[House Report 111-643]
[From the U.S. Government Publishing Office]
111th Congress Report
2d Session HOUSE OF REPRESENTATIVES 111-643
=======================================================================
STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2010
_______
September 28, 2010.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Waxman, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 6081]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 6081) to amend the Stem Cell Therapeutic and
Research Act of 2005, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 5
Background and Need for Legislation.............................. 5
Committee Consideration.......................................... 5
Committee Votes.................................................. 6
Committee Oversight Findings and Recommendations................. 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 6
Statement of General Performance Goals and Objectives............ 6
Constitutional Authority Statement............................... 6
Earmarks and Tax and Tariff Benefits............................. 7
Federal Advisory Committee Statement............................. 7
Applicability of Law to the Legislative Branch................... 7
Federal Mandates Statement....................................... 7
Committee Cost Estimate.......................................... 7
Congressional Budget Office Cost Estimate........................ 7
Section-by-Section Analysis of the Legislation................... 8
Explanation of Amendments........................................ 9
Changes in Existing Law Made by the Bill, as Reported............ 10
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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 (with appropriate indentation);
(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.
Purpose and Summary
H.R. 6081, the ``Stem Cell Therapeutic and Research
Reauthorization Act of 2010'', was introduced by Rep. C. W.
Bill Young (R-FL) and Doris O. Matsui (D-CA) on August 9, 2010,
and referred to the Committee on Energy and Commerce.
The goal of H.R. 6081 is to reauthorize the C.W. Bill Young
Cell Transplantation Program, which includes the National
Registry for adult donors of bone marrow, peripheral blood
(adult) stem cells, and umbilical cord blood units; the Office
of Patient Advocacy; and the Stem Cell Therapeutic Outcomes
Database. H.R. 6081 also reauthorizes the National Cord Blood
Inventory (NCBI) Program, a program that provides grants to
public cord blood banks to assist them in collecting donated
cord blood units, which, in turn, are listed on the National
Registry.
Background and Need for Legislation
A bone marrow or cord blood transplant replaces a patient's
diseased blood-forming cells with healthy ones. The procedure
is used in treating some people with a blood cancer (such as
leukemia or lymphoma) or an inherited metabolic or immune
system disorder. According to the Health Resources and Services
Administration (HRSA), at any given time there are some 6,000
people across the United States searching for a matched bone
marrow donor or cord blood unit.
HRSA funds two major programs that facilitate the provision
of blood stem cell units to individuals in need of a
transplant. The C.W. Bill Young Cell Transplantation Program
supports activities to increase the number of transplants for
recipients suitably matched to biologically unrelated donors of
bone marrow and cord blood. The National Cord Blood Inventory
(NCBI) Program supports the collection, processing, and storage
of a genetically and ethnically diverse inventory of high-
quality umbilical cord blood for transplantation. These cord
blood units, as well as other units in the inventories of
participating cord blood banks, are made available to
physicians and patients for blood stem cell transplants through
the C.W. Bill Young Cell Transplantation Program.
The reauthorization of both the C.W. Bill Young Cell
Transplantation Program and the NCBI Program is necessary to
allow HRSA to continue these important and life-saving
activities.
Committee Consideration
H.R. 6081, the ``Stem Cell Therapeutic and Research
Reauthorization Act of 2010'', was introduced by Mr. Young of
Florida and Ms. Matsui of California on August 9, 2010, and
referred to the Committee on Energy and Commerce. The bill was
subsequently referred to the Subcommittee on Health on August
10, 2010. On September 15, 2010, the Subcommittee held a
legislative hearing on the bill. The Subcommittee met in open
markup session to consider H.R. 6081 on September 16, 2010.
During subcommittee consideration, an amendment in the nature
of a substitute (manager's amendment) by Mr. Pallone of New
Jersey was adopted by a voice vote. Subsequently, H.R. 6081 was
favorably forwarded to the full Committee, amended, by a voice
vote.
On September 23, 2010, the Committee on Energy and Commerce
met in open markup session to consider H.R. 6081 as approved by
the Subcommittee. During the Committee's consideration, an
amendment in the nature of a substitute was offered by Ms.
Matsui of California, which was adopted by a voice vote.
Subsequently, the Committee ordered H.R. 6081 favorably
reported to the House, amended, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. A
motion by Mr. Waxman ordering H.R. 6081 reported to the House,
amended, was approved by a voice vote. There were no record
votes taken during consideration of this bill.
Committee Oversight Findings and Recommendations
In compliance with clause 3(c)(1) of rule XIII and clause
(2)(b)(1) of rule X of the Rules of the House of
Representatives, the oversight findings and recommendations of
the Committee are reflected in the descriptive portions of this
report, including the finding that reauthorization of the C.W.
Bill Young Cell Transplantation Program is important to support
activities to increase the number of transplants for recipients
suitably matched to biologically unrelated donors of bone
marrow and cord blood.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee finds
that H.R. 6081 would result in no new budget authority,
entitlement authority, or tax expenditures or revenues.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the performance goals and
objectives of the Committee are reflected in the descriptive
portions of this report, including the goal of reauthorizing
the C.W. Bill Young Cell Transplantation Program.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
constitutional authority for H.R. 6081 is provided under
article I, section 8, clauses 3 and 18 of the Constitution of
the United States.
Earmarks and Tax and Tariff Benefits
H.R. 6081 does not contain any congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9 of rule XXI of the Rules of the House of
Representatives.
Federal Advisory Committee Statement
The Committee finds that the legislation does not establish
or authorize the establishment of an advisory committee within
the definition of 5 U.S.C. App., section 5(b) of the Federal
Advisory Committee Act.
Applicability of Law to the Legislative Branch
Section 102(b)(3) of Public Law 104-1 requires a
description of the application of this bill to the legislative
branch where the bill relates to terms and conditions of
employment or access to public services and accommodations.
H.R. 6081 contains no such provisions.
Federal Mandates Statement
Section 423 of the Congressional Budget and Impoundment
Control Act of 1974 (as amended by section 101(a)(2) of the
Unfunded Mandates Reform Act, Public Law 104-4) requires a
statement on whether the provisions of the report include
unfunded mandates. In compliance with this requirement the
Committee adopts as its own the analysis of federal mandates
prepared by the Director of the Congressional Budget Office
regarding H.R. 6081.
Committee Cost Estimate
Pursuant to clause 3(d)(2) of rule XIII of the Rules of the
House of Representatives, the Committee adopts as its own the
cost estimate of H.R. 6081 prepared by the Director of the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Congressional Budget Office Cost Estimate
With respect to the requirements of clause (3)(c)(3) of
rule XIII of the Rules of the House of Representatives and
section 402 of the Congressional Budget Act of 1974, the
Committee has received the following cost estimate for H.R.
6081 from the Director of Congressional Budget Office:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 23, 2010.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 6081, the Stem
Cell Therapeutic and Research Reauthorization Act of 2010.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Lisa Ramirez-
Branum.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 6081--Stem Cell Therapeutic and Research Reauthorization Act of
2010
H.R. 6081 would reauthorize the National Cord Blood
Inventory program and the C.W. Bill Young Cell Transplantation
program. In 2010, over $35 million was appropriated for these
purposes. The bill also would require the Government
Accountability Office to conduct a report that reviews the
studies, demonstration programs, and outreach efforts for the
purpose of increasing cord blood unit donations and collections
for the National Cord Blood Inventory program.
The bill would authorize the appropriation of $53 million
in fiscal year 2011 and $265 million for fiscal years 2011
through 2015. Assuming appropriation of those amounts, and
based on historical spending patterns for similar programs, CBO
estimates that implementing H.R. 6081 would cost $220 million
over the 2011-2015 period as shown in the following table. The
costs of this legislation fall primarily within budget function
550 (health). Enacting H.R. 6081 would not affect direct
spending or revenues; therefore, pay-as-you-go procedures do
not apply.
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------------
2011-
2011 2012 2013 2014 2015 2015
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATIONAuthorization Level................................. 53 53 53 53 53 265
Estimated Outlays................................... 21 44 51 52 52 220
----------------------------------------------------------------------------------------------------------------
H.R. 6081 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act and
would not affect the budgets of state, local or tribal
governments.
The CBO staff contact for this estimate is Lisa Ramirez-
Branum. This estimate was approved by Holly Harvey, Deputy
Assistant Director for Budget Analysis.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the Act may be cited as the
``Stem Cell Therapeutic and Research Reauthorization Act of
2010''.
Section 2. Amendments to the Stem Cell Therapeutic and Research Act of
2005
Subsection (a) of section 2 clarifies the requirement
regarding the number of new units of high-quality cord blood
for the NCBI Program to be ``the inventory goal of at least
150,000''. It also makes numerous changes to the application
requirements for qualified blood banks that wish to participate
in the Cord Blood Inventory and allows for the extension of a
cord blood bank contract from three to five years under
specified circumstances. In addition, subsection (a) provides
for the authorization of appropriations for the NCBI Program at
a level of $23 million for each of FY2011 through FY2014 and
$20 million for FY2015.
Subsection (b) of section 2 clarifies the functions with
regard to cord blood under the C.W. Bill Young Cell
Transplantation Program to include support for studies and
demonstration and outreach projects designed to increase cord
blood unit donation and collection from a genetically diverse
population and to expand the number of cord blood unit
collection sites partnering with cord blood banks that
participate in the NCBI Program. Such studies and projects
include those designed to explore novel approaches or
incentives to encourage innovative technological advances that
could be used to collect cord blood units. Subsection (b) also
directs the Secretary of Health and Human Services to set an
annual goal of increasing collections of high-quality cord
blood units consistent with the inventory goal established
through the NCBI Program and provides for the expansion of
remote collection (as defined in the legislation) of high-
quality cord units under certain conditions.
Subsection (c) of section 2 requires the Secretary to
submit an interim report to Congress in addition to the annual
report required under the C.W. Bill Young Cell Transplantation
Program.
Subsection (d) of section 2 provides for the authorization
of appropriations for the C.W. Bill Young Cell Transplantation
Program at a level of $30 million for each of FY2011 through
FY2014 and $33 million for FY2015.
Subsection (e) directs the Government Accountability Office
(GAO) to submit a report to Congress on cord blood unit
donation and collection, including recommendations on efforts
to increase cord blood unit donation and collection for the
NCBI Program. Such report shall address, among other issues,
methods used to distribute funds to cord blood banks prior to
the date of enactment of this legislation.
Explanation of Amendments
During the Subcommittee on Health markup of H.R. 6081, Mr.
Pallone of New Jersey offered an amendment in the nature of a
substitute (manager's amendment), which was adopted by a voice
vote. During the full Committee consideration of the bill as
approved by the Subcommittee, Ms. Matsui of California offered
an amendment in the nature of a substitute, which was also
adopted by a voice vote. The substance of each amendment is
reflected in the section-by-section analysis contained in this
report.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005
* * * * * * *
SEC. 2. CORD BLOOD INVENTORY.
(a) In General.--The Secretary of Health and Human Services
shall enter into one-time contracts with qualified cord blood
banks to assist in the collection and maintenance of the
inventory goal of at least 150,000 new units of high-quality
cord blood to be made available for transplantation through the
C.W. Bill Young Cell Transplantation Program and to carry out
the requirements of subsection (b).
* * * * * * *
(c) Related Cord Blood Donors.--
(1) * * *
(2) Availability.--Qualified cord blood banks that
are operating a program under paragraph (1) shall
provide assurances that the cord blood units in such
banks will be available for directed transplantation
until such time that the cord blood unit is released
for transplantation [or is transferred by the family to
the C.W. Bill Young Cell Transplantation Program in
accordance with guidance or regulations promulgated by
the Secretary.] for a first-degree relative.
(3) Inventory.--Cord blood units collected through
the program under this section shall not be counted
toward the [150,000] inventory goal under the C.W. Bill
Young Cell Transplantation Program.
* * * * * * *
(d) Application.--To seek to enter into a contract under this
section, a qualified cord blood bank shall submit an
application to the Secretary at such time, in such manner, and
containing such information as the Secretary may reasonably
require. At a minimum, an application for a contract under this
section shall include a requirement that the applicant--
(1) will participate in the C.W. Bill Young Cell
Transplantation Program for 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;
(2) will make cord blood units collected pursuant to
this section available through the C.W. Bill Young Cell
Transplantation Program in perpetuity or for such time
as determined viable by the Secretary[; and];
(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
[(3)] (5) if the Secretary determines through an
assessment, or through petition by the applicant, that
a cord blood bank is no longer operational or does not
meet the requirements of section 379(d)(4) of the
Public Health Service Act (as added by this Act) and as
a result may not distribute the units, transfer the
units collected pursuant to this section to another
qualified cord blood bank approved by the Secretary to
ensure continued availability of cord blood units.
(e) Duration of Contracts.--
(1) In general.--Except as provided in paragraph (2),
the term of each contract entered into by the Secretary
under this section shall be for [10 years] 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. [The Secretary shall
ensure that no Federal funds shall be obligated under
any such contract after the earlier of--
[(A) the date that is 3 years after the date
on which the contract is entered into; or
[(B) September 30, 2010.] 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).
(2) Extensions.--[Subject to paragraph (1)(B), the]
The Secretary may extend the period of funding under a
contract under this section to exceed a period of [3] 5
years if--
(A) the Secretary finds that [150,000 new
units of high-quality cord blood have not yet
been collected pursuant to this section; and]
the inventory goal described in subsection (a)
has not yet been met;
(B) the Secretary does not receive an
application for a contract under this section
meeting the requirements under subsection (d)
from any qualified cord blood bank that has not
previously entered into a contract under this
section [or the Secretary determines that the
outstanding inventory need cannot be met by the
one or more qualified cord blood banks that
have submitted an application for a contract
under this section.]; or
(C) the Secretary determines that the
outstanding inventory need cannot be met by the
qualified cord blood banks under contract under
this section.
[(3) Preference.--In considering contract extensions
under paragraph (2), the Secretary shall give
preference to qualified cord blood banks that the
Secretary determines have demonstrated a superior
ability to satisfy the requirements described in
subsection (b) and to achieve the overall goals for
which the contract was awarded.]
(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.
* * * * * * *
(g) Definitions.--In this section:
(1) * * *
* * * * * * *
(4) The term ``first-degree relative'' means a
sibling [or parent] who is one meiosis away from a
particular individual in a family.
* * * * * * *
(h) Authorization of Appropriations.--
[(1) Existing funds.--Any amounts appropriated to the
Secretary for fiscal year 2004 or 2005 for the purpose
of assisting in the collection or maintenance of cord
blood shall remain available to the Secretary until the
end of fiscal year 2007.
[(2) Subsequent fiscal years.--There are authorized
to be appropriated to the Secretary $15,000,000 for
each of fiscal years 2007, 2008, 2009, and 2010 to
carry out this section.]
(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.
[(3)] (2) Limitation.--Not to exceed 5 percent of the
amount appropriated under this section [in each of
fiscal years 2007 through 2009] for each of fiscal
years 2011 through 2015 may be used to carry out the
demonstration project under subsection (c).
* * * * * * *
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PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
PART I--C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM
SEC. 379. NATIONAL PROGRAM.
(a) Establishment.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall by one or more contracts establish and
maintain a C.W. Bill Young Cell Transplantation Program
(referred to in this section as the ``Program''), successor to
the National Bone Marrow Donor Registry, that has the purpose
of increasing the number of transplants for recipients suitably
matched to biologically unrelated donors of bone marrow and
cord blood, and that meets the requirements of this section.
The Secretary may award a separate contract to perform each of
the major functions of the Program described in paragraphs (1)
and (2) of subsection (d) if deemed necessary by the Secretary
to operate an effective and efficient system that is in the
best interest of patients. The Secretary shall conduct a
separate competition for the initial establishment of the cord
blood functions of the Program. The Program shall be under the
general supervision of the Secretary. The Secretary shall
establish an Advisory Council to advise, assist, consult with,
and make recommendations to the Secretary on matters related to
the activities carried out by the Program. The members of the
Advisory Council shall be appointed in accordance with the
following:
(1) * * *
* * * * * * *
[(6) The Secretary, acting through the Advisory
Council, shall submit to the Congress--
[(A) an annual report on the activities
carried out under this section; and
[(B) not later than 6 months after the date
of the enactment of the Stem Cell Therapeutic
and Research Act of 2005, a report of
recommendations on the scientific factors
necessary to define a cord blood unit as a
high-quality unit.]
(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.
* * * * * * *
(d) Functions.--
(1) * * *
(2) Cord blood functions.--[With respect to cord
blood, the Program shall--]
(A) In general.--With respect to cord blood,
the Program shall--
[(A)] (i) operate a system for
identifying, matching, and facilitating
the distribution of donated cord blood
units that are suitably matched to
candidate patients and meet all
applicable Federal and State
regulations (including informed consent
and Food and Drug Administration
regulations) from a qualified cord
blood bank;
[(B)] (ii) consistent with paragraph
(3), allow transplant physicians, other
appropriate health care professionals,
and patients to search by means of
electronic access all available cord
blood units made available through the
Program;
[(C)] (iii) allow transplant
physicians and other appropriate health
care professionals to reserve, as
defined by the Secretary, a cord blood
unit for transplantation;
[(D) support studies and demonstration and
outreach projects for the purpose of increasing
cord blood donation to ensure a genetically
diverse collection of cord blood units;]
(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;
[(E)] (v) provide for a system of
patient advocacy through the office
established under subsection (h);
[(F)] (vi) coordinate with the
qualified cord blood banks to support
informational and educational
activities in accordance with
subsection (g);
[(G)] (vii) maintain and expand
medical contingency response
capabilities, in coordination with
Federal programs, to prepare for and
respond effectively to biological,
chemical, or radiological attacks, and
other public health emergencies that
can damage marrow, so that the
capability of supporting patients with
marrow damage from disease can be used
to support casualties with marrow
damage; and
[(H)] (viii) with respect to the
system under subparagraph (A), collect,
analyze, and publish data in a
standardized electronic format, as
required by the Secretary, on the
number and percentage of patients at
each of the various stages of the
search process, including data
regarding the furthest stage reached,
the number and percentage of patients
who are unable to complete the search
process, and the reasons underlying
such circumstances.
(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.
(3) Single point of access; standard data.--
(A) Single point of access.--The Secretary
shall ensure that health care professionals and
patients are able to search electronically for
and facilitate access to, in the manner and to
the extent defined by the Secretary and
consistent with the functions described in
paragraphs (1)(A) and [(2)(A)] (2)(A)(i), cells
from bone marrow donors and cord blood units
through a single point of access.
* * * * * * *
(f) Bone Marrow Criteria, Standards, and Procedures.--The
Secretary shall enforce, for participating entities, including
the Program, individual marrow donor centers, marrow donor
registries, marrow collection centers, and marrow transplant
centers--
(1) * * *
* * * * * * *
(5) standards that--
[(A) require the establishment of a system of
strict confidentiality of records relating to
the identity, address, HLA type, and managing
marrow donor center for marrow donors and
potential marrow donors; and]
(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
* * * * * * *
SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are
authorized to be appropriated [$34,000,000 for fiscal year 2006
and $38,000,000 for each of fiscal years 2007 through 2010.]
$30,000,000 for each of fiscal years 2011 through 2014 and
$33,000,000 for fiscal year 2015.
* * * * * * *