[111th Congress Public Law 264]
[From the U.S. Government Printing Office]



[[Page 124 STAT. 2789]]

Public Law 111-264
111th Congress

                                 An Act


 
         To amend the Stem Cell Therapeutic and Research Act of 
               2005. <<NOTE: Oct. 8, 2010 -  [S. 3751]>> 

    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 2010.>> 
SECTION 1. <<NOTE: 42 USC 201 note.>> 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) <<NOTE: Plan.>> 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) <<NOTE: Deadline. Plan.>> 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 124 STAT. 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) <<NOTE: Determination.>> 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 <<NOTE: Contracts.>>  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 124 STAT. 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) <<NOTE: Deadline. Reports.>> 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 <<NOTE: Deadlines.>> 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 <<NOTE: Plan. Deadline.>>  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 124 STAT. 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. <<NOTE: Public information.>> 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 124 STAT. 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 <<NOTE: Review.>>  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 124 STAT. 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:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 156 (2010):
            Sept. 28, considered and passed Senate.
            Sept. 29, considered and passed House.

                                  <all>