II 

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 peerreviewed 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 ‘‘Cord Blood Stem Cell 

5 Act of 2005’’. 
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1 SEC. 2. NATIONAL CORD BLOOD STEM CELL BANK NET2 WORK. 

3 Part H of title III of the Public Health Service Act 

4 (42 U.S.C. 273 et seq.) is amended by inserting after sec5 tion 376 the following: 

6 ‘‘SEC. 376A. NATIONAL CORD BLOOD STEM CELL BANK NET7 WORK. 

8 ‘‘(a) DEFINITIONS.—In this section: 

9 ‘‘(1) ADMINISTRATOR.—The term ‘Adminis10 trator’ means the Administrator of the Health Re11 sources and Services Administration. 

12 ‘‘(2) CORD BLOOD UNIT.—The term ‘cord blood 

13 unit’ means the blood collected from a single pla14 centa and umbilical cord. 

15 ‘‘(3) DONOR.—The term ‘donor’ means a moth16 er who has delivered a baby and consents to donate 

17 the newborn’s blood remaining in the placenta and 

18 umbilical cord. 

19 ‘‘(4) DONOR BANK.—The term ‘donor bank’ 

20 means a qualified cord blood stem cell bank that en21 ters into a contract with the Secretary under sub22 section (b)(1). 

23 ‘‘(5) HUMAN CORD BLOOD STEM CELLS.—The 

24 term ‘human cord blood stem cells’ means 

25 hematopoietic stem cells and any other stem cells 

26 contained in the neonatal blood collected imme-
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1 diately after the birth from the separated placenta 

2 and umbilical cord. 

3 ‘‘(6) NATIONAL CORD BLOOD STEM CELL

4 BANK NETWORK.—The term ‘National Cord Blood 

5 Stem Cell Bank Network’ means a network of quali6 fied cord blood stem cell banks established under 

7 subsection (b). 

8 ‘‘(b) NATIONAL CORD BLOOD STEM CELL BANK

9 NETWORK.— 

10 ‘‘(1) IN GENERAL.—The Secretary, acting 

11 through the Administrator, shall enter into contracts 

12 with qualified cord blood stem cell banks to assist in 

13 the establishment, provision, and maintenance of a 

14 National Cord Blood Stem Cell Bank Network that 

15 contains at least 150,000 units of human cord blood 

16 stem cells. 

17 ‘‘(2) PURPOSE OF DONOR BANKS.—It is the 

18 purpose of the donor banks that are a part of the 

19 Network to— 

20 ‘‘(A) acquire, tissue-type, test, 

21 cryopreserve, and store donated units of human 

22 cord blood acquired with the informed consent 

23 of the donor, in a manner that complies with 

24 applicable Federal regulations; 
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1 ‘‘(B) make cord blood units collected under 

2 this section, or otherwise, available to trans3 plant centers for stem cell transplantation; and 

4 ‘‘(C) allocate up to 10 percent of the cord 

5 blood inventory each year for peer-reviewed re6 search. 

7 ‘‘(3) ELIGIBILITY OF DONOR BANKS.—A cord 

8 blood stem cell bank shall be eligible to be a donor 

9 bank if such a bank— 

10 ‘‘(A) has obtained all applicable Federal 

11 and State licenses, certifications, registrations 

12 (including registration with the Food and Drug 

13 Administration), and other authorizations re14 quired to operate and maintain a cord blood 

15 stem cell bank; 

16 ‘‘(B) has implemented donor screening and 

17 cord blood collection practices adequate to pro18 tect both donors and transplant recipients and 

19 to prevent transmission of potentially harmful 

20 infections and other diseases; 

21 ‘‘(C) has established a system of strict con22 fidentiality to protect the identity and privacy 

23 of patients and donors in accordance with exist24 ing Federal and State law, and consistent with 

25 the regulations promulgated under section 
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1 264(c) of the Health Insurance Portability and 

2 Accountability Act of 1996 for the release of 

3 the identity of donors, recipients, or identifiable 

4 records; 

5 ‘‘(D) has established a system for encour6 aging donation by an ethnically diverse group of 

7 donors; 

8 ‘‘(E) has developed adequate systems for 

9 communication with other cord blood stem cell 

10 banks, transplant centers, and physicians with 

11 respect to the request, release, and distribution 

12 of cord blood units nationally, and has devel13 oped such systems, consistent with the regula14 tions promulgated under section 264(c) of the 

15 Health Insurance Portability and Accountability 

16 Act of 1996, to track recipients’ clinical out17 comes for distributed units; and 

18 ‘‘(F) has developed a system for educating 

19 the public, including patient advocacy organiza20 tions, about the benefits of donating and uti21 lizing cord blood stem cells in appropriate cir22 cumstances. 

23 ‘‘(c) ADMINISTRATION OF THE NETWORK.— 

24 ‘‘(1) BOARD OF DIRECTORS.— 
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1 ‘‘(A) IN GENERAL.—The Secretary shall 

2 provide for the establishment of a Board of Di3 rectors, including a chairperson, who shall ad4 minister the National Cord Blood Stem Cell 

5 Network, including establishing a national cord 

6 blood stem cell registry within the Network and 

7 coordinating the donor banks in the Network. 

8 ‘‘(B) COMPOSITION.— 

9 ‘‘(i) IN GENERAL.—The Board of Di10 rectors shall be composed of members to 

11 be appointed by the Secretary who shall 

12 serve 3-year terms, and shall include rep13 resentatives from— 

14 ‘‘(I) cord blood stem cell trans15 plant centers; 

16 ‘‘(II) physicians from partici17 pating birthing hospitals; 

18 ‘‘(III) the cord blood stem cell re19 search community; 

20 ‘‘(IV) recipients of cord blood 

21 stem cell transplants; 

22 ‘‘(V) patients or family members 

23 of a patient who has requested the as24 sistance of the national cord blood 
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1 stem cell registry in searching for 

2 donor cord blood; 

3 ‘‘(VI) individuals with expertise 

4 in the social sciences; 

5 ‘‘(VII) members of the general 

6 public; 

7 ‘‘(VIII) the Health Resources 

8 and Services Administration, who 

9 shall serve as a nonvoting member; 

10 and 

11 ‘‘(IX) the network donor banks. 

12 ‘‘(ii) TERMS OF SERVICE.—Each 

13 member appointed under clause (i) may 

14 serve up to 2 consecutive 3-year terms, ex15 cept that this clause shall not apply to the 

16 member appointed under subclause (VIII) 

17 of clause (i). 

18 ‘‘(C) CONTINUITY.—In order to ensure the 

19 continuity of the Board of Directors, the Board 

20 shall be appointed so that each year the terms 

of approximately 1 21 ⁄3 of the Board members ex22 pire. A member of the Board may continue to 

23 serve after the expiration of the term of such a 

24 member until a successor is appointed. 
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1 ‘‘(2) NATIONAL CORD BLOOD STEM CELL REG2 ISTRY.— 

3 ‘‘(A) IN GENERAL.—The Secretary, acting 

4 through the Administrator, shall establish as 

5 part of the Network a National Cord Blood 

6 Stem Cell Registry. The Registry shall— 

7 ‘‘(i) operate a system for identifying, 

8 acquiring, and distributing donated units 

9 of cord blood that are suitably matched to 

10 candidate patients; 

11 ‘‘(ii) provide transplant physicians 

12 and other appropriate health care profes13 sionals the ability to search the entire reg14 istry for a suitable donor match for pa15 tients; and 

16 ‘‘(iii) maintain a database to docu17 ment the collection, storage, distribution, 

18 and clinical outcomes related to the Net19 work. 

20 ‘‘(B) DATABASE.—The database main21 tained under subparagraph (A)(iii) shall be op22 erated according to standards of consent, dis23 closure, and confidentiality, including those ap24 plicable under the regulations promulgated 

25 under section 264(c) of the Health Insurance 
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1 Portability and Accountability Act of 1996. The 

2 Administrator, using the database, shall report 

3 to the Secretary on a periodic basis regarding 

4 the safety, efficacy, and cost-effectiveness of the 

5 clinical, research, and educational activities of 

6 the Network. The Secretary shall make such in7 formation available to the public. 

8 ‘‘(3) NETWORK STANDARDS.—The Board of Di9 rectors shall ensure that— 

10 ‘‘(A) the donor banks within the National 

11 Cord Blood Stem Cell Bank Network meet the 

12 requirements of subsection (b)(3); and 

13 ‘‘(B) the National Cord Blood Stem Cell 

14 Bank Network is geographically distributed 

15 throughout the United States. 

16 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

17 carry out this section, there are authorized to be appro18 priated, $15,000,000 for fiscal year 2006, and such sums 

19 as may be necessary for each of fiscal years 2007 through 

20 2010.’’.

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