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 reg-
istries, 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 dis-
eases 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 provi-
sion of appropriate information (at the start of the search 
process and throughout the process) to patients and their fami-
lies 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 subpara-
graph (A) with respect to such populations. 
‘‘(2) INFORMATION
AND
EDUCATION
REGARDING
RECRUIT-
MENT; TESTING AND DONATION.— 
‘‘(A) IN GENERAL.—In carrying out the recruitment pro-
gram 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 preg-
nant 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 preg-
nant 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 main-
tain, through a contract or other means determined appropriate 
by the Secretary, an office of patient advocacy (in this sub-
section referred to as the ‘Office’). 
‘‘(2) GENERAL FUNCTIONS.—The Office shall meet the fol-
lowing 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 con-
duct, 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 sub-
section (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 informa-
tion regarding the progress being made in the search. 
‘‘(ii) Informing the patient (or such other indi-
vidual) if the search has been interrupted or discon-
tinued. 
‘‘(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 deter-
mines 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-trans-
plant 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 per-
sons 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 Pro-
gram, 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 appro-
priate 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 sub-
contract 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 impris-
oned 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 proce-
dures, 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 sum-
maries 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.