[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3751 Introduced in Senate (IS)]

111th CONGRESS
  2d Session
                                S. 3751

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 5, 2010

 Mr. Hatch (for himself, Mr. Dodd, Mr. Burr, Mr. Reed, Mr. Ensign, and 
 Mr. Franken) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
      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 ``at least'' before 
        ``150,000'';
            (2) in subsection (c)(3), by inserting ``at least'' before 
        ``150,000'';
            (3) in subsection (d)--
                    (A) in paragraph (2), by striking ``; and'' and 
                inserting ``;'';
                    (B) by redesignating paragraph (3) as paragraph 
                (5); and
                    (C) 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)--
                                    (I) by inserting ``at least'' 
                                before ``150,000''; and
                                    (II) by striking ``; and'' and 
                                inserting ``;'';
                            (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 paragraph (2) and inserting the 
                following:
            ``(2) 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. Such 
        funds so appropriated shall remain available until expended.''; 
        and
                    (B) in paragraph (3), by striking ``in each of 
                fiscal years 2007 through 2009'' and inserting ``for 
                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 Advisory Council, 
        shall submit to Congress an annual report on the activities 
        carried out under this section.'';
            (2) by striking subsection (d)(2)(D) and inserting the 
        following:
                    ``(D) support studies and demonstration and 
                outreach projects for the purpose of increasing cord 
                blood unit donation and collection from a genetically 
                diverse population, including exploring novel 
                approaches or incentives, such as remote or other 
                innovative technological advances that could be used to 
                collect cord blood units, to expand the number of cord 
                blood unit collection sites partnering with cord blood 
                banks that receive a contract under the National Cord 
                Blood Bank Inventory program under section 2 of the 
                Stem Cell Therapeutic and Research Act of 2005;''; 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) 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. Such funds so appropriated shall 
remain available until expended.''.
    (d) 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 impact of regulatory and 
                administrative requirements, and the capacity of cord 
                blood banks to maintain high-quality units;
                    (B) remote 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; and
                    (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.
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