II 
Calendar No. 256 
109TH CONGRESS 
1ST SESSION H. R. 2520 
IN THE SENATE OF THE UNITED STATES 
MAY 26, 2005 
Received 
OCTOBER 24, 2005 
Read twice and placed on the calendar 
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 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’’.
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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
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(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
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(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.
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(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 
maintenance of human cord blood shall remain avail-
able to the Secretary until the end of fiscal year 
2006 for the purpose of carrying out this section. 
(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. Amounts
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appropriated pursuant to this paragraph shall re-
main available for obligation through the end of fis-
cal year 2010. 
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— 
(1) in the section heading, by striking ‘‘NA-
TIONAL
REGISTRY’’ and inserting ‘‘NATIONAL 
PROGRAM’’; 
(2) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘The Secretary shall by contract’’ 
and all that follows through the end of such 
matter and inserting ‘‘The Secretary, acting 
through the Administrator of the Health Re-
sources and Services Administration, shall by 
one or more contracts establish and maintain a 
C.W. Bill Young Cell Transplantation Program 
that has the purpose of increasing the number 
of transplants 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
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major functions of the Program described in 
paragraphs (1) and (2) of subsection (b) if 
deemed necessary by the Secretary to operate 
an effective and efficient system. The Secretary 
shall conduct a separate competition for the ini-
tial establishment of the cord blood functions of 
the Program. The Program shall be under the 
general supervision of the Secretary. The Sec-
retary shall establish an Advisory Council to ad-
vise, assist, consult with, and make rec-
ommendations to the Secretary on matters re-
lated to the activities carried out by the Pro-
gram. The members of the Advisory Council 
shall be appointed in accordance with the fol-
lowing:’’; 
(B) in paragraph (1), by striking ‘‘except 
that’’ and all that follows and inserting ‘‘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) 1 additional consecutive 2-year term 
may be served by any member of the Advisory 
Council who has no employment, governance, or
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financial affiliation with any donor center, re-
cruitment group, transplant center, or cord 
blood stem cell bank.’’; 
(C) by amending paragraph (4) to read as 
follows: 
‘‘(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, representatives of 
cord blood stem cell banks and participating 
birthing hospitals, recipients of a bone marrow 
transplant and cord blood transplants, persons 
who require such transplants, family members 
of such a recipient or family members of a pa-
tient who has requested the assistance of the 
Program in searching for an unrelated donor of 
bone marrow or cord blood, persons with exper-
tise in blood stem cell transplantation including 
cord blood, persons with expertise in typing, 
matching, and transplant outcome data anal-
ysis, persons with expertise in the social 
sciences, and members of the general public; 
and
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‘‘(B) shall include as nonvoting members 
representatives from the Department of De-
fense Marrow Donor Recruitment and Research 
Program 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 Institutes of Health.’’; and 
(D) by adding at the end the following: 
‘‘(5) Members of the Advisory Council shall be 
chosen so as to ensure objectivity and balance and 
reduce the potential for conflicts of interest. The 
Secretary 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 group, transplant center, or 
cord blood stem cell bank from participating in 
any decision that materially affects the center, 
recruitment group, transplant center, or cord 
blood stem cell bank; and 
‘‘(B) to limit the number of members of 
the Advisory Council with any such affiliation. 
‘‘(6) The Secretary, acting through the Advi-
sory Council, shall submit to the Congress—
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‘‘(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 Thera-
peutic and Research Act of 2005, a report of 
recommendations on the scientific factors nec-
essary to define a cord blood unit as a high- 
quality unit.’’; 
(3) by amending subsection (b) to read as fol-
lows: 
‘‘(b) FUNCTIONS.— 
‘‘(1) BONE MARROW FUNCTIONS.—With respect 
to bone marrow, the Program shall— 
‘‘(A) operate a system for listing, search-
ing, and facilitating the distribution of bone 
marrow that is suitably matched to candidate 
patients; 
‘‘(B) carry out a program for the recruit-
ment of bone marrow donors in accordance with 
subsection (c), including with respect to increas-
ing the representation of racial and ethnic mi-
nority groups (including persons of mixed an-
cestry) in the enrollment of the Program; 
‘‘(C) maintain and expand medical emer-
gency contingency response capabilities in con-
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cert with Federal programs for response to 
threats of use of terrorist or military weapons 
that can damage marrow, such as ionizing radi-
ation or chemical agents containing mustard, so 
that the capability of supporting patients with 
marrow damage from disease can be used to 
support casualties with marrow damage; 
‘‘(D) carry out informational and edu-
cational activities in accordance with subsection 
(c); 
‘‘(E) at least annually update information 
to account for changes in the status of individ-
uals as potential donors of bone marrow; 
‘‘(F) provide for a system of patient advo-
cacy through the office established under sub-
section (d); 
‘‘(G) provide case management services for 
any potential donor of bone marrow to whom 
the Program has provided a notice that the po-
tential donor may be suitably matched to a par-
ticular patient (which services shall be provided 
through a mechanism other than the system of 
patient advocacy under subsection (d)), and 
conduct surveys of donors and potential donors 
to determine the extent of satisfaction with
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such services and to identify ways in which the 
services can be improved; 
‘‘(H) with respect to searches for unrelated 
donors of bone marrow that are conducted 
through the system under subparagraph (A), 
collect, analyze, and publish data on the num-
ber and percentage of patients at each of the 
various stages of the search process, including 
data regarding the furthest stage reached, the 
number and percentage of patients who are un-
able to complete the search process, and the 
reasons underlying such circumstances; 
‘‘(I) support studies and demonstration 
and outreach projects for the purpose of in-
creasing the number of individuals who are will-
ing to be marrow donors to ensure a genetically 
diverse donor pool; 
‘‘(J) conduct and support research to im-
prove the availability, efficiency, safety, and 
cost of transplants from unrelated donors and 
the effectiveness of Program operations; and 
‘‘(K) assist qualified cord blood stem cell 
banks in the Program in accordance with para-
graph (3).
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Subsections (c) through (e) apply with respect to 
each entity awarded a contract under this section 
with respect to bone marrow. 
‘‘(2) CORD BLOOD FUNCTIONS.—With respect 
to cord blood, the Program shall— 
‘‘(A) operate a system for identifying, 
matching, and facilitating the distribution of 
donated cord blood units that are suitably 
matched to candidate patients and meet all ap-
plicable Federal and State regulations (includ-
ing informed consent and Food and Drug Ad-
ministration regulations) from a qualified cord 
blood stem cell bank; 
‘‘(B) allow transplant physicians, other ap-
propriate health care professionals, and patients 
to search by means of electronic access all avail-
able cord blood units listed in the Program; 
‘‘(C) allow transplant physicians and other 
appropriate health care professionals to ten-
tatively reserve a cord blood unit for transplan-
tation; 
‘‘(D) support studies and demonstration 
and outreach projects for the purpose of in-
creasing cord blood donation to ensure a geneti-
cally diverse collection of cord blood units; and
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‘‘(E) coordinate with the Secretary to 
carry out information and educational activities 
for the purpose of increasing cord blood dona-
tion and promoting the availability of cord 
blood units as a transplant option. 
‘‘(3) SINGLE POINT OF ACCESS.—If the Sec-
retary enters into a contract with more than one en-
tity to perform the functions outlined in this sub-
section, the Secretary shall establish procedures to 
ensure that health care professionals and patients 
are able to obtain, consistent with the functions de-
scribed in paragraphs (1)(A) and (2)(A), cells from 
adult donors and cord blood units through a single 
point of access. 
‘‘(4) DEFINITION.—The term ‘qualified cord 
blood stem cell bank’ means a cord blood stem cell 
bank that— 
‘‘(A) has obtained all applicable Federal 
and State licenses, certifications, registrations 
(including pursuant to the regulations of the 
Food and Drug Administration), and other au-
thorizations required to operate and maintain a 
cord blood stem cell bank; 
‘‘(B) has implemented donor screening, 
cord blood collection practices, and processing
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methods intended to protect the health and 
safety of donors and transplant recipients to 
improve transplant outcomes, including with re-
spect to the transmission of potentially harmful 
infections and other diseases; 
‘‘(C) is accredited by an accreditation body 
recognized pursuant to a public process by the 
Secretary; 
‘‘(D) has established a system of strict 
confidentiality to protect the identity and pri-
vacy of patients and donors in accordance with 
existing Federal and State law; and 
‘‘(E) has established a system for encour-
aging donation by a genetically diverse group of 
donors.’’; 
(4) in subsection (c)— 
(A) in paragraph (1), by striking ‘‘The 
Registry shall carry out a program for the re-
cruitment’’ and inserting ‘‘With respect to bone 
marrow, the Program shall carry out a program 
for the recruitment’’; 
(B) in paragraph (2)(A)— 
(i) in the matter preceding clause (i), 
by striking the first sentence and inserting 
‘‘In carrying out the program under para-
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graph (1), the Program shall carry out in-
formational and educational activities, in 
coordination with organ donation public 
awareness campaigns operated through the 
Department of Health and Human Serv-
ices, for purposes of recruiting individuals 
to serve as donors of bone marrow and 
shall test and enroll with the Program po-
tential donors.’’; and 
(ii) in clause (ii), by striking ‘‘, in-
cluding providing updates’’; and 
(C) in paragraph (3), by striking ‘‘the 
availability, as a potential treatment option, of 
receiving a transplant of bone marrow from an 
unrelated donor’’ and inserting ‘‘transplants 
from unrelated donors as a treatment option 
and resources for identifying and evaluating 
other therapeutic alternatives’’; 
(5) in subsection (d)— 
(A) in paragraph (1), by striking ‘‘The 
Registry shall’’ and inserting ‘‘With respect to 
bone marrow, the Program shall’’; 
(B) in paragraph (2)(C), by inserting ‘‘and 
assist with information regarding third party
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payor matters’’ after ‘‘ongoing search for a 
donor’’; 
(C) in subparagraphs (C), (D), and (E) of 
paragraph (2), by striking the term ‘‘subsection 
(b)(1)’’ each place such term appears and in-
serting ‘‘subsection (b)(1)(A)’’; 
(D) in paragraph (2)(F)— 
(i) by redesignating clause (v) as 
clause (vi); and 
(ii) by inserting after clause (iv) the 
following: 
‘‘(v) Information concerning issues 
that patients may face after a transplant 
regarding continuity of care and quality of 
life.’’; and 
(E) in paragraph (3)(B), by striking ‘‘Of-
fice may’’ and inserting ‘‘Office shall’’; 
(6) in the matter preceding paragraph (1) in 
subsection (e), by striking ‘‘the Secretary shall’’ and 
inserting ‘‘with respect to bone marrow, the Sec-
retary shall’’; 
(7) by amending subsection (f) to read as fol-
lows: 
‘‘(f) COMMENT PROCEDURES.—The Secretary shall 
establish and provide information to the public on proce-
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dures under which the Secretary shall receive and consider 
comments from interested persons relating to the manner 
in which the Program is carrying out the duties of the 
Program.’’; 
(8) by amending subsection (g) to read as fol-
lows: 
‘‘(g) CONSULTATION.—In developing policies affect-
ing the Program, the Secretary shall consult with the Ad-
visory Council, the Department of Defense Marrow Donor 
Recruitment and Research Program operated by the De-
partment of the Navy, and the board of directors of each 
entity awarded a contract under this section.’’; 
(9) in subsection (h)— 
(A) by striking ‘‘APPLICATION.—’’ and in-
serting ‘‘CONTRACTS.—’’; 
(B) by striking ‘‘To be eligible’’ and insert-
ing the following: 
‘‘(1) APPLICATION.—To be eligible’’; and 
(C) by adding at the end the following: 
‘‘(2) CONSIDERATIONS.—In awarding contracts 
under this section, the Secretary shall give substan-
tial weight to the continued safety of donors and pa-
tients and other factors deemed appropriate by the 
Secretary.’’; and 
(10) by striking subsection (l).
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(b) STEM CELL THERAPEUTIC OUTCOMES DATA-
BASE.—Section 379A of the Public Health Service Act (42 
U.S.C. 274l) is amended to read as follows: 
‘‘SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATA-
BASE. 
‘‘(a) ESTABLISHMENT.—The Secretary shall by con-
tract establish and maintain a scientific database of infor-
mation relating to patients who have been recipients of 
stem cell therapeutics product (including bone marrow, 
cord blood, or other such product) from a biologically un-
related donor. 
‘‘(b) INFORMATION.—The outcomes database shall 
include information with respect to patients described in 
subsection (a), transplant procedures, and such other in-
formation as the Secretary determines to be appropriate, 
to conduct an ongoing evaluation of the scientific and clin-
ical status of transplantation involving recipients of bone 
marrow from biologically unrelated donors and recipients 
of a stem cell therapeutics product. 
‘‘(c) ANNUAL REPORT ON PATIENT OUTCOMES.— 
The Secretary shall require the entity awarded a contract 
under this section to submit to the Secretary an annual 
report concerning patient outcomes with respect to each 
transplant center, based on data collected and maintained 
by the entity pursuant to this section.
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‘‘(d) PUBLICLY AVAILABLE DATA.—The outcomes 
database shall make relevant scientific information not 
containing individually identifiable information available 
to the public in the form of summaries and data sets to 
encourage medical research and to provide information to 
transplant programs, physicians, patients, entities award-
ed a contract under section 379 donor registries, and cord 
blood stem cell banks.’’. 
(c) DEFINITIONS.—Part I of title III of the Public 
Health Service Act (42 U.S.C. 274k et seq.) is amended 
by inserting after section 379A the following: 
‘‘SEC. 379A–1. DEFINITIONS. 
‘‘In this part: 
‘‘(1) The term ‘Advisory Council’ means the ad-
visory council established by the Secretary under 
section 379(a)(1). 
‘‘(2) The term ‘bone marrow’ means the cells 
found in adult bone marrow and peripheral blood. 
‘‘(3) The term ‘outcomes database’ means the 
database established by the Secretary under section 
379A. 
‘‘(4) The term ‘Program’ means the C.W. Bill 
Young Cell Transplantation Program established 
under section 379.’’.
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(d) AUTHORIZATION OF APPROPRIATIONS.—Section 
379B of the Public Health Service Act (42 U.S.C. 274m) 
is amended to read as follows: 
‘‘SEC. 379B. AUTHORIZATION OF APPROPRIATIONS. 
‘‘(a) IN GENERAL.—For the purpose of carrying out 
this part, there are authorized to be appropriated 
$28,000,000 for fiscal year 2006 and $32,000,000 for 
each of fiscal years 2007 through 2010. 
‘‘(b) EMERGENCY CONTINGENCY RESPONSE CAPA-
BILITIES.—In addition to the amounts authorized to be 
appropriated under subsection (a), there is authorized to 
be appropriated $2,000,000 for the maintenance and ex-
pansion of emergency contingency response capabilities 
under section 379(b)(1)(C).’’. 
(e) CONFORMING AMENDMENTS.—Part I of title III 
of the Public Health Service Act (42 U.S.C. 274k et seq.) 
is amended— 
(1) in the title heading, by striking ‘‘NA-
TIONAL BONE MARROW DONOR REG-
ISTRY’’ and inserting ‘‘C.W. BILL YOUNG 
CELL TRANSPLANTATION PROGRAM’’; 
and 
(2) in section 379, as amended by this sec-
tion—
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(A) in subsection (a), by striking the term 
‘‘board’’ each place such term appears and in-
serting ‘‘Advisory Council’’; 
(B) in subection (c)— 
(i) in the matter preceding subpara-
graph (A) in paragraph (1), by striking 
‘‘Such program’’ and inserting ‘‘Such re-
cruitment program’’; 
(ii) in paragraph (2), by striking 
‘‘program under paragraph (1)’’ and in-
serting ‘‘recruitment program under para-
graph (1)’’; and 
(iii) in paragraph (3), by striking 
‘‘program under paragraph (1)’’ and in-
serting ‘‘recruitment program under para-
graph (1)’’; 
(C) in subsection (d)(2)(E), by striking 
‘‘Registry program’’ and inserting ‘‘Program’’; 
(D) in subsection (e)— 
(i) in the matter preceding paragraph 
(1), by striking ‘‘participating in the pro-
gram, including the Registry,’’ and insert-
ing ‘‘participating in the Program, includ-
ing’’; and
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(ii) in paragraph (6), by striking ‘‘the 
program’’ and inserting ‘‘the Program’’; 
and 
(E) by striking the term ‘‘Registry’’ each 
place such term appears and inserting ‘‘Pro-
gram’’. 
Passed the House of Representatives May 24, 2005. 
Attest: 
JEFF TRANDAHL, 
Clerk.
Calendar No. 256 
109TH CONGRESS 
1ST SESSION 
H. R. 2520 
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. 
OCTOBER 24, 2005 
Read twice and placed on the calendar