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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 330 Engrossed in Senate (ES)]

113th CONGRESS
  1st Session
                                 S. 330

_______________________________________________________________________

                                 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''.

            Passed the Senate June 17, 2013.

            Attest:

                                                             Secretary.
113th CONGRESS

  1st Session

                                 S. 330

_______________________________________________________________________

                                 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).
```