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). 

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

2 This Act may be cited as the ‘‘HIV Organ Policy Eq3 uity Act’’. 

4 SEC. 2. AMENDMENTS TO THE PUBLIC HEALTH SERVICE 

5 ACT. 

6 (a) STANDARDS OF QUALITY FOR THE ACQUISITION

7 AND TRANSPORTATION OF DONATED ORGANS.— 

8 (1) ORGAN PROCUREMENT AND TRANSPLAN9 TATION NETWORK.—Section 372(b) of the Public 

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

11 (A) in paragraph (2)(E), by striking ‘‘, in12 cluding standards for preventing the acquisition 

13 of organs that are infected with the etiologic 

14 agent for acquired immune deficiency syn15 drome’’; and 

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

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

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

19 Organ Procurement and Transplantation Network 

20 may adopt and use such standards with respect to 

21 organs infected with human immunodeficiency virus 

22 (in this paragraph referred to as ‘HIV’), provided 

23 that any such standards ensure that organs infected 

24 with HIV may be transplanted only into individuals 

25 who— 
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1 ‘‘(A) are infected with HIV before receiv2 ing such organ; and 

3 ‘‘(B)(i) are participating in clinical re4 search approved by an institutional review 

5 board under the criteria, standards, and regula6 tions described in subsections (a) and (b) of 

7 section 377E; or 

8 ‘‘(ii) if the Secretary has determined under 

9 section 377E(c) that participation in such clin10 ical research, as a requirement for such trans11 plants, is no longer warranted, are receiving a 

12 transplant under the standards and regulations 

13 under section 377E(c).’’. 

14 (2) CONFORMING AMENDMENT.—Section 

15 371(b)(3)(C) of the Public Health Service Act (42 

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

17 organizations) is amended by striking ‘‘including ar18 ranging for testing with respect to preventing the 

19 acquisition of organs that are infected with the etio20 logic agent for acquired immune deficiency syn21 drome’’ and inserting ‘‘including arranging for test22 ing with respect to identifying organs that are in23 fected with human immunodeficiency virus (HIV)’’. 
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1 (3) TECHNICAL AMENDMENTS.—Section 

2 371(b)(1) of the Public Health Service Act (42 

3 U.S.C. 273(b)(1)) is amended by— 

4 (A) striking subparagraph (E); 

5 (B) redesignating subparagraphs (F) and 

6 (G) as subparagraphs (E) and (F), respectively; 

7 (C) striking ‘‘(H) has a director’’ and in8 serting ‘‘(G) has a director’’; and 

9 (D) in subparagraph (H)— 

10 (i) in clause (i) (V), by striking ‘‘para11 graph (2)(G)’’ and inserting ‘‘paragraph 

12 (3)(G)’’; and 

13 (ii) in clause (ii), by striking ‘‘para14 graph (2)’’ and inserting ‘‘paragraph (3)’’. 

15 (b) PUBLICATION OF RESEARCH GUIDELINES.—Part 

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

17 273 et seq.) is amended by inserting after section 377D 

18 the following: 

19 ‘‘SEC. 377E. CRITERIA, STANDARDS, AND REGULATIONS 

20 WITH RESPECT TO ORGANS INFECTED WITH 

21 HIV. 

22 ‘‘(a) IN GENERAL.—Not later than 2 years after the 

23 date of the enactment of the HIV Organ Policy Equity 

24 Act, the Secretary shall develop and publish criteria for 

25 the conduct of research relating to transplantation of or-
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1 gans from donors infected with human immunodeficiency 

2 virus (in this section referred to as ‘HIV’) into individuals 

3 who are infected with HIV before receiving such organ. 

4 ‘‘(b) CORRESPONDING CHANGES TO STANDARDS AND

5 REGULATIONS APPLICABLE TO RESEARCH.—Not later 

6 than 2 years after the date of the enactment of the HIV 

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

8 Secretary to be necessary to allow the conduct of research 

9 in accordance with the criteria developed under subsection 

10 (a)— 

11 ‘‘(1) the Organ Procurement and Transplan12 tation Network shall revise the standards of quality 

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

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

15 title 42, Code of Federal Regulations (or any suc16 cessor regulations). 

17 ‘‘(c) REVISION OF STANDARDS AND REGULATIONS

18 GENERALLY.—Not later than 4 years after the date of 

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

20 annually thereafter, the Secretary, shall— 

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

22 conjunction with the Organ Procurement and Trans23 plantation Network to determine whether the results 

24 warrant revision of the standards of quality adopted 

25 under section 372(b)(2)(E) with respect to donated 
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1 organs infected with HIV and with respect to the 

2 safety of transplanting an organ with a particular 

3 strain of HIV into a recipient with a different strain 

4 of HIV; 

5 ‘‘(2) if the Secretary determines under para6 graph (1) that such results warrant revision of the 

7 standards of quality adopted under section 

8 372(b)(2)(E) with respect to donated organs in9 fected with HIV and with respect to transplanting 

10 an organ with a particular strain of HIV into a re11 cipient with a different strain of HIV, direct the 

12 Organ Procurement and Transplantation Network to 

13 revise such standards, consistent with section 372 

14 and in a way that ensures the changes will not re15 duce the safety of organ transplantation; and 

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

17 standards under paragraph (2), revise section 121.6 

18 of title 42, Code of Federal Regulations (or any suc19 cessor regulations).’’. 

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

21 UNITED STATES CODE. 

22 Section 1122(a) of title 18, United States Code, is 

23 amended by inserting ‘‘or in accordance with all applicable 

24 guidelines and regulations made by the Secretary of 
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1 Health and Human Services under section 377E of the 

2 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 estabwith human immunodeficiency virus (HIV). search and transplantation of organs infected lish safeguards and standards of quality for re-