II

107TH CONGRESS

1ST SESSION S. 1349

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 SENATE OF THE UNITED STATES

AUGUST 3, 2001

Mr. ENSIGN (for himself and Mr. BROWNBACK) introduced the following bill;

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Responsible Stem Cell

5 Research Act of 2001’’.

6 SEC. 2. FINDINGS.

7 The Congress finds as follows:

8 (1) Past investments in biomedical research

9 have resulted in better health, an improved quality
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1 of life for all Americans, and a reduction in national

2 health care expenditures.

3 (2) The Nation’s commitment to biomedical re4 search has expanded the base of scientific knowledge

5 about health and disease and revolutionized the

6 practice of medicine.

7 (3) Research sponsored by the National Insti8 tutes of Health is responsible for the identification

9 of genetic mutations relating to nearly 100 diseases,

10 including Alzheimer’s disease, cystic fibrosis, Hun11 tington’s disease, osteoporosis, many forms of can12 cer, and immune deficiency disorders.

13 (4) Many Americans still face serious and life14 threatening health problems, both acute and chronic.

15 (5) Neurodegenerative diseases of the elderly,

16 such as Alzheimer’s and Parkinson’s disease, threat17 en to destroy the lives of millions of Americans.

18 (6) Cancer remains a comprehensive threat to

19 any tissue or organ of the body at any age, and re20 mains a leading cause of morbidity and mortality.

21 (7) The extent of psychiatric and neurological

22 diseases poses considerable challenges in under23 standing the workings of the brain and nervous sys24 tem.
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1 (8) Diabetes, both insulin and noninsulin forms,

2 afflicts 16 million Americans and places them at risk

3 for acute and chronic complications, including blind4 ness, kidney failure, atherosclerosis, and nerve de5 generation.

6 (9) Recent scientific developments show that

7 human stem cell research based on ethically respon8 sible stem cell sources may lead to exponential im9 provements in the treatment of many terminal and

10 debilitating conditions, from cancer to Parkinson’s

11 to Alzheimer’s to diabetes to heart disease.

12 (10) To take full advantage of the tremendous

13 potential for finding a cure or effective treatment for

14 many debilitating diseases, the Federal investment

15 in ethical stem cell research must be expanded.

16 SEC. 3. NATIONAL STEM CELL DONOR BANK.

17 (a) IN GENERAL.—The Secretary of Health and

18 Human Services shall by contract establish and maintain

19 a National Stem Cell Donor Bank (in this section referred

20 to as the ‘‘Donor Bank’’). The purpose of the Donor Bank

21 shall be to seek and preserve donations of qualifying

22 human stem cells and to make such donated cells available

23 for biomedical research and for therapeutic purposes.

24 (b) QUALIFYING HUMAN STEM CELLS.—For pur25 poses of this Act, the term ‘‘qualifying human stem cells’’
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1 means human stem cells obtained from human placentas,

2 umbilical cord blood, organs or tissues of a living or de3 ceased human being who has been born, or organs or tis4 sues of unborn human offspring who died of natural

5 causes (such as spontaneous abortion).

6 (c) ADMINISTRATION OF DONOR BANK.—The Donor

7 Bank shall be under the general supervision of the Sec8 retary, and under the direction of a board of directors

9 meeting such criteria as the Secretary may establish.

10 (d) PATIENT REGISTRY.—The Donor Bank shall

11 with respect to qualifying human stem cells—

12 (1) operate a registry of patients who are trans13 plant candidates;

14 (2) establish a system for finding donors who

15 are unrelated to the candidate patients and are suit16 ably matched to the patients; and

17 (3) carry out informational and educational ac18 tivities.

19 (e) CRITERIA.—The Secretary shall establish criteria

20 for the Donor Bank and other entities that participate in

21 the program under this section, including—

22 (1) quality standards and standards for tissue

23 typing and obtaining the informed consent of do24 nors, or the parents or legal representatives of do25 nors as appropriate;
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1 (2) donor selection criteria, based on estab2 lished medical criteria, to protect both donors and

3 transplant recipients and to prevent the trans4 mission of potentially harmful infectious diseases;

5 (3) procedures to ensure the proper collection

6 and transportation of qualifying human stem cells;

7 and

8 (4) standards that—

9 (A) require the establishment of a system

10 of strict confidentiality of records relating to

11 the identity and address of and medical infor12 mation on patients and donors; and

13 (B) prescribe the purposes for which the

14 records described in subparagraph (A) may be

15 disclosed, and the circumstances and extent of

16 the disclosure.

17 (f) AUTHORIZATION OF APPROPRIATIONS.—For the

18 purpose of carrying out this section, there are authorized

19 to be appropriated such sums as may be necessary for

20 each of the fiscal years 2002 through 2006.

21 SEC. 4. USE OF QUALIFYING HUMAN STEM CELLS IN RE22 SEARCH CONDUCTED OR SUPPORTED BY NA23 TIONAL INSTITUTES OF HEALTH.

24 (a) IN GENERAL.—The Secretary, acting through the

25 Director of the National Institutes of Health, may conduct
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1 and support research that uses qualifying human stem

2 cells.

3 (b) AUTHORIZATION OF APPROPRIATIONS.—For the

4 purpose of carrying out subsection (a), there are author5 ized to be appropriated $275,000,000 for fiscal year 2002,

6 and such sums as may be necessary for each of the fiscal

7 years 2003 through 2006.

8 SEC. 5. DEFINITIONS.

9 For purposes of this Act:

10 (1) The term ‘‘qualifying human stem cells’’

11 has the meaning given such term in section 3.

12 (2) The term ‘‘Secretary’’ means the Secretary

13 of Health and Human Services.

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