[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).

           *       *       *       *       *       *       *

                              ----------                              


                       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.

           *       *       *       *       *       *       *