[Congressional Record (Bound Edition), Volume 159 (2013), Part 7]
[Senate]
[Pages 9245-9246]
[From the U.S. 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

[[Page 9246]]

     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.''.

  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''.

                          ____________________