[Congressional Record Volume 156, Number 132 (Tuesday, September 28, 2010)] [Senate] [Pages S7650-S7653] From the Congressional Record Online through the Government Publishing Office [www.gpo.gov] STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2010 Mr. FRANKEN. Mr. President, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 587, S. 3751. The PRESIDING OFFICER. The clerk will report the bill by title. The assistant legislative clerk read as follows: A bill (S. 3751) to amend the Stem Cell Therapeutic and Research Act of 2005. There being no objection, the Senate proceeded to consider the bill, which had been reported from the Committee on Health, Education, Labor, and Pensions, with an amendment in the nature of a substitute to strike all after the enacting clause and insert in lieu thereof the following: SECTION 1. SHORT TITLE. This Act may be cited as the ``Stem Cell Therapeutic and Research Reauthorization Act of 2010''. SEC. 2. AMENDMENTS TO THE STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005. (a) Cord Blood Inventory.--Section 2 of the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended-- (1) in subsection (a), by inserting ``the inventory goal of at least'' before ``150,000''; (2) in subsection (c)-- (A) in paragraph (2), by striking ``or is transferred'' and all that follows through the period and inserting ``for a first-degree relative.''; and (B) in paragraph (3), by striking ``150,000''; (3) in subsection (d)-- (A) in paragraph (1), by inserting ``beginning on the last date on which the recipient of a contract under this section receives Federal funds under this section'' after ``10 years''; (B) in paragraph (2), by striking ``; and'' and inserting ``;''; (C) by redesignating paragraph (3) as paragraph (5); and (D) by inserting after paragraph (2) the following: ``(3) will provide a plan to increase cord blood unit collections at collection sites that exist at the time of application, assist with the establishment of new collection sites, or contract with new collection sites; ``(4) will annually provide to the Secretary a plan for, and demonstrate, ongoing measurable progress toward achieving self-sufficiency of cord blood unit collection and banking operations; and''; (4) in subsection (e)-- (A) in paragraph (1)-- (i) by striking ``10 years'' and inserting ``a period of at least 10 years beginning on the last date on which the recipient of a contract under this section receives Federal funds under this section''; and (ii) by striking the second sentence and inserting ``The Secretary shall ensure that no Federal funds shall be obligated under any such contract after the date that is 5 years after the date on which the contract is entered into, except as provided in paragraphs (2) and (3).''; (B) in paragraph (2)-- (i) in the matter preceding subparagraph (A)-- (I) by striking ``Subject to paragraph (1)(B), the'' and inserting ``The''; and (II) by striking ``3'' and inserting ``5''; (ii) in subparagraph (A) by striking ``150,000'' and all that follows through ``and'' at the end and inserting ``the inventory goal described in subsection (a) has not yet been met;''; (iii) in subparagraph (B)-- (I) by inserting ``meeting the requirements under subsection (d)'' after ``receive an application for a contract under this section''; and (II) by striking ``or the Secretary'' and all that follows through the period at the end and inserting ``; or''; and (iv) by adding at the end the following: ``(C) the Secretary determines that the outstanding inventory need cannot be met by the qualified cord blood banks under contract under this section.''; and (C) by striking paragraph (3) and inserting the following: ``(3) Extension eligibility.--A qualified cord blood bank shall be eligible for a 5-year extension of a contract awarded under this section, as described in paragraph (2), provided that the qualified cord blood bank-- ``(A) demonstrates a superior ability to satisfy the requirements described in subsection (b) and achieves the overall goals for which the contract was awarded; ``(B) provides a plan for how the qualified cord blood bank will increase cord blood unit collections at collection sites that exist at the time of consideration for such extension of a contract, assist with the establishment of new collection sites, or contract with new collection sites; and ``(C) annually provides to the Secretary a plan for, and demonstrates, ongoing measurable progress toward achieving self-sufficiency of cord blood unit collection and banking operations.''; (5) in subsection (g)(4), by striking ``or parent''; and (6) in subsection (h)-- (A) by striking paragraphs (1) and (2) and inserting the following: ``(1) Authorization of appropriations.--There are authorized to be appropriated to the Secretary to carry out the program under this section $23,000,000 for each of fiscal years 2011 through 2014 and $20,000,000 for fiscal year 2015.''; (B) by redesignating paragraph (3) as paragraph (2); and (C) in paragraph (2), as so redesignated, by striking ``in each of fiscal years 2007 through 2009'' and inserting ``for each of fiscal years 2011 through 2015''. (b) National Program.--Section 379 of the Public Health Service Act (42 U.S.C. 274k) is amended-- (1) by striking subsection (a)(6) and inserting the following: ``(6) The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit to Congress an annual report on the activities carried out under this section.''; (2) in subsection (d)-- (A) in paragraph (2)-- (i) in the matter preceding subparagraph (A), by striking ``With respect to cord blood, the Program shall--'' and inserting the following: ``(A) In general.--With respect to cord blood, the Program shall--''; [[Page S7651]] (ii) by redesignating subparagraphs (A) through (H) as clauses (i) through (viii) respectively; (iii) by striking clause (iv), as so redesignated, and inserting the following: ``(iv) support and expand new and existing studies and demonstration and outreach projects for the purpose of increasing cord blood unit donation and collection from a genetically diverse population and expanding the number of cord blood unit collection sites partnering with cord blood banks receiving a contract under the National Cord Blood Inventory program under section 2 of the Stem Cell Therapeutic and Research Act of 2005, including such studies and projects that focus on-- ``(I) remote collection of cord blood units, consistent with the requirements under the Program and the National Cord Blood Inventory program goal described in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005; and ``(II) exploring novel approaches or incentives to encourage innovative technological advances that could be used to collect cord blood units, consistent with the requirements under the Program and such National Cord Blood Inventory program goal;''; and (iv) by adding at the end the following: ``(B) Efforts to increase collection of high quality cord blood units.--In carrying out subparagraph (A)(iv), not later than 1 year after the date of enactment of the Stem Cell Therapeutic and Research Reauthorization Act of 2010 and annually thereafter, the Secretary shall set an annual goal of increasing collections of high quality cord blood units, consistent with the inventory goal described in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005 (referred to in this subparagraph as the `inventory goal'), and shall identify at least one project under subparagraph (A)(iv) to replicate and expand nationwide, as appropriate. If the Secretary cannot identify a project as described in the preceding sentence, the Secretary shall submit a plan, not later than 180 days after the date on which the Secretary was required to identify such a project, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives for expanding remote collection of high quality cord blood units, consistent with the requirements under the National Cord Blood Inventory program under section 2 of the Stem Cell Therapeutic and Research Act of 2005 and the inventory goal. Each such plan shall be made available to the public. ``(C) Definition.--In this paragraph, the term `remote collection' means the collection of cord blood units at locations that do not have written contracts with cord blood banks for collection support.''; and (B) in paragraph (3)(A), by striking ``(2)(A)'' and inserting ``(2)(A)(i)''; and (3) by striking subsection (f)(5)(A) and inserting the following: ``(A) require the establishment of a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance with Federal and State law; and''. (c) Additional Reports.-- (1) Interim report.--In addition to the annual report required under section 379(a)(6) of the Public Health Service Act (42 U.S.C. 274k(a)(6)), the Secretary of Health and Human Services (referred to in this subsection as the ``Secretary''), in consultation with the Advisory Council established under such section 379, shall submit to Congress an interim report not later than 180 days after the date of enactment of this Act describing-- (A) the methods to distribute Federal funds to cord blood banks used at the time of submission of the report; (B) how cord blood banks contract with collection sites for the collection of cord blood units; and (C) recommendations for improving the methods to distribute Federal funds described in subparagraph (A) in order to encourage the efficient collection of high-quality and diverse cord blood units. (2) Recommendations.--Not later than 1 year after the date of enactment of this Act, the Advisory Council shall submit recommendations to the Secretary with respect to-- (A) whether models for remote collection of cord blood units should be allowed only with limited, scientifically- justified safety protections; and (B) whether the Secretary 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. (d) Authorization of Appropriations.--Section 379B of the Public Health Service Act (42 U.S.C. 274m) is amended by striking ``$34,000,000'' and all that follows through the period at the end, and inserting ``$30,000,000 for each of fiscal years 2011 through 2014 and $33,000,000 for fiscal year 2015.''. (e) Report on Cord Blood Unit Donation and Collection.-- (1) In general.--Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Secretary of Health and Human Services a report reviewing studies, demonstration programs, and outreach efforts for the purpose of increasing cord blood unit donation and collection for the National Cord Blood Inventory to ensure a high-quality and genetically diverse inventory of cord blood units. (2) Contents.--The report described in paragraph (1) shall include a review of such studies, demonstration programs, and outreach efforts under section 2 of the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) (as amended by this Act) and section 379 of the Public Health Service Act (42 U.S.C. 274k) (as amended by this Act), including-- (A) a description of the challenges and barriers to expanding the number of cord blood unit collection sites, including cost, the cash flow requirements and operations of awarding contracts, the methods by which funds are distributed through contracts, the impact of regulatory and administrative requirements, and the capacity of cord blood banks to maintain high-quality units; (B) remote collection or other innovative technological advances that could be used to collect cord blood units; (C) appropriate methods for improving provider education about collecting cord blood units for the national inventory and participation in such collection activities; (D) estimates of the number of cord blood unit collection sites necessary to meet the outstanding national inventory need and the characteristics of such collection sites that would help increase the genetic diversity and enhance the quality of cord blood units collected; (E) best practices for establishing and sustaining partnerships for cord blood unit collection at medical facilities with a high number of minority births; (F) potential and proven incentives to encourage hospitals to become cord blood unit collection sites and partner with cord blood banks participating in the National Cord Blood Inventory under section 2 of the Stem Cell Therapeutic and Research Act of 2005 and to assist cord blood banks in expanding the number of cord blood unit collection sites with which such cord blood banks partner; (G) recommendations about methods cord blood banks and collection sites could use to lower costs and improve efficiency of cord blood unit collection without decreasing the quality of the cord blood units collected; and (H) a description of the methods used prior to the date of enactment of this Act to distribute funds to cord blood banks and recommendations for how to improve such methods to encourage the efficient collection of high-quality and diverse cord blood units, consistent with the requirements of the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory program under section 2 of the Stem Cell Therapeutic and Research Act of 2005. (f) Definition.--In this Act, the term ``remote collection'' has the meaning given such term in section 379(d)(2)(C) of the Public Health Service Act. Mr. REED. Mr. President, today the Senate passed the Stem Cell Therapeutic and Research Reauthorization Act of 2010. I was pleased to have been involved in the crafting of this bill, which is the product of months of bipartisan discussions, collaboration, and negotiation. I also want to recognize the hard work and dedication of Senators Dodd, Hatch, Burr, and Ensign in getting this bill across the finish line in the Senate. This bill offers promise to the tens of thousands of individuals diagnosed with leukemia and lymphomas, sickle cell anemia, and rare genetic blood disorders. It will reauthorize the C.W. Bill Young National Marrow Donor Program, which has been helping to connect individuals in need of a bone marrow transplant with donors since 1986, and the National Cord Blood Inventory, which has been helping to connect individuals in need of an umbilical cord blood transplant with donors since 1999. I am particularly pleased that the bill will remove a cap on the number of cord blood units that could be stored by qualified cord blood banks in the National Cord Blood Inventory. The original law limited the number to 150,000 units. As the science has evolved, we know that 150,000 is nowhere near the amount necessary to meet the demands of those in need of a cord blood transplant. And, in eliminating this cap, I am pleased that we have included provisions to encourage greater cord blood donation and collection as well as provisions to help shed light onto the obstacles to greater donation and collection. I am proud that the Rhode Island Blood Center has contributed to the success of the National Marrow Donor Program with over 61,000 registered marrow donors. In addition, last year a new partnership formed between the Rhode Island Blood Bank and Women and Infants Hospital in Providence, RI, to begin collecting umbilical cord blood units as part of a pilot project. Over 1,000 units have already been collected, and I look forward to the time when Rhode Island will be contributing to the National Cord Blood Inventory. The public registries made up of Rhode Island donors and those from all over the country have been a true lifeline for the Americans who have found an unrelated match. By strengthening and enhancing the important programs operating these registries, many more [[Page S7652]] Americans will be afforded the opportunity to find a match if they are ever in need. I look forward to swift passage of this legislation in the House of Representatives and the President signing this bill into law shortly thereafter. 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: Sec. 1. Short title Stem Cell Therapeutic and Research Reauthorization Act of 2010. Sec. 2. Amendments to the Stem Cell Therapeutic and Research Act of 2005 (a) Instructs the Secretary of Health and Human Services (HHS) to enter into contracts with qualified cord blood banks in order to create and maintain a national inventory of at least 150,000 new high quality cord blood units suitable for transplantation into unrelated recipients. The 2005 law authorized a 3-year demonstration project to collect umbilical cord blood units specifically for use in a first- degree relative. The law instructed these units to be combined with the national inventory at the end of the 3-year demo. Since the FDA follows different collection and storage requirements for cord blood units intended for use in a first-degree relative and a stranger, the substitute amendment eliminates this instruction and requires the units collected for the demonstration program only be stored for use in a first-degree relative. Includes additional requirements for entities applying to be qualified cord blood banks. First, the entity must provide a plan to increase cord blood unit collections at collection sites that exist at the time of application, assist with the establishment of new collection sites or contract with new collection sites. Second, contract recipients must annually provide to the HHS Secretary [[Page S7653]] a plan for and demonstrate ongoing, measurable progress toward achieving self-sufficiency of cord blood collection and banking operations. Extends the length of a cord blood bank contract from three years to five years. A five year extension of cord blood contracts will be permitted if such entities: (1) demonstrate a superior ability to satisfy the requirements included in the original statute to be federal cord blood banks; (2) provide a plan for increasing cord blood unit collections at collection sites that exist at the time of consideration of such extension, assist with the establishment of new collection sites, or contract with new collection sites; and (3) annually provide to the HHS Secretary a plan for and demonstrate ongoing, measurable progress toward achieving self-sufficiency of cord blood collection and banking operations. Redefines the term, ``first-degree relative'' as a sibling of the individual requiring a transplant. Authorizes appropriations for the National Cord Blood Inventory Program (NCBI) at $23 million in fiscal years 2011-2014 and $20 million in fiscal year 2015. The substitute amendment eliminates language in the law which allows funds to remain available until expended since this is overridden by long- standing policy in appropriations bills. The statutory language was originally necessary because the 2005 authorization law passed after funds had been appropriated. (b) Clarifies that the C.W. Bill Young Cell Transplantation Program, known as the Program, shall support studies and outreach projects to increase cord collection donation and collection from a genetically diverse population, including exploring novel approaches or incentives, such as remote or other innovative technological advances that could be used to collect cord blood units, to expand the number of cord blood collection sites partnering with cord blood banks that receive a contract under the NCBI program. Directs the Secretary, acting though the Administrator of the Health Resources and Services Administration, to submit to Congress an annual report on activities conducted through the National Program including novel approaches for the purpose of increasing cord blood unit donation and collection. Directs the Secretary to set an annual goal of increasing collections of high quality cord blood units through remote collection or other novel approaches. The Secretary shall identify at least one of these approaches to replicate and expand nationwide as appropriate. If such a project cannot be identified by the Secretary, then the Secretary shall submit a plan for expanding remote collection of high quality cord blood units. Remote collection is defined as cord blood unit collections occurring at locations that do not hold written contracts with existing cord blood banks for collection support. Requires the Secretary, in consultation with the Advisory Council, to submit to Congress an interim report not later than 6 months after date of enactment, describing the existing methods used to distribute federal funds to cord blood banks; how cord blood banks contract with collection sites for the collection of cord blood units; and recommendations to improve these methods to encourage the efficient collection of high quality and diverse cord blood units. Requires the Advisory Council shall submit recommendations to the Secretary one year after enactment about whether: 1. remote models for cord blood unit collection should be allowed with only limited, scientifically justified safety protections; and 2. 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. Authorizes appropriations for the C.W. Bill Young Cell Transplantation Program (the Program) at $30 million in fiscal years 2011-2014 and $33 million in fiscal year 2015. The substitute amendment eliminates language in the law which allows funds to remain available until expended since this is overridden by long-standing policy in appropriations bills. The statutory language was originally necessary because the 2005 authorization law passed after funds had been appropriated. Directs the Government Accountability Office (GAO) to submit a report on cord blood unit donation and collection as well as methods used to distribute funds to cord blood banks no later than one year after enactment. The report shall be submitted to the Senate Committee on Health, Education, Labor and Pensions, the Senate Committee on Appropriations, the House Energy and Commerce Committee and the House Committee on Appropriations. Mr. FRANKEN. Mr. President, I ask unanimous consent that the committee-reported substitute amendment be agreed to, the bill, as amended, be read three times, passed, the motion to reconsider be laid upon the table, and that any statements relating thereto be printed in the Record. The PRESIDING OFFICER. Without objection, it is so ordered. The committee amendment in the nature of a substitute was agreed to. The bill (S. 3751), as amended, was ordered to be engrossed for a third reading, was read the third time, and passed. ____________________