[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6081 Introduced in House (IH)]
111th CONGRESS
2d Session
H. R. 6081
To amend the Stem Cell Therapeutic and Research Act of 2005.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 9, 2010
Mr. Young of Florida (for himself and Ms. Matsui) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Stem Cell Therapeutic and Research Act of 2005.
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.
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