[Congressional Record (Bound Edition), Volume 156 (2010), Part 12] [House] [Pages 16945-16947] [From the U.S. Government Publishing Office, www.gpo.gov]STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2010 Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (S. 3751) to amend the Stem Cell Therapeutic and Research Act of 2005. The Clerk read the title of the bill. The text of the bill is as follows: S. 3751 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 ``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--''; (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 [[Page 16946]] 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. The SPEAKER pro tempore (Mr. Kratovil). Pursuant to the rule, the gentleman from New Jersey (Mr. Pallone) and the gentleman from Texas (Mr. Burgess) each will control 20 minutes. The Chair recognizes the gentleman from New Jersey. General Leave Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and to include extraneous material in the Record. The SPEAKER pro tempore. Is there objection to the request of the gentleman from New Jersey? There was no objection. Mr. PALLONE. I yield myself such time as I may consume. Mr. Speaker, S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act of 2010, is identical to legislation sponsored by Representatives Young and Matsui, H.R. 6081, and passed by voice vote by the Energy and Commerce Committee. S. 3751 would reauthorize the C.W. Bill Young Cell Transplantation Program, which includes the national registry for adult donors of bone marrow, peripheral blood adult stem cells and umbilical cord blood units, the Office of Patient Advocacy, and the Stem Cell Therapeutic Outcomes Database. It would also reauthorize the National Cord Blood Inventory, which is a program that provides grants to public cord blood banks to assist them in collecting donated cord blood units that are then listed on the national registry. This is good legislation. It has strong bipartisan support, and I urge my colleagues to support the bill. I reserve the balance of my time. Mr. BURGESS. I yield such time as he may consume to the gentleman from New Jersey (Mr. Smith). Mr. SMITH of New Jersey. I thank my good friend for yielding. To Chairman Pallone, thank you. Mr. Speaker, today the House will vote to reauthorize the Stem Cell Therapeutic and Research Act, which is the law that I, along with Artur Davis, sponsored back in 2005. That law created a new nationwide umbilical cord blood stem cell program, designed to collect, derive, type, and freeze cord blood units for transplantation into patients to mitigate and to even cure serious disease. Pursuant to the law, it also provided stem cells for research. The new cord blood program was combined in our 2005 law with an expanded bone marrow initiative, which was crafted over several years by our distinguished colleague Bill Young. Since the program was enacted in 2005, 12 cord blood banks have received contracts with the Health Resources and Services Administration. Earlier this year, HRSA reported that there were some 27,493 cord blood units collected and that another 13,000-plus units will be collected with the funds that have already been awarded. [[Page 16947]] The reauthorization before us authorizes $23 million to be appropriated for fiscal year 2011 through fiscal year 2014 and $20 million for fiscal year 2015 for the national cord blood inventory, and it also authorizes $30 million to be appropriated for fiscal years 2011 through 2014 and $33 million for fiscal year 2015 for the bone marrow transplant program. {time} 2210 It also enhances the studies, demonstration programs and outreach projects related to cord blood donation and collection to include exploring innovative technologies, novel approaches, and expanding the number of collection sites. It also extends the term of initial and contract extensions from 3 to 5 years, making it easier for banks to engage in long-term relationship building with birthing hospitals. It will also require the cord blood banks to establish a plan for increasing cord blood unit collections and/or to expand the number of collection sites with which they work and provide a plan for becoming self-sufficient Mr. Speaker, each year over 4 million babies are born in America. In the past, virtually every placenta and umbilical cord was tossed as medical waste. Today, doctors have turned this medical waste into medical miracles. Not only has God in His wisdom and goodness created a placenta and umbilical cord to nurture and protect the precious life of an unborn child, but now we know that another gift awaits us immediately after birth. Something very special is left behind--cord blood that is teeming with lifesaving stem cells. Indeed, it remains one of the best kept secrets in America that umbilical cord blood stem cells and adult stem cells in general are curing people of a myriad of terrible conditions and diseases--over 70 diseases in adults as well as in children. Cord blood transplants are on the cutting edge of science for the treatment of leukemia. In June, researcher Dr. Mary Eapen of the Medical College of Wisconsin said that, in treating leukemia in adult patients, cord blood is so flexible that it even worked when it's not an exact match. ``What we found is when you look at the outcome of leukemia-free survival, which is the likelihood of a patient being alive without disease, it's the same whether you are transplanting using an adult graft which is from an adult donor or a cord blood unit.'' Very promising results are also being found in children with leukemia who undergo cord blood transplants, with 60 percent of patients alive and leukemia-free at 60 months. In addition to treating blood cancers, clinical trials are underway for the treatment of many other cancers, such as breast and kidney cancer and treating solid tumors. Human clinical trials show promise in treating type 1 diabetes, cerebral palsy, metabolic storage diseases, brain injury and encephalopathy, respiratory distress in newborns, spinal cord injury, and cartilage injuries. Cord blood stem cells transplants can cure sickle cell anemia, one of the most horrific diseases suffered by and affecting one out of every 500 African Americans in America. The legislation that is before us, thankfully, has already cleared the Senate and will soon be down to the President's desk for signature. The legislation before us lays out many important goals and benchmarks so that more patients will be able to receive the treatments that they so desperately need. Dr. Joanne Kurtzberg with Duke University Medical Center recently stated in a review of the successes of cord blood transplantations: ``Cord blood transplantation is now an established field with enormous potential. In the future, it may emerge as a source of cells for cellular therapies focused on tissue repair and regeneration.'' This is a great bill. It is bipartisan and deserves the support of the entire body. Mr. BURGESS. Mr. Speaker, I yield myself 1 minute. I urge passage of S. 3751 to reauthorize the Stem Cell Therapeutic and Research Authorization Act that was enacted in 2005 and is now being implemented. The C.W. Bill Young Cell Transplantation Program provides support to patients with leukemia, lymphoma, and sickle cell who need a potentially lifesaving bone marrow or cord blood transplant. One of the goals of the program is to increase the amount of marrow donors and cord blood units. This program has been a success, and the reauthorization will allow us to continue the good work that was started in 2005. Again, I urge my colleagues to support the bill. I yield back the balance of my time. Ms. MATSUI. Mr. Speaker, I rise today in strong support of S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act of 2010. This legislation is identical to H.R. 6081, a bill that I introduced with Mr. Young of Florida to reauthorize critical bone marrow and cord blood transplant programs that save thousands of lives each year. Each year, nearly 40,000 people under the age of 55 are diagnosed with fatal bone marrow illnesses, and about 16,000 of those individuals can only be treated via blood stem cell transplant. These patient's lives depend on finding an acceptable adult stem cell donor match--quickly and easily. The Stem Cell Therapeutic and Research Reauthorization Act of 2010 would reauthorize the key programs responsible for helping these individuals by recruiting bone marrow, adult stem cell, and cord blood donations; matching donors and potential recipients; and linking these patients to care. S. 3751 includes two main parts to achieve this spectrum of donation, connection, and care. The first is the C.W. Bill Young Cell Transplantation Program, which houses the National Registry, the Office of Patient Advocacy, and the Stem Cell Therapeutic Outcomes Database. The second is the National Cord Blood Inventory (NCBI), a program that provides grants to public cord blood banks to assist them in collecting a diverse population of donated cord blood units. These units are then listed on the National Registry, where patients and doctors can find them. The reauthorization represents legislation that is truly bipartisan and bicameral, which is evident in the fact that it passed the Senate by unanimous consent on September 28, 2010. Mr. Speaker, I commend our Leadership and thank Chairman Waxman, Chairman Pallone and their staffs for bringing the reauthorization to the floor in time to vote before these programs expire on Thursday, September 30, 2010. This is meaningful legislation with strong bi-partisan support and a proven track record. I urge my colleagues to support passage of this important legislation. Mr. PALLONE. Mr. Speaker, I urge passage of the bill, and I yield back the balance of my time. The SPEAKER pro tempore. The question is on the motion offered by the gentleman from New Jersey (Mr. Pallone) that the House suspend the rules and pass the bill, S. 3751. The question was taken. The SPEAKER pro tempore. In the opinion of the Chair, two-thirds being in the affirmative, the ayes have it. Mr. BURGESS. Mr. Speaker, I object to the vote on the ground that a quorum is not present and make the point of order that a quorum is not present. The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the Chair's prior announcement, further proceedings on this motion will be postponed. The point of no quorum is considered withdrawn. ____________________