[Congressional Record Volume 156, Number 132 (Tuesday, September 28, 2010)]
[House]
[Pages H7186-H7189]
From the Congressional Record Online through the 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''.
[[Page H7187]]
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 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
[[Page H7188]]
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.
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
[[Page H7189]]
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.
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.
____________________