[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).

           *       *       *       *       *       *       *


                                
