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, 
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 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 popu-
lation; 
(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 Sec-
retary, 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 main-
tained under section 379A of the Public Health Service Act, 
as amended by this Act. 
(c) RELATED CORD BLOOD DONORS.—
H. R. 2520—2
(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, malig-
nancies, 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 assur-
ances 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 rec-
ommendations 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 Transplan-
tation 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 Transplan-
tation 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 con-
tract after the earlier of—
H. R. 2520—3
(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 out-
standing inventory need cannot be met by the one or more 
qualified cord blood banks that have submitted an applica-
tion 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 dem-
onstrated 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 Pro-
gram’’ means the C.W. Bill Young Cell Transplantation Pro-
gram 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 separa-
tion from the newborn baby. 
(3) The term ‘‘cord blood unit’’ means the neonatal blood 
collected from the placenta and umbilical cord of a single new-
born 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).
H. R. 2520—4
SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM. 
(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 Administration, 
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 trans-
plants for recipients 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 Program described 
in paragraphs (1) and (2) of subsection (d) if deemed necessary 
by the Secretary to operate an effective 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 Program. 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, except 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) one 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, recruitment organization, transplant 
center, or cord blood bank. 
‘‘(2) A member of the Advisory Council may continue 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 Advisory 
Council, the Advisory Council shall be appointed so that each 
year the terms of approximately one-third of the members 
of the Advisory Council expire. 
‘‘(4) The membership of the Advisory Council— 
‘‘(A) shall include as voting members a balanced 
number of representatives including representatives of 
marrow donor centers and marrow transplant centers, rep-
resentatives of cord blood banks and participating birthing 
hospitals, recipients of a bone marrow transplant, recipi-
ents of a cord blood transplant, persons who require 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