II 

Calendar No. 311 

114TH CONGRESS 

1ST SESSION H. R. 2820 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 9, 2015 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

DECEMBER 3, 2015 

Reported by Mr. ALEXANDER, with an amendment 

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

AN ACT 

To reauthorize the Stem Cell Therapeutic and Research Act 

of 2005, and for other purposes. 

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 2015’’. 


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1 SEC. 2. AMENDMENTS TO THE STEM CELL THERAPEUTIC 

2 AND RESEARCH ACT OF 2005. 

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

4 Stem Cell Therapeutic and Research Act of 2005 (42 

5 U.S.C. 274k note) is amended in subsection (h)— 

6 (1) in paragraph (1)— 

7 (A) by striking ‘‘$23,000,000 for each of 

8 fiscal years 2011 through 2014 and’’; and 

9 (B) by inserting before the period at the 

10 end the following: ‘‘and $23,000,000 for each of 

11 fiscal years 2016 through 2020’’; and 

12 (2) in paragraph (2), by striking ‘‘2011 

13 through 2015’’ and inserting ‘‘2015 through 2020’’. 

14 (b) NATIONAL PROGRAM.—Section 379B of the Pub15 lic Health Service Act (42 U.S.C. 274m) is amended by 

16 striking ‘‘2011 through 2014’’ and inserting ‘‘2016 

17 through 2020’’. 

18 SECTION 1. SHORT TITLE. 

19 This Act may be cited as the ‘‘Stem Cell Therapeutic 

20 and Research Reauthorization Act of 2015’’. 

21 SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL 

22 TRANSPLANTATION PROGRAM. 

23 (a) IN GENERAL.—Section 379(d)(2)(B) of the Public 

24 Health Service Act (42 U.S.C. 274k(d)(2)(B)) is amended— 

25 (1) by striking ‘‘remote collection’’ and inserting 

26 ‘‘collection’’; and 


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1 (2) by inserting ‘‘including remote collection,’’ 

2 after ‘‘cord blood units,’’. 

3 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

4 379B of the Public Health Service Act (42 U.S.C. 274m) 

5 is amended— 

6 (1) by striking ‘‘$30,000,000 for each of fiscal 

7 years 2011 through 2014 and’’; and 

8 (2) by inserting ‘‘and $30,000,000 for each of fis9 cal years 2016 through 2020’’ before the period at the 

10 end. 

11 (c) SECRETARY REVIEW ON STATE OF SCIENCE.—The 

12 Secretary of Health and Human Services, in consultation 

13 with the Director of the National Institutes of Health, the 

14 Commissioner of the Food and Drug Administration, and 

15 the Administrator of the Health Resources and Services Ad16 ministration, including the Advisory Council on Blood 

17 Stem Cell Transplantation established under section 379(a) 

18 of the Public Health Service Act (42 U.S.C. 274k(a)), and 

19 other stakeholders, where appropriate given relevant exper20 tise, shall conduct a review of the state of the science of 

21 using adult stem cells and birthing tissues to develop new 

22 types of therapies for patients, for the purpose of consid23 ering the potential inclusion of such new types of therapies 

24 in the C.W. Bill Young Cell Transplantation Program (es25 tablished under such section 379) in addition to the conVerDate Sep 11 2014 03:00 Dec 04, 2015 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H2820.RS H2820

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1 tinuation of ongoing activities. Not later than June 30, 

2 2019, the Secretary shall submit to the Committee on 

3 Health, Education, Labor, and Pensions of the Senate and 

4 the Committee on Energy and Commerce of the House of 

5 Representatives recommendations on the appropriateness of 

6 such new types of therapies for inclusion in the C.W. Bill 

7 Young Cell Transplantation Program. 

8 SEC. 3. CORD BLOOD INVENTORY. 

9 Section 2 of the Stem Cell Therapeutic and Research 

10 Act of 2005 (42 U.S.C. 274k note) is amended— 

11 (1) in subsection (a), by striking ‘‘one-time’’; 

12 (2) by striking subsection (c); 

13 (3) by redesignating subsections (d) through (h) 

14 as subsections (c) through (g), respectively; 

15 (4) in subsection (d) (as so redesignated)— 

16 (A) in paragraph (1), by striking ‘‘para17 graphs (2) and (3)’’ and inserting ‘‘paragraphs 

18 (2), (3), and (4)’’; 

19 (B) in paragraph (2)(B), by striking ‘‘sub20 section (d)’’ and inserting ‘‘subsection (c)’’; and 

21 (C) by adding at the end the following: 

22 ‘‘(4) CONSIDERATION OF BEST SCIENCE.—The 

23 Secretary shall take into consideration the best sci24 entific information available in order to maximize the 

25 number of cord blood units available for transplant 


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1 when entering into contracts under this section, or 

2 when extending a period of funding under such a con3 tract under paragraph (2). 

4 ‘‘(5) CONSIDERATION OF BANKED UNITS OF CORD

5 BLOOD.—In extending contracts pursuant to para6 graph (3), and determining new allocation amounts 

7 for the next contract period or contract extension for 

8 such cord blood bank, the Secretary shall take into ac9 count the number of cord blood units banked in the 

10 National Cord Blood Inventory by a cord blood bank 

11 during the previous contract period, in addition to 

12 consideration of the ability of such cord blood bank to 

13 increase the collection and maintenance of additional, 

14 genetically diverse cord blood units.’’; 

15 (5) in subsection (f) (as so redesignated)— 

16 (A) by striking paragraph (4); and 

17 (B) by redesignating paragraphs (5) and 

18 (6) as paragraphs (4) and (5), respectively; and 

19 (6) in subsection (g) (as so redesignated)— 

20 (A) in paragraph (1)— 

21 (i) by striking ‘‘$23,000,000 for each of 

22 fiscal years 2011 through 2014 and’’; and 

23 (ii) by inserting ‘‘and $23,000,000 for 

24 each of fiscal years 2016 through 2020’’ be25 fore the period at the end; and 


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1 (B) by striking paragraph (2). 

2 SEC. 4. DETERMINATION ON THE DEFINITION OF HUMAN 

3 ORGAN. 

4 Not later than one year after the date of enactment 

5 of this Act, the Secretary of Health and Human Services 

6 shall issue determinations with respect to the inclusion of 

7 peripheral blood stem cells and umbilical cord blood in the 

8 definition of human organ. 


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Calendar No. 311 

114TH CONGRESS 

1ST SESSION H. R. 2820 

AN ACT 

Research Act of 2005, and for other purposes. 

To reauthorize the Stem Cell Therapeutic and 

DECEMBER 3, 2015 

Reported with an amendment 


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