I 

111TH CONGRESS 

2D SESSION H. R. 6083 

To amend the Stem Cell Therapeutic and Research Act of 2005. 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 10, 2010 

Mr. SMITH of New Jersey (for himself, Mr. DAVIS of Alabama, Mr. PITTS, 

Mr. LIPINSKI, and Mr. FATTAH) introduced the following bill; which was 

referred to the Committee on Energy and Commerce 

A BILL 

To amend the Stem Cell Therapeutic and Research Act of 

2005. 

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 ‘‘Stem Cell Therapeutic 

5 and Research Reauthorization Act of 2010’’. 

6 SEC. 2. AMENDMENTS TO THE STEM CELL THERAPEUTIC 

7 AND RESEARCH ACT OF 2005. 

8 (a) CORD BLOOD INVENTORY.—Section 2 of the 

9 Stem Cell Therapeutic and Research Act of 2005 (42 

10 U.S.C. 274k note) is amended— 


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1 (1) in subsection (a), by inserting ‘‘at least’’ be2 fore ‘‘150,000’’; 

3 (2) in subsection (c)(3), by inserting ‘‘at least’’ 

4 before ‘‘150,000’’; 

5 (3) in subsection (d)— 

6 (A) in paragraph (2), by striking ‘‘; and’’ 

7 and inserting ‘‘;’’; 

8 (B) by redesignating paragraph (3) as 

9 paragraph (5); and 

10 (C) by inserting after paragraph (2) the 

11 following: 

12 ‘‘(3) will provide a plan to increase cord blood 

13 unit collections at collection sites that exist at the 

14 time of application, assist with the establishment of 

15 new collection sites, or contract with new collection 

16 sites; 

17 ‘‘(4) will annually provide to the Secretary a 

18 plan for, and demonstrate, ongoing measurable 

19 progress toward achieving self-sufficiency of cord 

20 blood unit collection and banking operations; and’’; 

21 (4) in subsection (e)— 

22 (A) in paragraph (1)— 

23 (i) by striking ‘‘10 years’’ and insert24 ing ‘‘a period of at least 10 years begin25 ning on the last date on which the recipiVerDate Mar 15 2010 23:47 Aug 10, 2010 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6083.IH H6083

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1 ent of a contract under this section re2 ceives Federal funds under this section’’; 

3 and 

4 (ii) by striking the second sentence 

5 and inserting ‘‘The Secretary shall ensure 

6 that no Federal funds shall be obligated 

7 under any such contract after the date 

8 that is 5 years after the date on which the 

9 contract is entered into, except as provided 

10 in paragraphs (2) and (3).’’; 

11 (B) in paragraph (2)— 

12 (i) in the matter preceding subpara13 graph (A)— 

14 (I) by striking ‘‘Subject to para15 graph (1)(B), the’’ and inserting 

16 ‘‘The’’; and 

17 (II) by striking ‘‘3’’ and inserting 

18 ‘‘5’’; 

19 (ii) in subparagraph (A)— 

20 (I) by inserting ‘‘at least’’ before 

21 ‘‘150,000’’; and 

22 (II) by striking ‘‘; and’’ and in23 serting ‘‘;’’; 

24 (iii) in subparagraph (B)— 


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1 (I) by inserting ‘‘meeting the re2 quirements under subsection (d)’’ 

3 after ‘‘receive an application for a 

4 contract under this section’’; and 

5 (II) by striking ‘‘or the Sec6 retary’’ and all that follows through 

7 the period at the end and inserting ‘‘; 

8 or’’; and 

9 (iv) by adding at the end the fol10 lowing: 

11 ‘‘(C) the Secretary determines that the 

12 outstanding inventory need cannot be met by 

13 the qualified cord blood banks under contract 

14 under this section.’’; and 

15 (C) by striking paragraph (3) and insert16 ing the following: 

17 ‘‘(3) EXTENSION ELIGIBILITY.—A qualified 

18 cord blood bank shall be eligible for a 5-year exten19 sion of a contract awarded under this section, as de20 scribed in paragraph (2), provided that the qualified 

21 cord blood bank— 

22 ‘‘(A) demonstrates a superior ability to 

23 satisfy the requirements described in subsection 

24 (b) and achieves the overall goals for which the 

25 contract was awarded; 


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1 ‘‘(B) provides a plan for how the qualified 

2 cord blood bank will increase cord blood unit 

3 collections at collection sites that exist at the 

4 time of consideration for such extension of a 

5 contract, assist with the establishment of new 

6 collection sites, or contract with new collection 

7 sites; and 

8 ‘‘(C) annually provides to the Secretary a 

9 plan for, and demonstrates, ongoing measurable 

10 progress toward achieving self-sufficiency of 

11 cord blood unit collection and banking oper12 ations.’’; 

13 (5) in subsection (g)(4), by striking ‘‘or par14 ent’’; and 

15 (6) in subsection (h)— 

16 (A) by striking paragraph (2) and insert17 ing the following: 

18 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

19 There are authorized to be appropriated to the Sec20 retary to carry out the program under this section 

21 $23,000,000 for each of fiscal years 2011 through 

22 2014 and $20,000,000 for fiscal year 2015. Such 

23 funds so appropriated shall remain available until 

24 expended.’’; and 


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1 (B) in paragraph (3), by striking ‘‘in each 

2 of fiscal years 2007 through 2009’’ and insert3 ing ‘‘for fiscal years 2011 through 2015’’. 

4 (b) NATIONAL PROGRAM.—Section 379 of the Public 

5 Health Service Act (42 U.S.C. 274k) is amended— 

6 (1) by striking subsection (a)(6) and inserting 

7 the following: 

8 ‘‘(6) The Secretary, acting through the Advi9 sory Council, shall submit to Congress an annual re10 port on the activities carried out under this sec11 tion.’’; 

12 (2) by striking subsection (d)(2)(D) and insert13 ing the following: 

14 ‘‘(D) support studies and demonstration 

15 and outreach projects for the purpose of in16 creasing cord blood unit donation and collection 

17 from a genetically diverse population, including 

18 exploring novel approaches or incentives, such 

19 as remote or other innovative technological ad20 vances that could be used to collect cord blood 

21 units, to expand the number of cord blood unit 

22 collection sites partnering with cord blood 

23 banks that receive a contract under the Na24 tional Cord Blood Bank Inventory program 


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1 under section 2 of the Stem Cell Therapeutic 

2 and Research Act of 2005;’’; and 

3 (3) by striking subsection (f)(5)(A) and insert4 ing the following: 

5 ‘‘(A) require the establishment of a system 

6 of strict confidentiality to protect the identity 

7 and privacy of patients and donors in accord8 ance with Federal and State law; and’’. 

9 (c) AUTHORIZATION OF APPROPRIATIONS.—Section 

10 379B of the Public Health Service Act (42 U.S.C. 274m) 

11 is amended by striking ‘‘$34,000,000’’ and all that follows 

12 through the period at the end, and inserting ‘‘$30,000,000 

13 for each of fiscal years 2011 through 2014 and 

14 $33,000,000 for fiscal year 2015. Such funds so appro15 priated shall remain available until expended.’’. 

16 (d) REPORT ON CORD BLOOD UNIT DONATION AND

17 COLLECTION.— 

18 (1) IN GENERAL.—Not later than 1 year after 

19 the date of enactment of this Act, the Comptroller 

20 General of the United States shall submit to the 

21 Committee on Health, Education, Labor, and Pen22 sions and the Committee on Appropriations of the 

23 Senate, the Committee on Energy and Commerce 

24 and the Committee on Appropriations of the House 

25 of Representatives, and the Secretary of Health and 


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1 Human Services a report reviewing studies, dem2 onstration programs, and outreach efforts for the 

3 purpose of increasing cord blood unit donation and 

4 collection for the National Cord Blood Inventory to 

5 ensure a high-quality and genetically diverse inven6 tory of cord blood units. 

7 (2) CONTENTS.—The report described in para8 graph (1) shall include a review of such studies, 

9 demonstration programs, and outreach efforts under 

10 section 2 of the Stem Cell Therapeutic and Research 

11 Act of 2005 (42 U.S.C. 274k note) (as amended by 

12 this Act) and section 379 of the Public Health Serv13 ice Act (42 U.S.C. 274k) (as amended by this Act), 

14 including— 

15 (A) a description of the challenges and 

16 barriers to expanding the number of cord blood 

17 unit collection sites, including cost, the impact 

18 of regulatory and administrative requirements, 

19 and the capacity of cord blood banks to main20 tain high-quality units; 

21 (B) remote or other innovative techno22 logical advances that could be used to collect 

23 cord blood units; 

24 (C) appropriate methods for improving 

25 provider education about collecting cord blood 


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1 units for the national inventory and participa2 tion in such collection activities; 

3 (D) estimates of the number of cord blood 

4 unit collection sites necessary to meet the out5 standing national inventory need and the char6 acteristics of such collection sites that would 

7 help increase the genetic diversity and enhance 

8 the quality of cord blood units collected; 

9 (E) best practices for establishing and sus10 taining partnerships for cord blood unit collec11 tion at medical facilities with a high number of 

12 minority births; 

13 (F) potential and proven incentives to en14 courage hospitals to become cord blood unit col15 lection sites and partner with cord blood banks 

16 participating in the National Cord Blood Inven17 tory under section 2 of the Stem Cell Thera18 peutic and Research Act of 2005 and to assist 

19 cord blood banks in expanding the number of 

20 cord blood unit collection sites with which such 

21 cord blood banks partner; and 

22 (G) recommendations about methods cord 

23 blood banks and collection sites could use to 

24 lower costs and improve efficiency of cord blood 


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1 unit collection without decreasing the quality of 

2 the cord blood units collected. 

Æ 


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