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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\
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\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.
* * * * * * *
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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