II 

Calendar No. 75 

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, Mr. PAUL, Mr. ENZI, 

Ms. WARREN, Mr. BURR, Mr. KIRK, Mrs. FEINSTEIN, Ms. LANDRIEU, 

Mr. BLUMENTHAL, and Mr. SCHATZ) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

MAY 21, 2013 

Reported by Mr. HARKIN, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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, 


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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 (HIV), provided that any such standards ensure that 

23 organs infected with human immunodeficiency virus 

24 may be transplanted only into individuals who are 

25 infected with such virus before receiving such 

26 organ.’’. 


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1 (2) CONFORMING AMENDMENT.—Section 

2 371(b)(3)(C) of the Public Health Service Act (42 

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

4 organizations) is amended by striking ‘‘including ar5 ranging for testing with respect to preventing the 

6 acquisition of organs that are infected with the etio7 logic agent for acquired immune deficiency syn8 drome’’ and inserting ‘‘including arranging for test9 ing with respect to identifying organs that are in10 fected with human immunodeficiency virus (HIV)’’. 

11 (b) PUBLICATION OF RESEARCH GUIDELINES.—Part 

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

13 273 et seq.) is amended by inserting after section 377D 

14 the following: 

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

16 WITH RESPECT TO ORGANS INFECTED WITH 

17 HIV. 

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

19 date of the enactment of the HIV Organ Policy Equity 

20 Act, the Secretary shall develop and publish guidelines for 

21 the conduct of research relating to transplantation of or22 gans from donors infected with human immunodeficiency 

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

24 ‘‘(b) CORRESPONDING CHANGES TO STANDARDS AND

25 REGULATIONS APPLICABLE TO RESEARCH.—Not later 


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

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

3 Secretary to be necessary to allow the conduct of research 

4 in accordance with the guidelines developed under sub5 section (a)— 

6 ‘‘(1) the Organ Procurement and Transplan7 tation Network shall revise the standards of quality 

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

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

10 title 42, Code of Federal Regulations (or any suc11 cessor regulations). 

12 ‘‘(c) REVISION OF STANDARDS AND REGULATIONS

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

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

15 annually thereafter, the Secretary, shall— 

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

17 conjunction with the Organ Procurement and Trans18 plantation Network to determine whether the results 

19 warrant revision of the standards of quality adopted 

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

21 organs infected with HIV and with respect to the 

22 safety of cross-strain transplantation; 

23 ‘‘(2) if the Secretary determines under para24 graph (1) that such results warrant revision of the 

25 standards of quality adopted under section 


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1 372(b)(2)(E) with respect to donated organs in2 fected with HIV and with respect to cross-strain 

3 transplantation, direct the Organ Procurement and 

4 Transplantation Network to revise such standards, 

5 consistent with section 372 and in a way that en6 sures the changes will not reduce the safety of organ 

7 transplantation; and 

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

9 standards under paragraph (2), shall revise section 

10 121.6 of title 42, Code of Federal Regulations (or 

11 any successor regulations) for consistency with such 

12 standards.’’. 

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

14 UNITED STATES CODE. 

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

16 amended by adding at the end the following: 

17 ‘‘(d) EXCEPTION.—An organ donation does not vio18 late this section if the donation is in accordance with all 

19 applicable guidelines and regulations of the Secretary 

20 made under section 377E of the Public Health Service 

21 Act.’’. 

22 SECTION 1. SHORT TITLE. 

23 This Act may be cited as the ‘‘HIV Organ Policy Eq24 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 or18 gans infected with human immunodeficiency virus 

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

20 that any such standards ensure that organs infected 

21 with HIV may be transplanted only into individuals 

22 who— 

23 ‘‘(A) are infected with HIV before receiving 

24 such organ; and 

25 ‘‘(B)(i) are participating in clinical re26 search approved by an institutional review board 


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1 under the criteria, standards, and regulations 

2 described in subsections (a) and (b) of section 

3 377E; or 

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

5 section 377E(c) that participation in such clin6 ical research, as a requirement for such trans7 plants, is no longer warranted, are receiving a 

8 transplant under the standards and regulations 

9 under section 377E(c).’’. 

10 (2) CONFORMING AMENDMENT.—Section 

11 371(b)(3)(C) of the Public Health Service Act (42 

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

13 organizations) is amended by striking ‘‘including ar14 ranging for testing with respect to preventing the ac15 quisition of organs that are infected with the etiologic 

16 agent for acquired immune deficiency syndrome’’ and 

17 inserting ‘‘including arranging for testing with re18 spect to identifying organs that are infected with 

19 human immunodeficiency virus (HIV)’’. 

20 (3) TECHNICAL AMENDMENTS.—Section 

21 371(b)(1) of the Public Health Service Act (42 U.S.C. 

22 273(b)(1)) is amended by— 

23 (A) striking subparagraph (E); 

24 (B) redesignating subparagraphs (F) and 

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


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1 (C) striking ‘‘(H) has a director’’ and in2 serting ‘‘(G) has a director’’; and 

3 (D) in subparagraph (H)— 

4 (i) in clause (i) (V), by striking ‘‘para5 graph (2)(G)’’ and inserting ‘‘paragraph 

6 (3)(G)’’; and 

7 (ii) in clause (ii), by striking ‘‘para8 graph (2)’’ and inserting ‘‘paragraph (3)’’. 

9 (b) PUBLICATION OF RESEARCH GUIDELINES.—Part 

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

11 273 et seq.) is amended by inserting after section 377D the 

12 following: 

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

14 WITH RESPECT TO ORGANS INFECTED WITH 

15 HIV. 

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

17 date of the enactment of the HIV Organ Policy Equity Act, 

18 the Secretary shall develop and publish criteria for the con19 duct of research relating to transplantation of organs from 

20 donors infected with human immunodeficiency virus (in 

21 this section referred to as ‘HIV’) into individuals who are 

22 infected with HIV before receiving such organ. 

23 ‘‘(b) CORRESPONDING CHANGES TO STANDARDS AND

24 REGULATIONS APPLICABLE TO RESEARCH.—Not later than 

25 2 years after the date of the enactment of the HIV Organ 


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1 Policy Equity Act, to the extent determined by the Secretary 

2 to be necessary to allow the conduct of research in accord3 ance with the criteria developed under subsection (a)— 

4 ‘‘(1) the Organ Procurement and Transplan5 tation Network shall revise the standards of quality 

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

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

8 title 42, Code of Federal Regulations (or any suc9 cessor regulations). 

10 ‘‘(c) REVISION OF STANDARDS AND REGULATIONS

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

12 enactment of the HIV Organ Policy Equity Act, and annu13 ally thereafter, the Secretary, shall— 

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

15 conjunction with the Organ Procurement and Trans16 plantation Network to determine whether the results 

17 warrant revision of the standards of quality adopted 

18 under section 372(b)(2)(E) with respect to donated or19 gans infected with HIV and with respect to the safety 

20 of transplanting an organ with a particular strain of 

21 HIV into a recipient with a different strain of HIV; 

22 ‘‘(2) if the Secretary determines under para23 graph (1) that such results warrant revision of the 

24 standards of quality adopted under section 

25 372(b)(2)(E) with respect to donated organs infected 


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1 with HIV and with respect to transplanting an organ 

2 with a particular strain of HIV into a recipient with 

3 a different strain of HIV, direct the Organ Procure4 ment and Transplantation Network to revise such 

5 standards, consistent with section 372 and in a way 

6 that ensures the changes will not reduce the safety of 

7 organ transplantation; and 

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

9 standards under paragraph (2), revise section 121.6 

10 of title 42, Code of Federal Regulations (or any suc11 cessor regulations).’’. 

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

13 UNITED STATES CODE. 

14 Section 1122 of title 18, United States Code, is amend15 ed by adding at the end the following: 

16 ‘‘(d) EXCEPTION.—An organ donation does not violate 

17 this section if the donation is in accordance with all appli18 cable criteria and regulations of the Secretary made under 

19 section 377E of the Public Health Service Act.’’. 


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Calendar No. 75 

113TH CONGRESS 

1ST SESSION S. 330 

A BILL 

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 reMAY 21, 2013 

Reported with an amendment 


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