[House Report 111-643]
[From the U.S. Government Publishing Office]


111th Congress                                                   Report
  2d Session                  HOUSE OF REPRESENTATIVES          111-643
=======================================================================
 
     STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2010 

                                _______
                                

 September 28, 2010.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Waxman, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 6081]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 6081) to amend the Stem Cell Therapeutic and 
Research Act of 2005, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     5
Background and Need for Legislation..............................     5
Committee Consideration..........................................     5
Committee Votes..................................................     6
Committee Oversight Findings and Recommendations.................     6
New Budget Authority, Entitlement Authority, and Tax Expenditures     6
Statement of General Performance Goals and Objectives............     6
Constitutional Authority Statement...............................     6
Earmarks and Tax and Tariff Benefits.............................     7
Federal Advisory Committee Statement.............................     7
Applicability of Law to the Legislative Branch...................     7
Federal Mandates Statement.......................................     7
Committee Cost Estimate..........................................     7
Congressional Budget Office Cost Estimate........................     7
Section-by-Section Analysis of the Legislation...................     8
Explanation of Amendments........................................     9
Changes in Existing Law Made by the Bill, as Reported............    10

                               Amendment

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

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 (with appropriate indentation);
                          (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.

                          Purpose and Summary

    H.R. 6081, the ``Stem Cell Therapeutic and Research 
Reauthorization Act of 2010'', was introduced by Rep. C. W. 
Bill Young (R-FL) and Doris O. Matsui (D-CA) on August 9, 2010, 
and referred to the Committee on Energy and Commerce.
    The goal of H.R. 6081 is to reauthorize the C.W. Bill Young 
Cell Transplantation Program, which includes the National 
Registry for adult donors of bone marrow, peripheral blood 
(adult) stem cells, and umbilical cord blood units; the Office 
of Patient Advocacy; and the Stem Cell Therapeutic Outcomes 
Database. H.R. 6081 also reauthorizes the National Cord Blood 
Inventory (NCBI) Program, a program that provides grants to 
public cord blood banks to assist them in collecting donated 
cord blood units, which, in turn, are listed on the National 
Registry.

                  Background and Need for Legislation

    A bone marrow or cord blood transplant replaces a patient's 
diseased blood-forming cells with healthy ones. The procedure 
is used in treating some people with a blood cancer (such as 
leukemia or lymphoma) or an inherited metabolic or immune 
system disorder. According to the Health Resources and Services 
Administration (HRSA), at any given time there are some 6,000 
people across the United States searching for a matched bone 
marrow donor or cord blood unit.
    HRSA funds two major programs that facilitate the provision 
of blood stem cell units to individuals in need of a 
transplant. The C.W. Bill Young Cell Transplantation Program 
supports activities to increase the number of transplants for 
recipients suitably matched to biologically unrelated donors of 
bone marrow and cord blood. The National Cord Blood Inventory 
(NCBI) Program supports the collection, processing, and storage 
of a genetically and ethnically diverse inventory of high-
quality umbilical cord blood for transplantation. These cord 
blood units, as well as other units in the inventories of 
participating cord blood banks, are made available to 
physicians and patients for blood stem cell transplants through 
the C.W. Bill Young Cell Transplantation Program.
    The reauthorization of both the C.W. Bill Young Cell 
Transplantation Program and the NCBI Program is necessary to 
allow HRSA to continue these important and life-saving 
activities.

                        Committee Consideration

    H.R. 6081, the ``Stem Cell Therapeutic and Research 
Reauthorization Act of 2010'', was introduced by Mr. Young of 
Florida and Ms. Matsui of California on August 9, 2010, and 
referred to the Committee on Energy and Commerce. The bill was 
subsequently referred to the Subcommittee on Health on August 
10, 2010. On September 15, 2010, the Subcommittee held a 
legislative hearing on the bill. The Subcommittee met in open 
markup session to consider H.R. 6081 on September 16, 2010. 
During subcommittee consideration, an amendment in the nature 
of a substitute (manager's amendment) by Mr. Pallone of New 
Jersey was adopted by a voice vote. Subsequently, H.R. 6081 was 
favorably forwarded to the full Committee, amended, by a voice 
vote.
    On September 23, 2010, the Committee on Energy and Commerce 
met in open markup session to consider H.R. 6081 as approved by 
the Subcommittee. During the Committee's consideration, an 
amendment in the nature of a substitute was offered by Ms. 
Matsui of California, which was adopted by a voice vote. 
Subsequently, the Committee ordered H.R. 6081 favorably 
reported to the House, amended, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. A 
motion by Mr. Waxman ordering H.R. 6081 reported to the House, 
amended, was approved by a voice vote. There were no record 
votes taken during consideration of this bill.

            Committee Oversight Findings and Recommendations

    In compliance with clause 3(c)(1) of rule XIII and clause 
(2)(b)(1) of rule X of the Rules of the House of 
Representatives, the oversight findings and recommendations of 
the Committee are reflected in the descriptive portions of this 
report, including the finding that reauthorization of the C.W. 
Bill Young Cell Transplantation Program is important to support 
activities to increase the number of transplants for recipients 
suitably matched to biologically unrelated donors of bone 
marrow and cord blood.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee finds 
that H.R. 6081 would result in no new budget authority, 
entitlement authority, or tax expenditures or revenues.

         Statement of General Performance Goals and Objectives

    In accordance with clause 3(c)(4) of rule XIII of the Rules 
of the House of Representatives, the performance goals and 
objectives of the Committee are reflected in the descriptive 
portions of this report, including the goal of reauthorizing 
the C.W. Bill Young Cell Transplantation Program.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
constitutional authority for H.R. 6081 is provided under 
article I, section 8, clauses 3 and 18 of the Constitution of 
the United States.

                  Earmarks and Tax and Tariff Benefits

    H.R. 6081 does not contain any congressional earmarks, 
limited tax benefits, or limited tariff benefits as defined in 
clause 9 of rule XXI of the Rules of the House of 
Representatives.

                  Federal Advisory Committee Statement

    The Committee finds that the legislation does not establish 
or authorize the establishment of an advisory committee within 
the definition of 5 U.S.C. App., section 5(b) of the Federal 
Advisory Committee Act.

             Applicability of Law to the Legislative Branch

    Section 102(b)(3) of Public Law 104-1 requires a 
description of the application of this bill to the legislative 
branch where the bill relates to terms and conditions of 
employment or access to public services and accommodations. 
H.R. 6081 contains no such provisions.

                       Federal Mandates Statement

    Section 423 of the Congressional Budget and Impoundment 
Control Act of 1974 (as amended by section 101(a)(2) of the 
Unfunded Mandates Reform Act, Public Law 104-4) requires a 
statement on whether the provisions of the report include 
unfunded mandates. In compliance with this requirement the 
Committee adopts as its own the analysis of federal mandates 
prepared by the Director of the Congressional Budget Office 
regarding H.R. 6081.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(2) of rule XIII of the Rules of the 
House of Representatives, the Committee adopts as its own the 
cost estimate of H.R. 6081 prepared by the Director of the 
Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

               Congressional Budget Office Cost Estimate

    With respect to the requirements of clause (3)(c)(3) of 
rule XIII of the Rules of the House of Representatives and 
section 402 of the Congressional Budget Act of 1974, the 
Committee has received the following cost estimate for H.R. 
6081 from the Director of Congressional Budget Office:

                                     U.S. Congress,
                               Congressional Budget Office,
                                Washington, DC, September 23, 2010.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 6081, the Stem 
Cell Therapeutic and Research Reauthorization Act of 2010.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Lisa Ramirez-
Branum.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 6081--Stem Cell Therapeutic and Research Reauthorization Act of 
        2010

    H.R. 6081 would reauthorize the National Cord Blood 
Inventory program and the C.W. Bill Young Cell Transplantation 
program. In 2010, over $35 million was appropriated for these 
purposes. The bill also would require the Government 
Accountability Office to conduct a report that reviews the 
studies, demonstration programs, and outreach efforts for the 
purpose of increasing cord blood unit donations and collections 
for the National Cord Blood Inventory program.
    The bill would authorize the appropriation of $53 million 
in fiscal year 2011 and $265 million for fiscal years 2011 
through 2015. Assuming appropriation of those amounts, and 
based on historical spending patterns for similar programs, CBO 
estimates that implementing H.R. 6081 would cost $220 million 
over the 2011-2015 period as shown in the following table. The 
costs of this legislation fall primarily within budget function 
550 (health). Enacting H.R. 6081 would not affect direct 
spending or revenues; therefore, pay-as-you-go procedures do 
not apply.

----------------------------------------------------------------------------------------------------------------
                                                               By fiscal year, in millions of dollars--
                                                     -----------------------------------------------------------
                                                                                                          2011-
                                                        2011      2012      2013      2014      2015      2015
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATIONAuthorization Level.................................        53        53        53        53        53       265
Estimated Outlays...................................        21        44        51        52        52       220
----------------------------------------------------------------------------------------------------------------

    H.R. 6081 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act and 
would not affect the budgets of state, local or tribal 
governments.
    The CBO staff contact for this estimate is Lisa Ramirez-
Branum. This estimate was approved by Holly Harvey, Deputy 
Assistant Director for Budget Analysis.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the Act may be cited as the 
``Stem Cell Therapeutic and Research Reauthorization Act of 
2010''.

Section 2. Amendments to the Stem Cell Therapeutic and Research Act of 
        2005

    Subsection (a) of section 2 clarifies the requirement 
regarding the number of new units of high-quality cord blood 
for the NCBI Program to be ``the inventory goal of at least 
150,000''. It also makes numerous changes to the application 
requirements for qualified blood banks that wish to participate 
in the Cord Blood Inventory and allows for the extension of a 
cord blood bank contract from three to five years under 
specified circumstances. In addition, subsection (a) provides 
for the authorization of appropriations for the NCBI Program at 
a level of $23 million for each of FY2011 through FY2014 and 
$20 million for FY2015.
    Subsection (b) of section 2 clarifies the functions with 
regard to cord blood under the C.W. Bill Young Cell 
Transplantation Program to include support for studies and 
demonstration and outreach projects designed to increase cord 
blood unit donation and collection from a genetically diverse 
population and to expand the number of cord blood unit 
collection sites partnering with cord blood banks that 
participate in the NCBI Program. Such studies and projects 
include those designed to explore novel approaches or 
incentives to encourage innovative technological advances that 
could be used to collect cord blood units. Subsection (b) also 
directs the Secretary of Health and Human Services to set an 
annual goal of increasing collections of high-quality cord 
blood units consistent with the inventory goal established 
through the NCBI Program and provides for the expansion of 
remote collection (as defined in the legislation) of high-
quality cord units under certain conditions.
    Subsection (c) of section 2 requires the Secretary to 
submit an interim report to Congress in addition to the annual 
report required under the C.W. Bill Young Cell Transplantation 
Program.
    Subsection (d) of section 2 provides for the authorization 
of appropriations for the C.W. Bill Young Cell Transplantation 
Program at a level of $30 million for each of FY2011 through 
FY2014 and $33 million for FY2015.
    Subsection (e) directs the Government Accountability Office 
(GAO) to submit a report to Congress on cord blood unit 
donation and collection, including recommendations on efforts 
to increase cord blood unit donation and collection for the 
NCBI Program. Such report shall address, among other issues, 
methods used to distribute funds to cord blood banks prior to 
the date of enactment of this legislation.

                       Explanation of Amendments

    During the Subcommittee on Health markup of H.R. 6081, Mr. 
Pallone of New Jersey offered an amendment in the nature of a 
substitute (manager's amendment), which was adopted by a voice 
vote. During the full Committee consideration of the bill as 
approved by the Subcommittee, Ms. Matsui of California offered 
an amendment in the nature of a substitute, which was also 
adopted by a voice vote. The substance of each amendment is 
reflected in the section-by-section analysis contained in this 
report.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005

           *       *       *       *       *       *       *



SEC. 2. CORD BLOOD INVENTORY.

  (a) In General.--The Secretary of Health and Human Services 
shall enter into one-time contracts with qualified cord blood 
banks to assist in the collection and maintenance of the 
inventory goal of at least 150,000 new units of high-quality 
cord blood to be made available for transplantation through the 
C.W. Bill Young Cell Transplantation Program and to carry out 
the requirements of subsection (b).

           *       *       *       *       *       *       *

  (c) Related Cord Blood Donors.--
          (1) * * *
          (2) Availability.--Qualified cord blood banks that 
        are operating a program under paragraph (1) shall 
        provide assurances that the cord blood units in such 
        banks will be available for directed transplantation 
        until such time that the cord blood unit is released 
        for transplantation [or is transferred by the family to 
        the C.W. Bill Young Cell Transplantation Program in 
        accordance with guidance or regulations promulgated by 
        the Secretary.] for a first-degree relative.
          (3) Inventory.--Cord blood units collected through 
        the program under this section shall not be counted 
        toward the [150,000] inventory goal under the C.W. Bill 
        Young Cell Transplantation Program.

           *       *       *       *       *       *       *

  (d) Application.--To seek to enter into a contract under this 
section, a qualified cord blood bank shall submit an 
application to the Secretary at such time, in such manner, and 
containing such information as the Secretary may reasonably 
require. At a minimum, an application for a contract under this 
section shall include a requirement that the applicant--
          (1) will participate in the C.W. Bill Young Cell 
        Transplantation Program for 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;
          (2) will make cord blood units collected pursuant to 
        this section available through the C.W. Bill Young Cell 
        Transplantation Program in perpetuity or for such time 
        as determined viable by the Secretary[; and];
          (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
          [(3)] (5) if the Secretary determines through an 
        assessment, or through petition by the applicant, that 
        a cord blood bank is no longer operational or does not 
        meet the requirements of section 379(d)(4) of the 
        Public Health Service Act (as added by this Act) and as 
        a result may not distribute the units, transfer the 
        units collected pursuant to this section to another 
        qualified cord blood bank approved by the Secretary to 
        ensure continued availability of cord blood units.
  (e) Duration of Contracts.--
          (1) In general.--Except as provided in paragraph (2), 
        the term of each contract entered into by the Secretary 
        under this section shall be for [10 years] 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. [The Secretary shall 
        ensure that no Federal funds shall be obligated under 
        any such contract after the earlier of--
                  [(A) the date that is 3 years after the date 
                on which the contract is entered into; or
                  [(B) September 30, 2010.] 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).
          (2) Extensions.--[Subject to paragraph (1)(B), the] 
        The Secretary may extend the period of funding under a 
        contract under this section to exceed a period of [3] 5 
        years if--
                  (A) the Secretary finds that [150,000 new 
                units of high-quality cord blood have not yet 
                been collected pursuant to this section; and] 
                the inventory goal described in subsection (a) 
                has not yet been met;
                  (B) the Secretary does not receive an 
                application for a contract under this section 
                meeting the requirements under subsection (d) 
                from any qualified cord blood bank that has not 
                previously entered into a contract under this 
                section [or the Secretary determines that the 
                outstanding inventory need cannot be met by the 
                one or more qualified cord blood banks that 
                have submitted an application for a contract 
                under this section.]; or
                  (C) the Secretary determines that the 
                outstanding inventory need cannot be met by the 
                qualified cord blood banks under contract under 
                this section.
          [(3) Preference.--In considering contract extensions 
        under paragraph (2), the Secretary shall give 
        preference to qualified cord blood banks that the 
        Secretary determines have demonstrated a superior 
        ability to satisfy the requirements described in 
        subsection (b) and to achieve the overall goals for 
        which the contract was awarded.]
          (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.

           *       *       *       *       *       *       *

  (g) Definitions.--In this section:
          (1) * * *

           *       *       *       *       *       *       *

          (4) The term ``first-degree relative'' means a 
        sibling [or parent] who is one meiosis away from a 
        particular individual in a family.

           *       *       *       *       *       *       *

  (h) Authorization of Appropriations.--
          [(1) Existing funds.--Any amounts appropriated to the 
        Secretary for fiscal year 2004 or 2005 for the purpose 
        of assisting in the collection or maintenance of cord 
        blood shall remain available to the Secretary until the 
        end of fiscal year 2007.
          [(2) Subsequent fiscal years.--There are authorized 
        to be appropriated to the Secretary $15,000,000 for 
        each of fiscal years 2007, 2008, 2009, and 2010 to 
        carry out this section.]
          (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.
          [(3)] (2) Limitation.--Not to exceed 5 percent of the 
        amount appropriated under this section [in each of 
        fiscal years 2007 through 2009]  for each of fiscal 
        years 2011 through 2015 may be used to carry out the 
        demonstration project under subsection (c).

           *       *       *       *       *       *       *

                              ----------                              


PUBLIC HEALTH SERVICE ACT

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TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *



          PART I--C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM

SEC. 379. NATIONAL PROGRAM.

  (a) Establishment.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration, shall by one or more contracts establish and 
maintain a C.W. Bill Young Cell Transplantation Program 
(referred to in this section as the ``Program''), successor to 
the National Bone Marrow Donor Registry, that has the purpose 
of increasing the number of transplants for recipients suitably 
matched to biologically unrelated donors of bone marrow and 
cord blood, and that meets the requirements of this section. 
The Secretary may award a separate contract to perform each of 
the major functions of the Program described in paragraphs (1) 
and (2) of subsection (d) if deemed necessary by the Secretary 
to operate an effective and efficient system that is in the 
best interest of patients. The Secretary shall conduct a 
separate competition for the initial establishment of the cord 
blood functions of the Program. The Program shall be under the 
general supervision of the Secretary. The Secretary shall 
establish an Advisory Council to advise, assist, consult with, 
and make recommendations to the Secretary on matters related to 
the activities carried out by the Program. The members of the 
Advisory Council shall be appointed in accordance with the 
following:
          (1) * * *

           *       *       *       *       *       *       *

          [(6) The Secretary, acting through the Advisory 
        Council, shall submit to the Congress--
                  [(A) an annual report on the activities 
                carried out under this section; and
                  [(B) not later than 6 months after the date 
                of the enactment of the Stem Cell Therapeutic 
                and Research Act of 2005, a report of 
                recommendations on the scientific factors 
                necessary to define a cord blood unit as a 
                high-quality unit.]
          (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.

           *       *       *       *       *       *       *

  (d) Functions.--
          (1) * * *
          (2) Cord blood functions.--[With respect to cord 
        blood, the Program shall--]
                  (A) In general.--With respect to cord blood, 
                the Program shall--
                          [(A)] (i) operate a system for 
                        identifying, matching, and facilitating 
                        the distribution of donated cord blood 
                        units that are suitably matched to 
                        candidate patients and meet all 
                        applicable Federal and State 
                        regulations (including informed consent 
                        and Food and Drug Administration 
                        regulations) from a qualified cord 
                        blood bank;
                          [(B)] (ii) consistent with paragraph 
                        (3), allow transplant physicians, other 
                        appropriate health care professionals, 
                        and patients to search by means of 
                        electronic access all available cord 
                        blood units made available through the 
                        Program;
                          [(C)] (iii) allow transplant 
                        physicians and other appropriate health 
                        care professionals to reserve, as 
                        defined by the Secretary, a cord blood 
                        unit for transplantation;
                  [(D) support studies and demonstration and 
                outreach projects for the purpose of increasing 
                cord blood donation to ensure a genetically 
                diverse collection of cord blood units;]
                          (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;
                          [(E)] (v) provide for a system of 
                        patient advocacy through the office 
                        established under subsection (h);
                          [(F)] (vi) coordinate with the 
                        qualified cord blood banks to support 
                        informational and educational 
                        activities in accordance with 
                        subsection (g);
                          [(G)] (vii) maintain and expand 
                        medical contingency response 
                        capabilities, in coordination with 
                        Federal programs, to prepare for and 
                        respond effectively to biological, 
                        chemical, or radiological attacks, and 
                        other public health emergencies that 
                        can damage marrow, so that the 
                        capability of supporting patients with 
                        marrow damage from disease can be used 
                        to support casualties with marrow 
                        damage; and
                          [(H)] (viii) with respect to the 
                        system under subparagraph (A), collect, 
                        analyze, and publish data in a 
                        standardized electronic format, as 
                        required by the Secretary, on the 
                        number and percentage of patients at 
                        each of the various stages of the 
                        search process, including data 
                        regarding the furthest stage reached, 
                        the number and percentage of patients 
                        who are unable to complete the search 
                        process, and the reasons underlying 
                        such circumstances.
                  (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.
          (3) Single point of access; standard data.--
                  (A) Single point of access.--The Secretary 
                shall ensure that health care professionals and 
                patients are able to search electronically for 
                and facilitate access to, in the manner and to 
                the extent defined by the Secretary and 
                consistent with the functions described in 
                paragraphs (1)(A) and [(2)(A)] (2)(A)(i), cells 
                from bone marrow donors and cord blood units 
                through a single point of access.

           *       *       *       *       *       *       *

  (f) Bone Marrow Criteria, Standards, and Procedures.--The 
Secretary shall enforce, for participating entities, including 
the Program, individual marrow donor centers, marrow donor 
registries, marrow collection centers, and marrow transplant 
centers--
          (1) * * *

           *       *       *       *       *       *       *

          (5) standards that--
                  [(A) require the establishment of a system of 
                strict confidentiality of records relating to 
                the identity, address, HLA type, and managing 
                marrow donor center for marrow donors and 
                potential marrow donors; and]
                  (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

           *       *       *       *       *       *       *


SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.

  For the purpose of carrying out this part, there are 
authorized to be appropriated [$34,000,000 for fiscal year 2006 
and $38,000,000 for each of fiscal years 2007 through 2010.] 
$30,000,000 for each of fiscal years 2011 through 2014 and 
$33,000,000 for fiscal year 2015.

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