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. PICKERING, Mr. PITTS, Mr. RAHALL, Mr. ROHRABACHER, Mr. RYUN of Kansas, 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 Commerce

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’’.
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1 SEC. 2. FINDINGS.

2 The Congress finds as follows:

3 (1) Past investments in biomedical research

4 have resulted in better health, an improved quality

5 of life for all Americans, and a reduction in national

6 health care expenditures.

7 (2) The Nation’s commitment to biomedical re8 search has expanded the base of scientific knowledge

9 about health and disease and revolutionized the

10 practice of medicine.

11 (3) Research sponsored by the National Insti12 tutes of Health is responsible for the identification

13 of genetic mutations relating to nearly 100 diseases,

14 including Alzheimer’s disease, cystic fibrosis, Hun15 tington’s disease, osteoporosis, many forms of can16 cer, and immune deficiency disorders.

17 (4) Many Americans still face serious and life18 threatening health problems, both acute and chronic.

19 (5) Neurodegenerative diseases of the elderly,

20 such as Alzheimer’s and Parkinson’s disease, threat21 en to destroy the lives of millions of Americans.

22 (6) Cancer remains a comprehensive threat to

23 any tissue or organ of the body at any age, and re24 mains a leading cause of morbidity and mortality.

25 (7) The extent of psychiatric and neurological

26 diseases poses considerable challenges in under-
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1 standing the workings of the brain and nervous sys2 tem.

3 (8) Diabetes, both insulin and noninsulin forms,

4 afflicts 16 million Americans and places them at risk

5 for acute and chronic complications, including blind6 ness, kidney failure, atherosclerosis, and nerve de7 generation.

8 (9) Recent scientific developments show that

9 human stem cell research based on ethically respon10 sible stem cell sources may lead to exponential im11 provements in the treatment of many terminal and

12 debilitating conditions, from cancer to Parkinson’s

13 to Alzheimer’s to diabetes to heart disease.

14 (10) To take full advantage of the tremendous

15 potential for finding a cure or effective treatment for

16 many debilitating diseases, the Federal investment

17 in ethical stem cell research must be expanded.

18 SEC. 3. NATIONAL STEM CELL DONOR BANK.

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

20 Human Services shall by contract establish and maintain

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

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

23 shall be to seek and preserve donations of qualifying

24 human stem cells and to make such donated cells available

25 for biomedical research and for therapeutic purposes.
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1 (b) QUALIFYING HUMAN STEM CELLS.—For pur2 poses of this Act, the term ‘‘qualifying human stem cells’’

3 means human stem cells obtained from human placentas,

4 umbilical cord blood, organs or tissues of a living or de5 ceased human being who has been born, or organs or tis6 sues of unborn human offspring who died of natural

7 causes (such as spontaneous abortion).

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

9 Bank shall be under the general supervision of the Sec10 retary, and under the direction of a board of directors

11 meeting such criteria as the Secretary may establish.

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

13 with respect to qualifying human stem cells—

14 (1) operate a registry of patients who are trans15 plant candidates;

16 (2) establish a system for finding donors who

17 are unrelated to the candidate patients and are suit18 ably matched to the patients; and

19 (3) carry out informational and educational ac20 tivities.

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

22 for the Donor Bank and other entities that participate in

23 the program under this section, including—

24 (1) quality standards and standards for tissue

25 typing and obtaining the informed consent of do-
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1 nors, or the parents or legal representatives of do2 nors as appropriate;

3 (2) donor selection criteria, based on estab4 lished medical criteria, to protect both donors and

5 transplant recipients and to prevent the trans6 mission of potentially harmful infectious diseases;

7 (3) procedures to ensure the proper collection

8 and transportation of qualifying human stem cells;

9 and

10 (4) standards that—

11 (A) require the establishment of a system

12 of strict confidentiality of records relating to

13 the identity and address of and medical infor14 mation on patients and donors; and

15 (B) prescribe the purposes for which the

16 records described in subparagraph (A) may be

17 disclosed, and the circumstances and extent of

18 the disclosure.

19 (f) AUTHORIZATION OF APPROPRIATIONS.—For the

20 purpose of carrying out this section, there are authorized

21 to be appropriated such sums as may be necessary for

22 each of the fiscal years 2002 through 2006.
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1 SEC. 4. USE OF QUALIFYING HUMAN STEM CELLS IN RE2 SEARCH CONDUCTED OR SUPPORTED BY NA3 TIONAL INSTITUTES OF HEALTH.

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

5 Director of the National Institutes of Health, may conduct

6 and support research that uses qualifying human stem

7 cells.

8 (b) AUTHORIZATION OF APPROPRIATIONS.—For the

9 purpose of carrying out subsection (a), there are author10 ized to be appropriated $30,000,000 for fiscal year 2002,

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

12 years 2003 through 2006.

13 SEC. 5. DEFINITIONS.

14 For purposes of this Act:

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

16 has the meaning given such term in section 3.

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

18 of Health and Human Services.

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