I 
109TH CONGRESS 
1ST SESSION 
H. R. 596
To amend the Public Health Service Act to establish a National Cord Blood 
Stem Cell Bank Network to prepare, store, and distribute human umbil-
ical cord blood stem cells for the treatment of patients and to support 
peer-reviewed research using such cells. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 2, 2005
Mr. SMITH of New Jersey (for himself, Mr. DAVIS of Alabama, Mrs. MYRICK, 
Mr. TOWNS, Mr. NORWOOD, Mrs. CHRISTENSEN, Mr. WAMP, Mr. 
CUMMINGS, Mr. BURGESS, Ms. MILLENDER-MCDONALD, Mrs. JO ANN 
DAVIS of Virginia, Ms. ESHOO, Mr. LEWIS of Kentucky, Mr. RYUN of 
Kansas, Mr. MARSHALL, Mr. KENNEDY of Minnesota, Mr. RANGEL, Mr. 
WELDON of Florida, and Mr. BARTLETT of Maryland) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce 
A BILL 
To amend the Public Health Service Act to establish a Na-
tional Cord Blood Stem Cell Bank Network to prepare, 
store, and distribute human umbilical cord blood stem 
cells for the treatment of patients and to support peer-
reviewed research using such cells.
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 ‘‘Cord Blood Stem Cell Act 
of 2005’’. 
SEC. 2. FINDINGS. 
The Congress makes the following findings: 
(1) Research sponsored by the National Insti-
tutes of Health and conducted in full compliance 
with applicable Food and Drug Administration regu-
lations has demonstrated the feasibility of using cord 
blood for clinical applications. Stem cells, obtained 
from the blood contained in the delivered placenta 
and umbilical cord and donated by the mother, can 
be used for bone marrow reconstitution by trans-
plantation to recipients with certain malignancies 
(such as leukemia and lymphoma), genetic disorders 
(such as sickle cell anemia), and acquired diseases. 
(2) The placenta, umbilical cord, and the neo-
natal blood they contain are normally discarded 
after childbirth. This residual neonatal blood, termed 
cord blood, is a source of stem cells that can be col-
lected as donor tissue without risk to the donor and 
can be preserved through freezing for many years 
and be made immediately available for transplan-
tation in routine or emergency clinical situations. 
Scientific research on cord blood stem cells may un-
cover a potential to treat a wide variety of diseases 
not yet attempted. 
(3) Advantages of cord blood stem cell trans-
plants include no risk to the donor, and reduced risk 
of certain transplant complications, including graft 
versus host disease and latent virus infections (such 
as Epstein-Barr virus or cytomegalovirus) and im-
mediate availability of cord blood stem cell units, 
whenever needed. 
(4) Cord blood gives all patients a chance for 
a transplant, regardless of their ethnic background. 
An ethnically diverse inventory of 150,000 cord 
blood stem cell units would help provide appropriate 
matches for 80 to 90 percent of patients seeking 
matched cord blood stem cell transplants. 
(5) Some genetic conditions are more prevalent 
in members of particular ethnic groups, such as 
sickle cell anemia, a disease that occurs in one out 
of 500 African-American newborns. From early in-
fancy, patients with sickle cell anemia have a high 
risk of severe or fatal bacterial blood infections. 
Many patients develop painful crises beginning in in-
fancy and occurring up to 20 times per year. Chil-
dren with recurrent crises, chest syndrome or 
strokes, are at great risk of dying before the age of
20 years. The median life-span of a patient with 
sickle cell disease is 42 years, but patients with se-
vere disease in childhood rarely live beyond 20 years. 
Cord blood stem cell transplantation has cured pa-
tients with sickle cell anemia: 80 percent of children 
transplanted with related cord blood to correct sickle 
cell anemia or thalassemia were cured in a recently 
published study. The earlier in the course of severe 
disease, the transplant is performed, the better the 
outcomes. Unrelated cord blood transplants are es-
pecially beneficial for African-American and other 
ethnic minority patients because cord blood does not 
have to match as closely as bone marrow. With an 
ethnically balanced national cord blood stem cell net-
work of at least 150,000 units, some 80 to 90 per-
cent of African American patients who suffer from 
sickle cell anemia or other conditions requiring bone 
marrow replacement would be able to find appro-
priately matched cord blood stem cells for successful 
treatment. 
(6) Cord blood is an alternate to bone marrow 
as a source of stem cells for transplantation. Cord 
blood banks, therefore, serve the same kinds of pa-
tients as marrow donor registries. However, its col-
lection, processing, storage and selection for trans-
plant require unique systems and expertise. 
(7) Radiation exposure, from accidents or hos-
tile actions, could cause bone marrow failure in a 
portion of those exposed and require treatment, in-
cluding bone marrow reconstitution. In these cases 
the rapid availability of frozen cord blood stem cell 
units may be an important resource to help rescue 
the victims years later, those who were exposed and 
survived may incur an increased risk of leukemia or 
lymphoma, which might also require stem cell trans-
plantation. 
(8) Recent scientific developments suggest that 
further research on cord blood stem cells may lead 
to a greater understanding of certain chronic dis-
eases. This research might improve therapies for, 
and possibly cure, debilitating diseases such as Par-
kinson’s disease, insulin-dependent diabetes, heart 
disease, and certain types of cancer. These diseases 
cause a disproportionately large share of chronic dis-
abilities and account for a large portion of health 
care expenditures in the United States.
SEC. 3. NATIONAL CORD BLOOD STEM CELL BANK NET-
WORK. 
Part H of title III of the Public Health Service Act 
(42 U.S.C. 273 et seq.) is amended by inserting after sec-
tion 376 the following: 
‘‘SEC. 376A. NATIONAL CORD BLOOD STEM CELL BANK NET-
WORK. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ADMINISTRATOR.—The term ‘Adminis-
trator’ means the Administrator of the Health Re-
sources and Services Administration. 
‘‘(2) CORD BLOOD UNIT.—The term ‘cord blood 
unit’ means the blood collected from a single pla-
centa and umbilical cord. 
‘‘(3) DONOR.—The term ‘donor’ means a moth-
er who has delivered a baby and consents to donate 
the newborn’s blood remaining in the placenta and 
umbilical cord. 
‘‘(4) DONOR
BANK.—The term ‘donor bank’ 
means a qualified cord blood stem cell bank that en-
ters into a contract with the Secretary under sub-
section (b)(1). 
‘‘(5) HUMAN CORD BLOOD STEM CELLS.—The 
term 
‘human 
cord 
blood 
stem 
cells’ 
means 
hematopoietic stem cells and any other stem cells 
contained in the neonatal blood collected imme-
diately after the birth from the separated placenta 
and umbilical cord. 
‘‘(6) NATIONAL CORD BLOOD STEM CELL BANK 
NETWORK.—The term ‘National Cord Blood Stem 
Cell Bank Network’ means a network of qualified 
cord blood stem cell banks established under sub-
section (b). 
‘‘(b) NATIONAL CORD BLOOD STEM CELL BANK 
NETWORK.—
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Administrator, shall enter into contracts 
with qualified cord blood stem cell banks to assist in 
the establishment, provision, and maintenance of a 
National Network of Cord Blood Stem Cell Banks 
that contains at least 150,000 units of human cord 
blood stem cells. 
‘‘(2) PURPOSE
OF
DONOR
BANKS.—It is the 
purpose of the donor banks that are a part of the 
Network to—
‘‘(A) 
acquire, 
tissue-type, 
test, 
cryopreserve, and store donated units of human 
cord blood acquired with the informed consent 
of the donor, in a manner that complies with 
applicable Federal regulations;
‘‘(B) make cord blood units collected under 
this section, or otherwise, available to trans-
plant centers for stem cell transplantation; and 
‘‘(C) allocate up to 10 percent of the cord 
blood inventory each year for peer-reviewed re-
search. 
‘‘(3) ELIGIBILITY OF DONOR BANKS.—A cord 
blood stem cell bank shall be eligible to be a donor 
bank if such a bank—
‘‘(A) has obtained all applicable Federal 
and State licenses, certifications, registrations 
(including registration with the Food and Drug 
Administration), and other authorizations re-
quired to operate and maintain a cord blood 
stem cell bank; 
‘‘(B) has implemented donor screening and 
cord blood collection practices adequate to pro-
tect both donors and transplant recipients and 
to prevent transmission of potentially harmful 
infections and other diseases; 
‘‘(C) has established a system of strict con-
fidentiality to protect the identity and privacy 
of patients and donors in accordance with exist-
ing Federal and State law, and consistent with 
the regulations promulgated under section
264(c) of the Health Insurance Portability and 
Accountability Act of 1996 for the release of 
the identity of donors, recipients, or identifiable 
records; 
‘‘(D) has established a system for encour-
aging donation by an ethnically diverse group of 
donors; 
‘‘(E) has developed adequate systems for 
communication with other cord blood stem cell 
banks, transplant centers, and physicians with 
respect to the request, release, and distribution 
of cord blood units nationally and has developed 
such systems, consistent with the regulations 
promulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act of 
1996, to track recipients’ clinical outcomes for 
distributed units; and 
‘‘(F) has developed a system for educating 
the public, including patient advocacy organiza-
tions, about the benefits of donating and uti-
lizing cord blood stem cells in appropriate cir-
cumstances. 
‘‘(c) ADMINISTRATION OF THE NETWORK.—
‘‘(1) BOARD OF DIRECTORS.—
‘‘(A) IN
GENERAL.—The Secretary shall 
provide for the establishment of a Board of Di-
rectors, including a chairperson, who shall ad-
minister the National Cord Blood Stem Cell 
Bank Network, including establishing a na-
tional cord blood stem cell registry within the 
Network and coordinating the donor banks in 
the Network. 
‘‘(B) COMPOSITION.—
‘‘(i) IN GENERAL.—The Board of Di-
rectors shall be composed of members to 
be appointed by the Secretary who shall 
serve 3-year terms, and shall include rep-
resentatives from—
‘‘(I) cord blood stem cell trans-
plant centers; 
‘‘(II) physicians from partici-
pating birthing hospitals; 
‘‘(III) the cord blood stem cell re-
search community; 
‘‘(IV) recipients of cord blood 
stem cell transplants; 
‘‘(V) family members of a patient 
of the National Cord Blood Stem Cell 
Bank;
‘‘(VI) individuals with expertise 
in the social sciences; 
‘‘(VII) members of the general 
public; 
‘‘(VIII) the Division of Stem Cell 
Transplantation of the Health Re-
sources and Services Administration, 
who shall serve as nonvoting member; 
and 
‘‘(IX) the network donor banks. 
‘‘(ii) 
TERMS
OF
SERVICE.—Each 
member appointed under clause (i) may 
serve up to 2 consecutive 3-year terms, ex-
cept that this clause shall not apply to the 
members 
appointed 
under 
subclauses 
(VIII) and (IX) of clause (i). 
‘‘(C) CONTINUITY.—In order to ensure the 
continuity of the Board of Directors, the Board 
shall be appointed so that each year the terms 
of approximately 1/3 of the Board members ex-
pire. A member of the Board may continue to 
serve after the expiration of the term of such a 
member until a successor is appointed. 
‘‘(2) NATIONAL CORD BLOOD STEM CELL REG-
ISTRY.—
‘‘(A) IN GENERAL.—The Secretary, acting 
through the Administrator, shall establish as 
part of the Network a National Cord Blood 
Stem Cell Registry. The Registry shall—
‘‘(i) operate a system for identifying, 
acquiring, and distributing donated units 
of cord blood that are suitably matched to 
candidate patients; 
‘‘(ii) provide transplant physicians 
and other appropriate health care profes-
sionals a website function that enables 
searching the entire registry for suitable 
donor matches for patients, and requesting 
specific cord blood units; and 
‘‘(iii) maintain a database to docu-
ment the collection, storage, distribution, 
and transplantation of cord blood units 
and 
the 
clinical 
outcomes 
of 
all 
transplantations related to the Network. 
‘‘(B) DATABASE.—The database main-
tained under subparagraph (A)(iii) shall be op-
erated according to standards of consent, dis-
closure, and confidentiality, including those ap-
plicable under the regulations promulgated 
under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996. The 
Administrator, using the database, shall report 
to the Secretary on a periodic basis regarding 
the safety, efficacy, and cost-effectiveness of the 
clinical, research, and educational activities of 
the Network. The Secretary shall make such in-
formation available to the public. 
‘‘(3) NETWORK STANDARDS.—The Board of Di-
rectors shall ensure that—
‘‘(A) the donor banks within the National 
Cord Blood Stem Cell Bank Network meet the 
requirements of subsection (b)(3) on a con-
tinuing basis; and 
‘‘(B) the National Cord Blood Stem Cell 
Bank Network and their birthing hospital col-
lection 
sites 
be 
geographically 
distributed 
throughout the United States. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated $15,000,000 for fiscal year 2006, and 
$30,000,000 for fiscal year 2007 and such sums as may 
be necessary for each of fiscal years 2008 through 2010 
or until the 150,000 unit inventory is successfully ac-
quired.’’.
Æ