S. 330 — Reported in Senate

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