II 

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). 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘HIV Organ Policy Eq5 uity Act’’. 


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1 SEC. 2. AMENDMENTS TO THE PUBLIC HEALTH SERVICE 

2 ACT. 

3 (a) STANDARDS OF QUALITY FOR THE ACQUISITION

4 AND TRANSPORTATION OF DONATED ORGANS.— 

5 (1) ORGAN PROCUREMENT AND TRANSPLAN6 TATION NETWORK.—Section 372(b) of the Public 

7 Health Service Act (42 U.S.C. 274(b)) is amended— 

8 (A) in paragraph (2)(E), by striking ‘‘, in9 cluding standards for preventing the acquisition 

10 of organs that are infected with the etiologic 

11 agent for acquired immune deficiency syn12 drome’’; and 

13 (B) by adding at the end the following: 

14 ‘‘(3) CLARIFICATION.—In adopting and using 

15 standards of quality under paragraph (2)(E), the 

16 Organ Procurement and Transplantation Network 

17 may adopt and use such standards with respect to 

18 organs infected with human immunodeficiency virus 

19 (HIV), provided that any such standards ensure that 

20 organs infected with human immunodeficiency virus 

21 may be transplanted only into individuals who are 

22 infected with such virus before receiving such 

23 organ.’’. 

24 (2) CONFORMING AMENDMENT.—Section 

25 371(b)(3)(C) of the Public Health Service Act (42 

26 U.S.C. 273(b)(3)(C); relating to organ procurement 


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1 organizations) is amended by striking ‘‘including ar2 ranging for testing with respect to preventing the 

3 acquisition of organs that are infected with the etio4 logic agent for acquired immune deficiency syn5 drome’’ and inserting ‘‘including arranging for test6 ing with respect to identifying organs that are in7 fected with human immunodeficiency virus (HIV)’’. 

8 (b) PUBLICATION OF RESEARCH GUIDELINES.—Part 

9 H of title III of the Public Health Service Act (42 U.S.C. 

10 273 et seq.) is amended by inserting after section 377D 

11 the following: 

12 ‘‘SEC. 377E. GUIDELINES, STANDARDS, AND REGULATIONS 

13 WITH RESPECT TO ORGANS INFECTED WITH 

14 HIV. 

15 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

16 date of the enactment of the HIV Organ Policy Equity 

17 Act, the Secretary shall develop and publish guidelines for 

18 the conduct of research relating to transplantation of or19 gans from donors infected with human immunodeficiency 

20 virus (in this section referred to as ‘HIV’). 

21 ‘‘(b) CORRESPONDING CHANGES TO STANDARDS AND

22 REGULATIONS APPLICABLE TO RESEARCH.—Not later 

23 than 1 year after the date of the enactment of the HIV 

24 Organ Policy Equity Act, to the extent determined by the 

25 Secretary to be necessary to allow the conduct of research 


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1 in accordance with the guidelines developed under sub2 section (a)— 

3 ‘‘(1) the Organ Procurement and Transplan4 tation Network shall revise the standards of quality 

5 adopted under section 372(b)(2)(E); and 

6 ‘‘(2) the Secretary shall revise section 121.6 of 

7 title 42, Code of Federal Regulations (or any suc8 cessor regulations). 

9 ‘‘(c) REVISION OF STANDARDS AND REGULATIONS

10 GENERALLY.—Not later than 2 years after the date of 

11 the enactment of the HIV Organ Policy Equity Act, and 

12 annually thereafter, the Secretary, shall— 

13 ‘‘(1) review the results of scientific research in 

14 conjunction with the Organ Procurement and Trans15 plantation Network to determine whether the results 

16 warrant revision of the standards of quality adopted 

17 under section 372(b)(2)(E) with respect to donated 

18 organs infected with HIV and with respect to the 

19 safety of cross-strain transplantation; 

20 ‘‘(2) if the Secretary determines under para21 graph (1) that such results warrant revision of the 

22 standards of quality adopted under section 

23 372(b)(2)(E) with respect to donated organs in24 fected with HIV and with respect to cross-strain 

25 transplantation, direct the Organ Procurement and 


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1 Transplantation Network to revise such standards, 

2 consistent with section 372 and in a way that en3 sures the changes will not reduce the safety of organ 

4 transplantation; and 

5 ‘‘(3) in conjunction with any revision of such 

6 standards under paragraph (2), shall revise section 

7 121.6 of title 42, Code of Federal Regulations (or 

8 any successor regulations) for consistency with such 

9 standards.’’. 

10 SEC. 3. CONFORMING AMENDMENT TO TITLE 18 OF THE 

11 UNITED STATES CODE. 

12 Section 1122 of title 18, United States Code, is 

13 amended by adding at the end the following: 

14 ‘‘(d) EXCEPTION.—An organ donation does not vio15 late this section if the donation is in accordance with all 

16 applicable guidelines and regulations of the Secretary 

17 made under section 377E of the Public Health Service 

18 Act.’’. 

Æ 


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