[Congressional Record Volume 151, Number 163 (Saturday, December 17, 2005)]
[House]
[Pages H12063-H12072]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005

  Mr. DEAL of Georgia. Mr. Speaker, I move to suspend the rules and 
concur in the Senate amendment to the bill (H.R. 2520) to provide for 
the collection and maintenance of human cord blood stem cells for the 
treatment of patients and research, and to amend the Public Health 
Service Act to authorize the C.W. Bill Young Cell Transplantation 
Program.
  The Clerk read as follows:

       Senate amendment:
       Strike out all after the enacting clause and insert:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Stem Cell Therapeutic 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 C.W. Bill Young 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, as determined by the Secretary pursuant 
     to section 379(c) of the Public Health Service Act, 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(d)(3) of the Public Health 
     Service Act (42 U.S.C. 274k(d)(3)), as amended by this Act, 
     in a standardized electronic format, as determined by the 
     Secretary, for the C.W. Bill Young 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 C.W. Bill Young 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 C.W. Bill Young 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 C.W. Bill Young 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 C.W. Bill Young Cell 
     Transplantation Program in perpetuity or for such time as 
     determined viable by the Secretary; 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(d)(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 no Federal funds shall be obligated under any 
     such contract after 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

[[Page H12064]]

     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 ``C. W. Bill Young Cell Transplantation 
     Program'' means the C.W. Bill Young 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(d)(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. C.W. BILL YOUNG 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 C.W. Bill Young Cell Transplantation Program 
     (referred to in this section as the `Program'), successor to 
     the National Bone Marrow Donor Registry, 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 (d) 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--
       ``(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 Stem Cell Therapeutic 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) Informed Consent.--The Secretary shall, through a 
     public process, examine issues of informed consent, 
     including--
       ``(1) the appropriate timing of such consent; and
       ``(2) the information provided to the maternal donor 
     regarding all of her medically appropriate cord blood 
     options.

     Based on such examination, the Secretary shall require that 
     the standards used by the accreditation entities recognized 
     under subsection (b) ensure that a cord blood unit is 
     acquired with the informed consent of the maternal donor.
       ``(d) Functions.--
       ``(1) Bone marrow functions.--With respect to bone marrow, 
     the Program shall--
       ``(A) operate a system for identifying, matching, 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 (e), 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 (e);
       ``(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 (h);
       ``(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 (h);
       ``(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 research with the appropriate Federal 
     agencies 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 identifying, matching, 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

[[Page H12065]]

     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 (h);
       ``(F) coordinate with the qualified cord blood banks to 
     support informational and educational activities in 
     accordance with subsection (g);
       ``(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; standard data.--
       ``(A) Single point of access.--The Secretary shall ensure 
     that health care professionals and patients are able to 
     search electronically for and facilitate access to, in the 
     manner and to the extent defined by the Secretary and 
     consistent with the functions described in paragraphs (1)(A) 
     and (2)(A), cells from bone marrow donors and cord blood 
     units through a single 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 that 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.
       ``(e) 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:
       ``(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 (d)(1).
       ``(f) 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 (h), 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.
       ``(g) 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 (d)(2).
       ``(h) 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.

[[Page H12066]]

       ``(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 (d) 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 
     (d) 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.
       ``(i) 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. The 
     Secretary may promulgate regulations under this section.
       ``(j) 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.
       ``(k) 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.
       ``(l) Eligibility.--Entities eligible to receive a contract 
     under this section shall include private nonprofit entities.
       ``(m) 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.
       ``(n) Penalties for Disclosure.--Any person who discloses 
     the content of any record referred to in subsection (d)(4)(D) 
     or (f)(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 (f)(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 C.W. Bill Young 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 ``C. W. BILL YOUNG 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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Georgia (Mr. Deal) and the gentlewoman from Colorado (Ms. DeGette) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Georgia.


                             General Leave

  Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that all 
Members may have 5 legislative days within which to revise and extend 
their remarks and include extraneous material on H.R. 2520.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Georgia?
  There was no objection.
  Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise in strong support of H.R. 2520, the Stem Cell 
Therapeutic and Research Act of 2005. This legislation will expand the 
number of stem cell options available to Americans suffering from life-
threatening diseases.
  Every year, nearly two-thirds of the approximately 200,000 patients 
in need of a bone marrow transplant will not find a marrow donor that 
matches within their families. These patients must rely on the help of 
strangers to donate bone marrow or transplant. To assist these 
patients, Congress established the National Bone Marrow Registry to 
quickly facilitate unrelated donor transplants. Through this program, 
Congress made a significant investment to connect patients with a rich 
source of stem cells that offer immediate clinical benefits.
  With scientific advances, Congress must now make changes to reflect 
new therapeutic options. Cord blood stem cell units have been shown to 
be a suitable alternative to adult bone marrow for the treatment of 
many diseases, including sickle cell anemia. This is an

[[Page H12067]]

especially important advancement for those Americans who have 
desperately searched for a bone marrow donor, but could not find a 
suitable match, even with the help of the National Bone Marrow 
Registry. As another rich source of stem cells, cord blood transplant 
is another chance at life for many patients.
  The bill before us today builds on the critical investments we have 
made over the past two decades with the National Bone Marrow Registry 
and retools this design into a new, more comprehensive stem cell 
transplantation program which will include not only bone marrow but 
cord blood units.
  Through a competitive contracting process, this new program will 
allow transplant doctors and patients to access information about cord 
blood units and bone marrow donors at the same time through a single 
point of access. This new program does not create a preference for 
either cord blood or bone marrow. Instead, it will provide 
comprehensive information about both sources to stem cells to doctors 
and patients and allow them to make the clinically most appropriate 
choice.
  I would like to recognize Congressman Bill Young. It is his drive and 
steadfast support for an idea of a national registry for bone marrow 
that lead to the program's creation. Mr. Young has continuously 
supported improving this program and does so today by reformatting the 
program's design. I am pleased that Congress is recognizing his 
dedication by naming the new program the C.W. Bill Young Cell 
Transplantation Program.
  Lastly, I would like to note that through the discussions with the 
Senate, we have improved the original House bill to make the program 
more effective, including improved patient advocacy and case management 
services. We have created a new demonstration program to allow families 
with a sick child who could be helped with a cord blood transplant from 
a sibling to bank cord blood from newborns should they decide to have 
another child. We have also expanded the clinical outcomes database to 
include biologically related donors in addition to unrelated donors.
  Finally, we require the Food and Drug Administration to provide a 
report on its progress in developing licensure requirements for cord 
blood units.
  Mr. Speaker, I reserve the balance of my time.
  Ms. DeGETTE. Mr. Speaker, I yield myself such time as I may consume. 
Mr. Speaker, I want to thank my colleague and friend from Georgia on 
the Energy and Commerce Committee for his leadership on issues like 
this.
  Mr. Speaker, I rise today in support of this legislation; however, I 
am concerned that the other body has chosen to send us only the cord 
blood bill today. This bill is essentially the same bill that the House 
passed last May by a vote of 431-1. The legislation is important, and 
it will help advance medical research which is why I support it and why 
we passed it by such an overwhelming majority last spring. What we need 
to be clear about, though, is what this bill really will and will not 
do; and we also need to be clear that this bill is not a substitute for 
embryonic stem cell research, the Castle-DeGette bill, H.R. 810, which 
is an important bill to advance scientific research to affect diseases 
that will potentially kill millions of Americans.
  Like adult stem cells, umbilical cord stem cells have proven over the 
last decade or so to be a reliable source of blood-forming stem cells 
that are used as a technique to treat blood diseases like leukemia and 
lymphoma. That established technique has led to about 600 cord blood 
transplants which were performed in the United States in 2004 to treat 
blood disorders. But these cord blood cells are not regenerative and 
they are not reprogramming, which is why they cannot be used to be made 
into other types of stem cells that can cure other types of diseases 
besides blood-related diseases.
  It is true that cord blood has been reliably used for a number of 
years, and that is why it is so important that we pass this cord blood 
registry. But we must not overstate or exaggerate the capabilities of 
cord stem cells. Significant limitations exists that must be 
considered.
  Unlike human embryonic stem cells, stem cells from umbilical blood 
cord cannot continually reproduce themselves. Instead of proliferating, 
they quickly evolve into specialized cells. Umbilical cord stem cells 
cannot be induced to form diverse nonblood cell types, as I mentioned. 
Although some initial experiments appear to be promising, few stem cell 
researcher now believe that umbilical cords will be a reliable source 
of replacement cells other than blood cells.
  Now, I support this very early research that I talked about, as I 
support any kind of research that could lead to stem cells that could 
cure diseases. But these studies are few, and they have not shown 
conclusive results.
  Finally, umbilical cord stem cells are in short supply. Only a small 
number of cells can be obtained from each umbilical cord, making it 
hard to obtain enough stem cells for treatment.

                              {time}  1600

  Because of the limitations, we must also support embryonic stem cell 
research. I do not need to tell the House that, though, because we 
already did that with support from both sides of the aisle.
  Last May, this House passed both the umbilical cord stem cell 
legislation along with H.R. 810, the Stem Cell Research Enhancement 
Act. H.R. 810, cosponsored by myself and Congressman Mike Castle, 
expands the number of embryonic stem cell lines that are eligible for 
federally funded research. The goal of the legislation is to accelerate 
scientific progress toward life-saving cures and treatments for a wide 
range of diseases, not just blood-related diseases.
  Unfortunately, the other body has not yet embraced the wisdom of the 
people's House. Here is what has happened in our country because of our 
failure to federally fund embryonic stem cell research: As I think we 
can all agree, the National Institutes of Health is not only one of the 
foremost institutions, probably the foremost institution for medical 
research in the world, but it also stands as the gold standard in the 
world in defining ethical research. Because NIH is not able to fund 
embryonic stem cell research, it is limited in its ability to define 
the ethics for that research, certainly in this country but definitely 
abroad.
  Many here have heard about the embryonic stem cell studies that have 
been done in South Korea, and frankly, Mr. Castle and I, the research 
community and others have warned for a long time that when you take 
embryonic stem cell research offshore, not only do you lose your 
ethical ability to oversee that research, but you also lose the ability 
to make sure that the studies are done in a scientifically sound 
manner. We saw what we hoped to be some tremendous advancements in 
South Korea last year, but now what we are seeing is news out of South 
Korea that the scientific method and also the ethics have been called 
into question.
  If we allowed ethical stem cell research, looked over by the National 
Institutes of Health, in this country, this would not happen, and we 
would have advances in science fueled by the engine of the NIH but also 
overseen by their ethical guidelines.
  That is why we need to pass H.R. 810. We need to make sure that we 
bring the ethics as well as the scientific method back under the 
umbrella of the NIH so that we can continue to be a leader in this 
research in the world.
  Mr. Speaker, it is time for the other body of Congress to move 
forward on swift passage of H.R. 810 so that we can retain our 
leadership position in the world.
  Again, I support the bill that is before us today. It is a very 
important registry for cord blood, and it is also important for 
expansion of cord blood for blood diseases that affect so many, 
including in the minority community, but we also need to move forward 
with H.R. 810 so that we can have scientific progress that is done in 
an ethical manner and that will cover the waterfront in curing diseases 
that will affect millions of Americans.
  Mr. Speaker, I reserve the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that the 
gentleman from Texas (Mr. Burgess) be allowed to control the remainder 
of the time on our side.
  The SPEAKER pro tempore (Mr. Boozman). Is there objection to the 
request of the gentleman from Georgia?
  There was no objection.

[[Page H12068]]

  Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from New 
Jersey (Mr. Smith).
  Mr. SMITH of New Jersey. Mr. Speaker, I thank my friend for yielding 
me the time.
  Mr. Speaker, it occurred to me on the way to work this afternoon that 
it is especially fitting that during this season of holiness and faith 
and surpassing religious significance that Congress send to the 
President a bill designed to effectuate cures of some of the most 
devastating diseases and cancers on earth.
  Not only has God in His wisdom and goodness created a placenta and 
umbilical cord to nurture and protect the precious life of an unborn 
child, but now we know that another gift awaits us immediately after 
birth. Something very special is left behind, cord blood that is 
teeming with life-saving stem cells. Indeed, it is one of the best kept 
secrets in America that umbilical cord blood stem cells and adult stem 
cells are curing people of a myriad of terrible conditions and disease 
and are now showing the plasticity and pluripotency that my previous 
colleague just mentioned. So I would hasten to correct the gentlelady 
from Colorado that cord blood stem cells are not just for blood-related 
diseases, it also has the capability increasingly, as research shows, 
to do other miraculous things as well.
  Let me just remind Members that we passed this legislation 6 months 
ago. Many things have happened since those 6 months. Much progress has 
been made. This bill law will establish a national program to collect 
upwards of 150,000 units, with great diversity, so that most Americans 
who suffer from anomalies that could be cured by cord blood will be 
able to get it.
  Let me thank so many people, the Speaker, Tom DeLay, Roy Blunt, Joe 
Barton whom we all pray for and wish a very speedy recovery. Let me 
thank my friend on the other side of the aisle, the gentleman from 
Alabama (Mr. Davis) and the Congressional Black Caucus for the yeoman's 
work that they expended in getting this legislation first passed in the 
House, then passed over on the Senate side, because there was a 
Democratic hold on it regrettably, Tom Harkin, but then he lifted it.
  Let me especially thank Senator Frist for the good work he did; Sam 
Brownback; Mike Enzi; Orrin Hatch; Jon Kyl; so many others as well as 
so many here; the gentleman from Florida (Mr. Weldon); the gentleman 
from Pennsylvania (Mr. Pitts); the gentleman from California (Mr. 
Daniel E. Lungren); the gentleman from Indiana (Mr. Pence) and I could 
go on and on. I have a list of three pages of people who have been 
instrumental in getting this legislation to the point where it will be 
passed and sent down to the President for signature.
  Let me especially thank Cassie Bevan in the Majority Leader's Office 
who has worked so hard. She is amazing. John Cusey, on September 11, 
2001, put together our first drafting meeting on this legislation. He 
too is amazing. That is how far back it goes. It has been a long time 
coming, and so many others. Cheryl Jaeger, Chuck Clapton, Kikki Kless 
in the Speaker's Office, Nicole Gustafson and Autumn Fredericks in the 
ProLife Caucus, Eric Euling in Senator Frist's office and Doug Branch 
with Senator Brownback and some of the others were outstanding. I will 
put the full statement in regarding all the many, many fine people who 
worked on this.
  I will insert the remainder of my statement and the material I 
referred to previously at this point in the Record.
  Cord-blood stem cells are, as we speak, treating and curing patients. 
Amazingly, we are on the threshold of systematically turning medical 
waste, umbilical cords and placentas, into medical miracles for huge 
numbers of very sick and terminally ill patients who suffer from such 
maladies as leukemia and sickle cell anemia. And because this 
legislation promotes cord-blood research as well, we can expect new and 
expanded uses of these very versatile stem cells.
  For the first time ever, our bill establishes a nationwide stem cell 
transplantation system. It also authorizes the national bone marrow 
transplant system and combines both under a new program, providing an 
easy, single-access point for information for doctors and patients and 
for the purpose of collecting and analyzing outcomes data.
  The cord blood stem cell portion of this bill will provide federal 
funding to increase the number of cord blood units available to match 
and treat patients. The goal is to reach a total inventory of 150,000 
units so that matched stem cells will be available to treat more than 
90 percent of patients, especially focusing on providing genetic 
diversity. The legislation would also link all the cord blood banks 
participating in the inventory program into a search system that would 
allow transplant physicians to search for cord blood and bone marrow 
matches through a single access point. The national program would 
promote stem cell research by requiring any participating cord blood 
banks to donate units not suitable for transplant because of disease or 
size to researchers who are working on new applications for cord blood 
stem cells. The National Bone Marrow Registry authorization expired on 
September 30, 2003. The bill reauthorizes an updated program through 
fiscal year 2010 for $34 million in FY06 and $38 million for each 
additional year of the program.
  In the more than 6 months since we passed this bill, even more 
advances have been made in the field. Peer-reviewed studies have been 
published showing increased plasticity and flexibility. In August, it 
was released that cord blood stem cells are as flexible as embryonic 
stem cells. Two young Maryland siblings have been cured of severe 
combined immune deficiency syndrome by cord blood from unrelated 
donors. Victims of Krabbe's and Hurler's diseases have found new hope 
in cord blood treatments--these are severe genetic neurological 
diseases that kill most of their victims before they reach 2 years old. 
A Duke University group treated newborns with cord blood--the lead 
author, Dr. Maria Escolar, now reports of the oldest survivor that the 
seven-year-old is ``now running, jumping and doing well in school.'' 
Earlier this month, Michelle Farrar from Leesburg, Virginia, traveled 
to South Korea to be treated for her spinal cord injury. True hope 
exists for countless other medical conditions, ranging from heart 
attacks to muscular dystrophy to diabetes.
  Just over a month ago, Dr. Brian Mason, an OB/GYN at Detroit's St. 
John Hospital, explained that ``People literally are dying on the 
transplant list who could be cured with this.'' I am so happy that for 
those people, delayed action on this bill has ended. No longer will 
they be denied access to the cures that are out there. Those suffering 
from the nearly 70 often terminal diseases will now get the cures that 
the legislation will make available to them. The door to the treatments 
that have cured people like Keone Penn, Steven Sprague, and Jacklyn 
Albanese will now be opened for thousands of others.
  As I mentioned before, there are so many people who deserve thanks in 
helping get this bill moved through the legislative process on both 
sides of the Hill. Among those people are Rich Doerflinger and Mark 
Gallagher from the U.S. Conference of Catholic Bishops, Dr. David 
Prentice and David Christensen from the Family Research Council, the 
staff of the New York Blood Center including Pablo Rubenstein, Cladd 
Stevens, and Kathleen Reichert, Sue Ramthun who has been so personally 
invested in this issue, Dr. Edward Guindi at Cordus and NBA Hall of 
Famer Julius ``Dr. J'' Erving, Richie Weiblinger with the Senate Budget 
Committee, and the folks at Concerned Women for American, Focus on the 
Family, and the Susan B. Anthony List. I am ecstatic that we are 
passing it through here today and getting it to the President, so that 
we may set up this network that will absolutely save thousands of 
lives.
  Ms. DeGETTE. Mr. Speaker, I am delighted to yield 2\1/2\ minutes to 
the gentleman from Alabama (Mr. Davis).
  Mr. DAVIS of Alabama. Mr. Speaker, I thank my friend from Colorado 
for yielding.
  Let me first begin by congratulating my friend from New Jersey (Mr. 
Smith) for what he has done in the last several years, and I thank my 
friend from New Jersey for letting me walk just a short stem of this 
path with you. You asked me a couple of years ago to join you as the 
lead Democratic sponsor on this bill, but let the record very clearly 
reflect that way before that this was a cause of yours. It was 
something you believed in very strongly, and I thank you for your 
persistence, and I thank you for your courage on this issue.
  Let me just say a couple of things. First of all, I want to thank our 
colleagues in the Senate. As the gentleman from New Jersey just said, 
initially, there was a reluctance to move this bill in the Senate, not 
because of any doubts about the substance of the bill. This bill has 
been the classic example of uncontroversial legislation, but there were 
some in the Senate who believed that this bill should not be given a 
vote unless the stem cell bill was given a vote.
  I understood the force of their argument. I voted for the stem cell 
bill on

[[Page H12069]]

this side. I understood the political analysis they were making, but 
every now and then, this Chamber gets to do something that shines 
beyond politics. Every now and then, this Chamber gets to find 
something that we can give the American people that does not admit to a 
liberal or conservative or Democrat or Republican level, and in the 
last 24 hours, that happened.
  So I thank Senator Harkin and I thank Senator Reid for deciding to 
take the politics out of this issue, on our side of the aisle, 
Democratic side. I thank them for letting this bill come to a vote, and 
this is a good Christmas present to give to many families around this 
country who have the tragedy of sickle cell anemia, who have the 
tragedy of diabetes in their family and who count on some look to 
science to improve it.
  The final point that I will make, I will pick up on what my friend, 
the gentlewoman from Colorado (Ms. DeGette), said. I happen to think 
that God gave us the power of genius for a reason. God gave us the 
power of genius to somehow close the gap between this imperfect world 
and what we could be. This is an example of that power of genius being 
used to save lives.
  I agree with her that stem cell research is an example of the power 
of genius. So I simply say in conclusion, this is what happens when we 
find a paradigm, a way of talking about issues that cuts us out of the 
crisscross of politics.
  This is good legislation. I thank the gentleman from New Jersey for 
working with me on it and urge the Members of this House to pass it.
  Mr. BURGESS. Mr. Speaker, it is now my pleasure to yield 2 minutes to 
the gentlewoman from Ohio (Mrs. Schmidt).
  (Mrs. SCHMIDT asked and was given permission to revise and extend her 
remarks.)
  Mrs. SCHMIDT. Mr. Speaker, I thank the gentleman from Texas for 
yielding me this time.
  Mr. Speaker, I rise in strong support of H.R. 2520, the Stem Cell 
Therapeutic Research Act. Cord blood is already making a groundbreaking 
difference in the treatment of patients who are suffering from over 67 
diseases, including leukemia and sickle cell disease. Cord blood is 
tremendously versatile. Its transplants do not require exact matches. 
It is frozen, and it is ready to go. It works for adults. Cord blood 
benefits minority patients who have difficulty finding exact matches 
and others with rare tissue types.
  The possibilities for cord blood in research are almost limitless 
since cord blood can potentially become any cell type in the body, and 
it is plentiful, since it is derived from umbilical cords that 
hospitals routinely discard.
  H.R. 2520 will provide Federal funding to increase the number of cord 
blood units available for patient genetic matching and treatment, link 
all cord blood banks in a searchable inventory and promote research in 
cord blood stem cell research.
  This is a bill we can truly support. I urge my colleagues to vote for 
this legislation that will help create new hope and new opportunities 
for doctors and patients who are urgently seeking cures.
  God always gives us a spare part. Umbilical cords are that spare 
part.
  Ms. DeGETTE. Mr. Speaker, I am happy to yield 2 minutes to the 
gentleman from Illinois (Mr. Lipinski).
  Mr. LIPINSKI. Mr. Speaker, I would like to thank my friend from 
Colorado for yielding me time.
  Mr. Speaker, this is a great day for the countless number of 
Americans who may receive the gift of health and prolonged life because 
of what will be provided in this bill.
  Cord blood and bone marrow stem cell treatments have been proven 
effective in combating over 65 different debilitating diseases, 
including leukemia, sickle cell anemia and osteoporosis.
  Cord blood transplants have proven to be a viable alternative for 
those with difficulty finding an exact bone marrow match. Since the 
match does not have to be exact, this research benefits both children 
and adults alike and is especially helpful for people of various races 
and ethnicities. This bill will offer a much greater opportunity for a 
cure for thousands of Americans around this country who often struggle 
with blood matches.
  But cord blood also holds the great potential of producing pleural 
potential cells that could cure many other diseases such as juvenile 
diabetes, a disease that I live with every day.
  Mr. Speaker, I am proud that we are acting to advance the possibility 
that this type of treatment will provide. A national cord blood bank 
will facilitate the expanded use of proven treatment to improve the 
health of so many Americans inflicted with these horrible diseases. 
This is a great Christmas gift of health to the American people.
  Mr. BURGESS. Mr. Speaker, it is now my pleasure to yield 2 minutes to 
the gentleman from Florida (Mr. Weldon), someone who has really been a 
leader in this issue.
  Mr. WELDON of Florida. Mr. Speaker, I thank the gentleman from Texas 
for yielding me the time, and I rise in strong support of this piece of 
legislation. I am extremely pleased that we were able to see the Senate 
finally move it forward and that it is going to move from here on to 
the President's desk.
  The reason I am very pleased is this is not theoretical, as some 
treatment modalities that we often talk about in this body. This is 
real and now. There have been 67 different diseases in humans reported 
in the medical literature successfully treated with cord blood. So we 
are not even talking about research anymore. We are talking about 
clinical applications.
  Indeed, one of those diseases I am most excited about, and that is 
sickle cell anemia. I had the opportunity to treat sickle cell anemia 
in my clinical practice, and I can tell my colleagues here that is one 
of the most unfortunate conditions to see a young child writhing in 
pain on a gurney in an emergency room in a sickle cell crisis. And to 
be told that cord blood stem cells have cured children with sickle cell 
anemia, I never thought in my life that I would actually see the day 
when sickle cell anemia could be cured.
  This bill authorizes funds for the expansion of the existing bone 
marrow bank, which is a bank that essentially I am registered with. It 
has my name, and if somebody needs a transplant, they can try to find 
me and get my blood, but in this case, we are taking the placental 
blood and the cord blood from 3 million live births a year and creating 
a bank so that everybody would have a match and the potential for 
regenerative medicine would be here and now.

                              {time}  1615

  So I am very, very pleased that we are bringing this to the floor. I 
am very glad it is finally going to move on to the President's desk, 
because people will be helped by this now. I am also very delighted to 
have been part of it, and Mr. Smith deserves a tremendous amount of 
credit for his unflagging efforts on this.
  Ms. DeGETTE. Mr. Speaker, I am pleased to yield 2 minutes to the 
gentleman from Delaware (Mr. Castle), my compadre and cosponsor of H.R. 
810.
  Mr. CASTLE. Mr. Speaker, I thank the gentlewoman from Colorado for 
yielding me this time, and I am also pleased to rise in support of this 
legislation, as we did before when it was on the floor of the House of 
Representatives. I think it does make a difference.
  But we do need to understand some of the differences amongst the 
various things that we are talking about, because this is essentially 
dealing with a blood type of stem cell. It is great for use in a lot of 
blood diseases, as has been pointed out, particularly leukemia, 
lymphoma, and perhaps others at a later time.
  But even with those benefits, we need to stress some of the 
limitations. And one of them is just the difficulty of getting these 
and the lack of them. I have actually visited a storage location for 
these and have seen that as a real problem.
  Embryonic stem cells, which are in H.R. 810, which Senator Frist 
promises will be brought up sometime in the course of the next year, do 
not have those limitations. It allows these embryonic stem cells to be 
used in a way that they could be formed into any stem cell in your 
body, and that is just not true of the cells that are before us here 
today. They have the potential to treat a wide range of diseases and 
injuries because they can reproduce themselves almost indefinitely. The 
best scientific evidence in this country indicates that umbilical stem 
cells can do neither at this time.

[[Page H12070]]

  My point is this: we need, as far as I am concerned, to advance all 
of this type of research. That is really what it is all about. We need 
to give people an opportunity. We need to understand that one out of 
three people in the United States of America, and I assume across the 
world, and perhaps a greater percentage across the world, suffer from 
some type of disease that could be helped by stem cell research.
  For that reason, in my judgment, we need to do everything in our 
power here in the Congress of the United States to pass any of this 
legislation that would help advance the medical research that could 
save or help the lives of so many people across the United States and 
across the world. For that reason, I absolutely support this 
legislation.
  But I would beseech everybody to really understand the science and 
the medicine behind all of the stem cell legislation, including 
embryonic stem cell legislation, so that we can come to agreement as to 
complete stem cell research to aid everybody. And the sooner we do 
that, the better. Every day that is lost is a day that somebody is 
going to be ill longer. And we need to get about it as soon as we 
possibly can.
  Mr. BURGESS. Mr. Speaker, I am pleased to yield 2 minutes to the 
gentlewoman from Pennsylvania (Ms. Hart).
  Ms. HART. Mr. Speaker, I thank the gentleman for yielding me this 
time and for the opportunity to speak in support of this bill.
  I was here when we passed the bill on the House side earlier in the 
year; and I am very pleased, especially pleased today, that the Senate 
chose to agree with us that this is an exceptionally valuable treatment 
now. And it is one that we must address and make more easily available 
to all Americans now.
  People talk about all different kinds of stem cell research, but cord 
blood stem cells are being used today. Cord blood has cured people 
today. Cord blood, if made available, can cure a whole lot of people 
tomorrow. It is rich in the type of stem cell that is similar to those 
found in bone marrow, and bone marrow transplants have been done for 
years. However, cord blood is better. Physicians tell us that it is a 
better treatment and a treatment that is more likely to be successful.
  It makes sense for us in Congress to work hard to try to fund the NIH 
to help cure diseases. It makes most sense for us to help make 
available cures that are already known to work. This bill will allow 
more collection of cord blood stem cells. It will allow the collection 
and storage of those from diverse populations that currently may not be 
able to access this kind of treatment. It will help many, many more 
people who can be cured with cord blood to be cured.
  That is what we are about here, Mr. Speaker. The story of Keone Penn, 
who actually had a connection to my hometown of Pittsburgh, his doctor, 
now at the university, helped cure him of a very severe form of sickle 
cell anemia with treatment from cord blood. Anthony Dones, who had a 
cord blood transplant, was cured of a very rare form of osteoporosis 
using cord blood. Katherine Marguerite Sutter, at only 5 months was 
diagnosed with AML. She too was cured by use of cord blood, and the 
story I like the most, because on the Web site for the New York Cord 
Blood Center, it shows a picture of her in her wedding gown. She 
suffered through transfusions for 20 years before she too was cured 
with cord blood.
  Mr. Speaker, I am very pleased to be here today and also very pleased 
to have bipartisan support for this bill, because it will help many, 
many more people tomorrow.
  Ms. DeGETTE. Mr. Speaker, I am happy to yield 2 minutes to the 
gentlewoman from California (Ms. Millender-McDonald).
  Ms. MILLENDER-McDONALD. Mr. Speaker, I want to thank Representative 
Chris Smith for his tireless efforts in bringing this very important 
lifesaving legislation forward and getting me to work with him to get 
the Senate to do the right thing and put this forward.
  I would also like to say I supported the stem cell research bill also 
because I feel it has a broader significance to lifesaving measures. In 
this 21st century, we cannot afford to not look at both of these as 
provisions for helping to save the lives of American people. This is 
why I stand before you today in support of H.R. 2520.
  Too many members of the minority population live with life-
threatening diseases. We must provide them with the benefits of cord 
blood stem cells. Cord blood stem cells can be used for bone marrow 
reconstitution by transplantation to recipients with certain 
abnormalities such as leukemia and lymphoma, genetic disorders such as 
sickle cell anemia, and acquired diseases.
  The promise of using stem cells for medical treatment has been the 
focus of research projects that are showing encouraging results. Cord 
blood stem cells have been triggered to differentiate into neural 
cells, which could lead to treatments for diseases such as Alzheimer's 
and Parkinson's. They have also proven their ability to turn into blood 
vessel cells, which could someday benefit treatment for heart disease, 
allowing patients to essentially grow their own bypass.
  We need the hope that cord blood stem cells can bring. Sickle cell 
anemia is the most common inherited blood disorder in the United 
States, affecting 70,000 to 80,000 Americans. The disease occurs in 
approximately one in 500 African American newborns. People with sickle 
cell disease have a diminished quality of life and greatly enhanced 
fatality rate.
  The suffering has gone on far too long. We must use every resource at 
our disposal to cure this and other blood-related diseases. In my 
district, I have a lot of young children who have sickle cell disease. 
These cord blood cells would certainly help in furthering their lives.
  I ask all my colleagues to please support H.R. 2520. I believe it 
should pass today.
  Mr. BURGESS. Mr. Speaker, I am pleased to yield 2 minutes to the 
gentleman from Nebraska (Mr. Fortenberry).
  Mr. FORTENBERRY. Mr. Speaker, this is a bright day for many 
individuals suffering from previously untreatable diseases, and I 
commend our colleagues in the Senate for passing the Stem Cell 
Therapeutic Research Act of 2005. It was the right thing to do. It will 
save many lives and avoid the ethically divisive issue of the 
destruction of human embryos for stem cell research.
  As we have heard today, cord blood stem cells have helped effectively 
treat over 67 diseases in human beings, including leukemia, sickle 
cell, lupus, multiple sclerosis, type I diabetes, Parkinson's, and even 
blindness. Cord blood cells show great promise for helping spinal cord 
patients, many of whom have experienced improved sensation and movement 
from cord blood stem cell treatments.
  Cord blood stem cells also possess the regenerative flexibility to 
form virtually every type of human tissue. And research has shown these 
cells are far less susceptible to transplant rejection than bone 
marrow.
  I want to commend my colleague, Mr. Smith, for his tireless effort in 
this regard, and for the leadership of Mr. Davis on this important 
issue. Their efforts transcend political differences. Mr. Speaker, this 
bill truly represents good science.
  Ms. DeGETTE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman 
from Texas (Ms. Jackson-Lee).
  Ms. JACKSON-LEE of Texas. Mr. Speaker, I want to thank the 
distinguished gentlewoman from Colorado for yielding me this time and 
for the leadership she has given, along with the Congressman from 
Delaware on this stem cell legislation, and we hope that we will see 
that move.
  I want to thank Mr. Smith, Mr. Davis, Ms. Millender-McDonald, and the 
many others who have been so supportive on this legislation, the 
collection and maintenance of human cord blood stems. Just a few 
minutes from now we will be discussing the NASA reauthorization bill, 
and I raise that point because I believe it is the mission of the 
United States to be at the forefront of science and research to save 
lives.
  The world looks to our leadership, our labs, our scientists, our 
inventors, our medical professionals as they do to the Texas Medical 
Center to be able to add enhancement to the quality of lives. In my 
community alone, I realize that the organizations that fight against 
leukemia, multiple sclerosis,

[[Page H12071]]

lupus, and sickle cell anemia are looking forward to the passage of 
this legislation and a new day of research.
  Those newborn African American babies who are born with sickle cell 
also will benefit from this kind of research. But this does not 
highlight a particular minority group. This research, this maintenance 
of the human cord blood stem cells will in actuality provide the 
underpinnings of the research for all kinds of medical science.
  So I ask my colleagues to support this legislation. And the important 
aspect of it singularly is for America to take her rightful and 
prominent place in medical research to save lives around the world.
  Mr. BURGESS. Mr. Speaker, I am pleased to yield 2 minutes to the 
gentleman from California (Mr. Daniel E. Lungren).
  Mr. DANIEL E. LUNGREN of California. Mr. Speaker, I rise in strong 
support of H.R. 2520. The fact of the matter is, I believe all of us 
would like to support the application of science and technical research 
to the problems of the day. There are times when we have moral 
dilemmas, and reference has been made to another bill involving 
embryonic stem cells which does divide many people in this country 
because of the ethical dilemma that is presented.
  That is why it is so wonderful we have come today in support, those 
who may find themselves on the other side of the dilemma in the other 
respect, and come in common support for the cord blood stem cell bill. 
This is both a therapeutic and research bill. It is therapeutic in that 
it affords the banking of units that will be allowed to help people 
now, diseases that can be affected by the use of these units now.
  So much of what we do here is theoretical. We hope that things might 
be accomplished by what we do. But we know that this will accomplish 
success right away. Secondly, it allows for research to see how far we 
can go in this area. It gives the opportunity for this which would 
otherwise be thrown away, placenta blood and the blood from the cord 
that is thrown away now on every single day, to be utilized for both 
research and for life-giving purposes.

                              {time}  1630

  Mr. Speaker, if I had the ability to, I would change the name of this 
bill to the Giving Life Twice bill, once with the production of new 
life and secondly with the use of that blood that otherwise would be 
thrown away to help someone else sustain their life; or we could call 
this the Lifeline bill. We are extending a lifeline of hope to those 
who otherwise would have no hope.
  This is a joyous day here in this body. People may disagree on other 
matters, coming together in strong support for a bill that will save 
lives and save lives now.
  Ms. DeGETTE. Mr. Speaker, I yield myself the balance of my time.
  Mr. Speaker, today we are fortunate to take the first step of what I 
see as a two-step process, and that is passage of this cord blood bill 
which, as I said, we passed last May in this House by an overwhelming 
vote.
  The second step, of course, will be when the other body passes H.R. 
810, which also passed last May, and when that bill is finally signed 
into law.
  The two bills working together will greatly expand availability of 
research and of cures for Americans who suffer not just from blood-
related diseases but from diseases like Alzheimer's, Parkinson's, nerve 
damage, and so many other diseases that cannot be reached simply by 
cord blood. That is the day that a true dawning of a new scientific era 
will occur in this country.
  This is a good bill today, and I urge all of my colleagues to support 
it, and I want to thank my colleagues on both sides of the aisle for 
their co-sponsorship. But let us be clear exactly what this bill does. 
It authorizes a new granted program to provide subsidies to cord blood 
stem cell banks to expand the inventory of high quality cord blood 
units. It sets up a registry for cord blood, which will in some cases 
take the place of bone marrow transplants which it is beginning to 
supersede. This will be enormously important, particularly for sickle 
cell patients who will be helped. The bill also authorizes research on 
the clinical outcomes of patients who are recipients of a stem cell 
therapeutics product from biologically related and unrelated donors. 
That is what this bill does. This bill does not set up any cures for 
any diseases, nor does it do anything to put ethical controls onto stem 
cell research and other types of research that are scientifically being 
explored now and need the oversight of the National Institutes of 
Health.
  So this is a good start. I commend all my colleagues. It is going to 
make us all feel good to go home for the holidays knowing that certain 
classes of patients will be helped. But I would say to my friends on 
both sides of the aisle, let us not stop there. In the second session 
of this Congress, let us take the bold scientific step necessary to 
provide cures for diseases that affect tens of millions of Americans 
and citizens around the world.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield myself the remaining time.
  Mr. Speaker, I believe this is a bold scientific step to pass this 
legislation today, and I am pleased that the Senate released their hold 
on it and passed this bill. It is good legislation.
  We heard during the arguments on the previous bill that was debated 
here on the floor, science certainly moves a lot more swiftly than the 
legislative process, and that is certainly true in this case today. By 
allowing this bill, we are going to allow hundreds, perhaps thousands 
of Americans the opportunity for a cure that we were withholding by 
delaying passage of this bill.
  I have heard diseases like Alzheimer's and Parkinson's referenced. 
Alzheimer's and Parkinson's, unfortunately, are unlikely to be cured by 
umbilical cord stem cells, but they are also unlikely to be cured by 
embryonic stem cell research. The promise for cure for these diseases 
lies in protein science and our understanding of the human genome, not 
in stem cell research.
  This bill is a good bill because it authorizes a significant amount 
of money for the collection, the documentation and the maintenance of 
150,000 new stem cell lives. These are pluripotential cells.
  What has changed since we had our debate on the stem cell lines here 
last spring? Well, we have read a lot of stuff in the newspapers just 
the past 2 weeks about some of the changes, some of the research that 
has now been withdrawn. Think about this, Mr. Speaker: We do not even 
know what research is just out there over the horizon. What if we 
unlock some of the proteinemic keys that allow us to understand what 
signals one cell to another? What if we could make the umbilical cord 
stem cell behave more like the embryonic stem cell? Think of that, Mr. 
Speaker. Then we have got 150,000 lines banked and ready to go when 
that research which is being done in my home State of Texas at the 
University of Texas Southwestern Medical School, if that research shows 
the promise that it one day may, we will have 150,000 cell lines banked 
and ready to go.
  Mr. Speaker, this procedure, this technique, this ability to bank 
umbilical cord cells allows for there to be greater diversity within 
the marrow donor pool than was previously known. It has been difficult 
to get minority populations to become marrow donors. Now we will be 
able to collect that cell material at the time of birth painlessly, at 
no risk to anyone, material that was otherwise going to be discarded, 
and it will be put into these stem cell lines. And the database will be 
there for people to reference and find these life-saving cures that 
will be now available by umbilical cord stem cells.
  We are expanding America's inventory of cord blood cells today, and 
that is a good thing for all Americans. Whether they are sick or not, 
one day they may need this technology. We have the ability and the 
capacity within our hands to expand this program and save American 
lives, and I say that is a good thing.
  Ms. EDDIE BERNICE JOHNSON of Texas. Mr. Speaker, I rise today in 
support of H.R. 2520, the Stem Cell Therapeutic and Research Act of 
2005.
  Long before my days as the Ranking Member on the Research 
Subcommittee, I have been a strong advocate of all types of research.
  Stem cell research holds the potential to help paralyzed people walk, 
help blind people see, and re-generate organ tissue without immune 
rejection.

[[Page H12072]]

  As our colleagues on the other side of the Capitol concur, H.R. 2520 
is a good start. This bill would allow the Secretary of Health and 
Human Services to work with cord blood banks to collect and maintain 
cord blood for the purpose of stem cell research.
  The cord blood would be collected with informed consent, in a manner 
that complies with Federal and State regulations, and from a 
genetically diverse population.
  It is my hope that this legislation will give us a taste of the 
marvelous potential of stem cell research, and I urge my colleagues to 
support this legislation.
  Mr. HOLT. Mr. Speaker, I rise to congratulate the State of New Jersey 
on its national leadership in efforts to treat deadly and debilitating 
illnesses. Yesterday, New Jersey became the first State in the Nation 
to award public funds to conduct human embryonic stem cell research.
  Under the leadership of Acting Governor Richard Codey and NJCST 
Executive Director Sherrie Preische, the New Jersey Commission on 
Science and Technology (NJCST) will award 17 grants totaling $5 million 
to scientists at corporate, non-profit, and university laboratories to 
research the potential of stem cells as a means to diagnose, treat, 
cure, and prevent disease. Each scientist will receive around $300,000 
to conduct their research. Three of these grants will go to scientists 
researching embryonic stem cells.
  Since the formation of the New Jersey Stem Cell Institute, New Jersey 
has established itself as a leader in furthering potentially life-
saving research on adult stem cells. And by awarding these research 
grants, New Jersey is actively working to support groundbreaking 
research on embryonic stem cells, which hold great promise in improving 
health care as we know it.
  Embryonic stems cells--undifferentiated cells produced early in 
embryonic development--offer possible treatments for a variety of 
diseases from cancer to Parkinson's disease to diabetes. Ultimately, 
scientists may be able to develop reparative tissue, treat a host of 
debilitating diseases, and even generate organs specifically tailored 
to a person's unique genetic blueprint. This research offers mankind 
the prospect of overcoming devastating diseases, affording us the 
opportunity to live longer, healthier lives. For these advances to take 
place, we must invest public funding in critical research to support 
scientists, rather than restrict them.
  I am proud that the people of New Jersey have committed public funds 
for this important research, and I am glad that New Jersey has moved 
quickly to distribute grants to researchers so that their work can 
begin. I am particularly pleased that these grants were awarded after 
exhaustive ethical review led by former Princeton University President 
Harold Shapiro, and that research ethics will play an important role as 
the awardees move forward with their research.
  I am confident that States who have established programs with similar 
goals will move quickly to support this research as well. But despite 
the forward thinking and progressive research that New Jersey and other 
states are exploring, it is unfortunate that the Federal Government has 
delayed and restricted research using federal dollars. I am hopeful 
that the leadership of New Jersey to fund embryonic stem cell research 
will have tremendous dividends, not just for New Jersey, but for 
society. New Jersey understands that it is ethical and wise to invest 
in research that will benefit so many. The Federal Government must 
recognize this fact as well.
  Again, I congratulate New Jersey for supporting ground-breaking 
research on embryonic stem cells. I ask unanimous consent to include a 
list of the researchers who have received these important stem cell 
research grants in the Record.
  Mr. BURGESS. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Boozman). The question is on the motion 
offered by the gentleman from Georgia (Mr. Deal) that the House suspend 
the rules and concur in the Senate amendment to the bill, H.R. 2520.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of 
those present have voted in the affirmative.
  Mr. BURGESS. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this question will 
be postponed.

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