In the Senate of the United States,

December 16, 2005.

Resolved, That the bill from the House of Representatives (H.R. 2520) entitled ‘‘An Act to provide for the collection and maintenance of human cord blood stem cells for the

treatment of patients and research, and to amend the Public

Health Service Act to authorize the C.W. Bill Young Cell

Transplantation Program.’’, do pass with the following

AMENDMENT:

Strike out all after the enacting clause and insert:

1 SECTION 1. SHORT TITLE.

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

3 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
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1 C.W. Bill Young Cell Transplantation Program and to

2 carry out the requirements of subsection (b).

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

4 recipient of a contract under this section—

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

6 store donated units of cord blood acquired with the

7 informed consent of the donor, as determined by the

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

9 Health Service Act, in a manner that complies with

10 applicable Federal and State regulations;

11 (2) to encourage donation from a genetically di12 verse population;

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

14 pursuant to this section or otherwise and meet all ap15 plicable Federal standards available to transplant

16 centers for transplantation;

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

18 but not appropriate for clinical use, available for

19 peer-reviewed research;

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

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

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

23 amended by this Act, in a standardized electronic for24 mat, as determined by the Secretary, for the C.W. Bill

25 Young Cell Transplantation Program; and
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1 (6) to submit data in a standardized electronic

2 format for inclusion in the stem cell therapeutic out3 comes database maintained under section 379A of the

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

5 (c) RELATED CORD BLOOD DONORS.—

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

7 a 3-year demonstration project under which qualified

8 cord blood banks receiving a contract under this sec9 tion may use a portion of the funding under such

10 contract for the collection and storage of cord blood

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

12 been diagnosed with a condition that will benefit from

13 transplantation (including selected blood disorders,

14 malignancies, metabolic storage disorders,

15 hemoglobinopathies, and congenital

16 immunodeficiencies) at no cost to such family. Quali17 fied cord blood banks collecting cord blood units under

18 this paragraph shall comply with the requirements of

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

20 (2) AVAILABILITY.—Qualified cord blood banks

21 that are operating a program under paragraph (1)

22 shall provide assurances that the cord blood units in

23 such banks will be available for directed transplan24 tation until such time that the cord blood unit is re25 leased for transplantation or is transferred by the
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1 family to the C.W. Bill Young Cell Transplantation

2 Program in accordance with guidance or regulations

3 promulgated by the Secretary.

4 (3) INVENTORY.—Cord blood units collected

5 through the program under this section shall not be

6 counted toward the 150,000 inventory goal under the

7 C.W. Bill Young Cell Transplantation Program.

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

9 date on which the project under paragraph (1) is ter10 minated by the Secretary, the Secretary shall submit

11 to Congress a report on the outcomes of the project

12 that shall include the recommendations of the Sec13 retary with respect to the continuation of such

14 project.

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

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

17 an application to the Secretary at such time, in such man18 ner, and containing such information as the Secretary may

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

20 contract under this section shall include a requirement that

21 the applicant—

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

23 Transplantation Program for a period of at least 10

24 years;
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1 (2) will make cord blood units collected pursuant

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

3 Cell Transplantation Program in perpetuity or for

4 such time as determined viable by the Secretary; and

5 (3) if the Secretary determines through an as6 sessment, or through petition by the applicant, that a

7 cord blood bank is no longer operational or does not

8 meet the requirements of section 379(d)(4) of the Pub9 lic Health Service Act (as added by this Act) and as

10 a result may not distribute the units, transfer the

11 units collected pursuant to this section to another

12 qualified cord blood bank approved by the Secretary

13 to ensure continued availability of cord blood units.

14 (e) DURATION OF CONTRACTS.—

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

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

18 The Secretary shall ensure that no Federal funds shall

19 be obligated under any such contract after the earlier

20 of—

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

22 on which the contract is entered into; or

23 (B) September 30, 2010.

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

25 the Secretary may extend the period of funding under
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1 a contract under this section to exceed a period of 3

2 years if—

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

4 units of high-quality cord blood have not yet

5 been collected pursuant to this section; and

6 (B) the Secretary does not receive an appli7 cation for a contract under this section from any

8 qualified cord blood bank that has not previously

9 entered into a contract under this section or the

10 Secretary determines that the outstanding inven11 tory need cannot be met by the one or more

12 qualified cord blood banks that have submitted

13 an application for a contract under this section.

14 (3) PREFERENCE.—In considering contract ex15 tensions under paragraph (2), the Secretary shall give

16 preference to qualified cord blood banks that the Sec17 retary determines have demonstrated a superior abil18 ity to satisfy the requirements described in subsection

19 (b) and to achieve the overall goals for which the con20 tract was awarded.

21 (f) REGULATIONS.—The Secretary may promulgate

22 regulations to carry out this section.

23 (g) DEFINITIONS.—In this section:

24 (1) The term ‘‘C. W. Bill Young Cell Transplan25 tation Program’’ means the C.W. Bill Young Cell
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1 Transplantation Program under section 379 of the

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

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

4 who has delivered a baby and consents to donate the

5 neonatal blood remaining in the placenta and umbil6 ical cord after separation from the newborn baby.

7 (3) The term ‘‘cord blood unit’’ means the neo8 natal blood collected from the placenta and umbilical

9 cord of a single newborn baby.

10 (4) The term ‘‘first-degree relative’’ means a sib11 ling or parent who is one meiosis away from a par12 ticular individual in a family.

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

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

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

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

17 Health and Human Services.

18 (h) AUTHORIZATION OF APPROPRIATIONS.—

19 (1) EXISTING FUNDS.—Any amounts appro20 priated to the Secretary for fiscal year 2004 or 2005

21 for the purpose of assisting in the collection or main22 tenance of cord blood shall remain available to the

23 Secretary until the end of fiscal year 2007.

24 (2) SUBSEQUENT FISCAL YEARS.—There are au25 thorized to be appropriated to the Secretary
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1 $15,000,000 for each of fiscal years 2007, 2008, 2009,

2 and 2010 to carry out this section.

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

4 amount appropriated under this section in each of

5 fiscal years 2007 through 2009 may be used to carry

6 out the demonstration project under subsection (c).

7 SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PRO8 GRAM.

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

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

11 as follows:

12 ‘‘SEC. 379. NATIONAL PROGRAM.

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

14 the Administrator of the Health Resources and Services Ad15 ministration, shall by one or more contracts establish and

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

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

18 the National Bone Marrow Donor Registry, that has the

19 purpose of increasing the number of transplants for recipi20 ents suitably matched to biologically unrelated donors of

21 bone marrow and cord blood, and that meets the require22 ments of this section. The Secretary may award a separate

23 contract to perform each of the major functions of the Pro24 gram described in paragraphs (1) and (2) of subsection (d)

25 if deemed necessary by the Secretary to operate an effective
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1 and efficient system that is in the best interest of patients.

2 The Secretary shall conduct a separate competition for the

3 initial establishment of the cord blood functions of the Pro4 gram. The Program shall be under the general supervision

5 of the Secretary. The Secretary shall establish an Advisory

6 Council to advise, assist, consult with, and make rec7 ommendations to the Secretary on matters related to the

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

9 Advisory Council shall be appointed in accordance with the

10 following:

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

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

13 may serve as many as 3 consecutive 2-year terms, ex14 cept that

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

16 Chair of the Advisory Council (or the Chair17 elect) or to the member of the Advisory Council

18 who most recently served as the Chair; and

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

20 may be served by any member of the Advisory

21 Council who has no employment, governance, or

22 financial affiliation with any donor center, re23 cruitment organization, transplant center, or

24 cord blood bank.
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1 ‘‘(2) A member of the Advisory Council may con2 tinue to serve after the expiration of the term of such

3 member until a successor is appointed.

4 ‘‘(3) In order to ensure the continuity of the Ad5 visory Council, the Advisory Council shall be ap6 pointed so that each year the terms of approximately

7 one-third of the members of the Advisory Council ex8 pire.

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

10 ‘‘(A) shall include as voting members a bal11 anced number of representatives including rep12 resentatives of marrow donor centers and mar13 row transplant centers, representatives of cord

14 blood banks and participating birthing hospitals,

15 recipients of a bone marrow transplant, recipi16 ents of a cord blood transplant, persons who re17 quire such transplants, family members of such

18 a recipient or family members of a patient who

19 has requested the assistance of the Program in

20 searching for an unrelated donor of bone marrow

21 or cord blood, persons with expertise in bone

22 marrow and cord blood transplantation, persons

23 with expertise in typing, matching, and trans24 plant outcome data analysis, persons with exper25 tise in the social sciences, basic scientists with
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1 expertise in the biology of adult stem cells, and

2 members of the general public; and

3 ‘‘(B) shall include as nonvoting members

4 representatives from the Department of Defense

5 Marrow Donor Recruitment and Research Pro6 gram operated by the Department of the Navy,

7 the Division of Transplantation of the Health

8 Resources and Services Administration, the Food

9 and Drug Administration, and the National In10 stitutes of Health.

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

12 chosen so as to ensure objectivity and balance and re13 duce the potential for conflicts of interest. The Sec14 retary shall establish bylaws and procedures—

15 ‘‘(A) to prohibit any member of the Advi16 sory Council who has an employment, govern17 ance, or financial affiliation with a donor cen18 ter, recruitment organization, transplant center,

19 or cord blood bank from participating in any de20 cision that materially affects the center, recruit21 ment organization, transplant center, or cord

22 blood bank; and

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

24 Advisory Council with any such affiliation.
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1 ‘‘(6) The Secretary, acting through the Advisory

2 Council, shall submit to the Congress—

3 ‘‘(A) an annual report on the activities car4 ried out under this section; and

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

6 of the enactment of the Stem Cell Therapeutic

7 and Research Act of 2005, a report of rec8 ommendations on the scientific factors necessary

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

10 unit.

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

12 public process, recognize one or more accreditation entities

13 for the accreditation of cord blood banks.

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

15 through a public process, examine issues of informed con16 sent, including—

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

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

19 donor regarding all of her medically appropriate cord

20 blood options.

21 Based on such examination, the Secretary shall require that

22 the standards used by the accreditation entities recognized

23 under subsection (b) ensure that a cord blood unit is ac24 quired with the informed consent of the maternal donor.

25 ‘‘(d) FUNCTIONS.—
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1 ‘‘(1) BONE MARROW FUNCTIONS.—With respect

2 to bone marrow, the Program shall—

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

4 matching, and facilitating the distribution of

5 bone marrow that is suitably matched to can6 didate patients;

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

8 transplant physicians, other appropriate health

9 care professionals, and patients to search by

10 means of electronic access all available bone

11 marrow donors listed in the Program;

12 ‘‘(C) carry out a program for the recruit13 ment of bone marrow donors in accordance with

14 subsection (e), including with respect to increas15 ing the representation of racial and ethnic mi16 nority groups (including persons of mixed ances17 try) in the enrollment of the Program;

18 ‘‘(D) maintain and expand medical contin19 gency response capabilities, in coordination with

20 Federal programs, to prepare for and respond ef21 fectively to biological, chemical, or radiological

22 attacks, and other public health emergencies that

23 can damage marrow, so that the capability of

24 supporting patients with marrow damage from
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1 disease can be used to support casualties with

2 marrow damage;

3 ‘‘(E) carry out informational and edu4 cational activities in accordance with subsection

5 (e);

6 ‘‘(F) at least annually update information

7 to account for changes in the status of individ8 uals as potential donors of bone marrow;

9 ‘‘(G) provide for a system of patient advo10 cacy through the office established under sub11 section (h);

12 ‘‘(H) provide case management services for

13 any potential donor of bone marrow to whom the

14 Program has provided a notice that the potential

15 donor may be suitably matched to a particular

16 patient through the office established under sub17 section (h);

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

19 donors of bone marrow that are conducted

20 through the system under subparagraph (A), col21 lect, analyze, and publish data in a standardized

22 electronic format on the number and percentage

23 of patients at each of the various stages of the

24 search process, including data regarding the fur25 thest stage reached, the number and percentage of
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1 patients who are unable to complete the search

2 process, and the reasons underlying such cir3 cumstances;

4 ‘‘(J) support studies and demonstration and

5 outreach projects for the purpose of increasing

6 the number of individuals who are willing to be

7 marrow donors to ensure a genetically diverse

8 donor pool; and

9 ‘‘(K) facilitate research with the appro10 priate Federal agencies to improve the avail11 ability, efficiency, safety, and cost of transplants

12 from unrelated donors and the effectiveness of

13 Program operations.

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

15 cord blood, the Program shall—

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

17 matching, and facilitating the distribution of do18 nated cord blood units that are suitably matched

19 to candidate patients and meet all applicable

20 Federal and State regulations (including in21 formed consent and Food and Drug Administra22 tion regulations) from a qualified cord blood

23 bank;

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

25 transplant physicians, other appropriate health
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1 care professionals, and patients to search by

2 means of electronic access all available cord

3 blood units made available through the Program;

4 ‘‘(C) allow transplant physicians and other

5 appropriate health care professionals to reserve,

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

7 transplantation;

8 ‘‘(D) support studies and demonstration

9 and outreach projects for the purpose of increas10 ing cord blood donation to ensure a genetically

11 diverse collection of cord blood units;

12 ‘‘(E) provide for a system of patient advo13 cacy through the office established under sub14 section (h);

15 ‘‘(F) coordinate with the qualified cord

16 blood banks to support informational and edu17 cational activities in accordance with subsection

18 (g);

19 ‘‘(G) maintain and expand medical contin20 gency response capabilities, in coordination with

21 Federal programs, to prepare for and respond ef22 fectively to biological, chemical, or radiological

23 attacks, and other public health emergencies that

24 can damage marrow, so that the capability of

25 supporting patients with marrow damage from
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1 disease can be used to support casualties with

2 marrow damage; and

3 ‘‘(H) with respect to the system under sub4 paragraph (A), collect, analyze, and publish data

5 in a standardized electronic format, as required

6 by the Secretary, on the number and percentage

7 of patients at each of the various stages of the

8 search process, including data regarding the fur9 thest stage reached, the number and percentage of

10 patients who are unable to complete the search

11 process, and the reasons underlying such cir12 cumstances.

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

14 DATA.—

15 ‘‘(A) SINGLE POINT OF ACCESS.—The Sec16 retary shall ensure that health care professionals

17 and patients are able to search electronically for

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

19 extent defined by the Secretary and consistent

20 with the functions described in paragraphs

21 (1)(A) and (2)(A), cells from bone marrow do22 nors and cord blood units through a single point

23 of access.

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

25 require all recipients of contracts under this sec-
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1 tion to make available a standard dataset for

2 purposes of subparagraph (A) in a standardized

3 electronic format that enables transplant physi4 cians to compare among and between bone mar5 row donors and cord blood units to ensure the

6 best possible match for the patient.

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

8 blood bank’ means a cord blood bank that—

9 ‘‘(A) has obtained all applicable Federal

10 and State licenses, certifications, registrations

11 (including pursuant to the regulations of the

12 Food and Drug Administration), and other au13 thorizations required to operate and maintain a

14 cord blood bank;

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

16 blood collection practices, and processing meth17 ods intended to protect the health and safety of

18 donors and transplant recipients to improve

19 transplant outcomes, including with respect to

20 the transmission of potentially harmful infec21 tions and other diseases;

22 ‘‘(C) is accredited by an accreditation enti23 ty recognized by the Secretary under subsection

24 (b);
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1 ‘‘(D) has established a system of strict con2 fidentiality to protect the identity and privacy of

3 patients and donors in accordance with existing

4 Federal and State law;

5 ‘‘(E) has established a system for encour6 aging donation by a genetically diverse group of

7 donors; and

8 ‘‘(F) has established a system to confiden9 tially maintain linkage between a cord blood

10 unit and a maternal donor.

11 ‘‘(e) BONE MARROW RECRUITMENT; PRIORITIES; IN12 FORMATION AND EDUCATION.—

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

14 shall carry out activities for the recruitment of bone

15 marrow donors. Such recruitment program shall

16 identify populations that are underrepresented among

17 potential donors enrolled with the Program. In the

18 case of populations that are identified under the pre19 ceding sentence:

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

21 carrying out activities under this part to in22 crease representation for such populations in

23 order to enable a member of such a population,

24 to the extent practicable, to have a probability of

25 finding a suitable unrelated donor that is com-
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1 parable to the probability that an individual

2 who is not a member of an underrepresented

3 population would have.

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

5 ethnic minority groups (including persons of

6 mixed ancestry) to be populations that have been

7 identified for purposes of this paragraph, and

8 shall carry out subparagraph (A) with respect to

9 such populations.

10 ‘‘(2) INFORMATION AND EDUCATION REGARDING

11 RECRUITMENT; TESTING AND ENROLLMENT.—

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

13 carry out informational and educational activi14 ties, in coordination with organ donation public

15 awareness campaigns operated through the De16 partment of Health and Human Services, for

17 purposes of recruiting individuals to serve as do18 nors of bone marrow, and shall test and enroll

19 with the Program potential bone marrow donors.

20 Such information and educational activities

21 shall include the following:

22 ‘‘(i) Making information available to

23 the general public, including information

24 describing the needs of patients with respect

25 to donors of bone marrow.
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1 ‘‘(ii) Educating and providing infor2 mation to individuals who are willing to

3 serve as potential bone marrow donors.

4 ‘‘(iii) Training individuals in request5 ing individuals to serve as potential bone

6 marrow donors.

7 ‘‘(B) PRIORITIES.—In carrying out infor8 mational and educational activities under sub9 paragraph (A), the Program shall give priority

10 to recruiting individuals to serve as donors of

11 bone marrow for populations that are identified

12 under paragraph (1).

13 ‘‘(3) TRANSPLANTATION AS TREATMENT OP14 TION.—In addition to activities regarding recruit15 ment, the recruitment program under paragraph (1)

16 shall provide information to physicians, other health

17 care professionals, and the public regarding bone

18 marrow transplants from unrelated donors as a treat19 ment option.

20 ‘‘(4) IMPLEMENTATION OF SUBSECTION.—The re21 quirements of this subsection shall be carried out by

22 the entity that has been awarded a contract by the

23 Secretary under subsection (a) to carry out the func24 tions described in subsection (d)(1).
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1 ‘‘(f) BONE MARROW CRITERIA, STANDARDS, AND PRO2 CEDURES.—The Secretary shall enforce, for participating

3 entities, including the Program, individual marrow donor

4 centers, marrow donor registries, marrow collection centers,

5 and marrow transplant centers—

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

7 typing, obtaining the informed consent of donors, and

8 providing patient advocacy;

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

10 medical criteria, to protect both the donor and the re11 cipient and to prevent the transmission of potentially

12 harmful infectious diseases such as the viruses that

13 cause hepatitis and the etiologic agent for Acquired

14 Immune Deficiency Syndrome;

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

16 and transportation of the marrow;

17 ‘‘(4) standards for the system for patient advo18 cacy operated under subsection (h), including stand19 ards requiring the provision of appropriate informa20 tion (at the start of the search process and throughout

21 the process) to patients and their families and physi22 cians;

23 ‘‘(5) standards that—

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

25 of strict confidentiality of records relating to the
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1 identity, address, HLA type, and managing

2 marrow donor center for marrow donors and po3 tential marrow donors; and

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

5 records described in subparagraph (A) may be

6 disclosed, and the circumstances and extent of

7 the disclosure; and

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

9 marrow donor registry participating in the program,

10 procedures to ensure the establishment of a method for

11 integrating donor files, searches, and general proce12 dures of the center or registry with the Program.

13 ‘‘(g) CORD BLOOD RECRUITMENT; PRIORITIES; INFOR14 MATION AND EDUCATION.—

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

16 shall support activities, in cooperation with qualified

17 cord blood banks, for the recruitment of cord blood do18 nors. Such recruitment program shall identify popu19 lations that are underrepresented among cord blood

20 donors. In the case of populations that are identified

21 under the preceding sentence:

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

23 supporting activities under this part to increase

24 representation for such populations in order to

25 enable a member of such a population, to the ex-
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1 tent practicable, to have a probability of finding

2 a suitable cord blood unit that is comparable to

3 the probability that an individual who is not a

4 member of an underrepresented population

5 would have.

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

7 ethnic minority groups (including persons of

8 mixed ancestry) to be populations that have been

9 identified for purposes of this paragraph, and

10 shall support activities under subparagraph (A)

11 with respect to such populations.

12 ‘‘(2) INFORMATION AND EDUCATION REGARDING

13 RECRUITMENT; TESTING AND DONATION.—

14 ‘‘(A) IN GENERAL.—In carrying out the re15 cruitment program under paragraph (1), the

16 Program shall support informational and edu17 cational activities in coordination with qualified

18 cord blood banks and organ donation public

19 awareness campaigns operated through the De20 partment of Health and Human Services, for

21 purposes of recruiting pregnant women to serve

22 as donors of cord blood. Such information and

23 educational activities shall include the following:

24 ‘‘(i) Making information available to

25 the general public, including information
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1 describing the needs of patients with respect

2 to cord blood units.

3 ‘‘(ii) Educating and providing infor4 mation to pregnant women who are willing

5 to donate cord blood units.

6 ‘‘(iii) Training individuals in request7 ing pregnant women to serve as cord blood

8 donors.

9 ‘‘(B) PRIORITIES.—In carrying out infor10 mational and educational activities under sub11 paragraph (A), the Program shall give priority

12 to supporting the recruitment of pregnant

13 women to serve as donors of cord blood for popu14 lations that are identified under paragraph (1).

15 ‘‘(3) TRANSPLANTATION AS TREATMENT OP16 TION.—In addition to activities regarding recruit17 ment, the recruitment program under paragraph (1)

18 shall provide information to physicians, other health

19 care professionals, and the public regarding cord

20 blood transplants from donors as a treatment option.

21 ‘‘(4) IMPLEMENTATION OF SUBSECTION.—The re22 quirements of this subsection shall be carried out by

23 the entity that has been awarded a contract by the

24 Secretary under subsection (a) to carry out the func25 tions described in subsection (d)(2).
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1 ‘‘(h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR

2 BONE MARROW AND CORD BLOOD.—

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

4 and maintain, through a contract or other means de5 termined appropriate by the Secretary, an office of

6 patient advocacy (in this subsection referred to as the

7 ‘Office’).

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

9 meet the following requirements:

10 ‘‘(A) The Office shall be headed by a direc11 tor.

12 ‘‘(B) The Office shall be staffed by individ13 uals with expertise in bone marrow and cord

14 blood therapy covered under the Program.

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

16 patient advocacy, which shall be separate from

17 mechanisms for donor advocacy, and which shall

18 serve patients for whom the Program is con19 ducting, or has been requested to conduct, a

20 search for a bone marrow donor or cord blood

21 unit.

22 ‘‘(D) In the case of such a patient, the Of23 fice shall serve as an advocate for the patient by

24 directly providing to the patient (or family

25 members, physicians, or other individuals acting
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1 on behalf of the patient) individualized services

2 with respect to efficiently utilizing the system

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

4 to conduct an ongoing search for a bone marrow

5 donor or cord blood unit and assist with infor6 mation regarding third party payor matters.

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

8 Office shall monitor the system under para9 graphs (1) and (2) of subsection (d) to determine

10 whether the search needs of the patient involved

11 are being met, including with respect to the fol12 lowing:

13 ‘‘(i) Periodically providing to the pa14 tient (or an individual acting on behalf of

15 the patient) information regarding bone

16 marrow donors or cord blood units that are

17 suitably matched to the patient, and other

18 information regarding the progress being

19 made in the search.

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

21 other individual) if the search has been in22 terrupted or discontinued.

23 ‘‘(iii) Identifying and resolving prob24 lems in the search, to the extent practicable.
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1 ‘‘(F) The Office shall ensure that the fol2 lowing data are made available to patients:

3 ‘‘(i) The resources available through

4 the Program.

5 ‘‘(ii) A comparison of transplant cen6 ters regarding search and other costs that

7 prior to transplantation are charged to pa8 tients by transplant centers.

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

10 individual transplant centers.

11 ‘‘(iv) Information concerning issues

12 that patients may face after a transplant.

13 ‘‘(v) Such other information as the

14 Program determines to be appropriate.

15 ‘‘(G) The Office shall conduct surveys of pa16 tients (or family members, physicians, or other

17 individuals acting on behalf of patients) to deter18 mine the extent of satisfaction with the system

19 for patient advocacy under this subsection, and

20 to identify ways in which the system can be im21 proved to best meet the needs of patients.

22 ‘‘(3) CASE MANAGEMENT.—

23 ‘‘(A) IN GENERAL.—In serving as an advo24 cate for a patient under paragraph (2), the Of25 fice shall provide individualized case manage-
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1 ment services directly to the patient (or family

2 members, physicians, or other individuals acting

3 on behalf of the patient), including—

4 ‘‘(i) individualized case assessment;

5 and

6 ‘‘(ii) the functions described in para7 graph (2)(D) (relating to progress in the

8 search process).

9 ‘‘(B) POSTSEARCH FUNCTIONS.—In addi10 tion to the case management services described in

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

12 behalf of patients who have completed the search

13 for a bone marrow donor or cord blood unit, pro14 vide information and education on the process of

15 receiving a transplant, including the post-trans16 plant process.

17 ‘‘(i) COMMENT PROCEDURES.—The Secretary shall es18 tablish and provide information to the public on procedures

19 under which the Secretary shall receive and consider com20 ments from interested persons relating to the manner in

21 which the Program is carrying out the duties of the Pro22 gram. The Secretary may promulgate regulations under

23 this section.

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

25 the Program, the Secretary shall consult with the Advisory
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1 Council, the Department of Defense Marrow Donor Recruit2 ment and Research Program operated by the Department

3 of the Navy, and the board of directors of each entity award4 ed a contract under this section.

5 ‘‘(k) CONTRACTS.—

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

7 a contract under this section, an entity shall submit

8 to the Secretary and obtain approval of an applica9 tion at such time, in such manner, and containing

10 such information as the Secretary shall by regulation

11 prescribe.

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

13 under this section, the Secretary shall give consider14 ation to the continued safety of donors and patients

15 and other factors deemed appropriate by the Sec16 retary.

17 ‘‘(l) ELIGIBILITY.—Entities eligible to receive a con18 tract under this section shall include private nonprofit enti19 ties.

20 ‘‘(m) RECORDS.—

21 ‘‘(1) RECORDKEEPING.—Each recipient of a con22 tract or subcontract under subsection (a) shall keep

23 such records as the Secretary shall prescribe, includ24 ing records that fully disclose the amount and dis25 position by the recipient of the proceeds of the con-
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1 tract, the total cost of the undertaking in connection

2 with which the contract was made, and the amount

3 of the portion of the cost of the undertaking supplied

4 by other sources, and such other records as will facili5 tate an effective audit.

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

7 and the Comptroller General of the United States

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

9 and records of the recipient of a contract or sub10 contract entered into under this section that are perti11 nent to the contract, for the purpose of conducting au12 dits and examinations.

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

14 discloses the content of any record referred to in subsection

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

16 the donor or potential donor with respect to whom the

17 record is maintained, or in violation of the standards de18 scribed in subsection (f)(5)(B), shall be imprisoned for not

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

20 United States Code, or both.’’.

21 (b) STEM CELL THERAPEUTIC OUTCOMES DATA22 BASE.—Section 379A of the Public Health Service Act (42

23 U.S.C. 274l) is amended to read as follows:
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1 ‘‘SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATA2 BASE.

3 ‘‘(a) ESTABLISHMENT.—The Secretary shall by con4 tract establish and maintain a scientific database of infor5 mation relating to patients who have been recipients of a

6 stem cell therapeutics product (including bone marrow, cord

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

8 ‘‘(b) INFORMATION.—The outcomes database shall in9 clude information in a standardized electronic format with

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

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

12 such other information as the Secretary determines to be

13 appropriate, to conduct an ongoing evaluation of the sci14 entific and clinical status of transplantation involving re15 cipients of a stem cell therapeutics product from a donor.

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

17 Secretary shall require the entity awarded a contract under

18 this section to submit to the Secretary an annual report

19 concerning patient outcomes with respect to each transplant

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

21 pursuant to this section.

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

23 database shall make relevant scientific information not con24 taining individually identifiable information available to

25 the public in the form of summaries and data sets to encour26 age medical research and to provide information to trans-
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1 plant programs, physicians, patients, entities awarded a

2 contract under section 379 donor registries, and cord blood

3 banks.’’.

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

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

6 inserting after section 379A the following:

7 ‘‘SEC. 379A–1. DEFINITIONS.

8 ‘‘In this part:

9 ‘‘(1) The term ‘Advisory Council’ means the ad10 visory council established by the Secretary under sec11 tion 379(a)(1).

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

13 found in adult bone marrow and peripheral blood.

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

15 database established by the Secretary under section

16 379A.

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

18 Young Cell Transplantation Program established

19 under section 379.’’.

20 (d) AUTHORIZATION OF APPROPRIATIONS.—Section

21 379B of the Public Health Service Act (42 U.S.C. 274m)

22 is amended to read as follows:

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

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

25 authorized to be appropriated $34,000,000 for fiscal year
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1 2006 and $38,000,000 for each of fiscal years 2007 through

2 2010.’’.

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

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

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

6 BONE MARROW DONOR REGISTRY’’ and in7 serting ‘‘C. W. BILL YOUNG CELL TRANSPLAN8 TATION PROGRAM’’.

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

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

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

12 consultation with the Commissioner of Food and Drugs,

13 shall submit to Congress a report concerning the progress

14 made by the Food and Drug Administration in developing

15 requirements for the licensing of cord blood units.

Attest:

Secretary.
109TH CONGRESS

1ST SESSION H. R. 2520

AMENDMENT