[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 330 Reported in Senate (RS)]
Calendar No. 75
113th CONGRESS
1st Session
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).
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 14, 2013
Mrs. Boxer (for herself, Mr. Coburn, Ms. Baldwin, Mr. Paul, Mr. Enzi,
Ms. Warren, Mr. Burr, Mr. Kirk, Mrs. Feinstein, Ms. Landrieu, Mr.
Blumenthal, and Mr. Schatz) introduced the following bill; which was
read twice and referred to the Committee on Health, Education, Labor,
and Pensions
May 21, 2013
Reported by Mr. Harkin, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
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).
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``HIV Organ Policy Equity
Act''.</DELETED>
<DELETED>SEC. 2. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.</DELETED>
<DELETED> (a) Standards of Quality for the Acquisition and
Transportation of Donated Organs.--</DELETED>
<DELETED> (1) Organ procurement and transplantation
network.--Section 372(b) of the Public Health Service Act (42
U.S.C. 274(b)) is amended--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (B) by adding at the end the
following:</DELETED>
<DELETED> ``(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 (HIV), provided that any such standards
ensure that organs infected with human immunodeficiency virus
may be transplanted only into individuals who are infected with
such virus before receiving such organ.''.</DELETED>
<DELETED> (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)''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``SEC. 377E. GUIDELINES, STANDARDS, AND REGULATIONS WITH
RESPECT TO ORGANS INFECTED WITH HIV.</DELETED>
<DELETED> ``(a) In General.--Not later than 1 year after the date of
the enactment of the HIV Organ Policy Equity Act, the Secretary shall
develop and publish guidelines for the conduct of research relating to
transplantation of organs from donors infected with human
immunodeficiency virus (in this section referred to as
`HIV').</DELETED>
<DELETED> ``(b) Corresponding Changes to Standards and Regulations
Applicable to Research.--Not later than 1 year 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 guidelines developed under subsection (a)--
</DELETED>
<DELETED> ``(1) the Organ Procurement and Transplantation
Network shall revise the standards of quality adopted under
section 372(b)(2)(E); and</DELETED>
<DELETED> ``(2) the Secretary shall revise section 121.6 of
title 42, Code of Federal Regulations (or any successor
regulations).</DELETED>
<DELETED> ``(c) Revision of Standards and Regulations Generally.--
Not later than 2 years after the date of the enactment of the HIV Organ
Policy Equity Act, and annually thereafter, the Secretary, shall--
</DELETED>
<DELETED> ``(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 cross-strain
transplantation;</DELETED>
<DELETED> ``(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 cross-
strain transplantation, 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</DELETED>
<DELETED> ``(3) in conjunction with any revision of such
standards under paragraph (2), shall revise section 121.6 of
title 42, Code of Federal Regulations (or any successor
regulations) for consistency with such standards.''.</DELETED>
<DELETED>SEC. 3. CONFORMING AMENDMENT TO TITLE 18 OF THE UNITED STATES
CODE.</DELETED>
<DELETED> Section 1122 of title 18, United States Code, is amended
by adding at the end the following:</DELETED>
<DELETED> ``(d) Exception.--An organ donation does not violate this
section if the donation is in accordance with all applicable guidelines
and regulations of the Secretary made under section 377E of the Public
Health Service Act.''.</DELETED>
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 of the Secretary made under section 377E of the Public
Health Service Act.''.
Calendar No. 75
113th CONGRESS
1st Session
S. 330
_______________________________________________________________________
A BILL
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).
_______________________________________________________________________
May 21, 2013
Reported with an amendment