[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3751 Enrolled Bill (ENR)]
S.3751
One Hundred Eleventh Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the fifth day of January, two thousand and ten
An Act
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 ``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 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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.