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

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, and Mr. Paul) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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,

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 
        (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.''.
            (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)''.
    (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. GUIDELINES, STANDARDS, AND REGULATIONS WITH RESPECT TO 
              ORGANS INFECTED WITH HIV.

    ``(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').
    ``(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)--
            ``(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 2 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 cross-strain transplantation;
            ``(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
            ``(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.''.

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 guidelines and 
regulations of the Secretary made under section 377E of the Public 
Health Service Act.''.
                                 <all>
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