[109th Congress Public Law 129]
[From the U.S. Government Printing Office]
[DOCID: f:publ129.109]
[[Page 2549]]
STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005
[[Page 119 STAT. 2550]]
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. <<NOTE: Dec. 20, 2005 - [H.R. 2520]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Stem Cell
Therapeutic and Research Act of 2005.>>
SECTION 1. <<NOTE: 42 USC 201 note.>> SHORT TITLE.
This Act may be cited as the ``Stem Cell Therapeutic and Research
Act of 2005''.
SEC. 2. <<NOTE: 42 USC 274k note.>> CORD BLOOD INVENTORY.
(a) <<NOTE: Contracts.>> 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) <<NOTE: Records.>> 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) <<NOTE: Records.>> 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.--
[[Page 119 STAT. 2551]]
(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) <<NOTE: Regulations.>> 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--
[[Page 119 STAT. 2552]]
(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).
[[Page 119 STAT. 2553]]
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) <<NOTE: Contracts.>> 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
[[Page 119 STAT. 2554]]
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) <<NOTE: Reports.>> 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) <<NOTE: Deadline.>> 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
[[Page 119 STAT. 2555]]
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) <<NOTE: Records.>> 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;
[[Page 119 STAT. 2556]]
``(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) <<NOTE: Publication. Records.>> 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;
[[Page 119 STAT. 2557]]
``(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) <<NOTE: Minorities.>> 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).
[[Page 119 STAT. 2558]]
``(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) <<NOTE: Records.>> standards that--
``(A) <<NOTE: Confidentiality.>> 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) <<NOTE: Minorities.>> 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
[[Page 119 STAT. 2559]]
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) <<NOTE: Establishment.>> 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
[[Page 119 STAT. 2560]]
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) <<NOTE: Surveys.>> 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) <<NOTE: Public information.>> 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.
[[Page 119 STAT. 2561]]
``(k) Contracts.--
``(1) <<NOTE: Regulations.>> 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) <<NOTE: Contracts.>> 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.
[[Page 119 STAT. 2562]]
``(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. <<NOTE: 42 USC 274l-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, <<NOTE: 42 USC prec. 274k.>> 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
[[Page 119 STAT. 2563]]
Administration in developing requirements for the licensing of cord
blood units.
Approved December 20, 2005.
LEGISLATIVE HISTORY--H.R. 2520 (S. 1317):
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SENATE REPORTS: No. 109-129 accompanying S. 1317 (Comm. on Health,
Education, 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.
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