[House Report 105-538]
[From the U.S. Government Publishing Office]



105th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 2d Session                                                     105-538
_______________________________________________________________________


 
       NATIONAL BONE MARROW REGISTRY REAUTHORIZATION ACT OF 1998

                                _______
                                

  May 18, 1998.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

_______________________________________________________________________


  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                        [To accompany H.R. 2202]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Commerce, to whom was referred the bill 
(H.R. 2202) to amend the Public Health Service Act to revise 
and extend the bone marrow donor program, and for other 
purposes, having considered the same, reports favorably thereon 
with an amendment and recommends that the bill as amended do 
pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     1
Purpose and Summary..............................................     6
Background and Need for Legislation..............................     6
Hearings.........................................................     7
Committee Consideration..........................................     7
Roll Call Votes..................................................     8
Committee Oversight Findings.....................................     8
Committee on Government Reform and Oversight.....................     8
New Budget Authority, Entitlement Authority, and Tax Expenditures     8
Committee Cost Estimate..........................................     8
Congressional Budget Office Estimate.............................     8
Federal Mandates Statement.......................................     9
Advisory Committee Statement.....................................     9
Constitutional Authority Statement...............................     9
Applicability to Legislative Branch..............................     9
Section-by-Section Analysis of the Legislation...................     9
Changes in Existing Law Made by the Bill, as Reported............    12

  The amendment is as follows:
  Strike out all after the enacting clause and insert in lieu 
thereof the following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``National Bone Marrow Registry 
Reauthorization Act of 1998''.

SEC. 2. REAUTHORIZATION.

  (a) Establishment of Registry.--Section 379(a) of the Public Health 
Service Act (42 U.S.C. 274k(a)) is amended--
          (1) by striking ``(referred to in this part as the 
        `Registry') that meets'' and inserting ``(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'';
          (2) by striking ``under the direction of a board of directors 
        that shall include representatives of'' and all that follows 
        and inserting the following: ``under the direction of a board 
        of directors meeting the following requirements:
          ``(1) Each member of the board shall serve for a term of two 
        years, and each such member may serve as many as three 
        consecutive two-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.
          ``(2) A member of the board may continue to serve after the 
        expiration of the term of such member until a successor is 
        appointed.
          ``(3) In order to ensure the continuity of the board, the 
        board shall be appointed so that each year the terms of 
        approximately \1/3\ of the members of the board expire.
          ``(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 and from the Division of Organ 
        Transplantation of the Health Resources and Services 
        Administration.''.
  (b) Program for Unrelated Marrow Transplants.--
          (1) In general.--Section 379(b) of the Public Health Service 
        Act (42 U.S.C. 274k(b)) is amended by redesignating paragraph 
        (7) as paragraph (8), and by striking paragraphs (2) through 
        (6) and inserting the following:
          ``(2) carry out a program for the recruitment of bone marrow 
        donors in accordance with subsection (c), including with 
        respect to increasing the representation of racial and ethnic 
        minority groups (including persons of mixed ancestry) in the 
        enrollment of the Registry;
          ``(3) carry out informational and educational activities in 
        accordance with subsection (c);
          ``(4) annually update information to account for changes in 
        the status of individuals as potential donors of bone marrow;
          ``(5) provide for a system of patient advocacy through the 
        office established under subsection (d);
          ``(6) 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) 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''.
          (2) Report of inspector general; plan regarding relationship 
        between registry 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 National Bone 
        Marrow Donor Registry (under section 379 of the Public Health 
        Service Act) develops, evaluates, and implements a plan to 
        effectuate efficiencies in the relationship between such 
        Registry and donor centers. The plan shall incorporate, to the 
        extent practicable, the findings and recommendations 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 Marrow Program Inspection.
  (c) Program for Information and Education.--Section 379 of the Public 
Health Service Act (42 U.S.C. 274k) is amended by striking subsection 
(j), by redesignating subsections (c) through (i) as subsections (e) 
through (k), respectively, and by inserting after subsection (b) the 
following subsection:
  ``(c) Recruitment; Priorities; Information and Education.--
          ``(1) Recruitment; priorities.--The Registry shall carry out 
        a program for the recruitment of bone marrow donors. Such 
        program shall identify populations that are underrepresented 
        among potential donors enrolled with the Registry. In the case 
        of populations that are identified under the preceding 
        sentence:
                  ``(A) The Registry shall give priority to carrying 
                out activities under this part to increase 
                representation for such populations in order to enable 
                a member of such a population, to the extent 
                practicable, to have a probability of finding a 
                suitable unrelated donor that is comparable to the 
                probability that an individual who is not a member of 
                an underrepresented population would have.
                  ``(B) The Registry shall consider racial and ethnic 
                minority groups (including persons of mixed ancestry) 
                to be populations that have been identified for 
                purposes of this paragraph, and shall carry out 
                subparagraph (A) with respect to such populations.
          ``(2) Information and education regarding recruitment; 
        testing and enrollment.--
                  ``(A) In general.--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) Making information available to the 
                        general public, including information 
                        describing the needs of patients with respect 
                        to donors of bone marrow.
                          ``(ii) Educating and providing information to 
                        individuals who are willing to serve as 
                        potential donors, including providing updates.
                          ``(iii) Training individuals in requesting 
                        individuals to serve as potential donors.
                  ``(B) Priorities.--In carrying out informational and 
                educational activities under subparagraph (A), the 
                Registry shall give priority to recruiting individuals 
                to serve as donors of bone marrow for populations that 
                are identified under paragraph (1).
          ``(3) Transplantation as treatment option.--In addition to 
        activities regarding recruitment, the 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.''.
  (d) Patient Advocacy and Case Management.--Section 379 of the Public 
Health Service Act (42 U.S.C. 274k), as amended by subsection (c) of 
this section, is amended by inserting after subsection (c) the 
following subsection:
  ``(d) Patient Advocacy; Case Management.--
          ``(1) In general.--The Registry shall establish and maintain 
        an office of patient advocacy (in this subsection referred to 
        as the `Office').
          ``(2) General functions.--The Office shall meet the following 
        requirements:
                  ``(A) The Office shall be headed by a director.
                  ``(B) The Office shall operate a system for patient 
                advocacy, which shall be separate from mechanisms for 
                donor advocacy, and which shall serve patients for whom 
                the Registry is conducting, or has been requested to 
                conduct, a search for an unrelated donor of bone 
                marrow.
                  ``(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.
                  ``(D) In carrying out subparagraph (C), the Office 
                shall monitor the system under subsection (b)(1) to 
                determine whether the search needs of the patient 
                involved are being met, including with respect to the 
                following:
                          ``(i) Periodically providing to the patient 
                        (or an individual acting on behalf of the 
                        patient) information regarding donors who are 
                        suitability matched to the patient, and other 
                        information regarding the progress being made 
                        in the search.
                          ``(ii) Informing the patient (or such other 
                        individual) if the search has been interrupted 
                        or discontinued.
                          ``(iii) Identifying and resolving problems in 
                        the search, to the extent practicable.
                  ``(E) In carrying out subparagraph (C), the Office 
                shall monitor the system under subsection (b)(1) to 
                determine whether the Registry, donor centers, 
                transplant centers, and other entities participating in 
                the Registryprogram are complying with standards issued 
under subsection (e)(4) for the system for patient advocacy under this 
subsection.
                  ``(F) The Office shall ensure that the following data 
                are made available to patients:
                          ``(i) The resources available through the 
                        Registry.
                          ``(ii) A comparison of transplant centers 
                        regarding search and other costs that prior to 
                        transplantation are charged to patients by 
                        transplant centers.
                          ``(iii) A list of donor registries, 
                        transplant centers, and other entities that 
                        meet the applicable standards, criteria, and 
                        procedures under subsection (e).
                          ``(iv) The posttransplant outcomes for 
                        individual transplant centers.
                          ``(v) Such other information as the Registry 
                        determines to be appropriate.
                  ``(G) The Office shall conduct surveys of patients 
                (or family members, physicians, or other individuals 
                acting on behalf of patients) to determine the extent 
                of satisfaction with the system for patient advocacy 
                under this subsection, and to identify ways in which 
                the system can be improved.
          ``(3) Case management.--
                  ``(A) In general.--In serving as an advocate for a 
                patient under paragraph (2), the Office shall provide 
                individualized case management services directly to the 
                patient (or family members, physicians, or other 
                individuals acting on behalf of the patient), 
                including--
                          ``(i) individualized case assessment; and
                          ``(ii) the functions described in paragraph 
                        (2)(D) (relating to progress in the search 
                        process).
                  ``(B) Postsearch functions.--In addition to the case 
                management services described in paragraph (1) for 
                patients, the Office may, 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.''.
  (e) Criteria, Standards, and Procedures.--Section 379(e) of the 
Public Health Service Act (42 U.S.C. 274k), as redesignated by 
subsection (c) of this section, is amended by striking paragraph (4) 
and inserting the following:
          ``(4) standards for the system for patient advocacy operated 
        under subsection (d), including standards requiring the 
        provision of appropriate information (at the start of the 
        search process and throughout the process) to patients and 
        their families and physicians;''.
  (f) Report.--Section 379 of the Public Health Service Act, as amended 
by subsection (c) of this section, is amended by adding at the end the 
following subsection:
  ``(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).''.
  (g) Conforming Amendments.--Section 379 of the Public Health Service 
Act, as amended by subsection (c) of this section, is amended--
          (1) in subsection (f), by striking ``subsection (c)'' and 
        inserting ``subsection (e)''; and
          (2) in subsection (k), by striking ``subsection (c)(5)(A)'' 
        and inserting ``subsection (e)(5)(A)'' and by striking 
        ``subsection (c)(5)(B)'' and inserting ``subsection 
        (e)(5)(B)''.

SEC. 3. RECIPIENT REGISTRY.

  Part I of title III of the Public Health Service Act (42 U.S.C. 274k 
et seq.) is amended by striking section 379A and inserting the 
following:

``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.
  ``(b) Information.--The scientific registry under subsection (a) 
shall include information with respect to patients described in 
subsection (a), transplant procedures, and such other information as 
the Secretary determines to be appropriate to conduct an ongoing 
evaluation of the scientific and clinical status of transplantation 
involving recipients of bone marrow from biologically unrelated donors.
  ``(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).''.

SEC. 4. AUTHORIZATION OF APPROPRIATIONS.

  Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is 
amended--
          (1) by transferring section 378 from the current placement of 
        the section and inserting the section after section 377; and
          (2) in part I, by inserting after section 379A the following 
        section:

``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. 5. STUDY BY GENERAL ACCOUNTING OFFICE.

  (a) In General.--During the period indicated pursuant to subsection 
(b), the Comptroller General of the United States shall conduct a study 
of the National Bone Marrow Donor Registry under section 379 of the 
Public Health Service Act for purposes of making determinations of the 
following:
          (1) The extent to which, relative to the effective date of 
        this Act, such Registry has increased the representation of 
        racial and ethnic minority groups (including persons of mixed 
        ancestry) among potential donors of bone marrow who are 
        enrolled with the Registry, and whether the extent of increase 
        results in a level of representation that meets the standard 
        established in subsection (c)(1)(A) of such section 379 (as 
        added by section 2(c) of this Act).
          (2) The extent to which patients in need of a transplant of 
        bone marrow from a biologically unrelated donor, and the 
        physicians of such patients, have been utilizing the Registry 
        in the search for such a donor.
          (3) The number of such patients for whom the Registry began a 
        preliminary search but for whom the full search process was not 
        completed, and the reasons underlying such circumstances.
          (4) The extent to which the plan required in section 2(b)(2) 
        of this Act (relating to the relationship between the Registry 
        and donor centers) has been implemented.
          (5) The extent to which the Registry, donor centers, donor 
        registries, collection centers, transplant centers, and other 
        appropriate entities have been complying with the standards, 
        criteria, and procedures under subsection (e) of such section 
        379 (as redesignated by section 2(c) of this Act).
  (b) Report.--A report describing the findings of the study under 
subsection (a) shall be submitted to the Congress not later than 
October 1, 2001. The report may not be submitted before January 1, 
2001.

SEC. 6. COMPLIANCE WITH NEW REQUIREMENTS FOR OFFICE OF PATIENT 
                    ADVOCACY.

  With respect to requirements for the office of patient advocacy under 
section 379(d) of the Public Health Service Act, the Secretary of 
Health and Human Services shall ensure that, not later than 180 days 
after the effective date of this Act, such office is in compliance with 
all requirements (established pursuant to the amendment made by section 
2(d)) that are additional to the requirements that under section 379 of 
such Act were in effect with respect to patient advocacy on the day 
before the date of the enactment of this Act.

SEC. 7. EFFECTIVE DATE.

  This Act takes effect October 1, 1998, or upon the date of the 
enactment of this Act, whichever occurs later.

                          Purpose and Summary

    H.R. 2202, the National Bone Marrow Registry 
Reauthorization Act of 1998, amends Section 379 of the Public 
Health Service Act (42 U.S.C. 274k) to reauthorize the National 
Bone Marrow Donor Registry.

                  Background and Need for Legislation

    More than 30,000 children and adults in the U.S. are 
diagnosed each year with leukemia, aplastic anemia, or other 
life-threatening diseases. For many, the only hope for survival 
is a marrow transplant.
    The National Marrow Donor Program (NMDP) was designed to 
coordinate the national matching of allogeneic unrelated donors 
and recipients. Under the Public Health Service Act, the 
program is charged with the following: (1) to establish a 
national registry of voluntary bone marrow donors; and (2) to 
increase the representation of individuals from racial and 
ethnic minority groups in the pool of potential donors.
    The NMDP maintains a Registry of nearly 3 million 
volunteers willing to become marrow donors if matched. To date, 
the NMDP has facilitated more than 6,000 bone marrow 
transplants. Of these, nearly 25 percent have involved 
transplants between donors and patients from different 
countries.
    A preliminary search automatically looks at more than 2.4 
million volunteer donors in the United States and international 
registries including the Netherlands, Germany, Sweden, and 
Israel. In addition, the patient's antigens are run through a 
worldwide donor database called the Bone Marrow Donors 
Worldwide (BMDW) which includes the national registry. This 
database searches 37 registries in 29 countries. Through BMDW, 
the NMDP has direct access to over 4 million volunteer donors 
worldwide who have registered to save the lives of people they 
have never met.
    NMDP has created a coordinated network of donor centers and 
collection and transplant centers. The functions of the NMDP 
are: (1) to develop a large, centrally organized file of 
potential marrow donors; (2) to coordinate searches for 
unrelated marrow donors involving donor and transplant centers 
throughout the United States (and with registries in seven 
other countries); (3) to facilitate the donor matching, work-
up, and collection and transport of marrow to increase the 
number of marrow transplants from unrelated donors; and (4) to 
evaluate the outcomes of marrow transplants from unrelated 
marrow donors.
    The genesis of the NMDP was in 1986, when Congressional 
appropriators directed the U.S. Navy to establish a national 
registry of bone marrow donors. The National Marrow Donor 
Program began accepting requests for donors in 1987. The 
following year, the Health Omnibus Programs Extension Act (P.L. 
100-607) amended the National Organ Transplantation Act (NOTA) 
(P.L. 98-507) to include establishment of a registry of bone 
marrow donors within the Department of Health and Human 
Services (HHS).
    In 1989, HHS assumed responsibility of the NMDP, first 
under the authority of National Heart, Lung, and Blood 
Institute (NHLBI) within NIH. The administration of the program 
was transferred again in 1994 to the Health Resources and 
Services Administration (HRSA).
    The Transplant Amendments Act of 1990 (P. L. 101-616) 
further amended NOTA by establishing the National Bone Marrow 
Donor Registry in law, reauthorizing it for three years, and 
requiring HHS to increase the representation of racial and 
ethnic minorities in the data base.
    In 1996, the Senate passed S. 1324, which among other 
things, proposed reauthorization of the National Bone Marrow 
Donor Program. S. 1324 was referred to the House Committee on 
Commerce on September 10, 1996, but no action was taken prior 
to the adjournment of the 104th Congress.
    In June 1997, HHS/HRSA sponsored a policy forum to address 
the needs of the Registry, including ways to (1) increase the 
number of bone marrow transplants and (2) resolve the new 
problems that might arise if the number of bone marrow 
transplants increased. A broad range of participants, including 
scientists, physicians, patients, ethicists, and educators 
attended the forum, which was funded by Amgen. The six core 
recommendations of the forum addressed costs, insurance 
coverage, donor recruitment and retention, the matching 
process, and the psychological needs of donors and recipients. 
Many of the concerns raised at the June 1997 HHS/HRSA policy 
forum are addressed in H.R. 2202, as reported.

                                Hearings

    On April 23, 1998, the Subcommittee on Health and 
Environment held a joint hearing with the Senate Labor and 
Human Resources Committee Subcommittee on Public Health and 
Safety on ``The Gift of Life: Increasing Bone Marrow Donation 
and Transplantation''. Testimony was received from the 
following witnesses: The Honorable C.W. Bill Young, 
Representative of the 10th Congressional District, State of 
Florida; Dr. Claude Earl Fox, Acting Administrator, Health 
Resources and Services Administration, Department of Health and 
Human Services; Admiral Elmo Russell Zumwalt, Jr., USN 
(Retired), Chairman, National Public Policy Committee, National 
Marrow Donor Program; Dr. Craig W.S. Howe, Chief Executive 
Officer, National Marrow Donor Program; Mr. Robert Wedge, 
patient; Mr. Angel Hernandez, father of patient; Dr. Clive O. 
Callender, Founder and Principal Investigator, Minority Organ 
and Tissue Transplant Education Program; Dr. Claude J.M. 
Lenfant, Director, National Heart, Lung, and Blood Institute, 
National Institutes of Health, Department of Health and Human 
Services; and Dr. Edward L. Snyder, President, American 
Association of Blood Banks.

                        Committee Consideration

    On May 12, 1998, the Subcommittee on Health and Environment 
met in open markup session to consider H.R. 2202 and approved 
the bill for Full Committee consideration, amended, by a voice 
vote.
    On May 14, 1998, the Full Committee met in open markup 
session to consider H.R. 2202 and ordered the bill reported to 
the House, as amended, by a voice vote.

                             Rollcall Votes

    Clause 2(l)(2)(B) of rule XI of the Rules of the House 
requires the Committee to list the recorded votes on the motion 
to report legislation and amendments thereto. There were no 
recorded votes taken in connection with ordering H.R. 2202 
reported. A motion by Mr. Bliley to order H.R. 2202 reported to 
the House, as amended, was agreed to by a voice vote, a quorum 
being present.

                      Committee Oversight Findings

    Pursuant to clause 2(l)(3)(A) of rule XI of the Rules of 
the House of Representatives, the Committee held an oversight 
hearing and made findings that are reflected in this report.

              Committee on Government Reform and Oversight

    Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform and Oversight.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 2(l)(3)(B) of rule XI of the 
Rules of the House of Representatives, the Committee finds that 
H.R. 2202, the National Bone Marrow Registry Reauthorization 
Act of 1998, 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 2(l)(3)(C) of rule XI 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, May 18, 1998.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2202, National 
Bone Marrow Donor Program Reauthorization Act of 1998.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Cyndi 
Dudzinski.
            Sincerely,
                                         June E. O'Neill, Director.
    Enclosure.

H.R. 2202--National Bone Marrow Registry Reauthorization Act of 1998

    Summary: H.R. 2202 would reauthorize and amend the National 
Bone Marrow Donor Registry (Registry) operated by the Health 
Resources and Services Administration. The Registry operates a 
system for finding marrow donors suitably matched to unrelated 
recipients for bone marrow transplantation. The legislation 
would authorize appropriations for fiscal years 1999 through 
2003.
    Assuming appropriation of the authorized amounts, CBO 
estimates that enacting H.R. 2202 would result in additional 
discretionary spending of $94 million during the 1999-2003 
period. The legislation would not affect direct spending or 
receipts; therefore, pay-as-you-go procedures would not apply. 
The legislation does not contain any intergovernmental or 
private-sector mandates as defined in the Unfunded Mandates 
Reform Act of 1995.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 2202 is shown in the following table. 
For the purposes of this estimate, CBO assumes that all amounts 
authorized in H.R. 2202 would be appropriated by the start of 
each fiscal year and that outlays would follow the historical 
spending patterns for the National Bone Marrow Donor Registry.

----------------------------------------------------------------------------------------------------------------
                                                                     By fiscal years, in millions of dollars--  
                                                                 -----------------------------------------------
                                                                   1998    1999    2000    2001    2202    2203 
----------------------------------------------------------------------------------------------------------------
                                       SPENDING SUBJECT TOP APPROPRIATIONS                                      
                                                                                                                
Spending Under Current Law:                                                                                     
    Budget Authority \1\........................................      15       0       0       0       0       0
    Estimated Outlays...........................................      15       0       0       0       0       0
                                                                                                                
                                          WITH ADJUSTMENT FOR INFLATION                                         
                                                                                                                
Proposed Changes:                                                                                               
    Authorization Level.........................................       0      18      18      19      19      20
    Estimated Outlays...........................................       0      18      18      19      19      20
Spending Under H.R. 2202:                                                                                       
    Authorization Level \1\.....................................      15      18      18      19      19      20
    Estimated Outlays...........................................      15      18      18      19      19      20
                                                                                                                
                                        WITHOUT ADJUSTMENTS FOR INFLATION                                       
                                                                                                                
Proposed Changes:                                                                                               
    Authorization Level.........................................       0      18      18      18      18      18
    Estimated Outlays...........................................       0      18      18      18      18      18
Spending Under H.R. 2202:                                                                                       
    Authorization Level \1\.....................................      15      18      18      18      18      18
    Estimated Outlays...........................................      15      18      18      18      18      18
----------------------------------------------------------------------------------------------------------------
\1\ The 1998 level is the amount appropriated for that year.                                                    

    The costs of this legislation fall within budget function 
550 (health).
    Basic of Estimate: The bill would authorize appropriations 
of $18 million for 1999 and such sums as may be necessary for 
2000-2003. CBO's estimates of the authorizations for 2000-2003 
are based on the 1999 amount, with or without adjustments for 
inflation.
    Pay-as-you-go considerations: None.
    Intergovernmental and private-section impact: The 
legislation does not contain any intergovernmental or private-
sector mandates as defined in the Unfunded Mandates Reform Act 
of 1995.
    Estimate prepared by: Federal Costs: Cyndi Dudzinski. 
Impact on State, Local Tribal Governments; Marc Nicole. Impact 
on the Private Sector: Bruce Vavrichek.
    Estimate approval by: Paul N. Van de Water, 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 2(l)(4) of rule XI 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 of 1998''.

Section 2. Reauthorization

    Section 2 reauthorizes the National Bone Marrow Registry 
and establishes procedures for rotating its board of directors. 
It establishes two-year terms of office, with a maximum of 
three consecutive terms; permits service to continue until a 
successor is appointed; and provides that approximately one-
third of the board members'' terms expire each year. 
Furthermore, the characteristics of the Board of Directors are 
mandated to broaden representation (e.g., representatives of 
marrow donor centers, recipients of bone marrow transplants, 
persons who require such a transplant.)
    Section 2 also amends the National Bone Marrow Registry to 
carry out a program to: recruit potential donors; include 
educational activities to support potential donor recruitment; 
include annual updates of status change for potential donors; 
include a system of patient advocacy; conduct case management 
services for those potential donors notified of a match; and 
collect and analyze data, including cost comparisons among 
transplant centers.
    Within a year after passage, the registry is mandated to 
develop and implement a plan to increase the efficiencies of 
working with donor centers.
    This section directs the registry to carry out a program 
for the recruitment of bone marrow donors. Due to larger 
varieties of human leukocyte antigens (HLA) in minority 
populations, special attention to under represented minority 
groups will be given such that their probability of finding a 
match will be comparable to the probability of finding a match 
for someone not from an under represented group.
    Section 2 directs the registry to carry out informational 
and educational activity for the purposes of recruitment of 
donors; priority is given to those who are from under 
represented groups. Information is also to be provided to 
physicians and the public regarding transplantation as an 
option.
    Section 2 creates an office of patient advocacy and case 
management for those whom the registry is searching for an 
unrelated donor of bone marrow. The office will provide 
information periodically to the patients concerning the status 
of the search and work to resolve difficulties. The office will 
also provide consumer data comparing costs of transplant 
centers (required in an annual report), post-transplant 
outcomes, survey data measuring patient satisfaction, and other 
information as deemed appropriate.

Section 3. Recipient registry

    Section 3 establishes a ``Bone Marrow Scientific 
Registry,'' which shall serve as a repository of information 
relating to patients who have received bone marrow transplants 
from an unrelated donor; such information will include 
transplant procedures and other data deemed appropriate by the 
Secretary of HHS. The Registry will also annually publish a 
report comparing transplant center costs and patient outcomes 
to better inform the public.

Section 4. Authorization of appropriations

    Section 4 authorizes the National Bone Marrow Registry for 
$18,000,000 for Fiscal Year 1999, and such sums as may be 
necessary for Fiscal Years 2000 through 2003.

Section 5. Studies by General Accounting Office

    Section 5 commissions a General Accounting Office study 
measuring the: (1) registry effectiveness of increasing 
minority representation; (2) registry utilization rates; (3) 
reasons preliminary searches in the registry were not 
completed; (4) and effectiveness of the program generally.
    As a result of objections raised by the Administration and 
others to the inclusion of cord blood in the Registry, the 
Committee removed provisions contained in H.R. 2202 as 
introduced relating to cord blood. It is the Committee's 
intent, however, that if ongoing research on the safety and 
efficacy of cord blood confirms the initial promise of cord 
blood as an effective treatment for diseases presently treated 
by bone marrow transplants, that cord blood be included in the 
Registry. The Committee directs the Secretary of HHS to 
regularly report in writing to the House Committee on Commerce 
and the House Committee on Appropriations Subcommittee on 
Labor, Health and Human Services, and Education as to the 
status of ongoing research on the safety, efficacy, collection, 
storage and confidentiality of cord blood and its viability and 
desirability for inclusion in the Registry, so that the 
Committee could consider an appropriate amendment for including 
cord blood in the Registry.

Section 6. Compliance with new requirements for Office of Patient 
        Advocacy

    Section 6 stipulates that any additional duties due to the 
provisions for patient advocacy are to be implemented within 
180 days.

Section 7. Effective date

    Section 7 provides that this legislation takes effect on 
October 1, 1998, or upon the date of enactment, whichever 
occurs later.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3 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



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TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH

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                       Part H--Organ Transplants

                    organ procurement organizations

  Sec. 371. * * *

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SEC. 378. AUTHORIZATION OF APPROPRIATIONS.

  For the purpose of carrying out this part, there are 
authorized to be appropriated $8,000,000 for fiscal year 1991, 
and such sums as may be necessary for each of the fiscal years 
1992 and 1993.

              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 meets] (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 that shall include 
representatives of marrow donor centers, marrow transplant 
centers, persons with expertise in the social science, and the 
general public.] under the direction of a board of directors 
meeting the following requirements:
          (1) Each member of the board shall serve for a term 
        of two years, and each such member may serve as many as 
        three consecutive two-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.
          (2) A member of the board may continue to serve after 
        the expiration of the term of such member until a 
        successor is appointed.
          (3) In order to ensure the continuity of the board, 
        the board shall be appointed so that each year the 
        terms of approximately \1/3\ of the members of the 
        board expire.
          (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 and 
        from the Division of Organ Transplantation of the 
        Health Resources and Services Administration.
  (b) Functions.--The Registry shall--
          (1) establish a system for finding marrow donors 
        suitably matched to unrelated recipients for bone 
        marrow transplantation;
          [(2) establish a system for patient advocacy, 
        separate from mechanisms for donor advocacy, that 
        directly assists patients, their families, and their 
        physicians in the search for an unrelated marrow donor;
          [(3) increase the representation of individuals from 
        racial and ethnic minority groups in the pool of 
        potential donors for the Registry in order to enable an 
        individual in a minority group, to the extent 
        practicable, to have a comparable chance of finding a 
        suitable unrelated donor as would an individual not in 
        a minority group;
          [(4) provide information to physicians, other health 
        care professionals, and the public regarding bone 
        marrow transplantation;
          [(5) recruit potential bone marrow donors;
          [(6) collect, analyze, and publish data concerning 
        bone marrow donation and transplantation; and]
          (2) carry out a program for the recruitment of bone 
        marrow donors in accordance with subsection (c), 
        including with respect to increasing the representation 
        of racial and ethnic minority groups (including persons 
        of mixed ancestry) in the enrollment of the Registry;
          (3) carry out informational and educational 
        activities in accordance with subsection (c);
          (4) annually update information to account for 
        changes in the status of individuals as potential 
        donors of bone marrow;
          (5) provide for a system of patient advocacy through 
        the office established under subsection (d);
          (6) 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) 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
          [(7)] (8) support studies and demonstration projects 
        for the purpose of increasing the number of 
        individuals, especially minorities, who are willing to 
        be marrow donors.
  (c) Recruitment; Priorities; Information and Education.--
          (1) Recruitment; priorities.--The Registry shall 
        carry out a program for the recruitment of bone marrow 
        donors. Such program shall identify populations that 
        are underrepresented among potential donors enrolled 
        with the Registry. In the case of populations that are 
        identified under the preceding sentence:
                  (A) The Registry shall give priority to 
                carrying out activities under this part to 
                increase representation for such populations in 
                order to enable a member of such a population, 
                to the extent practicable, to have a 
                probability of finding a suitable unrelated 
                donor that is comparable to the probability 
                that an individual who is not a member of an 
                underrepresented population would have.
                  (B) The Registry shall consider racial and 
                ethnic minority groups (including persons of 
                mixed ancestry) to be populations that have 
                been identified for purposes of this paragraph, 
                and shall carry out subparagraph (A) with 
                respect to such populations.
          (2) Information and education regarding recruitment; 
        testing and enrollment.--
                  (A) In general.--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) Making information available to 
                        the general public, including 
                        information describing the needs of 
                        patients with respect to donors of bone 
                        marrow.
                          (ii) Educating and providing 
                        information to individuals who are 
                        willing to serve as potential donors, 
                        including providing updates.
                          (iii) Training individuals in 
                        requesting individuals to serve as 
                        potential donors.
                  (B) Priorities.--In carrying out 
                informational and educational activities under 
                subparagraph (A), the Registry shall give 
                priority to recruiting individuals to serve as 
                donors of bone marrow for populations that are 
                identified under paragraph (1).
          (3) Transplantation as treatment option.--In addition 
        to activities regarding recruitment, the 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.
  (d) Patient Advocacy; Case Management.--
          (1) In general.--The Registry shall establish and 
        maintain an office of patient advocacy (in this 
        subsection referred to as the ``Office'').
          (2) General functions.--The Office shall meet the 
        following requirements:
                  (A) The Office shall be headed by a director.
                  (B) The Office shall operate a system for 
                patient advocacy, which shall be separate from 
                mechanisms for donor advocacy, and which shall 
                serve patients for whom the Registry is 
                conducting, or has been requested to conduct, a 
                search for an unrelated donor of bone marrow.
                  (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.
                  (D) In carrying out subparagraph (C), the 
                Office shall monitor the system under 
                subsection (b)(1) to determine whether the 
                search needs of the patient involved are being 
                met, including with respect to the following:
                          (i) Periodically providing to the 
                        patient (or an individual acting on 
                        behalf of the patient) information 
                        regarding donors who are suitability 
                        matched to the patient, and other 
                        information regarding the progress 
                        being made in the search.
                          (ii) Informing the patient (or such 
                        other individual) if the search has 
                        been interrupted or discontinued.
                          (iii) Identifying and resolving 
                        problems in the search, to the extent 
                        practicable.
                  (E) In carrying out subparagraph (C), the 
                Office shall monitor the system under 
                subsection (b)(1) to determine whether the 
                Registry, donor centers, transplant centers, 
                and other entities participating in the 
                Registry program are complying with standards 
                issued under subsection (e)(4) for the system 
                for patient advocacy under this subsection.
                  (F) The Office shall ensure that the 
                following data are made available to patients:
                          (i) The resources available through 
                        the Registry.
                          (ii) A comparison of transplant 
                        centers regarding search and other 
                        costs that prior to transplantation are 
                        charged to patients by transplant 
                        centers.
                          (iii) A list of donor registries, 
                        transplant centers, and other entities 
                        that meet the applicable standards, 
                        criteria, and procedures under 
                        subsection (e).
                          (iv) The posttransplant outcomes for 
                        individual transplant centers.
                          (v) Such other information as the 
                        Registry determines to be appropriate.
                  (G) The Office shall conduct surveys of 
                patients (or family members, physicians, or 
                other individuals acting on behalf of patients) 
                to determine the extent of satisfaction with 
                the system for patient advocacy under this 
                subsection, and to identify ways in which the 
                system can be improved.
          (3) Case management.--
                  (A) In general.--In serving as an advocate 
                for a patient under paragraph (2), the Office 
                shall provide individualized case management 
                services directly to the patient (or family 
                members, physicians, or other individuals 
                acting on behalf of the patient), including--
                          (i) individualized case assessment; 
                        and
                          (ii) the functions described in 
                        paragraph (2)(D) (relating to progress 
                        in the search process).
                  (B) Postsearch functions.--In addition to the 
                case management services described in paragraph 
                (1) for patients, the Office may, 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.
  [(c)] (e) Criteria, Standards, and Procedures.--Not later 
than 180 days after the date of enactment of this part, the 
Secretary shall establish and enforce, for entities 
participating in the program, including the Registry, 
individual marrow donor centers, marrow donor registries, 
marrow collection centers, and marrow transplant centers--
          (1) quality standards and standards for tissue 
        typing, obtaining the informed consent of donors, and 
        providing patient advocacy;
          (2) donor selection criteria, based on established 
        medical criteria, to protect both the donor and the 
        recipient and to prevent the transmission of 
        potentially harmful infectious diseases such as the 
        viruses that cause hepatitis and the etiologic agent 
        for Acquired Immune Deficiency Syndrome;
          (3) procedures to ensure the proper collection and 
        transportation of the marrow;
          [(4) standards that require the provision of 
        information to patients, their families, and their 
        physicians at the start of the search process 
        concerning--
                  [(A) the resources available through the 
                Registry;
                  [(B) all other marrow donor registries 
                meeting the standards described in this 
                paragraph; and
                  [(C) in the case of the Registry--
                          [(i) the comparative costs of all 
                        charges by marrow transplant centers 
                        incurred by patients prior to 
                        transplantation; and
                          [(ii) the success rates of individual 
                        marrow transplant centers;]
          (4) standards for the system for patient advocacy 
        operated under subsection (d), including standards 
        requiring the provision of appropriate information (at 
        the start of the search process and throughout the 
        process) to patients and their families and physicians;
          (5) standards that--
                  (A) require the establishment of a system of 
                strict confidentiality of records relating to 
                the identity, address, HLA type, and managing 
                marrow donor center for marrow donors and 
                potential marrow donors; and
                  (B) prescribe the purposes for which the 
                records described in subparagraph (A) may be 
                disclosed, and the circumstances and extent of 
                the disclosure; and
          (6) in the case of a marrow donor center or marrow 
        donor registry participating in the program, procedures 
        to ensure the establishment of a method for integrating 
        donor files, searches, and general procedures of the 
        center or registry with the Registry.
  [(d)] (f) Comment Procedures.--The Secretary shall establish 
and provide information to the public on procedures, which may 
include 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 Registry 
is carrying out the duties of the Registry under subsection (b) 
and complying with the criteria, standards, and procedures 
described in subsection [(c)] (e).
  [(e)] (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 in developing policies 
affecting the Registry.
  [(f)] (h) 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.
  [(g)] (i) Eligibility.--Entities eligible to receive a 
contract under this section shall include private nonprofit 
entities.
  [(h)] (j) Records.--
          (1) Recordkeeping.--Each recipient of a contract or 
        subcontract under subsection (a) shall keep such 
        records as the Secretary shall prescribe, including 
        records that fully disclose the amount and disposition 
        by the recipient of the proceeds of the contract, the 
        total cost of the undertaking in connection with which 
        the contract was made, and the amount of the portion of 
        the cost of the undertaking supplied by other sources, 
        and such other records as will facilitate an effective 
        audit.
          (2) Examination of records.--The Secretary and the 
        Comptroller General of the United States shall have 
        access to any books, documents, papers, and records of 
        the recipient of a contract or subcontract entered into 
        under this section that are pertinent to the contract, 
        for the purpose of conducting audits and examinations.
  [(i)] (k)  Penalties for Disclosure.--Any person who 
discloses the content of any record referred to in subsection 
[(c)(5)(A)] (e)(5)(A) without the prior written consent of the 
donor or potential donor with respect to whom the record is 
maintained, or in violation of the standards described in 
subsection [(c)(5)(B)] (e)(5)(B),shall be imprisoned for not 
more than 2 years or fined in accordance with title 18, United States 
Code, or both.
  [(j) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $15,000,000 for 
fiscal year 1991 and such sums as may be necessary for each of 
fiscal years 1992 and 1993.]
  (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. STUDY BY THE GENERAL ACCOUNTING OFFICE.

  [(a) In General.--The Comptroller General of the United 
States shall conduct a study that evaluates--
          [(1) the costs and benefits of the search process for 
        an unrelated bone marrow donor among different marrow 
        donor registries;
          [(2) the extent to which marrow donor registries 
        protect donor confidentiality;
          [(3) the relationship between the Registry, 
        individual marow donor centers, and other marrow donor 
        registries;
          [(4) the effectiveness and appropriateness of 
        policies and procedures of marrow donor centers, marrow 
        transplant centers, and marrow donor registries, 
        including--
                  [(A) the process of donor recruitment, 
                including the policy of asking each donor 
                whether the donor would want to donate more 
                than one time;
                  [(B) the maintenance and updating of donor 
                files; and
                  [(C) the policy of initially typing donors 
                for A/B antigens only instead of initially 
                typing for both A/B and D/R antigens;
          [(5) the ability of the marrow donor registries to 
        incorporate changes in medical research and clinical 
        practice; and
          [(6) the costs associated with tissue typing.
  [(b) Report.--Not later than 1 year after the date of 
enactment of this part, the Comptroller General shall complete 
the study required under subsection (a) and submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Labor and Human Resources 
of the Senate a report describing the findings made by the 
study and recommendations for legislative reform.]

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.
  (b) Information.--The scientific registry under subsection 
(a) shall include information with respect to patients 
described in subsection (a), transplant procedures, and such 
other information as the Secretary determines to be appropriate 
to conduct an ongoing evaluation of the scientific and clinical 
status of transplantation involving recipients of bone marrow 
from biologically unrelated donors.
  (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).

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.

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