II 109th CONGRESS 1st Session S. 681 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.

1.

Short title

This Act may be cited as the Cord Blood Stem Cell Act of 2005.

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:

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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