[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 596 Introduced in House (IH)]






109th CONGRESS
  1st Session
                                H. R. 596

  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

                            February 2, 2005

   Mr. Smith of New Jersey (for himself, Mr. Davis of Alabama, Mrs. 
    Myrick, Mr. Towns, Mr. Norwood, Mrs. Christensen, Mr. Wamp, Mr. 
  Cummings, Mr. Burgess, Ms. Millender-McDonald, Mrs. Jo Ann Davis of 
  Virginia, Ms. Eshoo, Mr. Lewis of Kentucky, Mr. Ryun of Kansas, Mr. 
Marshall, Mr. Kennedy of Minnesota, Mr. Rangel, Mr. Weldon of Florida, 
and Mr. Bartlett of Maryland) 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 ``Cord Blood Stem Cell Act of 2005''.

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. Scientific research on cord 
        blood stem cells may uncover a potential to treat a wide 
        variety of diseases not yet attempted.
            (3) Advantages of cord blood stem cell transplants include 
        no risk to the donor, and reduced risk of certain transplant 
        complications, including graft versus host disease and latent 
        virus infections (such as Epstein-Barr virus or 
        cytomegalovirus) and immediate availability of cord blood stem 
        cell units, whenever needed.
            (4) Cord blood gives all patients a chance for a 
        transplant, regardless of their ethnic background. An 
        ethnically diverse inventory of 150,000 cord blood stem cell 
        units would help provide appropriate matches for 80 to 90 
        percent of patients seeking matched cord blood stem cell 
        transplants.
            (5) Some genetic conditions are 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. With an ethnically balanced national cord blood 
        stem cell network of at least 150,000 units, some 80 to 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.
            (6) Cord blood is an alternate to bone marrow as a source 
        of stem cells for transplantation. Cord blood banks, therefore, 
        serve the same kinds of patients as marrow donor registries. 
        However, its collection, processing, storage and selection for 
        transplant require unique systems and expertise.
            (7) Radiation exposure, from accidents or hostile actions, 
        could cause bone marrow failure in a portion of those exposed 
        and require treatment, including bone marrow reconstitution. In 
        these cases the rapid availability of frozen cord blood stem 
        cell units may be an important resource to help rescue the 
        victims years later, those who were exposed and survived may 
        incur an increased risk of leukemia or lymphoma, which might 
        also require stem cell transplantation.
            (8) 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 2006, and $30,000,000 for fiscal year 2007 and such 
sums as may be necessary for each of fiscal years 2008 through 2010 or 
until the 150,000 unit inventory is successfully acquired.''.
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