[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3751 Enrolled Bill (ENR)]

        S.3751

                      One Hundred Eleventh Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
             the fifth day of January, two thousand and ten


                                 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
                (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''.
    (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 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 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.
    (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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.