[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 681 Introduced in Senate (IS)]







109th CONGRESS
  1st Session
                                 S. 681

  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 SENATE OF THE UNITED STATES

                             March 17, 2005

 Mr. Hatch (for himself, Mr. Dodd, Mr. Brownback, Mr. Harkin, and Mr. 
   Specter) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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 2005''.

SEC. 2. 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 Cord Blood Stem Cell 
        Bank Network 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 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) patients or family members of 
                                a patient who has requested the 
                                assistance of the national cord blood 
                                stem cell registry in searching for 
                                donor cord blood;
                                    ``(VI) individuals with expertise 
                                in the social sciences;
                                    ``(VII) members of the general 
                                public;
                                    ``(VIII) the Health Resources and 
                                Services Administration, who shall 
                                serve as a 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 member appointed 
                        under subclause (VIII) 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 the 
                        ability to search the entire registry for a 
                        suitable donor match for patients; and
                            ``(iii) maintain a database to document the 
                        collection, storage, distribution, and clinical 
                        outcomes 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); and
                    ``(B) the National Cord Blood Stem Cell Bank 
                Network is geographically distributed throughout the 
                United States.
    ``(d) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated, $15,000,000 for fiscal year 
2006, and such sums as may be necessary for each of fiscal years 2007 
through 2010.''.
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