I 
108TH CONGRESS 
1ST SESSION H. R. 2852
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 
JULY 24, 2003
Mr. SMITH of New Jersey (for himself, Mr. BURR, Mr. DAVIS of Alabama, 
Mr. TOWNS, Mr. DOOLITTLE, Mr. TOOMEY, Mr. FALEOMAVAEGA, Mr. 
WELDON of Florida, and Mrs. MYRICK) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
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 the ‘‘Cord Blood Stem Cell 
Act of 2003’’ .
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. It 
can also be used for scientific research involving its 
stem cells. 
(3) Advantages of cord blood stem cell trans-
plants relative to bone marrow transplants include 
the reduction of risks to the donor, availability of
donor cell units in days rather than months, and 
lower risk of transplant complications, including 
graft versus host disease and latent virus infections 
(such as Epstein-Barr virus or Cytomegalovirus). 
(4) In conventional bone marrow transplan-
tation, matched siblings are the preferred donors, 
but only 30 percent of patients have a matched sib-
ling. When no sibling match is found, a search is ini-
tiated for an unrelated donor. 
(5) Finding a fully matched unrelated donor op-
timizes the chances of successful bone marrow trans-
plantation. In conventional bone marrow transplan-
tation, patients of ethnic minorities generally have 
difficulty finding fully matched donors, leaving par-
tially matched transplants as their only transplant 
option. Partially matched bone marrow transplan-
tation leads to a disproportionately high rate of com-
plications, including graft versus host disease and 
mortality. 
(6) Cord blood stem cell banks would provide 
increased genetic diversity in the supply of donors 
and increase the opportunity to identify fully 
matched and partially matched transplant units for 
qualified candidates. Cord blood stem cell trans-
plants using partially matched units reduce the risk
of graft versus host disease with its attending mor-
bidity and mortality as compared to conventional 
bone marrow transplantation. 
(7) Identifying and delivering an unrelated bone 
marrow donor from among the several millions in 
the National registry typically requires many 
months, sometimes more than 1 year. An inventory 
of 150,000 cord blood stem cell units, that takes 
into account the ethnic diversity of the country, 
would help provide appropriate matches for at least 
90 percent of those seeking matched cord blood stem 
cell transplants, within days of a formal request. 
(8) Matched donors are more likely within the 
same ethnic group as the patient’s. Some genetic 
conditions are also 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 infancy, patients 
with Sickle Cell Anemia have a high risk of severe 
or fatal bacterial blood infections. Many patients de-
velop painful crises beginning in infancy and occur-
ring up to 20 times per year. Children with recur-
rent 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 severe disease in childhood 
rarely live beyond 20 years. Cord blood stem cell 
transplantation has cured patients with Sickle Cell 
Anemia: 80 percent of children transplanted with re-
lated 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 especially bene-
ficial for African American and other ethnic minor-
ity patients because cord blood does not have to 
match as closely as bone marrow. For this reason, 
an African American patient is much more likely to 
find a suitable unrelated cord blood donor as com-
pared to a matched bone marrow donor. With an 
ethnically balanced national cord blood bank of at 
least 150,000 units, some 90 percent of African 
American patients who suffer from Sickle Cell Ane-
mia or other conditions requiring bone marrow re-
placement would be able to find appropriately 
matched cord blood stem cells for successful treat-
ment. 
(9) Since its inception in 1987, the National 
Marrow Donor Program has facilitated 17,000 bone 
marrow transplants. Cord blood transplantation
complements conventional bone marrow transplan-
tation by providing appropriately matched units to 
patients, especially those of non-caucasoid ethnicity, 
who have a much lower probability of finding an 
adequate match through the National Marrow Donor 
Program. Cord blood is one of the sources of stem 
cells used in transplantation, however, its collection, 
preparation, storage and dissemination require spe-
cific systems and expertise. 
(10) Radiation exposure, from accidents or hos-
tile actions could cause bone marrow failure in a 
portion of those exposed, requiring treatment includ-
ing bone marrow reconstitution. In these cases the 
rapid availability of cryopreserved cord blood stem 
cell units may be important. Years later, those ex-
posed would incur an increased risk of leukemia 
orlymphoma, which might also require stem cell 
transplantation. 
(11) Recent scientific developments suggest 
that further research on cord blood stem cells may 
lead to a greater understanding of certain chronic 
diseases. 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 2004, and 
$30,000,000 for fiscal year 2005 and such sums as may