulations
[[Page S4534]]
of the Secretary made under section 377E of the Public Health
Service Act.''.
Mr. KING. I further ask that the committee-reported substitute be
considered; the Grassley amendment, which is at the desk, be agreed to;
the substitute, as amended, be agreed to; the bill, as amended, be read
a third time and passed; and the motions to reconsider be made and laid
upon the table, with no intervening action or debate.
The amendment (No. 1315) was agreed to, as follows:
amendment no. 1315
Strike section 3 and insert the following:
SEC. 3. 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''.
The committee amendment, as amended, was agreed to.
The bill was ordered to be engrossed for a third reading, was read
the third time, and passed, as follows:
S. 330
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``HIV Organ Policy Equity
Act''.
SEC. 2. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
(a) Standards of Quality for the Acquisition and
Transportation of Donated Organs.--
(1) Organ procurement and transplantation network.--Section
372(b) of the Public Health Service Act (42 U.S.C. 274(b)) is
amended--
(A) 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
(B) by adding at the end the following:
``(3) 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--
``(A) are infected with HIV before receiving such organ;
and
``(B)(i) 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
``(ii) 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).''.
(2) 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)''.
(3) Technical amendments.--Section 371(b)(1) of the Public
Health Service Act (42 U.S.C. 273(b)(1)) is amended by--
(A) striking subparagraph (E);
(B) redesignating subparagraphs (F) and (G) as
subparagraphs (E) and (F), respectively;
(C) striking ``(H) has a director'' and inserting ``(G) has
a director''; and
(D) in subparagraph (H)--
(i) in clause (i) (V), by striking ``paragraph (2)(G)'' and
inserting ``paragraph (3)(G)''; and
(ii) in clause (ii), by striking ``paragraph (2)'' and
inserting ``paragraph (3)''.
(b) 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:
``SEC. 377E. CRITERIA, STANDARDS, AND REGULATIONS WITH
RESPECT TO ORGANS INFECTED WITH HIV.
``(a) 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.
``(b) 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)--
``(1) the Organ Procurement and Transplantation Network
shall revise the standards of quality adopted under section
372(b)(2)(E); 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 the date of the enactment of the HIV
Organ Policy Equity Act, 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 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;
``(2) 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
``(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).''.
SEC. 3. 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''.
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