I
113th CONGRESS
1st Session
H. R. 698
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
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).
Short title
This Act may be cited as the
HIV Organ Policy Equity
Act
.
Amendments to the Public Health Service Act
Standards of quality for the acquisition and transportation of donated organs
Organ Procurement and Transplantation Network
Section 372(b) of the Public Health Service Act (42 U.S.C. 274(b)) is amended—
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
by adding at the end the following:
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.
.
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)
.
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:
Guidelines, standards, and regulations with respect to organs infected with HIV
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
).
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)—
the Organ Procurement and Transplantation Network shall revise the standards of quality adopted under section 372(b)(2)(E); and
the Secretary shall revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations).
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—
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;
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
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.
.
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:
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.
.
