Stem Cell Therapeutic and Research Act of 2005
PL 109-129 (H.R.2520), enacted 12/20/2005

119 STAT. 2550
PUBLIC LAW 109–129—DEC. 20, 2005
Public Law 109–129
109th Congress
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 Representatives 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’’.
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 banks
to assist in the collection and maintenance of 150,000 new units
of high-quality cord blood to be made available for transplantation
through the C.W. Bill Young Cell Transplantation Program 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 cord blood acquired with the informed consent
of the donor, as determined by the Secretary pursuant to section
379(c) of the Public Health Service Act, in a manner that
complies with applicable Federal and State regulations;
(2) to encourage donation from a genetically diverse popu-
lation;
(3) 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 transplantation;
(4) to make cord blood units that are collected, but not
appropriate for clinical use, available for peer-reviewed
research;
(5) to make data available, as required by the Secretary
and consistent with section 379(d)(3) of the Public Health
Service Act (42 U.S.C. 274k(d)(3)), as amended by this Act,
in a standardized electronic format, as determined by the Sec-
retary, for the C.W. Bill Young Cell Transplantation Program;
and
(6) to submit data in a standardized electronic format for
inclusion in the stem cell therapeutic outcomes database main-
tained under section 379A of the Public Health Service Act,
as amended by this Act.
(c) RELATED CORD BLOOD DONORS.—
Records.
Records.
Contracts.
42 USC 274k
note.
42 USC 201 note.
Stem Cell
Therapeutic and
Research Act of
2005.
Dec. 20, 2005
[H.R. 2520]
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119 STAT. 2551
PUBLIC LAW 109–129—DEC. 20, 2005
(1) IN GENERAL.—The Secretary shall establish a 3-year
demonstration project under which qualified cord blood banks
receiving a contract under this section may use a portion of
the funding under such contract for the collection and storage
of cord blood units for a family where a first-degree relative
has been diagnosed with a condition that will benefit from
transplantation (including selected blood disorders, malig-
nancies, metabolic storage disorders, hemoglobinopathies, and
congenital immunodeficiencies) at no cost to such family. Quali-
fied cord blood banks collecting cord blood units under this
paragraph shall comply with the requirements of paragraphs
(1), (2), (3), and (5) of subsection (b).
(2) AVAILABILITY.—Qualified cord blood banks that are
operating a program under paragraph (1) shall provide assur-
ances that the cord blood units in such banks will be available
for directed transplantation until such time that the cord blood
unit is released for transplantation or is transferred by the
family to the C.W. Bill Young Cell Transplantation Program
in accordance with guidance or regulations promulgated by
the Secretary.
(3) INVENTORY.—Cord blood units collected through the
program under this section shall not be counted toward the
150,000 inventory goal under the C.W. Bill Young Cell
Transplantation Program.
(4) REPORT.—Not later than 90 days after the date on
which the project under paragraph (1) is terminated by the
Secretary, the Secretary shall submit to Congress a report
on the outcomes of the project that shall include the rec-
ommendations of the Secretary with respect to the continuation
of such project.
(d) APPLICATION.—To seek to enter into a contract under this
section, a qualified cord blood 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 application for a contract under this section shall
include a requirement that the applicant—
(1) will participate in the C.W. Bill Young Cell Transplan-
tation Program for a period of at least 10 years;
(2) will make cord blood units collected pursuant to this
section available through the C.W. Bill Young Cell Transplan-
tation Program in perpetuity or for such time as determined
viable by the Secretary; and
(3) if the Secretary determines through an assessment,
or through petition by the applicant, that a cord blood bank
is no longer operational or does not meet the requirements
of section 379(d)(4) of the Public Health Service Act (as added
by this Act) and as a result may not distribute the units,
transfer the units collected pursuant to this section to another
qualified cord blood bank approved by the Secretary to ensure
continued availability of cord blood units.
(e) DURATION OF CONTRACTS.—
(1) IN GENERAL.—Except as provided in paragraph (2), the
term of each contract entered into by the Secretary under
this section shall be for 10 years. The Secretary shall ensure
that no Federal funds shall be obligated under any such con-
tract after the earlier of—
Regulations.
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119 STAT. 2552
PUBLIC LAW 109–129—DEC. 20, 2005
(A) the date that is 3 years after the date on which
the contract is entered into; or
(B) September 30, 2010.
(2) EXTENSIONS.—Subject to paragraph (1)(B), the Secretary
may extend the period of funding under a contract under this
section to exceed a period of 3 years if—
(A) the Secretary finds that 150,000 new units of high-
quality cord blood have not yet been collected pursuant
to this section; and
(B) the Secretary does not receive an application for
a contract under this section from any qualified cord blood
bank that has not previously entered into a contract under
this section or the Secretary determines that the out-
standing inventory need cannot be met by the one or more
qualified cord blood banks that have submitted an applica-
tion for a contract under this section.
(3) PREFERENCE.—In considering contract extensions under
paragraph (2), the Secretary shall give preference to qualified
cord blood banks that the Secretary determines have dem-
onstrated a superior ability to satisfy the requirements
described in subsection (b) and to achieve the overall goals
for which the contract was awarded.
(f) REGULATIONS.—The Secretary may promulgate regulations
to carry out this section.
(g) DEFINITIONS.—In this section:
(1) The term ‘‘C.W. Bill Young Cell Transplantation Pro-
gram’’ means the C.W. Bill Young Cell Transplantation Pro-
gram under section 379 of the Public Health Service Act, as
amended by this Act.
(2) The term ‘‘cord blood donor’’ means a mother who
has delivered a baby and consents to donate the neonatal
blood remaining in the placenta and umbilical cord after separa-
tion from the newborn baby.
(3) The term ‘‘cord blood unit’’ means the neonatal blood
collected from the placenta and umbilical cord of a single new-
born baby.
(4) The term ‘‘first-degree relative’’ means a sibling or
parent who is one meiosis away from a particular individual
in a family.
(5) The term ‘‘qualified cord blood bank’’ has the meaning
given to that term in section 379(d)(4) of the Public Health
Service Act, as amended by this Act.
(6) The term ‘‘Secretary’’ means the Secretary of Health
and Human Services.
(h) AUTHORIZATION OF APPROPRIATIONS.—
(1) EXISTING
FUNDS.—Any amounts appropriated to the
Secretary for fiscal year 2004 or 2005 for the purpose of
assisting in the collection or maintenance of cord blood shall
remain available to the Secretary until the end of fiscal year
2007.
(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.
(3) LIMITATION.—Not to exceed 5 percent of the amount
appropriated under this section in each of fiscal years 2007
through 2009 may be used to carry out the demonstration
project under subsection (c).
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119 STAT. 2553
PUBLIC LAW 109–129—DEC. 20, 2005
SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM.
(a) NATIONAL PROGRAM.—Section 379 of the Public Health
Service Act (42 U.S.C. 274k) is amended to read as follows:
‘‘SEC. 379. NATIONAL PROGRAM.
‘‘(a) ESTABLISHMENT.—The Secretary, acting through the
Administrator of the Health Resources and Services Administration,
shall by one or more contracts establish and maintain a C.W.
Bill Young Cell Transplantation Program (referred to in this section
as the ‘Program’), successor to the National Bone Marrow Donor
Registry, that has the purpose of increasing the number of trans-
plants 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 major functions of the Program described
in paragraphs (1) and (2) of subsection (d) if deemed necessary
by the Secretary to operate an effective and efficient system that
is in the best interest of patients. The Secretary shall conduct
a separate competition for the initial establishment of the cord
blood functions of the Program. The Program shall be under the
general supervision of the Secretary. The Secretary shall establish
an Advisory Council to advise, assist, consult with, and make rec-
ommendations to the Secretary on matters related to the activities
carried out by the Program. The members of the Advisory Council
shall be appointed in accordance with the following:
‘‘(1) Each member of the Advisory Council shall serve for
a term of 2 years, and each such member may serve as many
as 3 consecutive 2-year terms, 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) one additional consecutive 2-year term may be
served by any member of the Advisory Council who has
no employment, governance, or financial affiliation with
any donor center, recruitment organization, transplant
center, or cord blood bank.
‘‘(2) A member of the Advisory Council may continue to
serve after the expiration of the term of such member until
a successor is appointed.
‘‘(3) In order to ensure the continuity of the Advisory
Council, the Advisory Council shall be appointed so that each
year the terms of approximately one-third of the members
of the Advisory Council expire.
‘‘(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, rep-
resentatives of cord blood banks and participating birthing
hospitals, recipients of a bone marrow transplant, recipi-
ents of a cord blood transplant, persons who require such
transplants, family members of such a recipient or family
members of a patient who has requested the assistance
of the Program in searching for an unrelated donor of
bone marrow or cord blood, persons with expertise in bone
Contracts.
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119 STAT. 2554
PUBLIC LAW 109–129—DEC. 20, 2005
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
Deadline.
Reports.
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119 STAT. 2555
PUBLIC LAW 109–129—DEC. 20, 2005
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;
Records.
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119 STAT. 2556
PUBLIC LAW 109–129—DEC. 20, 2005
‘‘(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;
Publication.
Records.
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119 STAT. 2557
PUBLIC LAW 109–129—DEC. 20, 2005
‘‘(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).
Minorities.
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119 STAT. 2558
PUBLIC LAW 109–129—DEC. 20, 2005
‘‘(f) BONE MARROW CRITERIA, STANDARDS, AND PROCEDURES.—
The Secretary shall enforce, for participating entities, including
the Program, individual marrow donor centers, marrow donor reg-
istries, 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 recipient and to
prevent the transmission of potentially harmful infectious dis-
eases 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 advocacy operated
under subsection (h), including standards requiring the provi-
sion of appropriate information (at the start of the search
process and throughout the process) to patients and their fami-
lies and physicians;
‘‘(5) standards that—
‘‘(A) require the establishment of a system of strict
confidentiality of records relating to the identity, address,
HLA type, and managing marrow donor center for marrow
donors and potential 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 procedures of the center or registry with
the Program.
‘‘(g) CORD BLOOD RECRUITMENT; PRIORITIES; INFORMATION AND
EDUCATION.—
‘‘(1) RECRUITMENT; PRIORITIES.—The Program shall support
activities, in cooperation with qualified cord blood banks, for
the recruitment of cord blood donors. Such recruitment program
shall identify populations 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 extent 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 subpara-
graph (A) with respect to such populations.
‘‘(2) INFORMATION
AND
EDUCATION
REGARDING
RECRUIT-
MENT; TESTING AND DONATION.—
‘‘(A) IN GENERAL.—In carrying out the recruitment pro-
gram under paragraph (1), the Program shall support
informational and educational activities in coordination
Minorities.
Confidentiality.
Records.
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119 STAT. 2559
PUBLIC LAW 109–129—DEC. 20, 2005
with qualified cord blood banks and organ donation public
awareness campaigns operated through the Department
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 describing the needs of
patients with respect to cord blood units.
‘‘(ii) Educating and providing information to preg-
nant women who are willing to donate cord blood units.
‘‘(iii) Training individuals in requesting pregnant
women to serve as cord blood donors.
‘‘(B) PRIORITIES.—In carrying out informational and
educational activities under subparagraph (A), the Program
shall give priority to supporting the recruitment of preg-
nant women to serve as donors of cord blood 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 cord
blood transplants from 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)(2).
‘‘(h) PATIENT ADVOCACY
AND CASE MANAGEMENT
FOR BONE
MARROW AND CORD BLOOD.—
‘‘(1) IN GENERAL.—The Secretary shall establish and main-
tain, through a contract or other means determined appropriate
by the Secretary, an office of patient advocacy (in this sub-
section referred to as the ‘Office’).
‘‘(2) GENERAL FUNCTIONS.—The Office shall meet the fol-
lowing requirements:
‘‘(A) The Office shall be headed by a director.
‘‘(B) The Office shall be staffed by individuals 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 conducting, or has been requested to con-
duct, a search for a bone marrow donor or cord blood
unit.
‘‘(D) In the case of such a patient, the Office shall
serve as an advocate for the patient by directly providing
to the patient (or family members, physicians, or other
individuals acting 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 information regarding third party
payor matters.
‘‘(E) In carrying out subparagraph (D), the Office shall
monitor the system under paragraphs (1) and (2) of sub-
section (d) to determine whether the search needs of the
Establishment.
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119 STAT. 2560
PUBLIC LAW 109–129—DEC. 20, 2005
patient involved are being met, including with respect to
the following:
‘‘(i) Periodically providing to the patient (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 informa-
tion regarding the progress being made in the search.
‘‘(ii) Informing the patient (or such other indi-
vidual) if the search has been interrupted or discon-
tinued.
‘‘(iii) Identifying and resolving problems in the
search, to the extent practicable.
‘‘(F) The Office shall ensure that the following data
are made available to patients:
‘‘(i) The resources available through the Program.
‘‘(ii) A comparison of transplant centers regarding
search and other costs that prior to transplantation
are charged to patients 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 deter-
mines to be appropriate.
‘‘(G) The Office shall conduct surveys of patients (or
family members, physicians, or other individuals acting
on behalf of patients) to determine the extent of satisfaction
with the system for patient advocacy under this subsection,
and to identify ways in which the system can be improved
to best meet the needs of patients.
‘‘(3) CASE MANAGEMENT.—
‘‘(A) IN
GENERAL.—In serving as an advocate for a
patient under paragraph (2), the Office shall provide
individualized case management 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 paragraph (2)(D)
(relating to progress in the search process).
‘‘(B) POSTSEARCH FUNCTIONS.—In addition 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, provide information and education on the
process of receiving a transplant, including the post-trans-
plant process.
‘‘(i) COMMENT PROCEDURES.—The Secretary shall establish and
provide information to the public on procedures under which the
Secretary shall receive and consider comments from interested per-
sons relating to the manner in which the Program is carrying
out the duties of the Program. The Secretary may promulgate
regulations under this section.
‘‘(j) CONSULTATION.—In developing policies affecting the Pro-
gram, the Secretary shall consult with the Advisory Council, the
Department of Defense Marrow Donor Recruitment and Research
Program operated by the Department of the Navy, and the board
of directors of each entity awarded a contract under this section.
Public
information.
Surveys.
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PUBLIC LAW 109–129—DEC. 20, 2005
‘‘(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 application 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 consideration to the continued
safety of donors and patients and other factors deemed appro-
priate by the Secretary.
‘‘(l) ELIGIBILITY.—Entities eligible to receive a contract under
this section shall include private nonprofit entities.
‘‘(m) RECORDS.—
‘‘(1) RECORDKEEPING.—Each recipient of a contract or sub-
contract under subsection (a) shall keep such records as the
Secretary shall prescribe, including records that fully disclose
the amount and disposition by the recipient of the proceeds
of the contract, 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 facilitate 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 subcontract entered into under this section
that are pertinent to the contract, for the purpose of conducting
audits 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 described in subsection (f)(5)(B), shall be impris-
oned for not more than 2 years or fined in accordance with title
18, United States Code, or both.’’.
(b) STEM CELL THERAPEUTIC OUTCOMES DATABASE.—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 DATABASE.
‘‘(a) ESTABLISHMENT.—The Secretary shall by contract establish
and maintain a scientific database of information 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 include
information in a standardized electronic format with respect to
patients described in subsection (a), diagnosis, transplant proce-
dures, results, long-term follow-up, and such other information as
the Secretary determines to be appropriate, to conduct an ongoing
evaluation of the scientific and clinical status of transplantation
involving recipients 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.
Contracts.
Regulations.
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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 sum-
maries and data sets to encourage medical research and to provide
information to transplant 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 advisory 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.’’.
(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 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 
inserting 
‘‘C.W. 
BILL 
YOUNG 
CELL
TRANSPLANTATION 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
42 USC prec.
274k.
42 USC 274l–1.
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LEGISLATIVE HISTORY—H.R. 2520 (S. 1317):
SENATE REPORTS: No. 109–129 accompanying S. 1317 (Comm. on Health, Edu-
cation, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 151 (2005):
May 24, considered and passed House.
Dec. 16, considered and passed Senate, amended.
Dec. 17, House concurred in Senate amendment.
Administration in developing requirements for the licensing of cord
blood units.
Approved December 20, 2005.
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