[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.

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