[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2520 Enrolled Bill (ENR)]
H.R.2520
One Hundred Ninth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the fourth day of January, two thousand and five
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
population;
(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 Secretary, 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 maintained
under section 379A of the Public Health Service Act, as amended by
this Act.
(c) Related Cord Blood Donors.--
(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, malignancies, metabolic
storage disorders, hemoglobinopathies, and congenital
immunodeficiencies) at no cost to such family. Qualified 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 assurances
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 recommendations 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
Transplantation 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 Transplantation
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 contract after the earlier
of--
(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 outstanding
inventory need cannot be met by the one or more qualified cord
blood banks that have submitted an application 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 demonstrated 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 Program''
means the C.W. Bill Young Cell Transplantation Program 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 separation from
the newborn baby.
(3) The term ``cord blood unit'' means the neonatal blood
collected from the placenta and umbilical cord of a single newborn
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).
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 transplants for recipients
suitably matched to biologically unrelated donors of bone marrow and
cord blood, and that meets the requirements 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 recommendations 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, representatives of cord
blood banks and participating birthing hospitals, recipients of
a bone marrow transplant, recipients 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 marrow and cord blood transplantation,
persons with expertise in typing, matching, and transplant
outcome data analysis, 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 representatives
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 decision 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 factors
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
accreditation 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
subsection (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 marrow, 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 available
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 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 programs, to prepare
for and respond effectively 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 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 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
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
individuals 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 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 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 regulations) 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 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 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 programs, to prepare
for and respond effectively 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 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;
``(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
underrepresented among potential donors enrolled with the Program.
In the case of populations that are identified under the preceding
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 recruitment; 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 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.
``(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).
``(f) Bone Marrow Criteria, Standards, and Procedures.--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 recipient 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 advocacy operated
under subsection (h), including standards requiring the provision
of appropriate information (at the start of the search process and
throughout the process) to patients and their families 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 subparagraph (A) with respect to
such populations.
``(2) Information and education regarding recruitment; testing
and donation.--
``(A) In general.--In carrying out the recruitment program
under paragraph (1), the Program shall support informational
and educational activities in coordination 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 pregnant
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 pregnant
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 maintain,
through a contract or other means determined 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 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 conduct, 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 subsection
(d) to determine whether the search needs of the 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 information
regarding the progress being made in the search.
``(ii) Informing the patient (or such other individual)
if the search has been interrupted or discontinued.
``(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 determines
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-transplant 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 persons
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 Program,
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.
``(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 appropriate
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
subcontract 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 imprisoned 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 procedures, 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.
``(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
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 Administration in
developing requirements for the licensing of cord blood units.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.