[House Report 116-549]
[From the U.S. Government Publishing Office]


116th Congress    }                                   {         Report
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                   {        116-549

======================================================================



 
TIMELY REAUTHORIZATION OF NECESSARY STEM-CELL PROGRAMS LENDS ACCESS TO 
                      NEEDED THERAPIES ACT OF 2019

                                _______
                                

 September 29, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 4764]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 4764) to reauthorize the Stem Cell Therapeutic 
and Research Act of 2005, and for other purposes, having 
considered the same, reports favorably thereon without 
amendment and recommends that the bill do pass.

                                CONTENTS

                                                                    Page
  I. Purpose and Summary.............................................. 1
 II. Background and Need for the Legislation.......................... 2
III. Committee Hearings............................................... 2
 IV. Committee Consideration.......................................... 3
  V. Committee Votes.................................................. 3
 VI. Oversight Findings............................................... 3
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures 4
VIII.Federal Mandates Statement....................................... 4

 IX. Statement of General Performance Goals and Objectives............ 4
  X. Duplication of Federal Programs.................................. 4
 XI. Committee Cost Estimate.......................................... 4
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits...... 4
XIII.Advisory Committee Statement..................................... 4
 
XIV. Applicability to Legislative Branch.............................. 4
 XV. Section-by-Section Analysis of the Legislation................... 5
XVI. Changes in Existing Law Made by the Bill, as Reported............ 5

                         I. Purpose and Summary

    H.R. 4764, the ``Timely ReAuthorization of Necessary Stem-
cell Programs Lends Access to Needed Therapies Act of 2019'', 
or the ``TRANSPLANT Act of 2019'', introduced by 
Representatives Doris O. Matsui (D-CA), Gus Bilirakis (R-FL), 
and Chellie Pingree (D-ME), reauthorizes the C.W. Bill Young 
Transplantation Program (the Program) at level funding of $30 
million each year from fiscal year (FY) 2021 through FY 2025. 
The bill also requires Health Resources and Services 
Administration's (HRSA) Advisory Council on Blood Stem Cell 
Transplantation to meet at least twice a year and requires the 
Department of Health and Human Services (HHS) to review the 
state of the science related to adult stem cells and birthing 
tissues for the purpose of potentially including these 
innovative therapies in the Program. In addition, the bill 
would reauthorize the cord blood inventory program under the 
Stem Cell Therapeutic and Research Act of 2005 at level funding 
of $23 million for each year from FY 2021 through FY 2025.

              II. Background and Need for the Legislation

    The C.W. Bill Young Transplant Program was first 
established through a partnership with the Navy in 1986, 
transferred to the National Institutes of Health (NIH) for 
oversight in 1987, then authorized by the House Committee on 
Energy and Commerce in 1990; it has since been reauthorized in 
1998, 2005, 2010, and 2015.\1\
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    \1\https://bethematch.org/support-the-cause/participate/join-our-
legislative-advocacy-efforts/authorizing-statute/
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    This Program provides life-saving bone marrow and umbilical 
cord blood transplants to help patients suffering from more 
than 70 diseases for which hematologic or immunologic 
reconstruction using bone marrow, peripheral blood, and cord 
blood have been demonstrated to be safe and effective 
including, leukemia, lymphoma, sickle cell anemia, and certain 
other immune system disorders.\2\ For some patients, these 
transplants may come from a familial donor, whereas other 
patients might require an unrelated donor.\3\ The program's 
purpose is to assist transplant patients by providing 
additional information about bone marrow and cord blood 
transplants, maintaining an efficient process for identifying 
donor matches, increasing the number of unrelated donors 
available for transplant, and collecting data and expanding 
research to improve patient outcomes.\4\
---------------------------------------------------------------------------
    \2\Health Resources and Services Administration, Blood Stem Cell, 
About (bloodstemcell.hrsa.gov/about) (accessed September 11, 2020).
    \3\Id.
    \4\Id.
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    The National Cord Blood Inventory (NCBI) receives Federal 
funding for the collection and storage of at least 150,000 cord 
blood units, which are then made available through the C.W. 
Bill Young Transplant Program.\5\
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    \5\Health Resources and Services Administration, Blood Stem Cell, 
About, Contracts, National Cord Blood Inventory Contract Summary (NCBI) 
(bloodstemcell.hrsa.gov/about/contracts/national-cord-blood-inventory-
contract-summary-ncbi) (accessed September 11, 2020).
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                        III. Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 4764:
    The Subcommittee on Health held a legislative hearing on 
July 29, 2020, entitled ``Improving Access to Care: Legislation 
to Reauthorize Key Public Health Programs,'' to consider H.R. 
4764, the ``Timely ReAuthorization of Necessary Stem-cell 
Programs Lends Access to Needed Therapies Act of 2019'' or the 
``TRANSPLANT Act of 2019''. The Subcommittee received testimony 
from the following witnesses:
           Robert Boyd, M.C.R.P., M.Div., President, 
        School-Based Health Alliance;
           Linda Goler Blount, M.P.H., President and 
        CEO, Black Women's Health Imperative;
           Nancy Goodman, M.P.P., J.D., Founder and 
        Executive Director, Kids v. Cancer;
           Aaron Seth Kesselheim, M.D., J.D., M.P.H., 
        Professor of Medicine, Harvard Medical School;
           Brian Lindberg, Chief Legal Officer and 
        General Counsel, National Bone Marrow Donor Program; 
        and
           Travis T. Tygart, Chief Executive Officer, 
        U.S. Anti-Doping Agency.

                      IV. Committee Consideration

    Representatives Matsui (D-CA), Bilirakis (R-FL), and 
Pingree (D-ME) introduced H.R. 4764, the ``Timely 
ReAuthorization of Necessary Stem-cell Programs Lends Access to 
Needed Therapies Act of 2019'' or the ``TRANSPLANT Act of 
2019'', on October 18, 2019, and the bill was referred to the 
Committee on Energy and Commerce. H.R. 4764 was then referred 
to the Subcommittee on Health on October 21, 2019. A 
legislative hearing was held on the bill on July 29, 2020.
    On September 9, 2020, H.R. 4764 was discharged from further 
consideration by the Subcommittee on Health as it was called up 
for markup by the full Committee on Energy and Commerce. The 
full Committee met in virtual open markup session on September 
9, 2020, pursuant to notice, to consider H.R. 4764. There were 
no amendments offered to H.R. 4764. Upon conclusion of 
consideration of the bill, the full Committee agreed to a 
motion on final passage by Mr. Pallone, Chairman of the 
committee, to order H.R. 4764 reported favorably to the House, 
without amendment, by a voice vote, a quorum being present.

                           V. 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. The 
Committee advises that there were no record votes taken on H.R. 
4764, including the motion for final passage of the bill.

                         VI. Oversight Findings

    Pursuant to 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 portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. 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.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to 
reauthorize the Stem Cell Therapeutic and Research Act of 2005 
and provide technical and clarifying changes to the C.W. Bill 
Young Transplantation Program.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 4764 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, 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.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 4764 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. 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.

           XV. Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the short title may be cited as 
the ``Timely ReAuthorization of Necessary Stem-cell Programs 
Lends Access to Needed Therapies Act of 2019'' or the 
``TRANSPLANT Act of 2019''.

Sec. 2. Reauthorization of the C.W. Bill Young Transplantation Program

    Section 2 amends section 379 of the Public Health Service 
Act to reauthorize the C.W. Bill Young Transplantation Program 
for $30,000,000 for each fiscal year (FY) 2021 through 2025.
    The section also requires the Secretary of the U.S. 
Department of Health and Human Services (the Secretary) to 
convene advisory council meetings at least two times each 
calendar year, provides a technical clarification to increase 
collection of high-quality cord blood units, and eliminates an 
obsolete provision in the underlying statute. Finally, section 
2 requires the Secretary, in consultation with other Health and 
Human Services agencies, the Advisory Council, and other 
external stakeholders, to periodically review the state of 
adult stem cell and birthing tissue science and assess the 
ability to expand the C.W. Bill Young Transplantation Program 
to include new types of therapies. No later than June 30, 2024, 
the Secretary shall complete the review and share 
recommendations with the House Committee on Energy and Commerce 
and the Senate Committee on Health, Education, Labor, and 
Pensions.

Sec. 3. Cord blood inventory

    Section 3 reauthorizes funding for the cord blood 
inventory. It authorizes $23,000,000 for each of the fiscal 
years 2021 through 2025.

       XVI. 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 italics, and existing law in which no 
change is proposed is shown in roman):

                       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) Each member of the Advisory Council shall serve 
        for a term of 2 years, and each such member may serve 
        as many as 3 consecutive 2-year terms, except that--
                  (A) such limitations shall not apply to the 
                Chair of the Advisory Council (or the Chair-
                elect) or to the member of the Advisory Council 
                who most recently served as the Chair; and
                  (B) one additional consecutive 2-year term 
                may be served by any member of the Advisory 
                Council who has no employment, governance, or 
                financial affiliation with any donor center, 
                recruitment organization, transplant center, or 
                cord blood bank.
          (2) A member of the Advisory Council may continue to 
        serve after the expiration of the term of such member 
        until a successor is appointed.
          (3) In order to ensure the continuity of the Advisory 
        Council, the Advisory Council shall be appointed so 
        that each year the terms of approximately one-third of 
        the members of the Advisory Council expire.
          (4) The membership of the Advisory Council--
                  (A) shall include as voting members a 
                balanced number of representatives including 
                representatives of marrow donor centers and 
                marrow transplant centers, representatives of 
                cord blood banks and participating birthing 
                hospitals, recipients of a bone marrow 
                transplant, recipients of a cord blood 
                transplant, persons who require such 
                transplants, family members of such a recipient 
                or family members of a patient who has 
                requested the assistance of the Program in 
                searching for an unrelated donor of bone marrow 
                or cord blood, persons with expertise in bone 
                marrow and cord blood transplantation, persons 
                with expertise in typing, matching, and 
                transplant outcome data analysis, persons with 
                expertise in the social sciences, basic 
                scientists with expertise in the biology of 
                adult stem cells, and members of the general 
                public; and
                  (B) shall include as nonvoting members 
                representatives from the Department of Defense 
                Marrow Donor Recruitment and Research Program 
                operated by the Department of the Navy, the 
                Division of Transplantation of the Health 
                Resources and Services Administration, the Food 
                and Drug Administration, and the National 
                Institutes of Health.
          (5) Members of the Advisory Council shall be chosen 
        so as to ensure objectivity and balance and reduce the 
        potential for conflicts of interest. The Secretary 
        shall establish bylaws and procedures--
                  (A) to prohibit any member of the Advisory 
                Council who has an employment, governance, or 
                financial affiliation with a donor center, 
                recruitment organization, transplant center, or 
                cord blood bank from participating in any 
                decision that materially affects the center, 
                recruitment organization, transplant center, or 
                cord blood bank; and
                  (B) to limit the number of members of the 
                Advisory Council with any such affiliation.
          (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.
          (7) The Secretary shall convene the Advisory Council 
        at least two times each calendar year.
  (b) Accreditation.--The Secretary shall, through a public 
process, recognize one or more accreditation entities for the 
accreditation of cord blood banks.
  (c) Informed Consent.--The Secretary shall, through a public 
process, examine issues of informed consent, including--
          (1) the appropriate timing of such consent; and
          (2) the information provided to the maternal donor 
        regarding all of her medically appropriate cord blood 
        options.
Based on such examination, the Secretary shall require that the 
standards used by the accreditation entities recognized under 
subsection (b) ensure that a cord blood unit is acquired with 
the informed consent of the maternal donor.
  (d) Functions.--
          (1) Bone marrow functions.--With respect to bone 
        marrow, the Program shall--
                  (A) operate a system for identifying, 
                matching, and facilitating the distribution of 
                bone marrow that is suitably matched to 
                candidate patients;
                  (B) consistent with paragraph (3), permit 
                transplant physicians, other appropriate health 
                care professionals, and patients to search by 
                means of electronic access all available bone 
                marrow donors listed in the Program;
                  (C) carry out a program for the recruitment 
                of bone marrow donors in accordance with 
                subsection (e), including with respect to 
                increasing the representation of racial and 
                ethnic minority groups (including persons of 
                mixed ancestry) in the enrollment of the 
                Program;
                  (D) 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;
                  (E) carry out informational and educational 
                activities in accordance with subsection (e);
                  (F) at least annually update information to 
                account for changes in the status of 
                individuals as potential donors of bone marrow;
                  (G) provide for a system of patient advocacy 
                through the office established under subsection 
                (h);
                  (H) provide case management services for any 
                potential donor of bone marrow to whom the 
                Program has provided a notice that the 
                potential donor may be suitably matched to a 
                particular patient through the office 
                established under subsection (h);
                  (I) with respect to searches for unrelated 
                donors of bone marrow that are conducted 
                through the system under subparagraph (A), 
                collect, analyze, and publish data in a 
                standardized electronic format 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;
                  (J) support studies and demonstration and 
                outreach projects for the purpose of increasing 
                the number of individuals who are willing to be 
                marrow donors to ensure a genetically diverse 
                donor pool; and
                  (K) facilitate research with the appropriate 
                Federal agencies to improve the availability, 
                efficiency, safety, and cost of transplants 
                from unrelated donors and the effectiveness of 
                Program operations.
          (2) Cord blood functions.--
                  (A) In general.--With respect to cord blood, 
                the Program shall--
                  (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;
                  (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;
                  (iii) allow transplant physicians and other 
                appropriate health care professionals to 
                reserve, as defined by the Secretary, a cord 
                blood unit for transplantation;
                          (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;
                  (v) provide for a system of patient advocacy 
                through the office established under subsection 
                (h);
                  (vi) coordinate with the qualified cord blood 
                banks to support informational and educational 
                activities in accordance with subsection (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
                  (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 
                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)(i), cells from 
                bone marrow donors and cord blood units through 
                a single point of access.
                  (B) Standard data.--The Secretary shall 
                require all recipients of contracts under this 
                section to make available a standard dataset 
                for purposes of subparagraph (A) in a 
                standardized electronic format that enables 
                transplant physicians to compare among and 
                between bone marrow donors and cord blood units 
                to ensure the best possible match for the 
                patient.
          (4) Definition.--The term ``qualified cord blood 
        bank'' means a cord blood bank that--
                  (A) has obtained all applicable Federal and 
                State licenses, certifications, registrations 
                (including pursuant to the regulations of the 
                Food and Drug Administration), and other 
                authorizations required to operate and maintain 
                a cord blood bank;
                  (B) has implemented donor screening, cord 
                blood collection practices, and processing 
                methods intended to protect the health and 
                safety of donors and transplant recipients to 
                improve transplant outcomes, including with 
                respect to the transmission of potentially 
                harmful infections and other diseases;
                  (C) is accredited by an accreditation entity 
                recognized by the Secretary under subsection 
                (b);
                  (D) has established a system of strict 
                confidentiality to protect the identity and 
                privacy of patients and donors in accordance 
                with existing Federal and State law;
                  (E) has established a system for encouraging 
                donation by a genetically diverse group of 
                donors; and
                  (F) has established a system to 
                confidentially maintain linkage between a cord 
                blood unit and a maternal donor.
  (e) Bone Marrow Recruitment; Priorities; Information and 
Education.--
          (1) Recruitment; priorities.--The Program shall carry 
        out activities for the recruitment of bone marrow 
        donors. Such recruitment program shall identify 
        populations that are underrepresented among potential 
        donors enrolled with the Program. In the case of 
        populations that are identified under the preceding 
        sentence:
                  (A) The Program shall give priority to 
                carrying out activities under this part to 
                increase representation for such populations in 
                order to enable a member of such a population, 
                to the extent practicable, to have a 
                probability of finding a suitable unrelated 
                donor that is comparable to the probability 
                that an individual who is not a member of an 
                underrepresented population would have.
                  (B) The Program shall consider racial and 
                ethnic minority groups (including persons of 
                mixed ancestry) to be populations that have 
                been identified for purposes of this paragraph, 
                and shall carry out subparagraph (A) with 
                respect to such populations.
          (2) Information and education regarding recruitment; 
        testing and enrollment.--
                  (A) In general.--The Program shall carry out 
                informational and educational activities, in 
                coordination with organ donation public 
                awareness campaigns operated through the 
                Department of Health and Human Services, for 
                purposes of recruiting individuals to serve as 
                donors of bone marrow, and shall test and 
                enroll with the Program potential bone marrow 
                donors. Such information and educational 
                activities shall include the following:
                          (i) Making information available to 
                        the general public, including 
                        information describing the needs of 
                        patients with respect to donors of bone 
                        marrow.
                          (ii) Educating and providing 
                        information to individuals who are 
                        willing to serve as potential bone 
                        marrow donors.
                          (iii) Training individuals in 
                        requesting individuals to serve as 
                        potential bone marrow donors.
                  (B) Priorities.--In carrying out 
                informational and educational activities under 
                subparagraph (A), the Program shall give 
                priority to recruiting individuals to serve as 
                donors of bone marrow for populations that are 
                identified under paragraph (1).
          (3) Transplantation as treatment option.--In addition 
        to activities regarding recruitment, the recruitment 
        program under paragraph (1) shall provide information 
        to physicians, other health care professionals, and the 
        public regarding bone marrow transplants from unrelated 
        donors as a treatment option.
          (4) Implementation of subsection.--The requirements 
        of this subsection shall be carried out by the entity 
        that has been awarded a contract by the Secretary under 
        subsection (a) to carry out the functions described in 
        subsection (d)(1).
  (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) quality standards and standards for tissue 
        typing, obtaining the informed consent of donors, and 
        providing patient advocacy;
          (2) donor selection criteria, based on established 
        medical criteria, to protect both the donor and the 
        recipient and to prevent the transmission of 
        potentially harmful infectious diseases such as the 
        viruses that cause hepatitis and the etiologic agent 
        for Acquired Immune Deficiency Syndrome;
          (3) procedures to ensure the proper collection and 
        transportation of the marrow;
          (4) standards for the system for patient advocacy 
        operated under subsection (h), including standards 
        requiring the provision of appropriate information (at 
        the start of the search process and throughout the 
        process) to patients and their families and physicians;
          (5) standards that--
                  (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
                  (B) prescribe the purposes for which the 
                records described in subparagraph (A) may be 
                disclosed, and the circumstances and extent of 
                the disclosure; and
          (6) in the case of a marrow donor center or marrow 
        donor registry participating in the program, procedures 
        to ensure the establishment of a method for integrating 
        donor files, searches, and general procedures of the 
        center or registry with the Program.
  (g) Cord Blood Recruitment; Priorities; Information and 
Education.--
          (1) Recruitment; priorities.--The Program shall 
        support activities, in cooperation with qualified cord 
        blood banks, for the recruitment of cord blood donors. 
        Such recruitment program shall identify populations 
        that are underrepresented among cord blood donors. In 
        the case of populations that are identified under the 
        preceding sentence:
                  (A) The Program shall give priority to 
                supporting activities under this part to 
                increase representation for such populations in 
                order to enable a member of such a population, 
                to the extent practicable, to have a 
                probability of finding a suitable cord blood 
                unit that is comparable to the probability that 
                an individual who is not a member of an 
                underrepresented population would have.
                  (B) The Program shall consider racial and 
                ethnic minority groups (including persons of 
                mixed ancestry) to be populations that have 
                been identified for purposes of this paragraph, 
                and shall support activities under subparagraph 
                (A) with respect to such populations.
          (2) Information and education regarding recruitment; 
        testing and donation.--
                  (A) In general.--In carrying out the 
                recruitment program under paragraph (1), the 
                Program shall support informational and 
                educational activities in coordination with 
                qualified cord blood banks and organ donation 
                public awareness campaigns operated through the 
                Department of Health and Human Services, for 
                purposes of recruiting pregnant women to serve 
                as donors of cord blood. Such information and 
                educational activities shall include the 
                following:
                          (i) Making information available to 
                        the general public, including 
                        information describing the needs of 
                        patients with respect to cord blood 
                        units.
                          (ii) Educating and providing 
                        information to pregnant women who are 
                        willing to donate cord blood units.
                          (iii) Training individuals in 
                        requesting pregnant women to serve as 
                        cord blood donors.
                  (B) Priorities.--In carrying out 
                informational and educational activities under 
                subparagraph (A), the Program shall give 
                priority to supporting the recruitment of 
                pregnant women to serve as donors of cord blood 
                for populations that are identified under 
                paragraph (1).
          (3) Transplantation as treatment option.--In addition 
        to activities regarding recruitment, the recruitment 
        program under paragraph (1) shall provide information 
        to physicians, other health care professionals, and the 
        public regarding cord blood transplants from donors as 
        a treatment option.
          (4) Implementation of subsection.--The requirements 
        of this subsection shall be carried out by the entity 
        that has been awarded a contract by the Secretary under 
        subsection (a) to carry out the functions described in 
        subsection (d)(2).
  (h) Patient Advocacy and Case Management for Bone Marrow and 
Cord Blood.--
          (1) In general.--The Secretary shall establish and 
        maintain, through a contract or other means determined 
        appropriate by the Secretary, an office of patient 
        advocacy (in this subsection referred to as the 
        ``Office'').
          (2) General functions.--The Office shall meet the 
        following requirements:
                  (A) The Office shall be headed by a director.
                  (B) The Office shall be staffed by 
                individuals with expertise in bone marrow and 
                cord blood therapy covered under the Program.
                  (C) The Office shall operate a system for 
                patient advocacy, which shall be separate from 
                mechanisms for donor advocacy, and which shall 
                serve patients for whom the Program is 
                conducting, or has been requested to conduct, a 
                search for a bone marrow donor or cord blood 
                unit.
                  (D) In the case of such a patient, the Office 
                shall serve as an advocate for the patient by 
                directly providing to the patient (or family 
                members, physicians, or other individuals 
                acting on behalf of the patient) individualized 
                services with respect to efficiently utilizing 
                the system under paragraphs (1) and (2) of 
                subsection (d) to conduct an ongoing search for 
                a bone marrow donor or cord blood unit and 
                assist with information regarding third party 
                payor matters.
                  (E) In carrying out subparagraph (D), the 
                Office shall monitor the system under 
                paragraphs (1) and (2) of subsection (d) to 
                determine whether the search needs of the 
                patient involved are being met, including with 
                respect to the following:
                          (i) Periodically providing to the 
                        patient (or an individual acting on 
                        behalf of the patient) information 
                        regarding bone marrow donors or cord 
                        blood units that are suitably matched 
                        to the patient, and other information 
                        regarding the progress being made in 
                        the search.
                          (ii) Informing the patient (or such 
                        other individual) if the search has 
                        been interrupted or discontinued.
                          (iii) Identifying and resolving 
                        problems in the search, to the extent 
                        practicable.
                  (F) The Office shall ensure that the 
                following data are made available to patients:
                          (i) The resources available through 
                        the Program.
                          (ii) A comparison of transplant 
                        centers regarding search and other 
                        costs that prior to transplantation are 
                        charged to patients by transplant 
                        centers.
                          (iii) The post-transplant outcomes 
                        for individual transplant centers.
                          (iv) Information concerning issues 
                        that patients may face after a 
                        transplant.
                          (v) Such other information as the 
                        Program determines to be appropriate.
                  (G) The Office shall conduct surveys of 
                patients (or family members, physicians, or 
                other individuals acting on behalf of patients) 
                to determine the extent of satisfaction with 
                the system for patient advocacy under this 
                subsection, and to identify ways in which the 
                system can be improved to best meet the needs 
                of patients.
          (3) Case management.--
                  (A) In general.--In serving as an advocate 
                for a patient under paragraph (2), the Office 
                shall provide individualized case management 
                services directly to the patient (or family 
                members, physicians, or other individuals 
                acting on behalf of the patient), including--
                          (i) individualized case assessment; 
                        and
                          (ii) the functions described in 
                        paragraph (2)(D) (relating to progress 
                        in the search process).
                  (B) Postsearch functions.--In addition to the 
                case management services described in paragraph 
                (1) for patients, the Office shall, on behalf 
                of patients who have completed the search for a 
                bone marrow donor or cord blood unit, provide 
                information and education on the process of 
                receiving a transplant, including the post-
                transplant process.
  (i) Comment Procedures.--The Secretary shall establish and 
provide information to the public on procedures under which the 
Secretary shall receive and consider comments from interested 
persons relating to the manner in which the Program is carrying 
out the duties of the Program. The Secretary may promulgate 
regulations under this section.
  (j) Consultation.--In developing policies affecting the 
Program, the Secretary shall consult with the Advisory Council, 
the Department of Defense Marrow Donor Recruitment and Research 
Program operated by the Department of the Navy, and the board 
of directors of each entity awarded a contract under this 
section.
  (k) Contracts.--
          (1) Application.--To be eligible to enter into a 
        contract under this section, an entity shall submit to 
        the Secretary and obtain approval of an application at 
        such time, in such manner, and containing such 
        information as the Secretary shall by regulation 
        prescribe.
          (2) Considerations.--In awarding contracts under this 
        section, the Secretary shall give consideration to the 
        continued safety of donors and patients and other 
        factors deemed appropriate by the Secretary.
  (l) Eligibility.--Entities eligible to receive a contract 
under this section shall include private nonprofit entities.
  (m) Records.--
          (1) Recordkeeping.--Each recipient of a contract or 
        subcontract under subsection (a) shall keep such 
        records as the Secretary shall prescribe, including 
        records that fully disclose the amount and disposition 
        by the recipient of the proceeds of the contract, the 
        total cost of the undertaking in connection with which 
        the contract was made, and the amount of the portion of 
        the cost of the undertaking supplied by other sources, 
        and such other records as will facilitate an effective 
        audit.
          (2) Examination of records.--The Secretary and the 
        Comptroller General of the United States shall have 
        access to any books, documents, papers, and records of 
        the recipient of a contract or subcontract entered into 
        under this section that are pertinent to the contract, 
        for the purpose of conducting audits and examinations.
  (n) Penalties for Disclosure.--Any person who discloses the 
content of any record referred to in subsection (d)(4)(D) or 
(f)(5)(A) without the prior written consent of the donor or 
potential donor with respect to whom the record is maintained, 
or in violation of the standards described in subsection 
(f)(5)(B), shall be imprisoned for not more than 2 years or 
fined in accordance with title 18, United States Code, or both.
  (o) Periodic Review of State of Science.--
          (1) Review.--Not less than every two years, the 
        Secretary, in consultation with the Director of the 
        National Institutes of Health, the Commissioner of Food 
        and Drugs, the Administrator of the Health Resources 
        and Services Administration, the Advisory Council, and 
        other stakeholders, where appropriate given relevant 
        expertise, shall conduct a review of the state of the 
        science of using adult stem cells and birthing tissues 
        to develop new types of therapies for patients, for the 
        purpose of considering the potential inclusion of such 
        new types of therapies in the Program.
          (2) Recommendations.--Not later than June 30, 2024, 
        the Secretary shall--
                  (A) complete the second review required by 
                paragraph (1); and
                  (B) informed by such review, submit to the 
                Committee on Health, Education, Labor, and 
                Pensions of the Senate and the Committee on 
                Energy and Commerce of the House of 
                Representatives recommendations on the 
                appropriateness of the inclusion of new types 
                of therapies in the Program.

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SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.

  For the purpose of carrying out this part, there are 
authorized to be appropriated [$33,000,000 for fiscal year 2015 
and $30,000,000 for each of fiscal years 2016 through 2020] 
$30,000,000 for each of fiscal years 2021 through 2025.

           *       *       *       *       *       *       *

                              ----------                              


SECTION 2 OF THE STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT 
                                OF 2015


SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL TRANSPLANTATION 
                    PROGRAM.

  (a) In General.--Section 379(d)(2)(B) of the Public Health 
Service Act (42 U.S.C. 274k(d)(2)(B)) is amended--
          (1) by striking ``remote collection'' and inserting 
        ``collection''; and
          (2) by inserting ``including remote collection,'' 
        after ``goal of increasing collections of high quality 
        cord blood units,''.
  (b) Authorization of Appropriations.--Section 379B of the 
Public Health Service Act (42 U.S.C. 274m) is amended--
          (1) by striking ``$30,000,000 for each of fiscal 
        years 2011 through 2014 and''; and
          (2) by inserting ``and $30,000,000 for each of fiscal 
        years 2016 through 2020'' before the period at the end.
  (c) Secretary Review on State of Science.--The Secretary of 
Health and Human Services, in consultation with the Director of 
the National Institutes of Health, the Commissioner of the Food 
and Drug Administration, and the Administrator of the Health 
Resources and Services Administration, including the Advisory 
Council on Blood Stem Cell Transplantation established under 
section 379(a) of the Public Health Service Act (42 U.S.C. 
274k(a)), and other stakeholders, where appropriate given 
relevant expertise, shall conduct a review of the state of the 
science of using adult stem cells and birthing tissues to 
develop new types of therapies for patients, for the purpose of 
considering the potential inclusion of such new types of 
therapies in the C.W. Bill Young Cell Transplantation Program 
(established under such section 379) in addition to the 
continuation of ongoing activities. Not later than June 30, 
2019, the Secretary shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives 
recommendations on the appropriateness of such new types of 
therapies for inclusion in the C.W. Bill Young Cell 
Transplantation Program.
                              ----------                              


             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 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) 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.
  (d) 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), (3), and (4).
          (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 (c) 
                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.
          (4) Consideration of best science.--The Secretary 
        shall take into consideration the best scientific 
        information available in order to maximize the number 
        of cord blood units available for transplant when 
        entering into contracts under this section, or when 
        extending a period of funding under such a contract 
        under paragraph (2).
          (5) Consideration of banked units of cord blood.--In 
        extending contracts pursuant to paragraph (3), and 
        determining new allocation amounts for the next 
        contract period or contract extension for such cord 
        blood bank, the Secretary shall take into account the 
        number of cord blood units banked in the National Cord 
        Blood Inventory by a cord blood bank during the 
        previous contract period, in addition to consideration 
        of the ability of such cord blood bank to increase the 
        collection and maintenance of additional, genetically 
        diverse cord blood units.
  (e) Regulations.--The Secretary may promulgate regulations to 
carry out this section.
  (f) 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 ``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.
          (5) The term ``Secretary'' means the Secretary of 
        Health and Human Services.
  [(g) Authorization of Appropriations.--
          [(1) Authorization of Appropriations.--There are 
        authorized to be appropriated to the Secretary to carry 
        out the program under this section $20,000,000 for 
        fiscal year 2015 and $23,000,000 for each of fiscal 
        years 2016 through 2020.]
  (g) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated $23,000,000 for 
each of fiscal years 2021 through 2025.

           *       *       *       *       *       *       *


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