[Congressional Record Volume 151, Number 87 (Monday, June 27, 2005)]
[Senate]
[Pages S7433-S7438]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HATCH (for himself, Mr. Dodd, Mr. Burr, Mr. Reed, and Mr. 
        Ensign):
  S. 1317. A bill to provide for the collection and maintenance of cord 
blood units for the treatment of patients and research, and to amend 
the Public Health Service Act to authorize the Bone Marrow and Cord 
Blood Cell Transplantation Program to increase the number of 
transplants for recipients suitable matched to donors of bone marrow 
and cord blood; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. HATCH. Mr. President, today, I am pleased to introduce ``The Bone 
Marrow and Cord Blood Therapy and Research Act of 2005.'' I am grateful 
that Senators Dodd, Burr, Reed and Ensign have joined me as sponsors of 
this important, bipartisan bill. All five sponsors of this bill have 
been working on this legislation for the past few months. We have met 
with organizations that are deeply interested in participating in this 
new program and heard their input. We talked to other Senators, 
including members of the Senate Health, Education, Labor and Pension 
Committee, who have a deep commitment to getting this legislation 
signed into law by the President. This bill was a group effort and I 
commend the sponsors of this bill on a job well done.
  I am pleased that this legislation will be considered by the Senate 
HELP Committee on Wednesday; we are hopeful it will then be passed by 
the Senate in the near future. HELP Chairman Enzi and Ranking Democrat 
Kennedy and their staffs have been very supportive of our efforts in 
getting this bill through the Senate in a timely manner. I greatly 
appreciate their willingness to work with all of us on this important 
issue.
  As many of my colleagues know, I introduced a bill earlier this year 
S. 681, the Cord Blood Stem Cell Act of 2005. I have introduced that 
legislation during the past three Congresses. The bill I have 
introduced with my colleagues today is a much improved version of my 
original cord blood legislation, primarily because it reflects a 
compromise between the key stakeholder groups that are deeply 
interested in providing federal funding to establish cord blood banks 
for public use. This legislation creates an easily accessible network 
of adult stem cell transplant material for the treatment of patients 
and supports the research into the uses of such cells.
  One of the biggest changes in this bill is the establishment of a 
three year demonstration project for the collection and storage of cord 
blood units for a family in which a child has been diagnosed with a 
condition that will benefit from a cord blood transplant at no cost to 
the family. When we were meeting with individuals interested in this 
legislation, we were told by scientific experts that the most 
successful cord blood transplants come from a sibling's cord blood. 
Once a cord blood unit is put in a public cord blood bank, there is no 
guarantee that a family will be able to get that specific cord blood 
unit back if it is needed. Therefore, we believed that it was necessary 
to create this demonstration project so that families would have 
immediate access to its cord blood units. It is important to emphasize 
that the only families that may participate in this demonstration 
project are those that have a sick child or parent.
  In addition, this legislation includes language calling for single 
point of access. The purpose of a single point of access is to provide 
health care providers with the ability to search for bone marrow donors 
and cord blood units through a single electronic point of access. 
Today, doctors have to search several places in order to find available 
cord blood units and bone marrow donors. A single point of access 
improves this process dramatically for both doctor and patient by 
making the search process much more efficient.
  There is strong, bipartisan interest throughout the Congress for 
using adult stem cells to treat a wide variety of medical conditions. 
Our bill not only reauthorizes the National Marrow Donor Program, but 
it also creates a national network of public cord blood banks. 
Together, these two programs for umbilical cord blood and adult bone 
marrow will provide us with a widely-accepted source of hematopoietic 
stem cells for transplant and research.
  For several decades, thousands of Americans have received and been 
saved by bone marrow transplants. But thousands more die for lack of an 
appropriate donor. The good news is that research now suggests that the 
blood and stem cells from human placenta and umbilical cords may in 
some cases provide an alternative to bone marrow transplantation. For 
some patients, particularly those for whom a bone marrow match cannot 
be found, transplantation of these cells may be a life-saving therapy. 
Cord blood stem cells are readily available, and they require less-
stringent matching from donors to recipients, thus decreasing the 
difficulty of finding a fully matched donor.
  Cord blood transplantation has been used successfully to treat 
leukemia, lymphoma, immunodeficiency diseases, sickle cell anemia, and 
certain metabolic diseases. However, the number of available cord blood 
stem cell units in the United States is insufficient to meet the need. 
The Bone Marrow and Cord Blood Therapy and Research Act of 2005 will 
establish an inventory of 150,000 new cord blood stem cell units that 
reflects the diversity of the United States' population. In conjunction 
with the five million potential bone marrow donors registered through 
the National Marrow Donor Program, this cord blood network will enable 
95 percent of Americans to receive an appropriately matched transplant.
  The Bone Marrow and Cord Blood Therapy and Research Act of 2005 also 
incorporates recommendations from the Institute of Medicine's recent 
report on cord blood. The Institute provided Congress with guidelines 
and recommendations to enhance the structure, function, and utility of 
the program. As a result, I am confident that this Nation's system for 
obtaining adult stem cells for transplantation purposes will improve 
dramatically, and that many more of our citizens will have access to 
the life-saving therapies they offer. Through transplants of this 
nature, we can finally cure previously incurable diseases such as 
sickle cell anemia. It is my hope that this legislation will help us 
ensure that children with this and other illnesses will be able to 
achieve their full potential, unhindered by poor health.
  My goal, which I share with the other sponsors of this bill, is to 
create the best possible system to provide patients, clinicians, and 
families with access to these life-saving treatments. I believe the 
current bill does this by ensuring that the number of bone marrow 
donors and cord blood units available for transplant and research 
increases in the coming years.
  The integrated system will include not only the international bone 
marrow donor registry, but also a network of qualified cord blood banks 
which will collect, test, and preserve cord blood stem cells. In 
addition, the system will educate and recruit donors, facilitate the 
rapid matching of donors and recipients, and quickly make such cells 
available to transplant centers for stem cell transplantation.
  The establishment of a national infrastructure for transplant 
material will help save the lives of thousands of critically ill 
Americans. We must be sure that our Nation can meet the needs of 
patients and physicians by ensuring a strong future for bone marrow and 
cord blood in this country. My primary goal is to ensure that the 
amount of transplant material available for patient care and research 
increases in the coming years. The only way that goal may be 
accomplished is through strong federal support. I look forward to 
working with my colleagues on doing everything possible to provide 
transplant patients with the best possible options by ensuring a strong 
future for bone marrow and cord blood transplantation in this country. 
This is a good bill and I urge my colleagues to support it.
  I ask unanimous consent that the text of this bill be printed in the 
Record.

[[Page S7434]]

  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1317

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Bone Marrow and Cord Blood 
     Therapy and Research Act of 2005''.

     SEC. 2. CORD BLOOD INVENTORY.

       (a) In General.--The Secretary of Health and Human Services 
     shall enter into one-time contracts with qualified cord blood 
     banks to assist in the collection and maintenance of 150,000 
     new units of high-quality cord blood to be made available for 
     transplantation through the Bone Marrow and Cord Blood Cell 
     Transplantation Program and to carry out the requirements of 
     subsection (b).
       (b) Requirements.--The Secretary shall require each 
     recipient of a contract under this section--
       (1) to acquire, tissue-type, test, cryopreserve, and store 
     donated units of cord blood acquired with the informed 
     consent of the donor in a manner that complies with 
     applicable Federal and State regulations;
       (2) to encourage donation from a genetically diverse 
     population;
       (3) to make cord blood units that are collected pursuant to 
     this section or otherwise and meet all applicable Federal 
     standards available to transplant centers for 
     transplantation;
       (4) to make cord blood units that are collected, but not 
     appropriate for clinical use, available for peer-reviewed 
     research;
       (5) to make data available, as required by the Secretary 
     and consistent with section 379(c)(3) of the Public Health 
     Service Act (42 U.S.C. 274k(c)(3)), as amended by this Act, 
     in a standardized electronic format, as determined by the 
     Secretary, for the Bone Marrow and Cord Blood Cell 
     Transplantation Program; and
       (6) to submit data in a standardized electronic format for 
     inclusion in the stem cell therapeutic outcomes database 
     maintained under section 379A of the Public Health Service 
     Act, as amended by this Act.
       (c) Related Cord Blood Donors.--
       (1) In general.--The Secretary shall establish a 3-year 
     demonstration project under which qualified cord blood banks 
     receiving a contract under this section may use a portion of 
     the funding under such contract for the collection and 
     storage of cord blood units for a family where a first-degree 
     relative has been diagnosed with a condition that will 
     benefit from transplantation (including selected blood 
     disorders, malignancies, metabolic storage disorders, 
     hemoglobinopathies, and congenital immunodeficiencies) at no 
     cost to such family. Qualified cord blood banks collecting 
     cord blood units under this paragraph shall comply with the 
     requirements of paragraphs (1), (2), (3), and (5) of 
     subsection (b).
       (2) Availability.--Qualified cord blood banks that are 
     operating a program under paragraph (1) shall provide 
     assurances that the cord blood units in such banks will be 
     available for directed transplantation until such time that 
     the cord blood unit is released for transplantation or is 
     transferred by the family to the Bone Marrow and Cord Blood 
     Cell Transplantation Program in accordance with guidance or 
     regulations promulgated by the Secretary.
       (3) Inventory.--Cord blood units collected through the 
     program under this section shall not be counted toward the 
     150,000 inventory goal under the Bone Marrow and Cord Blood 
     Cell Transplantation Program.
       (4) Report.--Not later than 90 days after the date on which 
     the project under paragraph (1) is terminated by the 
     Secretary, the Secretary shall submit to Congress a report on 
     the outcomes of the project that shall include the 
     recommendations of the Secretary with respect to the 
     continuation of such project.
       (d) Application.--To seek to enter into a contract under 
     this section, a qualified cord blood bank shall submit an 
     application to the Secretary at such time, in such manner, 
     and containing such information as the Secretary may 
     reasonably require. At a minimum, an application for a 
     contract under this section shall include a requirement that 
     the applicant--
       (1) will participate in the Bone Marrow and Cord Blood Cell 
     Transplantation Program for a period of at least 10 years;
       (2) will make cord blood units collected pursuant to this 
     section available through the Bone Marrow and Cord Blood Cell 
     Transplantation Program in perpetuity; and
       (3) if the Secretary determines through an assessment, or 
     through petition by the applicant, that a cord blood bank is 
     no longer operational or does not meet the requirements of 
     section 379(c)(4) of the Public Health Service Act (as added 
     by this Act) and as a result may not distribute the units, 
     transfer the units collected pursuant to this section to 
     another qualified cord blood bank approved by the Secretary 
     to ensure continued availability of cord blood units.
       (e) Duration of Contracts.--
       (1) In general.--Except as provided in paragraph (2), the 
     term of each contract entered into by the Secretary under 
     this section shall be for 10 years. The Secretary shall 
     ensure that Federal funds provided under any such contract 
     terminate on the earlier of--
       (A) the date that is 3 years after the date on which the 
     contract is entered into; or
       (B) September 30, 2010.
       (2) Extensions.--Subject to paragraph (1)(B), the Secretary 
     may extend the period of funding under a contract under this 
     section to exceed a period of 3 years if--
       (A) the Secretary finds that 150,000 new units of high-
     quality cord blood have not yet been collected pursuant to 
     this section; and
       (B) the Secretary does not receive an application for a 
     contract under this section from any qualified cord blood 
     bank that has not previously entered into a contract under 
     this section or the Secretary determines that the outstanding 
     inventory need cannot be met by the one or more qualified 
     cord blood banks that have submitted an application for a 
     contract under this section.
       (3) Preference.--In considering contract extensions under 
     paragraph (2), the Secretary shall give preference to 
     qualified cord blood banks that the Secretary determines have 
     demonstrated a superior ability to satisfy the requirements 
     described in subsection (b) and to achieve the overall goals 
     for which the contract was awarded.
       (f) Regulations.--The Secretary may promulgate regulations 
     to carry out this section.
       (g) Definitions.--In this section:
       (1) The term ``Bone Marrow and Cord Blood Cell 
     Transplantation Program'' means the Bone Marrow and Cord 
     Blood Cell Transplantation Program under section 379 of the 
     Public Health Service Act, as amended by this Act.
       (2) The term ``cord blood donor'' means a mother who has 
     delivered a baby and consents to donate the neonatal blood 
     remaining in the placenta and umbilical cord after separation 
     from the newborn baby.
       (3) The term ``cord blood unit'' means the neonatal blood 
     collected from the placenta and umbilical cord of a single 
     newborn baby.
       (4) The term ``first-degree relative'' means a sibling or 
     parent who is one meiosis away from a particular individual 
     in a family.
       (5) The term ``qualified cord blood bank'' has the meaning 
     given to that term in section 379(c)(4) of the Public Health 
     Service Act, as amended by this Act.
       (6) The term ``Secretary'' means the Secretary of Health 
     and Human Services.
       (h) Authorization of Appropriations.--
       (1) Existing funds.--Any amounts appropriated to the 
     Secretary for fiscal year 2004 or 2005 for the purpose of 
     assisting in the collection or maintenance of cord blood 
     shall remain available to the Secretary until the end of 
     fiscal year 2007.
       (2) Subsequent fiscal years.--There are authorized to be 
     appropriated to the Secretary $15,000,000 for each of fiscal 
     years 2007, 2008, 2009, and 2010 to carry out this section.
       (3) Limitation.--Not to exceed 5 percent of the amount 
     appropriated under this section in each of fiscal years 2007 
     through 2009 may be used to carry out the demonstration 
     project under subsection (c).

     SEC. 3. BONE MARROW AND CORD BLOOD CELL TRANSPLANTATION 
                   PROGRAM.

       (a) National Program.--Section 379 of the Public Health 
     Service Act (42 U.S.C. 274k) is amended to read as follows:

     ``SEC. 379. NATIONAL PROGRAM.

       ``(a) Establishment.--The Secretary, acting through the 
     Administrator of the Health Resources and Services 
     Administration, shall by one or more contracts establish and 
     maintain a Bone Marrow and Cord Blood Cell Transplantation 
     Program (referred to in this section as the `Program') that 
     has the purpose of increasing the number of transplants for 
     recipients suitably matched to biologically unrelated donors 
     of bone marrow and cord blood, and that meets the 
     requirements of this section. The Secretary may award a 
     separate contract to perform each of the major functions of 
     the Program described in paragraphs (1) and (2) of subsection 
     (c) if deemed necessary by the Secretary to operate an 
     effective and efficient system that is in the best interest 
     of patients. The Secretary shall conduct a separate 
     competition for the initial establishment of the cord blood 
     functions of the Program. The Program shall be under the 
     general supervision of the Secretary. The Secretary shall 
     establish an Advisory Council to advise, assist, consult 
     with, and make recommendations to the Secretary on matters 
     related to the activities carried out by the Program. The 
     members of the Advisory Council shall be appointed in 
     accordance with the following:
       ``(1) Each member of the Advisory Council shall serve for a 
     term of 2 years, and each such member may serve as many as 3 
     consecutive 2-year terms, except that
       ``(A) such limitations shall not apply to the Chair of the 
     Advisory Council (or the Chair-elect) or to the member of the 
     Advisory Council who most recently served as the Chair; and
       ``(B) 1 additional consecutive 2-year term may be served by 
     any member of the Advisory Council who has no employment, 
     governance, or financial affiliation with any donor center, 
     recruitment organization, transplant center, or cord blood 
     bank.
       ``(2) A member of the Advisory Council 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 Advisory 
     Council, the Advisory Council shall be appointed so that each 
     year the terms of approximately one-third of the members of 
     the Advisory Council expire.
       ``(4) The membership of the Advisory Council--

[[Page S7435]]

       ``(A) shall include as voting members a balanced number of 
     representatives including representatives of marrow donor 
     centers and marrow transplant centers, representatives of 
     cord blood banks and participating birthing hospitals, 
     recipients of a bone marrow transplant, recipients of a cord 
     blood transplant, persons who require such transplants, 
     family members of such a recipient or family members of a 
     patient who has requested the assistance of the Program in 
     searching for an unrelated donor of bone marrow or cord 
     blood, persons with expertise in bone marrow and cord blood 
     transplantation, persons with expertise in typing, matching, 
     and transplant outcome data analysis, persons with expertise 
     in the social sciences, basic scientists with expertise in 
     the biology of adult stem cells, and members of the general 
     public; and
       ``(B) shall include as nonvoting members representatives 
     from the Department of Defense Marrow Donor Recruitment and 
     Research Program operated by the Department of the Navy, the 
     Division of Transplantation of the Health Resources and 
     Services Administration, the Food and Drug Administration, 
     and the National Institutes of Health.
       ``(5) Members of the Advisory Council shall be chosen so as 
     to ensure objectivity and balance and reduce the potential 
     for conflicts of interest. The Secretary shall establish 
     bylaws and procedures--
       ``(A) to prohibit any member of the Advisory Council who 
     has an employment, governance, or financial affiliation with 
     a donor center, recruitment organization, transplant center, 
     or cord blood bank from participating in any decision that 
     materially affects the center, recruitment organization, 
     transplant center, or cord blood bank; and
       ``(B) to limit the number of members of the Advisory 
     Council with any such affiliation.
       ``(6) The Secretary, acting through the Advisory Council, 
     shall submit to the Congress--
       ``(A) an annual report on the activities carried out under 
     this section; and
       ``(B) not later than 6 months after the date of the 
     enactment of the Bone Marrow and Cord Blood Therapy and 
     Research Act of 2005, a report of recommendations on the 
     scientific factors necessary to define a cord blood unit as a 
     high-quality unit.
       ``(b) Accreditation.--The Secretary shall, through a public 
     process, recognize one or more accreditation entities for the 
     accreditation of cord blood banks.
       ``(c) Functions.--
       ``(1) Bone marrow functions.--With respect to bone marrow, 
     the Program shall--
       ``(A) operate a system for listing, searching, and 
     facilitating the distribution of bone marrow that is suitably 
     matched to candidate patients;
       ``(B) consistent with paragraph (3), permit transplant 
     physicians, other appropriate health care professionals, and 
     patients to search by means of electronic access all 
     available bone marrow donors listed in the Program;
       ``(C) carry out a program for the recruitment of bone 
     marrow donors in accordance with subsection (d), including 
     with respect to increasing the representation of racial and 
     ethnic minority groups (including persons of mixed ancestry) 
     in the enrollment of the Program;
       ``(D) maintain and expand medical contingency response 
     capabilities, in coordination with Federal programs, to 
     prepare for and respond effectively to biological, chemical, 
     or radiological attacks, and other public health emergencies 
     that can damage marrow, so that the capability of supporting 
     patients with marrow damage from disease can be used to 
     support casualties with marrow damage;
       ``(E) carry out informational and educational activities in 
     accordance with subsection (d);
       ``(F) at least annually update information to account for 
     changes in the status of individuals as potential donors of 
     bone marrow;
       ``(G) provide for a system of patient advocacy through the 
     office established under subsection (g);
       ``(H) provide case management services for any potential 
     donor of bone marrow to whom the Program has provided a 
     notice that the potential donor may be suitably matched to a 
     particular patient through the office established under 
     subsection (g);
       ``(I) with respect to searches for unrelated donors of bone 
     marrow that are conducted through the system under 
     subparagraph (A), collect, analyze, and publish data in a 
     standardized electronic format 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;
       ``(J) support studies and demonstration and outreach 
     projects for the purpose of increasing the number of 
     individuals who are willing to be marrow donors to ensure a 
     genetically diverse donor pool; and
       ``(K) facilitate and support research to improve the 
     availability, efficiency, safety, and cost of transplants 
     from unrelated donors and the effectiveness of Program 
     operations.
       ``(2) Cord blood functions.--With respect to cord blood, 
     the Program shall--
       ``(A) operate a system for listing, searching, and 
     facilitating the distribution of donated cord blood units 
     that are suitably matched to candidate patients and meet all 
     applicable Federal and State regulations (including informed 
     consent and Food and Drug Administration regulations) from a 
     qualified cord blood bank;
       ``(B) consistent with paragraph (3), allow transplant 
     physicians, other appropriate health care professionals, and 
     patients to search by means of electronic access all 
     available cord blood units made available through the 
     Program;
       ``(C) allow transplant physicians and other appropriate 
     health care professionals to reserve, as defined by the 
     Secretary, a cord blood unit for transplantation;
       ``(D) support studies and demonstration and outreach 
     projects for the purpose of increasing cord blood donation to 
     ensure a genetically diverse collection of cord blood units;
       ``(E) provide for a system of patient advocacy through the 
     office established under subsection (g);
       ``(F) coordinate with the qualified cord blood banks to 
     carry out informational and educational activities in 
     accordance with subsection (f);
       ``(G) maintain and expand medical contingency response 
     capabilities, in coordination with Federal programs, to 
     prepare for and respond effectively to biological, chemical, 
     or radiological attacks, and other public health emergencies 
     that can damage marrow, so that the capability of supporting 
     patients with marrow damage from disease can be used to 
     support casualties with marrow damage; and
       ``(H) with respect to the system under subparagraph (A), 
     collect, analyze, and publish data in a standardized 
     electronic format, as required by the Secretary, 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.
       ``(3) Single point of access; submission of data.--
       ``(A) Single point of access.--The Secretary shall ensure 
     that health care professionals and patients are able to, at a 
     minimum, locate, consistent with the functions described in 
     paragraphs (1)(A) and (2)(A), cells from bone marrow donors 
     and cord blood units through a single electronic point of 
     access.
       ``(B) Standard data.--The Secretary shall require all 
     recipients of contracts under this section to make available 
     a standard dataset for purposes of subparagraph (A) in a 
     standardized electronic format the enables transplant 
     physicians to compare among and between bone marrow donors 
     and cord blood units to ensure the best possible match for 
     the patient.
       ``(4) Definition.--The term `qualified cord blood bank' 
     means a cord blood bank that--
       ``(A) has obtained all applicable Federal and State 
     licenses, certifications, registrations (including pursuant 
     to the regulations of the Food and Drug Administration), and 
     other authorizations required to operate and maintain a cord 
     blood bank;
       ``(B) has implemented donor screening, cord blood 
     collection practices, and processing methods intended to 
     protect the health and safety of donors and transplant 
     recipients to improve transplant outcomes, including with 
     respect to the transmission of potentially harmful infections 
     and other diseases;
       ``(C) is accredited by an accreditation entity recognized 
     by the Secretary under subsection (b);
       ``(D) has established a system of strict confidentiality to 
     protect the identity and privacy of patients and donors in 
     accordance with existing Federal and State law;
       ``(E) has established a system for encouraging donation by 
     a genetically diverse group of donors; and
       ``(F) has established a system to confidentially maintain 
     linkage between a cord blood unit and a maternal donor.
       ``(d) Bone Marrow Recruitment; Priorities; Information and 
     Education.--
       ``(1) Recruitment; priorities.--The Program shall carry out 
     activities for the recruitment of bone marrow donors. Such 
     recruitment program shall identify populations that are 
     underrepresented among potential donors enrolled with the 
     Program. In the case of populations that are identified under 
     the preceding sentence:
       ``(A) The Program 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 Program shall consider racial and ethnic minority 
     groups (including persons of mixed ancestry) to be 
     populations that have been identified for purposes of this 
     paragraph, and shall carry out subparagraph (A) with respect 
     to such populations.
       ``(2) Information and education regarding recruitment; 
     testing and enrollment.--
       ``(A) In general.--The Program shall carry out 
     informational and educational activities, in coordination 
     with organ donation public awareness campaigns operated 
     through the Department of Health and Human Services, for 
     purposes of recruiting individuals to serve as donors of bone 
     marrow, and shall test and enroll with the Program potential 
     bone marrow donors. Such information and educational 
     activities shall include the following:

[[Page S7436]]

       ``(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 bone marrow donors.
       ``(iii) Training individuals in requesting individuals to 
     serve as potential bone marrow donors.
       ``(B) Priorities.--In carrying out informational and 
     educational activities under subparagraph (A), the Program 
     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 recruitment program 
     under paragraph (1) shall provide information to physicians, 
     other health care professionals, and the public regarding 
     bone marrow transplants from unrelated donors as a treatment 
     option.
       ``(4) Implementation of subsection.--The requirements of 
     this subsection shall be carried out by the entity that has 
     been awarded a contract by the Secretary under subsection (a) 
     to carry out the functions described in subsection (c)(1).
       ``(e) Bone Marrow Criteria, Standards, and Procedures.--The 
     Secretary shall enforce, for participating entities, 
     including the Program, 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 for the system for patient advocacy 
     operated under subsection (g), 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 Program.
       ``(f) Cord Blood Recruitment; Priorities; Information and 
     Education.--
       ``(1) Recruitment; priorities.--The Program shall support 
     activities, in cooperation with qualified cord blood banks, 
     for the recruitment of cord blood donors. Such recruitment 
     program shall identify populations that are underrepresented 
     among cord blood donors. In the case of populations that are 
     identified under the preceding sentence:
       ``(A) The Program shall give priority to supporting 
     activities under this part to increase representation for 
     such populations in order to enable a member of such a 
     population, to the extent practicable, to have a probability 
     of finding a suitable cord blood unit that is comparable to 
     the probability that an individual who is not a member of an 
     underrepresented population would have.
       ``(B) The Program shall consider racial and ethnic minority 
     groups (including persons of mixed ancestry) to be 
     populations that have been identified for purposes of this 
     paragraph, and shall support activities under subparagraph 
     (A) with respect to such populations.
       ``(2) Information and education regarding recruitment; 
     testing and donation.--
       ``(A) In general.--In carrying out the recruitment program 
     under paragraph (1), the Program shall support informational 
     and educational activities in coordination with qualified 
     cord blood banks and organ donation public awareness 
     campaigns operated through the Department of Health and Human 
     Services, for purposes of recruiting pregnant women to serve 
     as donors of cord blood. Such information and educational 
     activities shall include the following:
       ``(i) Making information available to the general public, 
     including information describing the needs of patients with 
     respect to cord blood units.
       ``(ii) Educating and providing information to pregnant 
     women who are willing to donate cord blood units.
       ``(iii) Training individuals in requesting pregnant women 
     to serve as cord blood donors.
       ``(B) Priorities.--In carrying out informational and 
     educational activities under subparagraph (A), the Program 
     shall give priority to supporting the recruitment of pregnant 
     women to serve as donors of cord blood for populations that 
     are identified under paragraph (1).
       ``(3) Transplantation as treatment option.--In addition to 
     activities regarding recruitment, the recruitment program 
     under paragraph (1) shall provide information to physicians, 
     other health care professionals, and the public regarding 
     cord blood transplants from donors as a treatment option.
       ``(4) Implementation of subsection.--The requirements of 
     this subsection shall be carried out by the entity that has 
     been awarded a contract by the Secretary under subsection (a) 
     to carry out the functions described in subsection (c)(2).
       ``(g) Patient Advocacy and Case Management for Bone Marrow 
     and Cord Blood.--
       ``(1) In general.--The Secretary shall establish and 
     maintain, through a contract or other means determined 
     appropriate by the Secretary, 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 be staffed by individuals with 
     expertise in bone marrow and cord blood therapy covered under 
     the Program.
       ``(C) The Office shall operate a system for patient 
     advocacy, which shall be separate from mechanisms for donor 
     advocacy, and which shall serve patients for whom the Program 
     is conducting, or has been requested to conduct, a search for 
     a bone marrow donor or cord blood unit.
       ``(D) In the case of such a patient, the Office shall serve 
     as an advocate for the patient by directly providing to the 
     patient (or family members, physicians, or other individuals 
     acting on behalf of the patient) individualized services with 
     respect to efficiently utilizing the system under paragraphs 
     (1) and (2) of subsection (c) to conduct an ongoing search 
     for a bone marrow donor or cord blood unit and assist with 
     information regarding third party payor matters.
       ``(E) In carrying out subparagraph (D), the Office shall 
     monitor the system under paragraphs (1) and (2) of subsection 
     (c) 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 bone marrow donors or cord blood units that are 
     suitably 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.
       ``(F) The Office shall ensure that the following data are 
     made available to patients:
       ``(i) The resources available through the Program.
       ``(ii) A comparison of transplant centers regarding search 
     and other costs that prior to transplantation are charged to 
     patients by transplant centers.
       ``(iii) The post-transplant outcomes for individual 
     transplant centers.
       ``(iv) Information concerning issues that patients may face 
     after a transplant.
       ``(v) Such other information as the Program 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 to 
     best meet the needs of patients.
       ``(3) Case management.--
       ``(A) In general.--In serving as an advocate for a patient 
     under paragraph (2), the Office shall provide individualized 
     case management services directly to the patient (or family 
     members, physicians, or other individuals acting on behalf of 
     the patient), including--
       ``(i) individualized case assessment; and
       ``(ii) the functions described in paragraph (2)(D) 
     (relating to progress in the search process).
       ``(B) Postsearch functions.--In addition to the case 
     management services described in paragraph (1) for patients, 
     the Office shall, on behalf of patients who have completed 
     the search for a bone marrow donor or cord blood unit, 
     provide information and education on the process of receiving 
     a transplant, including the post-transplant process.
       ``(h) Comment Procedures.--The Secretary shall establish 
     and provide information to the public on procedures under 
     which the Secretary shall receive and consider comments from 
     interested persons relating to the manner in which the 
     Program is carrying out the duties of the Program.
       ``(i) Consultation.--In developing policies affecting the 
     Program, the Secretary shall consult with the Advisory 
     Council, the Department of Defense Marrow Donor Recruitment 
     and Research Program operated by the Department of the Navy, 
     and the board of directors of each entity awarded a contract 
     under this section.
       ``(j) Contracts.--
       ``(1) Application.--To be eligible to enter into a contract 
     under this section, an entity shall submit to the Secretary 
     and obtain approval of an application at such time, in such 
     manner, and containing such information as the Secretary 
     shall by regulation prescribe.
       ``(2) Considerations.--In awarding contracts under this 
     section, the Secretary shall give consideration to the 
     continued safety of donors and patients and other factors 
     deemed appropriate by the Secretary.

[[Page S7437]]

       ``(k) Eligibility.--Entities eligible to receive a contract 
     under this section shall include private nonprofit entities.
       ``(l) 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.
       ``(m) Penalties for Disclosure.--Any person who discloses 
     the content of any record referred to in subsection (c)(4)(D) 
     or (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 (e)(5)(B), shall be imprisoned for not more than 2 
     years or fined in accordance with title 18, United States 
     Code, or both.''.
       (b) Stem Cell Therapeutic Outcomes Database.--Section 379A 
     of the Public Health Service Act (42 U.S.C. 274l) is amended 
     to read as follows:

     ``SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATABASE.

       ``(a) Establishment.--The Secretary shall by contract 
     establish and maintain a scientific database of information 
     relating to patients who have been recipients of a stem cell 
     therapeutics product (including bone marrow, cord blood, or 
     other such product) from a donor.
       ``(b) Information.--The outcomes database shall include 
     information in a standardized electronic format with respect 
     to patients described in subsection (a), diagnosis, 
     transplant procedures, results, long-term follow-up, and such 
     other information as the Secretary determines to be 
     appropriate, to conduct an ongoing evaluation of the 
     scientific and clinical status of transplantation involving 
     recipients of a stem cell therapeutics product from a donor.
       ``(c) Annual Report on Patient Outcomes.--The Secretary 
     shall require the entity awarded a contract under this 
     section to submit to the Secretary an annual report 
     concerning patient outcomes with respect to each transplant 
     center, based on data collected and maintained by the entity 
     pursuant to this section.
       ``(d) Publicly Available Data.--The outcomes database shall 
     make relevant scientific information not containing 
     individually identifiable information available to the public 
     in the form of summaries and data sets to encourage medical 
     research and to provide information to transplant programs, 
     physicians, patients, entities awarded a contract under 
     section 379 donor registries, and cord blood banks.''.
       (c) Definitions.--Part I of title III of the Public Health 
     Service Act (42 U.S.C. 274k et seq.) is amended by inserting 
     after section 379A the following:

     ``SEC. 379A-1. DEFINITIONS.

       ``In this part:
       ``(1) The term `Advisory Council' means the advisory 
     council established by the Secretary under section 379(a)(1).
       ``(2) The term `bone marrow' means the cells found in adult 
     bone marrow and peripheral blood.
       ``(3) The term `outcomes database' means the database 
     established by the Secretary under section 379A.
       ``(4) The term `Program' means the Bone Marrow and Cord 
     Blood Cell Transplantation Program established under section 
     379.''.
       (d) Authorization of Appropriations.--Section 379B of the 
     Public Health Service Act (42 U.S.C. 274m) is amended to read 
     as follows:

     ``SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.

       ``For the purpose of carrying out this part, there are 
     authorized to be appropriated $34,000,000 for fiscal year 
     2006 and $38,000,000 for each of fiscal years 2007 through 
     2010.''.
       (e) Conforming Amendments.--Part I of title III of the 
     Public Health Service Act (42 U.S.C. 274k et seq.) is amended 
     in the part heading, by striking ``NATIONAL BONE MARROW DONOR 
     REGISTRY'' and inserting `` BONE MARROW AND CORD BLOOD CELL 
     TRANSPLANTATION PROGRAM''.

     SEC. 4. REPORT ON LICENSURE OF CORD BLOOD UNITS.

       Not later than 90 days after the date of enactment of this 
     Act, the Secretary of Health and Human Services, in 
     consultation with the Commissioner of Food and Drugs, shall 
     submit to Congress a report concerning the progress made by 
     the Food and Drug Administration in developing requirements 
     for the licensing of cord blood units.

  Mr. DODD. Mr. President, I am pleased to join Senator Hatch, Senator 
Burr, Senator Reed, and Senator Ensign in introducing legislation that 
will significantly benefit some of the most gravely ill patients--those 
in need of a blood stem cell transplant. By reauthorizing the national 
program for bone marrow, creating a similar program for umbilical cord 
blood, and expanding the national stockpile of umbilical cord blood 
units, this legislation will dramatically increase the chances that 
patients in need of a life-saving transplant will be able to find an 
appropriate genetic match.
  The bill that we are introducing today is similar to legislation that 
Senator Hatch and I introduced earlier this year to create a national 
network of cord blood banks and a cord blood registry. However, there 
are two important differences. First, this legislation is consistent 
with recommendations made by the Institute of Medicine, IOM, in their 
recent report, ``Cord Blood: Establishing a National Hematopoietic Stem 
Cell Bank Program,'' about the structure of a national cord blood 
program. Second, and more importantly, this bill would also reauthorize 
the national bone marrow program, and put both bone marrow and cord 
blood under the auspices of a single national program. This structure 
reflects the complimentary nature of bone marrow and cord blood, and 
will ensure that physicians and patients can more easily find the best 
possible match for transplantation.
  The therapeutic benefits of bone marrow are well established. Bone 
marrow transplants have been used for nearly half a century to treat 
patients suffering from diseases such as leukemia, Hodgkin's Disease, 
sickle cell anemia, and others. The use of cord blood as an alternative 
to bone marrow is a more recent development, but one that is just as 
promising and exciting.
  The bill that we are introducing today will begin a new national 
commitment to the development of this technology which has the 
potential to reduce pain and suffering and save the lives of so many 
Americans afflicted with some of the most debilitating illnesses. Cord 
blood has already been used successfully in treating a number of 
diseases, including sickle cell anemia and certain childhood cancers. 
However, the use of cord blood is still in an early stage relative to 
the use of bone marrow, and may have even broader application in the II 
future.
  Like many Americans, I had never heard of cord blood before the birth 
of my first daughter, almost 4 years ago. It is not widely used--at 
least in this country. Approximately 95 percent of all bone marrow 
reconstitutions are done using a bone marrow transplant--only 5 percent 
use cord blood. This figure is surprising when we consider the benefits 
of cord blood.
  First, it can be very difficult to find a suitable bone marrow donor. 
According to a General Accounting Office, GAO, report, of the 15,231 
individuals needing bone marrow transplants between 1997 and 2000 who 
conducted a preliminary search of the National Bone Marrow Donor 
Registry, NBMDR, only 4,056 received a transplant--a 27 percent success 
rate. This number is even lower for minorities. Cord blood would not 
only produce an additional source of donation; it also does not require 
as exact a genetic match as bone marrow.

  In addition, cord blood is readily available. While it can take 
months between finding a bone marrow match and actually receiving a 
transplant, a unit of cord blood can be utilized in a matter of days or 
weeks. Cord blood also lowers the risk of complications for both the 
donor and the recipient. The need to extract bone marrow from the donor 
is eliminated, and the risk of infection or rejection by the recipient 
is significantly reduced. Finally, research has suggested that cord 
blood might produce better outcomes than bone morrow in children.
  Why then, given all of these benefits, has the use of cord blood not 
become much more prevalent in the United States? In Japan, where the 
use of cord blood in clinical settings is more advanced, nearly half of 
all transplants now use cord blood rather than bone marrow.
  The relatively infrequent use of cord blood in our country is at 
least partly attributable to the lack of a national infrastructure for 
the matching and distribution of cord blood units. There are a handful 
of cord blood banks around the country doing excellent work, but there 
is a much more developed infrastructure for bone marrow. This is thanks 
to legislation passed by Congress in 1986 that established a national 
registry for bone marrow, which this bill would reauthorize. Our bill

[[Page S7438]]

would create a similar infrastructure for cord blood, operating under 
the auspices of a newly established Bone Marrow and Cord Blood Cell 
Transplantation Program. In addition to connecting physicians and 
patients with a suitable bone marrow donor or cord blood unit, the 
program would be required to educate the general public about cord 
blood and bone marrow, and encourage an ethnically diverse population 
of donors.
  Our bill would also provide grants to qualified cord blood banks to 
acquire 150,000 new cord blood units. This number is consistent with 
recommendations made by the IOM, and should be sufficient to provide a 
suitable match for 90 percent of the U.S. population.
  Finally, the legislation authorizes an appropriation of $15 million 
for each of fiscal years 2007 through 2010 for the cord blood inventory 
grants, and $186 million over the next 5 years for the establishment 
and maintenance of the Bone Marrow and Cord Blood Cell Transplantation 
Program.
  Before finishing today I would like to make it clear that, just as I 
believe that cord blood should act as a complement to, not a 
replacement for, bone marrow, I also believe that cord blood does not 
eliminate the need for research into the potential benefits of 
embryonic stem cells. Just as cord blood seems to be preferable to bone 
marrow for treating certain individuals or conditions--and the reverse 
is certainly true as well--the same may prove to be true for embryonic 
stem cells. Certainly, we should provide doctors with the best tools to 
help cure their patients, whether those tools come from bone marrow, 
cord blood, embryonic stem cells, or another source entirely.
  I firmly believe that the strengthening of our national 
infrastructure for bone marrow and the creation of a similar 
infrastructure for cord blood will save the lives of thousands of 
gravely ill Americans. I urge my colleagues to support this 
legislation.
  Mr. REED. Mr. President, I join my colleagues, Senators Ensign, Dodd, 
Hatch, and Burr, in introducing the Bone Marrow and Cord Blood Therapy 
and Research Act of 2005. This bipartisan legislation represents a 
critical step forward in expanding access to lifesaving therapies to 
millions of patients with conditions that can be treated and even cured 
with bone marrow or cord blood.
  The bill we are introducing today builds upon the already highly 
successful National Marrow Donor Program that has been in operation 
since 1987. In addition to reauthorizing this program, our bill calls 
for the establishment of a formal registry of cord blood units 
available for transplantation and expands to cord blood transplant 
recipients many of the program's existing functions, such as donor 
recruitment, education, information, and patient advocacy, presently 
available to only bone marrow recipients. It creates an umbrella 
program, aptly called the Bone Marrow and Cord Blood Cell 
Transplantation Program.
  Our legislation also captures many of the key recommendations of the 
Institute of Medicine, IOM, in their April 2004 report entitled, ``Cord 
Blood: Establishing a National Hematopoietip Stem Cell Bank Program.'' 
The report called for a stepped up effort to expand the inventory of 
cord blood units available for transplantation and, when appropriate, 
for research. Our bill establishes a grant program for qualified cord 
blood banks to help facilitate building an inventory of 150,000 new 
cord blood units. At that level, 95 percent of Americans with a 
condition that can be treated through a cord blood transplant could 
find a genetically suitable match. Additionally, the bill establishes 
an advisory council to consult and make recommendations to ensure the 
efficient and effective operation of the program.
  Another important aspect of this bill is the creation of a 
demonstration project to study cord blood donations within families 
where a first degree relative has been I diagnosed with a condition 
that could benefit from a cord blood transplant. The legislation sets 
aside 5 percent of the cord blood inventory grants for the collection 
and storage of cord blood units at no cost to such families. This 
effort will be beneficial for families who find themselves in the 
tragic situation of having a sick child with another child on the way 
whose cord blood could provide a cure to the sibling. This 
demonstration program ensures that families will have this treatment 
option available to them.
  I believe that the Bone Marrow and Cord Blood Transplantation and 
Research Act of 2005 represents a strong compromise that upholds the 
principals my colleagues and I held as essential in developing a 
combined bone marrow and cord blood program. The bill also builds on 
the many strengths of the National Marrow Donor Program, which has 
facilitated over 20,000 transplants since its inception and has built a 
donor registry of over 5.5 million potential donors.
  I urge the support of all of my colleagues for this bipartisan 
legislation so that we can send it quickly to the President for his 
signature.

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