[Congressional Record Volume 156, Number 118 (Thursday, August 5, 2010)]
[Senate]
[Pages S6900-S6902]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  By Mr. HATCH (for himself, Mr. Dodd, Mr. Burr, Mr. Reed, Mr. Ensign, 
and Mr. Franken):
  S. 3751. A bill to amend the Stem Cell Therapeutic and Research Act 
of 2005; to the Committee on Health, Education, Labor, and Pensions.
  Mr. HATCH. Mr. President, I am pleased today to introduce 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 and Franken have joined me as sponsors of this 
bipartisan bill.
  Over the past few months, we have worked with the National Marrow 
Donor Program, NMDP, and cord blood transplantation experts, 
specifically Dr. Linda Kelley of the University of Utah and Dr. Joanne 
Kurtzberg of Duke University. It is my strong hope that our bill is 
considered by the Senate Committee on Health, Education, Labor and 
Pensions when the Congress returns in mid-September and is signed into 
law before the end of the year.
  Our legislation makes several small but important additions to the 
existing program.
  First, the bill reauthorizes both the C.W. Bill Young Cell 
Transplantation Program, which is commonly referred to as the Program 
and the National Cord Blood Inventory program, which is often called 
the NCBI, for an additional 5 years through 2015.
  The total authorization levels for both programs combined would be 
$53 million in each of the 5 years, thus staying consistent with the 
authorization level established in the original statute. Specifically, 
the authorization level for the program would be $30 million in fiscal 
years 2011 through 2014 and $33 million in fiscal year 2015. The 
authorization levels for NCBI would be $23 million for fiscal years 
2011 through 2014 and $20 million in fiscal year 2015.
  Second, the original statute intended for cord blood banks to become 
self-sufficient in the future. Five years ago, it was our intent that 
cord blood banks would eventually be able to function and operate 
without federal funding. In fact, the HELP Committee's August 31, 2005 
report states the following on this important issue: ``The committee 
anticipated that the funding authorized for establishing and 
strengthening the cord blood unit inventory will be devoted primarily 
to defraying the start-up expenses, including developing the expanded 
inventory in an optimal fashion. While we feel that such activities 
clearly have the potential to be self-supporting in time, we also 
recognize that sufficient funding over an adequate period of time will 
be necessary for these activities to realize their full potential. It 
is the committee's expectation that the Secretary will closely 
scrutinize all costs related to this legislation, so that tax dollars 
are spent judiciously to achieve the maximum effect.''
  Almost 5 years have passed since the original statute was signed into 
law and cord blood banks are still dependent on Federal funding due to 
the many obstacles surrounding cord blood collection and cord blood 
storage. Therefore, our bill includes language to the contracting 
section requiring qualified cord blood banks to develop an annual plan 
and demonstrate ongoing measurable progress toward achieving self-
sufficiency. While I recognize and understand that cord blood donation 
and collection is a new, challenging field of research, this 
modification was extremely important to me to ensure that taxpayers' 
precious dollars are spent prudently and that public cord blood banks 
are actually doing what the drafters of the original law intended.
  The contracting provisions of our bill also require cord blood banks 
to provide a plan on how to increase cord blood collection, assist with 
the establishment of new collection sites or contract with new 
collection sites. Both the self-sufficiency requirements and the cord 
blood collection requirements would apply to both new cord blood bank 
applicants and existing cord blood banks extending their contracts.
  Third, our bill also calls for the collection and maintenance of at 
least 150,000 new units of high-quality cord blood to be made available 
for transplantation through the C.W. Bill Young Cell Transplantation 
Program. The original statute called for the collection of 150,000 new 
units, and we believed that there needed to be some flexibility on the 
total number of units collected.
  Fourth, in order to ensure that the appropriate science is reflected 
in this bill, the legislation modifies the definition of a first degree 
relative as the sibling of an individual in need of a transplant. 
According to scientists and researchers who specialize in cord blood 
transplantation, the only immediate family members able to donate cord 
blood are the siblings of a person in need of a transplant. The 
original statute defined first degree relatives as parents and 
siblings.
  Fifth, the Program would support studies and demonstration projects 
that would study increasing cord blood donation and collection from a 
genetically diverse population, including exploring novel approaches or 
incentives to expand the number of cord blood collection sites 
partnering with federal cord blood banks.
  Sixth, our bill extends the privacy protections included in the 
original statute for cord blood transplant patients and donors to bone 
marrow transplant patients and donors.
  Finally, the legislation includes a study on cord blood donation and 
collection by the General Accountability Office. The final report would 
be submitted to the appropriate House and Senate Committees one year 
after enactment of our bill.

[[Page S6901]]

  I am proud of this legislation because it proves that bipartisanship 
still exists in the United States Senate. This subject is near and dear 
to my heart. When this legislation was signed into law in 2005, it 
offered us a rare opportunity to make a difference in the lives of 
those suffering from a serious illness or those who have family members 
with illnesses requiring cord blood or bone marrow transplants. Back 
then, our goal was to increase the number of bone marrow and cord blood 
donors. Today, our goal continues to be increasing the number of bone 
marrow and cord blood donations and passage of this legislation will 
make it easier to do just that.
  I will continue to do everything possible to provide transplant 
patients with the best possible options by ensuring a strong future for 
bone marrow and cord blood transplantation in this country. Patients in 
need of a transplant deserve nothing less and passing this legislation 
is the pathway to being successful in that endeavor.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, 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 ``at least'' before 
     ``150,000'';
       (2) in subsection (c)(3), by inserting ``at least'' before 
     ``150,000'';
       (3) in subsection (d)--
       (A) in paragraph (2), by striking ``; and'' and inserting 
     ``;'';
       (B) by redesignating paragraph (3) as paragraph (5); and
       (C) 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)--

       (I) by inserting ``at least'' before ``150,000''; and
       (II) by striking ``; and'' and inserting ``;'';

       (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 paragraph (2) and inserting the following:
       ``(2) 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. 
     Such funds so appropriated shall remain available until 
     expended.''; and
       (B) in paragraph (3), by striking ``in each of fiscal years 
     2007 through 2009'' and inserting ``for 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 Advisory Council, 
     shall submit to Congress an annual report on the activities 
     carried out under this section.'';
       (2) by striking subsection (d)(2)(D) and inserting the 
     following:
       ``(D) support studies and demonstration and outreach 
     projects for the purpose of increasing cord blood unit 
     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 unit collection sites 
     partnering with cord blood banks that receive a contract 
     under the National Cord Blood Bank Inventory program under 
     section 2 of the Stem Cell Therapeutic and Research Act of 
     2005;''; 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) 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. Such funds so appropriated shall remain available 
     until expended.''.
       (d) 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 impact of regulatory and administrative 
     requirements, and the capacity of cord blood banks to 
     maintain high-quality units;
       (B) remote 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; and
       (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.

  Mr. DODD. Mr. President, I am pleased to join Senator Hatch, Senator 
Reed, Senator Burr, Senator Ensign and Senator Franken in introducing 
the Stem Cell Therapeutic and Research Reauthorization Act of 2010, a 
bill that will benefit some of the most gravely ill patients--those in 
need of a

[[Page S6902]]

blood stem cell transplant. The bill we are introducing today 
reauthorizes the vital work being done for patients as a result of the 
Stem Cell Therapeutic and Research Act of 2005.
  I first joined Senator Hatch more than seven years ago on legislation 
to create a national network of cord blood banks and a cord blood 
registry. Five years ago, when the Health, Education, Labor and 
Pensions Committee took up cord blood legislation, Senator Hatch and I, 
working with many of our colleagues on and off the committee, expanded 
the scope of our legislation to include a reauthorization of the 
national bone marrow program and updated the cord blood provisions to 
be consistent with the recommendations made by the Institute of 
Medicine's report, ``Cord Blood: Establishing a National Hematopoietic 
Stem Cell Bank Program.'' In the end, that legislation, the Stem Cell 
Therapeutic and Research Act of 2005, passed the senate unanimously.
  Since then we have learned a lot of about adult stem cell 
transplantation. There are currently twelve public cord blood banks 
across the U.S. and cord blood cells account for 22 percent of all 
transplants as of 2009. Among minorities, transplants using cord blood 
as the cell source are even higher. As of 2005, survival rates for 
transplants involving an unrelated donor are almost identical to those 
of a related donor which represents a near doubling of the survival 
rates for unrelated donor recipients over the past 15 years.
  The bill we are introducing today builds on the success of the 
National Cord Blood Inventory and the national bone marrow 
transplantation program, making minor improvements to both. Among the 
most critical changes to the law is the prioritization of the creation 
of new cord blood collection sites so that we can increase the National 
Cord Blood Inventory. The 2005 law set a goal of collecting and 
maintaining 150,000 new units of high-quality cord blood. 
Unfortunately, the inventory is well below that goal and the 
transplantation needs of patients. In part, that is because the funding 
has not kept pace with what was authorized by the 2005 law. While I 
applaud President Obama for including additional funding for the 
National Cord Blood Inventory and the national bone marrow 
transplantation program in his fiscal year 2011 budget, I find it 
regrettable that President Bush did not provide full funding for these 
programs in any of his budgets, despite his vocal support for these 
programs and adult stem cells generally.
  In my own state of Connecticut, there are more than 128,000 donors 
participating in the National Marrow Donor Program. There is some very 
exciting work going on at Yale University and Yale New Haven Hospital 
involving marrow or cord blood transplantation. In fact, last May, I 
had the privilege of meeting Ms. Teena Conquest, a bone marrow donor 
from Middletown, Connecticut, and the recipient of her bone marrow, 
Rebecca Christy, from Iowa. It was truly inspiring to hear their story 
and how one woman's generosity saved another woman's life.
  I am deeply disappointed that there are currently no cord blood 
collection sites in the state of Connecticut through the National Cord 
Blood Inventory program. Currently, more than 160 hospitals in the U.S. 
have an agreement with a public cord blood bank through the National 
Cord Blood Inventory program to perform collections for banks within 
the National Marrow Donor Program network. While none of those 
hospitals are in Connecticut, it is my strong hope that with this 
reauthorization, we will be prioritizing the establishment of new cord 
blood collection sites for the public program. I strongly encourage 
hospitals in Connecticut who meet the criteria to become a cord blood 
collection site and help increase the inventory of cord blood so that 
patients in need can find a match.
  As was the case for Ms. Conquest and Ms. Christy, the therapeutic 
benefits of bone marrow are tremendous and well established. Bone 
marrow transplants have been used for nearly half a century to treat 
patients suffering from diseases such as leukemia, Hodgkin's Disease, 
sickle cell anemia, and others. The National Marrow Donor Program, 
NMDP, provides a single point of access, the National Registry, to 
nearly 8 million volunteer bone marrow donors and 160,000 cord blood 
units, including more than 28,000 federally funded units in the 
National Cord Blood Inventory. The NMDP has helped countless patients 
and families understand their disease and treatment options with 
educational resources and one-on-one case management support.
  I urge my colleagues on both sides of the aisle to join me and my 
colleagues in support of this important legislation. It is my strong 
hope that we can move quickly to mark up this legislation in September 
and shortly thereafter pass this bill in the Senate.
                                 ______