IIB 

109TH CONGRESS 

1ST SESSION H. R. 2520 

IN THE SENATE OF THE UNITED STATES 

MAY 26, 2005 

Received 

AN ACT 

To provide for the collection and maintenance of human 

cord blood stem cells for the treatment of patients and 

research, and to amend the Public Health Service Act 

to authorize the C.W. Bill Young Cell Transplantation 

Program. 
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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 Act of 2005’’. 

6 SEC. 2. CORD BLOOD INVENTORY. 

7 (a) IN GENERAL.—The Secretary of Health and 

8 Human Services shall enter into one-time contracts with 

9 qualified cord blood stem cell banks to assist in the collec10 tion and maintenance of 150,000 units of high-quality 

11 human cord blood to be made available for transplantation 

12 through the C.W. Bill Young Cell Transplantation Pro13 gram and to carry out the requirements of subsection (b). 

14 (b) REQUIREMENTS.—The Secretary shall require 

15 each recipient of a contract under this section— 

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

17 and store donated units of human cord blood ac18 quired with the informed consent of the donor in a 

19 manner that complies with applicable Federal and 

20 State regulations; 

21 (2) to make cord blood units that are collected 

22 pursuant to this section or otherwise and meet all 

23 applicable Federal standards available to transplant 

24 centers for stem cell transplantation; 
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1 (3) to make cord blood units that are collected, 

2 but not appropriate for clinical use, available for 

3 peer-reviewed research; 

4 (4) to submit data in a standardized format, as 

5 required by the Secretary, for the C.W. Bill Young 

6 Cell Transplantation Program; and 

7 (5) to submit data for inclusion in the stem cell 

8 therapeutic outcomes database maintained under 

9 section 379A of the Public Health Service Act, as 

10 amended by this Act. 

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

12 under this section, a qualified cord blood stem cell bank 

13 shall submit an application to the Secretary at such time, 

14 in such manner, and containing such information as the 

15 Secretary may reasonably require. At a minimum, an ap16 plication for a contract under this section shall include an 

17 assurance that the applicant— 

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

19 Transplantation Program for a period of at least 10 

20 years; and 

21 (2) in the event of abandonment of this activity 

22 prior to the expiration of such period, will transfer 

23 the units collected pursuant to this section to an24 other qualified cord blood stem cell bank approved 
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1 by the Secretary to ensure continued availability of 

2 cord blood units. 

3 (d) DURATION OF CONTRACTS.— 

4 (1) IN GENERAL.—The Secretary may not enter 

5 into any contract under this section for a period 

6 that— 

7 (A) exceeds 3 years; or 

8 (B) ends after September 30, 2010. 

9 (2) EXTENSIONS.—Subject to paragraph 

10 (1)(B), the Secretary may extend the period of a 

11 contract under this section to exceed a period of 3 

12 years if— 

13 (A) the Secretary finds that 150,000 units 

14 of high-quality human cord blood have not yet 

15 been collected pursuant to this section; and 

16 (B) the Secretary does not receive an ap17 plication for a contract under this section from 

18 any qualified cord blood stem cell bank that has 

19 not previously entered into a contract under 

20 this section or the Secretary determines that 

21 the outstanding inventory need cannot be met 

22 by the one or more qualified cord blood stem 

23 cell banks that have submitted an application 

24 for a contract under this section. 
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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 Program’’ means the C.W. Bill Young Cell 

6 Transplantation Program under section 379 of the 

7 Public Health Service Act, as amended by this Act. 

8 (2) The term ‘‘cord blood donor’’ means a 

9 mother who has delivered a baby and consents to do10 nate the neonatal blood remaining in the placenta 

11 and umbilical cord after separation from the new12 born baby. 

13 (3) The term ‘‘human cord blood unit’’ means 

14 the neonatal blood collected from the placenta and 

15 umbilical cord. 

16 (4) The term ‘‘qualified cord blood stem cell 

17 bank’’ has the meaning given to that term in section 

18 379(b) of the Public Health Service Act, as amended 

19 by this Act. 

20 (5) The term ‘‘Secretary’’ means the Secretary 

21 of Health and Human Services. 

22 (g) AUTHORIZATION OF APPROPRIATIONS.— 

23 (1) FISCAL YEAR 2006.—Any amounts appro24 priated to the Secretary for fiscal year 2004 or 2005 

25 for the purpose of assisting in the collection or 
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1 maintenance of human cord blood shall remain avail2 able to the Secretary until the end of fiscal year 

3 2006 for the purpose of carrying out this section. 

4 (2) SUBSEQUENT FISCAL YEARS.—There are 

5 authorized to be appropriated to the Secretary 

6 $15,000,000 for each of fiscal years 2007, 2008, 

7 2009, and 2010 to carry out this section. Amounts 

8 appropriated pursuant to this paragraph shall re9 main available for obligation through the end of fis10 cal year 2010. 

11 SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PRO12 GRAM. 

13 (a) NATIONAL PROGRAM.—Section 379 of the Public 

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

15 (1) in the section heading, by striking ‘‘NA16 TIONAL REGISTRY’’ and inserting ‘‘NATIONAL

17 PROGRAM’’; 

18 (2) in subsection (a)— 

19 (A) in the matter preceding paragraph (1), 

20 by striking ‘‘The Secretary shall by contract’’ 

21 and all that follows through the end of such 

22 matter and inserting ‘‘The Secretary, acting 

23 through the Administrator of the Health Re24 sources and Services Administration, shall by 

25 one or more contracts establish and maintain a 
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1 C.W. Bill Young Cell Transplantation Program 

2 that has the purpose of increasing the number 

3 of transplants for recipients suitably matched to 

4 biologically unrelated donors of bone marrow 

5 and cord blood, and that meets the require6 ments of this section. The Secretary may award 

7 a separate contract to perform each of the 

8 major functions of the Program described in 

9 paragraphs (1) and (2) of subsection (b) if 

10 deemed necessary by the Secretary to operate 

11 an effective and efficient system. The Secretary 

12 shall conduct a separate competition for the ini13 tial establishment of the cord blood functions of 

14 the Program. The Program shall be under the 

15 general supervision of the Secretary. The Sec16 retary shall establish an Advisory Council to ad17 vise, assist, consult with, and make rec18 ommendations to the Secretary on matters re19 lated to the activities carried out by the Pro20 gram. The members of the Advisory Council 

21 shall be appointed in accordance with the fol22 lowing:’’; 

23 (B) in paragraph (1), by striking ‘‘except 

24 that’’ and all that follows and inserting ‘‘except 

25 that— 
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1 ‘‘(A) such limitations shall not apply to the 

2 Chair of the Advisory Council (or the Chair3 elect) or to the member of the Advisory Council 

4 who most recently served as the Chair; and 

5 ‘‘(B) 1 additional consecutive 2-year term 

6 may be served by any member of the Advisory 

7 Council who has no employment, governance, or 

8 financial affiliation with any donor center, re9 cruitment group, transplant center, or cord 

10 blood stem cell bank.’’; 

11 (C) by amending paragraph (4) to read as 

12 follows: 

13 ‘‘(4) The membership of the Advisory Council— 

14 ‘‘(A) shall include as voting members a 

15 balanced number of representatives including 

16 representatives of marrow donor centers and 

17 marrow transplant centers, representatives of 

18 cord blood stem cell banks and participating 

19 birthing hospitals, recipients of a bone marrow 

20 transplant and cord blood transplants, persons 

21 who require such transplants, family members 

22 of such a recipient or family members of a pa23 tient who has requested the assistance of the 

24 Program in searching for an unrelated donor of 

25 bone marrow or cord blood, persons with exper-
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1 tise in blood stem cell transplantation including 

2 cord blood, persons with expertise in typing, 

3 matching, and transplant outcome data anal4 ysis, persons with expertise in the social 

5 sciences, and members of the general public; 

6 and 

7 ‘‘(B) shall include as nonvoting members 

8 representatives from the Department of De9 fense Marrow Donor Recruitment and Research 

10 Program operated by the Department of the 

11 Navy, the Division of Transplantation of the 

12 Health Resources and Services Administration, 

13 the Food and Drug Administration, and the 

14 National Institutes of Health.’’; and 

15 (D) by adding at the end the following: 

16 ‘‘(5) Members of the Advisory Council shall be 

17 chosen so as to ensure objectivity and balance and 

18 reduce the potential for conflicts of interest. The 

19 Secretary shall establish bylaws and procedures— 

20 ‘‘(A) to prohibit any member of the Advi21 sory Council who has an employment, govern22 ance, or financial affiliation with a donor cen23 ter, recruitment group, transplant center, or 

24 cord blood stem cell bank from participating in 

25 any decision that materially affects the center, 
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1 recruitment group, transplant center, or cord 

2 blood stem cell bank; and 

3 ‘‘(B) to limit the number of members of 

4 the Advisory Council with any such affiliation. 

5 ‘‘(6) The Secretary, acting through the Advi6 sory Council, shall submit to the Congress— 

7 ‘‘(A) an annual report on the activities car8 ried out under this section; and 

9 ‘‘(B) not later than 6 months after the 

10 date of the enactment of the Stem Cell Thera11 peutic and Research Act of 2005, a report of 

12 recommendations on the scientific factors nec13 essary to define a cord blood unit as a high14 quality unit.’’; 

15 (3) by amending subsection (b) to read as fol16 lows: 

17 ‘‘(b) FUNCTIONS.— 

18 ‘‘(1) BONE MARROW FUNCTIONS.—With respect 

19 to bone marrow, the Program shall— 

20 ‘‘(A) operate a system for listing, search21 ing, and facilitating the distribution of bone 

22 marrow that is suitably matched to candidate 

23 patients; 

24 ‘‘(B) carry out a program for the recruit25 ment of bone marrow donors in accordance with 
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1 subsection (c), including with respect to increas2 ing the representation of racial and ethnic mi3 nority groups (including persons of mixed an4 cestry) in the enrollment of the Program; 

5 ‘‘(C) maintain and expand medical emer6 gency contingency response capabilities in con7 cert with Federal programs for response to 

8 threats of use of terrorist or military weapons 

9 that can damage marrow, such as ionizing radi10 ation or chemical agents containing mustard, so 

11 that the capability of supporting patients with 

12 marrow damage from disease can be used to 

13 support casualties with marrow damage; 

14 ‘‘(D) carry out informational and edu15 cational activities in accordance with subsection 

16 (c); 

17 ‘‘(E) at least annually update information 

18 to account for changes in the status of individ19 uals as potential donors of bone marrow; 

20 ‘‘(F) provide for a system of patient advo21 cacy through the office established under sub22 section (d); 

23 ‘‘(G) provide case management services for 

24 any potential donor of bone marrow to whom 

25 the Program has provided a notice that the po-
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1 tential donor may be suitably matched to a par2 ticular patient (which services shall be provided 

3 through a mechanism other than the system of 

4 patient advocacy under subsection (d)), and 

5 conduct surveys of donors and potential donors 

6 to determine the extent of satisfaction with 

7 such services and to identify ways in which the 

8 services can be improved; 

9 ‘‘(H) with respect to searches for unrelated 

10 donors of bone marrow that are conducted 

11 through the system under subparagraph (A), 

12 collect, analyze, and publish data on the num13 ber and percentage of patients at each of the 

14 various stages of the search process, including 

15 data regarding the furthest stage reached, the 

16 number and percentage of patients who are un17 able to complete the search process, and the 

18 reasons underlying such circumstances; 

19 ‘‘(I) support studies and demonstration 

20 and outreach projects for the purpose of in21 creasing the number of individuals who are will22 ing to be marrow donors to ensure a genetically 

23 diverse donor pool; 

24 ‘‘(J) conduct and support research to im25 prove the availability, efficiency, safety, and 
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1 cost of transplants from unrelated donors and 

2 the effectiveness of Program operations; and 

3 ‘‘(K) assist qualified cord blood stem cell 

4 banks in the Program in accordance with para5 graph (3). 

6 Subsections (c) through (e) apply with respect to 

7 each entity awarded a contract under this section 

8 with respect to bone marrow. 

9 ‘‘(2) CORD BLOOD FUNCTIONS.—With respect 

10 to cord blood, the Program shall— 

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

12 matching, and facilitating the distribution of 

13 donated cord blood units that are suitably 

14 matched to candidate patients and meet all ap15 plicable Federal and State regulations (includ16 ing informed consent and Food and Drug Ad17 ministration regulations) from a qualified cord 

18 blood stem cell bank; 

19 ‘‘(B) allow transplant physicians, other ap20 propriate health care professionals, and patients 

21 to search by means of electronic access all avail22 able cord blood units listed in the Program; 

23 ‘‘(C) allow transplant physicians and other 

24 appropriate health care professionals to ten-
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1 tatively reserve a cord blood unit for transplan2 tation; 

3 ‘‘(D) support studies and demonstration 

4 and outreach projects for the purpose of in5 creasing cord blood donation to ensure a geneti6 cally diverse collection of cord blood units; and 

7 ‘‘(E) coordinate with the Secretary to 

8 carry out information and educational activities 

9 for the purpose of increasing cord blood dona10 tion and promoting the availability of cord 

11 blood units as a transplant option. 

12 ‘‘(3) SINGLE POINT OF ACCESS.—If the Sec13 retary enters into a contract with more than one en14 tity to perform the functions outlined in this sub15 section, the Secretary shall establish procedures to 

16 ensure that health care professionals and patients 

17 are able to obtain, consistent with the functions de18 scribed in paragraphs (1)(A) and (2)(A), cells from 

19 adult donors and cord blood units through a single 

20 point of access. 

21 ‘‘(4) DEFINITION.—The term ‘qualified cord 

22 blood stem cell bank’ means a cord blood stem cell 

23 bank that— 

24 ‘‘(A) has obtained all applicable Federal 

25 and State licenses, certifications, registrations 
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1 (including pursuant to the regulations of the 

2 Food and Drug Administration), and other au3 thorizations required to operate and maintain a 

4 cord blood stem cell bank; 

5 ‘‘(B) has implemented donor screening, 

6 cord blood collection practices, and processing 

7 methods intended to protect the health and 

8 safety of donors and transplant recipients to 

9 improve transplant outcomes, including with re10 spect to the transmission of potentially harmful 

11 infections and other diseases; 

12 ‘‘(C) is accredited by an accreditation body 

13 recognized pursuant to a public process by the 

14 Secretary; 

15 ‘‘(D) has established a system of strict 

16 confidentiality to protect the identity and pri17 vacy of patients and donors in accordance with 

18 existing Federal and State law; and 

19 ‘‘(E) has established a system for encour20 aging donation by a genetically diverse group of 

21 donors.’’; 

22 (4) in subsection (c)— 

23 (A) in paragraph (1), by striking ‘‘The 

24 Registry shall carry out a program for the re25 cruitment’’ and inserting ‘‘With respect to bone 
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1 marrow, the Program shall carry out a program 

2 for the recruitment’’; 

3 (B) in paragraph (2)(A)— 

4 (i) in the matter preceding clause (i), 

5 by striking the first sentence and inserting 

6 ‘‘In carrying out the program under para7 graph (1), the Program shall carry out in8 formational and educational activities, in 

9 coordination with organ donation public 

10 awareness campaigns operated through the 

11 Department of Health and Human Serv12 ices, for purposes of recruiting individuals 

13 to serve as donors of bone marrow and 

14 shall test and enroll with the Program po15 tential donors.’’; and 

16 (ii) in clause (ii), by striking ‘‘, in17 cluding providing updates’’; and 

18 (C) in paragraph (3), by striking ‘‘the 

19 availability, as a potential treatment option, of 

20 receiving a transplant of bone marrow from an 

21 unrelated donor’’ and inserting ‘‘transplants 

22 from unrelated donors as a treatment option 

23 and resources for identifying and evaluating 

24 other therapeutic alternatives’’; 

25 (5) in subsection (d)— 
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1 (A) in paragraph (1), by striking ‘‘The 

2 Registry shall’’ and inserting ‘‘With respect to 

3 bone marrow, the Program shall’’; 

4 (B) in paragraph (2)(C), by inserting ‘‘and 

5 assist with information regarding third party 

6 payor matters’’ after ‘‘ongoing search for a 

7 donor’’; 

8 (C) in subparagraphs (C), (D), and (E) of 

9 paragraph (2), by striking the term ‘‘subsection 

10 (b)(1)’’ each place such term appears and in11 serting ‘‘subsection (b)(1)(A)’’; 

12 (D) in paragraph (2)(F)— 

13 (i) by redesignating clause (v) as 

14 clause (vi); and 

15 (ii) by inserting after clause (iv) the 

16 following: 

17 ‘‘(v) Information concerning issues 

18 that patients may face after a transplant 

19 regarding continuity of care and quality of 

20 life.’’; and 

21 (E) in paragraph (3)(B), by striking ‘‘Of22 fice may’’ and inserting ‘‘Office shall’’; 

23 (6) in the matter preceding paragraph (1) in 

24 subsection (e), by striking ‘‘the Secretary shall’’ and 
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1 inserting ‘‘with respect to bone marrow, the Sec2 retary shall’’; 

3 (7) by amending subsection (f) to read as fol4 lows: 

5 ‘‘(f) COMMENT PROCEDURES.—The Secretary shall 

6 establish and provide information to the public on proce7 dures under which the Secretary shall receive and consider 

8 comments from interested persons relating to the manner 

9 in which the Program is carrying out the duties of the 

10 Program.’’; 

11 (8) by amending subsection (g) to read as fol12 lows: 

13 ‘‘(g) CONSULTATION.—In developing policies affect14 ing the Program, the Secretary shall consult with the Ad15 visory Council, the Department of Defense Marrow Donor 

16 Recruitment and Research Program operated by the De17 partment of the Navy, and the board of directors of each 

18 entity awarded a contract under this section.’’; 

19 (9) in subsection (h)— 

20 (A) by striking ‘‘APPLICATION.—’’ and in21 serting ‘‘CONTRACTS.—’’; 

22 (B) by striking ‘‘To be eligible’’ and insert23 ing the following: 

24 ‘‘(1) APPLICATION.—To be eligible’’; and 

25 (C) by adding at the end the following: 
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1 ‘‘(2) CONSIDERATIONS.—In awarding contracts 

2 under this section, the Secretary shall give substan3 tial weight to the continued safety of donors and pa4 tients and other factors deemed appropriate by the 

5 Secretary.’’; and 

6 (10) by striking subsection (l). 

7 (b) STEM CELL THERAPEUTIC OUTCOMES DATA8 BASE.—Section 379A of the Public Health Service Act (42 

9 U.S.C. 274l) is amended to read as follows: 

10 ‘‘SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATA11 BASE. 

12 ‘‘(a) ESTABLISHMENT.—The Secretary shall by con13 tract establish and maintain a scientific database of infor14 mation relating to patients who have been recipients of 

15 stem cell therapeutics product (including bone marrow, 

16 cord blood, or other such product) from a biologically un17 related donor. 

18 ‘‘(b) INFORMATION.—The outcomes database shall 

19 include information with respect to patients described in 

20 subsection (a), transplant procedures, and such other in21 formation as the Secretary determines to be appropriate, 

22 to conduct an ongoing evaluation of the scientific and clin23 ical status of transplantation involving recipients of bone 

24 marrow from biologically unrelated donors and recipients 

25 of a stem cell therapeutics product. 
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1 ‘‘(c) ANNUAL REPORT ON PATIENT OUTCOMES.— 

2 The Secretary shall require the entity awarded a contract 

3 under this section to submit to the Secretary an annual 

4 report concerning patient outcomes with respect to each 

5 transplant center, based on data collected and maintained 

6 by the entity pursuant to this section. 

7 ‘‘(d) PUBLICLY AVAILABLE DATA.—The outcomes 

8 database shall make relevant scientific information not 

9 containing individually identifiable information available 

10 to the public in the form of summaries and data sets to 

11 encourage medical research and to provide information to 

12 transplant programs, physicians, patients, entities award13 ed a contract under section 379 donor registries, and cord 

14 blood stem cell banks.’’. 

15 (c) DEFINITIONS.—Part I of title III of the Public 

16 Health Service Act (42 U.S.C. 274k et seq.) is amended 

17 by inserting after section 379A the following: 

18 ‘‘SEC. 379A–1. DEFINITIONS. 

19 ‘‘In this part: 

20 ‘‘(1) The term ‘Advisory Council’ means the ad21 visory council established by the Secretary under 

22 section 379(a)(1). 

23 ‘‘(2) The term ‘bone marrow’ means the cells 

24 found in adult bone marrow and peripheral blood. 
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1 ‘‘(3) The term ‘outcomes database’ means the 

2 database established by the Secretary under section 

3 379A. 

4 ‘‘(4) The term ‘Program’ means the C.W. Bill 

5 Young Cell Transplantation Program established 

6 under section 379.’’. 

7 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

8 379B of the Public Health Service Act (42 U.S.C. 274m) 

9 is amended to read as follows: 

10 ‘‘SEC. 379B. AUTHORIZATION OF APPROPRIATIONS. 

11 ‘‘(a) IN GENERAL.—For the purpose of carrying out 

12 this part, there are authorized to be appropriated 

13 $28,000,000 for fiscal year 2006 and $32,000,000 for 

14 each of fiscal years 2007 through 2010. 

15 ‘‘(b) EMERGENCY CONTINGENCY RESPONSE CAPA16 BILITIES.—In addition to the amounts authorized to be 

17 appropriated under subsection (a), there is authorized to 

18 be appropriated $2,000,000 for the maintenance and ex19 pansion of emergency contingency response capabilities 

20 under section 379(b)(1)(C).’’. 

21 (e) CONFORMING AMENDMENTS.—Part I of title III 

22 of the Public Health Service Act (42 U.S.C. 274k et seq.) 

23 is amended— 

24 (1) in the title heading, by striking ‘‘NA25 TIONAL BONE MARROW DONOR REG-
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1 ISTRY’’ and inserting ‘‘C.W. BILL YOUNG 

2 CELL TRANSPLANTATION PROGRAM’’; 

3 and 

4 (2) in section 379, as amended by this sec5 tion— 

6 (A) in subsection (a), by striking the term 

7 ‘‘board’’ each place such term appears and in8 serting ‘‘Advisory Council’’; 

9 (B) in subection (c)— 

10 (i) in the matter preceding subpara11 graph (A) in paragraph (1), by striking 

12 ‘‘Such program’’ and inserting ‘‘Such re13 cruitment program’’; 

14 (ii) in paragraph (2), by striking 

15 ‘‘program under paragraph (1)’’ and in16 serting ‘‘recruitment program under para17 graph (1)’’; and 

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

19 ‘‘program under paragraph (1)’’ and in20 serting ‘‘recruitment program under para21 graph (1)’’; 

22 (C) in subsection (d)(2)(E), by striking 

23 ‘‘Registry program’’ and inserting ‘‘Program’’; 

24 (D) in subsection (e)— 
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1 (i) in the matter preceding paragraph 

2 (1), by striking ‘‘participating in the pro3 gram, including the Registry,’’ and insert4 ing ‘‘participating in the Program, includ5 ing’’; and 

6 (ii) in paragraph (6), by striking ‘‘the 

7 program’’ and inserting ‘‘the Program’’; 

8 and 

9 (E) by striking the term ‘‘Registry’’ each 

10 place such term appears and inserting ‘‘Pro11 gram’’. 

Passed the House of Representatives May 24, 2005. 

Attest: JEFF TRANDAHL, 

Clerk.