[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2852 Introduced in House (IH)]






108th CONGRESS
  1st Session
                                H. R. 2852

  To amend the Public Health Service Act to establish a National Cord 
 Blood Stem Cell Bank Network to prepare, store, and distribute human 
 umbilical cord blood stem cells for the treatment of patients and to 
            support peer-reviewed research using such cells.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 24, 2003

 Mr. Smith of New Jersey (for himself, Mr. Burr, Mr. Davis of Alabama, 
 Mr. Towns, Mr. Doolittle, Mr. Toomey, Mr. Faleomavaega, Mr. Weldon of 
  Florida, and Mrs. Myrick) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Public Health Service Act to establish a National Cord 
 Blood Stem Cell Bank Network to prepare, store, and distribute human 
 umbilical cord blood stem cells for the treatment of patients and to 
            support peer-reviewed research using such cells.

    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 ``Cord Blood Stem Cell Act of 2003'' .

SEC. 2. FINDINGS.

    The Congress makes the following findings:
            (1) Research sponsored by the National Institutes of Health 
        and conducted in full compliance with applicable Food and Drug 
        Administration regulations has demonstrated the feasibility of 
        using cord blood for clinical applications. Stem cells, 
        obtained from the blood contained in the delivered placenta and 
        umbilical cord and donated by the mother, can be used for bone 
        marrow reconstitution by transplantation to recipients with 
        certain malignancies (such as leukemia and lymphoma), genetic 
        disorders (such as sickle cell anemia), and acquired diseases.
            (2) The placenta, umbilical cord, and the neonatal blood 
        they contain are normally discarded after childbirth. This 
        residual neonatal blood, termed cord blood, is a source of stem 
        cells that can be collected as donor tissue without risk to the 
        donor and can be preserved through freezing for many years and 
        be made immediately available for transplantation in routine or 
        emergency clinical situations. It can also be used for 
        scientific research involving its stem cells.
            (3) Advantages of cord blood stem cell transplants relative 
        to bone marrow transplants include the reduction of risks to 
        the donor, availability of donor cell units in days rather than 
        months, and lower risk of transplant complications, including 
        graft versus host disease and latent virus infections (such as 
        Epstein-Barr virus or Cytomegalovirus).
            (4) In conventional bone marrow transplantation, matched 
        siblings are the preferred donors, but only 30 percent of 
        patients have a matched sibling. When no sibling match is 
        found, a search is initiated for an unrelated donor.
            (5) Finding a fully matched unrelated donor optimizes the 
        chances of successful bone marrow transplantation. In 
        conventional bone marrow transplantation, patients of ethnic 
        minorities generally have difficulty finding fully matched 
        donors, leaving partially matched transplants as their only 
        transplant option. Partially matched bone marrow 
        transplantation leads to a disproportionately high rate of 
        complications, including graft versus host disease and 
        mortality.
            (6) Cord blood stem cell banks would provide increased 
        genetic diversity in the supply of donors and increase the 
        opportunity to identify fully matched and partially matched 
        transplant units for qualified candidates. Cord blood stem cell 
        transplants using partially matched units reduce the risk of 
        graft versus host disease with its attending morbidity and 
        mortality as compared to conventional bone marrow 
        transplantation.
            (7) Identifying and delivering an unrelated bone marrow 
        donor from among the several millions in the National registry 
        typically requires many months, sometimes more than 1 year. An 
        inventory of 150,000 cord blood stem cell units, that takes 
        into account the ethnic diversity of the country, would help 
        provide appropriate matches for at least 90 percent of those 
        seeking matched cord blood stem cell transplants, within days 
        of a formal request.
            (8) Matched donors are more likely within the same ethnic 
        group as the patient's. Some genetic conditions are also more 
        prevalent in members of particular ethnic groups, such as 
        Sickle Cell Anemia, a disease that occurs in one out of 500 
        African- American newborns. From early infancy, patients with 
        Sickle Cell Anemia have a high risk of severe or fatal 
        bacterial blood infections. Many patients develop painful 
        crises beginning in infancy and occurring up to 20 times per 
        year. Children with recurrent crises, chest syndrome or 
        strokes, are at great risk of dying before the age of 20 years. 
        The median life-span of a patient with Sickle Cell Disease is 
        42 years, but patients with severe disease in childhood rarely 
        live beyond 20 years. Cord blood stem cell transplantation has 
        cured patients with Sickle Cell Anemia: 80 percent of children 
        transplanted with related cord blood to correct Sickle Cell 
        Anemia or thalassemia were cured in a recently published study. 
        The earlier in the course of severe disease, the transplant is 
        performed, the better the outcomes. Unrelated cord blood 
        transplants are especially beneficial for African American and 
        other ethnic minority patients because cord blood does not have 
        to match as closely as bone marrow. For this reason, an African 
        American patient is much more likely to find a suitable 
        unrelated cord blood donor as compared to a matched bone marrow 
        donor. With an ethnically balanced national cord blood bank of 
        at least 150,000 units, some 90 percent of African American 
        patients who suffer from Sickle Cell Anemia or other conditions 
        requiring bone marrow replacement would be able to find 
        appropriately matched cord blood stem cells for successful 
        treatment.
            (9) Since its inception in 1987, the National Marrow Donor 
        Program has facilitated 17,000 bone marrow transplants. Cord 
        blood transplantation complements conventional bone marrow 
        transplantation by providing appropriately matched units to 
        patients, especially those of non-caucasoid ethnicity, who have 
        a much lower probability of finding an adequate match through 
        the National Marrow Donor Program. Cord blood is one of the 
        sources of stem cells used in transplantation, however, its 
        collection, preparation, storage and dissemination require 
        specific systems and expertise.
            (10) Radiation exposure, from accidents or hostile actions 
        could cause bone marrow failure in a portion of those exposed, 
        requiring treatment including bone marrow reconstitution. In 
        these cases the rapid availability of cryopreserved cord blood 
        stem cell units may be important. Years later, those exposed 
        would incur an increased risk of leukemia orlymphoma, which 
        might also require stem cell transplantation.
            (11) Recent scientific developments suggest that further 
        research on cord blood stem cells may lead to a greater 
        understanding of certain chronic diseases. This research might 
        improve therapies for, and possibly cure, debilitating diseases 
        such as Parkinson's disease, insulin-dependent diabetes, heart 
        disease, and certain types of cancer. These diseases cause a 
        disproportionately large share of chronic disabilities and 
        account for a large portion of health care expenditures in the 
        United States.

SEC. 3. NATIONAL CORD BLOOD STEM CELL BANK NETWORK.

    Part H of title III of the Public Health Service Act (42 U.S.C. 273 
et seq.) is amended by inserting after section 376 the following:

``SEC. 376A. NATIONAL CORD BLOOD STEM CELL BANK NETWORK.

    ``(a) Definitions.--In this section:
            ``(1) Administrator.--The term `Administrator' means the 
        Administrator of the Health Resources and Services 
        Administration.
            ``(2) Cord blood unit.--The term `cord blood unit' means 
        the blood collected from a single placenta and umbilical cord.
            ``(3) Donor.--The term `donor' means a mother who has 
        delivered a baby and consents to donate the newborn's blood 
        remaining in the placenta and umbilical cord.
            ``(4) Donor bank.--The term `donor bank' means a qualified 
        cord blood stem cell bank that enters into a contract with the 
        Secretary under subsection (b)(1).
            ``(5) Human cord blood stem cells.--The term `human cord 
        blood stem cells' means hematopoietic stem cells and any other 
        stem cells contained in the neonatal blood collected 
        immediately after the birth from the separated placenta and 
        umbilical cord.
            ``(6) National cord blood stem cell bank network.--The term 
        `National Cord Blood Stem Cell Bank Network' means a network of 
        qualified cord blood stem cell banks established under 
        subsection (b).
    ``(b) National Cord Blood Stem Cell Bank Network.--
            ``(1) In general.--The Secretary, acting through the 
        Administrator, shall enter into contracts with qualified cord 
        blood stem cell banks to assist in the establishment, 
        provision, and maintenance of a National Network of Cord Blood 
        Stem Cell Banks that contains at least 150,000 units of human 
        cord blood stem cells.
            ``(2) Purpose of donor banks.--It is the purpose of the 
        donor banks that are a part of the Network to--
                    ``(A) acquire, tissue-type, test, cryopreserve, and 
                store donated units of human cord blood acquired with 
                the informed consent of the donor, in a manner that 
                complies with applicable Federal regulations;
                    ``(B) make cord blood units collected under this 
                section, or otherwise, available to transplant centers 
                for stem cell transplantation; and
                    ``(C) allocate up to 10 percent of the cord blood 
                inventory each year for peer-reviewed research.
            ``(3) Eligibility of donor banks.--A cord blood stem cell 
        bank shall be eligible to be a donor bank if such a bank--
                    ``(A) has obtained all applicable Federal and State 
                licenses, certifications, registrations (including 
                registration with the Food and Drug Administration), 
                and other authorizations required to operate and 
                maintain a cord blood stem cell bank;
                    ``(B) has implemented donor screening and cord 
                blood collection practices adequate to protect both 
                donors and transplant recipients and to prevent 
                transmission of potentially harmful infections and 
                other diseases;
                    ``(C) 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, and consistent with the regulations 
                promulgated under section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996 
                for the release of the identity of donors, recipients, 
                or identifiable records;
                    ``(D) has established a system for encouraging 
                donation by an ethnically diverse group of donors;
                    ``(E) has developed adequate systems for 
                communication with other cord blood stem cell banks, 
                transplant centers, and physicians with respect to the 
                request, release, and distribution of cord blood units 
                nationally and has developed such systems, consistent 
                with the regulations promulgated under section 264(c) 
                of the Health Insurance Portability and Accountability 
                Act of 1996, to track recipients' clinical outcomes for 
                distributed units; and
                    ``(F) has developed a system for educating the 
                public, including patient advocacy organizations, about 
                the benefits of donating and utilizing cord blood stem 
                cells in appropriate circumstances.
    ``(c) Administration of the Network.--
            ``(1) Board of directors.--
                    ``(A) In general.--The Secretary shall provide for 
                the establishment of a Board of Directors, including a 
                chairperson, who shall administer the National Cord 
                Blood Stem Cell Bank Network, including establishing a 
                national cord blood stem cell registry within the 
                Network and coordinating the donor banks in the 
                Network.
                    ``(B) Composition.--
                            ``(i) In general.--The Board of Directors 
                        shall be composed of members to be appointed by 
                        the Secretary who shall serve 3-year terms, and 
                        shall include representatives from--
                                    ``(I) cord blood stem cell 
                                transplant centers;
                                    ``(II) physicians from 
                                participating birthing hospitals;
                                    ``(III) the cord blood stem cell 
                                research community;
                                    ``(IV) recipients of cord blood 
                                stem cell transplants;
                                    ``(V) family members of a patient 
                                of the National Cord Blood Stem Cell 
                                Bank;
                                    ``(VI) individuals with expertise 
                                in the social sciences;
                                    ``(VII) members of the general 
                                public;
                                    ``(VIII) the Division of Stem Cell 
                                Transplantation of the Health Resources 
                                and Services Administration, who shall 
                                serve as nonvoting member; and
                                    ``(IX) the network donor banks.
                            ``(ii) Terms of service.--Each member 
                        appointed under clause (i) may serve up to 2 
                        consecutive 3-year terms, except that this 
                        clause shall not apply to the members appointed 
                        under subclauses (VIII) and (IX) of clause (i).
                    ``(C) Continuity.--In order to ensure the 
                continuity of the Board of Directors, the Board shall 
                be appointed so that each year the terms of 
                approximately 1/3 of the Board members expire. A member 
                of the Board may continue to serve after the expiration 
                of the term of such a member until a successor is 
                appointed.
            ``(2) National cord blood stem cell registry.--
                    ``(A) In general.--The Secretary, acting through 
                the Administrator, shall establish as part of the 
                Network a National Cord Blood Stem Cell Registry. The 
                Registry shall--
                            ``(i) operate a system for identifying, 
                        acquiring, and distributing donated units of 
                        cord blood that are suitably matched to 
                        candidate patients;
                            ``(ii) provide transplant physicians and 
                        other appropriate health care professionals a 
                        website function that enables searching the 
                        entire registry for suitable donor matches for 
                        patients, and requesting specific cord blood 
                        units; and
                            ``(iii) maintain a database to document the 
                        collection, storage, distribution, and 
                        transplantation of cord blood units and the 
                        clinical outcomes of all transplantations 
                        related to the Network.
                    ``(B) Database.--The database maintained under 
                subparagraph (A)(iii) shall be operated according to 
                standards of consent, disclosure, and confidentiality, 
                including those applicable under the regulations 
                promulgated under section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996. 
                The Administrator, using the database, shall report to 
                the Secretary on a periodic basis regarding the safety, 
                efficacy, and cost-effectiveness of the clinical, 
                research, and educational activities of the Network. 
                The Secretary shall make such information available to 
                the public.
            ``(3) Network standards.--The Board of Directors shall 
        ensure that--
                    ``(A) the donor banks within the National Cord 
                Blood Stem Cell Bank Network meet the requirements of 
                subsection (b)(3) on a continuing basis; and
                    ``(B) the National Cord Blood Stem Cell Bank 
                Network and their birthing hospital collection sites be 
                geographically distributed throughout the United 
                States.
    ``(d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $15,000,000 
for fiscal year 2004, and $30,000,000 for fiscal year 2005 and such 
sums as may be necessary for each of fiscal years 2006 through 2008 or 
until the 150,000 unit inventory is successfully acquired.''.
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