I
105TH CONGRESS
1ST SESSION
H. R. 2202
To amend the Public Health Service Act to revise and extend the bone
marrow donor program, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JULY 17, 1997
Mr. YOUNG of Florida (for himself, Mr. BLILEY, Mr. SAXTON, Mr. STOKES,
Mr. HOYER, Mr. HALL of Ohio, Mr. MCDADE, Mr. SHAW, Mr. WATTS
of Oklahoma, Mr. WAXMAN, Mr. HEFLEY, Mr. MOAKLEY, Mr. DELLUMS,
Mr. HILLEARY, Mr. BORSKI, Ms. GRANGER, Mr. HORN, Mr. COBURN,
Mr. HASTINGS of Florida, Mr. THOMPSON, Mr. PICKETT, Mr. MASCARA,
Mr. PETERSON of Minnesota, Mr. THORNBERRY, Mr. GORDON, Mr.
BLUNT, Mr. MCNULTY, Mr. PASTOR, Mr. MORAN of Virginia, Ms. ROS-
LEHTINEN, Mrs. MINK of Hawaii, Ms. EDDIE BERNICE JOHNSON of
Texas, Ms. DUNN, Mr. FALEOMAVAEGA, Mr. CONDIT, Mr. DUNCAN, Mr.
GREENWOOD, Mr. GUTIERREZ, Mr. SHIMKUS, Mr. CLAY, Mr. BOB
SCHAFFER of Colorado, Mr. BOEHLERT, Mr. DEFAZIO, Mr. QUINN, Ms.
NORTON, Mr. CALVERT, Mr. WISE, Ms. PELOSI, Mr. FRELINGHUYSEN,
Mr. FROST, Mrs. LOWEY, Mr. BARTON of Texas, Ms. DELAURO, Mr.
LATHAM, Mr. FOLEY, Mr. SPENCE, Mr. CANADY of Florida, Mr.
HINCHEY, Ms. KILPATRICK, Mr. BOYD, Ms. SLAUGHTER, Mr. BONILLA,
Mr. ABERCROMBIE, Mrs. THURMAN, and Mr. PORTER) introduced the
following bill; which was referred to the Committee on Commerce
A BILL
To amend the Public Health Service Act to revise and extend
the bone marrow donor program, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘National Marrow
Donor Program Reauthorization Act of 1997’’.
SEC. 2. REVISION AND EXTENSION OF NATIONAL BONE
MARROW DONOR PROGRAM.
Title III of the Public Health Service Act (42 U.S.C.
241 et seq.) is amended—
(1) by transferring section 378 from the cur-
rent placement of the section and inserting the sec-
tion after section 377; and
(2) by amending part I to read as follows:
‘‘PART I—NATIONAL BONE MARROW AND BLOOD
STEM CELL DONOR PROGRAM
‘‘SEC. 379. ESTABLISHMENT OF NATIONAL PROGRAM.
‘‘(a) IN GENERAL.—The Secretary shall by contract
establish a program whose purpose is to carry out in ac-
cordance with this part a system to assist patients who
are in need of a transplant of blood stem cells in searching
for individuals who are biologically unrelated to the pa-
tients and willing to be donors of such cells.
‘‘(b) ADMINISTRATION OF PROGRAM.—
‘‘(1) IN GENERAL.—The program under sub-
section (a) (referred to in this part as the ‘Pro-
gram’) shall be under the general supervision of the
Secretary, and under the direction of a board of di-
rectors meeting the requirements of section 379C(a).
‘‘(2) CONSULTATIONS.—In developing policies
affecting the Program, the Secretary shall consult
with the board of directors of the Program and with
the bone marrow donor program of the Department
of the Navy.
‘‘(c) BLOOD STEM CELLS; RELATION TO BONE MAR-
ROW.—For purposes of subsection (a), the term ‘blood
stem cells’ (referred to in this part as ‘stem cells’) means
hematopoietic cells found in bone marrow, umbilical-cord
blood, peripheral blood, and such other sources as may
be identified.
‘‘SEC. 379A. FUNCTIONS OF NATIONAL PROGRAM.
‘‘(a) IN GENERAL.—In providing for the system
under section 379(a), the Program shall carry out the fol-
lowing:
‘‘(1) Establish the system through coordinating
with entities that operate programs relevant to the
purpose described in such section, including the op-
eration of donor and recipient registries, donor cen-
ters, collection centers, and transplant centers.
‘‘(2) Maintain registries in accordance with sub-
section (b).
‘‘(3) Recruit potential donors of stem cells, and
carry out educational activities, in accordance with
subsection (c).
‘‘(4) Carry out activities for patient advocacy
and case management in accordance with subsection
(d).
‘‘(5) Collect, analyze, and publish data concern-
ing the donation and transplantation of stem cells.
‘‘(6) With respect to searches for a biologically
unrelated donor of stem cells that are conducted
through the system, collect and analyze and publish
data on the number and percentage of patients at
each of the various stages of the search process, in-
cluding data regarding the furthest stage reached;
the number and percentage of patients who are un-
able to complete the search process; and the com-
parative search costs of transplant centers incurred
by patients prior to transplantation.
‘‘(7) 
Support 
studies 
and 
demonstration
projects for the purpose of increasing the number of
individuals, especially individuals who are members
of racial or ethnic minority groups, who are willing
to be donors of stem cells.
‘‘(b) REGISTRIES.—
‘‘(1) DONOR REGISTRY.—
‘‘(A) IN
GENERAL.—The Program shall
under subsection (a)(2) maintain one or more
registries containing information relating to in-
dividuals who are willing to be donors of stem
cells to biologically unrelated recipients.
‘‘(B) BONE MARROW; CORD BLOOD.—In-
formation regarding bone marrow, and informa-
tion regarding umbilical-cord blood, shall be in-
cluded for purposes of subparagraph (A).
‘‘(C) MONITORING OF SCIENTIFIC DATA.—
In carrying out subparagraph (A), the Program
shall monitor the available scientific data on the
use as a source of stem cells of bone marrow,
umbilical-cord blood, peripheral blood, and such
other sources as may be identified, and shall
consider such data in carrying out subpara-
graph (A).
‘‘(D) PRIORITY FOR UNDERREPRESENTED
POPULATIONS.—The Program shall identify
populations that are underepresented with re-
spect to the information maintained under sub-
paragraph (A). In the case of populations that
are identified under the preceding sentence:
‘‘(i) The Program shall give priority
to carrying out activities under this part to
increase representation for such popu-
lations in order to enable a member of
such a population, to the extent prac-
ticable, to have a probability of finding a
suitable unrelated donor that is com-
parable to the probability that an individ-
ual who is not a member of an underrep-
resented population would have.
‘‘(ii) The Program shall consider ra-
cial and ethnic minority groups to be popu-
lations that have been identified for pur-
poses of this subparagraph, and shall carry
out clause (i) with respect to such popu-
lations.
‘‘(E) ANNUAL
UPDATING.—The Program
shall annually update information under sub-
paragraph (A) to account for changes in the
status of individuals as potential donors of stem
cells.
‘‘(2) RECIPIENT REGISTRY.—
‘‘(A) IN
GENERAL.—The Program shall
under subsection (a)(2) maintain one or more
registries containing—
‘‘(i) information relating to individuals
who have been a recipient of a stem-cell
transplant from a biologically unrelated
donor; and
‘‘(ii) to the extent practicable, infor-
mation relating to individuals who have
been a recipient of such a transplant from
an autologous donation or from a bio-
logically related donor.
‘‘(B) PATIENT
OUTCOMES; ANNUAL
RE-
PORT.—Information under subparagraph (A)
shall include information regarding medical out-
comes for patients who have been a recipient of
a stem-cell transplant. Such information shall
be categorized according to the diseases that
necessitated the transplants and according to
the transplant centers involved. The Program
shall annually submit to the Secretary a report
on such medical outcomes.
‘‘(3) ADDITIONAL INFORMATION.—In addition
to the information required in paragraphs (1) and
(2) to be included in the registries under such para-
graphs, the Program may include in the registries
such information as may be appropriate with respect
to the purpose described in section 379(a) (including
information necessary to conduct an ongoing evalua-
tion of the scientific and clinical status of individuals
who have been a recipient of a stem-cell transplant
from a biologically unrelated donor of such cells).
‘‘(c) EDUCATIONAL ACTIVITIES.—
‘‘(1) RECRUITMENT OF DONORS.—
‘‘(A) IN
GENERAL.—The Program shall
under subsection (a)(3) carry out activities, in-
cluding providing information, for purposes of
recruiting individuals to serve as donors of stem
cells. Such activities shall include testing poten-
tial donors, and providing information to up-
date potential donors.
‘‘(B) PRIORITY FOR UNDERREPRESENTED
POPULATIONS.—In carrying out subparagraph
(A), the Program shall give priority to recruit-
ing individuals to serve as donors of stem cells
for populations that are identified under sub-
section (b)(1)(D).
‘‘(2) TRANSPLANTATION
AS
TREATMENT
OP-
TION.—The Program shall under subsection (a)(3)
provide information to physicians, other health care
professionals, and the public regarding the availabil-
ity as a potential treatment option of receiving a
stem-cell transplant from a biologically unrelated
donor.
‘‘(3) CONTRACTS
FOR
EDUCATIONAL
ACTIVI-
TIES.—The Program may enter into contracts with
public and nonprofit private entities for the purpose
of assisting the Program in carrying out paragraphs
(1) and (2).
‘‘(d) OFFICE
OF PATIENT ADVOCACY
AND CASE
MANAGEMENT.—
‘‘(1) IN GENERAL.—The Program shall under
subsection (a)(4) establish within the Program an
office to be known as the Office of Patient Advocacy
and Case Management (referred to in this subsection
as the ‘Office’), which shall be headed by a director
appointed by the Program.
‘‘(2) FUNCTIONS.—With respect to utilizing the
system under section 379(a) to conduct on behalf of
patients searches for a biologically unrelated donor
of stem cells, the Office shall carry out the following:
‘‘(A) Through coordinating with donor reg-
istries, transplant centers, and other entities,
carry out under the Program a system for pa-
tient advocacy and case management (separate
from mechanisms for donor advocacy).
‘‘(B) In the case of patients who (directly
or through family members, physicians, or other
individuals) request the assistance of the Pro-
gram, directly provide individualized services
with respect to efficiently utilizing the system
under section 379(a) to conduct an ongoing
search (including individualized services regard-
ing each stage of the search process).
‘‘(C) In carrying out subparagraph (B)
with respect to a patient—
‘‘(i) serve as an advocate on behalf of
the patient; and
‘‘(ii) provide individualized case man-
agement services on behalf of the patient.
‘‘(D) In carrying out subparagraph (B),
monitor the system under section 379(a) to de-
termine—
‘‘(i) whether the search needs of pa-
tients are being met (including the periodic
provision to the patient of information re-
garding donors who are suitability matched
to the patient, and of other information re-
garding the progress being made in the
search; informing the patient if the search
has been interrupted or discontinued; and
identifying and resolving problems in the
search, to the extent practicable); and
‘‘(ii) whether donor registries, trans-
plant centers, and other entities are com-
plying with standards issued under section
379B(a)(4) for the system for patient ad-
vocacy and case management under this
subsection.
‘‘(E) Provide for patients the following
data:
‘‘(i) The resources available through
the Program.
‘‘(ii) The comparative search costs of
transplant centers incurred by patients
prior to transplantation.
‘‘(iii) A list of donor registries, trans-
plant centers, and other entities that meet
the applicable standards, criteria, and pro-
cedures under section 379B.
‘‘(iv) The posttransplant outcomes for
individual transplant centers.
‘‘(v) Such other information as the
Program determines to be appropriate.
‘‘(F) Conduct surveys of patients and their
families and physicians to determine the extent
of satisfaction with the system for patient advo-
cacy and case management under this sub-
section, and to identify ways in which the sys-
tem can be improved.
‘‘(3) ADDITIONAL FUNCTIONS.—In addition to
the functions established in paragraph (2) for the
Office, the Office may, on behalf of patients who
have completed the search described in such para-
graph, provide information and education on the
process of receiving a stem-cell transplant, including
the posttransplant process.
‘‘SEC. 379B. CRITERIA, STANDARDS, AND PROCEDURES.
‘‘(a) IN GENERAL.—For the Program and for entities
participating in the system established under section
379(a) (including individual donor centers, donor and re-
cipient registries, collection centers, and transplant cen-
ters), the Secretary shall with respect to such system es-
tablish and enforce the following:
‘‘(1) Quality standards and standards for tissue
typing, obtaining the informed consent of donors,
and providing patient advocacy.
‘‘(2) Donor selection criteria, based on estab-
lished medical criteria, to protect both the donor and
the recipient and to prevent the transmission of po-
tentially harmful infectious diseases such as the vi-
ruses that cause hepatitis and such as the human
immunodeficiency virus (commonly known as HIV).
‘‘(3) Procedures to ensure the proper collection
and transportation of stem cells.
‘‘(4) Standards for the system for patient advo-
cacy and case management carried out under section
379A(d), including standards requiring the provision
of appropriate information (at the start of the
search process and throughout the process) to pa-
tients and their families and physicians.
‘‘(5) Standards that accomplish the following:
‘‘(A) Require the establishment of a sys-
tem of strict confidentiality of records relating
to the identity, address, HLA type, and manag-
ing donor center for donors and potential do-
nors, including such records that are electroni-
cally maintained.
‘‘(B) Prescribe the purposes for which the
records described in subparagraph (A) may be
disclosed, and the circumstances and extent of
the disclosure.
‘‘(6) In the case of donor registries and donor
centers participating in the system under section
379(a), procedures to ensure the establishment of a
method for integrating with the Program the donor
files, searches, and general procedures of such reg-
istries and centers.
‘‘(b) PENALTIES FOR VIOLATION OF CONFIDENTIAL-
ITY PROVISIONS.—Any person who discloses the content
of any record referred to in subparagraph (A) of sub-
section (a)(5) 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 subparagraph (B) of such subsection, shall be fined in
accordance with title 18, United States Code, or impris-
oned for not more than 2 years, or both.
‘‘SEC. 379C. GENERAL PROVISIONS.
‘‘(a) BOARD
OF DIRECTORS.—The Program shall
under section 379(b)(1) appoint a board of directors and
shall provide for such board in accordance with the follow-
ing:
‘‘(1) The membership of the board shall include
representatives of donor centers, transplant centers,
and blood banks; recipients of a stem-cell transplant;
family members of such a recipient or family mem-
bers of a patient who has requested the assistance
of the Program in searching for a biologically unre-
lated donor of such cells; persons with expertise in
the social sciences; and members of the general pub-
lic.
‘‘(2) The Program shall select a member of the
board to serve as the Chair of the board.
‘‘(3) The term for a member of the board shall
be two years, and a member shall not serve for more
than three consecutive terms, except that such limi-
tations shall not apply to the Chair of the board (or
the Chair-elect) or to the member of the board who
most recently served as the Chair.
‘‘(4) Appointments to the board shall be made
such that each year the terms of approximately 1⁄3
of the members of the board expire.
‘‘(5) A member of the board may continue to
serve after the expiration of the term of the member
until a successor is appointed.
‘‘(b) PROCEDURES REGARDING PUBLIC COMMENT
ON PROGRAM.—The Secretary shall establish and provide
information to the public on procedures, which may in-
clude establishment of a policy advisory committee, under
which the Secretary shall receive and consider comments
from interested persons relating to the manner in which
the Program is carrying out the functions of the Program
under section 379A and complying with the criteria,
standards, and procedures under section 379B.
‘‘(c) PROVISIONS REGARDING CONTRACT FOR PRO-
GRAM.—
‘‘(1) RECORDS.—
‘‘(A) RECORDKEEPING.—Each recipient of
a contract or subcontract under section 379(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 por-
tion of the cost of the undertaking supplied by
other sources; and such other records as will fa-
cilitate an effective audit.
‘‘(B) 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
section 379(a) that are pertinent to the con-
tract, for the purpose of conducting audits and
examinations.
‘‘(2) AWARDING OF CONTRACT.—
‘‘(A) ELIGIBILITY.—Entities eligible to re-
ceive a contract under section 379(a) include
nonprofit private entities.
‘‘(B) APPLICATION
FOR
CONTRACT.—To
be eligible to enter into a contract under section
379(a), an entity shall submit to the Secretary
and obtain approval of an application submitted
at such time and in such manner, and contain-
ing such information, as the Secretary shall by
regulation prescribe.
‘‘SEC. 379D. AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are
authorized to be appropriated $18,000,000 for fiscal year
1998, and such sums as may be necessary for each of the
fiscal years 1999 through 2002.’’.
SEC. 3. MISCELLANEOUS PROVISIONS REGARDING NA-
TIONAL BONE MARROW AND BLOOD STEM
CELL DONOR PROGRAM.
(a) COMPLIANCE WITH NEW REQUIREMENTS FOR
OFFICE
OF PATIENT ADVOCACY
AND CASE MANAGE-
MENT.—With respect to requirements for the Office of Pa-
tient Advocacy and Case Management under part I of title
III of the Public Health Service Act, the Secretary of
Health and Human Services shall ensure that, not later
than 180 days after the date of the enactment of this Act,
such Office is in compliance with all requirements (estab-
lished pursuant to the amendment made by section 2(2))
that are additional to the requirements that under such
part were in effect for the Office on the day before the
date of the enactment of this Act.
(b) PLAN REGARDING RELATIONSHIP BETWEEN NA-
TIONAL PROGRAM AND DONOR CENTERS.—The Secretary
of Health and Human Services shall ensure that, not later
than one year after the date of the enactment of this Act,
the Program develops, evaluates, and implements a plan
to effectuate efficiencies in the relationship between the
Program and donor centers. The plan shall incorporate,
to the extent practicable, the findings and recommenda-
tions made in the inspection conducted by the Office of
the Inspector General (Department of Health and Human
Services) as of January 1997 and known as the Bone Mar-
row Program Inspection. For purposes of this subsection,
the terms ‘‘Program’’ and ‘‘donor center’ have the mean-
ings applicable to such terms under part I of title III of
the Public Health Service Act.
(c) RULE OF CONSTRUCTION REGARDING NATIONAL
HEART, LUNG, AND BLOOD INSTITUTE.—The provisions
of part I of title III of the Public Health Service Act may
not be construed as having any legal effect on any pro-
gram of research carried out by the National Heart, Lung
and Blood Institute with respect to blood stem cells (in-
cluding such cells found in umbilical-cord blood).
SEC. 4. EFFECTIVE DATE.
This Act takes effect October 1, 1997, or upon the
date of the enactment of this Act, whichever occurs later.
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