[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 330 Enrolled Bill (ENR)]
S.330
One Hundred Thirteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and thirteen
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).
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''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.