1.This Act may be cited as the
Bone Marrow and Cord Blood Therapy and
Research Act of 2005
.
2.
(a)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 Bone Marrow and Cord Blood Cell Transplantation Program and to
carry out the requirements of subsection (b).
(b)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 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(c)(3) of the Public Health Service
Act (42 U.S.C. 274k(c)(3)), as amended by this Act, in a standardized
electronic format, as determined by the Secretary, for the Bone Marrow and Cord
Blood 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)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)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 Bone Marrow and Cord Blood Cell
Transplantation Program in accordance with guidance or regulations promulgated
by the Secretary.
(3)Cord blood units collected through the
program under this section shall not be counted toward the 150,000 inventory
goal under the Bone Marrow and Cord Blood Cell Transplantation Program.
(4)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)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 Bone Marrow and
Cord Blood 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 Bone Marrow and Cord Blood Cell
Transplantation Program in perpetuity; 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(c)(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)
(1)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 Federal
funds provided under any such contract terminate on 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)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)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)The Secretary may promulgate regulations to
carry out this section.
(g)In this section:
(1)The term Bone Marrow and Cord Blood
Cell Transplantation Program means the Bone Marrow and Cord Blood 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(c)(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)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)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)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).
3. Bone Marrow and Cord
Blood Cell Transplantation Program
(a)Section 379 of the
Public Health Service Act (42 U.S.C.
274k) is amended to read as follows:
379.
(a)The Secretary, acting through the
Administrator of the Health Resources and Services Administration, shall by one
or more contracts establish and maintain a Bone Marrow and Cord Blood Cell
Transplantation Program (referred to in this section as the
Program
) 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 (c)
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)1 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 Bone Marrow and Cord Blood Therapy 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)The Secretary shall, through a public
process, recognize one or more accreditation entities for the accreditation of
cord blood banks.
(c)
(1)With respect to
bone marrow, the Program shall—
(A)operate a system for listing, searching,
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 (d), 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 (d);
(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 (g);
(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 (g);
(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 and support research to improve
the availability, efficiency, safety, and cost of transplants from unrelated
donors and the effectiveness of Program operations.
(2)With respect to
cord blood, the Program shall—
(A)operate a system for listing, searching,
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 (g);
(F)coordinate with the qualified cord blood
banks to carry out informational and educational activities in accordance with
subsection (f);
(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; submission of data
(A)The Secretary shall
ensure that health care professionals and patients are able to, at a minimum,
locate, consistent with the functions described in paragraphs (1)(A) and
(2)(A), cells from bone marrow donors and cord blood units through a single
electronic point of access.
(B)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 the 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)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.
(d)Bone marrow
recruitment; priorities; information and education
(1)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)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)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 optionIn
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 subsectionThe
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 (c)(1).
(e)Bone marrow
criteria, standards, and proceduresThe 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 (g), 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.
(f)Cord blood
recruitment; priorities; information and education
(1)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 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)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 optionIn
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 subsectionThe
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 (c)(2).
(g)Patient advocacy
and case management for bone marrow and cord blood
(1)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)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 (c) 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 (c)
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)
(A)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)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.
(h)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.
(i)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.
(j)
(1)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)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.
(k)Entities eligible to receive a contract
under this section shall include private nonprofit entities.
(l)
(1)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)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.
(m)Any person who
discloses the content of any record referred to in subsection (c)(4)(D) or
(e)(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 (e)(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 databaseSection 379A of the
Public Health Service Act (42 U.S.C.
274l) is amended to read as follows:
379A.Stem cell
therapeutic outcomes database
(a)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)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 outcomesThe
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)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)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:
379A–1.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
Bone Marrow and Cord Blood Cell Transplantation Program established under
section
379.
.
(d)Authorization of
appropriationsSection 379B
of the Public Health Service Act (42
U.S.C. 274m) is amended to read as follows:
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)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 BONE MARROW AND CORD BLOOD CELL TRANSPLANTATION
PROGRAM
.
4.Report on licensure of
cord blood unitsNot 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.
1.This Act may be cited as the
Stem Cell Therapeutic and Research Act
of 2005
.
2.
(a)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)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)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)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)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)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)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)
(1)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)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)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)The
Secretary may promulgate regulations to carry out this section.
(g)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)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)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)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).
3. C.W. Bill Young Cell
Transplantation Program
(a)Section 379 of the Public
Health Service Act (42 U.S.C. 274k) is amended to read as
follows:
379.
(a)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)1 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)The
Secretary shall, through a public process, recognize one or more accreditation
entities for the accreditation of cord blood banks.
(c)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)
(1)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)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)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)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)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)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)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)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 optionIn 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
subsectionThe 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 proceduresThe 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)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 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)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 optionIn 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
subsectionThe 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)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)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)
(A)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)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)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)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)
(1)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)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)Entities
eligible to receive a contract under this section shall include private
nonprofit entities.
(m)
(1)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)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)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 databaseSection 379A of the
Public Health Service Act (42 U.S.C.
274l) is amended to read as follows:
379A.Stem cell therapeutic
outcomes database
(a)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)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 outcomesThe 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)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)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:
379A–1.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
appropriationsSection 379B of the Public Health Service Act (42 U.S.C. 274m) is
amended to read as follows:
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)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
.
4.Report on licensure of
cord blood unitsNot 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.
July 11, 2005
Reported with an amendment