    [United States Statutes at Large, Volume 124, 111th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 111-264
    111th Congress

    An Act

    To amend the Stem Cell Therapeutic and Research Act of
    2005. <>

    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 2010''.
    SEC. 2. AMENDMENTS TO THE STEM CELL THERAPEUTIC AND RESEARCH ACT
    OF 2005.

    (a) 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 inserting ``the inventory goal of
    at least'' before ``150,000'';
    (2) in subsection (c)--
    (A) in paragraph (2), by striking ``or is
    transferred'' and all that follows through the period
    and inserting ``for a first-degree relative.''; and
    (B) in paragraph (3), by striking ``150,000'';
    (3) in subsection (d)--
    (A) in paragraph (1), by inserting ``beginning on
    the last date on which the recipient of a contract under
    this section receives Federal funds under this section''
    after ``10 years'';
    (B) in paragraph (2), by striking ``; and'' and
    inserting ``;'';
    (C) by redesignating paragraph (3) as paragraph (5);
    and
    (D) by inserting after paragraph (2) the following:
    ``(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'';
    (4) in subsection (e)--
    (A) in paragraph (1)--
    (i) by striking ``10 years'' and inserting ``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''; and

    [[Page 2790]]

    (ii) by striking the second sentence and
    inserting ``The Secretary shall ensure that no
    Federal funds shall be obligated under any such
    contract after the date that is 5 years after the
    date on which the contract is entered into, except
    as provided in paragraphs (2) and (3).'';
    (B) in paragraph (2)--
    (i) in the matter preceding subparagraph (A)--
    (I) by striking ``Subject to
    paragraph (1)(B), the'' and inserting
    ``The''; and
    (II) by striking ``3'' and inserting
    ``5'';
    (ii) in subparagraph (A) by striking
    ``150,000'' and all that follows through ``and''
    at the end and inserting ``the inventory goal
    described in subsection (a) has not yet been
    met;'';
    (iii) in subparagraph (B)--
    (I) by inserting ``meeting the
    requirements under subsection (d)''
    after ``receive an application for a
    contract under this section''; and
    (II) by striking ``or the
    Secretary'' and all that follows through
    the period at the end and inserting ``;
    or''; and
    (iv) by adding at the end the following:
    ``(C) <> the Secretary
    determines that the outstanding inventory need cannot be
    met by the qualified cord blood banks under contract
    under this section.''; and
    (C) by striking paragraph (3) and inserting the
    following:
    ``(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.'';
    (5) in subsection (g)(4), by striking ``or parent''; and
    (6) in subsection (h)--
    (A) by striking paragraphs (1) and (2) and inserting
    the following:
    ``(1) Authorization of appropriations.--There are authorized
    to be appropriated to the Secretary to carry out the program
    under this section $23,000,000 for each of fiscal years 2011
    through 2014 and $20,000,000 for fiscal year 2015.'';
    (B) by redesignating paragraph (3) as paragraph (2);
    and
    (C) in paragraph (2), as so redesignated, by
    striking ``in each of fiscal years 2007 through 2009''
    and inserting ``for each of fiscal years 2011 through
    2015''.

    [[Page 2791]]

    (b) National Program.--Section 379 of the Public Health Service Act
    (42 U.S.C. 274k) is amended--
    (1) by striking subsection (a)(6) and inserting the
    following:
    ``(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.'';
    (2) in subsection (d)--
    (A) in paragraph (2)--
    (i) in the matter preceding subparagraph (A),
    by striking ``With respect to cord blood, the
    Program shall--'' and inserting the following:
    ``(A) In general.--With respect to cord blood, the
    Program shall--'';
    (ii) by redesignating subparagraphs (A)
    through (H) as clauses (i) through (viii)
    respectively;
    (iii) by striking clause (iv), as so
    redesignated, and inserting the following:
    ``(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;''; and
    (iv) by adding at the end the following:
    ``(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

    [[Page 2792]]

    on Energy and Commerce of the House of Representatives
    for expanding remote 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.''; and
    (B) in paragraph (3)(A), by striking ``(2)(A)'' and
    inserting ``(2)(A)(i)''; and
    (3) by striking subsection (f)(5)(A) and inserting the
    following:
    ``(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''.

    (c) Additional Reports.--
    (1) Interim report.--In addition to the annual report
    required under section 379(a)(6) of the Public Health Service
    Act (42 U.S.C. 274k(a)(6)), the Secretary of Health and Human
    Services (referred to in this subsection as the ``Secretary''),
    in consultation with the Advisory Council established under such
    section 379, shall submit to Congress an interim report not
    later than 180 days after the date of enactment of this Act
    describing--
    (A) the methods to distribute Federal funds to cord
    blood banks used at the time of submission of the
    report;
    (B) how cord blood banks contract with collection
    sites for the collection of cord blood units; and
    (C) recommendations for improving the methods to
    distribute Federal funds described in subparagraph (A)
    in order to encourage the efficient collection of high-
    quality and diverse cord blood units.
    (2) Recommendations.--Not later than 1 year after the date
    of enactment of this Act, the Advisory Council shall submit
    recommendations to the Secretary with respect to--
    (A) whether models for remote collection of cord
    blood units should be allowed only with limited,
    scientifically-justified safety protections; and
    (B) whether the Secretary should allow for cord
    blood unit collection from routine deliveries without
    temperature or humidity monitoring of delivery rooms in
    hospitals approved by the Joint Commission.

    (d) Authorization of Appropriations.--Section 379B of the Public
    Health Service Act (42 U.S.C. 274m) is amended by striking
    ``$34,000,000'' and all that follows through the period at the end, and
    inserting ``$30,000,000 for each of fiscal years 2011 through 2014 and
    $33,000,000 for fiscal year 2015.''.
    (e) Report on Cord Blood Unit Donation and Collection.--
    (1) In general.--Not later than 1 year after the date of
    enactment of this Act, the Comptroller General of the United
    States shall submit to the Committee on Health, Education,
    Labor, and Pensions and the Committee on Appropriations of the
    Senate, the Committee on Energy and Commerce and

    [[Page 2793]]

    the Committee on Appropriations of the House of Representatives,
    and the Secretary of Health and Human Services a report
    reviewing studies, demonstration programs, and outreach efforts
    for the purpose of increasing cord blood unit donation and
    collection for the National Cord Blood Inventory to ensure a
    high-quality and genetically diverse inventory of cord blood
    units.
    (2) Contents.--The <>  report described in
    paragraph (1) shall include a review of such studies,
    demonstration programs, and outreach efforts under section 2 of
    the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C.
    274k note) (as amended by this Act) and section 379 of the
    Public Health Service Act (42 U.S.C. 274k) (as amended by this
    Act), including--
    (A) a description of the challenges and barriers to
    expanding the number of cord blood unit collection
    sites, including cost, the cash flow requirements and
    operations of awarding contracts, the methods by which
    funds are distributed through contracts, the impact of
    regulatory and administrative requirements, and the
    capacity of cord blood banks to maintain high-quality
    units;
    (B) remote collection or other innovative
    technological advances that could be used to collect
    cord blood units;
    (C) appropriate methods for improving provider
    education about collecting cord blood units for the
    national inventory and participation in such collection
    activities;
    (D) estimates of the number of cord blood unit
    collection sites necessary to meet the outstanding
    national inventory need and the characteristics of such
    collection sites that would help increase the genetic
    diversity and enhance the quality of cord blood units
    collected;
    (E) best practices for establishing and sustaining
    partnerships for cord blood unit collection at medical
    facilities with a high number of minority births;
    (F) potential and proven incentives to encourage
    hospitals to become cord blood unit collection sites and
    partner with cord blood banks participating in the
    National Cord Blood Inventory under section 2 of the
    Stem Cell Therapeutic and Research Act of 2005 and to
    assist cord blood banks in expanding the number of cord
    blood unit collection sites with which such cord blood
    banks partner;
    (G) recommendations about methods cord blood banks
    and collection sites could use to lower costs and
    improve efficiency of cord blood unit collection without
    decreasing the quality of the cord blood units
    collected; and
    (H) a description of the methods used prior to the
    date of enactment of this Act to distribute funds to
    cord blood banks and recommendations for how to improve
    such methods to encourage the efficient collection of
    high-quality and diverse cord blood units, consistent
    with the requirements of the C.W. Bill Young Cell
    Transplantation Program and the National Cord Blood
    Inventory program under section 2 of the Stem Cell
    Therapeutic and Research Act of 2005.

    [[Page 2794]]

    (f) Definition.--In this Act, the term ``remote collection'' has the
    meaning given such term in section 379(d)(2)(C) of the Public Health
    Service Act.

    Approved October 8, 2010.

    LEGISLATIVE HISTORY--S. 3751:
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    CONGRESSIONAL RECORD, Vol. 156 (2010):
    Sept. 28, considered and passed Senate.
    Sept. 29, considered and passed House.