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

                                                       Calendar No. 587
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, Mr. 
  Franken, Mrs. Hagan, Ms. Klobuchar, and Mr. Coburn) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

                           September 23, 2010

               Reported by Mr. Harkin, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Stem Cell Therapeutic and 
Research Reauthorization Act of 2010''.</DELETED>

<DELETED>SEC. 2. AMENDMENTS TO THE STEM CELL THERAPEUTIC AND RESEARCH 
              ACT OF 2005.</DELETED>

<DELETED>    (a) Cord Blood Inventory.--Section 2 of the Stem Cell 
Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended--
</DELETED>
        <DELETED>    (1) in subsection (a), by inserting ``at least'' 
        before ``150,000'';</DELETED>
        <DELETED>    (2) in subsection (c)(3), by inserting ``at 
        least'' before ``150,000'';</DELETED>
        <DELETED>    (3) in subsection (d)--</DELETED>
                <DELETED>    (A) in paragraph (2), by striking ``; 
                and'' and inserting ``;'';</DELETED>
                <DELETED>    (B) by redesignating paragraph (3) as 
                paragraph (5); and</DELETED>
                <DELETED>    (C) by inserting after paragraph (2) the 
                following:</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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'';</DELETED>
        <DELETED>    (4) in subsection (e)--</DELETED>
                <DELETED>    (A) in paragraph (1)--</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (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).'';</DELETED>
                <DELETED>    (B) in paragraph (2)--</DELETED>
                        <DELETED>    (i) in the matter preceding 
                        subparagraph (A)--</DELETED>
                                <DELETED>    (I) by striking ``Subject 
                                to paragraph (1)(B), the'' and 
                                inserting ``The''; and</DELETED>
                                <DELETED>    (II) by striking ``3'' and 
                                inserting ``5'';</DELETED>
                        <DELETED>    (ii) in subparagraph (A)--
                        </DELETED>
                                <DELETED>    (I) by inserting ``at 
                                least'' before ``150,000''; 
                                and</DELETED>
                                <DELETED>    (II) by striking ``; and'' 
                                and inserting ``;'';</DELETED>
                        <DELETED>    (iii) in subparagraph (B)--
                        </DELETED>
                                <DELETED>    (I) by inserting ``meeting 
                                the requirements under subsection (d)'' 
                                after ``receive an application for a 
                                contract under this section''; 
                                and</DELETED>
                                <DELETED>    (II) by striking ``or the 
                                Secretary'' and all that follows 
                                through the period at the end and 
                                inserting ``; or''; and</DELETED>
                        <DELETED>    (iv) by adding at the end the 
                        following:</DELETED>
                <DELETED>    ``(C) the Secretary determines that the 
                outstanding inventory need cannot be met by the 
                qualified cord blood banks under contract under this 
                section.''; and</DELETED>
                <DELETED>    (C) by striking paragraph (3) and 
                inserting the following:</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) demonstrates a superior ability to 
                satisfy the requirements described in subsection (b) 
                and achieves the overall goals for which the contract 
                was awarded;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.'';</DELETED>
        <DELETED>    (5) in subsection (g)(4), by striking ``or 
        parent''; and</DELETED>
        <DELETED>    (6) in subsection (h)--</DELETED>
                <DELETED>    (A) by striking paragraph (2) and 
                inserting the following:</DELETED>
        <DELETED>    ``(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</DELETED>
                <DELETED>    (B) in paragraph (3), by striking ``in 
                each of fiscal years 2007 through 2009'' and inserting 
                ``for fiscal years 2011 through 2015''.</DELETED>
<DELETED>    (b) National Program.--Section 379 of the Public Health 
Service Act (42 U.S.C. 274k) is amended--</DELETED>
        <DELETED>    (1) by striking subsection (a)(6) and inserting 
        the following:</DELETED>
        <DELETED>    ``(6) The Secretary, acting through the Advisory 
        Council, shall submit to Congress an annual report on the 
        activities carried out under this section.'';</DELETED>
        <DELETED>    (2) by striking subsection (d)(2)(D) and inserting 
        the following:</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    (3) by striking subsection (f)(5)(A) and inserting 
        the following:</DELETED>
                <DELETED>    ``(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''.</DELETED>
<DELETED>    (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.''.</DELETED>
<DELETED>    (d) Report on Cord Blood Unit Donation and Collection.--
</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (B) remote or other innovative 
                technological advances that could be used to collect 
                cord blood units;</DELETED>
                <DELETED>    (C) appropriate methods for improving 
                provider education about collecting cord blood units 
                for the national inventory and participation in such 
                collection activities;</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (E) best practices for establishing and 
                sustaining partnerships for cord blood unit collection 
                at medical facilities with a high number of minority 
                births;</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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.</DELETED>

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.
                                                       Calendar No. 587

111th CONGRESS

  2d Session

                                S. 3751

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                           September 23, 2010

                       Reported with an amendment