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Stem Cell Therapeutic And Research Reauthorization Act Of 2010

Floor Speech

Location: Washington, DC


Mr. HATCH. Mr. President, I am pleased that the Senate is considering S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act of 2010 which reauthorizes the Stem Cell Therapeutic and Research Act of 2005--P.L. 109-129--through the end of 2015. I am also grateful that Senators Dodd, Burr, Reed, Ensign, Franken and Coburn have joined me as sponsors of this bipartisan bill, which was unanimously approved by the Senate Committee on Health, Education, Labor and Pensions and the House Energy and Commerce Committee last week.

S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act, reauthorizes the C.W. Bill Young Cell Transplantation Program--the Program--and the National Cord Blood Inventory program--NCBI. These programs maintain donor registries for individuals in need of bone marrow and umbilical cord blood transplants. Today, more than eight million Americans are registered bone marrow donors, and in the 5 years since NCBI was established, more than 28,600 cord blood units have been collected. Cord blood transplantation accounts for over 40 percent of all transplants in the country.

I believe it is important for Senators to understand the specifics of S. 3751. Our bill reauthorizes the program through the end of Fiscal Year 2015. The authorization levels for the Program are $30 million from FY11 through FY14 and $33 million in FY15. The NCBI authorization levels are $23 million from FY11 through FY14 and $20 million in FY15. The total authorization level for both programs combined is $53 million annually, which is the same authorization level included in the Stem Cell Therapeutic and Research Act of 2005.

Our bill calls for the collection and maintenance of at least 150,000 high-quality cord blood units. In order to collect high-quality and diverse units, the Health Resources and Services Administration--HRSA--contracts with cord blood banks to collect and maintain umbilical cord blood units for the national inventory. To achieve the goal of collecting at least 150,000 units, S. 3751 requires cord blood banks to provide a strategic plan to increase collection, assist with the creation of new collection sites, or contract with new collection sites when first applying for a contract or extending an existing contract. S. 3751 also requires cord blood banks to submit an annual plan for achieving self-sufficiency and demonstrates on-going measurable progress toward achieving self-sufficiency of cord blood collection and banking operations. The bill also extends the duration of a contract from 3 to 5 years and allows cord blood units to remain part of the national inventory for at least 10 years.

Additionally, S. 3751 redefines the term ``first-degree relative'' as a sibling of an individual requiring a transplant. Children are not a match for parents in need of a cord blood transplant, as the original law suggested. The bill also aligns the privacy protections provided to bone marrow donors and patients with umbilical cord blood donors and transplant patients.

The legislation encourages the Program to support studies and demonstration projects to increase cord blood donation and collection. More specifically, S. 3751 directs the Secretary of Health and Human Services--HHS, acting though the HRSA Administrator, to submit to Congress an annual report on the National Program's activities including novel approaches for increasing cord blood unit donation and collection. The HHS Secretary also is directed to set an annual goal of increasing collections of high-quality and diverse cord blood units through remote collection or other approaches. In addition, S. 3751 directs the HHS Secretary to identify at least one of these approaches to replicate and expand across the country. If a project is not identified, the HHS Secretary shall submit a plan for expanding remote collection of high-quality and diverse cord blood units.

S. 3751 requires the HHS Secretary, in consultation with the Advisory Council, to submit to Congress an interim report within 6 months after enactment, describing existing methods used to distribute Federal funds to cord blood banks. The report also would explain how cord blood banks contract with cord blood unit collection sites and recommend how these methods may be improved in order to encourage efficient collection of high-quality and diverse cord blood units.

Our legislation also requires the Advisory Council to submit recommendations to the HHS Secretary 1 year after enactment on whether remote models for cord blood unit collection should be allowed with only limited, scientifically justified safety protections. The Advisory Council would also make recommendations on whether HHS should allow for cord blood unit collection from routine deliveries without temperature or humidity monitoring of delivery rooms in hospitals approved by the Joint Commission.

Finally, S. 3751 requires the Government Accountability Office--GAO--to study existing cord blood donation and collection methods and the barriers responsible for limiting donation and collection. GAO also would analyze the methods used to distribute funds to cord blood banks and novel approaches to grow the NCBI.

S. 3751 proves that contrary to popular belief, bipartisanship still exists in the United States Congress. The original Stem Cell Therapeutic and Research Act passed Congress unanimously and became law--P.L 109-129--on December 20, 2005. This law offered a unique opportunity to assist those suffering from a serious illness requiring cord blood or bone marrow transplants. In 2005, our goal was to increase the number of bone marrow and cord blood donors to meet our goal of 150,000 high-quality and diverse cord blood units. Today, our goal remains the same except we are encouraging the collection of at least 150,000 units. The sponsors of this legislation want to do everything in our power to provide patients with the best transplant options and signing this legislation into law is how we achieve this second goal. Transplant patients and their families deserve nothing less.

S. 3751 is supported by the following organizations: American Society of Bone Marrow Transplant, Aplastic Anemia and MDS Society, Center for International Blood and Marrow Transplantation, Colorado Cord Blood Bank, Duke University Cord Blood Bank, Intermountain Primary Children's Hospital, Jeff Gordon Foundation, Leukemia and Lymphoma Foundation, LifeCord Cord Blood Bank, National Marrow Donor Program, Nevada Cancer Institute, New Jersey Cord Blood Bank, New York Blood Center Cord Blood Bank, Rhode Island Blood Center, St. Louis Cord Blood Bank, StemCyte International Cord Blood Bank, University of Utah's Cell Therapy Facility, Villanova football head coach Andy Talley, and Yale University Hospital.

Finally, I ask unanimous consent to have printed in the Record the section by section analysis of S. 3751.

There being no objection, the material was ordered to be printed in the Record, as follows:


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