H. R. 2520—5
marrow and cord blood transplantation, persons with exper-
tise in typing, matching, and transplant outcome data anal-
ysis, persons with expertise in the social sciences, basic 
scientists with expertise in the biology of adult stem cells, 
and members of the general public; and 
‘‘(B) shall include as nonvoting members representa-
tives from the Department of Defense 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. 
‘‘(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 Advisory Council 
who has an employment, governance, or financial affiliation 
with a donor center, recruitment organization, transplant 
center, or cord blood bank from participating in any deci-
sion that materially affects the center, recruitment 
organization, transplant center, or cord blood bank; and 
‘‘(B) to limit the number of members of the Advisory 
Council with any such affiliation. 
‘‘(6) The Secretary, acting through the Advisory Council, 
shall submit to the Congress— 
‘‘(A) an annual report on the activities carried out 
under this section; and 
‘‘(B) not later than 6 months after the date of the 
enactment of the Stem Cell Therapeutic and Research Act 
of 2005, a report of recommendations on the scientific fac-
tors necessary to define a cord blood unit as a high-quality 
unit. 
‘‘(b) ACCREDITATION.—The Secretary shall, through a public 
process, recognize one or more accreditation entities for the accredi-
tation of cord blood banks. 
‘‘(c) INFORMED CONSENT.—The Secretary shall, through a public 
process, examine issues of informed consent, including— 
‘‘(1) the appropriate timing of such consent; and 
‘‘(2) the information provided to the maternal donor 
regarding all of her medically appropriate cord blood options. 
Based on such examination, the Secretary shall require that the 
standards used by the accreditation entities recognized under sub-
section (b) ensure that a cord blood unit is acquired with the 
informed consent of the maternal donor. 
‘‘(d) FUNCTIONS.— 
‘‘(1) BONE MARROW FUNCTIONS.—With respect to bone mar-
row, the Program shall— 
‘‘(A) operate a system for identifying, matching, and 
facilitating the distribution of bone marrow that is suitably 
matched to candidate patients; 
‘‘(B) consistent with paragraph (3), permit transplant 
physicians, other appropriate health care professionals, and 
patients to search by means of electronic access all avail-
able bone marrow donors listed in the Program; 
‘‘(C) carry out a program for the recruitment of bone 
marrow donors in accordance with subsection (e), including
H. R. 2520—6
with respect to increasing the representation of racial and 
ethnic minority groups (including persons of mixed 
ancestry) in the enrollment of the Program; 
‘‘(D) 
maintain 
and 
expand 
medical 
contingency 
response capabilities, in coordination with Federal pro-
grams, to prepare for and respond effectively to biological, 
chemical, or radiological attacks, and other public health 
emergencies that can damage marrow, so that the capa-
bility of supporting patients with marrow damage from 
disease can be used to support casualties with marrow 
damage; 
‘‘(E) carry out informational and educational activities 
in accordance with subsection (e); 
‘‘(F) at least annually update information to account 
for changes in the status of individuals as potential donors 
of bone marrow; 
‘‘(G) provide for a system of patient advocacy through 
the office established under subsection (h); 
‘‘(H) provide case management services for any poten-
tial donor of bone marrow to whom the Program has pro-
vided a notice that the potential donor may be suitably 
matched to a particular patient through the office estab-
lished under subsection (h); 
‘‘(I) with respect to searches for unrelated donors of 
bone marrow that are conducted through the system under 
subparagraph (A), collect, analyze, and publish data in 
a standardized electronic format on the number 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 unable to complete the search process, and the reasons 
underlying such circumstances; 
‘‘(J) support studies and demonstration and outreach 
projects for the purpose of increasing the number of individ-
uals who are willing to be marrow donors to ensure a 
genetically diverse donor pool; and 
‘‘(K) facilitate research with the appropriate Federal 
agencies to improve the availability, efficiency, safety, and 
cost of transplants from unrelated donors and the effective-
ness of Program operations. 
‘‘(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 applicable Federal and State regulations (including 
informed consent and Food and Drug Administration regu-
lations) from a qualified cord blood bank; 
‘‘(B) consistent with paragraph (3), allow transplant 
physicians, other appropriate health care professionals, and 
patients to search by means of electronic access all avail-
able cord blood units made available through the Program; 
‘‘(C) allow transplant physicians and other appropriate 
health care professionals to reserve, as defined by the 
Secretary, a cord blood unit for transplantation;
H. R. 2520—7
‘‘(D) support studies and demonstration and outreach 
projects for the purpose of increasing cord blood donation 
to ensure a genetically diverse collection of cord blood units; 
‘‘(E) provide for a system of patient advocacy through 
the office established under subsection (h); 
‘‘(F) coordinate with the qualified cord blood banks 
to support informational and educational activities in 
accordance with subsection (g); 
‘‘(G) 
maintain 
and 
expand 
medical 
contingency 
response capabilities, in coordination with Federal pro-
grams, to prepare for and respond effectively to biological, 
chemical, or radiological attacks, and other public health 
emergencies that can damage marrow, so that the capa-
bility of supporting patients with marrow damage from 
disease can be used to support casualties with marrow 
damage; and 
‘‘(H) with respect to the system under subparagraph 
(A), collect, analyze, and publish data in a standardized 
electronic format, as required by the Secretary, on the 
number 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 unable to complete the search process, 
and the reasons underlying such circumstances. 
‘‘(3) SINGLE POINT OF ACCESS; STANDARD DATA.— 
‘‘(A) SINGLE
POINT
OF
ACCESS.—The Secretary shall 
ensure that health care professionals and patients are able 
to search electronically for and facilitate access to, in the 
manner and to the extent defined by the Secretary and 
consistent with the functions described in paragraphs (1)(A) 
and (2)(A), cells from bone marrow donors and cord blood 
units through a single point of access. 
‘‘(B) STANDARD DATA.—The Secretary shall require all 
recipients of contracts under this section to make available 
a standard dataset for purposes of subparagraph (A) in 
a standardized electronic format that enables transplant 
physicians to compare among and between bone marrow 
donors and cord blood units to ensure the best possible 
match for the patient. 
‘‘(4) DEFINITION.—The term ‘qualified cord blood bank’ 
means a cord blood 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 authorizations required to operate and maintain a 
cord blood bank; 
‘‘(B) has implemented donor screening, cord blood 
collection practices, and processing methods intended to 
protect the health and safety of donors and transplant 
recipients to improve transplant outcomes, including with 
respect to the transmission of potentially harmful infections 
and other diseases; 
‘‘(C) is accredited by an accreditation entity recognized 
by the Secretary under subsection (b); 
‘‘(D) has established a system of strict confidentiality 
to protect the identity and privacy of patients and donors 
in accordance with existing Federal and State law;
H. R. 2520—8
‘‘(E) has established a system for encouraging donation 
by a genetically diverse group of donors; and 
‘‘(F) has established a system to confidentially maintain 
linkage between a cord blood unit and a maternal donor. 
‘‘(e) BONE MARROW RECRUITMENT; PRIORITIES; INFORMATION 
AND EDUCATION.— 
‘‘(1) RECRUITMENT; PRIORITIES.—The Program shall carry 
out activities for the recruitment of bone marrow donors. Such 
recruitment program shall identify populations that are under-
represented among potential donors enrolled with the Program. 
In the case of populations that are identified under the pre-
ceding sentence: 
‘‘(A) The Program shall give priority to carrying out 
activities under this part to increase representation for 
such populations in order to enable a member of such 
a population, to the extent practicable, to have a probability 
of finding a suitable unrelated donor that is comparable 
to the probability that an individual who is not a member 
of an underrepresented population would have. 
‘‘(B) The Program shall consider racial and ethnic 
minority groups (including persons of mixed ancestry) to 
be populations that have been identified for purposes of 
this paragraph, and shall carry out subparagraph (A) with 
respect to such populations. 
‘‘(2) INFORMATION
AND
EDUCATION
REGARDING
RECRUIT-
MENT; TESTING AND ENROLLMENT.— 
‘‘(A) IN
GENERAL.—The Program shall carry out 
informational and educational activities, in coordination 
with organ donation public awareness campaigns operated 
through the Department of Health and Human Services, 
for purposes of recruiting individuals to serve as donors 
of bone marrow, and shall test and enroll with the Program 
potential bone marrow donors. Such information and edu-
cational activities shall include the following: 
‘‘(i) Making information available to the general 
public, including information describing the needs of 
patients with respect to donors of bone marrow. 
‘‘(ii) Educating and providing information to 
individuals who are willing to serve as potential bone 
marrow donors. 
‘‘(iii) Training individuals in requesting individuals 
to serve as potential bone marrow donors. 
‘‘(B) PRIORITIES.—In carrying out informational and 
educational activities under subparagraph (A), the Program 
shall give priority to recruiting individuals to serve as 
donors of bone marrow for populations that are identified 
under paragraph (1). 
‘‘(3) TRANSPLANTATION AS TREATMENT OPTION.—In addition 
to activities regarding recruitment, the recruitment program 
under paragraph (1) shall provide information to physicians, 
other health care professionals, and the public regarding bone 
marrow transplants from unrelated donors as a treatment 
option. 
‘‘(4) IMPLEMENTATION OF SUBSECTION.—The requirements 
of this subsection shall be carried out by the entity that has 
been awarded a contract by the Secretary under subsection 
(a) to carry out the functions described in subsection (d)(1).