IB 

Union Calendar No. 129 

113TH CONGRESS 

1ST SESSION H. R. 698 

[Report No. 113–181, Part I] 

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 HOUSE OF REPRESENTATIVES 

FEBRUARY 14, 2013 

Mrs. CAPPS introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each 

case for consideration of such provisions as fall within the jurisdiction of 

the committee concerned 

JULY 30, 2013 

Additional sponsors: Mr. HARRIS, Mr. CUMMINGS, Mr. GRIJALVA, Ms. LEE

of California, Mr. BURGESS, Ms. WILSON of Florida, Ms. MOORE, Mr. 

PAYNE, Mr. CLAY, Mr. RANGEL, Mr. SCHIFF, Mr. GRIFFIN of Arkansas, 

Mr. BRALEY of Iowa, Mr. HUFFMAN, Mr. LOEBSACK, Mr. POLIS, Mr. 

WITTMAN, Ms. NORTON, Mr. RADEL, Mr. COSTA, Mr. MICHAUD, Mr. 

RUIZ, Mr. CICILLINE, Ms. SCHAKOWSKY, Mrs. CAROLYN B. MALONEY of 

New York, Mr. RUSH, Mrs. MILLER of Michigan, Mr. TAKANO, Ms. PINGREE of Maine, Mr. PETRI, Mr. BRADY of Pennsylvania, Ms. SHEA-PORTER, Ms. SPEIER, Mr. HASTINGS of Florida, Mr. MCDERMOTT, Mr. 

SEAN PATRICK MALONEY of New York, Mr. CARTWRIGHT, Ms. JACKSON

LEE, Mr. YOUNG of Florida, Ms. TITUS, Mr. CARSON of Indiana, Mr. 

MCKINLEY, Mr. BENISHEK, Mr. LEVIN, Ms. ROS-LEHTINEN, Mr. 

COHEN, Mr. POCAN, Mrs. CHRISTENSEN, Ms. SCHWARTZ, Mr. HIMES, 

Ms. CHU, Mr. HARPER, and Mr. LIPINSKI

JULY 30, 2013 

Reported from the Committee on Energy and Commerce 


emcdonald on DSK67QTVN1PROD with BILLS
2 

•HR 698 RH

JULY 30, 2013 

The Committee on the Judiciary discharged; committed to the Committee of 

the Whole House on the State of the Union and ordered to be printed 

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). 


emcdonald on DSK67QTVN1PROD with BILLS
3 

•HR 698 RH

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’’. 

6 SEC. 2. AMENDMENTS TO THE PUBLIC HEALTH SERVICE 

7 ACT. 

8 (a) STANDARDS OF QUALITY FOR THE ACQUISITION

9 AND TRANSPORTATION OF DONATED ORGANS.— 

10 (1) ORGAN PROCUREMENT AND TRANSPLAN11 TATION NETWORK.—Section 372(b) of the Public 

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

13 (A) in paragraph (2)(E), by striking ‘‘, in14 cluding standards for preventing the acquisition 

15 of organs that are infected with the etiologic 

16 agent for acquired immune deficiency syn17 drome’’; and 

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

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

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

21 Organ Procurement and Transplantation Network 

22 may adopt and use such standards with respect to 

23 organs infected with human immunodeficiency virus 

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

25 organs infected with human immunodeficiency virus 


emcdonald on DSK67QTVN1PROD with BILLS
4 

•HR 698 RH

1 may be transplanted only into individuals who are 

2 infected with such virus before receiving such 

3 organ.’’. 

4 (2) CONFORMING AMENDMENT.—Section 

5 371(b)(3)(C) of the Public Health Service Act (42 

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

7 organizations) is amended by striking ‘‘including ar8 ranging for testing with respect to preventing the 

9 acquisition of organs that are infected with the etio10 logic agent for acquired immune deficiency syn11 drome’’ and inserting ‘‘including arranging for test12 ing with respect to identifying organs that are in13 fected with human immunodeficiency virus (HIV)’’. 

14 (b) PUBLICATION OF RESEARCH GUIDELINES.—Part 

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

16 273 et seq.) is amended by inserting after section 377D 

17 the following: 

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

19 WITH RESPECT TO ORGANS INFECTED WITH 

20 HIV. 

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

22 date of the enactment of the HIV Organ Policy Equity 

23 Act, the Secretary shall develop and publish guidelines for 

24 the conduct of research relating to transplantation of orVerDate Mar 15 2010 21:13 Jul 30, 2013 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H698.RH H698

emcdonald on DSK67QTVN1PROD with BILLS
5 

•HR 698 RH

1 gans from donors infected with human immunodeficiency 

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

3 ‘‘(b) CORRESPONDING CHANGES TO STANDARDS AND

4 REGULATIONS APPLICABLE TO RESEARCH.—Not later 

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

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

7 Secretary to be necessary to allow the conduct of research 

8 in accordance with the guidelines developed under sub9 section (a)— 

10 ‘‘(1) the Organ Procurement and Transplan11 tation Network shall revise the standards of quality 

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

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

14 title 42, Code of Federal Regulations (or any suc15 cessor regulations). 

16 ‘‘(c) REVISION OF STANDARDS AND REGULATIONS

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

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

19 annually thereafter, the Secretary, shall— 

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

21 conjunction with the Organ Procurement and Trans22 plantation Network to determine whether the results 

23 warrant revision of the standards of quality adopted 

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


emcdonald on DSK67QTVN1PROD with BILLS
6 

•HR 698 RH

1 organs infected with HIV and with respect to the 

2 safety of cross-strain transplantation; 

3 ‘‘(2) if the Secretary determines under para4 graph (1) that such results warrant revision of the 

5 standards of quality adopted under section 

6 372(b)(2)(E) with respect to donated organs in7 fected with HIV and with respect to cross-strain 

8 transplantation, direct the Organ Procurement and 

9 Transplantation Network to revise such standards, 

10 consistent with section 372 and in a way that en11 sures the changes will not reduce the safety of organ 

12 transplantation; and 

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

14 standards under paragraph (2), shall revise section 

15 121.6 of title 42, Code of Federal Regulations (or 

16 any successor regulations) for consistency with such 

17 standards.’’. 

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

19 UNITED STATES CODE. 

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

21 amended by adding at the end the following: 

22 ‘‘(d) EXCEPTION.—An organ donation does not vio23 late this section if the donation is in accordance with all 

24 applicable guidelines and regulations of the Secretary 


emcdonald on DSK67QTVN1PROD with BILLS
7 

•HR 698 RH

1 made under section 377E of the Public Health Service 

2 Act.’’. 


emcdonald on DSK67QTVN1PROD with BILLS
Union Calendar No. 129 

113TH CONGRESS 

1ST SESSION H. R. 698 

[Report No. 113–181, Part I] 

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 reJULY 30, 2013 

Reported from the Committee on Energy and Commerce 

JULY 30, 2013 

The Committee on the Judiciary discharged; committed 

the Union and ordered to be printed to the Committee of the Whole House on the State of 


emcdonald on DSK67QTVN1PROD with BILLS