Stem Cell Therapeutic and Research Reauthorization Act of 2010

S. 3751

One Hundred Eleventh Congress
of the
United States of America
AT T H E S E C O N D S E S S I O N
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

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(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’’.

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(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

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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, scientificallyjustified 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

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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.

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(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.