[United States Statutes at Large, Volume 124, 111th Congress, 2nd Session]
[From the U.S. Government Printing Office, www.gpo.gov]


Public Law 111-264
111th Congress

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

[[Page 2790]]

(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''.

[[Page 2791]]

(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

[[Page 2792]]

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

[[Page 2793]]

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.

[[Page 2794]]

(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.

Approved October 8, 2010.

LEGISLATIVE HISTORY--S. 3751:
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CONGRESSIONAL RECORD, Vol. 156 (2010):
Sept. 28, considered and passed Senate.
Sept. 29, considered and passed House.