I 
109TH CONGRESS 
1ST SESSION H. R. 2520
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 Trans-
plantation Program. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 23, 2005
Mr. SMITH of New Jersey (for himself, Mr. BARTON of Texas, Mr. DAVIS of 
Alabama, Mr. DELAY, Mr. DEAL of Georgia, Mr. BLUNT, Mr. TOWNS, 
Mr. DAVIS of Kentucky, Ms. FOXX, Mr. SHIMKUS, Mr. STUPAK, Mr. 
RENZI, Mr. CANTOR, Mr. PAYNE, Mr. GREEN of Wisconsin, Mr. MCIN-
TYRE, Mr. FERGUSON, Mr. NORWOOD, Ms. MILLENDER-MCDONALD, Mr. 
EVERETT, Mr. KENNEDY of Minnesota, Mr. CONYERS, Mr. BOUSTANY, 
Mr. LIPINSKI, Mr. ADERHOLT, Mr. BURGESS, Mr. WELDON of Florida, 
Mr. PENCE, Mrs. MYRICK, Mr. RYUN of Kansas, Mr. PITTS, Mr. 
MCCAUL of Texas, Mr. WAMP, Mr. CHABOT, Mr. MURPHY, Mr. INGLIS 
of South Carolina, Mr. TERRY, Mr. FORTENBERRY, Mr. NEUGEBAUER, 
Mr. STEARNS, Mr. WALSH, Mr. MCCOTTER, Mr. FOSSELLA, Mrs. JO 
ANN DAVIS of Virginia, Mr. HASTINGS of Washington, Mrs. DRAKE, Ms. 
HART, Mr. BURTON of Indiana, Mr. KING of New York, Mr. HAYWORTH, 
Mr. SULLIVAN, Mr. FITZPATRICK of Pennsylvania, Mr. GUTKNECHT, Mr. 
SHADEGG, Mr. AKIN, Mr. SOUDER, Mr. HAYES, Mr. BOOZMAN, Mr. DOO-
LITTLE, Mr. PRICE of Georgia, Mr. MEEK of Florida, Mr. KLINE, Mr. 
FORD, Mr. HYDE, Mrs. MUSGRAVE, Mr. FORBES, Mr. SAM JOHNSON of 
Texas, Mr. TANCREDO, Mr. DANIEL E. LUNGREN of California, Mr. 
MARSHALL, Ms. ESHOO, Mr. SODREL, Mr. PUTNAM, Mr. CANNON, Mr. 
LINCOLN DIAZ-BALART of Florida, Mr. CLAY, Ms. ROS-LEHTINEN, Mr. 
MCHENRY, and Mr. FRANKS of Arizona) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
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 Representa-
tives 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 stem cell banks to assist in the collec-
tion and maintenance of 150,000 units of high-quality 
human cord blood to be made available for transplantation 
through the C.W. Bill Young Cell Transplantation Pro-
gram 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 human cord blood ac-
quired with the informed consent of the donor in a 
manner that complies with applicable Federal and 
State regulations; 
(2) 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 stem cell transplantation; 
(3) to make cord blood units that are collected, 
but not appropriate for clinical use, available for 
peer-reviewed research; 
(4) to submit data in a standardized format, as 
required by the Secretary, for the C.W. Bill Young 
Cell Transplantation Program; and 
(5) to submit data 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) APPLICATION.—To seek to enter into a contract 
under this section, a qualified cord blood stem cell 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 ap-
plication for a contract under this section shall include an 
assurance that the applicant—
(1) will participate in the C.W. Bill Young Cell 
Transplantation Program for a period of at least 10 
years; and 
(2) in the event of abandonment of this activity 
prior to the expiration of such period, will transfer 
the units collected pursuant to this section to an-
other qualified cord blood stem cell bank approved 
by the Secretary to ensure continued availability of 
cord blood units. 
(d) DURATION OF CONTRACTS.—
(1) IN GENERAL.—The Secretary may not enter 
into any contract under this section for a period 
that—
(A) exceeds 3 years; or 
(B) ends after September 30, 2010. 
(2) 
EXTENSIONS.—Subject 
to 
paragraph 
(1)(B), the Secretary may extend the period of a 
contract under this section to exceed a period of 3 
years if—
(A) the Secretary finds that 150,000 units 
of high-quality human cord blood have not yet 
been collected pursuant to this section; and 
(B) the Secretary does not receive an ap-
plication for a contract under this section from 
any qualified cord blood stem cell 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 stem 
cell banks that have submitted an application 
for a contract under this section.
(e) REGULATIONS.—The Secretary may promulgate 
regulations to carry out this section. 
(f) DEFINITIONS.—In this section: 
(1) The term ‘‘C.W. Bill Young Cell Transplan-
tation 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 do-
nate the neonatal blood remaining in the placenta 
and umbilical cord after separation from the new-
born baby. 
(3) The term ‘‘human cord blood unit’’ means 
the neonatal blood collected from the placenta and 
umbilical cord. 
(4) The term ‘‘qualified cord blood stem cell 
bank’’ has the meaning given to that term in section 
379(b) of the Public Health Service Act, as amended 
by this Act. 
(5) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
(g) AUTHORIZATION OF APPROPRIATIONS.—
(1) FISCAL YEAR 2006.—Any amounts appro-
priated to the Secretary for fiscal year 2004 or 2005 
for the purpose of assisting in the collection or