In the Senate of the United States,
December 16, 2005.
Resolved, That the bill from the House of Representa-
tives (H.R. 2520) entitled ‘‘An Act to provide for the collec-
tion 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.’’, do pass with the following
AMENDMENT:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Stem Cell Therapeutic
and Research Act of 2005’’.
SEC. 2. CORD BLOOD INVENTORY.
(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
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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 di-
verse population;
(3) to make cord blood units that are collected
pursuant to this section or otherwise and meet all ap-
plicable 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 for-
mat, as determined by the Secretary, for the C.W. Bill
Young Cell Transplantation Program; and
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(6) to submit data in a standardized electronic
format for inclusion in the stem cell therapeutic out-
comes 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 sec-
tion 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. Quali-
fied 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 transplan-
tation until such time that the cord blood unit is re-
leased for transplantation or is transferred by the
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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 ter-
minated by the Secretary, the Secretary shall submit
to Congress a report on the outcomes of the project
that shall include the recommendations of the Sec-
retary 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 man-
ner, 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;
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(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 as-
sessment, 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 Pub-
lic 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 para-
graph (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
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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 appli-
cation 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 inven-
tory 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 ex-
tensions under paragraph (2), the Secretary shall give
preference to qualified cord blood banks that the Sec-
retary determines have demonstrated a superior abil-
ity to satisfy the requirements described in subsection
(b) and to achieve the overall goals for which the con-
tract 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 Transplan-
tation Program’’ means the C.W. Bill Young Cell
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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 umbil-
ical cord after separation from the newborn baby.
(3) The term ‘‘cord blood unit’’ means the neo-
natal blood collected from the placenta and umbilical
cord of a single newborn baby.
(4) The term ‘‘first-degree relative’’ means a sib-
ling or parent who is one meiosis away from a par-
ticular 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 appro-
priated to the Secretary for fiscal year 2004 or 2005
for the purpose of assisting in the collection or main-
tenance of cord blood shall remain available to the
Secretary until the end of fiscal year 2007.
(2) SUBSEQUENT FISCAL YEARS.—There are au-
thorized 
to 
be 
appropriated 
to 
the 
Secretary
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$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).
SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PRO-
GRAM.
(a) NATIONAL PROGRAM.—Section 379 of the Public
Health Service Act (42 U.S.C. 274k) is amended to read
as follows:
‘‘SEC. 379. NATIONAL PROGRAM.
‘‘(a) ESTABLISHMENT.—The Secretary, acting through
the Administrator of the Health Resources and Services Ad-
ministration, shall by one or more contracts establish and
maintain a C.W. Bill Young Cell Transplantation Program
(referred to in this section as the ‘Program’), successor to
the National Bone Marrow Donor Registry, that has the
purpose of increasing the number of transplants for recipi-
ents suitably matched to biologically unrelated donors of
bone marrow and cord blood, and that meets the require-
ments of this section. The Secretary may award a separate
contract to perform each of the major functions of the Pro-
gram described in paragraphs (1) and (2) of subsection (d)
if deemed necessary by the Secretary to operate an effective
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and efficient system that is in the best interest of patients.
The Secretary shall conduct a separate competition for the
initial establishment of the cord blood functions of the Pro-
gram. The Program shall be under the general supervision
of the Secretary. The Secretary shall establish an Advisory
Council to advise, assist, consult with, and make rec-
ommendations to the Secretary on matters related to the
activities carried out by the Program. The members of the
Advisory Council shall be appointed in accordance with the
following:
‘‘(1) Each member of the Advisory Council shall
serve for a term of 2 years, and each such member
may serve as many as 3 consecutive 2-year terms, ex-
cept that
‘‘(A) such limitations shall not apply to the
Chair of the Advisory Council (or the Chair-
elect) or to the member of the Advisory Council
who most recently served as the Chair; and
‘‘(B) 1 additional consecutive 2-year term
may be served by any member of the Advisory
Council who has no employment, governance, or
financial affiliation with any donor center, re-
cruitment organization, transplant center, or
cord blood bank.
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‘‘(2) A member of the Advisory Council may con-
tinue to serve after the expiration of the term of such
member until a successor is appointed.
‘‘(3) In order to ensure the continuity of the Ad-
visory Council, the Advisory Council shall be ap-
pointed so that each year the terms of approximately
one-third of the members of the Advisory Council ex-
pire.
‘‘(4) The membership of the Advisory Council—
‘‘(A) shall include as voting members a bal-
anced number of representatives including rep-
resentatives of marrow donor centers and mar-
row transplant centers, representatives of cord
blood banks and participating birthing hospitals,
recipients of a bone marrow transplant, recipi-
ents of a cord blood transplant, persons who re-
quire such transplants, family members of such
a recipient or family members of a patient who
has requested the assistance of the Program in
searching for an unrelated donor of bone marrow
or cord blood, persons with expertise in bone
marrow and cord blood transplantation, persons
with expertise in typing, matching, and trans-
plant outcome data analysis, persons with exper-
tise in the social sciences, basic scientists with
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expertise in the biology of adult stem cells, and
members of the general public; and
‘‘(B) shall include as nonvoting members
representatives from the Department of Defense
Marrow Donor Recruitment and Research Pro-
gram operated by the Department of the Navy,
the Division of Transplantation of the Health
Resources and Services Administration, the Food
and Drug Administration, and the National In-
stitutes of Health.
‘‘(5) Members of the Advisory Council shall be
chosen so as to ensure objectivity and balance and re-
duce the potential for conflicts of interest. The Sec-
retary shall establish bylaws and procedures—
‘‘(A) to prohibit any member of the Advi-
sory Council who has an employment, govern-
ance, or financial affiliation with a donor cen-
ter, recruitment organization, transplant center,
or cord blood bank from participating in any de-
cision that materially affects the center, recruit-
ment organization, transplant center, or cord
blood bank; and
‘‘(B) to limit the number of members of the
Advisory Council with any such affiliation.
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‘‘(6) The Secretary, acting through the Advisory
Council, shall submit to the Congress—
‘‘(A) an annual report on the activities car-
ried out under this section; and
‘‘(B) not later than 6 months after the date
of the enactment of the Stem Cell Therapeutic
and Research Act of 2005, a report of rec-
ommendations on the scientific factors necessary
to define a cord blood unit as a high-quality
unit.
‘‘(b) ACCREDITATION.—The Secretary shall, through a
public process, recognize one or more accreditation entities
for the accreditation of cord blood banks.
‘‘(c) INFORMED
CONSENT.—The Secretary shall,
through a public process, examine issues of informed con-
sent, including—
‘‘(1) the appropriate timing of such consent; and
‘‘(2) the information provided to the maternal
donor regarding all of her medically appropriate cord
blood options.
Based on such examination, the Secretary shall require that
the standards used by the accreditation entities recognized
under subsection (b) ensure that a cord blood unit is ac-
quired with the informed consent of the maternal donor.
‘‘(d) FUNCTIONS.—
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‘‘(1) BONE MARROW FUNCTIONS.—With respect
to bone marrow, the Program shall—
‘‘(A) operate a system for identifying,
matching, and facilitating the distribution of
bone marrow that is suitably matched to can-
didate patients;
‘‘(B) consistent with paragraph (3), permit
transplant physicians, other appropriate health
care professionals, and patients to search by
means of electronic access all available bone
marrow donors listed in the Program;
‘‘(C) carry out a program for the recruit-
ment of bone marrow donors in accordance with
subsection (e), including with respect to increas-
ing the representation of racial and ethnic mi-
nority groups (including persons of mixed ances-
try) in the enrollment of the Program;
‘‘(D) maintain and expand medical contin-
gency response capabilities, in coordination with
Federal programs, to prepare for and respond ef-
fectively to biological, chemical, or radiological
attacks, and other public health emergencies that
can damage marrow, so that the capability of
supporting patients with marrow damage from