[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3751 Reported in Senate (RS)]
Calendar No. 587
111th CONGRESS
2d Session
S. 3751
To amend the Stem Cell Therapeutic and Research Act of 2005.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 5, 2010
Mr. Hatch (for himself, Mr. Dodd, Mr. Burr, Mr. Reed, Mr. Ensign, Mr.
Franken, Mrs. Hagan, Ms. Klobuchar, and Mr. Coburn) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
September 23, 2010
Reported by Mr. Harkin, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Stem Cell Therapeutic and
Research Reauthorization Act of 2010''.</DELETED>
<DELETED>SEC. 2. AMENDMENTS TO THE STEM CELL THERAPEUTIC AND RESEARCH
ACT OF 2005.</DELETED>
<DELETED> (a) Cord Blood Inventory.--Section 2 of the Stem Cell
Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended--
</DELETED>
<DELETED> (1) in subsection (a), by inserting ``at least''
before ``150,000'';</DELETED>
<DELETED> (2) in subsection (c)(3), by inserting ``at
least'' before ``150,000'';</DELETED>
<DELETED> (3) in subsection (d)--</DELETED>
<DELETED> (A) in paragraph (2), by striking ``;
and'' and inserting ``;'';</DELETED>
<DELETED> (B) by redesignating paragraph (3) as
paragraph (5); and</DELETED>
<DELETED> (C) by inserting after paragraph (2) the
following:</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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'';</DELETED>
<DELETED> (4) in subsection (e)--</DELETED>
<DELETED> (A) in paragraph (1)--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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).'';</DELETED>
<DELETED> (B) in paragraph (2)--</DELETED>
<DELETED> (i) in the matter preceding
subparagraph (A)--</DELETED>
<DELETED> (I) by striking ``Subject
to paragraph (1)(B), the'' and
inserting ``The''; and</DELETED>
<DELETED> (II) by striking ``3'' and
inserting ``5'';</DELETED>
<DELETED> (ii) in subparagraph (A)--
</DELETED>
<DELETED> (I) by inserting ``at
least'' before ``150,000'';
and</DELETED>
<DELETED> (II) by striking ``; and''
and inserting ``;'';</DELETED>
<DELETED> (iii) in subparagraph (B)--
</DELETED>
<DELETED> (I) by inserting ``meeting
the requirements under subsection (d)''
after ``receive an application for a
contract under this section'';
and</DELETED>
<DELETED> (II) by striking ``or the
Secretary'' and all that follows
through the period at the end and
inserting ``; or''; and</DELETED>
<DELETED> (iv) by adding at the end the
following:</DELETED>
<DELETED> ``(C) the Secretary determines that the
outstanding inventory need cannot be met by the
qualified cord blood banks under contract under this
section.''; and</DELETED>
<DELETED> (C) by striking paragraph (3) and
inserting the following:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(A) demonstrates a superior ability to
satisfy the requirements described in subsection (b)
and achieves the overall goals for which the contract
was awarded;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (5) in subsection (g)(4), by striking ``or
parent''; and</DELETED>
<DELETED> (6) in subsection (h)--</DELETED>
<DELETED> (A) by striking paragraph (2) and
inserting the following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (B) in paragraph (3), by striking ``in
each of fiscal years 2007 through 2009'' and inserting
``for fiscal years 2011 through 2015''.</DELETED>
<DELETED> (b) National Program.--Section 379 of the Public Health
Service Act (42 U.S.C. 274k) is amended--</DELETED>
<DELETED> (1) by striking subsection (a)(6) and inserting
the following:</DELETED>
<DELETED> ``(6) The Secretary, acting through the Advisory
Council, shall submit to Congress an annual report on the
activities carried out under this section.'';</DELETED>
<DELETED> (2) by striking subsection (d)(2)(D) and inserting
the following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (3) by striking subsection (f)(5)(A) and inserting
the following:</DELETED>
<DELETED> ``(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''.</DELETED>
<DELETED> (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.''.</DELETED>
<DELETED> (d) Report on Cord Blood Unit Donation and Collection.--
</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (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;</DELETED>
<DELETED> (B) remote or other innovative
technological advances that could be used to collect
cord blood units;</DELETED>
<DELETED> (C) appropriate methods for improving
provider education about collecting cord blood units
for the national inventory and participation in such
collection activities;</DELETED>
<DELETED> (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;</DELETED>
<DELETED> (E) best practices for establishing and
sustaining partnerships for cord blood unit collection
at medical facilities with a high number of minority
births;</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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.</DELETED>
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.
Calendar No. 587
111th CONGRESS
2d Session
S. 3751
_______________________________________________________________________
A BILL
To amend the Stem Cell Therapeutic and Research Act of 2005.
_______________________________________________________________________
September 23, 2010
Reported with an amendment