[United States Statutes at Large, Volume 129, 114th Congress, 1st Session]
[From the U.S. Government Publishing Office, www.gpo.gov]


Public Law 114-104
114th Congress

An Act


 
To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and
for other purposes. <>

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <>
SECTION 1. SHORT TITLE.

This Act may be cited as 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
``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.

[[Page 128 STAT. 2217]]

SEC. 3. CORD BLOOD INVENTORY.

Section 2 of the Stem Cell Therapeutic and Research Act of 2005 (42
U.S.C. 274k note) is amended--
(1) in subsection (a), by striking ``one-time'';
(2) by striking subsection (c);
(3) by redesignating subsections (d) through (h) as
subsections (c) through (g), respectively;
(4) in subsection (d) (as so redesignated)--
(A) in paragraph (1), by striking ``paragraphs (2)
and (3)'' and inserting ``paragraphs (2), (3), and
(4)'';
(B) in paragraph (2)(B), by striking ``subsection
(d)'' and inserting ``subsection (c)''; and
(C) by adding at the end the following:
``(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.'';
(5) in subsection (f) (as so redesignated)--
(A) by striking paragraph (4); and
(B) by redesignating paragraphs (5) and (6) as
paragraphs (4) and (5), respectively; and
(6) in subsection (g) (as so redesignated)--
(A) in paragraph (1)--
(i) by striking ``$23,000,000 for each of
fiscal years 2011 through 2014 and''; and
(ii) by inserting ``and $23,000,000 for each
of fiscal years 2016 through 2020'' before the
period at the end; and
(B) by striking paragraph (2).

[[Page 128 STAT. 2218]]

SEC. 4. <>  DETERMINATION ON
THE DEFINITION OF HUMAN ORGAN.

Not later than one year after the date of enactment of this Act, the
Secretary of Health and Human Services shall issue determinations with
respect to the inclusion of peripheral blood stem cells and umbilical
cord blood in the definition of human organ.

Approved December 18, 2015.

LEGISLATIVE HISTORY--H.R. 2820:
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HOUSE REPORTS: No. 114-242 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 161 (2015):
Sept. 8, considered and passed House.
Dec. 9, considered and passed Senate, amended.
Dec. 16, House concurred in Senate amendment.