S. 330 

One Hundred Thirteenth Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Thursday, 

the third day of January, two thousand and thirteen 

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). 

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

any such standards ensure that organs infected with HIV may 

be transplanted only into individuals who— 

‘‘(A) are infected with HIV before receiving such organ; 

and 

‘‘(B)(i) are participating in clinical research approved 

by an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) 

of section 377E; or 

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

377E(c) that participation in such clinical research, as a 

requirement for such transplants, is no longer warranted, 

are receiving a transplant under the standards and regulations under section 377E(c).’’. 

(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 
S. 330—2 

‘‘including arranging for testing with respect to identifying 

organs that are infected with human immunodeficiency virus 

(HIV)’’. 

(3) TECHNICAL AMENDMENTS.—Section 371(b)(1) of the 

Public Health Service Act (42 U.S.C. 273(b)(1)) is amended 

by— 

(A) striking subparagraph (E); 

(B) redesignating subparagraphs (F) and (G) as subparagraphs (E) and (F), respectively; 

(C) striking ‘‘(H) has a director’’ and inserting ‘‘(G) 

has a director’’; and 

(D) in subparagraph (H)— 

(i) in clause (i) (V), by striking ‘‘paragraph (2)(G)’’ 

and inserting ‘‘paragraph (3)(G)’’; and 

(ii) in clause (ii), by striking ‘‘paragraph (2)’’ and 

inserting ‘‘paragraph (3)’’. 

(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. CRITERIA, STANDARDS, AND REGULATIONS WITH RESPECT 

TO ORGANS INFECTED WITH HIV. 

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

the enactment of the HIV Organ Policy Equity Act, the Secretary 

shall develop and publish criteria for the conduct of research 

relating to transplantation of organs from donors infected with 

human immunodeficiency virus (in this section referred to as ‘HIV’) 

into individuals who are infected with HIV before receiving such 

organ. 

‘‘(b) CORRESPONDING CHANGES TO STANDARDS AND REGULA- TIONS APPLICABLE TO RESEARCH.—Not later than 2 years 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 criteria 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 4 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 transplanting an organ with a particular strain of 

HIV into a recipient with a different strain of HIV; 

‘‘(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 transplanting 

an organ with a particular strain of HIV into a recipient with 

a different strain of HIV, direct the Organ Procurement and 
S. 330—3 

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), revise section 121.6 of title 42, Code 

of Federal Regulations (or any successor regulations).’’. 

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

STATES CODE. 

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

by inserting ‘‘or in accordance with all applicable guidelines and 

regulations made by the Secretary of Health and Human Services 

under section 377E of the Public Health Service Act’’ after ‘‘research 

or testing’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.