Stem Cell Research bill

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2520 Enrolled Bill (ENR)]
H.R.2520
One Hundred Ninth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the fourth day of January, two thousand and five
An Act
To provide for the collection and maintenance of human cord blood stem
cells for the treatment of patients and research, and to amend the
Public Health Service Act to authorize the C.W. Bill Young Cell
Transplantation Program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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This Act may be cited as the ``Stem Cell Therapeutic and Research
Act of 2005''.

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(a) In General.--The Secretary of Health and Human Services shall
enter into one-time contracts with qualified cord blood banks to assist
in the collection and maintenance of 150,000 new units of high-quality
cord blood to be made available for transplantation through the C.W.
Bill Young Cell Transplantation Program and to carry out the
requirements of subsection (b).
(b) Requirements.--The Secretary shall require each recipient of a
contract under this section--
(1) to acquire, tissue-type, test, cryopreserve, and store
donated units of cord blood acquired with the informed consent of
the donor, as determined by the Secretary pursuant to section
379(c) of the Public Health Service Act, in a manner that complies
with applicable Federal and State regulations;
(2) to encourage donation from a genetically diverse
population;
(3) to make cord blood units that are collected pursuant to
this section or otherwise and meet all applicable Federal standards
available to transplant centers for transplantation;
(4) to make cord blood units that are collected, but not
appropriate for clinical use, available for peer-reviewed research;
(5) to make data available, as required by the Secretary and
consistent with section 379(d)(3) of the Public Health Service Act
(42 U.S.C. 274k(d)(3)), as amended by this Act, in a standardized
electronic format, as determined by the Secretary, for the C.W.
Bill Young Cell Transplantation Program; and
(6) to submit data in a standardized electronic format for
inclusion in the stem cell therapeutic outcomes database maintained
under section 379A of the Public Health Service Act, as amended by
this Act.
(c) Related Cord Blood Donors.--
(1) In general.--The Secretary shall establish a 3-year
demonstration project under which qualified cord blood banks
receiving a contract under this section may use a portion of the
funding under such contract for the collection and storage of cord
blood units for a family where a first-degree relative has been
diagnosed with a condition that will benefit from transplantation
(including selected blood disorders, malignancies, metabolic
storage disorders, hemoglobinopathies, and congenital
immunodeficiencies) at no cost to such family. Qualified cord blood
banks collecting cord blood units under this paragraph shall comply
with the requirements of paragraphs (1), (2), (3), and (5) of
subsection (b).
(2) Availability.--Qualified cord blood banks that are
operating a program under paragraph (1) shall provide assurances
that the cord blood units in such banks will be available for
directed transplantation until such time that the cord blood unit
is released for transplantation or is transferred by the family to
the C.W. Bill Young Cell Transplantation Program in accordance with
guidance or regulations promulgated by the Secretary.
(3) Inventory.--Cord blood units collected through the program
under this section shall not be counted toward the 150,000
inventory goal under the C.W. Bill Young Cell Transplantation
Program.
(4) Report.--Not later than 90 days after the date on which the
project under paragraph (1) is terminated by the Secretary, the
Secretary shall submit to Congress a report on the outcomes of the
project that shall include the recommendations of the Secretary
with respect to the continuation of such project.
(d) Application.--To seek to enter into a contract under this
section, a qualified cord blood bank shall submit an application to the
Secretary at such time, in such manner, and containing such information
as the Secretary may reasonably require. At a minimum, an application
for a contract under this section shall include a requirement that the
applicant--
(1) will participate in the C.W. Bill Young Cell
Transplantation Program for a period of at least 10 years;
(2) will make cord blood units collected pursuant to this
section available through the C.W. Bill Young Cell Transplantation
Program in perpetuity or for such time as determined viable by the
Secretary; and
(3) if the Secretary determines through an assessment, or
through petition by the applicant, that a cord blood bank is no
longer operational or does not meet the requirements of section
379(d)(4) of the Public Health Service Act (as added by this Act)
and as a result may not distribute the units, transfer the units
collected pursuant to this section to another qualified cord blood
bank approved by the Secretary to ensure continued availability of
cord blood units.
(e) Duration of Contracts.--
(1) In general.--Except as provided in paragraph (2), the term
of each contract entered into by the Secretary under this section
shall be for 10 years. The Secretary shall ensure that no Federal
funds shall be obligated under any such contract after the earlier
of--
(A) the date that is 3 years after the date on which the
contract is entered into; or
(B) September 30, 2010.
(2) Extensions.--Subject to paragraph (1)(B), the Secretary may
extend the period of funding under a contract under this section to
exceed a period of 3 years if--
(A) the Secretary finds that 150,000 new units of high-
quality cord blood have not yet been collected pursuant to this
section; and
(B) the Secretary does not receive an application for a
contract under this section from any qualified cord blood bank
that has not previously entered into a contract under this
section or the Secretary determines that the outstanding
inventory need cannot be met by the one or more qualified cord
blood banks that have submitted an application for a contract
under this section.
(3) Preference.--In considering contract extensions under
paragraph (2), the Secretary shall give preference to qualified
cord blood banks that the Secretary determines have demonstrated a
superior ability to satisfy the requirements described in
subsection (b) and to achieve the overall goals for which the
contract was awarded.
(f) Regulations.--The Secretary may promulgate regulations to carry
out this section.
(g) Definitions.--In this section:
(1) The term ``C.W. Bill Young Cell Transplantation Program''
means the C.W. Bill Young Cell Transplantation Program under
section 379 of the Public Health Service Act, as amended by this
Act.
(2) The term ``cord blood donor'' means a mother who has
delivered a baby and consents to donate the neonatal blood
remaining in the placenta and umbilical cord after separation from
the newborn baby.
(3) The term ``cord blood unit'' means the neonatal blood
collected from the placenta and umbilical cord of a single newborn
baby.
(4) The term ``first-degree relative'' means a sibling or
parent who is one meiosis away from a particular individual in a
family.
(5) The term ``qualified cord blood bank'' has the meaning
given to that term in section 379(d)(4) of the Public Health
Service Act, as amended by this Act.
(6) The term ``Secretary'' means the Secretary of Health and
Human Services.
(h) Authorization of Appropriations.--
(1) Existing funds.--Any amounts appropriated to the Secretary
for fiscal year 2004 or 2005 for the purpose of assisting in the
collection or maintenance of cord blood shall remain available to
the Secretary until the end of fiscal year 2007.
(2) Subsequent fiscal years.--There are authorized to be
appropriated to the Secretary $15,000,000 for each of fiscal years
2007, 2008, 2009, and 2010 to carry out this section.
(3) Limitation.--Not to exceed 5 percent of the amount
appropriated under this section in each of fiscal years 2007
through 2009 may be used to carry out the demonstration project
under subsection (c).

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Not later than 90 days after the date of enactment of this Act, the
Secretary of Health and Human Services, in consultation with the
Commissioner of Food and Drugs, shall submit to Congress a report
concerning the progress made by the Food and Drug Administration in
developing requirements for the licensing of cord blood units.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

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Stem Cell Research bill — HR. 2520

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