II 

Calendar No. 156 

109TH CONGRESS 

1ST SESSION S. 1317 

To provide for the collection and maintenance of cord blood units for the 

treatment of patients and research, and to amend the Public Health 

Service Act to authorize the Bone Marrow and Cord Blood Cell Transplantation Program to increase the number of transplants for recipients 

suitably matched to donors of bone marrow and cord blood. 

IN THE SENATE OF THE UNITED STATES 

JUNE 27, 2005 

Mr. HATCH (for himself, Mr. DODD, Mr. BURR, Mr. REED, Mr. ENSIGN, Mrs. 

CLINTON, Ms. MIKULSKI, Mr. FRIST, Mrs. MURRAY, Mr. TALENT, Ms. 

COLLINS, Mr. SCHUMER, Mr. VOINOVICH, Mr. HARKIN, Mr. 

BROWNBACK, Mr. DEWINE, Mr. ROBERTS, Mrs. DOLE, Mrs. FEINSTEIN, 

Mr. GRASSLEY, Mr. HAGEL, and Mr. DURBIN) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

JULY 11, 2005 

Reported by Mr. ENZI, with an amendment 

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

A BILL 

To provide for the collection and maintenance of cord blood 

units for the treatment of patients and research, and 

to amend the Public Health Service Act to authorize 

the Bone Marrow and Cord Blood Cell Transplantation 

Program to increase the number of transplants for recipi-
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ents suitably matched to donors of bone marrow and 

cord blood. 

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 ‘‘Bone Marrow and 

5 Cord Blood Therapy 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 banks to assist in the collection and 

10 maintenance of 150,000 new units of high-quality cord 

11 blood to be made available for transplantation through the 

12 Bone Marrow and Cord Blood 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 cord blood acquired with 

18 the informed consent of the donor in a manner that 

19 complies with applicable Federal and State regula20 tions; 

21 (2) to encourage donation from a genetically di22 verse population; 

23 (3) to make cord blood units that are collected 

24 pursuant to this section or otherwise and meet all 
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1 applicable Federal standards available to transplant 

2 centers for transplantation; 

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

4 but not appropriate for clinical use, available for 

5 peer-reviewed research; 

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

7 Secretary and consistent with section 379(c)(3) of 

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

9 274k(c)(3)), as amended by this Act, in a standard10 ized electronic format, as determined by the Sec11 retary, for the Bone Marrow and Cord Blood Cell 

12 Transplantation Program; and 

13 (6) to submit data in a standardized electronic 

14 format for inclusion in the stem cell therapeutic out15 comes database maintained under section 379A of 

16 the Public Health Service Act, as amended by this 

17 Act. 

18 (c) RELATED CORD BLOOD DONORS.— 

19 (1) IN GENERAL.—The Secretary shall establish 

20 a 3-year demonstration project under which qualified 

21 cord blood banks receiving a contract under this sec22 tion may use a portion of the funding under such 

23 contract for the collection and storage of cord blood 

24 units for a family where a first-degree relative has 

25 been diagnosed with a condition that will benefit 
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1 from transplantation (including selected blood dis2 orders, malignancies, metabolic storage disorders, 

3 hemoglobinopathies, and congenital 

4 immunodeficiencies) at no cost to such family. Quali5 fied cord blood banks collecting cord blood units 

6 under this paragraph shall comply with the require7 ments of paragraphs (1), (2), (3), and (5) of sub8 section (b). 

9 (2) AVAILABILITY.—Qualified cord blood banks 

10 that are operating a program under paragraph (1) 

11 shall provide assurances that the cord blood units in 

12 such banks will be available for directed transplan13 tation until such time that the cord blood unit is re14 leased for transplantation or is transferred by the 

15 family to the Bone Marrow and Cord Blood Cell 

16 Transplantation Program in accordance with guid17 ance or regulations promulgated by the Secretary. 

18 (3) INVENTORY.—Cord blood units collected 

19 through the program under this section shall not be 

20 counted toward the 150,000 inventory goal under 

21 the Bone Marrow and Cord Blood Cell Transplan22 tation Program. 

23 (4) REPORT.—Not later than 90 days after the 

24 date on which the project under paragraph (1) is 

25 terminated by the Secretary, the Secretary shall sub-
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1 mit to Congress a report on the outcomes of the 

2 project that shall include the recommendations of 

3 the Secretary with respect to the continuation of 

4 such project. 

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

6 under this section, a qualified cord blood bank shall sub7 mit an application to the Secretary at such time, in such 

8 manner, and containing such information as the Secretary 

9 may reasonably require. At a minimum, an application for 

10 a contract under this section shall include a requirement 

11 that the applicant— 

12 (1) will participate in the Bone Marrow and 

13 Cord Blood Cell Transplantation Program for a pe14 riod of at least 10 years; 

15 (2) will make cord blood units collected pursu16 ant to this section available through the Bone Mar17 row and Cord Blood Cell Transplantation Program 

18 in perpetuity; and 

19 (3) if the Secretary determines through an as20 sessment, or through petition by the applicant, that 

21 a cord blood bank is no longer operational or does 

22 not meet the requirements of section 379(c)(4) of 

23 the Public Health Service Act (as added by this Act) 

24 and as a result may not distribute the units, trans25 fer the units collected pursuant to this section to an-
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1 other qualified cord blood bank approved by the Sec2 retary to ensure continued availability of cord blood 

3 units. 

4 (e) DURATION OF CONTRACTS.— 

5 (1) IN GENERAL.—Except as provided in para6 graph (2), the term of each contract entered into by 

7 the Secretary under this section shall be for 10 

8 years. The Secretary shall ensure that Federal funds 

9 provided under any such contract terminate on the 

10 earlier of— 

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

12 on which the contract is entered into; or 

13 (B) September 30, 2010. 

14 (2) EXTENSIONS.—Subject to paragraph 

15 (1)(B), the Secretary may extend the period of fund16 ing under a contract under this section to exceed a 

17 period of 3 years if— 

18 (A) the Secretary finds that 150,000 new 

19 units of high-quality cord blood have not yet 

20 been collected pursuant to this section; and 

21 (B) the Secretary does not receive an ap22 plication for a contract under this section from 

23 any qualified cord blood bank that has not pre24 viously entered into a contract under this sec25 tion or the Secretary determines that the out-
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1 standing inventory need cannot be met by the 

2 one or more qualified cord blood banks that 

3 have submitted an application for a contract 

4 under this section. 

5 (3) PREFERENCE.—In considering contract ex6 tensions under paragraph (2), the Secretary shall 

7 give preference to qualified cord blood banks that 

8 the Secretary determines have demonstrated a supe9 rior ability to satisfy the requirements described in 

10 subsection (b) and to achieve the overall goals for 

11 which the contract was awarded. 

12 (f) REGULATIONS.—The Secretary may promulgate 

13 regulations to carry out this section. 

14 (g) DEFINITIONS.—In this section: 

15 (1) The term ‘‘Bone Marrow and Cord Blood 

16 Cell Transplantation Program’’ means the Bone 

17 Marrow and Cord Blood Cell Transplantation Pro18 gram under section 379 of the Public Health Service 

19 Act, as amended by this Act. 

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

21 mother who has delivered a baby and consents to do22 nate the neonatal blood remaining in the placenta 

23 and umbilical cord after separation from the new24 born baby. 
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1 (3) The term ‘‘cord blood unit’’ means the neo2 natal blood collected from the placenta and umbilical 

3 cord of a single newborn baby. 

4 (4) The term ‘‘first-degree relative’’ means a 

5 sibling or parent who is one meiosis away from a 

6 particular individual in a family. 

7 (5) The term ‘‘qualified cord blood bank’’ has 

8 the meaning given to that term in section 379(c)(4) 

9 of the Public Health Service Act, as amended by this 

10 Act. 

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

12 of Health and Human Services. 

13 (h) AUTHORIZATION OF APPROPRIATIONS.— 

14 (1) EXISTING FUNDS.—Any amounts appro15 priated to the Secretary for fiscal year 2004 or 2005 

16 for the purpose of assisting in the collection or 

17 maintenance of cord blood shall remain available to 

18 the Secretary until the end of fiscal year 2007. 

19 (2) SUBSEQUENT FISCAL YEARS.—There are 

20 authorized to be appropriated to the Secretary 

21 $15,000,000 for each of fiscal years 2007, 2008, 

22 2009, and 2010 to carry out this section. 

23 (3) LIMITATION.—Not to exceed 5 percent of 

24 the amount appropriated under this section in each 

25 of fiscal years 2007 through 2009 may be used to 
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1 carry out the demonstration project under sub2 section (c). 

3 SEC. 3. BONE MARROW AND CORD BLOOD CELL TRANS4 PLANTATION PROGRAM. 

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

6 Health Service Act (42 U.S.C. 274k) is amended to read 

7 as follows: 

8 ‘‘SEC. 379. NATIONAL PROGRAM. 

9 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

10 through the Administrator of the Health Resources and 

11 Services Administration, shall by one or more contracts 

12 establish and maintain a Bone Marrow and Cord Blood 

13 Cell Transplantation Program (referred to in this section 

14 as the ‘Program’) that has the purpose of increasing the 

15 number of transplants for recipients suitably matched to 

16 biologically unrelated donors of bone marrow and cord 

17 blood, and that meets the requirements of this section. 

18 The Secretary may award a separate contract to perform 

19 each of the major functions of the Program described in 

20 paragraphs (1) and (2) of subsection (c) if deemed nec21 essary by the Secretary to operate an effective and effi22 cient system that is in the best interest of patients. The 

23 Secretary shall conduct a separate competition for the ini24 tial establishment of the cord blood functions of the Pro25 gram. The Program shall be under the general supervision 
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1 of the Secretary. The Secretary shall establish an Advisory 

2 Council to advise, assist, consult with, and make rec3 ommendations to the Secretary on matters related to the 

4 activities carried out by the Program. The members of the 

5 Advisory Council shall be appointed in accordance with the 

6 following: 

7 ‘‘(1) Each member of the Advisory Council 

8 shall serve for a term of 2 years, and each such 

9 member may serve as many as 3 consecutive 2-year 

10 terms, except that 

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

12 Chair of the Advisory Council (or the Chair13 elect) or to the member of the Advisory Council 

14 who most recently served as the Chair; and 

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

16 may be served by any member of the Advisory 

17 Council who has no employment, governance, or 

18 financial affiliation with any donor center, re19 cruitment organization, transplant center, or 

20 cord blood bank. 

21 ‘‘(2) A member of the Advisory Council may 

22 continue to serve after the expiration of the term of 

23 such member until a successor is appointed. 

24 ‘‘(3) In order to ensure the continuity of the 

25 Advisory Council, the Advisory Council shall be ap-
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1 pointed so that each year the terms of approximately 

2 one-third of the members of the Advisory Council ex3 pire. 

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

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

6 balanced number of representatives including 

7 representatives of marrow donor centers and 

8 marrow transplant centers, representatives of 

9 cord blood banks and participating birthing 

10 hospitals, recipients of a bone marrow trans11 plant, recipients of a cord blood transplant, per12 sons who require such transplants, family mem13 bers of such a recipient or family members of 

14 a patient who has requested the assistance of 

15 the Program in searching for an unrelated 

16 donor of bone marrow or cord blood, persons 

17 with expertise in bone marrow and cord blood 

18 transplantation, persons with expertise in typ19 ing, matching, and transplant outcome data 

20 analysis, persons with expertise in the social 

21 sciences, basic scientists with expertise in the 

22 biology of adult stem cells, and members of the 

23 general public; and 

24 ‘‘(B) shall include as nonvoting members 

25 representatives from the Department of De-
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1 fense Marrow Donor Recruitment and Research 

2 Program operated by the Department of the 

3 Navy, the Division of Transplantation of the 

4 Health Resources and Services Administration, 

5 the Food and Drug Administration, and the 

6 National Institutes of Health. 

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

8 chosen so as to ensure objectivity and balance and 

9 reduce the potential for conflicts of interest. The 

10 Secretary shall establish bylaws and procedures— 

11 ‘‘(A) to prohibit any member of the Advi12 sory Council who has an employment, govern13 ance, or financial affiliation with a donor cen14 ter, recruitment organization, transplant center, 

15 or cord blood bank from participating in any 

16 decision that materially affects the center, re17 cruitment organization, transplant center, or 

18 cord blood bank; and 

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

20 the Advisory Council with any such affiliation. 

21 ‘‘(6) The Secretary, acting through the Advi22 sory Council, shall submit to the Congress— 

23 ‘‘(A) an annual report on the activities car24 ried out under this section; and 
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1 ‘‘(B) not later than 6 months after the 

2 date of the enactment of the Bone Marrow and 

3 Cord Blood Therapy and Research Act of 2005, 

4 a report of recommendations on the scientific 

5 factors necessary to define a cord blood unit as 

6 a high-quality unit. 

7 ‘‘(b) ACCREDITATION.—The Secretary shall, through 

8 a public process, recognize one or more accreditation enti9 ties for the accreditation of cord blood banks. 

10 ‘‘(c) FUNCTIONS.— 

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

12 to bone marrow, the Program shall— 

13 ‘‘(A) operate a system for listing, search14 ing, and facilitating the distribution of bone 

15 marrow that is suitably matched to candidate 

16 patients; 

17 ‘‘(B) consistent with paragraph (3), permit 

18 transplant physicians, other appropriate health 

19 care professionals, and patients to search by 

20 means of electronic access all available bone 

21 marrow donors listed in the Program; 

22 ‘‘(C) carry out a program for the recruit23 ment of bone marrow donors in accordance with 

24 subsection (d), including with respect to in25 creasing the representation of racial and ethnic 
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1 minority groups (including persons of mixed an2 cestry) in the enrollment of the Program; 

3 ‘‘(D) maintain and expand medical contin4 gency response capabilities, in coordination with 

5 Federal programs, to prepare for and respond 

6 effectively to biological, chemical, or radiological 

7 attacks, and other public health emergencies 

8 that can damage marrow, so that the capability 

9 of supporting patients with marrow damage 

10 from disease can be used to support casualties 

11 with marrow damage; 

12 ‘‘(E) carry out informational and edu13 cational activities in accordance with subsection 

14 (d); 

15 ‘‘(F) at least annually update information 

16 to account for changes in the status of individ17 uals as potential donors of bone marrow; 

18 ‘‘(G) provide for a system of patient advo19 cacy through the office established under sub20 section (g); 

21 ‘‘(H) provide case management services for 

22 any potential donor of bone marrow to whom 

23 the Program has provided a notice that the po24 tential donor may be suitably matched to a par-
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1 ticular patient through the office established 

2 under subsection (g); 

3 ‘‘(I) 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 in a standard7 ized electronic format on the number and per8 centage of patients at each of the various stages 

9 of the search process, including data regarding 

10 the furthest stage reached, the number and per11 centage of patients who are unable to complete 

12 the search process, and the reasons underlying 

13 such circumstances; 

14 ‘‘(J) support studies and demonstration 

15 and outreach projects for the purpose of in16 creasing the number of individuals who are will17 ing to be marrow donors to ensure a genetically 

18 diverse donor pool; and 

19 ‘‘(K) facilitate and support research to im20 prove the availability, efficiency, safety, and 

21 cost of transplants from unrelated donors and 

22 the effectiveness of Program operations. 

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

24 to cord blood, the Program shall— 
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1 ‘‘(A) operate a system for listing, search2 ing, and facilitating the distribution of donated 

3 cord blood units that are suitably matched to 

4 candidate patients and meet all applicable Fed5 eral and State regulations (including informed 

6 consent and Food and Drug Administration 

7 regulations) from a qualified cord blood bank; 

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

9 transplant physicians, other appropriate health 

10 care professionals, and patients to search by 

11 means of electronic access all available cord 

12 blood units made available through the Pro13 gram; 

14 ‘‘(C) allow transplant physicians and other 

15 appropriate health care professionals to reserve, 

16 as defined by the Secretary, a cord blood unit 

17 for transplantation; 

18 ‘‘(D) support studies and demonstration 

19 and outreach projects for the purpose of in20 creasing cord blood donation to ensure a geneti21 cally diverse collection of cord blood units; 

22 ‘‘(E) provide for a system of patient advo23 cacy through the office established under sub24 section (g); 
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1 ‘‘(F) coordinate with the qualified cord 

2 blood banks to carry out informational and edu3 cational activities in accordance with subsection 

4 (f); 

5 ‘‘(G) maintain and expand medical contin6 gency response capabilities, in coordination with 

7 Federal programs, to prepare for and respond 

8 effectively to biological, chemical, or radiological 

9 attacks, and other public health emergencies 

10 that can damage marrow, so that the capability 

11 of supporting patients with marrow damage 

12 from disease can be used to support casualties 

13 with marrow damage; and 

14 ‘‘(H) 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 ‘‘(3) SINGLE POINT OF ACCESS; SUBMISSION OF

25 DATA.— 
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1 ‘‘(A) SINGLE POINT OF ACCESS.—The Sec2 retary shall ensure that health care profes3 sionals and patients are able to, at a minimum, 

4 locate, consistent with the functions described 

5 in paragraphs (1)(A) and (2)(A), cells from 

6 bone marrow donors and cord blood units 

7 through a single electronic point of access. 

8 ‘‘(B) STANDARD DATA.—The Secretary 

9 shall require all recipients of contracts under 

10 this section to make available a standard 

11 dataset for purposes of subparagraph (A) in a 

12 standardized electronic format the enables 

13 transplant physicians to compare among and 

14 between bone marrow donors and cord blood 

15 units to ensure the best possible match for the 

16 patient. 

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

18 blood bank’ means a cord blood bank that— 

19 ‘‘(A) has obtained all applicable Federal 

20 and State licenses, certifications, registrations 

21 (including pursuant to the regulations of the 

22 Food and Drug Administration), and other au23 thorizations required to operate and maintain a 

24 cord blood bank; 
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1 ‘‘(B) has implemented donor screening, 

2 cord blood collection practices, and processing 

3 methods intended to protect the health and 

4 safety of donors and transplant recipients to 

5 improve transplant outcomes, including with re6 spect to the transmission of potentially harmful 

7 infections and other diseases; 

8 ‘‘(C) is accredited by an accreditation enti9 ty recognized by the Secretary under subsection 

10 (b); 

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

12 confidentiality to protect the identity and pri13 vacy of patients and donors in accordance with 

14 existing Federal and State law; 

15 ‘‘(E) has established a system for encour16 aging donation by a genetically diverse group of 

17 donors; and 

18 ‘‘(F) has established a system to confiden19 tially maintain linkage between a cord blood 

20 unit and a maternal donor. 

21 ‘‘(d) BONE MARROW RECRUITMENT; PRIORITIES; IN22 FORMATION AND EDUCATION.— 

23 ‘‘(1) RECRUITMENT; PRIORITIES.—The Pro24 gram shall carry out activities for the recruitment of 

25 bone marrow donors. Such recruitment program 
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1 shall identify populations that are underrepresented 

2 among potential donors enrolled with the Program. 

3 In the case of populations that are identified under 

4 the preceding sentence: 

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

6 carrying out activities under this part to in7 crease representation for such populations in 

8 order to enable a member of such a population, 

9 to the extent practicable, to have a probability 

10 of finding a suitable unrelated donor that is 

11 comparable to the probability that an individual 

12 who is not a member of an underrepresented 

13 population would have. 

14 ‘‘(B) The Program shall consider racial 

15 and ethnic minority groups (including persons 

16 of mixed ancestry) to be populations that have 

17 been identified for purposes of this paragraph, 

18 and shall carry out subparagraph (A) with re19 spect to such populations. 

20 ‘‘(2) INFORMATION AND EDUCATION REGARD21 ING RECRUITMENT; TESTING AND ENROLLMENT.— 

22 ‘‘(A) IN GENERAL.—The Program shall 

23 carry out informational and educational activi24 ties, in coordination with organ donation public 

25 awareness campaigns operated through the De-
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1 partment of Health and Human Services, for 

2 purposes of recruiting individuals to serve as 

3 donors of bone marrow, and shall test and en4 roll with the Program potential bone marrow 

5 donors. Such information and educational ac6 tivities shall include the following: 

7 ‘‘(i) Making information available to 

8 the general public, including information 

9 describing the needs of patients with re10 spect to donors of bone marrow. 

11 ‘‘(ii) Educating and providing infor12 mation to individuals who are willing to 

13 serve as potential bone marrow donors. 

14 ‘‘(iii) Training individuals in request15 ing individuals to serve as potential bone 

16 marrow donors. 

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

20 to recruiting individuals to serve as donors of 

21 bone marrow for populations that are identified 

22 under paragraph (1). 

23 ‘‘(3) TRANSPLANTATION AS TREATMENT OP24 TION.—In addition to activities regarding recruit25 ment, the recruitment program under paragraph (1) 
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1 shall provide information to physicians, other health 

2 care professionals, and the public regarding bone 

3 marrow transplants from unrelated donors as a 

4 treatment option. 

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

6 requirements of this subsection shall be carried out 

7 by the entity that has been awarded a contract by 

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

9 functions described in subsection (c)(1). 

10 ‘‘(e) BONE MARROW CRITERIA, STANDARDS, AND

11 PROCEDURES.—The Secretary shall enforce, for partici12 pating entities, including the Program, individual marrow 

13 donor centers, marrow donor registries, marrow collection 

14 centers, and marrow transplant centers— 

15 ‘‘(1) quality standards and standards for tissue 

16 typing, obtaining the informed consent of donors, 

17 and providing patient advocacy; 

18 ‘‘(2) donor selection criteria, based on estab19 lished medical criteria, to protect both the donor and 

20 the recipient and to prevent the transmission of po21 tentially harmful infectious diseases such as the vi22 ruses that cause hepatitis and the etiologic agent for 

23 Acquired Immune Deficiency Syndrome; 

24 ‘‘(3) procedures to ensure the proper collection 

25 and transportation of the marrow; 
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1 ‘‘(4) standards for the system for patient advo2 cacy operated under subsection (g), including stand3 ards requiring the provision of appropriate informa4 tion (at the start of the search process and through5 out the process) to patients and their families and 

6 physicians; 

7 ‘‘(5) standards that— 

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

9 of strict confidentiality of records relating to 

10 the identity, address, HLA type, and managing 

11 marrow donor center for marrow donors and 

12 potential marrow donors; and 

13 ‘‘(B) prescribe the purposes for which the 

14 records described in subparagraph (A) may be 

15 disclosed, and the circumstances and extent of 

16 the disclosure; and 

17 ‘‘(6) in the case of a marrow donor center or 

18 marrow donor registry participating in the program, 

19 procedures to ensure the establishment of a method 

20 for integrating donor files, searches, and general 

21 procedures of the center or registry with the Pro22 gram. 

23 ‘‘(f) CORD BLOOD RECRUITMENT; PRIORITIES; IN24 FORMATION AND EDUCATION.— 
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1 ‘‘(1) RECRUITMENT; PRIORITIES.—The Pro2 gram shall support activities, in cooperation with 

3 qualified cord blood banks, for the recruitment of 

4 cord blood donors. Such recruitment program shall 

5 identify populations that are underrepresented 

6 among cord blood donors. In the case of populations 

7 that are identified under the preceding sentence: 

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

9 supporting activities under this part to increase 

10 representation for such populations in order to 

11 enable a member of such a population, to the 

12 extent practicable, to have a probability of find13 ing a suitable cord blood unit that is com14 parable to the probability that an individual 

15 who is not a member of an underrepresented 

16 population would have. 

17 ‘‘(B) The Program shall consider racial 

18 and ethnic minority groups (including persons 

19 of mixed ancestry) to be populations that have 

20 been identified for purposes of this paragraph, 

21 and shall support activities under subparagraph 

22 (A) with respect to such populations. 

23 ‘‘(2) INFORMATION AND EDUCATION REGARD24 ING RECRUITMENT; TESTING AND DONATION.— 
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1 ‘‘(A) IN GENERAL.—In carrying out the 

2 recruitment program under paragraph (1), the 

3 Program shall support informational and edu4 cational activities in coordination with qualified 

5 cord blood banks and organ donation public 

6 awareness campaigns operated through the De7 partment of Health and Human Services, for 

8 purposes of recruiting pregnant women to serve 

9 as donors of cord blood. Such information and 

10 educational activities shall include the following: 

11 ‘‘(i) Making information available to 

12 the general public, including information 

13 describing the needs of patients with re14 spect to cord blood units. 

15 ‘‘(ii) Educating and providing infor16 mation to pregnant women who are willing 

17 to donate cord blood units. 

18 ‘‘(iii) Training individuals in request19 ing pregnant women to serve as cord blood 

20 donors. 

21 ‘‘(B) PRIORITIES.—In carrying out infor22 mational and educational activities under sub23 paragraph (A), the Program shall give priority 

24 to supporting the recruitment of pregnant 

25 women to serve as donors of cord blood for pop-
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1 ulations that are identified under paragraph 

2 (1). 

3 ‘‘(3) TRANSPLANTATION AS TREATMENT OP4 TION.—In addition to activities regarding recruit5 ment, the recruitment program under paragraph (1) 

6 shall provide information to physicians, other health 

7 care professionals, and the public regarding cord 

8 blood transplants from donors as a treatment option. 

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

10 requirements of this subsection shall be carried out 

11 by the entity that has been awarded a contract by 

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

13 functions described in subsection (c)(2). 

14 ‘‘(g) PATIENT ADVOCACY AND CASE MANAGEMENT

15 FOR BONE MARROW AND CORD BLOOD.— 

16 ‘‘(1) IN GENERAL.—The Secretary shall estab17 lish and maintain, through a contract or other 

18 means determined appropriate by the Secretary, an 

19 office of patient advocacy (in this subsection referred 

20 to as the ‘Office’). 

21 ‘‘(2) GENERAL FUNCTIONS.—The Office shall 

22 meet the following requirements: 

23 ‘‘(A) The Office shall be headed by a direc24 tor. 
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1 ‘‘(B) The Office shall be staffed by individ2 uals with expertise in bone marrow and cord 

3 blood therapy covered under the Program. 

4 ‘‘(C) The Office shall operate a system for 

5 patient advocacy, which shall be separate from 

6 mechanisms for donor advocacy, and which 

7 shall serve patients for whom the Program is 

8 conducting, or has been requested to conduct, a 

9 search for a bone marrow donor or cord blood 

10 unit. 

11 ‘‘(D) In the case of such a patient, the Of12 fice shall serve as an advocate for the patient 

13 by directly providing to the patient (or family 

14 members, physicians, or other individuals acting 

15 on behalf of the patient) individualized services 

16 with respect to efficiently utilizing the system 

17 under paragraphs (1) and (2) of subsection (c) 

18 to conduct an ongoing search for a bone mar19 row donor or cord blood unit and assist with in20 formation regarding third party payor matters. 

21 ‘‘(E) In carrying out subparagraph (D), 

22 the Office shall monitor the system under para23 graphs (1) and (2) of subsection (c) to deter24 mine whether the search needs of the patient 
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1 involved are being met, including with respect 

2 to the following: 

3 ‘‘(i) Periodically providing to the pa4 tient (or an individual acting on behalf of 

5 the patient) information regarding bone 

6 marrow donors or cord blood units that are 

7 suitably matched to the patient, and other 

8 information regarding the progress being 

9 made in the search. 

10 ‘‘(ii) Informing the patient (or such 

11 other individual) if the search has been in12 terrupted or discontinued. 

13 ‘‘(iii) Identifying and resolving prob14 lems in the search, to the extent prac15 ticable. 

16 ‘‘(F) The Office shall ensure that the fol17 lowing data are made available to patients: 

18 ‘‘(i) The resources available through 

19 the Program. 

20 ‘‘(ii) A comparison of transplant cen21 ters regarding search and other costs that 

22 prior to transplantation are charged to pa23 tients by transplant centers. 

24 ‘‘(iii) The post-transplant outcomes 

25 for individual transplant centers. 
29 

•S 1317 RS

1 ‘‘(iv) Information concerning issues 

2 that patients may face after a transplant. 

3 ‘‘(v) Such other information as the 

4 Program determines to be appropriate. 

5 ‘‘(G) The Office shall conduct surveys of 

6 patients (or family members, physicians, or 

7 other individuals acting on behalf of patients) 

8 to determine the extent of satisfaction with the 

9 system for patient advocacy under this sub10 section, and to identify ways in which the sys11 tem can be improved to best meet the needs of 

12 patients. 

13 ‘‘(3) CASE MANAGEMENT.— 

14 ‘‘(A) IN GENERAL.—In serving as an advo15 cate for a patient under paragraph (2), the Of16 fice shall provide individualized case manage17 ment services directly to the patient (or family 

18 members, physicians, or other individuals acting 

19 on behalf of the patient), including— 

20 ‘‘(i) individualized case assessment; 

21 and 

22 ‘‘(ii) the functions described in para23 graph (2)(D) (relating to progress in the 

24 search process). 
30 

•S 1317 RS

1 ‘‘(B) POSTSEARCH FUNCTIONS.—In addi2 tion to the case management services described 

3 in paragraph (1) for patients, the Office shall, 

4 on behalf of patients who have completed the 

5 search for a bone marrow donor or cord blood 

6 unit, provide information and education on the 

7 process of receiving a transplant, including the 

8 post-transplant process. 

9 ‘‘(h) COMMENT PROCEDURES.—The Secretary shall 

10 establish and provide information to the public on proce11 dures under which the Secretary shall receive and consider 

12 comments from interested persons relating to the manner 

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

14 Program. 

15 ‘‘(i) CONSULTATION.—In developing policies affect16 ing the Program, the Secretary shall consult with the Ad17 visory Council, the Department of Defense Marrow Donor 

18 Recruitment and Research Program operated by the De19 partment of the Navy, and the board of directors of each 

20 entity awarded a contract under this section. 

21 ‘‘(j) CONTRACTS.— 

22 ‘‘(1) APPLICATION.—To be eligible to enter into 

23 a contract under this section, an entity shall submit 

24 to the Secretary and obtain approval of an applica25 tion at such time, in such manner, and containing 
31 

•S 1317 RS

1 such information as the Secretary shall by regulation 

2 prescribe. 

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

4 under this section, the Secretary shall give consider5 ation to the continued safety of donors and patients 

6 and other factors deemed appropriate by the Sec7 retary. 

8 ‘‘(k) ELIGIBILITY.—Entities eligible to receive a con9 tract under this section shall include private nonprofit en10 tities. 

11 ‘‘(l) RECORDS.— 

12 ‘‘(1) RECORDKEEPING.—Each recipient of a 

13 contract or subcontract under subsection (a) shall 

14 keep such records as the Secretary shall prescribe, 

15 including records that fully disclose the amount and 

16 disposition by the recipient of the proceeds of the 

17 contract, the total cost of the undertaking in connec18 tion with which the contract was made, and the 

19 amount of the portion of the cost of the undertaking 

20 supplied by other sources, and such other records as 

21 will facilitate an effective audit. 

22 ‘‘(2) EXAMINATION OF RECORDS.—The Sec23 retary and the Comptroller General of the United 

24 States shall have access to any books, documents, 

25 papers, and records of the recipient of a contract or 
32 

•S 1317 RS

1 subcontract entered into under this section that are 

2 pertinent to the contract, for the purpose of con3 ducting audits and examinations. 

4 ‘‘(m) PENALTIES FOR DISCLOSURE.—Any person 

5 who discloses the content of any record referred to in sub6 section (c)(4)(D) or (e)(5)(A) without the prior written 

7 consent of the donor or potential donor with respect to 

8 whom the record is maintained, or in violation of the 

9 standards described in subsection (e)(5)(B), shall be im10 prisoned for not more than 2 years or fined in accordance 

11 with title 18, United States Code, or both.’’. 

12 (b) STEM CELL THERAPEUTIC OUTCOMES DATA13 BASE.—Section 379A of the Public Health Service Act (42 

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

15 ‘‘SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATA16 BASE. 

17 ‘‘(a) ESTABLISHMENT.—The Secretary shall by con18 tract establish and maintain a scientific database of infor19 mation relating to patients who have been recipients of 

20 a stem cell therapeutics product (including bone marrow, 

21 cord blood, or other such product) from a donor. 

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

23 include information in a standardized electronic format 

24 with respect to patients described in subsection (a), diag25 nosis, transplant procedures, results, long-term follow-up, 
33 

•S 1317 RS

1 and such other information as the Secretary determines 

2 to be appropriate, to conduct an ongoing evaluation of the 

3 scientific and clinical status of transplantation involving 

4 recipients of a stem cell therapeutics product from a 

5 donor. 

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

7 The Secretary shall require the entity awarded a contract 

8 under this section to submit to the Secretary an annual 

9 report concerning patient outcomes with respect to each 

10 transplant center, based on data collected and maintained 

11 by the entity pursuant to this section. 

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

13 database shall make relevant scientific information not 

14 containing individually identifiable information available 

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

16 encourage medical research and to provide information to 

17 transplant programs, physicians, patients, entities award18 ed a contract under section 379 donor registries, and cord 

19 blood banks.’’. 

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

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

22 by inserting after section 379A the following: 

23 ‘‘SEC. 379A–1. DEFINITIONS. 

24 ‘‘In this part: 
34 

•S 1317 RS

1 ‘‘(1) The term ‘Advisory Council’ means the ad2 visory council established by the Secretary under 

3 section 379(a)(1). 

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

5 found in adult bone marrow and peripheral blood. 

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

7 database established by the Secretary under section 

8 379A. 

9 ‘‘(4) The term ‘Program’ means the Bone Mar10 row and Cord Blood Cell Transplantation Program 

11 established under section 379.’’. 

12 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

13 379B of the Public Health Service Act (42 U.S.C. 274m) 

14 is amended to read as follows: 

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

16 ‘‘For the purpose of carrying out this part, there are 

17 authorized to be appropriated $34,000,000 for fiscal year 

18 2006 and $38,000,000 for each of fiscal years 2007 

19 through 2010.’’. 

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

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

22 is amended in the part heading, by striking ‘‘NA23 TIONAL BONE MARROW DONOR REG24 ISTRY’’ and inserting ‘‘BONE MARROW AND 
35 

•S 1317 RS

1 CORD BLOOD CELL TRANSPLANTATION 

2 PROGRAM’’. 

3 SEC. 4. REPORT ON LICENSURE OF CORD BLOOD UNITS. 

4 Not later than 90 days after the date of enactment 

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

6 in consultation with the Commissioner of Food and Drugs, 

7 shall submit to Congress a report concerning the progress 

8 made by the Food and Drug Administration in developing 

9 requirements for the licensing of cord blood units. 

10 SECTION 1. SHORT TITLE. 

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

12 and Research Act of 2005’’. 

13 SEC. 2. CORD BLOOD INVENTORY. 

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

15 Human Services shall enter into one-time contracts with 

16 qualified cord blood banks to assist in the collection and 

17 maintenance of 150,000 new units of high-quality cord 

18 blood to be made available for transplantation through the 

19 C.W. Bill Young Cell Transplantation Program and to 

20 carry out the requirements of subsection (b). 

21 (b) REQUIREMENTS.—The Secretary shall require each 

22 recipient of a contract under this section— 

23 (1) to acquire, tissue-type, test, cryopreserve, and 

24 store donated units of cord blood acquired with the 

25 informed consent of the donor, as determined by the 
36 

•S 1317 RS

1 Secretary pursuant to section 379(c) of the Public 

2 Health Service Act, in a manner that complies with 

3 applicable Federal and State regulations; 

4 (2) to encourage donation from a genetically di5 verse population; 

6 (3) to make cord blood units that are collected 

7 pursuant to this section or otherwise and meet all ap8 plicable Federal standards available to transplant 

9 centers for transplantation; 

10 (4) to make cord blood units that are collected, 

11 but not appropriate for clinical use, available for 

12 peer-reviewed research; 

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

14 Secretary and consistent with section 379(d)(3) of the 

15 Public Health Service Act (42 U.S.C. 274k(d)(3)), as 

16 amended by this Act, in a standardized electronic for17 mat, as determined by the Secretary, for the C.W. Bill 

18 Young Cell Transplantation Program; and 

19 (6) to submit data in a standardized electronic 

20 format for inclusion in the stem cell therapeutic out21 comes database maintained under section 379A of the 

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

23 (c) RELATED CORD BLOOD DONORS.— 

24 (1) IN GENERAL.—The Secretary shall establish 

25 a 3-year demonstration project under which qualified 
37 

•S 1317 RS

1 cord blood banks receiving a contract under this sec2 tion may use a portion of the funding under such 

3 contract for the collection and storage of cord blood 

4 units for a family where a first-degree relative has 

5 been diagnosed with a condition that will benefit from 

6 transplantation (including selected blood disorders, 

7 malignancies, metabolic storage disorders, 

8 hemoglobinopathies, and congenital 

9 immunodeficiencies) at no cost to such family. Quali10 fied cord blood banks collecting cord blood units under 

11 this paragraph shall comply with the requirements of 

12 paragraphs (1), (2), (3), and (5) of subsection (b). 

13 (2) AVAILABILITY.—Qualified cord blood banks 

14 that are operating a program under paragraph (1) 

15 shall provide assurances that the cord blood units in 

16 such banks will be available for directed transplan17 tation until such time that the cord blood unit is re18 leased for transplantation or is transferred by the 

19 family to the C.W. Bill Young Cell Transplantation 

20 Program in accordance with guidance or regulations 

21 promulgated by the Secretary. 

22 (3) INVENTORY.—Cord blood units collected 

23 through the program under this section shall not be 

24 counted toward the 150,000 inventory goal under the 

25 C.W. Bill Young Cell Transplantation Program. 
38 

•S 1317 RS

1 (4) REPORT.—Not later than 90 days after the 

2 date on which the project under paragraph (1) is ter3 minated by the Secretary, the Secretary shall submit 

4 to Congress a report on the outcomes of the project 

5 that shall include the recommendations of the Sec6 retary with respect to the continuation of such 

7 project. 

8 (d) APPLICATION.—To seek to enter into a contract 

9 under this section, a qualified cord blood bank shall submit 

10 an application to the Secretary at such time, in such man11 ner, and containing such information as the Secretary may 

12 reasonably require. At a minimum, an application for a 

13 contract under this section shall include a requirement that 

14 the applicant— 

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

16 Transplantation Program for a period of at least 10 

17 years; 

18 (2) will make cord blood units collected pursuant 

19 to this section available through the C.W. Bill Young 

20 Cell Transplantation Program in perpetuity or for 

21 such time as determined viable by the Secretary; and 

22 (3) if the Secretary determines through an as23 sessment, or through petition by the applicant, that a 

24 cord blood bank is no longer operational or does not 

25 meet the requirements of section 379(d)(4) of the Pub-
39 

•S 1317 RS

1 lic Health Service Act (as added by this Act) and as 

2 a result may not distribute the units, transfer the 

3 units collected pursuant to this section to another 

4 qualified cord blood bank approved by the Secretary 

5 to ensure continued availability of cord blood units. 

6 (e) DURATION OF CONTRACTS.— 

7 (1) IN GENERAL.—Except as provided in para8 graph (2), the term of each contract entered into by 

9 the Secretary under this section shall be for 10 years. 

10 The Secretary shall ensure that no Federal funds shall 

11 be obligated under any such contract after the earlier 

12 of— 

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

14 on which the contract is entered into; or 

15 (B) September 30, 2010. 

16 (2) EXTENSIONS.—Subject to paragraph (1)(B), 

17 the Secretary may extend the period of funding under 

18 a contract under this section to exceed a period of 3 

19 years if— 

20 (A) the Secretary finds that 150,000 new 

21 units of high-quality cord blood have not yet 

22 been collected pursuant to this section; and 

23 (B) the Secretary does not receive an appli24 cation for a contract under this section from any 

25 qualified cord blood bank that has not previously 
40 

•S 1317 RS

1 entered into a contract under this section or the 

2 Secretary determines that the outstanding inven3 tory need cannot be met by the one or more 

4 qualified cord blood banks that have submitted 

5 an application for a contract under this section. 

6 (3) PREFERENCE.—In considering contract ex7 tensions under paragraph (2), the Secretary shall give 

8 preference to qualified cord blood banks that the Sec9 retary determines have demonstrated a superior abil10 ity to satisfy the requirements described in subsection 

11 (b) and to achieve the overall goals for which the con12 tract was awarded. 

13 (f) REGULATIONS.—The Secretary may promulgate 

14 regulations to carry out this section. 

15 (g) DEFINITIONS.—In this section: 

16 (1) The term ‘‘C. W. Bill Young Cell Transplan17 tation Program’’ means the C.W. Bill Young Cell 

18 Transplantation Program under section 379 of the 

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

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

21 who has delivered a baby and consents to donate the 

22 neonatal blood remaining in the placenta and umbil23 ical cord after separation from the newborn baby. 
41 

•S 1317 RS

1 (3) The term ‘‘cord blood unit’’ means the neo2 natal blood collected from the placenta and umbilical 

3 cord of a single newborn baby. 

4 (4) The term ‘‘first-degree relative’’ means a sib5 ling or parent who is one meiosis away from a par6 ticular individual in a family. 

7 (5) The term ‘‘qualified cord blood bank’’ has the 

8 meaning given to that term in section 379(d)(4) of the 

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

10 (6) The term ‘‘Secretary’’ means the Secretary of 

11 Health and Human Services. 

12 (h) AUTHORIZATION OF APPROPRIATIONS.— 

13 (1) EXISTING FUNDS.—Any amounts appro14 priated to the Secretary for fiscal year 2004 or 2005 

15 for the purpose of assisting in the collection or main16 tenance of cord blood shall remain available to the 

17 Secretary until the end of fiscal year 2007. 

18 (2) SUBSEQUENT FISCAL YEARS.—There are au19 thorized to be appropriated to the Secretary 

20 $15,000,000 for each of fiscal years 2007, 2008, 2009, 

21 and 2010 to carry out this section. 

22 (3) LIMITATION.—Not to exceed 5 percent of the 

23 amount appropriated under this section in each of 

24 fiscal years 2007 through 2009 may be used to carry 

25 out the demonstration project under subsection (c). 
42 

•S 1317 RS

1 SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PRO2 GRAM. 

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

4 Health Service Act (42 U.S.C. 274k) is amended to read 

5 as follows: 

6 ‘‘SEC. 379. NATIONAL PROGRAM. 

7 ‘‘(a) ESTABLISHMENT.—The Secretary, acting through 

8 the Administrator of the Health Resources and Services Ad9 ministration, shall by one or more contracts establish and 

10 maintain a C.W. Bill Young Cell Transplantation Program 

11 (referred to in this section as the ‘Program’), successor to 

12 the National Bone Marrow Donor Registry, that has the 

13 purpose of increasing the number of transplants for recipi14 ents suitably matched to biologically unrelated donors of 

15 bone marrow and cord blood, and that meets the require16 ments of this section. The Secretary may award a separate 

17 contract to perform each of the major functions of the Pro18 gram described in paragraphs (1) and (2) of subsection (d) 

19 if deemed necessary by the Secretary to operate an effective 

20 and efficient system that is in the best interest of patients. 

21 The Secretary shall conduct a separate competition for the 

22 initial establishment of the cord blood functions of the Pro23 gram. The Program shall be under the general supervision 

24 of the Secretary. The Secretary shall establish an Advisory 

25 Council to advise, assist, consult with, and make rec26 ommendations to the Secretary on matters related to the 
43 

•S 1317 RS

1 activities carried out by the Program. The members of the 

2 Advisory Council shall be appointed in accordance with the 

3 following: 

4 ‘‘(1) Each member of the Advisory Council shall 

5 serve for a term of 2 years, and each such member 

6 may serve as many as 3 consecutive 2-year terms, ex7 cept that 

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

9 Chair of the Advisory Council (or the Chair10 elect) or to the member of the Advisory Council 

11 who most recently served as the Chair; and 

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

13 may be served by any member of the Advisory 

14 Council who has no employment, governance, or 

15 financial affiliation with any donor center, re16 cruitment organization, transplant center, or 

17 cord blood bank. 

18 ‘‘(2) A member of the Advisory Council may con19 tinue to serve after the expiration of the term of such 

20 member until a successor is appointed. 

21 ‘‘(3) In order to ensure the continuity of the Ad22 visory Council, the Advisory Council shall be ap23 pointed so that each year the terms of approximately 

24 one-third of the members of the Advisory Council ex25 pire. 
44 

•S 1317 RS

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

2 ‘‘(A) shall include as voting members a bal3 anced number of representatives including rep4 resentatives of marrow donor centers and mar5 row transplant centers, representatives of cord 

6 blood banks and participating birthing hospitals, 

7 recipients of a bone marrow transplant, recipi8 ents of a cord blood transplant, persons who re9 quire such transplants, family members of such 

10 a recipient or family members of a patient who 

11 has requested the assistance of the Program in 

12 searching for an unrelated donor of bone marrow 

13 or cord blood, persons with expertise in bone 

14 marrow and cord blood transplantation, persons 

15 with expertise in typing, matching, and trans16 plant outcome data analysis, persons with exper17 tise in the social sciences, basic scientists with 

18 expertise in the biology of adult stem cells, and 

19 members of the general public; and 

20 ‘‘(B) shall include as nonvoting members 

21 representatives from the Department of Defense 

22 Marrow Donor Recruitment and Research Pro23 gram operated by the Department of the Navy, 

24 the Division of Transplantation of the Health 

25 Resources and Services Administration, the Food 
45 

•S 1317 RS

1 and Drug Administration, and the National In2 stitutes of Health. 

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

4 chosen so as to ensure objectivity and balance and re5 duce the potential for conflicts of interest. The Sec6 retary shall establish bylaws and procedures— 

7 ‘‘(A) to prohibit any member of the Advi8 sory Council who has an employment, govern9 ance, or financial affiliation with a donor cen10 ter, recruitment organization, transplant center, 

11 or cord blood bank from participating in any de12 cision that materially affects the center, recruit13 ment organization, transplant center, or cord 

14 blood bank; and 

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

16 Advisory Council with any such affiliation. 

17 ‘‘(6) The Secretary, acting through the Advisory 

18 Council, shall submit to the Congress— 

19 ‘‘(A) an annual report on the activities car20 ried out under this section; and 

21 ‘‘(B) not later than 6 months after the date 

22 of the enactment of the Stem Cell Therapeutic 

23 and Research Act of 2005, a report of rec24 ommendations on the scientific factors necessary 
46 

•S 1317 RS

1 to define a cord blood unit as a high-quality 

2 unit. 

3 ‘‘(b) ACCREDITATION.—The Secretary shall, through a 

4 public process, recognize one or more accreditation entities 

5 for the accreditation of cord blood banks. 

6 ‘‘(c) INFORMED CONSENT.—The Secretary shall, 

7 through a public process, examine issues of informed con8 sent, including— 

9 ‘‘(1) the appropriate timing of such consent; and 

10 ‘‘(2) the information provided to the maternal 

11 donor regarding all of her medically appropriate cord 

12 blood options. 

13 Based on such examination, the Secretary shall require that 

14 the standards used by the accreditation entities recognized 

15 under subsection (b) ensure that a cord blood unit is ac16 quired with the informed consent of the maternal donor. 

17 ‘‘(d) FUNCTIONS.— 

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

19 to bone marrow, the Program shall— 

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

21 matching, and facilitating the distribution of 

22 bone marrow that is suitably matched to can23 didate patients; 

24 ‘‘(B) consistent with paragraph (3), permit 

25 transplant physicians, other appropriate health 
47 

•S 1317 RS

1 care professionals, and patients to search by 

2 means of electronic access all available bone 

3 marrow donors listed in the Program; 

4 ‘‘(C) carry out a program for the recruit5 ment of bone marrow donors in accordance with 

6 subsection (e), including with respect to increas7 ing the representation of racial and ethnic mi8 nority groups (including persons of mixed ances9 try) in the enrollment of the Program; 

10 ‘‘(D) maintain and expand medical contin11 gency response capabilities, in coordination with 

12 Federal programs, to prepare for and respond ef13 fectively to biological, chemical, or radiological 

14 attacks, and other public health emergencies that 

15 can damage marrow, so that the capability of 

16 supporting patients with marrow damage from 

17 disease can be used to support casualties with 

18 marrow damage; 

19 ‘‘(E) carry out informational and edu20 cational activities in accordance with subsection 

21 (e); 

22 ‘‘(F) at least annually update information 

23 to account for changes in the status of individ24 uals as potential donors of bone marrow; 
48 

•S 1317 RS

1 ‘‘(G) provide for a system of patient advo2 cacy through the office established under sub3 section (h); 

4 ‘‘(H) provide case management services for 

5 any potential donor of bone marrow to whom the 

6 Program has provided a notice that the potential 

7 donor may be suitably matched to a particular 

8 patient through the office established under sub9 section (h); 

10 ‘‘(I) with respect to searches for unrelated 

11 donors of bone marrow that are conducted 

12 through the system under subparagraph (A), col13 lect, analyze, and publish data in a standardized 

14 electronic format on the number and percentage 

15 of patients at each of the various stages of the 

16 search process, including data regarding the fur17 thest stage reached, the number and percentage of 

18 patients who are unable to complete the search 

19 process, and the reasons underlying such cir20 cumstances; 

21 ‘‘(J) support studies and demonstration and 

22 outreach projects for the purpose of increasing 

23 the number of individuals who are willing to be 

24 marrow donors to ensure a genetically diverse 

25 donor pool; and 
49 

•S 1317 RS

1 ‘‘(K) facilitate research with the appro2 priate Federal agencies to improve the avail3 ability, efficiency, safety, and cost of transplants 

4 from unrelated donors and the effectiveness of 

5 Program operations. 

6 ‘‘(2) CORD BLOOD FUNCTIONS.—With respect to 

7 cord blood, the Program shall— 

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

9 matching, and facilitating the distribution of do10 nated cord blood units that are suitably matched 

11 to candidate patients and meet all applicable 

12 Federal and State regulations (including in13 formed consent and Food and Drug Administra14 tion regulations) from a qualified cord blood 

15 bank; 

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

17 transplant physicians, other appropriate health 

18 care professionals, and patients to search by 

19 means of electronic access all available cord 

20 blood units made available through the Program; 

21 ‘‘(C) allow transplant physicians and other 

22 appropriate health care professionals to reserve, 

23 as defined by the Secretary, a cord blood unit for 

24 transplantation; 
50 

•S 1317 RS

1 ‘‘(D) support studies and demonstration 

2 and outreach projects for the purpose of increas3 ing cord blood donation to ensure a genetically 

4 diverse collection of cord blood units; 

5 ‘‘(E) provide for a system of patient advo6 cacy through the office established under sub7 section (h); 

8 ‘‘(F) coordinate with the qualified cord 

9 blood banks to support informational and edu10 cational activities in accordance with subsection 

11 (g); 

12 ‘‘(G) maintain and expand medical contin13 gency response capabilities, in coordination with 

14 Federal programs, to prepare for and respond ef15 fectively to biological, chemical, or radiological 

16 attacks, and other public health emergencies that 

17 can damage marrow, so that the capability of 

18 supporting patients with marrow damage from 

19 disease can be used to support casualties with 

20 marrow damage; and 

21 ‘‘(H) with respect to the system under sub22 paragraph (A), collect, analyze, and publish data 

23 in a standardized electronic format, as required 

24 by the Secretary, on the number and percentage 

25 of patients at each of the various stages of the 
51 

•S 1317 RS

1 search process, including data regarding the fur2 thest stage reached, the number and percentage of 

3 patients who are unable to complete the search 

4 process, and the reasons underlying such cir5 cumstances. 

6 ‘‘(3) SINGLE POINT OF ACCESS; STANDARD

7 DATA.— 

8 ‘‘(A) SINGLE POINT OF ACCESS.—The Sec9 retary shall ensure that health care professionals 

10 and patients are able to search electronically for 

11 and facilitate access to, in the manner and to the 

12 extent defined by the Secretary and consistent 

13 with the functions described in paragraphs 

14 (1)(A) and (2)(A), cells from bone marrow do15 nors and cord blood units through a single point 

16 of access. 

17 ‘‘(B) STANDARD DATA.—The Secretary shall 

18 require all recipients of contracts under this sec19 tion to make available a standard dataset for 

20 purposes of subparagraph (A) in a standardized 

21 electronic format that enables transplant physi22 cians to compare among and between bone mar23 row donors and cord blood units to ensure the 

24 best possible match for the patient. 
52 

•S 1317 RS

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

2 blood bank’ means a cord blood bank that— 

3 ‘‘(A) has obtained all applicable Federal 

4 and State licenses, certifications, registrations 

5 (including pursuant to the regulations of the 

6 Food and Drug Administration), and other au7 thorizations required to operate and maintain a 

8 cord blood bank; 

9 ‘‘(B) has implemented donor screening, cord 

10 blood collection practices, and processing meth11 ods intended to protect the health and safety of 

12 donors and transplant recipients to improve 

13 transplant outcomes, including with respect to 

14 the transmission of potentially harmful infec15 tions and other diseases; 

16 ‘‘(C) is accredited by an accreditation enti17 ty recognized by the Secretary under subsection 

18 (b); 

19 ‘‘(D) has established a system of strict con20 fidentiality to protect the identity and privacy of 

21 patients and donors in accordance with existing 

22 Federal and State law; 

23 ‘‘(E) has established a system for encour24 aging donation by a genetically diverse group of 

25 donors; and 
53 

•S 1317 RS

1 ‘‘(F) has established a system to confiden2 tially maintain linkage between a cord blood 

3 unit and a maternal donor. 

4 ‘‘(e) BONE MARROW RECRUITMENT; PRIORITIES; IN5 FORMATION AND EDUCATION.— 

6 ‘‘(1) RECRUITMENT; PRIORITIES.—The Program 

7 shall carry out activities for the recruitment of bone 

8 marrow donors. Such recruitment program shall 

9 identify populations that are underrepresented among 

10 potential donors enrolled with the Program. In the 

11 case of populations that are identified under the pre12 ceding sentence: 

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

14 carrying out activities under this part to in15 crease representation for such populations in 

16 order to enable a member of such a population, 

17 to the extent practicable, to have a probability of 

18 finding a suitable unrelated donor that is com19 parable to the probability that an individual 

20 who is not a member of an underrepresented 

21 population would have. 

22 ‘‘(B) The Program shall consider racial and 

23 ethnic minority groups (including persons of 

24 mixed ancestry) to be populations that have been 

25 identified for purposes of this paragraph, and 
54 

•S 1317 RS

1 shall carry out subparagraph (A) with respect to 

2 such populations. 

3 ‘‘(2) INFORMATION AND EDUCATION REGARDING

4 RECRUITMENT; TESTING AND ENROLLMENT.— 

5 ‘‘(A) IN GENERAL.—The Program shall 

6 carry out informational and educational activi7 ties, in coordination with organ donation public 

8 awareness campaigns operated through the De9 partment of Health and Human Services, for 

10 purposes of recruiting individuals to serve as do11 nors of bone marrow, and shall test and enroll 

12 with the Program potential bone marrow donors. 

13 Such information and educational activities 

14 shall include the following: 

15 ‘‘(i) Making information available to 

16 the general public, including information 

17 describing the needs of patients with respect 

18 to donors of bone marrow. 

19 ‘‘(ii) Educating and providing infor20 mation to individuals who are willing to 

21 serve as potential bone marrow donors. 

22 ‘‘(iii) Training individuals in request23 ing individuals to serve as potential bone 

24 marrow donors. 
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1 ‘‘(B) PRIORITIES.—In carrying out infor2 mational and educational activities under sub3 paragraph (A), the Program shall give priority 

4 to recruiting individuals to serve as donors of 

5 bone marrow for populations that are identified 

6 under paragraph (1). 

7 ‘‘(3) TRANSPLANTATION AS TREATMENT OP8 TION.—In addition to activities regarding recruit9 ment, the recruitment program under paragraph (1) 

10 shall provide information to physicians, other health 

11 care professionals, and the public regarding bone 

12 marrow transplants from unrelated donors as a treat13 ment option. 

14 ‘‘(4) IMPLEMENTATION OF SUBSECTION.—The re15 quirements of this subsection shall be carried out by 

16 the entity that has been awarded a contract by the 

17 Secretary under subsection (a) to carry out the func18 tions described in subsection (d)(1). 

19 ‘‘(f) BONE MARROW CRITERIA, STANDARDS, AND PRO20 CEDURES.—The Secretary shall enforce, for participating 

21 entities, including the Program, individual marrow donor 

22 centers, marrow donor registries, marrow collection centers, 

23 and marrow transplant centers— 
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1 ‘‘(1) quality standards and standards for tissue 

2 typing, obtaining the informed consent of donors, and 

3 providing patient advocacy; 

4 ‘‘(2) donor selection criteria, based on established 

5 medical criteria, to protect both the donor and the re6 cipient and to prevent the transmission of potentially 

7 harmful infectious diseases such as the viruses that 

8 cause hepatitis and the etiologic agent for Acquired 

9 Immune Deficiency Syndrome; 

10 ‘‘(3) procedures to ensure the proper collection 

11 and transportation of the marrow; 

12 ‘‘(4) standards for the system for patient advo13 cacy operated under subsection (h), including stand14 ards requiring the provision of appropriate informa15 tion (at the start of the search process and throughout 

16 the process) to patients and their families and physi17 cians; 

18 ‘‘(5) standards that— 

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

20 of strict confidentiality of records relating to the 

21 identity, address, HLA type, and managing 

22 marrow donor center for marrow donors and po23 tential marrow donors; and 

24 ‘‘(B) prescribe the purposes for which the 

25 records described in subparagraph (A) may be 
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1 disclosed, and the circumstances and extent of 

2 the disclosure; and 

3 ‘‘(6) in the case of a marrow donor center or 

4 marrow donor registry participating in the program, 

5 procedures to ensure the establishment of a method for 

6 integrating donor files, searches, and general proce7 dures of the center or registry with the Program. 

8 ‘‘(g) CORD BLOOD RECRUITMENT; PRIORITIES; INFOR9 MATION AND EDUCATION.— 

10 ‘‘(1) RECRUITMENT; PRIORITIES.—The Program 

11 shall support activities, in cooperation with qualified 

12 cord blood banks, for the recruitment of cord blood do13 nors. Such recruitment program shall identify popu14 lations that are underrepresented among cord blood 

15 donors. In the case of populations that are identified 

16 under the preceding sentence: 

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

18 supporting activities under this part to increase 

19 representation for such populations in order to 

20 enable a member of such a population, to the ex21 tent practicable, to have a probability of finding 

22 a suitable cord blood unit that is comparable to 

23 the probability that an individual who is not a 

24 member of an underrepresented population 

25 would have. 
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1 ‘‘(B) The Program shall consider racial and 

2 ethnic minority groups (including persons of 

3 mixed ancestry) to be populations that have been 

4 identified for purposes of this paragraph, and 

5 shall support activities under subparagraph (A) 

6 with respect to such populations. 

7 ‘‘(2) INFORMATION AND EDUCATION REGARDING

8 RECRUITMENT; TESTING AND DONATION.— 

9 ‘‘(A) IN GENERAL.—In carrying out the re10 cruitment program under paragraph (1), the 

11 Program shall support informational and edu12 cational activities in coordination with qualified 

13 cord blood banks and organ donation public 

14 awareness campaigns operated through the De15 partment of Health and Human Services, for 

16 purposes of recruiting pregnant women to serve 

17 as donors of cord blood. Such information and 

18 educational activities shall include the following: 

19 ‘‘(i) Making information available to 

20 the general public, including information 

21 describing the needs of patients with respect 

22 to cord blood units. 

23 ‘‘(ii) Educating and providing infor24 mation to pregnant women who are willing 

25 to donate cord blood units. 
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1 ‘‘(iii) Training individuals in request2 ing pregnant women to serve as cord blood 

3 donors. 

4 ‘‘(B) PRIORITIES.—In carrying out infor5 mational and educational activities under sub6 paragraph (A), the Program shall give priority 

7 to supporting the recruitment of pregnant 

8 women to serve as donors of cord blood for popu9 lations that are identified under paragraph (1). 

10 ‘‘(3) TRANSPLANTATION AS TREATMENT OP11 TION.—In addition to activities regarding recruit12 ment, the recruitment program under paragraph (1) 

13 shall provide information to physicians, other health 

14 care professionals, and the public regarding cord 

15 blood transplants from donors as a treatment option. 

16 ‘‘(4) IMPLEMENTATION OF SUBSECTION.—The re17 quirements of this subsection shall be carried out by 

18 the entity that has been awarded a contract by the 

19 Secretary under subsection (a) to carry out the func20 tions described in subsection (d)(2). 

21 ‘‘(h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR

22 BONE MARROW AND CORD BLOOD.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall establish 

24 and maintain, through a contract or other means de25 termined appropriate by the Secretary, an office of 
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1 patient advocacy (in this subsection referred to as the 

2 ‘Office’). 

3 ‘‘(2) GENERAL FUNCTIONS.—The Office shall 

4 meet the following requirements: 

5 ‘‘(A) The Office shall be headed by a direc6 tor. 

7 ‘‘(B) The Office shall be staffed by individ8 uals with expertise in bone marrow and cord 

9 blood therapy covered under the Program. 

10 ‘‘(C) The Office shall operate a system for 

11 patient advocacy, which shall be separate from 

12 mechanisms for donor advocacy, and which shall 

13 serve patients for whom the Program is con14 ducting, or has been requested to conduct, a 

15 search for a bone marrow donor or cord blood 

16 unit. 

17 ‘‘(D) In the case of such a patient, the Of18 fice shall serve as an advocate for the patient by 

19 directly providing to the patient (or family 

20 members, physicians, or other individuals acting 

21 on behalf of the patient) individualized services 

22 with respect to efficiently utilizing the system 

23 under paragraphs (1) and (2) of subsection (d) 

24 to conduct an ongoing search for a bone marrow 
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1 donor or cord blood unit and assist with infor2 mation regarding third party payor matters. 

3 ‘‘(E) In carrying out subparagraph (D), the 

4 Office shall monitor the system under para5 graphs (1) and (2) of subsection (d) to determine 

6 whether the search needs of the patient involved 

7 are being met, including with respect to the fol8 lowing: 

9 ‘‘(i) Periodically providing to the pa10 tient (or an individual acting on behalf of 

11 the patient) information regarding bone 

12 marrow donors or cord blood units that are 

13 suitably matched to the patient, and other 

14 information regarding the progress being 

15 made in the search. 

16 ‘‘(ii) Informing the patient (or such 

17 other individual) if the search has been in18 terrupted or discontinued. 

19 ‘‘(iii) Identifying and resolving prob20 lems in the search, to the extent practicable. 

21 ‘‘(F) The Office shall ensure that the fol22 lowing data are made available to patients: 

23 ‘‘(i) The resources available through 

24 the Program. 
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1 ‘‘(ii) A comparison of transplant cen2 ters regarding search and other costs that 

3 prior to transplantation are charged to pa4 tients by transplant centers. 

5 ‘‘(iii) The post-transplant outcomes for 

6 individual transplant centers. 

7 ‘‘(iv) Information concerning issues 

8 that patients may face after a transplant. 

9 ‘‘(v) Such other information as the 

10 Program determines to be appropriate. 

11 ‘‘(G) The Office shall conduct surveys of pa12 tients (or family members, physicians, or other 

13 individuals acting on behalf of patients) to deter14 mine the extent of satisfaction with the system 

15 for patient advocacy under this subsection, and 

16 to identify ways in which the system can be im17 proved to best meet the needs of patients. 

18 ‘‘(3) CASE MANAGEMENT.— 

19 ‘‘(A) IN GENERAL.—In serving as an advo20 cate for a patient under paragraph (2), the Of21 fice shall provide individualized case manage22 ment services directly to the patient (or family 

23 members, physicians, or other individuals acting 

24 on behalf of the patient), including— 
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1 ‘‘(i) individualized case assessment; 

2 and 

3 ‘‘(ii) the functions described in para4 graph (2)(D) (relating to progress in the 

5 search process). 

6 ‘‘(B) POSTSEARCH FUNCTIONS.—In addi7 tion to the case management services described in 

8 paragraph (1) for patients, the Office shall, on 

9 behalf of patients who have completed the search 

10 for a bone marrow donor or cord blood unit, pro11 vide information and education on the process of 

12 receiving a transplant, including the post-trans13 plant process. 

14 ‘‘(i) COMMENT PROCEDURES.—The Secretary shall es15 tablish and provide information to the public on procedures 

16 under which the Secretary shall receive and consider com17 ments from interested persons relating to the manner in 

18 which the Program is carrying out the duties of the Pro19 gram. The Secretary may promulgate regulations under 

20 this section. 

21 ‘‘(j) CONSULTATION.—In developing policies affecting 

22 the Program, the Secretary shall consult with the Advisory 

23 Council, the Department of Defense Marrow Donor Recruit24 ment and Research Program operated by the Department 
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•S 1317 RS

1 of the Navy, and the board of directors of each entity award2 ed a contract under this section. 

3 ‘‘(k) CONTRACTS.— 

4 ‘‘(1) APPLICATION.—To be eligible to enter into 

5 a contract under this section, an entity shall submit 

6 to the Secretary and obtain approval of an applica7 tion at such time, in such manner, and containing 

8 such information as the Secretary shall by regulation 

9 prescribe. 

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

11 under this section, the Secretary shall give consider12 ation to the continued safety of donors and patients 

13 and other factors deemed appropriate by the Sec14 retary. 

15 ‘‘(l) ELIGIBILITY.—Entities eligible to receive a con16 tract under this section shall include private nonprofit enti17 ties. 

18 ‘‘(m) RECORDS.— 

19 ‘‘(1) RECORDKEEPING.—Each recipient of a con20 tract or subcontract under subsection (a) shall keep 

21 such records as the Secretary shall prescribe, includ22 ing records that fully disclose the amount and dis23 position by the recipient of the proceeds of the con24 tract, the total cost of the undertaking in connection 

25 with which the contract was made, and the amount 
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1 of the portion of the cost of the undertaking supplied 

2 by other sources, and such other records as will facili3 tate an effective audit. 

4 ‘‘(2) EXAMINATION OF RECORDS.—The Secretary 

5 and the Comptroller General of the United States 

6 shall have access to any books, documents, papers, 

7 and records of the recipient of a contract or sub8 contract entered into under this section that are perti9 nent to the contract, for the purpose of conducting au10 dits and examinations. 

11 ‘‘(n) PENALTIES FOR DISCLOSURE.—Any person who 

12 discloses the content of any record referred to in subsection 

13 (d)(4)(D) or (f)(5)(A) without the prior written consent of 

14 the donor or potential donor with respect to whom the 

15 record is maintained, or in violation of the standards de16 scribed in subsection (f)(5)(B), shall be imprisoned for not 

17 more than 2 years or fined in accordance with title 18, 

18 United States Code, or both.’’. 

19 (b) STEM CELL THERAPEUTIC OUTCOMES DATA20 BASE.—Section 379A of the Public Health Service Act (42 

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

22 ‘‘SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATA23 BASE. 

24 ‘‘(a) ESTABLISHMENT.—The Secretary shall by con25 tract establish and maintain a scientific database of infor-
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1 mation relating to patients who have been recipients of a 

2 stem cell therapeutics product (including bone marrow, cord 

3 blood, or other such product) from a donor. 

4 ‘‘(b) INFORMATION.—The outcomes database shall in5 clude information in a standardized electronic format with 

6 respect to patients described in subsection (a), diagnosis, 

7 transplant procedures, results, long-term follow-up, and 

8 such other information as the Secretary determines to be 

9 appropriate, to conduct an ongoing evaluation of the sci10 entific and clinical status of transplantation involving re11 cipients of a stem cell therapeutics product from a donor. 

12 ‘‘(c) ANNUAL REPORT ON PATIENT OUTCOMES.—The 

13 Secretary shall require the entity awarded a contract under 

14 this section to submit to the Secretary an annual report 

15 concerning patient outcomes with respect to each transplant 

16 center, based on data collected and maintained by the entity 

17 pursuant to this section. 

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

19 database shall make relevant scientific information not con20 taining individually identifiable information available to 

21 the public in the form of summaries and data sets to encour22 age medical research and to provide information to trans23 plant programs, physicians, patients, entities awarded a 

24 contract under section 379 donor registries, and cord blood 

25 banks.’’. 
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1 (c) DEFINITIONS.—Part I of title III of the Public 

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

3 inserting after section 379A the following: 

4 ‘‘SEC. 379A–1. DEFINITIONS. 

5 ‘‘In this part: 

6 ‘‘(1) The term ‘Advisory Council’ means the ad7 visory council established by the Secretary under sec8 tion 379(a)(1). 

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

10 found in adult bone marrow and peripheral blood. 

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

12 database established by the Secretary under section 

13 379A. 

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

15 Young Cell Transplantation Program established 

16 under section 379.’’. 

17 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

18 379B of the Public Health Service Act (42 U.S.C. 274m) 

19 is amended to read as follows: 

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

21 ‘‘For the purpose of carrying out this part, there are 

22 authorized to be appropriated $34,000,000 for fiscal year 

23 2006 and $38,000,000 for each of fiscal years 2007 through 

24 2010.’’. 
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1 (e) CONFORMING AMENDMENTS.—Part I of title III of 

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

3 amended in the part heading, by striking ‘‘NATIONAL 

4 BONE MARROW DONOR REGISTRY’’ and in5 serting ‘‘C. W. BILL YOUNG CELL TRANSPLAN6 TATION PROGRAM’’. 

7 SEC. 4. REPORT ON LICENSURE OF CORD BLOOD UNITS. 

8 Not later than 90 days after the date of enactment of 

9 this Act, the Secretary of Health and Human Services, in 

10 consultation with the Commissioner of Food and Drugs, 

11 shall submit to Congress a report concerning the progress 

12 made by the Food and Drug Administration in developing 

13 requirements for the licensing of cord blood units. 

Calendar No. 156 

109TH CONGRESS 

1ST SESSION S. 1317 

A BILL 

To provide for the collection and maintenance of 

cord blood. suitably matched to donors of bone marrow and crease the number of transplants for recipients Cord Blood Cell Transplantation Program to inService Act to authorize the Bone Marrow and and research, and to amend the Public Health cord blood units for the treatment of patients 

JULY 11, 2005 

Reported with an amendment