[114th Congress Public Law 104]
[From the U.S. Government Publishing Office]



[[Page 2215]]

     STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2015

[[Page 129 STAT. 2216]]

Public Law 114-104
114th Congress

                                 An Act


 
 To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and 
       for other purposes. <<NOTE: Dec. 18, 2015 -  [H.R. 2820]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Stem Cell 
Therapeutic and Research Reauthorization Act of 2015.>> 
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.-- 
<<NOTE: Consultation.>> 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. <<NOTE: Deadline. Recommenda- tions.>> 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) <<NOTE: Contracts.>>  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) <<NOTE: Contracts.>>  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 <<NOTE: Deadline.>> 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:
---------------------------------------------------------------------------

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.

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