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[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.
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