[House Report 108-276]
[From the U.S. Government Publishing Office]
108th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 108-276
======================================================================
NATIONAL BONE MARROW DONOR REGISTRY REAUTHORIZATION ACT
_______
September 17, 2003.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Tauzin, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 3034]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 3034) to amend the Public Health Service Act to
reauthorize the National Bone Marrow Donor Registry, and for
other purposes, having considered the same, report favorably
thereon with an amendment and recommend that the bill as
amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Hearings......................................................... 4
Committee Consideration.......................................... 4
Committee Votes.................................................. 4
Committee Oversight Findings..................................... 4
Statement of General Performance Goals and Objectives............ 4
New Budget Authority, Entitlement Authority, and Tax Expenditures 4
Committee Cost Estimate.......................................... 5
Congressional Budget Office Estimate............................. 5
Federal Mandates Statement....................................... 6
Advisory Committee Statement..................................... 6
Constitutional Authority Statement............................... 6
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Bone Marrow Donor Registry
Reauthorization Act''.
SEC. 2. NATIONAL BONE MARROW DONOR REGISTRY.
(a) National Registry.--Section 379 of the Public Health Service Act
(42 U.S.C. 274k) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by striking ``except that'' and
all that follows and inserting ``except that--
``(A) such limitations 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; and
``(B) 1 additional consecutive 2-year term may be
served by any member of the board who has no
employment, governance, or financial affiliation with
any donor center, recruitment group, transplant center,
or cord blood bank.''; and
(B) in paragraph (4)--
(i) by striking ``the Naval Medical Research
and Development Command'' and inserting ``the
Department of Defense Marrow Donor Recruitment
and Research Program operated by the Department
of the Navy''; and
(ii) by striking ``Organ'' after ``Division
of'';
(2) in subsection (b)--
(A) in paragraph (4), by inserting ``at least''
before ``annually'';
(B) in paragraph (7), by striking ``and comparisons
of transplant centers regarding search and other costs
that prior to transplantation are charged to patients
by transplant centers; and'';
(C) in paragraph (8), by inserting ``and outreach''
after ``and demonstration'';
(D) at the end of paragraph (8), by striking the
period and inserting a semicolon;
(E) by redesignating paragraphs (3) through (8) as
paragraphs (4) through (9);
(F) by inserting after paragraph (2), the following:
``(3) maintain and expand medical emergency contingency
response capabilities in concert with Federal programs for
response to threats of use of terrorist or military weapons
that can damage marrow, such as ionizing radiation or chemical
agents containing mustard, so that the capability of supporting
patients with marrow damage from disease can be used to support
casualties with marrow damage;''; and
(G) by adding at the end the following:
``(10) conduct and support research to improve the
availability, efficiency, safety, and cost of transplants from
unrelated donors and the effectiveness of Registry operations;
``(11) increase the number of umbilical cord blood units
listed in the Registry and assist cord blood banks in the
Registry program in accordance with subsection (c); and
``(12) establish bylaws and procedures--
``(A) to prohibit any member of the board of
directors of the Registry who has an employment,
governance, or financial affiliation with a donor
center, recruitment group, transplant center, or cord
blood bank from participating in any decision that
materially affects the center, recruitment group,
transplant center, or cord blood bank; and
``(B) to limit the number of members of the board
with any such affiliation.'';
(3) in subsection (c)--
(A) in clause (ii) of paragraph (2)(A), by striking
``, including providing updates''; and
(B) in paragraph (3), by striking ``the availability,
as a potential treatment option, of receiving a
transplant of bone marrow from an unrelated donor'' and
inserting ``transplants from unrelated donors as a
treatment option and resources for identifying and
evaluating other therapeutic alternatives'';
(4) in subsection (d)--
(A) in paragraph (2)(C), by inserting ``and assist
with information regarding third party payor matters''
after ``ongoing search for a donor'';
(B) in paragraph (2)(F)--
(i) by redesignating clause (v) as clause
(vi); and
(ii) by inserting after clause (iv) the
following:
``(v) Information concerning issues that
patients may face after a transplant regarding
continuity of care and quality of life.''; and
(C) in paragraph (3)(B), by striking ``Office may''
and inserting ``Office shall'';
(5) in subsection (g), by striking ``the bone marrow donor
program of the Department of the Navy'' and inserting ``the
Department of Defense Marrow Donor Recruitment and Research
Program operated by the Department of the Navy'';
(6) in subsection (h)--
(A) by striking ``Application.--'' and inserting
``Contracts.--'';
(B) by striking ``To be eligible'' and inserting the
following:
``(1) Application.--To be eligible''; and
(C) by adding at the end the following:
``(2) Considerations.--In awarding contracts under this
section, the Secretary shall give substantial weight to the
continued safety of donors and patients and other factors
deemed appropriate by the Secretary.'';
(7) in subsection (i), by striking ``include'' and inserting
``be''; and
(8) by striking subsection (l).
(b) Bone Marrow Scientific Registry.--Section 379A of the Public
Health Service Act (42 U.S.C. 274l) is amended--
(1) in subsection (a), by adding at the end the following:
``The scientific registry shall participate in medical research
that has the potential to improve transplant outcomes.'';
(2) in subsection (c), by striking ``Each such report shall
in addition include the data required in section 379(l)
(relating to pretransplant costs).''; and
(3) by adding after subsection (c) the following:
``(d) Publicly Available Data.--The scientific registry 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, and patients.''.
(c) Bone Marrow and Marrow Defined.--Part I of title III of the
Public Health Service Act (42 U.S.C. 274k et seq.) is amended--
(1) by redesignating section 379B as section 379C; and
(2) by inserting after section 379A the following:
``SEC. 379B. BONE MARROW AND MARROW DEFINED.
``For purposes of this part, the terms `bone marrow' and `marrow'
include bone marrow and any other source of hematopoietic progenitor
cells the acquisition or use of which is not inconsistent with Federal
law.''.
(d) Authorization of Appropriations.--Section 379C of the Public
Health Service Act, as redesignated by subsection (c), is amended to
read as follows:
``SEC. 379C. AUTHORIZATION OF APPROPRIATIONS.
``(a) In General.--For the purpose of carrying out this part, there
are authorized to be appropriated $32,000,000 for fiscal year 2004, and
such sums as may be necessary for each of the fiscal years 2005 through
2008.
``(b) Emergency Contingency Response Capabilities.--In addition to
the amounts authorized to be appropriated under subsection (a), there
are authorized to be appropriated such sums as may be necessary for the
maintenance and expansion of emergency contingency response
capabilities under section 379(b)(3).''.
Purpose and Summary
H.R. 3034 amends section 379 of the Public Health Service
Act to reauthorize the national bone marrow donor registry.
Background and Need for Legislation
Bone marrow transplants are often one of the last options
available to patients struggling to fight debilitating and
often terminal diseases. Unfortunately, finding a bone marrow
match is rather difficult. In fact, every year, nearly two-
thirds of patients in need of a bone marrow transplant will not
find a marrow donor match within their family and must rely on
the help of strangers. The national bone marrow donor registry
facilitates marrow and cord blood transplants for patients with
life-threatening diseases who do not have matching donors in
their families.
Federal support began in 1986 when Congress directed the
U.S. Navy to establish a national registry of bone marrow
donors. The following year, as part of the Health Omnibus
Programs Extension Act (P.L. 100-607), Congress expanded the
bone marrow registry by requiring the Department of Health and
Human Services (HHS) to assume the responsibility of managing
the bone marrow registry. Currently, HHS contracts with the
National Bone Marrow Donor Program, a non-profit organization
based in Minneapolis, MN, to operate the program. Congress last
reauthorized the national bone marrow donor registry in 1998.
Authorization of appropriations for the program expires in
fiscal year 2003.
H.R. 3034, the National Bone Marrow Donor Registry
Reauthorization Act, reauthorizes the registry for an
additional five-year period.
Hearings
The Committee on Energy and Commerce has not held hearings
on the legislation.
Committee Consideration
On September 10, 2003, the Full Committee met in open
markup session and favorably ordered H.R. 3034 reported to the
House, as amended, by a voice vote, a quorum being present.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 3034 reported. A motion by Mr. Tauzin to order H.R. 3034
reported to the House, as amended, was agreed to by a voice
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
Statement of General Performance Goals and Objectives
The goal of H.R. 3034 is to reauthorize the national bone
marrow donor registry for an additional five-year period.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
3034, the National Bone Marrow Donor Registry Act, would result
in no new or increased budget authority, entitlement authority,
or tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 16, 2003.
Hon. W.J. ``Billy'' Tauzin,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 3034, the National
Bone Marrow Donor Registry Reauthorization Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Margaret
Nowak.
Sincerely,
Douglas Holtz-Eakin,
Director.
Enclosure.
H.R. 3034--National Bone Marrow Donor Registry Reauthorization Act
Summary: H.R. 3034 would amend the Public Health Service
Act to reauthorize and amend the National Bone Marrow Donor
Registry operated by the Health Resources and Services
Administration (HRSA). The registry operates a system for
finding marrow donors suitably matched to unrelated recipients
for bone marrow transplantation. The bill would reauthorize
funding for the registry through 2008. H.R. 3034 also would
alter some of the term-limit requirements and establish
conflict interest regulations for board members involved in the
administration of donor centers. In addition, the bill would
require more frequent updates of information on potential
donors and would expand contingency plans for safeguarding
donated marrow in the event of a terrorist or military attack.
CBO estimates that implementing H.R. 3034 would cost $10
million in 2004 and $145 million over the 2004-2008 period,
assuming the appropriation of the necessary amounts. The
legislation would not affect direct spending or receipts.
The bill contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would impose no costs on State, local, or tribal
governments.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 3034 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------
2003 2004 2005 2006 2007 2008
------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Spending Under Current Law:
Budget Authority \1\...... 22 0 0 0 0 0
Estimated Outlays......... 9 10 4 2 0 0
Proposed Changes \2\:
Estimated Authorization 0 34 35 37 41 45
Level....................
Estimated Outlays......... 0 10 25 33 37 40
Spending Under H.R. 3034:
Estimated Authorization 22 34 35 37 41 45
Level \1\................
Estimated Outlays......... 9 21 29 34 37 40
------------------------------------------------------------------------
\1\ The 2003 level is the amount appropriated for that year for the
National Bone Marrow Donor Registry.
\2\ Including adjustments for anticipated inflation, the estimated
outlay changes would total $145 million over the 2004-2008 period.
Without such adjustments, the five-year total would be $133 million.
Basis of estimate: H.R. 3034 would reauthorize funding for
the National Bone Marrow Donor Registry through 2008. The
registry operates a system for finding marrow donors suitably
match to unrelated recipients for bone marrow transplantation.
H.R. 3034 would authorize the appropriation of $32 million in
2004 and such sums as necessary through 2008 for operating the
registry. Based on historical spending patterns for the
registry, CBO estimates that operating it would cost $9 million
in 2004 and $136 million over the 2004-2008 period, assuming
appropriation of the authorized amounts.
The bill also would expand the functions of the registry to
maintain and expand medical emergency contingency plans for
safeguarding donated marrow in the event of a terrorist or
military attack. Based on information provided by HRSA, CBO
estimates that implementing the contingency plans in H.R. 3034
would cost $1 million in 2004 and $9 million over the 2004-2008
period, assuming the appropriation of the necessary amounts.
Intergovernmental and private-sector impact: H.R. 3034
contains no intergovernmental or private-sector mandates as
defined in UMRA and would not affect the budgets of State,
local, or tribal governments.
Estimate prepared by: Federal Costs: Margaret Nowak. Impact
on State, local and tribal governments: Leo Lex. Impact on the
private sector: Samuel Kina.
Estimate approved by: Peter H. Fontaine. Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates the short title as the ``National Bone
Marrow Registry Reauthorization Act.''
Section 2. National bone marrow donor registry
Section 2 amends section 379 of the Public Health Service
Act to add more procedures for rotating the board of directors
of the national bone marrow donor registry. It provides that a
board member may serve one additional consecutive two-year term
if the board member has no employment, governance, or financial
affiliation with any donor center, recruitment group,
transplant center, or cord blood bank.
Section 2 corrects references to offices within the
Department of the Navy and the Health Resources and Service
Administration, the two federal agencies that manage bone
marrow registries.
Section 2 also amends the functions of the national bone
marrow registry to reflect new directions the national bone
marrow registry is undertaking to improve its capabilities.
Specifically, this section directs the registry to maintain and
expand medical response capabilities in concert with federal
programs for responding to terrorist threats that can damage
marrow. Additional appropriations for this purpose may be
awarded if the Secretary deems it necessary to significantly
expand this function of the registry. The registry must conduct
and support research to improve the availability, efficiency,
safety, and cost of transplants from unrelated donors and the
effectiveness of registry operations. Because of this new
language, this section deletes a duplicative existing
requirement that the registry make comparisons of transplant
centers regarding search and other costs that prior to
transplantation are charged to patients by transplant centers.
The registry must at least annually update information to
account for changes in the status of individuals as potential
donors of bone marrow. The registry is also directed to
increase the number of umbilical cord blood units listed in the
registry and assist cord blood banks in the registry program.
Finally, the registry must establish bylaws and procedures to
limit the affiliation and membership to the board of directors
to anyone who has an employment governance, or financial
affiliation with a donor center, recruitment group, transplant
center, or cord blood bank from participating in any decision
that will bring material gain.
Section 2 also directs the registry to provide information
to physicians, other health care professionals, and the public
regarding transplants from unrelated donors. In terms of
patient advocacy, the registry is directed to also assist
patients with information regarding third party payor matter.
In addition, this section permits private nonprofit
entities to enter into contracts with the registry. In awarding
contracts, the Secretary must give substantial weight to the
continued safety of donors and patients and other factors
deemed appropriate by the Secretary. It also deletes a
duplicative reporting requirement regarding transplantation
costs.
Section 2 expands the activities of the bone marrow
scientific registry, a registry of information relating to
patients who have been recipients of transplant bone marrow
from a biologically unrelated donor, to require the registry to
participate in medical research that has the potential to
improve transplant outcomes. The registry is also required to
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, and patients.
Section 2 formally defines the terms ``bone marrow'' and
``marrow'' to include bone marrow and any other source of
hematopoietic progenitor cells the acquisition or use of which
is not inconsistent with Federal law.
Finally, section 2 authorizes the appropriation of
$32,000,000 for fiscal year 2004 and such sums as may be
necessary for each of the years 2005 through 2008.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
PART I--NATIONAL BONE MARROW DONOR REGISTRY
SEC. 379. NATIONAL REGISTRY.
(a) Establishment.--The Secretary shall by contract establish
and maintain a National Bone Marrow Donor Registry (referred to
in this part as the ``Registry'') that has the purpose of
increasing the number of transplants for recipients suitably
matched to biologically unrelated donors of bone marrow, and
that meets the requirements of this section. The Registry shall
be under the general supervision of the Secretary, and under
the direction of a board of directors meeting the following
requirements:
(1) Each member of the board shall serve for a term
of 2 years, and each such member may serve as many as 3
consecutive 2-year terms, [except that such limitations
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.] except that--
(A) such limitations 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; and
(B) 1 additional consecutive 2-year term may
be served by any member of the board who has no
employment, governance, or financial
affiliation with any donor center, recruitment
group, transplant center, or cord blood bank.
* * * * * * *
(4) The membership of the board shall include
representatives of marrow donor centers and marrow
transplant centers; recipients of a bone marrow
transplant; persons who require or have required such a
transplant; family members of such a recipient or
family members of a patient who has requested the
assistance of the Registry in searching for an
unrelated donor of bone marrow; persons with expertise
in the social sciences; and members of the general
public; and in addition nonvoting representatives from
[the Naval Medical Research and Development Command]
the Department of Defense Marrow Donor Recruitment and
Research Program operated by the Department of the Navy
and from the Division of [Organ] Transplantation of the
Health Resources and Services Administration.
(b) Functions.--The Registry shall--
(1) * * *
* * * * * * *
(3) maintain and expand medical emergency contingency
response capabilities in concert with Federal programs
for response to threats of use of terrorist or military
weapons that can damage marrow, such as ionizing
radiation or chemical agents containing mustard, so
that the capability of supporting patients with marrow
damage from disease can be used to support casualties
with marrow damage;
[(3)] (4) carry out informational and educational
activities in accordance with subsection (c);
[(4)] (5) at least annually update information to
account for changes in the status of individuals as
potential donors of bone marrow;
[(5)] (6) provide for a system of patient advocacy
through the office established under subsection (d);
[(6)] (7) provide case management services for any
potential donor of bone marrow to whom the Registry has
provided a notice that the potential donor may be
suitably matched to a particular patient (which
services shall be provided through a mechanism other
than the system of patient advocacy under subsection
(d)), and conduct surveys of donors and potential
donors to determine the extent of satisfaction with
such services and to identify ways in which the
services can be improved;
[(7)] (8) with respect to searches for unrelated
donors of bone marrow that are conducted through the
system under paragraph (1), collect and analyze and
publish data 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; [and comparisons of transplant
centers regarding search and other costs that prior to
transplantation are charged to patients by transplant
centers; and]
[(8)] (9) support studies and demonstration and
outreach projects for the purpose of increasing the
number of individuals, especially minorities, who are
willing to be marrow donors[.];
(10) conduct and support research to improve the
availability, efficiency, safety, and cost of
transplants from unrelated donors and the effectiveness
of Registry operations;
(11) increase the number of umbilical cord blood
units listed in the Registry and assist cord blood
banks in the Registry program in accordance with
subsection (c); and
(12) establish bylaws and procedures--
(A) to prohibit any member of the board of
directors of the Registry who has an
employment, governance, or financial
affiliation with a donor center, recruitment
group, transplant center, or cord blood bank
from participating in any decision that
materially affects the center, recruitment
group, transplant center, or cord blood bank;
and
(B) to limit the number of members of the
board with any such affiliation.
(c) Recruitment; Priorities; Information and Education.--
(1) * * *
(2) Information and education regarding recruitment;
testing and enrollment.--
(A) In general.--In carrying out the program
under paragraph (1), the Registry shall carry
out informational and educational activities
for purposes of recruiting individuals to serve
as donors of bone marrow, and shall test and
enroll with the Registry potential donors. Such
information and educational activities shall
include the following:
(i) * * *
(ii) Educating and providing
information to individuals who are
willing to serve as potential donors[,
including providing updates].
* * * * * * *
(3) Transplantation as treatment option.--In addition
to activities regarding recruitment, the program under
paragraph (1) shall provide information to physicians,
other health care professionals, and the public
regarding [the availability, as a potential treatment
option, of receiving a transplant of bone marrow from
an unrelated donor] transplants from unrelated donors
as a treatment option and resources for identifying and
evaluating other therapeutic alternatives.
(d) Patient Advocacy; Case Management.--
(1) * * *
(2) General functions.--The Office shall meet the
following requirements:
(A) * * *
* * * * * * *
(C) 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 subsection (b)(1) to conduct
an ongoing search for a donor and assist with
information regarding third party payor
matters.
* * * * * * *
(F) The Office shall ensure that the
following data are made available to patients:
(i) * * *
* * * * * * *
(v) Information concerning issues
that patients may face after a
transplant regarding continuity of care
and quality of life.
[(v)] (vi) Such other information as
the Registry determines to be
appropriate.
* * * * * * *
(3) Case management.--
(A) * * *
(B) Postsearch functions.--In addition to the
case management services described in paragraph
(1) for patients, the Office [may] shall, on
behalf of patients who have completed the
search for an unrelated donor, provide
information and education on the process of
receiving a transplant of bone marrow,
including the posttransplant process.
* * * * * * *
(g) Consultation.--The Secretary shall consult with the board
of directors of the Registry and [the bone marrow donor program
of the Department of the Navy] the Department of Defense Marrow
Donor Recruitment and Research Program operated by the
Department of the Navy in developing policies affecting the
Registry.
(h) [Application.--To be eligible] 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 substantial weight to
the continued safety of donors and patients and other
factors deemed appropriate by the Secretary.
(i) Eligibility.--Entities eligible to receive a contract
under this section shall [include] be private nonprofit
entities.
* * * * * * *
[(l) Annual Report Regarding Pretransplant Costs.--The
Registry shall annually submit to the Secretary the data
collected under subsection (b)(7) on comparisons of transplant
centers regarding search and other costs that prior to
transplantation are charged to patients by transplant centers.
The data shall be submitted to the Secretary through inclusion
in the annual report required in section 379A(c).]
SEC. 379A. BONE MARROW SCIENTIFIC REGISTRY.
(a) Establishment of Recipient Registry.--The Secretary,
acting through the Registry under section 379 (in this section
referred to as the ``Registry''), shall establish and maintain
a scientific registry of information relating to patients who
have been recipients of a transplant of bone marrow from a
biologically unrelated donor. The scientific registry shall
participate in medical research that has the potential to
improve transplant outcomes.
* * * * * * *
(c) Annual Report on Patient Outcomes.--The Registry shall
annually submit to the Secretary a report concerning patient
outcomes with respect to each transplant center. Each such
report shall use data collected and maintained by the
scientific registry under subsection (a). [Each such report
shall in addition include the data required in section 379(l)
(relating to pretransplant costs).]
(d) Publicly Available Data.--The scientific registry 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, and patients.
[SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.
[For the purpose of carrying out this part, there are
authorized to be appropriated $18,000,000 for fiscal year 1999,
and such sums as may be necessary for each of the fiscal years
2000 through 2003.]
SEC. 379B. BONE MARROW AND MARROW DEFINED.
For purposes of this part, the terms ``bone marrow'' and
``marrow'' include bone marrow and any other source of
hematopoietic progenitor cells the acquisition or use of which
is not inconsistent with Federal law.
SEC. 379C. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For the purpose of carrying out this part,
there are authorized to be appropriated $32,000,000 for fiscal
year 2004, and such sums as may be necessary for each of the
fiscal years 2005 through 2008.
(b) Emergency Contingency Response Capabilities.--In addition
to the amounts authorized to be appropriated under subsection
(a), there are authorized to be appropriated such sums as may
be necessary for the maintenance and expansion of emergency
contingency response capabilities under section 379(b)(3).
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