II 

110TH CONGRESS 

1ST SESSION S. 957 

To provide for the collection and maintenance of amniotic fluid and placental 

stem cells for the treatment of patients and research. 

IN THE SENATE OF THE UNITED STATES 

MARCH 22, 2007 

Mr. BURR (for himself and Mr. COLEMAN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To provide for the collection and maintenance of amniotic 

fluid and placental stem cells for the treatment of patients and research. 

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 ‘‘Amniotic Fluid and 

5 Placental Stem Cell Banking Act of 2007’’. 

6 SEC. 2. AMNIOTIC FLUID AND PLACENTAL STEM CELL IN7 VENTORY. 

8 (a) IN GENERAL.—The Secretary shall enter into 

9 one-time contracts with qualified amniotic fluid and plaVerDate Aug 31 2005 23:46 Mar 29, 2007 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S957.IS S957

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1 cental stem cell banks to assist in the collection and main2 tenance of 100,000 new units of high-quality amniotic 

3 fluid and placental stem cells to be made available for 

4 treatment through the C.W. Bill Young Cell Transplan5 tation and Treatment Program and to carry out the re6 quirements of subsection (b). 

7 (b) REQUIREMENTS.—The Secretary shall require 

8 each recipient of a contract under this section— 

9 (1) to acquire, tissue-type, test, cryopreserve, 

10 and store donated units of amniotic fluid and pla11 cental stem cells acquired with the informed consent 

12 of the donor, as determined by the Secretary pursu13 ant to section 379(c) of the Public Health Service 

14 Act, in a manner that complies with applicable Fed15 eral and State regulations; 

16 (2) to encourage donation from a genetically di17 verse population; 

18 (3) to make amniotic fluid and placental stem 

19 cells that are collected pursuant to this section or 

20 otherwise and meet all applicable Federal standards 

21 available to physicians for treatment; 

22 (4) to make amniotic fluid and placental stem 

23 cell units that are collected, but not appropriate for 

24 clinical use, available for peer-reviewed research; 


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1 (5) to make data available, as required by the 

2 Secretary and consistent with section 379(d)(3) of 

3 the Public Health Service Act (42 U.S.C. 

4 274k(d)(3)), as amended by this Act, in a standard5 ized electronic format, as determined by the Sec6 retary, for the C.W. Bill Young Cell Transplantation 

7 and Treatment Program; and 

8 (6) to submit data in a standardized electronic 

9 format for inclusion in the stem cell therapeutic out10 comes database maintained under section 379A of 

11 the Public Health Service Act, as amended by this 

12 Act. 

13 (c) APPLICATION.—To seek to enter into a contract 

14 under this section, a qualified amniotic fluid and placental 

15 stem cell bank shall submit an application to the Secretary 

16 at such time, in such manner, and containing such infor17 mation as the Secretary may reasonably require. At a min18 imum, an application for a contract under this section 

19 shall include a requirement that the applicant— 

20 (1) will participate in the C.W. Bill Young Cell 

21 Transplantation and Treatment Program for a pe22 riod of at least 10 years; 

23 (2) will make amniotic fluid and placental stem 

24 cell units collected pursuant to this section available 

25 through the C.W. Bill Young Cell Transplantation 


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1 and Treatment Program in perpetuity or for such 

2 time as determined viable by the Secretary; and 

3 (3) if the Secretary determines through an as4 sessment, or through petition by the applicant, that 

5 an amniotic fluid and placental stem cell bank is no 

6 longer operational or does not meet the requirements 

7 of section 379(d)(4) of the Public Health Service 

8 Act (as added by this Act) and as a result may not 

9 distribute the units, transfer the units collected pur10 suant to this section to another qualified amniotic 

11 fluid and placental stem cell bank approved by the 

12 Secretary to ensure continued availability of 

13 amniotic fluid and placental stem cell units. 

14 (d) DURATION OF CONTRACTS.— 

15 (1) IN GENERAL.—Except as provided in para16 graph (2), the term of each contract entered into by 

17 the Secretary under this section shall be for 10 

18 years. The Secretary shall ensure that no Federal 

19 funds shall be obligated under any such contract 

20 after the earlier of— 

21 (A) the date that is 3 years after the date 

22 on which the contract is entered into; or 

23 (B) September 30, 2012. 

24 (2) EXTENSIONS.—Subject to paragraph 

25 (1)(B), the Secretary may extend the period of fundVerDate Aug 31 2005 23:46 Mar 29, 2007 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S957.IS S957

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1 ing under a contract under this section to exceed a 

2 period of 3 years if— 

3 (A) the Secretary finds that 100,000 new 

4 units of high-quality amniotic fluid and pla5 cental stem cells have not yet been collected 

6 pursuant to this section; and 

7 (B) the Secretary does not receive an ap8 plication for a contract under this section from 

9 any qualified amniotic fluid and placental stem 

10 cell bank that has not previously entered into a 

11 contract under this section or the Secretary de12 termines that the outstanding inventory need 

13 cannot be met by the one or more qualified 

14 amniotic fluid and placental stem cell banks 

15 that have submitted an application for a con16 tract under this section. 

17 (3) PREFERENCE.—In considering contract ex18 tensions under paragraph (2), the Secretary shall 

19 give preference to qualified amniotic fluid and pla20 cental stem cell banks that the Secretary determines 

21 have demonstrated a superior ability to satisfy the 

22 requirements described in subsection (b) and to 

23 achieve the overall goals for which the contract was 

24 awarded. 


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1 (e) REGULATIONS.—The Secretary may promulgate 

2 regulations to carry out this section. 

3 (f) DEFINITIONS.—In this section: 

4 (1) The term ‘‘C.W. Bill Young Cell Transplan5 tation and Treatment Program’’ means the C.W. 

6 Bill Young Cell Transplantation and Treatment Pro7 gram under section 379 of the Public Health Service 

8 Act, as amended by this Act. 

9 (2) The term ‘‘amniotic fluid and placental 

10 stem cell donor’’ means a mother who has delivered 

11 a baby and consents to donate the placental stem 

12 cells or a mother who undergoes amniocentesis or 

13 placental sampling for other diagnostic purposes and 

14 consents to donate the discarded amniotic fluid and 

15 placental stem cells after the diagnostic analysis is 

16 completed. 

17 (3) The term ‘‘amniotic fluid and placental 

18 stem cell unit’’ means the amniotic fluid and pla19 cental stem cells collected from the placenta of a sin20 gle newborn baby or collected from the discarded 

21 amniotic fluid or placenta after a diagnostic test. 

22 (5) The term ‘‘qualified amniotic fluid and pla23 cental stem cell bank’’ has the meaning given to that 

24 term in section 379(d)(4) of the Public Health Serv25 ice Act, as amended by this Act. 


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1 (6) The term ‘‘Secretary’’ means the Secretary 

2 of Health and Human Services. 

3 (g) AUTHORIZATION OF APPROPRIATIONS.—There 

4 are authorized to be appropriated to the Secretary 

5 $20,000,000 for each of fiscal years 2008 through 2012, 

6 to carry out this section. 

7 SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION AND 

8 TREATMENT PROGRAM. 

9 Part I of title III of the Public Health Service Act 

10 (42 U.S.C. 274k et seq.) is amended— 

11 (1) in the part heading by inserting ‘‘AND 

12 TREATMENT’’ after ‘‘TRANSPLANTATION’’; 

13 (2) in section 379— 

14 (A) in subsection (a) 

15 (i) in paragraph (4)(A), by inserting 

16 ‘‘representatives of amniotic fluid and pla17 cental stem cell banks and participating 

18 birthing hospitals and ob/gyn offices, re19 cipients of an amniotic fluid and placental 

20 stem cell treatment, basic scientists with 

21 expertise in the biology of amniotic fluid 

22 and placental stem cells,’’ after ‘‘adult 

23 stem cells,’’; 

24 (ii) in paragraph (5)(A), by striking 

25 ‘‘, or cord blood bank from participating in 


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1 any decision that materially affects the 

2 center, recruitment organization, trans3 plant center, or cord blood bank’’ and in4 serting ‘‘, cord blood bank, or amniotic 

5 fluid and placental stem cell bank from 

6 participating in any decision that materi7 ally affects the center, recruitment organi8 zation, transplant center, cord blood bank, 

9 or amniotic fluid and placental stem cell 

10 bank’’; and 

11 (iii) in paragraph (6) 

12 (I) in subparagraph (A), by strik13 ing ‘‘and’’ at the end. 

14 (II) in subparagraph (B), by 

15 striking the period and inserting ‘‘; 

16 and’’; and 

17 (III) by adding at the end the 

18 following: 

19 ‘‘(C) not later than 6 months after the 

20 date of enactment of the Amniotic Fluid and 

21 Placental Stem Cell Banking Act of 2007, a re22 port concerning the recommendations on the 

23 scientific factors necessary to define an 

24 amniotic fluid and placental stem cell unit as a 

25 high-quality unit.’’; 


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1 (B) in subsection (b), by inserting ‘‘and 

2 amniotic fluid and placental stem cell banks’’ 

3 before the period; 

4 (C) in subsection (c)— 

5 (i) in the matter preceding paragraph 

6 (1), by striking ‘‘process, examine’’ and in7 serting the following: ‘‘process— 

8 ‘‘(1) examine’’; 

9 (ii) by redesignating paragraphs (1) 

10 and (2) as subparagraphs (A) and (B) and 

11 indenting accordingly; 

12 (iii) by striking the first period and 

13 inserting ‘‘; and 

14 ‘‘(2) examine the informed consent procedures 

15 for cord blood donation and determine appropriate 

16 informed consent procedures for amniotic fluid and 

17 placental stem cell donation.’’; and 

18 (v) by adding at the end the following: 

19 ‘‘The Secretary shall require that the 

20 standards used by the accreditation enti21 ties recognized under subsection (b) en22 sures that an amniotic fluid and placental 

23 stem cell unit is acquired with the in24 formed consent of the maternal donor.’’; 

25 (D) in subsection (d)— 


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1 (i) by redesignating paragraphs (3) 

2 and (4) as paragraphs (4) and (5), respec3 tively; and 

4 (ii) by inserting after paragraph (2), 

5 the following; 

6 ‘‘(2) AMNIOTIC FLUID AND PLACENTAL STEM

7 CELL FUNCTIONS.—With respect to amniotic fluid 

8 and placental stem cells, the Program shall— 

9 ‘‘(A) operate a system for identifying, 

10 matching, and facilitating the distribution of 

11 donated amniotic fluid and placental stem cell 

12 units that are suitably matched to candidate 

13 patients and meet all applicable Federal and 

14 State regulations from a qualified amniotic 

15 fluid and placental stem cell bank; 

16 ‘‘(B) consistent with paragraph (3), allow 

17 treatment physicians, other appropriate health 

18 care professionals, and patients to search by 

19 means of electronic access all available amniotic 

20 fluid and placental stem cell units made avail21 able through the Program; 

22 ‘‘(C) allow treatment physicians and other 

23 appropriate health care professionals to reserve, 

24 as defined by the Secretary, an amniotic fluid 

25 and placental stem cell unit for treatment; 


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1 ‘‘(D) support studies and demonstration 

2 and outreach projects for the purpose of in3 creasing amniotic fluid and placental stem cell 

4 donation to ensure a genetically diverse collec5 tion of amniotic fluid and placental stem cell 

6 units; 

7 ‘‘(E) provide for a system of patient advo8 cacy through the office established under sub9 section (h); 

10 ‘‘(F) coordinate with the qualified amniotic 

11 fluid and placental stem cell banks to support 

12 informational and educational activities in ac13 cordance with subsection (g); and 

14 ‘‘(G) with respect to the system under sub15 paragraph (A), collect, analyze, and publish 

16 data in a standardized electronic format, as re17 quired by the Secretary, on the number and 

18 percentage of patients at each of the various 

19 stages of the search process, including data re20 garding the furthest stage reached, the number 

21 and percentage of patients who are unable to 

22 complete the search process, and the reasons 

23 underlying such circumstances.’’; 

24 (iii) in paragraph (4) (as so redesig25 nated)— 


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1 (I) in subparagraph (A), by strik2 ing ‘‘and (2)(A), cells from bone mar3 row donors and cord blood’’ and in4 serting ‘‘, (2)(A), and (3)(A), cells 

5 from bone marrow donors, cord blood, 

6 and amniotic fluid and placental stem 

7 cells’’; and 

8 (II) in subparagraph (B), by 

9 striking ‘‘that enables transplant,’’ 

10 and inserting ‘‘. The standardization 

11 shall enable’’; 

12 (iv) in paragraph (5) (as so redesig13 nated)— 

14 (I) by redesignating subpara15 graphs (A) through (F) as clauses (i) 

16 through (vi), respectively, and indent 

17 accordingly; 

18 (II) by striking ‘‘The term’’ and 

19 inserting the following: 

20 ‘‘(A) The term’’; and 

21 (III) by adding at the end the 

22 following: 

23 ‘‘(B) The term ‘qualified amniotic fluid 

24 and placental stem cell bank’ means a qualified 


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1 amniotic fluid and placental stem cell bank 

2 that— 

3 ‘‘(i) has obtained all applicable Fed4 eral and State licenses, certifications, reg5 istrations (including pursuant to the regu6 lations of the Food and Drug Administra7 tion), and other authorizations required to 

8 operate and maintain an amniotic fluid 

9 and placental stem cell bank; 

10 ‘‘(ii) has implemented donor screen11 ing, amniotic fluid and placental stem cell 

12 collection practices, and processing meth13 ods intended to protect the health and 

14 safety of donors and transplant recipients 

15 to improve transplant outcomes, including 

16 with respect to the transmission of poten17 tially harmful infections and other dis18 eases; 

19 ‘‘(iii) is accredited by an accreditation 

20 entity recognized by the Secretary under 

21 subsection (b); 

22 ‘‘(iv) has established a system of strict 

23 confidentiality to protect the identity and 

24 privacy of patients and donors in accord25 ance with existing Federal and State law; 


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1 ‘‘(v) has established a system for en2 couraging donation by a genetically diverse 

3 group of donors; and 

4 ‘‘(vi) has established a system to con5 fidentially maintain linkage between a 

6 amniotic fluid and placental stem cell unit 

7 and a maternal donor.’’; 

8 (E) by redesignating subsections (h) 

9 through (n) as subsections (i) through (o), re10 spectively; 

11 (F) by inserting after subsection (g), the 

12 following: 

13 ‘‘(h) AMNIOTIC FLUID AND PLACENTAL STEM CELL

14 RECRUITMENT; PRIORITIES; INFORMATION AND EDU15 CATION.— 

16 ‘‘(1) RECRUITMENT; PRIORITIES.—The Pro17 gram shall support activities, in cooperation with 

18 qualified amniotic fluid and placental stem cell 

19 banks, for the recruitment of amniotic fluid and pla20 cental stem cell donors. Such recruitment program 

21 shall identify populations that are underrepresented 

22 among amniotic fluid and placental stem cell donors. 

23 In the case of populations that are identified under 

24 the preceding sentence: 


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1 ‘‘(A) The Program shall give priority to 

2 supporting activities under this part to increase 

3 representation for such populations in order to 

4 enable a member of such a population, to the 

5 extent practicable, to have a probability of find6 ing a suitable amniotic fluid and placental stem 

7 cell unit that is comparable to the probability 

8 that an individual who is not a member of an 

9 underrepresented population would have. 

10 ‘‘(B) The Program shall consider racial 

11 and ethnic minority groups (including persons 

12 of mixed ancestry) to be populations that have 

13 been identified for purposes of this paragraph, 

14 and shall support activities under subparagraph 

15 (A) with respect to such populations. 

16 ‘‘(2) INFORMATION AND EDUCATION REGARD17 ING RECRUITMENT; TESTING AND DONATION.— 

18 ‘‘(A) IN GENERAL.—In carrying out the 

19 recruitment program under paragraph (1), the 

20 Program shall support informational and edu21 cational activities in coordination with qualified 

22 amniotic fluid and placental stem cell banks 

23 and organ donation public awareness campaigns 

24 operated through the Department of Health 

25 and Human Services, for purposes of recruiting 


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1 pregnant women to serve as donors of amniotic 

2 fluid and placental stem cells. Such information 

3 and educational activities shall include the fol4 lowing: 

5 ‘‘(i) Making information available to 

6 the general public, including information 

7 describing the needs of patients with re8 spect to amniotic fluid and placental stem 

9 cell units. 

10 ‘‘(ii) Educating and providing infor11 mation to pregnant women who are willing 

12 to donate amniotic fluid and placental 

13 stem cell units. 

14 ‘‘(iii) Training individuals in request15 ing pregnant women to serve as amniotic 

16 fluid and placental stem cell donors. 

17 ‘‘(B) PRIORITIES.—In carrying out infor18 mational and educational activities under sub19 paragraph (A), the Program shall give priority 

20 to supporting the recruitment of pregnant 

21 women to serve as donors of amniotic fluid and 

22 placental stem cell for populations that are 

23 identified under paragraph (1). 

24 ‘‘(3) TRANSPLANTATION AS TREATMENT OP25 TION.—In addition to activities regarding recruitVerDate Aug 31 2005 23:46 Mar 29, 2007 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S957.IS S957

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1 ment, the recruitment program under paragraph (1) 

2 shall provide information to physicians, other health 

3 care professionals, and the public regarding amniotic 

4 fluid and placental stem cell treatments as a treat5 ment option. 

6 ‘‘(4) IMPLEMENTATION OF SUBSECTION.—The 

7 requirements of this subsection shall be carried out 

8 by the entity that has been awarded a contract by 

9 the Secretary under subsection (a) to carry out the 

10 functions described in subsection (d)(3).’’; 

11 (G) in subsection (i) (as so redesignated)— 

12 (i) in the subsection heading by strik13 ing ‘‘AND CORD BLOOD’’ and inserting ‘‘, 

14 CORD BLOOD, AND AMNIOTIC FLUID AND

15 PLACENTAL STEM CELLS’’; 

16 (ii) in paragraph (2)— 

17 (I) in subparagraph (B), by 

18 striking ‘‘and cord blood therapy’’ and 

19 inserting ‘‘, cord blood, and amniotic 

20 fluid and placental stem cell therapy 

21 and treatment’’; 

22 (II) in subparagraph (C), by 

23 striking ‘‘or cord blood unit’’ and in24 serting ‘‘, cord blood unit, or amniotic 

25 fluid and placental stem cell unit’’; 


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1 (III) in subparagraph (D), by 

2 striking ‘‘and (2) of subsection (d) to 

3 conduct an ongoing search for a bone 

4 marrow donor or cord blood unit’’ and 

5 inserting ‘‘, (2), and (3) of subsection 

6 (d) to conduct an ongoing search for 

7 a bone marrow donor, cord blood unit, 

8 or amniotic fluid and placental stem 

9 cell unit’’; 

10 (IV) in subparagraph (E)— 

11 (aa) in the matter preceding 

12 clause (i), by striking ‘‘(1) and 

13 (2)’’ and inserting ‘‘(1), (2), and 

14 (3)’’; and 

15 (bb) in clause (i), by striking 

16 ‘‘or cord blood units’’ and insert17 ing ‘‘, cord blood units, or 

18 amniotic fluid and placental stem 

19 cell units’’; and 

20 (V) in subparagraph (F)— 

21 (aa) by redesignating clause 

22 (v) as clause (viii); and 

23 (bb) by inserting after 

24 clause (iv), the following: 


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1 ‘‘(v) A comparison of treatment cen2 ters with respect to search and other costs 

3 that prior to treatment are charged to pa4 tients by treatment centers. 

5 ‘‘(vi) The post-treatment outcomes for 

6 individual treatment centers. 

7 ‘‘(vii) Information concerning issues 

8 that patients may face after a treatment.’’; 

9 and 

10 (iii) in paragraph (3)(B), by inserting 

11 before the period the following: ‘‘and on 

12 behalf of patients who have completed the 

13 search for an amniotic fluid and placental 

14 stem cell unit, provide information and 

15 education on the process of receiving a 

16 treatment, including the post-treatment 

17 process’’; and 

18 (H) in subsection (o) (as so redesignated), 

19 by striking ‘‘(d)(4)(D)’’ and inserting 

20 ‘‘(d)(5)(A)(iv)’’; 

21 (3) in section 379A— 

22 (A) in subsection (b)— 

23 (i) by striking ‘‘, results’’ and insert24 ing ‘‘, treatments, results’’; and 


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1 (ii) by inserting ‘‘or treatment’’ after 

2 ‘‘transplantation’’; 

3 (B) in subsection (c), by inserting ‘‘or 

4 treatment’’ after ‘‘transplant’’; and 

5 (C) in subsection (d) 

6 (i) by inserting ‘‘treatment centers,’’ 

7 after ‘‘programs,’’; and 

8 (ii) by striking ‘‘and cord blood 

9 banks’’ and inserting ‘‘cord blood banks, 

10 and amniotic fluid and placental stem cell 

11 banks’’; and 

12 (4) in section 379A–1, in paragraph (4), by in13 serting ‘‘and Treatment’’ after ‘‘Transplantation’’. 

14 SEC. 4. AUTHORIZATION OF APPROPRIATIONS. 

15 Section 379B of the Public Health Service Act (42 

16 U.S.C. 274m) is amended by striking ‘‘2010’’ and insert17 ing ‘‘2012’’. 

Æ 


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