H. R. 2520

One Hundred Ninth Congress

of the

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Tuesday, 

the fourth day of January, two thousand and five 

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.

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

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

Research Act of 2005’’. 

SEC. 2. CORD BLOOD INVENTORY. 

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

shall enter into one-time contracts with qualified cord blood banks 

to assist in the collection and maintenance of 150,000 new units 

of high-quality cord blood to be made available for transplantation 

through the C.W. Bill Young Cell Transplantation Program and 

to carry out the requirements of subsection (b). 

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

of a contract under this section— 

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

donated units of cord blood acquired with the informed consent 

of the donor, as determined by the Secretary pursuant to section 

379(c) of the Public Health Service Act, in a manner that 

complies with applicable Federal and State regulations; 

(2) to encourage donation from a genetically diverse population; 

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

to this section or otherwise and meet all applicable Federal 

standards available to transplant centers for transplantation; 

(4) to make cord blood units that are collected, but not 

appropriate for clinical use, available for peer-reviewed 

research; 

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

and consistent with section 379(d)(3) of the Public Health 

Service Act (42 U.S.C. 274k(d)(3)), as amended by this Act, 

in a standardized electronic format, as determined by the Secretary, for the C.W. Bill Young Cell Transplantation Program; 

and 

(6) to submit data in a standardized electronic format for 

inclusion in the stem cell therapeutic outcomes database maintained under section 379A of the Public Health Service Act, 

as amended by this Act. 

(c) RELATED CORD BLOOD DONORS.— 
H. R. 2520—2

(1) IN GENERAL.—The Secretary shall establish a 3-year 

demonstration project under which qualified cord blood banks 

receiving a contract under this section may use a portion of 

the funding under such contract for the collection and storage 

of cord blood units for a family where a first-degree relative 

has been diagnosed with a condition that will benefit from 

transplantation (including selected blood disorders, malignancies, metabolic storage disorders, hemoglobinopathies, and 

congenital immunodeficiencies) at no cost to such family. Qualified cord blood banks collecting cord blood units under this 

paragraph shall comply with the requirements of paragraphs 

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

(2) AVAILABILITY.—Qualified cord blood banks that are 

operating a program under paragraph (1) shall provide assurances that the cord blood units in such banks will be available 

for directed transplantation until such time that the cord blood 

unit is released for transplantation or is transferred by the 

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

in accordance with guidance or regulations promulgated by 

the Secretary. 

(3) INVENTORY.—Cord blood units collected through the 

program under this section shall not be counted toward the 

150,000 inventory goal under the C.W. Bill Young Cell 

Transplantation Program. 

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

which the project under paragraph (1) is terminated by the 

Secretary, the Secretary shall submit to Congress a report 

on the outcomes of the project that shall include the recommendations of the Secretary with respect to the continuation 

of such project. 

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

section, a qualified cord blood bank shall submit an application 

to the Secretary at such time, in such manner, and containing 

such information as the Secretary may reasonably require. At a 

minimum, an application for a contract under this section shall 

include a requirement that the applicant— 

(1) will participate in the C.W. Bill Young Cell Transplantation Program for a period of at least 10 years; 

(2) will make cord blood units collected pursuant to this 

section available through the C.W. Bill Young Cell Transplantation Program in perpetuity or for such time as determined 

viable by the Secretary; and 

(3) if the Secretary determines through an assessment, 

or through petition by the applicant, that a cord blood bank 

is no longer operational or does not meet the requirements 

of section 379(d)(4) of the Public Health Service Act (as added 

by this Act) and as a result may not distribute the units, 

transfer the units collected pursuant to this section to another 

qualified cord blood bank approved by the Secretary to ensure 

continued availability of cord blood units. 

(e) DURATION OF CONTRACTS.— 

(1) IN GENERAL.—Except as provided in paragraph (2), the 

term of each contract entered into by the Secretary under 

this section shall be for 10 years. The Secretary shall ensure 

that no Federal funds shall be obligated under any such contract after the earlier of— 
H. R. 2520—3

(A) the date that is 3 years after the date on which 

the contract is entered into; or 

(B) September 30, 2010. 

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

may extend the period of funding under a contract under this 

section to exceed a period of 3 years if— 

(A) the Secretary finds that 150,000 new units of highquality cord blood have not yet been collected pursuant 

to this section; and 

(B) the Secretary does not receive an application for 

a contract under this section from any qualified cord blood 

bank that has not previously entered into a contract under 

this section or the Secretary determines that the outstanding inventory need cannot be met by the one or more 

qualified cord blood banks that have submitted an application for a contract under this section. 

(3) PREFERENCE.—In considering contract extensions under 

paragraph (2), the Secretary shall give preference to qualified 

cord blood banks that the Secretary determines have demonstrated a superior ability to satisfy the requirements 

described in subsection (b) and to achieve the overall goals 

for which the contract was awarded. 

(f) REGULATIONS.—The Secretary may promulgate regulations 

to carry out this section. 

(g) DEFINITIONS.—In this section: 

(1) The term ‘‘C.W. Bill Young Cell Transplantation Program’’ means the C.W. Bill Young Cell Transplantation Program under section 379 of the Public Health Service Act, as 

amended by this Act. 

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

has delivered a baby and consents to donate the neonatal 

blood remaining in the placenta and umbilical cord after separation from the newborn baby. 

(3) The term ‘‘cord blood unit’’ means the neonatal blood 

collected from the placenta and umbilical cord of a single newborn baby. 

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

parent who is one meiosis away from a particular individual 

in a family. 

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

given to that term in section 379(d)(4) of the Public Health 

Service Act, as amended by this Act. 

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

and Human Services. 

(h) AUTHORIZATION OF APPROPRIATIONS.— 

(1) EXISTING FUNDS.—Any amounts appropriated to the 

Secretary for fiscal year 2004 or 2005 for the purpose of 

assisting in the collection or maintenance of cord blood shall 

remain available to the Secretary until the end of fiscal year 

2007. 

(2) SUBSEQUENT FISCAL YEARS.—There are authorized to 

be appropriated to the Secretary $15,000,000 for each of fiscal 

years 2007, 2008, 2009, and 2010 to carry out this section. 

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

appropriated under this section in each of fiscal years 2007 

through 2009 may be used to carry out the demonstration 

project under subsection (c). 
H. R. 2520—4

SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM. 

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

Service Act (42 U.S.C. 274k) is amended to read as follows: 

‘‘SEC. 379. NATIONAL PROGRAM. 

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

Administrator of the Health Resources and Services Administration, 

shall by one or more contracts establish and maintain a C.W. 

Bill Young Cell Transplantation Program (referred to in this section 

as the ‘Program’), successor to the National Bone Marrow Donor 

Registry, that has the purpose of increasing the number of transplants for recipients suitably matched to biologically unrelated 

donors of bone marrow and cord blood, and that meets the requirements of this section. The Secretary may award a separate contract 

to perform each of the major functions of the Program described 

in paragraphs (1) and (2) of subsection (d) if deemed necessary 

by the Secretary to operate an effective and efficient system that 

is in the best interest of patients. The Secretary shall conduct 

a separate competition for the initial establishment of the cord 

blood functions of the Program. The Program shall be under the 

general supervision of the Secretary. The Secretary shall establish 

an Advisory Council to advise, assist, consult with, and make recommendations to the Secretary on matters related to the activities 

carried out by the Program. The members of the Advisory Council 

shall be appointed in accordance with the following: 

‘‘(1) Each member of the Advisory Council shall serve for 

a term of 2 years, and each such member may serve as many 

as 3 consecutive 2-year terms, except that—

‘‘(A) such limitations shall not apply to the Chair of 

the Advisory Council (or the Chair-elect) or to the member 

of the Advisory Council who most recently served as the 

Chair; and 

‘‘(B) one additional consecutive 2-year term may be 

served by any member of the Advisory Council who has 

no employment, governance, or financial affiliation with 

any donor center, recruitment organization, transplant 

center, or cord blood bank. 

‘‘(2) A member of the Advisory Council may continue to 

serve after the expiration of the term of such member until 

a successor is appointed. 

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

Council, the Advisory Council shall be appointed so that each 

year the terms of approximately one-third of the members 

of the Advisory Council expire. 

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

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

number of representatives including representatives of 

marrow donor centers and marrow transplant centers, representatives of cord blood banks and participating birthing 

hospitals, recipients of a bone marrow transplant, recipients of a cord blood transplant, persons who require such 

transplants, family members of such a recipient or family 

members of a patient who has requested the assistance 

of the Program in searching for an unrelated donor of 

bone marrow or cord blood, persons with expertise in bone 
H. R. 2520—5

marrow and cord blood transplantation, persons with expertise in typing, matching, and transplant outcome data analysis, persons with expertise in the social sciences, basic 

scientists with expertise in the biology of adult stem cells, 

and members of the general public; and 

‘‘(B) shall include as nonvoting members representatives from the Department of Defense Marrow Donor 

Recruitment and Research Program operated by the 

Department of the Navy, the Division of Transplantation 

of the Health Resources and Services Administration, the 

Food and Drug Administration, and the National Institutes 

of Health. 

‘‘(5) Members of the Advisory Council shall be chosen so 

as to ensure objectivity and balance and reduce the potential 

for conflicts of interest. The Secretary shall establish bylaws 

and procedures— 

‘‘(A) to prohibit any member of the Advisory Council 

who has an employment, governance, or financial affiliation 

with a donor center, recruitment organization, transplant 

center, or cord blood bank from participating in any decision that materially affects the center, recruitment 

organization, transplant center, or cord blood bank; and 

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

Council with any such affiliation. 

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

shall submit to the Congress— 

‘‘(A) an annual report on the activities carried out 

under this section; and 

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

enactment of the Stem Cell Therapeutic and Research Act 

of 2005, a report of recommendations on the scientific factors necessary to define a cord blood unit as a high-quality 

unit. 

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

process, recognize one or more accreditation entities for the accreditation of cord blood banks. 

‘‘(c) INFORMED CONSENT.—The Secretary shall, through a public 

process, examine issues of informed consent, including— 

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

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

regarding all of her medically appropriate cord blood options. 

Based on such examination, the Secretary shall require that the 

standards used by the accreditation entities recognized under subsection (b) ensure that a cord blood unit is acquired with the 

informed consent of the maternal donor. 

‘‘(d) FUNCTIONS.— 

‘‘(1) BONE MARROW FUNCTIONS.—With respect to bone marrow, the Program shall— 

‘‘(A) operate a system for identifying, matching, and 

facilitating the distribution of bone marrow that is suitably 

matched to candidate patients; 

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

physicians, other appropriate health care professionals, and 

patients to search by means of electronic access all available bone marrow donors listed in the Program; 

‘‘(C) carry out a program for the recruitment of bone 

marrow donors in accordance with subsection (e), including 
H. R. 2520—6

with respect to increasing the representation of racial and 

ethnic minority groups (including persons of mixed 

ancestry) in the enrollment of the Program; 

‘‘(D) maintain and expand medical contingency 

response capabilities, in coordination with Federal programs, to prepare for and respond effectively to biological, 

chemical, or radiological attacks, and other public health 

emergencies that can damage marrow, so that the capability of supporting patients with marrow damage from 

disease can be used to support casualties with marrow 

damage; 

‘‘(E) carry out informational and educational activities 

in accordance with subsection (e); 

‘‘(F) at least annually update information to account 

for changes in the status of individuals as potential donors 

of bone marrow; 

‘‘(G) provide for a system of patient advocacy through 

the office established under subsection (h); 

‘‘(H) provide case management services for any potential donor of bone marrow to whom the Program has provided a notice that the potential donor may be suitably 

matched to a particular patient through the office established under subsection (h); 

‘‘(I) with respect to searches for unrelated donors of 

bone marrow that are conducted through the system under 

subparagraph (A), collect, analyze, and publish data in 

a standardized electronic format on the number and 

percentage of patients at each of the various stages of 

the search process, including data regarding the furthest 

stage reached, the number and percentage of patients who 

are unable to complete the search process, and the reasons 

underlying such circumstances; 

‘‘(J) support studies and demonstration and outreach 

projects for the purpose of increasing the number of individuals who are willing to be marrow donors to ensure a 

genetically diverse donor pool; and 

‘‘(K) facilitate research with the appropriate Federal 

agencies to improve the availability, efficiency, safety, and 

cost of transplants from unrelated donors and the effectiveness of Program operations. 

‘‘(2) CORD BLOOD FUNCTIONS.—With respect to cord blood, 

the Program shall— 

‘‘(A) operate a system for identifying, matching, and 

facilitating the distribution of donated cord blood units 

that are suitably matched to candidate patients and meet 

all applicable Federal and State regulations (including 

informed consent and Food and Drug Administration regulations) from a qualified cord blood bank; 

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

physicians, other appropriate health care professionals, and 

patients to search by means of electronic access all available cord blood units made available through the Program; 

‘‘(C) allow transplant physicians and other appropriate 

health care professionals to reserve, as defined by the 

Secretary, a cord blood unit for transplantation; 
H. R. 2520—7

‘‘(D) support studies and demonstration and outreach 

projects for the purpose of increasing cord blood donation 

to ensure a genetically diverse collection of cord blood units; 

‘‘(E) provide for a system of patient advocacy through 

the office established under subsection (h); 

‘‘(F) coordinate with the qualified cord blood banks 

to support informational and educational activities in 

accordance with subsection (g); 

‘‘(G) maintain and expand medical contingency 

response capabilities, in coordination with Federal programs, to prepare for and respond effectively to biological, 

chemical, or radiological attacks, and other public health 

emergencies that can damage marrow, so that the capability of supporting patients with marrow damage from 

disease can be used to support casualties with marrow 

damage; and 

‘‘(H) with respect to the system under subparagraph 

(A), collect, analyze, and publish data in a standardized 

electronic format, as required by the Secretary, on the 

number and percentage of patients at each of the various 

stages of the search process, including data regarding the 

furthest stage reached, the number and percentage of 

patients who are unable to complete the search process, 

and the reasons underlying such circumstances. 

‘‘(3) SINGLE POINT OF ACCESS; STANDARD DATA.— ‘‘(A) SINGLE POINT OF ACCESS.—The Secretary shall 

ensure that health care professionals and patients are able 

to search electronically for and facilitate access to, in the 

manner and to the extent defined by the Secretary and 

consistent with the functions described in paragraphs (1)(A) 

and (2)(A), cells from bone marrow donors and cord blood 

units through a single point of access. 

‘‘(B) STANDARD DATA.—The Secretary shall require all 

recipients of contracts under this section to make available 

a standard dataset for purposes of subparagraph (A) in 

a standardized electronic format that enables transplant 

physicians to compare among and between bone marrow 

donors and cord blood units to ensure the best possible 

match for the patient. 

‘‘(4) DEFINITION.—The term ‘qualified cord blood bank’ 

means a cord blood bank that— 

‘‘(A) has obtained all applicable Federal and State 

licenses, certifications, registrations (including pursuant to 

the regulations of the Food and Drug Administration), and 

other authorizations required to operate and maintain a 

cord blood bank; 

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

collection practices, and processing methods intended to 

protect the health and safety of donors and transplant 

recipients to improve transplant outcomes, including with 

respect to the transmission of potentially harmful infections 

and other diseases; 

‘‘(C) is accredited by an accreditation entity recognized 

by the Secretary under subsection (b); 

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

to protect the identity and privacy of patients and donors 

in accordance with existing Federal and State law; 
H. R. 2520—8

‘‘(E) has established a system for encouraging donation 

by a genetically diverse group of donors; and 

‘‘(F) has established a system to confidentially maintain 

linkage between a cord blood unit and a maternal donor. 

‘‘(e) BONE MARROW RECRUITMENT; PRIORITIES; INFORMATION

AND EDUCATION.— 

‘‘(1) RECRUITMENT; PRIORITIES.—The Program shall carry 

out activities for the recruitment of bone marrow donors. Such 

recruitment program shall identify populations that are underrepresented among potential donors enrolled with the Program. 

In the case of populations that are identified under the preceding sentence: 

‘‘(A) The Program shall give priority to carrying out 

activities under this part to increase representation for 

such populations in order to enable a member of such 

a population, to the extent practicable, to have a probability 

of finding a suitable unrelated donor that is comparable 

to the probability that an individual who is not a member 

of an underrepresented population would have. 

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

minority groups (including persons of mixed ancestry) to 

be populations that have been identified for purposes of 

this paragraph, and shall carry out subparagraph (A) with 

respect to such populations. 

‘‘(2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND ENROLLMENT.— ‘‘(A) IN GENERAL.—The Program shall carry out 

informational and educational activities, in coordination 

with organ donation public awareness campaigns operated 

through the Department of Health and Human Services, 

for purposes of recruiting individuals to serve as donors 

of bone marrow, and shall test and enroll with the Program 

potential bone marrow donors. Such information and educational activities shall include the following: 

‘‘(i) Making information available to the general 

public, including information describing the needs of 

patients with respect to donors of bone marrow. 

‘‘(ii) Educating and providing information to 

individuals who are willing to serve as potential bone 

marrow donors. 

‘‘(iii) Training individuals in requesting individuals 

to serve as potential bone marrow donors. 

‘‘(B) PRIORITIES.—In carrying out informational and 

educational activities under subparagraph (A), the Program 

shall give priority to recruiting individuals to serve as 

donors of bone marrow for populations that are identified 

under paragraph (1). 

‘‘(3) TRANSPLANTATION AS TREATMENT OPTION.—In addition 

to activities regarding recruitment, the recruitment program 

under paragraph (1) shall provide information to physicians, 

other health care professionals, and the public regarding bone 

marrow transplants from unrelated donors as a treatment 

option. 

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

of this subsection shall be carried out by the entity that has 

been awarded a contract by the Secretary under subsection 

(a) to carry out the functions described in subsection (d)(1). 
H. R. 2520—9

‘‘(f) BONE MARROW CRITERIA, STANDARDS, AND PROCEDURES.—

The Secretary shall enforce, for participating entities, including 

the Program, individual marrow donor centers, marrow donor registries, marrow collection centers, and marrow transplant centers— 

‘‘(1) quality standards and standards for tissue typing, 

obtaining the informed consent of donors, and providing patient 

advocacy; 

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

criteria, to protect both the donor and the recipient and to 

prevent the transmission of potentially harmful infectious diseases such as the viruses that cause hepatitis and the etiologic 

agent for Acquired Immune Deficiency Syndrome; 

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

transportation of the marrow; 

‘‘(4) standards for the system for patient advocacy operated 

under subsection (h), including standards requiring the provision of appropriate information (at the start of the search 

process and throughout the process) to patients and their families and physicians; 

‘‘(5) standards that— 

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

confidentiality of records relating to the identity, address, 

HLA type, and managing marrow donor center for marrow 

donors and potential marrow donors; and 

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

described in subparagraph (A) may be disclosed, and the 

circumstances and extent of the disclosure; and 

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

registry participating in the program, procedures to ensure 

the establishment of a method for integrating donor files, 

searches, and general procedures of the center or registry with 

the Program. 

‘‘(g) CORD BLOOD RECRUITMENT; PRIORITIES; INFORMATION AND

EDUCATION.— ‘‘(1) RECRUITMENT; PRIORITIES.—The Program shall support 

activities, in cooperation with qualified cord blood banks, for 

the recruitment of cord blood donors. Such recruitment program 

shall identify populations that are underrepresented among 

cord blood donors. In the case of populations that are identified 

under the preceding sentence: 

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

activities under this part to increase representation for 

such populations in order to enable a member of such 

a population, to the extent practicable, to have a probability 

of finding a suitable cord blood unit that is comparable 

to the probability that an individual who is not a member 

of an underrepresented population would have. 

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

minority groups (including persons of mixed ancestry) to 

be populations that have been identified for purposes of 

this paragraph, and shall support activities under subparagraph (A) with respect to such populations. 

‘‘(2) INFORMATION AND EDUCATION REGARDING RECRUITMENT; TESTING AND DONATION.— 

‘‘(A) IN GENERAL.—In carrying out the recruitment program under paragraph (1), the Program shall support 

informational and educational activities in coordination 
H. R. 2520—10

with qualified cord blood banks and organ donation public 

awareness campaigns operated through the Department 

of Health and Human Services, for purposes of recruiting 

pregnant women to serve as donors of cord blood. Such 

information and educational activities shall include the 

following: 

‘‘(i) Making information available to the general 

public, including information describing the needs of 

patients with respect to cord blood units. 

‘‘(ii) Educating and providing information to pregnant women who are willing to donate cord blood units. 

‘‘(iii) Training individuals in requesting pregnant 

women to serve as cord blood donors. 

‘‘(B) PRIORITIES.—In carrying out informational and 

educational activities under subparagraph (A), the Program 

shall give priority to supporting the recruitment of pregnant women to serve as donors of cord blood for populations 

that are identified under paragraph (1). 

‘‘(3) TRANSPLANTATION AS TREATMENT OPTION.—In addition 

to activities regarding recruitment, the recruitment program 

under paragraph (1) shall provide information to physicians, 

other health care professionals, and the public regarding cord 

blood transplants from donors as a treatment option. 

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

of this subsection shall be carried out by the entity that has 

been awarded a contract by the Secretary under subsection 

(a) to carry out the functions described in subsection (d)(2). 

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

MARROW AND CORD BLOOD.— ‘‘(1) IN GENERAL.—The Secretary shall establish and maintain, through a contract or other means determined appropriate 

by the Secretary, an office of patient advocacy (in this subsection referred to as the ‘Office’). 

‘‘(2) GENERAL FUNCTIONS.—The Office shall meet the following requirements: 

‘‘(A) The Office shall be headed by a director. 

‘‘(B) The Office shall be staffed by individuals with 

expertise in bone marrow and cord blood therapy covered 

under the Program. 

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

advocacy, which shall be separate from mechanisms for 

donor advocacy, and which shall serve patients for whom 

the Program is conducting, or has been requested to conduct, a search for a bone marrow donor or cord blood 

unit. 

‘‘(D) In the case of such a patient, the Office shall 

serve as an advocate for the patient by directly providing 

to the patient (or family members, physicians, or other 

individuals acting on behalf of the patient) individualized 

services with respect to efficiently utilizing the system 

under paragraphs (1) and (2) of subsection (d) to conduct 

an ongoing search for a bone marrow donor or cord blood 

unit and assist with information regarding third party 

payor matters. 

‘‘(E) In carrying out subparagraph (D), the Office shall 

monitor the system under paragraphs (1) and (2) of subsection (d) to determine whether the search needs of the 
H. R. 2520—11

patient involved are being met, including with respect to 

the following: 

‘‘(i) Periodically providing to the patient (or an 

individual acting on behalf of the patient) information 

regarding bone marrow donors or cord blood units that 

are suitably matched to the patient, and other information regarding the progress being made in the search. 

‘‘(ii) Informing the patient (or such other individual) if the search has been interrupted or discontinued. 

‘‘(iii) Identifying and resolving problems in the 

search, to the extent practicable. 

‘‘(F) The Office shall ensure that the following data 

are made available to patients: 

‘‘(i) The resources available through the Program. 

‘‘(ii) A comparison of transplant centers regarding 

search and other costs that prior to transplantation 

are charged to patients by transplant centers. 

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

transplant centers. 

‘‘(iv) Information concerning issues that patients 

may face after a transplant. 

‘‘(v) Such other information as the Program determines to be appropriate. 

‘‘(G) The Office shall conduct surveys of patients (or 

family members, physicians, or other individuals acting 

on behalf of patients) to determine the extent of satisfaction 

with the system for patient advocacy under this subsection, 

and to identify ways in which the system can be improved 

to best meet the needs of patients. 

‘‘(3) CASE MANAGEMENT.— ‘‘(A) IN GENERAL.—In serving as an advocate for a 

patient under paragraph (2), the Office shall provide 

individualized case management services directly to the 

patient (or family members, physicians, or other individuals 

acting on behalf of the patient), including— 

‘‘(i) individualized case assessment; and 

‘‘(ii) the functions described in paragraph (2)(D) 

(relating to progress in the search process). 

‘‘(B) POSTSEARCH FUNCTIONS.—In addition to the case 

management services described in paragraph (1) for 

patients, the Office shall, on behalf of patients who have 

completed the search for a bone marrow donor or cord 

blood unit, provide information and education on the 

process of receiving a transplant, including the post-transplant process. 

‘‘(i) COMMENT PROCEDURES.—The Secretary shall establish and 

provide information to the public on procedures under which the 

Secretary shall receive and consider comments from interested persons relating to the manner in which the Program is carrying 

out the duties of the Program. The Secretary may promulgate 

regulations under this section. 

‘‘(j) CONSULTATION.—In developing policies affecting the Program, the Secretary shall consult with the Advisory Council, the 

Department of Defense Marrow Donor Recruitment and Research 

Program operated by the Department of the Navy, and the board 

of directors of each entity awarded a contract under this section. 
H. R. 2520—12

‘‘(k) CONTRACTS.— 

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

under this section, an entity shall submit to the Secretary 

and obtain approval of an application at such time, in such 

manner, and containing such information as the Secretary shall 

by regulation prescribe. 

‘‘(2) CONSIDERATIONS.—In awarding contracts under this 

section, the Secretary shall give consideration to the continued 

safety of donors and patients and other factors deemed appropriate by the Secretary. 

‘‘(l) ELIGIBILITY.—Entities eligible to receive a contract under 

this section shall include private nonprofit entities. 

‘‘(m) RECORDS.— 

‘‘(1) RECORDKEEPING.—Each recipient of a contract or subcontract under subsection (a) shall keep such records as the 

Secretary shall prescribe, including records that fully disclose 

the amount and disposition by the recipient of the proceeds 

of the contract, the total cost of the undertaking in connection 

with which the contract was made, and the amount of the 

portion of the cost of the undertaking supplied by other sources, 

and such other records as will facilitate an effective audit. 

‘‘(2) EXAMINATION OF RECORDS.—The Secretary and the 

Comptroller General of the United States shall have access 

to any books, documents, papers, and records of the recipient 

of a contract or subcontract entered into under this section 

that are pertinent to the contract, for the purpose of conducting 

audits and examinations. 

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

the content of any record referred to in subsection (d)(4)(D) or 

(f)(5)(A) without the prior written consent of the donor or potential 

donor with respect to whom the record is maintained, or in violation 

of the standards described in subsection (f)(5)(B), shall be imprisoned for not more than 2 years or fined in accordance with title 

18, United States Code, or both.’’. 

(b) STEM CELL THERAPEUTIC OUTCOMES DATABASE.—Section 

379A of the Public Health Service Act (42 U.S.C. 274l) is amended 

to read as follows: 

‘‘SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATABASE. 

‘‘(a) ESTABLISHMENT.—The Secretary shall by contract establish 

and maintain a scientific database of information relating to 

patients who have been recipients of a stem cell therapeutics 

product (including bone marrow, cord blood, or other such product) 

from a donor. 

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

information in a standardized electronic format with respect to 

patients described in subsection (a), diagnosis, transplant procedures, results, long-term follow-up, and such other information as 

the Secretary determines to be appropriate, to conduct an ongoing 

evaluation of the scientific and clinical status of transplantation 

involving recipients of a stem cell therapeutics product from a 

donor. 

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

shall require the entity awarded a contract under this section 

to submit to the Secretary an annual report concerning patient 

outcomes with respect to each transplant center, based on data 

collected and maintained by the entity pursuant to this section. 
H. R. 2520—13

‘‘(d) PUBLICLY AVAILABLE DATA.—The outcomes database shall 

make relevant scientific information not containing individually 

identifiable information available to the public in the form of summaries and data sets to encourage medical research and to provide 

information to transplant programs, physicians, patients, entities 

awarded a contract under section 379 donor registries, and cord 

blood banks.’’. 

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

Act (42 U.S.C. 274k et seq.) is amended by inserting after section 

379A the following: 

‘‘SEC. 379A–1. DEFINITIONS. 

‘‘In this part: 

‘‘(1) The term ‘Advisory Council’ means the advisory council 

established by the Secretary under section 379(a)(1). 

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

adult bone marrow and peripheral blood. 

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

established by the Secretary under section 379A. 

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

Transplantation Program established under section 379.’’. 

(d) AUTHORIZATION OF APPROPRIATIONS.—Section 379B of the 

Public Health Service Act (42 U.S.C. 274m) is amended to read 

as follows: 

‘‘SEC. 379B. AUTHORIZATION OF APPROPRIATIONS. 

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

to be appropriated $34,000,000 for fiscal year 2006 and $38,000,000 

for each of fiscal years 2007 through 2010.’’. 

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

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

part heading, by striking ‘‘NATIONAL BONE MARROW DONOR 

REGISTRY’’ and inserting ‘‘C.W. BILL YOUNG CELL 

TRANSPLANTATION PROGRAM’’. 

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

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

Act, the Secretary of Health and Human Services, in consultation 

with the Commissioner of Food and Drugs, shall submit to Congress 

a report concerning the progress made by the Food and Drug 
H. R. 2520—14

Administration in developing requirements for the licensing of cord 

blood units.

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.