PUBLIC LAW 109–129—DEC. 20, 2005

STEM CELL THERAPEUTIC AND RESEARCH

ACT OF 2005

119 STAT. 2550 PUBLIC LAW 109–129—DEC. 20, 2005

Public Law 109–129

109th Congress

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.—

Records.

Records.

Contracts.

42 USC 274k

note.

42 USC 201 note.

Stem Cell

Therapeutic and

Research Act of

2005.

Dec. 20, 2005

[H.R. 2520]

PUBLIC LAW 109–129—DEC. 20, 2005 119 STAT. 2551

(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—

Regulations.

119 STAT. 2552 PUBLIC LAW 109–129—DEC. 20, 2005

(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).

PUBLIC LAW 109–129—DEC. 20, 2005 119 STAT. 2553

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

Contracts.

119 STAT. 2554 PUBLIC LAW 109–129—DEC. 20, 2005

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

Deadline.

Reports.

PUBLIC LAW 109–129—DEC. 20, 2005 119 STAT. 2555

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;

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119 STAT. 2556 PUBLIC LAW 109–129—DEC. 20, 2005

‘‘(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;

Publication.

Records.

PUBLIC LAW 109–129—DEC. 20, 2005 119 STAT. 2557

‘‘(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 RECRUITMENT; 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).

Minorities.

119 STAT. 2558 PUBLIC LAW 109–129—DEC. 20, 2005

‘‘(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

Minorities.

Confidentiality.

Records.

PUBLIC LAW 109–129—DEC. 20, 2005 119 STAT. 2559

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

Establishment.

119 STAT. 2560 PUBLIC LAW 109–129—DEC. 20, 2005

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.

Public

information.

Surveys.

PUBLIC LAW 109–129—DEC. 20, 2005 119 STAT. 2561

‘‘(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.

Contracts.

Regulations.

119 STAT. 2562 PUBLIC LAW 109–129—DEC. 20, 2005

‘‘(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

42 USC prec.

274k.

42 USC 274l–1.

PUBLIC LAW 109–129—DEC. 20, 2005 119 STAT. 2563

LEGISLATIVE HISTORY—H.R. 2520 (S. 1317):

SENATE REPORTS: No. 109–129 accompanying S. 1317 (Comm. on Health, Education, Labor, and Pensions).

CONGRESSIONAL RECORD, Vol. 151 (2005):

May 24, considered and passed House.

Dec. 16, considered and passed Senate, amended.

Dec. 17, House concurred in Senate amendment.

Æ

Administration in developing requirements for the licensing of cord

blood units.

Approved December 20, 2005.