[Congressional Record (Bound Edition), Volume 156 (2010), Part 12]
[Senate]
[Pages 16729-16732]
[From the U.S. Government Publishing Office, www.gpo.gov]




     STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2010

  Mr. FRANKEN. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 587, S. 3751.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The assistant legislative clerk read as follows:

       A bill (S. 3751) to amend the Stem Cell Therapeutic and 
     Research Act of 2005.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment in the nature of a substitute to strike 
all after the enacting clause and insert in lieu thereof 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

[[Page 16730]]

     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.

  Mr. REED. Mr. President, today the Senate passed the Stem Cell 
Therapeutic and Research Reauthorization Act of 2010. I was pleased to 
have been involved in the crafting of this bill, which is the product 
of months of bipartisan discussions, collaboration, and negotiation. I 
also want to recognize the hard work and dedication of Senators Dodd, 
Hatch, Burr, and Ensign in getting this bill across the finish line in 
the Senate.
  This bill offers promise to the tens of thousands of individuals 
diagnosed with leukemia and lymphomas, sickle cell anemia, and rare 
genetic blood disorders.
  It will reauthorize the C.W. Bill Young National Marrow Donor 
Program, which has been helping to connect individuals in need of a 
bone marrow transplant with donors since 1986, and the National Cord 
Blood Inventory, which has been helping to connect individuals in need 
of an umbilical cord blood transplant with donors since 1999.
  I am particularly pleased that the bill will remove a cap on the 
number of cord blood units that could be stored by qualified cord blood 
banks in the National Cord Blood Inventory. The original law limited 
the number to 150,000 units. As the science has evolved, we know that 
150,000 is nowhere near the amount necessary to meet the demands of 
those in need of a cord blood transplant. And, in eliminating this cap, 
I am pleased that we

[[Page 16731]]

have included provisions to encourage greater cord blood donation and 
collection as well as provisions to help shed light onto the obstacles 
to greater donation and collection.
  I am proud that the Rhode Island Blood Center has contributed to the 
success of the National Marrow Donor Program with over 61,000 
registered marrow donors. In addition, last year a new partnership 
formed between the Rhode Island Blood Bank and Women and Infants 
Hospital in Providence, RI, to begin collecting umbilical cord blood 
units as part of a pilot project. Over 1,000 units have already been 
collected, and I look forward to the time when Rhode Island will be 
contributing to the National Cord Blood Inventory.
  The public registries made up of Rhode Island donors and those from 
all over the country have been a true lifeline for the Americans who 
have found an unrelated match. By strengthening and enhancing the 
important programs operating these registries, many more Americans will 
be afforded the opportunity to find a match if they are ever in need.
  I look forward to swift passage of this legislation in the House of 
Representatives and the President signing this bill into law shortly 
thereafter.
  Mr. HATCH. Mr. President, I am pleased that the Senate is considering 
S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act of 
2010 which reauthorizes the Stem Cell Therapeutic and Research Act of 
2005--P.L. 109-129--through the end of 2015. I am also grateful that 
Senators Dodd, Burr, Reed, Ensign, Franken and Coburn have joined me as 
sponsors of this bipartisan bill, which was unanimously approved by the 
Senate Committee on Health, Education, Labor and Pensions and the House 
Energy and Commerce Committee last week.
  S. 3751, the Stem Cell Therapeutic and Research Reauthorization Act, 
reauthorizes the C.W. Bill Young Cell Transplantation Program--the 
Program--and the National Cord Blood Inventory program--NCBI. These 
programs maintain donor registries for individuals in need of bone 
marrow and umbilical cord blood transplants. Today, more than eight 
million Americans are registered bone marrow donors, and in the 5 years 
since NCBI was established, more than 28,600 cord blood units have been 
collected. Cord blood transplantation accounts for over 40 percent of 
all transplants in the country.
  I believe it is important for Senators to understand the specifics of 
S. 3751. Our bill reauthorizes the program through the end of Fiscal 
Year 2015. The authorization levels for the Program are $30 million 
from FY11 through FY14 and $33 million in FY15. The NCBI authorization 
levels are $23 million from FY11 through FY14 and $20 million in FY15. 
The total authorization level for both programs combined is $53 million 
annually, which is the same authorization level included in the Stem 
Cell Therapeutic and Research Act of 2005.
  Our bill calls for the collection and maintenance of at least 150,000 
high-quality cord blood units. In order to collect high-quality and 
diverse units, the Health Resources and Services Administration--HRSA--
contracts with cord blood banks to collect and maintain umbilical cord 
blood units for the national inventory. To achieve the goal of 
collecting at least 150,000 units, S. 3751 requires cord blood banks to 
provide a strategic plan to increase collection, assist with the 
creation of new collection sites, or contract with new collection sites 
when first applying for a contract or extending an existing contract. 
S. 3751 also requires cord blood banks to submit an annual plan for 
achieving self-sufficiency and demonstrates on-going measurable 
progress toward achieving self-sufficiency of cord blood collection and 
banking operations. The bill also extends the duration of a contract 
from 3 to 5 years and allows cord blood units to remain part of the 
national inventory for at least 10 years.
  Additionally, S. 3751 redefines the term ``first-degree relative'' as 
a sibling of an individual requiring a transplant. Children are not a 
match for parents in need of a cord blood transplant, as the original 
law suggested. The bill also aligns the privacy protections provided to 
bone marrow donors and patients with umbilical cord blood donors and 
transplant patients.
  The legislation encourages the Program to support studies and 
demonstration projects to increase cord blood donation and collection. 
More specifically, S. 3751 directs the Secretary of Health and Human 
Services--HHS, acting though the HRSA Administrator, to submit to 
Congress an annual report on the National Program's activities 
including novel approaches for increasing cord blood unit donation and 
collection. The HHS Secretary also is directed to set an annual goal of 
increasing collections of high-quality and diverse cord blood units 
through remote collection or other approaches. In addition, S. 3751 
directs the HHS Secretary to identify at least one of these approaches 
to replicate and expand across the country. If a project is not 
identified, the HHS Secretary shall submit a plan for expanding remote 
collection of high-quality and diverse cord blood units.
  S. 3751 requires the HHS Secretary, in consultation with the Advisory 
Council, to submit to Congress an interim report within 6 months after 
enactment, describing existing methods used to distribute Federal funds 
to cord blood banks. The report also would explain how cord blood banks 
contract with cord blood unit collection sites and recommend how these 
methods may be improved in order to encourage efficient collection of 
high-quality and diverse cord blood units.
  Our legislation also requires the Advisory Council to submit 
recommendations to the HHS Secretary 1 year after enactment on whether 
remote models for cord blood unit collection should be allowed with 
only limited, scientifically justified safety protections. The Advisory 
Council would also make recommendations on whether HHS 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.
  Finally, S. 3751 requires the Government Accountability Office--GAO--
to study existing cord blood donation and collection methods and the 
barriers responsible for limiting donation and collection. GAO also 
would analyze the methods used to distribute funds to cord blood banks 
and novel approaches to grow the NCBI.
  S. 3751 proves that contrary to popular belief, bipartisanship still 
exists in the United States Congress. The original Stem Cell 
Therapeutic and Research Act passed Congress unanimously and became 
law--P.L 109-129--on December 20, 2005. This law offered a unique 
opportunity to assist those suffering from a serious illness requiring 
cord blood or bone marrow transplants. In 2005, our goal was to 
increase the number of bone marrow and cord blood donors to meet our 
goal of 150,000 high-quality and diverse cord blood units. Today, our 
goal remains the same except we are encouraging the collection of at 
least 150,000 units. The sponsors of this legislation want to do 
everything in our power to provide patients with the best transplant 
options and signing this legislation into law is how we achieve this 
second goal. Transplant patients and their families deserve nothing 
less.
  S. 3751 is supported by the following organizations: American Society 
of Bone Marrow Transplant, Aplastic Anemia and MDS Society, Center for 
International Blood and Marrow Transplantation, Colorado Cord Blood 
Bank, Duke University Cord Blood Bank, Intermountain Primary Children's 
Hospital, Jeff Gordon Foundation, Leukemia and Lymphoma Foundation, 
LifeCord Cord Blood Bank, National Marrow Donor Program, Nevada Cancer 
Institute, New Jersey Cord Blood Bank, New York Blood Center Cord Blood 
Bank, Rhode Island Blood Center, St. Louis Cord Blood Bank, StemCyte 
International Cord Blood Bank, University of Utah's Cell Therapy 
Facility, Villanova football head coach Andy Talley, and Yale 
University Hospital.
  Finally, I ask unanimous consent to have printed in the Record the 
section by section analysis of S. 3751.

[[Page 16732]]

  There being no objection, the material was ordered to be printed in 
the Record, as follows:


                          Sec. 1. Short title

       Stem Cell Therapeutic and Research Reauthorization Act of 
     2010.


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

       (a) Instructs the Secretary of Health and Human Services 
     (HHS) to enter into contracts with qualified cord blood banks 
     in order to create and maintain a national inventory of at 
     least 150,000 new high quality cord blood units suitable for 
     transplantation into unrelated recipients. The 2005 law 
     authorized a 3-year demonstration project to collect 
     umbilical cord blood units specifically for use in a first-
     degree relative. The law instructed these units to be 
     combined with the national inventory at the end of the 3-year 
     demo. Since the FDA follows different collection and storage 
     requirements for cord blood units intended for use in a 
     first-degree relative and a stranger, the substitute 
     amendment eliminates this instruction and requires the units 
     collected for the demonstration program only be stored for 
     use in a first-degree relative.
       Includes additional requirements for entities applying to 
     be qualified cord blood banks. First, the entity must 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. Second, contract recipients must annually 
     provide to the HHS Secretary a plan for and demonstrate 
     ongoing, measurable progress toward achieving self-
     sufficiency of cord blood collection and banking operations.
       Extends the length of a cord blood bank contract from three 
     years to five years. A five year extension of cord blood 
     contracts will be permitted if such entities: (1) demonstrate 
     a superior ability to satisfy the requirements included in 
     the original statute to be federal cord blood banks; (2) 
     provide a plan for increasing cord blood unit collections at 
     collection sites that exist at the time of consideration of 
     such extension, assist with the establishment of new 
     collection sites, or contract with new collection sites; and 
     (3) annually provide to the HHS Secretary a plan for and 
     demonstrate ongoing, measurable progress toward achieving 
     self-sufficiency of cord blood collection and banking 
     operations.
       Redefines the term, ``first-degree relative'' as a sibling 
     of the individual requiring a transplant. Authorizes 
     appropriations for the National Cord Blood Inventory Program 
     (NCBI) at $23 million in fiscal years 2011-2014 and $20 
     million in fiscal year 2015. The substitute amendment 
     eliminates language in the law which allows funds to remain 
     available until expended since this is overridden by long-
     standing policy in appropriations bills. The statutory 
     language was originally necessary because the 2005 
     authorization law passed after funds had been appropriated.
       (b) Clarifies that the C.W. Bill Young Cell Transplantation 
     Program, known as the Program, shall support studies and 
     outreach projects to increase cord collection 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 
     collection sites partnering with cord blood banks that 
     receive a contract under the NCBI program.
       Directs the Secretary, acting though the Administrator of 
     the Health Resources and Services Administration, to submit 
     to Congress an annual report on activities conducted through 
     the National Program including novel approaches for the 
     purpose of increasing cord blood unit donation and 
     collection. Directs the Secretary to set an annual goal of 
     increasing collections of high quality cord blood units 
     through remote collection or other novel approaches. The 
     Secretary shall identify at least one of these approaches to 
     replicate and expand nationwide as appropriate. If such a 
     project cannot be identified by the Secretary, then the 
     Secretary shall submit a plan for expanding remote collection 
     of high quality cord blood units. Remote collection is 
     defined as cord blood unit collections occurring at locations 
     that do not hold written contracts with existing cord blood 
     banks for collection support.
       Requires the Secretary, in consultation with the Advisory 
     Council, to submit to Congress an interim report not later 
     than 6 months after date of enactment, describing the 
     existing methods used to distribute federal funds to cord 
     blood banks; how cord blood banks contract with collection 
     sites for the collection of cord blood units; and 
     recommendations to improve these methods to encourage the 
     efficient collection of high quality and diverse cord blood 
     units.
       Requires the Advisory Council shall submit recommendations 
     to the Secretary one year after enactment about whether:
       1. remote models for cord blood unit collection should be 
     allowed with only limited, scientifically justified safety 
     protections; and
       2. HHS 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.
       Authorizes appropriations for the C.W. Bill Young Cell 
     Transplantation Program (the Program) at $30 million in 
     fiscal years 2011-2014 and $33 million in fiscal year 2015. 
     The substitute amendment eliminates language in the law which 
     allows funds to remain available until expended since this is 
     overridden by long-standing policy in appropriations bills. 
     The statutory language was originally necessary because the 
     2005 authorization law passed after funds had been 
     appropriated.
       Directs the Government Accountability Office (GAO) to 
     submit a report on cord blood unit donation and collection as 
     well as methods used to distribute funds to cord blood banks 
     no later than one year after enactment. The report shall be 
     submitted to the Senate Committee on Health, Education, Labor 
     and Pensions, the Senate Committee on Appropriations, the 
     House Energy and Commerce Committee and the House Committee 
     on Appropriations.

  Mr. FRANKEN. Mr. President, I ask unanimous consent that the 
committee-reported substitute amendment be agreed to, the bill, as 
amended, be read three times, passed, the motion to reconsider be laid 
upon the table, and that any statements relating thereto be printed in 
the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee amendment in the nature of a substitute was agreed to.
  The bill (S. 3751), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.

                          ____________________