[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2520 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 2520
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 23, 2005
Mr. Smith of New Jersey (for himself, Mr. Barton of Texas, Mr. Davis of
Alabama, Mr. DeLay, Mr. Deal of Georgia, Mr. Blunt, Mr. Towns, Mr.
Davis of Kentucky, Ms. Foxx, Mr. Shimkus, Mr. Stupak, Mr. Renzi, Mr.
Cantor, Mr. Payne, Mr. Green of Wisconsin, Mr. McIntyre, Mr. Ferguson,
Mr. Norwood, Ms. Millender-McDonald, Mr. Everett, Mr. Kennedy of
Minnesota, Mr. Conyers, Mr. Boustany, Mr. Lipinski, Mr. Aderholt, Mr.
Burgess, Mr. Weldon of Florida, Mr. Pence, Mrs. Myrick, Mr. Ryun of
Kansas, Mr. Pitts, Mr. McCaul of Texas, Mr. Wamp, Mr. Chabot, Mr.
Murphy, Mr. Inglis of South Carolina, Mr. Terry, Mr. Fortenberry, Mr.
Neugebauer, Mr. Stearns, Mr. Walsh, Mr. McCotter, Mr. Fossella, Mrs. Jo
Ann Davis of Virginia, Mr. Hastings of Washington, Mrs. Drake, Ms.
Hart, Mr. Burton of Indiana, Mr. King of New York, Mr. Hayworth, Mr.
Sullivan, Mr. Fitzpatrick of Pennsylvania, Mr. Gutknecht, Mr. Shadegg,
Mr. Akin, Mr. Souder, Mr. Hayes, Mr. Boozman, Mr. Doolittle, Mr. Price
of Georgia, Mr. Meek of Florida, Mr. Kline, Mr. Ford, Mr. Hyde, Mrs.
Musgrave, Mr. Forbes, Mr. Sam Johnson of Texas, Mr. Tancredo, Mr.
Daniel E. Lungren of California, Mr. Marshall, Ms. Eshoo, Mr. Sodrel,
Mr. Putnam, Mr. Cannon, Mr. Lincoln Diaz-Balart of Florida, Mr. Clay,
Ms. Ros-Lehtinen, Mr. McHenry, and Mr. Franks of Arizona) introduced
the following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To provide for the collection and maintenance of human cord blood stem
cells for the treatment of patients and research, and to amend the
Public Health Service Act to authorize the C.W. Bill Young Cell
Transplantation Program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Stem Cell Therapeutic and Research
Act of 2005''.
SEC. 2. CORD BLOOD INVENTORY.
(a) In General.--The Secretary of Health and Human Services shall
enter into one-time contracts with qualified cord blood stem cell banks
to assist in the collection and maintenance of 150,000 units of high-
quality human 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 human cord blood acquired with the informed
consent of the donor in a manner that complies with applicable
Federal and State regulations;
(2) 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 stem cell
transplantation;
(3) to make cord blood units that are collected, but not
appropriate for clinical use, available for peer-reviewed
research;
(4) to submit data in a standardized format, as required by
the Secretary, for the C.W. Bill Young Cell Transplantation
Program; and
(5) to submit data 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) Application.--To seek to enter into a contract under this
section, a qualified cord blood stem cell 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 an assurance that the applicant--
(1) will participate in the C.W. Bill Young Cell
Transplantation Program for a period of at least 10 years; and
(2) in the event of abandonment of this activity prior to
the expiration of such period, will transfer the units
collected pursuant to this section to another qualified cord
blood stem cell bank approved by the Secretary to ensure
continued availability of cord blood units.
(d) Duration of Contracts.--
(1) In general.--The Secretary may not enter into any
contract under this section for a period that--
(A) exceeds 3 years; or
(B) ends after September 30, 2010.
(2) Extensions.--Subject to paragraph (1)(B), the Secretary
may extend the period of a contract under this section to
exceed a period of 3 years if--
(A) the Secretary finds that 150,000 units of high-
quality human 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 stem cell 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 stem cell banks that have submitted an
application for a contract under this section.
(e) Regulations.--The Secretary may promulgate regulations to carry
out this section.
(f) 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 ``human cord blood unit'' means the neonatal
blood collected from the placenta and umbilical cord.
(4) The term ``qualified cord blood stem cell bank'' has
the meaning given to that term in section 379(b) of the Public
Health Service Act, as amended by this Act.
(5) The term ``Secretary'' means the Secretary of Health
and Human Services.
(g) Authorization of Appropriations.--
(1) Fiscal year 2006.--Any amounts appropriated to the
Secretary for fiscal year 2004 or 2005 for the purpose of
assisting in the collection or maintenance of human cord blood
shall remain available to the Secretary until the end of fiscal
year 2006 for the purpose of carrying out this section.
(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.
Amounts appropriated pursuant to this paragraph shall remain
available for obligation through the end of fiscal year 2010.
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--
(1) in the section heading, by striking ``national
registry'' and inserting ``national program'';
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by
striking ``The Secretary shall by contract'' and all
that follows through the end of such matter and
inserting ``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 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 (b) if deemed necessary by the
Secretary to operate an effective and efficient system.
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:'';
(B) in paragraph (1), by striking ``except that''
and all that follows and inserting ``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 group, transplant center,
or cord blood stem cell bank.'';
(C) by amending paragraph (4) to read as follows:
``(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 stem cell banks and
participating birthing hospitals, recipients of a bone
marrow transplant and cord blood transplants, 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 blood stem cell
transplantation including cord blood, persons with
expertise in typing, matching, and transplant outcome
data analysis, persons with expertise in the social
sciences, 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.''; and
(D) by adding at the end the following:
``(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 group,
transplant center, or cord blood stem cell bank from
participating in any decision that materially affects
the center, recruitment group, transplant center, or
cord blood stem cell 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.'';
(3) by amending subsection (b) to read as follows:
``(b) Functions.--
``(1) Bone marrow functions.--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) carry out a program for the recruitment of
bone marrow donors in accordance with subsection (c),
including with respect to increasing the representation
of racial and ethnic minority groups (including persons
of mixed ancestry) in the enrollment of the Program;
``(C) maintain and expand medical emergency
contingency response capabilities in concert with
Federal programs for response to threats of use of
terrorist or military weapons that can damage marrow,
such as ionizing radiation or chemical agents
containing mustard, so that the capability of
supporting patients with marrow damage from disease can
be used to support casualties with marrow damage;
``(D) carry out informational and educational
activities in accordance with subsection (c);
``(E) at least annually update information to
account for changes in the status of individuals as
potential donors of bone marrow;
``(F) provide for a system of patient advocacy
through the office established under subsection (d);
``(G) 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 (which
services shall be provided through a mechanism other
than the system of patient advocacy under subsection
(d)), and conduct surveys of donors and potential
donors to determine the extent of satisfaction with
such services and to identify ways in which the
services can be improved;
``(H) with respect to searches for unrelated donors
of bone marrow that are conducted through the system
under subparagraph (A), collect, analyze, and publish
data 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;
``(I) 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;
``(J) conduct and support research to improve the
availability, efficiency, safety, and cost of
transplants from unrelated donors and the effectiveness
of Program operations; and
``(K) assist qualified cord blood stem cell banks
in the Program in accordance with paragraph (3).
Subsections (c) through (e) apply with respect to each entity
awarded a contract under this section with respect to bone
marrow.
``(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
stem cell bank;
``(B) allow transplant physicians, other
appropriate health care professionals, and patients to
search by means of electronic access all available cord
blood units listed in the Program;
``(C) allow transplant physicians and other
appropriate health care professionals to tentatively
reserve 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; and
``(E) coordinate with the Secretary to carry out
information and educational activities for the purpose
of increasing cord blood donation and promoting the
availability of cord blood units as a transplant
option.
``(3) Single point of access.--If the Secretary enters into
a contract with more than one entity to perform the functions
outlined in this subsection, the Secretary shall establish
procedures to ensure that health care professionals and
patients are able to obtain, consistent with the functions
described in paragraphs (1)(A) and (2)(A), cells from adult
donors and cord blood units through a single point of access.
``(4) Definition.--The term `qualified cord blood stem cell
bank' means a cord blood stem cell 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 stem cell 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 body
recognized pursuant to a public process by the
Secretary;
``(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; and
``(E) has established a system for encouraging
donation by a genetically diverse group of donors.'';
(4) in subsection (c)--
(A) in paragraph (1), by striking ``The Registry
shall carry out a program for the recruitment'' and
inserting ``With respect to bone marrow, the Program
shall carry out a program for the recruitment'';
(B) in paragraph (2)(A)--
(i) in the matter preceding clause (i), by
striking the first sentence and inserting ``In
carrying out the program under paragraph (1),
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 donors.''; and
(ii) in clause (ii), by striking ``,
including providing updates''; and
(C) in paragraph (3), by striking ``the
availability, as a potential treatment option, of
receiving a transplant of bone marrow from an unrelated
donor'' and inserting ``transplants from unrelated
donors as a treatment option and resources for
identifying and evaluating other therapeutic
alternatives'';
(5) in subsection (d)--
(A) in paragraph (1), by striking ``The Registry
shall'' and inserting ``With respect to bone marrow,
the Program shall'';
(B) in paragraph (2)(C), by inserting ``and assist
with information regarding third party payor matters''
after ``ongoing search for a donor'';
(C) in subparagraphs (C), (D), and (E) of paragraph
(2), by striking the term ``subsection (b)(1)'' each
place such term appears and inserting ``subsection
(b)(1)(A)'';
(D) in paragraph (2)(F)--
(i) by redesignating clause (v) as clause
(vi); and
(ii) by inserting after clause (iv) the
following:
``(v) Information concerning issues that
patients may face after a transplant regarding
continuity of care and quality of life.''; and
(E) in paragraph (3)(B), by striking ``Office may''
and inserting ``Office shall'';
(6) in the matter preceding paragraph (1) in subsection
(e), by striking ``the Secretary shall'' and inserting ``with
respect to bone marrow, the Secretary shall'';
(7) by amending subsection (f) to read as follows:
``(f) 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.'';
(8) by amending subsection (g) to read as follows:
``(g) 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.'';
(9) in subsection (h)--
(A) by striking ``Application.--'' and inserting
``Contracts.--'';
(B) by striking ``To be eligible'' and inserting
the following:
``(1) Application.--To be eligible''; and
(C) by adding at the end the following:
``(2) Considerations.--In awarding contracts under this
section, the Secretary shall give substantial weight to the
continued safety of donors and patients and other factors
deemed appropriate by the Secretary.''; and
(10) by striking subsection (l).
(b) Stem Cell Therapeutic Outcomes Database.--Section 379A of the
Public Health Service Act (42 U.S.C. 274l) is amended to read as
follows:
``SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATABASE.
``(a) Establishment.--The Secretary shall by contract establish and
maintain a scientific database of information relating to patients who
have been recipients of stem cell therapeutics product (including bone
marrow, cord blood, or other such product) from a biologically
unrelated donor.
``(b) Information.--The outcomes database shall include information
with respect to patients described in subsection (a), transplant
procedures, 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 bone marrow
from biologically unrelated donors and recipients of a stem cell
therapeutics product.
``(c) Annual Report on Patient Outcomes.--The Secretary shall
require the entity awarded a contract under this section to submit to
the Secretary an annual report concerning patient outcomes with respect
to each transplant center, based on data collected and maintained by
the entity pursuant to this section.
``(d) Publicly Available Data.--The outcomes database shall make
relevant scientific information not containing individually
identifiable information available to the public in the form of
summaries and data sets to encourage medical research and to provide
information to transplant programs, physicians, patients, entities
awarded a contract under section 379 donor registries, and cord blood
stem cell banks.''.
(c) Definitions.--Part I of title III of the Public Health Service
Act (42 U.S.C. 274k et seq.) is amended by inserting after section 379A
the following:
``SEC. 379A-1. DEFINITIONS.
``In this part:
``(1) The term `Advisory Council' means the advisory
council established by the Secretary under section 379(a)(1).
``(2) The term `bone marrow' means the cells found in adult
bone marrow and peripheral blood.
``(3) The term `outcomes database' means the database
established by the Secretary under section 379A.
``(4) The term `Program' means the C.W. Bill Young Cell
Transplantation Program established under section 379.''.
(d) Authorization of Appropriations.--Section 379B of the Public
Health Service Act (42 U.S.C. 274m) is amended to read as follows:
``SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.
``(a) In General.--For the purpose of carrying out this part, there
are authorized to be appropriated $28,000,000 for fiscal year 2006 and
$32,000,000 for each of fiscal years 2007 through 2010.
``(b) Emergency Contingency Response Capabilities.--In addition to
the amounts authorized to be appropriated under subsection (a), there
is authorized to be appropriated $2,000,000 for the maintenance and
expansion of emergency contingency response capabilities under section
379(b)(1)(C).''.
(e) Conforming Amendments.--Part I of title III of the Public
Health Service Act (42 U.S.C. 274k et seq.) is amended--
(1) in the title heading, by striking ``NATIONAL BONE
MARROW DONOR REGISTRY'' and inserting ``C.W. BILL YOUNG CELL
TRANSPLANTATION PROGRAM''; and
(2) in section 379, as amended by this section--
(A) in subsection (a), by striking the term
``board'' each place such term appears and inserting
``Advisory Council'';
(B) in subection (c)--
(i) in the matter preceding subparagraph
(A) in paragraph (1), by striking ``Such
program'' and inserting ``Such recruitment
program'';
(ii) in paragraph (2), by striking
``program under paragraph (1)'' and inserting
``recruitment program under paragraph (1)'';
and
(iii) in paragraph (3), by striking
``program under paragraph (1)'' and inserting
``recruitment program under paragraph (1)'';
(C) in subsection (d)(2)(E), by striking ``Registry
program'' and inserting ``Program'';
(D) in subsection (e)--
(i) in the matter preceding paragraph (1),
by striking ``participating in the program,
including the Registry,'' and inserting
``participating in the Program, including'';
and
(ii) in paragraph (6), by striking ``the
program'' and inserting ``the Program''; and
(E) by striking the term ``Registry'' each place
such term appears and inserting ``Program''.
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