[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