I
107TH CONGRESS
1ST SESSION
H. R. 2096
To provide for a National Stem Cell Donor Bank regarding qualifying human
stem cells, and for the conduct and support of research using such cells.
IN THE HOUSE OF REPRESENTATIVES
JUNE 7, 2001
Mr. SMITH of New Jersey (for himself, Mr. ADERHOLT, Mr. BACHUS, Mr.
BAKER, Mr. BARCIA, Mr. BLUNT, Mr. BRYANT, Mr. CAMP, Mr.
COSTELLO, Mr. DEMINT, Mr. DOOLITTLE, Mr. GREEN of Wisconsin, Ms.
HART, Mr. HOEKSTRA, Mr. HOLDEN, Mr. LANGEVIN, Mr. LARGENT, Mr.
LEWIS of Kentucky, Mr. LIPINSKI, Mr. PENCE, Mr. PHELPS, Mr. PICK-
ERING, Mr. PITTS, Mr. RAHALL, Mr. ROHRABACHER, Mr. RYUN of Kan-
sas, Mr. SCHROCK, Mr. SHADEGG, Mr. SHIMKUS, Mr. SHOWS, Mr.
SOUDER, Mr. STUMP, Mr. TANCREDO, Mr. TIAHRT, Mr. VITTER, Mr.
WICKER, Mr. THUNE, Mrs. MYRICK, and Mr. STEARNS) introduced the
following bill; which was referred to the Committee on Energy and Com-
merce
A BILL
To provide for a National Stem Cell Donor Bank regarding
qualifying human stem cells, and for the conduct and
support of research using such cells.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Responsible Stem Cell
Research Act of 2001’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Past investments in biomedical research
have resulted in better health, an improved quality
of life for all Americans, and a reduction in national
health care expenditures.
(2) The Nation’s commitment to biomedical re-
search has expanded the base of scientific knowledge
about health and disease and revolutionized the
practice of medicine.
(3) Research sponsored by the National Insti-
tutes of Health is responsible for the identification
of genetic mutations relating to nearly 100 diseases,
including Alzheimer’s disease, cystic fibrosis, Hun-
tington’s disease, osteoporosis, many forms of can-
cer, and immune deficiency disorders.
(4) Many Americans still face serious and life-
threatening health problems, both acute and chronic.
(5) Neurodegenerative diseases of the elderly,
such as Alzheimer’s and Parkinson’s disease, threat-
en to destroy the lives of millions of Americans.
(6) Cancer remains a comprehensive threat to
any tissue or organ of the body at any age, and re-
mains a leading cause of morbidity and mortality.
(7) The extent of psychiatric and neurological
diseases poses considerable challenges in under-
standing the workings of the brain and nervous sys-
tem.
(8) Diabetes, both insulin and noninsulin forms,
afflicts 16 million Americans and places them at risk
for acute and chronic complications, including blind-
ness, kidney failure, atherosclerosis, and nerve de-
generation.
(9) Recent scientific developments show that
human stem cell research based on ethically respon-
sible stem cell sources may lead to exponential im-
provements in the treatment of many terminal and
debilitating conditions, from cancer to Parkinson’s
to Alzheimer’s to diabetes to heart disease.
(10) To take full advantage of the tremendous
potential for finding a cure or effective treatment for
many debilitating diseases, the Federal investment
in ethical stem cell research must be expanded.
SEC. 3. NATIONAL STEM CELL DONOR BANK.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall by contract establish and maintain
a National Stem Cell Donor Bank (in this section referred
to as the ‘‘Donor Bank’’). The purpose of the Donor Bank
shall be to seek and preserve donations of qualifying
human stem cells and to make such donated cells available
for biomedical research and for therapeutic purposes.
(b) QUALIFYING HUMAN STEM CELLS.—For pur-
poses of this Act, the term ‘‘qualifying human stem cells’’
means human stem cells obtained from human placentas,
umbilical cord blood, organs or tissues of a living or de-
ceased human being who has been born, or organs or tis-
sues of unborn human offspring who died of natural
causes (such as spontaneous abortion).
(c) ADMINISTRATION OF DONOR BANK.—The Donor
Bank shall be under the general supervision of the Sec-
retary, and under the direction of a board of directors
meeting such criteria as the Secretary may establish.
(d) PATIENT REGISTRY.—The Donor Bank shall
with respect to qualifying human stem cells—
(1) operate a registry of patients who are trans-
plant candidates;
(2) establish a system for finding donors who
are unrelated to the candidate patients and are suit-
ably matched to the patients; and
(3) carry out informational and educational ac-
tivities.
(e) CRITERIA.—The Secretary shall establish criteria
for the Donor Bank and other entities that participate in
the program under this section, including—
(1) quality standards and standards for tissue
typing and obtaining the informed consent of do-
nors, or the parents or legal representatives of do-
nors as appropriate;
(2) donor selection criteria, based on estab-
lished medical criteria, to protect both donors and
transplant recipients and to prevent the trans-
mission of potentially harmful infectious diseases;
(3) procedures to ensure the proper collection
and transportation of qualifying human stem cells;
and
(4) standards that—
(A) require the establishment of a system
of strict confidentiality of records relating to
the identity and address of and medical infor-
mation on patients and 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.
(f) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2006.
SEC. 4. USE OF QUALIFYING HUMAN STEM CELLS IN RE-
SEARCH CONDUCTED OR SUPPORTED BY NA-
TIONAL INSTITUTES OF HEALTH.
(a) IN GENERAL.—The Secretary, acting through the
Director of the National Institutes of Health, may conduct
and support research that uses qualifying human stem
cells.
(b) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out subsection (a), there are author-
ized to be appropriated $30,000,000 for fiscal year 2002,
and such sums as may be necessary for each of the fiscal
years 2003 through 2006.
SEC. 5. DEFINITIONS.
For purposes of this Act:
(1) The term ‘‘qualifying human stem cells’’
has the meaning given such term in section 3.
(2) The term ‘‘Secretary’’ means the Secretary
of Health and Human Services.
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