II 

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, and Mr. ENSIGN) 

introduced the following bill; which was read twice and referred to the 

Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for the collection and maintenance of 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Bone Marrow and 

3 Cord Blood Therapy and Research Act of 2005’’. 

4 SEC. 2. CORD BLOOD INVENTORY. 

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

6 Human Services shall enter into one-time contracts with 

7 qualified cord blood banks to assist in the collection and 

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

9 blood to be made available for transplantation through the 

10 Bone Marrow and Cord Blood Cell Transplantation Pro11 gram and to carry out the requirements of subsection (b). 

12 (b) REQUIREMENTS.—The Secretary shall require 

13 each recipient of a contract under this section— 

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

15 and store donated units of cord blood acquired with 

16 the informed consent of the donor in a manner that 

17 complies with applicable Federal and State regula18 tions; 

19 (2) to encourage donation from a genetically di20 verse population; 

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

22 pursuant to this section or otherwise and meet all 

23 applicable Federal standards available to transplant 

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

2 but not appropriate for clinical use, available for 

3 peer-reviewed research; 

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

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

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

7 274k(c)(3)), as amended by this Act, in a standard8 ized electronic format, as determined by the Sec9 retary, for the Bone Marrow and Cord Blood Cell 

10 Transplantation Program; and 

11 (6) to submit data in a standardized electronic 

12 format for inclusion in the stem cell therapeutic out13 comes database maintained under section 379A of 

14 the Public Health Service Act, as amended by this 

15 Act. 

16 (c) RELATED CORD BLOOD DONORS.— 

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

18 a 3-year demonstration project under which qualified 

19 cord blood banks receiving a contract under this sec20 tion may use a portion of the funding under such 

21 contract for the collection and storage of cord blood 

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

23 been diagnosed with a condition that will benefit 

24 from transplantation (including selected blood dis25 orders, malignancies, metabolic storage disorders, 
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1 hemoglobinopathies, and congenital 

2 immunodeficiencies) at no cost to such family. Quali3 fied cord blood banks collecting cord blood units 

4 under this paragraph shall comply with the require5 ments of paragraphs (1), (2), (3), and (5) of sub6 section (b). 

7 (2) AVAILABILITY.—Qualified cord blood banks 

8 that are operating a program under paragraph (1) 

9 shall provide assurances that the cord blood units in 

10 such banks will be available for directed transplan11 tation until such time that the cord blood unit is re12 leased for transplantation or is transferred by the 

13 family to the Bone Marrow and Cord Blood Cell 

14 Transplantation Program in accordance with guid15 ance or regulations promulgated by the Secretary. 

16 (3) INVENTORY.—Cord blood units collected 

17 through the program under this section shall not be 

18 counted toward the 150,000 inventory goal under 

19 the Bone Marrow and Cord Blood Cell Transplan20 tation Program. 

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

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

23 terminated by the Secretary, the Secretary shall sub24 mit to Congress a report on the outcomes of the 

25 project that shall include the recommendations of 
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1 the Secretary with respect to the continuation of 

2 such project. 

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

4 under this section, a qualified cord blood bank shall sub5 mit an application to the Secretary at such time, in such 

6 manner, and containing such information as the Secretary 

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

8 a contract under this section shall include a requirement 

9 that the applicant— 

10 (1) will participate in the Bone Marrow and 

11 Cord Blood Cell Transplantation Program for a pe12 riod of at least 10 years; 

13 (2) will make cord blood units collected pursu14 ant to this section available through the Bone Mar15 row and Cord Blood Cell Transplantation Program 

16 in perpetuity; and 

17 (3) if the Secretary determines through an as18 sessment, or through petition by the applicant, that 

19 a cord blood bank is no longer operational or does 

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

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

22 and as a result may not distribute the units, trans23 fer the units collected pursuant to this section to an24 other qualified cord blood bank approved by the Sec-
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1 retary to ensure continued availability of cord blood 

2 units. 

3 (e) DURATION OF CONTRACTS.— 

4 (1) IN GENERAL.—Except as provided in para5 graph (2), the term of each contract entered into by 

6 the Secretary under this section shall be for 10 

7 years. The Secretary shall ensure that Federal funds 

8 provided under any such contract terminate on the 

9 earlier of— 

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

11 on which the contract is entered into; or 

12 (B) September 30, 2010. 

13 (2) EXTENSIONS.—Subject to paragraph 

14 (1)(B), the Secretary may extend the period of fund15 ing under a contract under this section to exceed a 

16 period of 3 years if— 

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

18 units of high-quality cord blood have not yet 

19 been collected pursuant to this section; and 

20 (B) the Secretary does not receive an ap21 plication for a contract under this section from 

22 any qualified cord blood bank that has not pre23 viously entered into a contract under this sec24 tion or the Secretary determines that the out25 standing inventory need cannot be met by the 
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1 one or more qualified cord blood banks that 

2 have submitted an application for a contract 

3 under this section. 

4 (3) PREFERENCE.—In considering contract ex5 tensions under paragraph (2), the Secretary shall 

6 give preference to qualified cord blood banks that 

7 the Secretary determines have demonstrated a supe8 rior ability to satisfy the requirements described in 

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

10 which the contract was awarded. 

11 (f) REGULATIONS.—The Secretary may promulgate 

12 regulations to carry out this section. 

13 (g) DEFINITIONS.—In this section: 

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

15 Cell Transplantation Program’’ means the Bone 

16 Marrow and Cord Blood Cell Transplantation Pro17 gram under section 379 of the Public Health Service 

18 Act, as amended by this Act. 

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

20 mother who has delivered a baby and consents to do21 nate the neonatal blood remaining in the placenta 

22 and umbilical cord after separation from the new23 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. 
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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). 
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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 
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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 
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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, 
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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: 
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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 
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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. 

Æ