II
Calendar No. 587
111th CONGRESS
2d Session
S. 3751
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.
Short title
This Act may be cited as the
Stem Cell Therapeutic and Research
Reauthorization Act of 2010
.
Amendments to the stem cell therapeutic and research act of 2005
Cord blood inventory
Section 2 of the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended—
in subsection (a),
by inserting at least
before 150,000
;
in subsection
(c)(3), by inserting at least
before
150,000
;
in subsection (d)—
in paragraph (2),
by striking ; and
and inserting ;
;
by redesignating paragraph (3) as paragraph (5); and
by inserting after paragraph (2) the following:
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;
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
;
in subsection (e)—
in paragraph (1)—
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
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).
;
in paragraph (2)—
in the matter preceding subparagraph (A)—
by striking
Subject to paragraph (1)(B), the
and inserting
The
; and
by striking
3
and inserting 5
;
in subparagraph (A)—
by inserting
at least
before 150,000
; and
by striking
; and
and inserting ;
;
in subparagraph (B)—
by inserting
meeting the requirements under subsection (d)
after
receive an application for a contract under this section
;
and
by striking
or the Secretary
and all that follows through the period at the
end and inserting ; or
; and
by adding at the end the following:
the Secretary determines that the outstanding inventory need cannot be met by the qualified cord blood banks under contract under this section.
; and
by striking paragraph (3) and inserting the following:
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—
demonstrates a superior ability to satisfy the requirements described in subsection (b) and achieves the overall goals for which the contract was awarded;
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
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.
;
in subsection
(g)(4), by striking or parent
; and
in subsection (h)—
by striking paragraph (2) and inserting the following:
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
in paragraph (3),
by striking in each of fiscal years 2007 through 2009
and
inserting for fiscal years 2011 through 2015
.
National program
Section 379 of the Public Health Service Act (42 U.S.C. 274k) is amended—
by striking subsection (a)(6) and inserting the following:
The Secretary, acting through the Advisory Council, shall submit to Congress an annual report on the activities carried out under this section.
;
by striking subsection (d)(2)(D) and inserting the following:
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
by striking subsection (f)(5)(A) and inserting the following:
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
.
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.
.
Report on cord blood unit donation and collection
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.
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 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;
remote or other innovative technological advances that could be used to collect cord blood units;
appropriate methods for improving provider education about collecting cord blood units for the national inventory and participation in such collection activities;
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;
best practices for establishing and sustaining partnerships for cord blood unit collection at medical facilities with a high number of minority births;
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
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.
Short title
This Act may be cited as the
Stem Cell Therapeutic and Research
Reauthorization Act of 2010
.
Amendments to the stem cell therapeutic and research act of 2005
Cord blood inventory
Section 2 of the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended—
in subsection (a), by
inserting the inventory goal of at least
before
150,000
;
in subsection (c)—
in paragraph (2), by
striking or is transferred
and all that follows through the
period and inserting for a first-degree relative.
; and
in paragraph (3), by
striking 150,000
;
in subsection (d)—
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
;
in paragraph (2), by
striking ; and
and inserting ;
;
by redesignating paragraph (3) as paragraph (5); and
by inserting after paragraph (2) the following:
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;
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
;
in subsection (e)—
in paragraph (1)—
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
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).
;
in paragraph (2)—
in the matter preceding subparagraph (A)—
by striking
Subject to paragraph (1)(B), the
and inserting
The
; and
by striking
3
and inserting 5
;
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;
;
in subparagraph (B)—
by inserting
meeting the requirements under subsection (d)
after
receive an application for a contract under this section
;
and
by striking or
the Secretary
and all that follows through the period at the end and
inserting ; or
; and
by adding at the end the following:
the Secretary determines that the outstanding inventory need cannot be met by the qualified cord blood banks under contract under this section.
; and
by striking paragraph (3) and inserting the following:
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—
demonstrates a superior ability to satisfy the requirements described in subsection (b) and achieves the overall goals for which the contract was awarded;
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
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.
;
in subsection (g)(4), by
striking or parent
; and
in subsection (h)—
by striking paragraphs (1) and (2) and inserting the following:
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.
;
by redesignating paragraph (3) as paragraph (2); and
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
.
National program
Section 379 of the Public Health Service Act (42 U.S.C. 274k) is amended—
by striking subsection (a)(6) and inserting the following:
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.
;
in subsection (d)—
in paragraph (2)—
in the matter preceding
subparagraph (A), by striking With respect to cord blood, the Program
shall—
and inserting the following:
In general
With respect to cord blood, the Program shall—
;
by redesignating subparagraphs (A) through (H) as clauses (i) through (viii) respectively;
by striking clause (iv), as so redesignated, and inserting the following:
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—
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
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
by adding at the end the following:
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.
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
in paragraph (3)(A), by
striking (2)(A)
and inserting (2)(A)(i)
;
and
by striking subsection (f)(5)(A) and inserting the following:
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
.
Additional reports
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—
the methods to distribute Federal funds to cord blood banks used at the time of submission of the report;
how cord blood banks contract with collection sites for the collection of cord blood units; and
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.
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—
whether models for remote collection of cord blood units should be allowed only with limited, scientifically-justified safety protections; and
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.
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.
.
Report on cord blood unit donation and collection
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.
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 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;
remote collection or other innovative technological advances that could be used to collect cord blood units;
appropriate methods for improving provider education about collecting cord blood units for the national inventory and participation in such collection activities;
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;
best practices for establishing and sustaining partnerships for cord blood unit collection at medical facilities with a high number of minority births;
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;
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
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.
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.
September 23, 2010
Reported with an amendment
