H. Rept. 114-242 - STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2015114th Congress (2015-2016)
Committee Report
| Report Type: | House Report |
|---|---|
| Accompanies: | H.R.2820 |
| Committees: |
H. Rept. 114-242 - 114th Congress (2015-2016)
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House Report 114-242 - STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2015
[House Report 114-242]
[From the U.S. Government Publishing Office]
114th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 114-242
======================================================================
STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2015
_______
September 8, 2015.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 2820]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 2820) to reauthorize the Stem Cell Therapeutic
and Research Act of 2005, and for other purposes, having
considered the same, report favorably thereon without amendment
and recommend that the bill do pass.
CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Hearings......................................................... 3
Committee Consideration.......................................... 3
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Statement of General Performance Goals and Objectives............ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 3
Committee Cost Estimate.......................................... 4
Congressional Budget Office Estimate............................. 4
Federal Mandates Statement....................................... 5
Duplication of Federal Programs.................................. 5
Disclosure of Directed Rule Makings.............................. 5
Advisory Committee Statement..................................... 5
Applicability to Legislative Branch.............................. 5
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 6
Purpose and Summary
H.R. 2820, Stem Cell Therapeutic and Research
Reauthorization Act of 2015, was introduced on June 18, 2015,
by Rep. Chris Smith (R-NJ), Rep. Doris Matsui (D-CA), Rep.
Chaka Fattah (D-PA), and Rep. David Jolly (R-FL), to
reauthorize the Stem Cell Therapeutic and Research Act of 2005,
and for other purposes.
Background and Need for Legislation
Bone marrow transplantation, a type of adult stem cell
therapy, has been used for over 50 years to treat patients for
a variety of blood-related diseases and conditions, such as
leukemia, lymphoma, certain types of anemia, and inherited
disorders of immunity and metabolism. Both bone marrow and
umbilical cord blood contain hematopoietic stem cells. These
cells have the capacity to multiply and differentiate into all
types of blood cells. The hematopoietic stem cells found in
cord blood can be used as an alternative to bone marrow
transplantation in the treatment of patients for these various
blood related diseases. It can be very difficult to find a bone
marrow transplant match, and, as a result, cord blood may be
used.
The calculated need for unrelated transplant has increased
by 25 percent since 2005. Much of the reason is due to the
expansion in the number of indications for transplant. The
number of transplants for minority patients has increased from
253 in 2000 to 990 in 2014.
H.R. 2820 would reauthorize the National Marrow Donor
Program and continue to support the national network of public
cord blood banks. The bill also would provide health care
professionals the ability to search for bone marrow and cord
blood units through a single electronic point of access. The
bill also would provide for a national system for recruiting
potential bone marrow donors and coordinate the procurement of
bone marrow and umbilical cord blood units for transplantation.
H.R. 2820 would require the offering of patient and donor
advocacy services; provide for public and professional
education; and require the collection, analysis, and report of
data on transplant outcomes.
The Committee also supports the ongoing work of the public
cord blood banks participating in the National Cord Blood
Inventory (NCBI) program. The Committee heard from one witness
at the Subcommittee on Health hearing about the importance of
allowing the definition of high quality cord blood units to
evolve as physicians learn more about using cord blood units.
Today, some cord blood units on the registry supported through
NCBI subsidization may not be used because the transplant
physician prefers using larger cord blood units because they
believe that larger cord blood units lead to better patient
outcomes. The Committee supports the efforts of the Advisory
Council on Blood Stem Cell Transplantation to develop
recommendations as to what constitutes a high-quality cord
blood units. Depending on the recommendation of the Advisory
Council on Blood Stem Cell Transplantation, the Committee urges
the Health Resources and Services Administration to amend its
existing contracts with the cord blood banks, or, if necessary,
to conduct a new competition for the collection of high-
quality, diverse cord blood units to increase access to
unrelated blood stem cell transplants for patients.
Hearings
The Subcommittee on Health held a hearing on H.R. 2820 on
June 25, 2015. The Subcommittee received testimony from:
Joanne Kurtzberg, M.D., President, Cord
Blood Association;
Jeff Chell, M.D., Chief Executive Officer,
National Marrow Donor Program;
Patti Freemyer Martin, PhD, Director of
Audiology and Speech Language Pathology, Arkansas
Children's Hospital;
Stephen W. Patrick, M.D., M.P.H., M.S.,
Assistant Professor of Pediatrics and Health Policy,
Department of Pediatrics, Vanderbilt University School
of Medicine; and
Mishka Terplan, M.D., M.P.H., FACOG, Medical
Director, Behavior Health System Baltimore.
Committee Consideration
On July 23, 2015, the Subcommittee on Health met in open
markup session and forwarded H.R. 2820 to the full Committee,
without amendment, by a voice vote. On July 29, 2015, the full
Committee on Energy and Commerce met in open markup session and
ordered H.R. 2820 reported to the House, without amendment, 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 the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 2820 reported. A motion by Mr. Upton to order H.R. 2820
reported to the House, without amendment, was agreed to by a
voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held hearings
on this legislation.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(1) of rule XIII of the House of
Representatives, the goal of the legislation is to reauthorize
the Stem Cell Therapeutic and Research Act of 2005, and for
other purposes.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
2820, would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 2820 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, August 12, 2015.
Hon. Fred Upton,
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. 2820, the Stem
Cell Therapeutic and Research Reauthorization Act of 2015.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Lisa Ramirez-
Branum.
Sincerely,
Keith Hall.
Enclosure.
H.R. 2820--Stem Cell Therapeutic and Research Reauthorization Act of
2015
Summary: H.R. 2820 would reauthorize the National Cord
Blood Inventory program and the C.W. Bill Young Cell
Transplantation program. Those programs support efforts to
collect and store blood from umbilical cords and to conduct
research and facilitate transplants of bone marrow and blood
from umbilical cords. In 2015, more than $33 million was
appropriated for these purposes.
Over the 2016-2020 period the bill would authorize the
appropriation of $23 million and $30 million per year for the
National Cord Blood Inventory program and the C.W. Bill Young
Cell Transplantation program, respectively. CBO estimates that
implementing the bill would cost $220 million over the 2016-
2020 period, assuming appropriation of the authorized amounts.
Enacting H.R. 2820 would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
H.R. 2820 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
Estimated cost to the Federal Government: The estimated
budgetary effects of H.R. 2820 are shown in the following
table. The costs of this legislation fall within budget
function 550 (health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2016 2017 2018 2019 2020 2016-2020
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Authorization Level..................................... 53 53 53 53 53 265
Estimated Outlays....................................... 21 44 51 52 52 220
----------------------------------------------------------------------------------------------------------------
Basis of estimate: For this estimate, CBO assumes that H.R.
2820 will be enacted by the start of fiscal year 2016, that the
Congress will appropriate the authorized amounts for each year,
and that spending will follow historical patterns for the
authorized programs.
Pay-As-You-Go considerations: None.
Intergovernmental and private-sector impact: H.R. 2820
contains no intergovernmental or private-sector mandates as
defined in UMRA and would impose no costs on state, local, or
tribal governments.
Estimate prepared by: Federal costs: Lisa Ramirez-Branum;
Impact on state, local, and tribal governments: J'nell Blanco
Suchy; Impact on the private sector: Amy Petz.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 2820 would establish nor reauthorize a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 1725
specifically directs to be completed 0 rule makings within the
meaning of 5 U.S.C. 551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 states that the legislation may be cited as the
``Stem Cell Therapeutic and Research Reauthorization Act of
2015.''
Section 2. Amendments to the Stem Cell Therapeutic and Research Act of
2005
Section 2 would reauthorize the Cord Blood Inventory and
the National Marrow Donor Program for fiscal years 2016 through
2020.
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, and 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).
(b) Requirements.--The Secretary shall require each recipient
of a contract under this section--
(1) to acquire, tissue-type, test, cryopreserve, and
store donated units of cord blood acquired with the
informed consent of the donor, as determined by the
Secretary pursuant to section 379(c) of the Public
Health Service Act, in a manner that complies with
applicable Federal and State regulations;
(2) to encourage donation from a genetically diverse
population;
(3) to make cord blood units that are collected
pursuant to this section or otherwise and meet all
applicable Federal standards available to transplant
centers for transplantation;
(4) to make cord blood units that are collected, but
not appropriate for clinical use, available for peer-
reviewed research;
(5) to make data available, as required by the
Secretary and consistent with section 379(d)(3) of the
Public Health Service Act (42 U.S.C. 274k(d)(3)), as
amended by this Act, in a standardized electronic
format, as determined by the Secretary, for the C.W.
Bill Young Cell Transplantation Program; and
(6) to submit data in a standardized electronic
format for inclusion in the stem cell therapeutic
outcomes database maintained under section 379A of the
Public Health Service Act, as amended by this Act.
(c) Related Cord Blood Donors.--
(1) In general.--The Secretary shall establish a 3-
year demonstration project under which qualified cord
blood banks receiving a contract under this section may
use a portion of the funding under such contract for
the collection and storage of cord blood units for a
family where a first-degree relative has been diagnosed
with a condition that will benefit from transplantation
(including selected blood disorders, malignancies,
metabolic storage disorders, hemoglobinopathies, and
congenital immunodeficiencies) at no cost to such
family. Qualified cord blood banks collecting cord
blood units under this paragraph shall comply with the
requirements of paragraphs (1), (2), (3), and (5) of
subsection (b).
(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 for a first-degree relative.
(3) Inventory.--Cord blood units collected through
the program under this section shall not be counted
toward the inventory goal under the C.W. Bill Young
Cell Transplantation Program.
(4) Report.--Not later than 90 days after the date on
which the project under paragraph (1) is terminated by
the Secretary, the Secretary shall submit to Congress a
report on the outcomes of the project that shall
include the recommendations of the Secretary with
respect to the continuation of such project.
(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;
(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
(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 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 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.--The Secretary may extend the period
of funding under a contract under this section to
exceed a period of 5 years if--
(A) the Secretary finds that 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
(C) the Secretary determines that the
outstanding inventory need cannot be met by the
qualified cord blood banks under contract under
this section.
(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.
(f) Regulations.--The Secretary may promulgate regulations to
carry out this section.
(g) Definitions.--In this section:
(1) The term ``C.W. Bill Young Cell Transplantation
Program'' means the C.W. Bill Young Cell
Transplantation Program under section 379 of the Public
Health Service Act, as amended by this Act.
(2) The term ``cord blood donor'' means a mother who
has delivered a baby and consents to donate the
neonatal blood remaining in the placenta and umbilical
cord after separation from the newborn baby.
(3) The term ``cord blood unit'' means the neonatal
blood collected from the placenta and umbilical cord of
a single newborn baby.
(4) The term ``first-degree relative'' means a
sibling who is one meiosis away from a particular
individual in a family.
(5) The term ``qualified cord blood bank'' has the
meaning given to that term in section 379(d)(4) of the
Public Health Service Act, as amended by this Act.
(6) The term ``Secretary'' means the Secretary of
Health and Human Services.
(h) Authorization of Appropriations.--
(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 and $23,000,000 for each of fiscal
years 2016 through 2020 .
(2) Limitation.--Not to exceed 5 percent of the
amount appropriated under this section for each of
fiscal years [2011 through 2015] 2015 through 2020 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. 379B. AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this part, there are
authorized to be appropriated $30,000,000 for each of fiscal
years [2011 through 2014] 2016 through 2020 and $33,000,000 for
fiscal year 2015.
* * * * * * *