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Union Calendar No. 383 

111TH CONGRESS 

2D SESSION H. R. 6081 

[Report No. 111–643] 

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

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 9, 2010 

Mr. YOUNG of Florida (for himself and Ms. MATSUI) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

SEPTEMBER 28, 2010 

Additional sponsors: Mr. HIMES, Ms. RICHARDSON, Mr. JACKSON of Illinois, 

Mr. OBERSTAR, Mrs. CAPPS, Ms. EDDIE BERNICE JOHNSON of Texas, 

Mr. WEINER, Mr. COHEN, and Mr. ELLISON

SEPTEMBER 28, 2010 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on August 9, 2010] 


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A BILL 

To amend the Stem Cell Therapeutic and Research Act of 

2005. 


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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 Stem 

9 Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k 

10 note) is amended— 

11 (1) in subsection (a), by inserting ‘‘the inventory 

12 goal of at least’’ before ‘‘150,000’’; 

13 (2) in subsection (c)— 

14 (A) in paragraph (2), by striking ‘‘or is 

15 transferred’’ and all that follows through the pe16 riod and inserting ‘‘for a first-degree relative.’’; 

17 and 

18 (B) in paragraph (3), by striking 

19 ‘‘150,000’’; 

20 (3) in subsection (d)— 

21 (A) in paragraph (1), by inserting ‘‘begin22 ning on the last date on which the recipient of 

23 a contract under this section receives Federal 

24 funds under this section’’ after ‘‘10 years’’; 


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1 (B) in paragraph (2), by striking ‘‘; and’’ 

2 and inserting ‘‘;’’; 

3 (C) by redesignating paragraph (3) as 

4 paragraph (5); and 

5 (D) by inserting after paragraph (2) the fol6 lowing: 

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

8 unit collections at collection sites that exist at the 

9 time of application, assist with the establishment of 

10 new collection sites, or contract with new collection 

11 sites; 

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

13 plan for, and demonstrate, ongoing measurable 

14 progress toward achieving self-sufficiency of cord 

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

16 (4) in subsection (e)— 

17 (A) in paragraph (1)— 

18 (i) by striking ‘‘10 years’’ and insert19 ing ‘‘a period of at least 10 years beginning 

20 on the last date on which the recipient of a 

21 contract under this section receives Federal 

22 funds under this section’’; and 

23 (ii) by striking the second sentence and 

24 inserting ‘‘The Secretary shall ensure that 

25 no Federal funds shall be obligated under 


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1 any such contract after the date that is 5 

2 years after the date on which the contract is 

3 entered into, except as provided in para4 graphs (2) and (3).’’; 

5 (B) in paragraph (2)— 

6 (i) in the matter preceding subpara7 graph (A)— 

8 (I) by striking ‘‘Subject to para9 graph (1)(B), the’’ and inserting 

10 ‘‘The’’; and 

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

12 ‘‘5’’; 

13 (ii) in subparagraph (A) by striking 

14 ‘‘150,000’’ and all that follows through 

15 ‘‘and’’ at the end and inserting ‘‘the inven16 tory goal described in subsection (a) has not 

17 yet been met;’’; 

18 (iii) in subparagraph (B)— 

19 (I) by inserting ‘‘meeting the re20 quirements under subsection (d)’’ after 

21 ‘‘receive an application for a contract 

22 under this section’’; and 

23 (II) by striking ‘‘or the Secretary’’ 

24 and all that follows through the period 

25 at the end and inserting ‘‘; or’’; and 


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1 (iv) by adding at the end the following: 

2 ‘‘(C) the Secretary determines that the out3 standing inventory need cannot be met by the 

4 qualified cord blood banks under contract under 

5 this section.’’; and 

6 (C) by striking paragraph (3) and inserting 

7 the following: 

8 ‘‘(3) EXTENSION ELIGIBILITY.—A qualified cord 

9 blood bank shall be eligible for a 5-year extension of 

10 a contract awarded under this section, as described in 

11 paragraph (2), provided that the qualified cord blood 

12 bank— 

13 ‘‘(A) demonstrates a superior ability to sat14 isfy the requirements described in subsection (b) 

15 and achieves the overall goals for which the con16 tract was awarded; 

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

18 cord blood bank will increase cord blood unit col19 lections at collection sites that exist at the time 

20 of consideration for such extension of a contract, 

21 assist with the establishment of new collection 

22 sites, or contract with new collection sites; and 

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

24 plan for, and demonstrates, ongoing measurable 


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1 progress toward achieving self-sufficiency of cord 

2 blood unit collection and banking operations.’’; 

3 (5) in subsection (g)(4), by striking ‘‘or parent’’; 

4 and 

5 (6) in subsection (h)— 

6 (A) by striking paragraphs (1) and (2) and 

7 inserting the following: 

8 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.— 

9 There are authorized to be appropriated to the Sec10 retary to carry out the program under this section 

11 $23,000,000 for each of fiscal years 2011 through 

12 2014 and $20,000,000 for fiscal year 2015.’’; 

13 (B) by redesignating paragraph (3) as 

14 paragraph (2); and 

15 (C) in paragraph (2), as so redesignated, by 

16 striking ‘‘in each of fiscal years 2007 through 

17 2009’’ and inserting ‘‘for each of fiscal years 

18 2011 through 2015’’. 

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

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

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

22 the following: 

23 ‘‘(6) The Secretary, acting through the Adminis24 trator of the Health Resources and Services AdminisVerDate Mar 15 2010 22:34 Sep 28, 2010 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\H6081.RH H6081

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1 tration, shall submit to Congress an annual report on 

2 the activities carried out under this section.’’; 

3 (2) in subsection (d)— 

4 (A) in paragraph (2)— 

5 (i) in the matter preceding subpara6 graph (A), by striking ‘‘With respect to cord 

7 blood, the Program shall—’’ and inserting 

8 the following: 

9 ‘‘(A) IN GENERAL.—With respect to cord 

10 blood, the Program shall—’’; 

11 (ii) by redesignating subparagraphs 

12 (A) through (H) as clauses (i) through (viii) 

13 respectively (with appropriate indentation); 

14 (iii) by striking clause (iv), as so re15 designated, and inserting the following: 

16 ‘‘(iv) support and expand new and ex17 isting studies and demonstration and out18 reach projects for the purpose of increasing 

19 cord blood unit donation and collection 

20 from a genetically diverse population and 

21 expanding the number of cord blood unit 

22 collection sites partnering with cord blood 

23 banks receiving a contract under the Na24 tional Cord Blood Inventory program under 

25 section 2 of the Stem Cell Therapeutic and 


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1 Research Act of 2005, including such studies 

2 and projects that focus on— 

3 ‘‘(I) remote collection of cord 

4 blood units, consistent with the re5 quirements under the Program and the 

6 National Cord Blood Inventory pro7 gram goal described in section 2(a) of 

8 the Stem Cell Therapeutic and Re9 search Act of 2005; and 

10 ‘‘(II) exploring novel approaches 

11 or incentives to encourage innovative 

12 technological advances that could be 

13 used to collect cord blood units, con14 sistent with the requirements under the 

15 Program and such National Cord 

16 Blood Inventory program goal;’’; and 

17 (iv) by adding at the end the following: 

18 ‘‘(B) EFFORTS TO INCREASE COLLECTION

19 OF HIGH QUALITY CORD BLOOD UNITS.—In car20 rying out subparagraph (A)(iv), not later than 1 

21 year after the date of enactment of the Stem Cell 

22 Therapeutic and Research Reauthorization Act 

23 of 2010 and annually thereafter, the Secretary 

24 shall set an annual goal of increasing collections 

25 of high quality cord blood units, consistent with 


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1 the inventory goal described in section 2(a) of 

2 the Stem Cell Therapeutic and Research Act of 

3 2005 (referred to in this subparagraph as the 

4 ‘inventory goal’), and shall identify at least one 

5 project under subparagraph (A)(iv) to replicate 

6 and expand nationwide, as appropriate. If the 

7 Secretary cannot identify a project as described 

8 in the preceding sentence, the Secretary shall 

9 submit a plan, not later than 180 days after the 

10 date on which the Secretary was required to 

11 identify such a project, to the Committee on 

12 Health, Education, Labor, and Pensions of the 

13 Senate and the Committee on Energy and Com14 merce of the House of Representatives for ex15 panding remote collection of high quality cord 

16 blood units, consistent with the requirements 

17 under the National Cord Blood Inventory pro18 gram under section 2 of the Stem Cell Thera19 peutic and Research Act of 2005 and the inven20 tory goal. Each such plan shall be made avail21 able to the public. 

22 ‘‘(C) DEFINITION.—In this paragraph, the 

23 term ‘remote collection’ means the collection of 

24 cord blood units at locations that do not have 


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1 written contracts with cord blood banks for col2 lection support.’’; and 

3 (B) in paragraph (3)(A), by striking 

4 ‘‘(2)(A)’’ and inserting ‘‘(2)(A)(i)’’; and 

5 (3) by striking subsection (f)(5)(A) and inserting 

6 the following: 

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

8 of strict confidentiality to protect the identity 

9 and privacy of patients and donors in accord10 ance with Federal and State law; and’’. 

11 (c) ADDITIONAL REPORTS.— 

12 (1) INTERIM REPORT.—In addition to the an13 nual report required under section 379(a)(6) of the 

14 Public Health Service Act (42 U.S.C. 274k(a)(6)), the 

15 Secretary of Health and Human Services (referred to 

16 in this subsection as the ‘‘Secretary’’), in consultation 

17 with the Advisory Council established under such sec18 tion 379, shall submit to Congress an interim report 

19 not later than 180 days after the date of enactment 

20 of this Act describing— 

21 (A) the methods to distribute Federal funds 

22 to cord blood banks used at the time of submis23 sion of the report; 


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1 (B) how cord blood banks contract with col2 lection sites for the collection of cord blood units; 

3 and 

4 (C) recommendations for improving the 

5 methods to distribute Federal funds described in 

6 subparagraph (A) in order to encourage the effi7 cient collection of high-quality and diverse cord 

8 blood units. 

9 (2) RECOMMENDATIONS.—Not later than 1 year 

10 after the date of enactment of this Act, the Advisory 

11 Council shall submit recommendations to the Sec12 retary with respect to— 

13 (A) whether models for remote collection of 

14 cord blood units should be allowed only with lim15 ited, scientifically-justified safety protections; 

16 and 

17 (B) whether the Secretary should allow for 

18 cord blood unit collection from routine deliveries 

19 without temperature or humidity monitoring of 

20 delivery rooms in hospitals approved by the 

21 Joint Commission. 

22 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

23 379B of the Public Health Service Act (42 U.S.C. 274m) 

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

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


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1 for each of fiscal years 2011 through 2014 and $33,000,000 

2 for fiscal year 2015.’’. 

3 (e) REPORT ON CORD BLOOD UNIT DONATION AND

4 COLLECTION.— 

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

6 the date of enactment of this Act, the Comptroller 

7 General of the United States shall submit to the Com8 mittee on Health, Education, Labor, and Pensions 

9 and the Committee on Appropriations of the Senate, 

10 the Committee on Energy and Commerce and the 

11 Committee on Appropriations of the House of Rep12 resentatives, and the Secretary of Health and Human 

13 Services a report reviewing studies, demonstration 

14 programs, and outreach efforts for the purpose of in15 creasing cord blood unit donation and collection for 

16 the National Cord Blood Inventory to ensure a high17 quality and genetically diverse inventory of cord 

18 blood units. 

19 (2) CONTENTS.—The report described in para20 graph (1) shall include a review of such studies, dem21 onstration programs, and outreach efforts under sec22 tion 2 of the Stem Cell Therapeutic and Research Act 

23 of 2005 (42 U.S.C. 274k note) (as amended by this 

24 Act) and section 379 of the Public Health Service Act 


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1 (42 U.S.C. 274k) (as amended by this Act), includ2 ing— 

3 (A) a description of the challenges and bar4 riers to expanding the number of cord blood unit 

5 collection sites, including cost, the cash flow re6 quirements and operations of awarding con7 tracts, the methods by which funds are distrib8 uted through contracts, the impact of regulatory 

9 and administrative requirements, and the capac10 ity of cord blood banks to maintain high-quality 

11 units; 

12 (B) remote collection or other innovative 

13 technological advances that could be used to col14 lect cord blood units; 

15 (C) appropriate methods for improving pro16 vider education about collecting cord blood units 

17 for the national inventory and participation in 

18 such collection activities; 

19 (D) estimates of the number of cord blood 

20 unit collection sites necessary to meet the out21 standing national inventory need and the char22 acteristics of such collection sites that would help 

23 increase the genetic diversity and enhance the 

24 quality of cord blood units collected; 


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1 (E) best practices for establishing and sus2 taining partnerships for cord blood unit collec3 tion at medical facilities with a high number of 

4 minority births; 

5 (F) potential and proven incentives to en6 courage hospitals to become cord blood unit col7 lection sites and partner with cord blood banks 

8 participating in the National Cord Blood Inven9 tory under section 2 of the Stem Cell Thera10 peutic and Research Act of 2005 and to assist 

11 cord blood banks in expanding the number of 

12 cord blood unit collection sites with which such 

13 cord blood banks partner; 

14 (G) recommendations about methods cord 

15 blood banks and collection sites could use to 

16 lower costs and improve efficiency of cord blood 

17 unit collection without decreasing the quality of 

18 the cord blood units collected; and 

19 (H) a description of the methods used prior 

20 to the date of enactment of this Act to distribute 

21 funds to cord blood banks and recommendations 

22 for how to improve such methods to encourage 

23 the efficient collection of high-quality and diverse 

24 cord blood units, consistent with the require25 ments of the C.W. Bill Young Cell TransplanVerDate Mar 15 2010 22:34 Sep 28, 2010 Jkt 089200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6203 E:\BILLS\H6081.RH H6081

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1 tation Program and the National Cord Blood In2 ventory program under section 2 of the Stem 

3 Cell Therapeutic and Research Act of 2005. 

4 (f) DEFINITION.—In this Act, the term ‘‘remote collec5 tion’’ has the meaning given such term in section 

6 379(d)(2)(C) of the Public Health Service Act. 


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Union Calendar No. 383 

111TH CONGRESS 

2D SESSION H. R. 6081 

[Report No. 111–643] 

A BILL 

To amend the Stem Cell Therapeutic and Research 

Act of 2005. 

SEPTEMBER 28, 2010 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


hsrobinson on DSK69SOYB1PROD with BILLS