II 

Calendar No. 256 

109TH CONGRESS 

1ST SESSION H. R. 2520 

IN THE SENATE OF THE UNITED STATES 

MAY 26, 2005 

Received 

OCTOBER 24, 2005 

Read twice and placed on the calendar 

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. 

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’’. 
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1 SEC. 2. CORD BLOOD INVENTORY. 

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

3 Human Services shall enter into one-time contracts with 

4 qualified cord blood stem cell banks to assist in the collec5 tion and maintenance of 150,000 units of high-quality 

6 human cord blood to be made available for transplantation 

7 through the C.W. Bill Young Cell Transplantation Pro8 gram and to carry out the requirements of subsection (b). 

9 (b) REQUIREMENTS.—The Secretary shall require 

10 each recipient of a contract under this section— 

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

12 and store donated units of human cord blood ac13 quired with the informed consent of the donor in a 

14 manner that complies with applicable Federal and 

15 State regulations; 

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

17 pursuant to this section or otherwise and meet all 

18 applicable Federal standards available to transplant 

19 centers for stem cell transplantation; 

20 (3) to make cord blood units that are collected, 

21 but not appropriate for clinical use, available for 

22 peer-reviewed research; 

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

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

25 Cell Transplantation Program; and 
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1 (5) to submit data for inclusion in the stem cell 

2 therapeutic outcomes database maintained under 

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

4 amended by this Act. 

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

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

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

8 in such manner, and containing such information as the 

9 Secretary may reasonably require. At a minimum, an ap10 plication for a contract under this section shall include an 

11 assurance that the applicant— 

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

13 Transplantation Program for a period of at least 10 

14 years; and 

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

16 prior to the expiration of such period, will transfer 

17 the units collected pursuant to this section to an18 other qualified cord blood stem cell bank approved 

19 by the Secretary to ensure continued availability of 

20 cord blood units. 

21 (d) DURATION OF CONTRACTS.— 

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

23 into any contract under this section for a period 

24 that— 

25 (A) exceeds 3 years; or 
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1 (B) ends after September 30, 2010. 

2 (2) EXTENSIONS.—Subject to paragraph 

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

4 contract under this section to exceed a period of 3 

5 years if— 

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

7 of high-quality human cord blood have not yet 

8 been collected pursuant to this section; and 

9 (B) the Secretary does not receive an ap10 plication for a contract under this section from 

11 any qualified cord blood stem cell bank that has 

12 not previously entered into a contract under 

13 this section or the Secretary determines that 

14 the outstanding inventory need cannot be met 

15 by the one or more qualified cord blood stem 

16 cell banks that have submitted an application 

17 for a contract under this section. 

18 (e) REGULATIONS.—The Secretary may promulgate 

19 regulations to carry out this section. 

20 (f) DEFINITIONS.—In this section: 

21 (1) The term ‘‘C.W. Bill Young Cell Transplan22 tation Program’’ means the C.W. Bill Young Cell 

23 Transplantation Program under section 379 of the 

24 Public Health Service Act, as amended by this Act. 
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1 (2) The term ‘‘cord blood donor’’ means a 

2 mother who has delivered a baby and consents to do3 nate the neonatal blood remaining in the placenta 

4 and umbilical cord after separation from the new5 born baby. 

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

7 the neonatal blood collected from the placenta and 

8 umbilical cord. 

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

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

11 379(b) of the Public Health Service Act, as amended 

12 by this Act. 

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

14 of Health and Human Services. 

15 (g) AUTHORIZATION OF APPROPRIATIONS.— 

16 (1) FISCAL YEAR 2006.—Any amounts appro17 priated to the Secretary for fiscal year 2004 or 2005 

18 for the purpose of assisting in the collection or 

19 maintenance of human cord blood shall remain avail20 able to the Secretary until the end of fiscal year 

21 2006 for the purpose of carrying out this section. 

22 (2) SUBSEQUENT FISCAL YEARS.—There are 

23 authorized to be appropriated to the Secretary 

24 $15,000,000 for each of fiscal years 2007, 2008, 

25 2009, and 2010 to carry out this section. Amounts 
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1 appropriated pursuant to this paragraph shall re2 main available for obligation through the end of fis3 cal year 2010. 

4 SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PRO5 GRAM. 

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

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

8 (1) in the section heading, by striking ‘‘NA9 TIONAL REGISTRY’’ and inserting ‘‘NATIONAL

10 PROGRAM’’; 

11 (2) in subsection (a)— 

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

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

14 and all that follows through the end of such 

15 matter and inserting ‘‘The Secretary, acting 

16 through the Administrator of the Health Re17 sources and Services Administration, shall by 

18 one or more contracts establish and maintain a 

19 C.W. Bill Young Cell Transplantation Program 

20 that has the purpose of increasing the number 

21 of transplants for recipients suitably matched to 

22 biologically unrelated donors of bone marrow 

23 and cord blood, and that meets the require24 ments of this section. The Secretary may award 

25 a separate contract to perform each of the 
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1 major functions of the Program described in 

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

3 deemed necessary by the Secretary to operate 

4 an effective and efficient system. The Secretary 

5 shall conduct a separate competition for the ini6 tial establishment of the cord blood functions of 

7 the Program. The Program shall be under the 

8 general supervision of the Secretary. The Sec9 retary shall establish an Advisory Council to ad10 vise, assist, consult with, and make rec11 ommendations to the Secretary on matters re12 lated to the activities carried out by the Pro13 gram. The members of the Advisory Council 

14 shall be appointed in accordance with the fol15 lowing:’’; 

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

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

18 that— 

19 ‘‘(A) such limitations shall not apply to the 

20 Chair of the Advisory Council (or the Chair21 elect) or to the member of the Advisory Council 

22 who most recently served as the Chair; and 

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

24 may be served by any member of the Advisory 

25 Council who has no employment, governance, or 
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1 financial affiliation with any donor center, re2 cruitment group, transplant center, or cord 

3 blood stem cell bank.’’; 

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

5 follows: 

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

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

8 balanced number of representatives including 

9 representatives of marrow donor centers and 

10 marrow transplant centers, representatives of 

11 cord blood stem cell banks and participating 

12 birthing hospitals, recipients of a bone marrow 

13 transplant and cord blood transplants, persons 

14 who require such transplants, family members 

15 of such a recipient or family members of a pa16 tient who has requested the assistance of the 

17 Program in searching for an unrelated donor of 

18 bone marrow or cord blood, persons with exper19 tise in blood stem cell transplantation including 

20 cord blood, persons with expertise in typing, 

21 matching, and transplant outcome data anal22 ysis, persons with expertise in the social 

23 sciences, and members of the general public; 

24 and 
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1 ‘‘(B) shall include as nonvoting members 

2 representatives from the Department of De3 fense Marrow Donor Recruitment and Research 

4 Program operated by the Department of the 

5 Navy, the Division of Transplantation of the 

6 Health Resources and Services Administration, 

7 the Food and Drug Administration, and the 

8 National Institutes of Health.’’; and 

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

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

11 chosen so as to ensure objectivity and balance and 

12 reduce the potential for conflicts of interest. The 

13 Secretary shall establish bylaws and procedures— 

14 ‘‘(A) to prohibit any member of the Advi15 sory Council who has an employment, govern16 ance, or financial affiliation with a donor cen17 ter, recruitment group, transplant center, or 

18 cord blood stem cell bank from participating in 

19 any decision that materially affects the center, 

20 recruitment group, transplant center, or cord 

21 blood stem cell bank; and 

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

23 the Advisory Council with any such affiliation. 

24 ‘‘(6) The Secretary, acting through the Advi25 sory Council, shall submit to the Congress— 
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1 ‘‘(A) an annual report on the activities car2 ried out under this section; and 

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

4 date of the enactment of the Stem Cell Thera5 peutic and Research Act of 2005, a report of 

6 recommendations on the scientific factors nec7 essary to define a cord blood unit as a high8 quality unit.’’; 

9 (3) by amending subsection (b) to read as fol10 lows: 

11 ‘‘(b) FUNCTIONS.— 

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

13 to bone marrow, the Program shall— 

14 ‘‘(A) operate a system for listing, search15 ing, and facilitating the distribution of bone 

16 marrow that is suitably matched to candidate 

17 patients; 

18 ‘‘(B) carry out a program for the recruit19 ment of bone marrow donors in accordance with 

20 subsection (c), including with respect to increas21 ing the representation of racial and ethnic mi22 nority groups (including persons of mixed an23 cestry) in the enrollment of the Program; 

24 ‘‘(C) maintain and expand medical emer25 gency contingency response capabilities in con-
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1 cert with Federal programs for response to 

2 threats of use of terrorist or military weapons 

3 that can damage marrow, such as ionizing radi4 ation or chemical agents containing mustard, so 

5 that the capability of supporting patients with 

6 marrow damage from disease can be used to 

7 support casualties with marrow damage; 

8 ‘‘(D) carry out informational and edu9 cational activities in accordance with subsection 

10 (c); 

11 ‘‘(E) at least annually update information 

12 to account for changes in the status of individ13 uals as potential donors of bone marrow; 

14 ‘‘(F) provide for a system of patient advo15 cacy through the office established under sub16 section (d); 

17 ‘‘(G) provide case management services for 

18 any potential donor of bone marrow to whom 

19 the Program has provided a notice that the po20 tential donor may be suitably matched to a par21 ticular patient (which services shall be provided 

22 through a mechanism other than the system of 

23 patient advocacy under subsection (d)), and 

24 conduct surveys of donors and potential donors 

25 to determine the extent of satisfaction with 
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1 such services and to identify ways in which the 

2 services can be improved; 

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

4 donors of bone marrow that are conducted 

5 through the system under subparagraph (A), 

6 collect, analyze, and publish data on the num7 ber and percentage of patients at each of the 

8 various stages of the search process, including 

9 data regarding the furthest stage reached, the 

10 number and percentage of patients who are un11 able to complete the search process, and the 

12 reasons underlying such circumstances; 

13 ‘‘(I) support studies and demonstration 

14 and outreach projects for the purpose of in15 creasing the number of individuals who are will16 ing to be marrow donors to ensure a genetically 

17 diverse donor pool; 

18 ‘‘(J) conduct and support research to im19 prove the availability, efficiency, safety, and 

20 cost of transplants from unrelated donors and 

21 the effectiveness of Program operations; and 

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

23 banks in the Program in accordance with para24 graph (3). 
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1 Subsections (c) through (e) apply with respect to 

2 each entity awarded a contract under this section 

3 with respect to bone marrow. 

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

5 to cord blood, the Program shall— 

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

7 matching, and facilitating the distribution of 

8 donated cord blood units that are suitably 

9 matched to candidate patients and meet all ap10 plicable Federal and State regulations (includ11 ing informed consent and Food and Drug Ad12 ministration regulations) from a qualified cord 

13 blood stem cell bank; 

14 ‘‘(B) allow transplant physicians, other ap15 propriate health care professionals, and patients 

16 to search by means of electronic access all avail17 able cord blood units listed in the Program; 

18 ‘‘(C) allow transplant physicians and other 

19 appropriate health care professionals to ten20 tatively reserve a cord blood unit for transplan21 tation; 

22 ‘‘(D) support studies and demonstration 

23 and outreach projects for the purpose of in24 creasing cord blood donation to ensure a geneti25 cally diverse collection of cord blood units; and 
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1 ‘‘(E) coordinate with the Secretary to 

2 carry out information and educational activities 

3 for the purpose of increasing cord blood dona4 tion and promoting the availability of cord 

5 blood units as a transplant option. 

6 ‘‘(3) SINGLE POINT OF ACCESS.—If the Sec7 retary enters into a contract with more than one en8 tity to perform the functions outlined in this sub9 section, the Secretary shall establish procedures to 

10 ensure that health care professionals and patients 

11 are able to obtain, consistent with the functions de12 scribed in paragraphs (1)(A) and (2)(A), cells from 

13 adult donors and cord blood units through a single 

14 point of access. 

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

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

17 bank that— 

18 ‘‘(A) has obtained all applicable Federal 

19 and State licenses, certifications, registrations 

20 (including pursuant to the regulations of the 

21 Food and Drug Administration), and other au22 thorizations required to operate and maintain a 

23 cord blood stem cell bank; 

24 ‘‘(B) has implemented donor screening, 

25 cord blood collection practices, and processing 
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1 methods intended to protect the health and 

2 safety of donors and transplant recipients to 

3 improve transplant outcomes, including with re4 spect to the transmission of potentially harmful 

5 infections and other diseases; 

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

7 recognized pursuant to a public process by the 

8 Secretary; 

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

10 confidentiality to protect the identity and pri11 vacy of patients and donors in accordance with 

12 existing Federal and State law; and 

13 ‘‘(E) has established a system for encour14 aging donation by a genetically diverse group of 

15 donors.’’; 

16 (4) in subsection (c)— 

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

18 Registry shall carry out a program for the re19 cruitment’’ and inserting ‘‘With respect to bone 

20 marrow, the Program shall carry out a program 

21 for the recruitment’’; 

22 (B) in paragraph (2)(A)— 

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

24 by striking the first sentence and inserting 

25 ‘‘In carrying out the program under para-
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1 graph (1), the Program shall carry out in2 formational and educational activities, in 

3 coordination with organ donation public 

4 awareness campaigns operated through the 

5 Department of Health and Human Serv6 ices, for purposes of recruiting individuals 

7 to serve as donors of bone marrow and 

8 shall test and enroll with the Program po9 tential donors.’’; and 

10 (ii) in clause (ii), by striking ‘‘, in11 cluding providing updates’’; and 

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

13 availability, as a potential treatment option, of 

14 receiving a transplant of bone marrow from an 

15 unrelated donor’’ and inserting ‘‘transplants 

16 from unrelated donors as a treatment option 

17 and resources for identifying and evaluating 

18 other therapeutic alternatives’’; 

19 (5) in subsection (d)— 

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

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

22 bone marrow, the Program shall’’; 

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

24 assist with information regarding third party 
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1 payor matters’’ after ‘‘ongoing search for a 

2 donor’’; 

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

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

5 (b)(1)’’ each place such term appears and in6 serting ‘‘subsection (b)(1)(A)’’; 

7 (D) in paragraph (2)(F)— 

8 (i) by redesignating clause (v) as 

9 clause (vi); and 

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

11 following: 

12 ‘‘(v) Information concerning issues 

13 that patients may face after a transplant 

14 regarding continuity of care and quality of 

15 life.’’; and 

16 (E) in paragraph (3)(B), by striking ‘‘Of17 fice may’’ and inserting ‘‘Office shall’’; 

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

19 subsection (e), by striking ‘‘the Secretary shall’’ and 

20 inserting ‘‘with respect to bone marrow, the Sec21 retary shall’’; 

22 (7) by amending subsection (f) to read as fol23 lows: 

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

25 establish and provide information to the public on proce-
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1 dures under which the Secretary shall receive and consider 

2 comments from interested persons relating to the manner 

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

4 Program.’’; 

5 (8) by amending subsection (g) to read as fol6 lows: 

7 ‘‘(g) CONSULTATION.—In developing policies affect8 ing the Program, the Secretary shall consult with the Ad9 visory Council, the Department of Defense Marrow Donor 

10 Recruitment and Research Program operated by the De11 partment of the Navy, and the board of directors of each 

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

13 (9) in subsection (h)— 

14 (A) by striking ‘‘APPLICATION.—’’ and in15 serting ‘‘CONTRACTS.—’’; 

16 (B) by striking ‘‘To be eligible’’ and insert17 ing the following: 

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

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

20 ‘‘(2) CONSIDERATIONS.—In awarding contracts 

21 under this section, the Secretary shall give substan22 tial weight to the continued safety of donors and pa23 tients and other factors deemed appropriate by the 

24 Secretary.’’; and 

25 (10) by striking subsection (l). 
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1 (b) STEM CELL THERAPEUTIC OUTCOMES DATA2 BASE.—Section 379A of the Public Health Service Act (42 

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

4 ‘‘SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATA5 BASE. 

6 ‘‘(a) ESTABLISHMENT.—The Secretary shall by con7 tract establish and maintain a scientific database of infor8 mation relating to patients who have been recipients of 

9 stem cell therapeutics product (including bone marrow, 

10 cord blood, or other such product) from a biologically un11 related donor. 

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

13 include information with respect to patients described in 

14 subsection (a), transplant procedures, and such other in15 formation as the Secretary determines to be appropriate, 

16 to conduct an ongoing evaluation of the scientific and clin17 ical status of transplantation involving recipients of bone 

18 marrow from biologically unrelated donors and recipients 

19 of a stem cell therapeutics product. 

20 ‘‘(c) ANNUAL REPORT ON PATIENT OUTCOMES.— 

21 The Secretary shall require the entity awarded a contract 

22 under this section to submit to the Secretary an annual 

23 report concerning patient outcomes with respect to each 

24 transplant center, based on data collected and maintained 

25 by the entity pursuant to this section. 
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1 ‘‘(d) PUBLICLY AVAILABLE DATA.—The outcomes 

2 database shall make relevant scientific information not 

3 containing individually identifiable information available 

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

5 encourage medical research and to provide information to 

6 transplant programs, physicians, patients, entities award7 ed a contract under section 379 donor registries, and cord 

8 blood stem cell banks.’’. 

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

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

11 by inserting after section 379A the following: 

12 ‘‘SEC. 379A–1. DEFINITIONS. 

13 ‘‘In this part: 

14 ‘‘(1) The term ‘Advisory Council’ means the ad15 visory council established by the Secretary under 

16 section 379(a)(1). 

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

18 found in adult bone marrow and peripheral blood. 

19 ‘‘(3) The term ‘outcomes database’ means the 

20 database established by the Secretary under section 

21 379A. 

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

23 Young Cell Transplantation Program established 

24 under section 379.’’. 
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1 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

2 379B of the Public Health Service Act (42 U.S.C. 274m) 

3 is amended to read as follows: 

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

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

6 this part, there are authorized to be appropriated 

7 $28,000,000 for fiscal year 2006 and $32,000,000 for 

8 each of fiscal years 2007 through 2010. 

9 ‘‘(b) EMERGENCY CONTINGENCY RESPONSE CAPA10 BILITIES.—In addition to the amounts authorized to be 

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

12 be appropriated $2,000,000 for the maintenance and ex13 pansion of emergency contingency response capabilities 

14 under section 379(b)(1)(C).’’. 

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

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

17 is amended— 

18 (1) in the title heading, by striking ‘‘NA19 TIONAL BONE MARROW DONOR REG20 ISTRY’’ and inserting ‘‘C.W. BILL YOUNG 

21 CELL TRANSPLANTATION PROGRAM’’; 

22 and 

23 (2) in section 379, as amended by this sec24 tion— 
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1 (A) in subsection (a), by striking the term 

2 ‘‘board’’ each place such term appears and in3 serting ‘‘Advisory Council’’; 

4 (B) in subection (c)— 

5 (i) in the matter preceding subpara6 graph (A) in paragraph (1), by striking 

7 ‘‘Such program’’ and inserting ‘‘Such re8 cruitment program’’; 

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

10 ‘‘program under paragraph (1)’’ and in11 serting ‘‘recruitment program under para12 graph (1)’’; and 

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

14 ‘‘program under paragraph (1)’’ and in15 serting ‘‘recruitment program under para16 graph (1)’’; 

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

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

19 (D) in subsection (e)— 

20 (i) in the matter preceding paragraph 

21 (1), by striking ‘‘participating in the pro22 gram, including the Registry,’’ and insert23 ing ‘‘participating in the Program, includ24 ing’’; and 
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1 (ii) in paragraph (6), by striking ‘‘the 

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

3 and 

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

5 place such term appears and inserting ‘‘Pro6 gram’’. 

Passed the House of Representatives May 24, 2005. 

Attest: JEFF TRANDAHL, 

Clerk. 
Calendar No. 256 

109TH CONGRESS 

1ST SESSION H. R. 2520 

AN ACT 

To provide for the collection and maintenance of 

Young Cell Transplantation Program. Health Service Act to authorize the C.W. Bill patients and research, and to amend the Public human cord blood stem cells for the treatment of 

OCTOBER 24, 2005 

Read twice and placed on the calendar