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disease can be used to support casualties with
marrow damage;
‘‘(E) carry out informational and edu-
cational activities in accordance with subsection
(e);
‘‘(F) at least annually update information
to account for changes in the status of individ-
uals as potential donors of bone marrow;
‘‘(G) provide for a system of patient advo-
cacy through the office established under sub-
section (h);
‘‘(H) provide case management services for
any potential donor of bone marrow to whom the
Program has provided a notice that the potential
donor may be suitably matched to a particular
patient through the office established under sub-
section (h);
‘‘(I) with respect to searches for unrelated
donors of bone marrow that are conducted
through the system under subparagraph (A), col-
lect, 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 fur-
thest stage reached, the number and percentage of
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patients who are unable to complete the search
process, and the reasons underlying such cir-
cumstances;
‘‘(J) support studies and demonstration and
outreach projects for the purpose of increasing
the number of individuals who are willing to be
marrow donors to ensure a genetically diverse
donor pool; and
‘‘(K) facilitate research with the appro-
priate Federal agencies to improve the avail-
ability, efficiency, safety, and cost of transplants
from unrelated donors and the effectiveness 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 do-
nated cord blood units that are suitably matched
to candidate patients and meet all applicable
Federal and State regulations (including in-
formed consent and Food and Drug Administra-
tion regulations) from a qualified cord blood
bank;
‘‘(B) consistent with paragraph (3), allow
transplant physicians, other appropriate health
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care professionals, and patients to search by
means of electronic access all available 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;
‘‘(D) support studies and demonstration
and outreach projects for the purpose of increas-
ing cord blood donation to ensure a genetically
diverse collection of cord blood units;
‘‘(E) provide for a system of patient advo-
cacy through the office established under sub-
section (h);
‘‘(F) coordinate with the qualified cord
blood banks to support informational and edu-
cational activities in accordance with subsection
(g);
‘‘(G) maintain and expand medical contin-
gency response capabilities, in coordination with
Federal programs, to prepare for and respond ef-
fectively to biological, chemical, or radiological
attacks, and other public health emergencies that
can damage marrow, so that the capability of
supporting patients with marrow damage from
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disease can be used to support casualties with
marrow damage; and
‘‘(H) with respect to the system under sub-
paragraph (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 fur-
thest stage reached, the number and percentage of
patients who are unable to complete the search
process, and the reasons underlying such cir-
cumstances.
‘‘(3) SINGLE
POINT
OF
ACCESS; 
STANDARD
DATA.—
‘‘(A) SINGLE POINT OF ACCESS.—The Sec-
retary 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 do-
nors and cord blood units through a single point
of access.
‘‘(B) STANDARD DATA.—The Secretary shall
require all recipients of contracts under this sec-
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tion to make available a standard dataset for
purposes of subparagraph (A) in a standardized
electronic format that enables transplant physi-
cians to compare among and between bone mar-
row 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 au-
thorizations required to operate and maintain a
cord blood bank;
‘‘(B) has implemented donor screening, cord
blood collection practices, and processing meth-
ods 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 infec-
tions and other diseases;
‘‘(C) is accredited by an accreditation enti-
ty recognized by the Secretary under subsection
(b);
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‘‘(D) has established a system of strict con-
fidentiality to protect the identity and privacy of
patients and donors in accordance with existing
Federal and State law;
‘‘(E) has established a system for encour-
aging donation by a genetically diverse group of
donors; and
‘‘(F) has established a system to confiden-
tially maintain linkage between a cord blood
unit and a maternal donor.
‘‘(e) BONE MARROW RECRUITMENT; PRIORITIES; IN-
FORMATION 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 underrepresented 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 in-
crease 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 com-
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parable 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
RECRUITMENT; TESTING AND ENROLLMENT.—
‘‘(A) IN
GENERAL.—The Program shall
carry out informational and educational activi-
ties, in coordination with organ donation public
awareness campaigns operated through the De-
partment of Health and Human Services, for
purposes of recruiting individuals to serve as do-
nors of bone marrow, and shall test and enroll
with the Program potential bone marrow donors.
Such information and educational 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.
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‘‘(ii) Educating and providing infor-
mation to individuals who are willing to
serve as potential bone marrow donors.
‘‘(iii) Training individuals in request-
ing individuals to serve as potential bone
marrow donors.
‘‘(B) PRIORITIES.—In carrying out infor-
mational and educational activities under sub-
paragraph (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
OP-
TION.—In addition to activities regarding recruit-
ment, 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 treat-
ment option.
‘‘(4) IMPLEMENTATION OF SUBSECTION.—The re-
quirements 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 func-
tions described in subsection (d)(1).
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‘‘(f) BONE MARROW CRITERIA, STANDARDS, AND PRO-
CEDURES.—The Secretary shall enforce, for participating
entities, including the Program, individual marrow donor
centers, marrow donor registries, marrow collection centers,
and marrow transplant centers—
‘‘(1) quality standards and standards for tissue
typing, obtaining the informed consent of donors, and
providing patient advocacy;
‘‘(2) donor selection criteria, based on established
medical criteria, to protect both the donor and the re-
cipient and to prevent the transmission of potentially
harmful infectious diseases such as the viruses that
cause hepatitis and the etiologic agent for Acquired
Immune Deficiency Syndrome;
‘‘(3) procedures to ensure the proper collection
and transportation of the marrow;
‘‘(4) standards for the system for patient advo-
cacy operated under subsection (h), including stand-
ards requiring the provision of appropriate informa-
tion (at the start of the search process and throughout
the process) to patients and their families and physi-
cians;
‘‘(5) standards that—
‘‘(A) require the establishment of a system
of strict confidentiality of records relating to the
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identity, address, HLA type, and managing
marrow donor center for marrow donors and po-
tential marrow donors; and
‘‘(B) prescribe the purposes for which the
records described in subparagraph (A) may be
disclosed, and the circumstances and extent of
the disclosure; and
‘‘(6) in the case of a marrow donor center or
marrow donor registry participating in the program,
procedures to ensure the establishment of a method for
integrating donor files, searches, and general proce-
dures of the center or registry with the Program.
‘‘(g) CORD BLOOD RECRUITMENT; PRIORITIES; INFOR-
MATION AND EDUCATION.—
‘‘(1) RECRUITMENT; PRIORITIES.—The Program
shall support activities, in cooperation with qualified
cord blood banks, for the recruitment of cord blood do-
nors. Such recruitment program shall identify popu-
lations that are underrepresented among cord blood
donors. In the case of populations that are identified
under the preceding sentence:
‘‘(A) The Program shall give priority to
supporting activities under this part to increase
representation for such populations in order to
enable a member of such a population, to the ex-
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tent practicable, to have a probability of finding
a suitable cord blood unit 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 support activities under subparagraph (A)
with respect to such populations.
‘‘(2) INFORMATION AND EDUCATION REGARDING
RECRUITMENT; TESTING AND DONATION.—
‘‘(A) IN GENERAL.—In carrying out the re-
cruitment program under paragraph (1), the
Program shall support informational and edu-
cational activities in coordination with qualified
cord blood banks and organ donation public
awareness campaigns operated through the De-
partment of Health and Human Services, for
purposes of recruiting pregnant women to serve
as donors of cord blood. Such information and
educational activities shall include the following:
‘‘(i) Making information available to
the general public, including information
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describing the needs of patients with respect
to cord blood units.
‘‘(ii) Educating and providing infor-
mation to pregnant women who are willing
to donate cord blood units.
‘‘(iii) Training individuals in request-
ing pregnant women to serve as cord blood
donors.
‘‘(B) PRIORITIES.—In carrying out infor-
mational and educational activities under sub-
paragraph (A), the Program shall give priority
to supporting the recruitment of pregnant
women to serve as donors of cord blood for popu-
lations that are identified under paragraph (1).
‘‘(3) TRANSPLANTATION
AS
TREATMENT
OP-
TION.—In addition to activities regarding recruit-
ment, the recruitment program under paragraph (1)
shall provide information to physicians, other health
care professionals, and the public regarding cord
blood transplants from donors as a treatment option.
‘‘(4) IMPLEMENTATION OF SUBSECTION.—The re-
quirements 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 func-
tions described in subsection (d)(2).
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‘‘(h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR
BONE MARROW AND CORD BLOOD.—
‘‘(1) IN GENERAL.—The Secretary shall establish
and maintain, through a contract or other means de-
termined appropriate by the Secretary, an office of
patient advocacy (in this subsection referred to as the
‘Office’).
‘‘(2) GENERAL
FUNCTIONS.—The Office shall
meet the following requirements:
‘‘(A) The Office shall be headed by a direc-
tor.
‘‘(B) The Office shall be staffed by individ-
uals with expertise in bone marrow and cord
blood therapy covered under the Program.
‘‘(C) The Office shall operate a system for
patient advocacy, which shall be separate from
mechanisms for donor advocacy, and which shall
serve patients for whom the Program is con-
ducting, or has been requested to conduct, a
search for a bone marrow donor or cord blood
unit.
‘‘(D) In the case of such a patient, the Of-
fice shall serve as an advocate for the patient by
directly providing to the patient (or family
members, physicians, or other individuals acting
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on behalf of the patient) individualized services
with respect to efficiently utilizing the system
under paragraphs (1) and (2) of subsection (d)
to conduct an ongoing search for a bone marrow
donor or cord blood unit and assist with infor-
mation regarding third party payor matters.
‘‘(E) In carrying out subparagraph (D), the
Office shall monitor the system under para-
graphs (1) and (2) of subsection (d) to determine
whether the search needs of the patient involved
are being met, including with respect to the fol-
lowing:
‘‘(i) Periodically providing to the pa-
tient (or an individual acting on behalf of
the patient) information regarding bone
marrow donors or cord blood units that are
suitably matched to the patient, and other
information regarding the progress being
made in the search.
‘‘(ii) Informing the patient (or such
other individual) if the search has been in-
terrupted or discontinued.
‘‘(iii) Identifying and resolving prob-
lems in the search, to the extent practicable.
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‘‘(F) The Office shall ensure that the fol-
lowing data are made available to patients:
‘‘(i) The resources available through
the Program.
‘‘(ii) A comparison of transplant cen-
ters regarding search and other costs that
prior to transplantation are charged to pa-
tients by transplant centers.
‘‘(iii) The post-transplant outcomes for
individual transplant centers.
‘‘(iv) Information concerning issues
that patients may face after a transplant.
‘‘(v) Such other information as the
Program determines to be appropriate.
‘‘(G) The Office shall conduct surveys of pa-
tients (or family members, physicians, or other
individuals acting on behalf of patients) to deter-
mine the extent of satisfaction with the system
for patient advocacy under this subsection, and
to identify ways in which the system can be im-
proved to best meet the needs of patients.
‘‘(3) CASE MANAGEMENT.—
‘‘(A) IN GENERAL.—In serving as an advo-
cate for a patient under paragraph (2), the Of-
fice shall provide individualized case manage-
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ment services directly to the patient (or family
members, physicians, or other individuals acting
on behalf of the patient), including—
‘‘(i) individualized case assessment;
and
‘‘(ii) the functions described in para-
graph (2)(D) (relating to progress in the
search process).
‘‘(B) POSTSEARCH
FUNCTIONS.—In addi-
tion to the case management services described in
paragraph (1) for patients, the Office shall, on
behalf of patients who have completed the search
for a bone marrow donor or cord blood unit, pro-
vide information and education on the process of
receiving a transplant, including the post-trans-
plant process.
‘‘(i) COMMENT PROCEDURES.—The Secretary shall es-
tablish and provide information to the public on procedures
under which the Secretary shall receive and consider com-
ments from interested persons relating to the manner in
which the Program is carrying out the duties of the Pro-
gram. The Secretary may promulgate regulations under
this section.
‘‘(j) CONSULTATION.—In developing policies affecting
the Program, the Secretary shall consult with the Advisory
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Council, the Department of Defense Marrow Donor Recruit-
ment and Research Program operated by the Department
of the Navy, and the board of directors of each entity award-
ed a contract under this section.
‘‘(k) CONTRACTS.—
‘‘(1) APPLICATION.—To be eligible to enter into
a contract under this section, an entity shall submit
to the Secretary and obtain approval of an applica-
tion at such time, in such manner, and containing
such information as the Secretary shall by regulation
prescribe.
‘‘(2) CONSIDERATIONS.—In awarding contracts
under this section, the Secretary shall give consider-
ation to the continued safety of donors and patients
and other factors deemed appropriate by the Sec-
retary.
‘‘(l) ELIGIBILITY.—Entities eligible to receive a con-
tract under this section shall include private nonprofit enti-
ties.
‘‘(m) RECORDS.—
‘‘(1) RECORDKEEPING.—Each recipient of a con-
tract or subcontract under subsection (a) shall keep
such records as the Secretary shall prescribe, includ-
ing records that fully disclose the amount and dis-
position by the recipient of the proceeds of the con-
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tract, the total cost of the undertaking in connection
with which the contract was made, and the amount
of the portion of the cost of the undertaking supplied
by other sources, and such other records as will facili-
tate an effective audit.
‘‘(2) EXAMINATION OF RECORDS.—The Secretary
and the Comptroller General of the United States
shall have access to any books, documents, papers,
and records of the recipient of a contract or sub-
contract entered into under this section that are perti-
nent to the contract, for the purpose of conducting au-
dits and examinations.
‘‘(n) PENALTIES FOR DISCLOSURE.—Any person who
discloses the content of any record referred to in subsection
(d)(4)(D) or (f)(5)(A) without the prior written consent of
the donor or potential donor with respect to whom the
record is maintained, or in violation of the standards de-
scribed in subsection (f)(5)(B), shall be imprisoned for not
more than 2 years or fined in accordance with title 18,
United States Code, or both.’’.
(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:
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‘‘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 a
stem cell therapeutics product (including bone marrow, cord
blood, or other such product) from a donor.
‘‘(b) INFORMATION.—The outcomes database shall in-
clude information in a standardized electronic format with
respect to patients described in subsection (a), diagnosis,
transplant procedures, results, long-term follow-up, and
such other information as the Secretary determines to be
appropriate, to conduct an ongoing evaluation of the sci-
entific and clinical status of transplantation involving re-
cipients of a stem cell therapeutics product from a donor.
‘‘(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.
‘‘(d) PUBLICLY
AVAILABLE
DATA.—The outcomes
database shall make relevant scientific information not con-
taining individually identifiable information available to
the public in the form of summaries and data sets to encour-
age medical research and to provide information to trans-
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plant programs, physicians, patients, entities awarded a
contract under section 379 donor registries, and cord blood
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 sec-
tion 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.’’.
(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.
‘‘For the purpose of carrying out this part, there are
authorized to be appropriated $34,000,000 for fiscal year
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2006 and $38,000,000 for each of fiscal years 2007 through
2010.’’.
(e) CONFORMING AMENDMENTS.—Part I of title III of
the Public Health Service Act (42 U.S.C. 274k et seq.) is
amended in the part heading, by striking ‘‘NATIONAL
BONE MARROW DONOR REGISTRY’’ and in-
serting ‘‘C. W. BILL YOUNG CELL TRANSPLAN-
TATION PROGRAM’’.
SEC. 4. REPORT ON LICENSURE OF CORD BLOOD UNITS.
Not later than 90 days after the date of enactment of
this Act, the Secretary of Health and Human Services, in
consultation with the Commissioner of Food and Drugs,
shall submit to Congress a report concerning the progress
made by the Food and Drug Administration in developing
requirements for the licensing of cord blood units.
Attest:
Secretary.