Cord Blood Stem Cell Act of 2005 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to enter into contracts with qualified cord blood stem cell banks to assist in establishing and maintaining a National Cord Blood Stem Cell Bank Network to: (1) acquire, tissue-type, test, cryopreserve, and store donated units of human cord blood acquired with the informed consent of the donor; (2) make cord blood units available to transplant centers for stem cell transplantations; and (3) allocate up to 10 percent of the cord blood inventory each year for peer-reviewed research. Requires the Secretary to provide for the establishment of a Board of Directors to administer the Network.
Directs the Secretary, acting through the Administrator, to establish as part of the Network a National Cord Blood Stem Cell Registry to: (1) operate a system for identifying, acquiring, and distributing donated units of cord blood; (2) provide health care professionals with the ability to search the registry for suitable matches for patients; and (3) maintain a database to document the collection, storage, distribution, and clinical outcomes related to the Network.
Requires the Administrator to report to the Secretary regarding the safety, efficacy, and cost-effectiveness of the clinical, research, and education activities of the Network.
Requires the Board to ensure that: (1) the Network donor banks meet eligibility requirements; and (2) the Network is geographically distributed throughout the United States.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 681 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 681
To amend the Public Health Service Act to establish a National Cord
Blood Stem Cell Bank Network to prepare, store, and distribute human
umbilical cord blood stem cells for the treatment of patients and to
support peer-reviewed research using such cells.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 17, 2005
Mr. Hatch (for himself, Mr. Dodd, Mr. Brownback, Mr. Harkin, and Mr.
Specter) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to establish a National Cord
Blood Stem Cell Bank Network to prepare, store, and distribute human
umbilical cord blood stem cells for the treatment of patients and to
support peer-reviewed research using such cells.
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 ``Cord Blood Stem Cell Act of 2005''.
SEC. 2. NATIONAL CORD BLOOD STEM CELL BANK NETWORK.
Part H of title III of the Public Health Service Act (42 U.S.C. 273
et seq.) is amended by inserting after section 376 the following:
``SEC. 376A. NATIONAL CORD BLOOD STEM CELL BANK NETWORK.
``(a) Definitions.--In this section:
``(1) Administrator.--The term `Administrator' means the
Administrator of the Health Resources and Services
Administration.
``(2) Cord blood unit.--The term `cord blood unit' means
the blood collected from a single placenta and umbilical cord.
``(3) Donor.--The term `donor' means a mother who has
delivered a baby and consents to donate the newborn's blood
remaining in the placenta and umbilical cord.
``(4) Donor bank.--The term `donor bank' means a qualified
cord blood stem cell bank that enters into a contract with the
Secretary under subsection (b)(1).
``(5) Human cord blood stem cells.--The term `human cord
blood stem cells' means hematopoietic stem cells and any other
stem cells contained in the neonatal blood collected
immediately after the birth from the separated placenta and
umbilical cord.
``(6) National Cord Blood Stem Cell Bank Network.--The term
`National Cord Blood Stem Cell Bank Network' means a network of
qualified cord blood stem cell banks established under
subsection (b).
``(b) National Cord Blood Stem Cell Bank Network.--
``(1) In general.--The Secretary, acting through the
Administrator, shall enter into contracts with qualified cord
blood stem cell banks to assist in the establishment,
provision, and maintenance of a National Cord Blood Stem Cell
Bank Network that contains at least 150,000 units of human cord
blood stem cells.
``(2) Purpose of donor banks.--It is the purpose of the
donor banks that are a part of the Network to--
``(A) 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 regulations;
``(B) make cord blood units collected under this
section, or otherwise, available to transplant centers
for stem cell transplantation; and
``(C) allocate up to 10 percent of the cord blood
inventory each year for peer-reviewed research.
``(3) Eligibility of donor banks.--A cord blood stem cell
bank shall be eligible to be a donor bank if such a bank--
``(A) has obtained all applicable Federal and State
licenses, certifications, registrations (including
registration with the Food and Drug Administration),
and other authorizations required to operate and
maintain a cord blood stem cell bank;
``(B) has implemented donor screening and cord
blood collection practices adequate to protect both
donors and transplant recipients and to prevent
transmission of potentially harmful infections and
other diseases;
``(C) 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 consistent with the regulations
promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996
for the release of the identity of donors, recipients,
or identifiable records;
``(D) has established a system for encouraging
donation by an ethnically diverse group of donors;
``(E) has developed adequate systems for
communication with other cord blood stem cell banks,
transplant centers, and physicians with respect to the
request, release, and distribution of cord blood units
nationally, and has developed such systems, consistent
with the regulations promulgated under section 264(c)
of the Health Insurance Portability and Accountability
Act of 1996, to track recipients' clinical outcomes for
distributed units; and
``(F) has developed a system for educating the
public, including patient advocacy organizations, about
the benefits of donating and utilizing cord blood stem
cells in appropriate circumstances.
``(c) Administration of the Network.--
``(1) Board of directors.--
``(A) In general.--The Secretary shall provide for
the establishment of a Board of Directors, including a
chairperson, who shall administer the National Cord
Blood Stem Cell Network, including establishing a
national cord blood stem cell registry within the
Network and coordinating the donor banks in the
Network.
``(B) Composition.--
``(i) In general.--The Board of Directors
shall be composed of members to be appointed by
the Secretary who shall serve 3-year terms, and
shall include representatives from--
``(I) cord blood stem cell
transplant centers;
``(II) physicians from
participating birthing hospitals;
``(III) the cord blood stem cell
research community;
``(IV) recipients of cord blood
stem cell transplants;
``(V) patients or family members of
a patient who has requested the
assistance of the national cord blood
stem cell registry in searching for
donor cord blood;
``(VI) individuals with expertise
in the social sciences;
``(VII) members of the general
public;
``(VIII) the Health Resources and
Services Administration, who shall
serve as a nonvoting member; and
``(IX) the network donor banks.
``(ii) Terms of service.--Each member
appointed under clause (i) may serve up to 2
consecutive 3-year terms, except that this
clause shall not apply to the member appointed
under subclause (VIII) of clause (i).
``(C) Continuity.--In order to ensure the
continuity of the Board of Directors, the Board shall
be appointed so that each year the terms of
approximately \1/3\ of the Board members expire. A
member of the Board may continue to serve after the
expiration of the term of such a member until a
successor is appointed.
``(2) National cord blood stem cell registry.--
``(A) In general.--The Secretary, acting through
the Administrator, shall establish as part of the
Network a National Cord Blood Stem Cell Registry. The
Registry shall--
``(i) operate a system for identifying,
acquiring, and distributing donated units of
cord blood that are suitably matched to
candidate patients;
``(ii) provide transplant physicians and
other appropriate health care professionals the
ability to search the entire registry for a
suitable donor match for patients; and
``(iii) maintain a database to document the
collection, storage, distribution, and clinical
outcomes related to the Network.
``(B) Database.--The database maintained under
subparagraph (A)(iii) shall be operated according to
standards of consent, disclosure, and confidentiality,
including those applicable under the regulations
promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996.
The Administrator, using the database, shall report to
the Secretary on a periodic basis regarding the safety,
efficacy, and cost-effectiveness of the clinical,
research, and educational activities of the Network.
The Secretary shall make such information available to
the public.
``(3) Network standards.--The Board of Directors shall
ensure that--
``(A) the donor banks within the National Cord
Blood Stem Cell Bank Network meet the requirements of
subsection (b)(3); and
``(B) the National Cord Blood Stem Cell Bank
Network is geographically distributed throughout the
United States.
``(d) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated, $15,000,000 for fiscal year
2006, and such sums as may be necessary for each of fiscal years 2007
through 2010.''.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S3060-3061)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line