HIV Organ Policy Equity Act

Bill: 113-s-330
Sponsor: full_name: Sen. Boxer, Barbara [D-CA]
Introduced: 2013-02-14
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

HIV/AIDS

Health care quality

Medical ethics

Medical research

Organ and tissue donation and transplantation
Latest action: action_date: 2013-11-21
text: Became Public Law No: 113-51.

Summaries:
action_date: 2013-02-14
action_desc: Introduced in Senate
text: <p>HIV Organ Policy Equity Act - Amends the Public Health Service Act to repeal the requirement that the Organ Procurement and Transplantation Network adopt and use standards of quality for the acquisition and transportation of donated organs that include standards for preventing the acquisition of organs infected with the etiologic agent for acquired immune deficiency syndrome (AIDS).</p> <p>Replaces this requirement with authorization for the Network to adopt and use such standards with respect to organs infected with human immunodeficiency virus (HIV), provided that any such standards ensure that organs infected with HIV may be transplanted only into individuals who are infected with such virus before receiving such an organ.</p> <p>Revises similarly the requirement that organ procurement organizations arrange for testing to prevent the acquisition of organs infected with the AIDS etiologic agent to require that they arrange for testing to identify organs infected with HIV.</p> <p>Directs the Secretary of Health and Human Services (HHS) to develop and publish guidelines for the conduct of research relating to transplantation of organs from HIV-infected donors.</p> <p>Requires the Network to revise its standards of quality regarding HIV-infected organs and the Secretary to revise related regulations.</p> <p>Requires the Secretary to: (1) review annually the results of scientific research in conjunction with the Network to determine whether they warrant revision of quality standards relating to donated HIV-infected organs and to the safety of cross-strain transplantation; and (2) direct the Network, if the review so warrants, to revise its standards in a way that ensures the changes will not reduce the safety of organ transplantation.</p> <p>Amends the federal criminal code to declare that an organ donation does not violate the prohibition against a knowing organ donation by an HIV-infected individual if the donation is made in accordance with this Act.</p>

action_date: 2013-05-21
action_desc: Reported to Senate with amendment(s)
text: <p>HIV Organ Policy Equity Act - Amends the Public Health Service Act to repeal the requirement that the Organ Procurement and Transplantation Network adopt and use standards of quality for the acquisition and transportation of donated organs that include standards for preventing the acquisition of organs infected with the etiologic agent for acquired immune deficiency syndrome (AIDS).</p> <p>Replaces this requirement with authorization for the Network to adopt and use such standards with respect to organs infected with human immunodeficiency virus (HIV), provided that any such standards ensure that organs infected with HIV may be transplanted only into individuals who are: (1) infected with such virus before receiving such an organ; and (2) participating in clinical research approved by an institutional review board under the criteria, standards, and regulations regarding organs infected with HIV developed under this Act or, if participation in such research is no longer warranted, receiving a transplant under such standards and regulations.</p> <p>Revises similarly the requirement that organ procurement organizations arrange for testing to prevent the acquisition of organs infected with the AIDS etiologic agent to require that they arrange for testing to identify organs infected with HIV.</p> <p>Directs the Secretary of Health and Human Services (HHS) to develop and publish guidelines for the conduct of research relating to transplantation of organs from HIV-infected donors.</p> <p>Requires the Network to revise its standards of quality regarding HIV-infected organs and the Secretary to revise related regulations.</p> <p>Requires the Secretary to: (1) review annually the results of scientific research in conjunction with the Network to determine whether they warrant revision of quality standards relating to donated HIV-infected organs and to the safety of transplantation of organs with a particular strain of HIV into a recipient with a different strain; and (2) direct the Network, if the review so warrants, to revise its standards in a way that ensures the changes will not reduce the safety of organ transplantation.</p> <p>Amends the federal criminal code to declare that an organ donation does not violate the prohibition against a knowing organ donation by an HIV-infected individual if the donation is made in accordance with this Act.</p>

action_date: 2013-06-17
action_desc: Passed Senate amended
text: <p>HIV Organ Policy Equity Act - Amends the Public Health Service Act to repeal the requirement that the Organ Procurement and Transplantation Network adopt and use standards of quality for the acquisition and transportation of donated organs that include standards for preventing the acquisition of organs infected with the etiologic agent for acquired immune deficiency syndrome (AIDS).</p> <p>Replaces this requirement with authorization for the Network to adopt and use such standards with respect to organs infected with human immunodeficiency virus (HIV), provided that any such standards ensure that organs infected with HIV may be transplanted only into individuals who are: (1) infected with such virus before receiving such an organ; and (2) participating in clinical research approved by an institutional review board under the criteria, standards, and regulations regarding organs infected with HIV developed under this Act or, if participation in such research is no longer warranted, receiving a transplant under such standards and regulations.</p> <p>Revises similarly the requirement that organ procurement organizations arrange for testing to prevent the acquisition of organs infected with the AIDS etiologic agent to require that they arrange for testing to identify organs infected with HIV.</p> <p>Directs the Secretary of Health and Human Services (HHS) to develop and publish guidelines for the conduct of research relating to transplantation of organs from HIV-infected donors.</p> <p>Requires the Network to revise its standards of quality regarding HIV-infected organs and the Secretary to revise related regulations.</p> <p>Requires the Secretary to: (1) review annually the results of scientific research in conjunction with the Network to determine whether they warrant revision of quality standards relating to donated HIV-infected organs and to the safety of transplantation of organs with a particular strain of HIV into a recipient with a different strain; and (2) direct the Network, if the review so warrants, to revise its standards in a way that ensures the changes will not reduce the safety of organ transplantation.</p> <p>Amends the federal criminal code to declare that an organ donation does not violate the prohibition against a knowing organ donation by an HIV-infected individual if the donation is made in accordance with this Act.</p>

action_date: 2013-11-12
action_desc: Passed House without amendment
text: <p><b>(This measure has not been amended since it was passed by the Senate on June 17, 2013. The summary of that version is repeated here.)</b></p> <p>HIV Organ Policy Equity Act - Amends the Public Health Service Act to repeal the requirement that the Organ Procurement and Transplantation Network adopt and use standards of quality for the acquisition and transportation of donated organs that include standards for preventing the acquisition of organs infected with the etiologic agent for acquired immune deficiency syndrome (AIDS).</p> <p>Replaces this requirement with authorization for the Network to adopt and use such standards with respect to organs infected with human immunodeficiency virus (HIV), provided that any such standards ensure that organs infected with HIV may be transplanted only into individuals who are: (1) infected with such virus before receiving such an organ; and (2) participating in clinical research approved by an institutional review board under the criteria, standards, and regulations regarding organs infected with HIV developed under this Act or, if participation in such research is no longer warranted, receiving a transplant under such standards and regulations.</p> <p>Revises similarly the requirement that organ procurement organizations arrange for testing to prevent the acquisition of organs infected with the AIDS etiologic agent to require that they arrange for testing to identify organs infected with HIV.</p> <p>Directs the Secretary of Health and Human Services (HHS) to develop and publish guidelines for the conduct of research relating to transplantation of organs from HIV-infected donors.</p> <p>Requires the Network to revise its standards of quality regarding HIV-infected organs and the Secretary to revise related regulations.</p> <p>Requires the Secretary to: (1) review annually the results of scientific research in conjunction with the Network to determine whether they warrant revision of quality standards relating to donated HIV-infected organs and to the safety of transplantation of organs with a particular strain of HIV into a recipient with a different strain; and (2) direct the Network, if the review so warrants, to revise its standards in a way that ensures the changes will not reduce the safety of organ transplantation.</p> <p>Amends the federal criminal code to declare that an organ donation does not violate the prohibition against a knowing organ donation by an HIV-infected individual if the donation is made in accordance with this Act.</p>

action_date: 2013-11-21
action_desc: Public Law
text: <p><b>(This measure has not been amended since it was passed by the Senate on June 17, 2013. The summary of that version is repeated here.)</b></p> <p>HIV Organ Policy Equity Act - Amends the Public Health Service Act to repeal the requirement that the Organ Procurement and Transplantation Network adopt and use standards of quality for the acquisition and transportation of donated organs that include standards for preventing the acquisition of organs infected with the etiologic agent for acquired immune deficiency syndrome (AIDS).</p> <p>Replaces this requirement with authorization for the Network to adopt and use such standards with respect to organs infected with human immunodeficiency virus (HIV), provided that any such standards ensure that organs infected with HIV may be transplanted only into individuals who are: (1) infected with such virus before receiving such an organ; and (2) participating in clinical research approved by an institutional review board under the criteria, standards, and regulations regarding organs infected with HIV developed under this Act or, if participation in such research is no longer warranted, receiving a transplant under such standards and regulations.</p> <p>Revises similarly the requirement that organ procurement organizations arrange for testing to prevent the acquisition of organs infected with the AIDS etiologic agent to require that they arrange for testing to identify organs infected with HIV.</p> <p>Directs the Secretary of Health and Human Services (HHS) to develop and publish guidelines for the conduct of research relating to transplantation of organs from HIV-infected donors.</p> <p>Requires the Network to revise its standards of quality regarding HIV-infected organs and the Secretary to revise related regulations.</p> <p>Requires the Secretary to: (1) review annually the results of scientific research in conjunction with the Network to determine whether they warrant revision of quality standards relating to donated HIV-infected organs and to the safety of transplantation of organs with a particular strain of HIV into a recipient with a different strain; and (2) direct the Network, if the review so warrants, to revise its standards in a way that ensures the changes will not reduce the safety of organ transplantation.</p> <p>Amends the federal criminal code to declare that an organ donation does not violate the prohibition against a knowing organ donation by an HIV-infected individual if the donation is made in accordance with this Act.</p>

tv_txt: II 113th CONGRESS 1st Session S. 330 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. Short title This Act may be cited as the HIV Organ Policy Equity Act . 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 (HIV), provided that any such standards ensure that organs infected with human immunodeficiency virus may be transplanted only into individuals who are infected with such virus before receiving such organ. . (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 including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV) . (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: 377E. Guidelines, standards, and regulations with respect to organs infected with HIV (a) In general Not later than 1 year after the date of the enactment of the HIV Organ Policy Equity Act , the Secretary shall develop and publish guidelines for the conduct of research relating to transplantation of organs from donors infected with human immunodeficiency virus (in this section referred to as HIV ). (b) Corresponding changes to standards and regulations applicable to research Not later than 1 year 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 guidelines 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 2 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 cross-strain transplantation; (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 cross-strain transplantation, direct the Organ Procurement and 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), shall revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations) for consistency with such standards. . 3. Conforming amendment to title 18 of the United States Code Section 1122 of title 18, United States Code, is amended by adding at the end the following: (d) Exception An organ donation does not violate this section if the donation is in accordance with all applicable guidelines and regulations of the Secretary made under section 377E of the Public Health Service Act. .

tv_txt: II Calendar No. 75 113th CONGRESS 1st Session S. 330 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. Short title This Act may be cited as the HIV Organ Policy Equity Act . 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 (HIV), provided that any such standards ensure that organs infected with human immunodeficiency virus may be transplanted only into individuals who are infected with such virus before receiving such organ. . (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 including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV) . (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: 377E. Guidelines, standards, and regulations with respect to organs infected with HIV (a) In general Not later than 1 year after the date of the enactment of the HIV Organ Policy Equity Act , the Secretary shall develop and publish guidelines for the conduct of research relating to transplantation of organs from donors infected with human immunodeficiency virus (in this section referred to as HIV ). (b) Corresponding changes to standards and regulations applicable to research Not later than 1 year 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 guidelines 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 2 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 cross-strain transplantation; (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 cross-strain transplantation, direct the Organ Procurement and 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), shall revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations) for consistency with such standards. . 3. Conforming amendment to title 18 of the United States Code Section 1122 of title 18, United States Code, is amended by adding at the end the following: (d) Exception An organ donation does not violate this section if the donation is in accordance with all applicable guidelines and regulations of the Secretary made under section 377E of the Public Health Service Act. .

1. Short title This Act may be cited as the HIV Organ Policy Equity Act . 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 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: 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 regulations 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 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). . 3. Conforming amendment to title 18 of the United States Code Section 1122 of title 18, United States Code, is amended by adding at the end the following: (d) Exception An organ donation does not violate this section if the donation is in accordance with all applicable criteria and regulations of the Secretary made under section 377E of the Public Health Service Act. .

May 21, 2013 Reported with an amendment

tv_txt: 113th CONGRESS 1st Session S. 330 IN THE SENATE OF THE UNITED STATES 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. Short title This Act may be cited as the HIV Organ Policy Equity Act . 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 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: 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 regulations 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 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). . 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 .

Passed the Senate June 17, 2013. Secretary

tv_txt: IC 113th CONGRESS 1st Session S. 330 IN THE HOUSE OF REPRESENTATIVES June 18, 2013 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 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. Short title This Act may be cited as the HIV Organ Policy Equity Act . 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 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: 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 regulations 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 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). . 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 .

Passed the Senate June 17, 2013. Nancy Erickson, Secretary

tv_txt: One Hundred Thirteenth Congress of the United States of America 1st Session Begun and held at the City of Washington on Thursday, the third day of January, two thousand and thirteen S. 330 IN THE SENATE OF THE UNITED STATES 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. Short title This Act may be cited as the HIV Organ Policy Equity Act . 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 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: 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 regulations 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 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). . 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