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[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2520 Engrossed in House (EH)]

  1st Session

                               H. R. 2520

_______________________________________________________________________

                                 AN ACT

To provide for the collection and maintenance of human cord blood stem 
  cells for the treatment of patients and research, and to amend the 
    Public Health Service Act to authorize the C.W. Bill Young Cell 
                        Transplantation Program.
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
109th CONGRESS
  1st Session
                                H. R. 2520

_______________________________________________________________________

                                 AN ACT

 
To provide for the collection and maintenance of human cord blood stem 
  cells for the treatment of patients and research, and to amend the 
    Public Health Service Act to authorize the C.W. Bill Young Cell 
                        Transplantation Program.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Stem Cell Therapeutic and Research 
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 stem cell banks 
to assist in the collection and maintenance of 150,000 units of high-
quality human 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).
    (b) Requirements.--The Secretary shall require each recipient of a 
contract under this section--
            (1) to acquire, tissue-type, test, cryopreserve, and store 
        donated units of human cord blood acquired with the informed 
        consent of the donor in a manner that complies with applicable 
        Federal and State regulations;
            (2) to make cord blood units that are collected pursuant to 
        this section or otherwise and meet all applicable Federal 
        standards available to transplant centers for stem cell 
        transplantation;
            (3) to make cord blood units that are collected, but not 
        appropriate for clinical use, available for peer-reviewed 
        research;
            (4) to submit data in a standardized format, as required by 
        the Secretary, for the C.W. Bill Young Cell Transplantation 
        Program; and
            (5) to submit data for inclusion in the stem cell 
        therapeutic outcomes database maintained under section 379A of 
        the Public Health Service Act, as amended by this Act.
    (c) Application.--To seek to enter into a contract under this 
section, a qualified cord blood stem cell 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 an assurance that the applicant--
            (1) will participate in the C.W. Bill Young Cell 
        Transplantation Program for a period of at least 10 years; and
            (2) in the event of abandonment of this activity prior to 
        the expiration of such period, will transfer the units 
        collected pursuant to this section to another qualified cord 
        blood stem cell bank approved by the Secretary to ensure 
        continued availability of cord blood units.
    (d) Duration of Contracts.--
            (1) In general.--The Secretary may not enter into any 
        contract under this section for a period that--
                    (A) exceeds 3 years; or
                    (B) ends after September 30, 2010.
            (2) Extensions.--Subject to paragraph (1)(B), the Secretary 
        may extend the period of a contract under this section to 
        exceed a period of 3 years if--
                    (A) the Secretary finds that 150,000 units of high-
                quality human cord blood have not yet been collected 
                pursuant to this section; and
                    (B) the Secretary does not receive an application 
                for a contract under this section from any qualified 
                cord blood stem cell 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 stem cell banks that have submitted an 
                application for a contract under this section.
    (e) Regulations.--The Secretary may promulgate regulations to carry 
out this section.
    (f) Definitions.--In this section:
            (1) The term ``C.W. Bill Young Cell Transplantation 
        Program'' means the C.W. Bill Young Cell Transplantation 
        Program under section 379 of the Public Health Service Act, as 
        amended by this Act.
            (2) The term ``cord blood donor'' means a mother who has 
        delivered a baby and consents to donate the neonatal blood 
        remaining in the placenta and umbilical cord after separation 
        from the newborn baby.
            (3) The term ``human cord blood unit'' means the neonatal 
        blood collected from the placenta and umbilical cord.
            (4) The term ``qualified cord blood stem cell bank'' has 
        the meaning given to that term in section 379(b) of the Public 
        Health Service Act, as amended by this Act.
            (5) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
    (g) Authorization of Appropriations.--
            (1) Fiscal year 2006.--Any amounts appropriated to the 
        Secretary for fiscal year 2004 or 2005 for the purpose of 
        assisting in the collection or maintenance of human cord blood 
        shall remain available to the Secretary until the end of fiscal 
        year 2006 for the purpose of carrying out this section.
            (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. 
        Amounts appropriated pursuant to this paragraph shall remain 
        available for obligation through the end of fiscal year 2010.

SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM.

    (a) National Program.--Section 379 of the Public Health Service Act 
(42 U.S.C. 274k) is amended--
            (1) in the section heading, by striking ``national 
        registry'' and inserting ``national program'';
            (2) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``The Secretary shall by contract'' and all 
                that follows through the end of such matter and 
                inserting ``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 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 (b) if deemed necessary by the 
                Secretary to operate an effective and efficient system. 
                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:'';
                    (B) in paragraph (1), by striking ``except that'' 
                and all that follows and inserting ``except that--
                    ``(A) such limitations shall not apply to the Chair 
                of the Advisory Council (or the Chair-elect) or to the 
                member of the Advisory Council who most recently served 
                as the Chair; and
                    ``(B) 1 additional consecutive 2-year term may be 
                served by any member of the Advisory Council who has no 
                employment, governance, or financial affiliation with 
                any donor center, recruitment group, transplant center, 
                or cord blood stem cell bank.'';
                    (C) by amending paragraph (4) to read as follows:
            ``(4) The membership of the Advisory Council--
                    ``(A) shall include as voting members a balanced 
                number of representatives including representatives of 
                marrow donor centers and marrow transplant centers, 
                representatives of cord blood stem cell banks and 
                participating birthing hospitals, recipients of a bone 
                marrow transplant and cord blood transplants, persons 
                who require such transplants, family members of such a 
                recipient or family members of a patient who has 
                requested the assistance of the Program in searching 
                for an unrelated donor of bone marrow or cord blood, 
                persons with expertise in blood stem cell 
                transplantation including cord blood, persons with 
                expertise in typing, matching, and transplant outcome 
                data analysis, persons with expertise in the social 
                sciences, and members of the general public; and
                    ``(B) shall include as nonvoting members 
                representatives from the Department of Defense Marrow 
                Donor Recruitment and Research Program operated by the 
                Department of the Navy, the Division of Transplantation 
                of the Health Resources and Services Administration, 
                the Food and Drug Administration, and the National 
                Institutes of Health.''; and
                    (D) by adding at the end the following:
            ``(5) Members of the Advisory Council shall be chosen so as 
        to ensure objectivity and balance and reduce the potential for 
        conflicts of interest. The Secretary shall establish bylaws and 
        procedures--
                    ``(A) to prohibit any member of the Advisory 
                Council who has an employment, governance, or financial 
                affiliation with a donor center, recruitment group, 
                transplant center, or cord blood stem cell bank from 
                participating in any decision that materially affects 
                the center, recruitment group, transplant center, or 
                cord blood stem cell bank; and
                    ``(B) to limit the number of members of the 
                Advisory Council with any such affiliation.
            ``(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.'';
            (3) by amending subsection (b) to read as follows:
    ``(b) Functions.--
            ``(1) Bone marrow functions.--With respect to bone marrow, 
        the Program shall--
                    ``(A) operate a system for listing, searching, and 
                facilitating the distribution of bone marrow that is 
                suitably matched to candidate patients;
                    ``(B) carry out a program for the recruitment of 
                bone marrow donors in accordance with subsection (c), 
                including with respect to increasing the representation 
                of racial and ethnic minority groups (including persons 
                of mixed ancestry) in the enrollment of the Program;
                    ``(C) maintain and expand medical emergency 
                contingency response capabilities in concert with 
                Federal programs for response to threats of use of 
                terrorist or military weapons that can damage marrow, 
                such as ionizing radiation or chemical agents 
                containing mustard, so that the capability of 
                supporting patients with marrow damage from disease can 
                be used to support casualties with marrow damage;
                    ``(D) carry out informational and educational 
                activities in accordance with subsection (c);
                    ``(E) at least annually update information to 
                account for changes in the status of individuals as 
                potential donors of bone marrow;
                    ``(F) provide for a system of patient advocacy 
                through the office established under subsection (d);
                    ``(G) provide case management services for any 
                potential donor of bone marrow to whom the Program has 
                provided a notice that the potential donor may be 
                suitably matched to a particular patient (which 
                services shall be provided through a mechanism other 
                than the system of patient advocacy under subsection 
                (d)), and conduct surveys of donors and potential 
                donors to determine the extent of satisfaction with 
                such services and to identify ways in which the 
                services can be improved;
                    ``(H) with respect to searches for unrelated donors 
                of bone marrow that are conducted through the system 
                under subparagraph (A), collect, analyze, and publish 
                data 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;
                    ``(I) support studies and demonstration and 
                outreach projects for the purpose of increasing the 
                number of individuals who are willing to be marrow 
                donors to ensure a genetically diverse donor pool;
                    ``(J) conduct and support research to improve the 
                availability, efficiency, safety, and cost of 
                transplants from unrelated donors and the effectiveness 
                of Program operations; and
                    ``(K) assist qualified cord blood stem cell banks 
                in the Program in accordance with paragraph (3).
        Subsections (c) through (e) apply with respect to each entity 
        awarded a contract under this section with respect to bone 
        marrow.
            ``(2) Cord blood functions.--With respect to cord blood, 
        the Program shall--
                    ``(A) 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 
                stem cell bank;
                    ``(B) allow transplant physicians, other 
                appropriate health care professionals, and patients to 
                search by means of electronic access all available cord 
                blood units listed in the Program;
                    ``(C) allow transplant physicians and other 
                appropriate health care professionals to tentatively 
                reserve 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; and
                    ``(E) coordinate with the Secretary to carry out 
                information and educational activities for the purpose 
                of increasing cord blood donation and promoting the 
                availability of cord blood units as a transplant 
                option.
            ``(3) Single point of access.--If the Secretary enters into 
        a contract with more than one entity to perform the functions 
        outlined in this subsection, the Secretary shall establish 
        procedures to ensure that health care professionals and 
        patients are able to obtain, consistent with the functions 
        described in paragraphs (1)(A) and (2)(A), cells from adult 
        donors and cord blood units through a single point of access.
            ``(4) Definition.--The term `qualified cord blood stem cell 
        bank' means a cord blood stem cell bank that--
                    ``(A) has obtained all applicable Federal and State 
                licenses, certifications, registrations (including 
                pursuant to the regulations of the Food and Drug 
                Administration), and other authorizations required to 
                operate and maintain a cord blood stem cell bank;
                    ``(B) has implemented donor screening, cord blood 
                collection practices, and processing methods intended 
                to protect the health and safety of donors and 
                transplant recipients to improve transplant outcomes, 
                including with respect to the transmission of 
                potentially harmful infections and other diseases;
                    ``(C) is accredited by an accreditation body 
                recognized pursuant to a public process by the 
                Secretary;
                    ``(D) has established a system of strict 
                confidentiality to protect the identity and privacy of 
                patients and donors in accordance with existing Federal 
                and State law; and
                    ``(E) has established a system for encouraging 
                donation by a genetically diverse group of donors.'';
            (4) in subsection (c)--
                    (A) in paragraph (1), by striking ``The Registry 
                shall carry out a program for the recruitment'' and 
                inserting ``With respect to bone marrow, the Program 
                shall carry out a program for the recruitment'';
                    (B) in paragraph (2)(A)--
                            (i) in the matter preceding clause (i), by 
                        striking the first sentence and inserting ``In 
                        carrying out the program under paragraph (1), 
                        the Program shall carry out informational and 
                        educational activities, in coordination with 
                        organ donation public awareness campaigns 
                        operated through the Department of Health and 
                        Human Services, for purposes of recruiting 
                        individuals to serve as donors of bone marrow 
                        and shall test and enroll with the Program 
                        potential donors.''; and
                            (ii) in clause (ii), by striking ``, 
                        including providing updates''; and
                    (C) in paragraph (3), by striking ``the 
                availability, as a potential treatment option, of 
                receiving a transplant of bone marrow from an unrelated 
                donor'' and inserting ``transplants from unrelated 
                donors as a treatment option and resources for 
                identifying and evaluating other therapeutic 
                alternatives'';
            (5) in subsection (d)--
                    (A) in paragraph (1), by striking ``The Registry 
                shall'' and inserting ``With respect to bone marrow, 
                the Program shall'';
                    (B) in paragraph (2)(C), by inserting ``and assist 
                with information regarding third party payor matters'' 
                after ``ongoing search for a donor'';
                    (C) in subparagraphs (C), (D), and (E) of paragraph 
                (2), by striking the term ``subsection (b)(1)'' each 
                place such term appears and inserting ``subsection 
                (b)(1)(A)'';
                    (D) in paragraph (2)(F)--
                            (i) by redesignating clause (v) as clause 
                        (vi); and
                            (ii) by inserting after clause (iv) the 
                        following:
                            ``(v) Information concerning issues that 
                        patients may face after a transplant regarding 
                        continuity of care and quality of life.''; and
                    (E) in paragraph (3)(B), by striking ``Office may'' 
                and inserting ``Office shall'';
            (6) in the matter preceding paragraph (1) in subsection 
        (e), by striking ``the Secretary shall'' and inserting ``with 
        respect to bone marrow, the Secretary shall'';
            (7) by amending subsection (f) to read as follows:
    ``(f) Comment Procedures.--The Secretary shall establish and 
provide information to the public on procedures under which the 
Secretary shall receive and consider comments from interested persons 
relating to the manner in which the Program is carrying out the duties 
of the Program.'';
            (8) by amending subsection (g) to read as follows:
    ``(g) Consultation.--In developing policies affecting the Program, 
the Secretary shall consult with the Advisory Council, the Department 
of Defense Marrow Donor Recruitment and Research Program operated by 
the Department of the Navy, and the board of directors of each entity 
awarded a contract under this section.'';
            (9) in subsection (h)--
                    (A) by striking ``Application.--'' and inserting 
                ``Contracts.--'';
                    (B) by striking ``To be eligible'' and inserting 
                the following:
            ``(1) Application.--To be eligible''; and
                    (C) by adding at the end the following:
            ``(2) Considerations.--In awarding contracts under this 
        section, the Secretary shall give substantial weight to the 
        continued safety of donors and patients and other factors 
        deemed appropriate by the Secretary.''; and
            (10) by striking subsection (l).
    (b) Stem Cell Therapeutic Outcomes Database.--Section 379A of the 
Public Health Service Act (42 U.S.C. 274l) is amended to read as 
follows:

``SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATABASE.

    ``(a) Establishment.--The Secretary shall by contract establish and 
maintain a scientific database of information relating to patients who 
have been recipients of stem cell therapeutics product (including bone 
marrow, cord blood, or other such product) from a biologically 
unrelated donor.
    ``(b) Information.--The outcomes database shall include information 
with respect to patients described in subsection (a), transplant 
procedures, and such other information as the Secretary determines to 
be appropriate, to conduct an ongoing evaluation of the scientific and 
clinical status of transplantation involving recipients of bone marrow 
from biologically unrelated donors and recipients of a stem cell 
therapeutics product.
    ``(c) Annual Report on Patient Outcomes.--The Secretary shall 
require the entity awarded a contract under this section to submit to 
the Secretary an annual report concerning patient outcomes with respect 
to each transplant center, based on data collected and maintained by 
the entity pursuant to this section.
    ``(d) Publicly Available Data.--The outcomes database shall make 
relevant scientific information not containing individually 
identifiable information available to the public in the form of 
summaries and data sets to encourage medical research and to provide 
information to transplant programs, physicians, patients, entities 
awarded a contract under section 379 donor registries, and cord blood 
stem cell banks.''.
    (c) Definitions.--Part I of title III of the Public Health Service 
Act (42 U.S.C. 274k et seq.) is amended by inserting after section 379A 
the following:

``SEC. 379A-1. DEFINITIONS.

    ``In this part:
            ``(1) The term `Advisory Council' means the advisory 
        council established by the Secretary under section 379(a)(1).
            ``(2) The term `bone marrow' means the cells found in adult 
        bone marrow and peripheral blood.
            ``(3) The term `outcomes database' means the database 
        established by the Secretary under section 379A.
            ``(4) The term `Program' means the C.W. Bill Young Cell 
        Transplantation Program established under section 379.''.
    (d) Authorization of Appropriations.--Section 379B of the Public 
Health Service Act (42 U.S.C. 274m) is amended to read as follows:

``SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.

    ``(a) In General.--For the purpose of carrying out this part, there 
are authorized to be appropriated $28,000,000 for fiscal year 2006 and 
$32,000,000 for each of fiscal years 2007 through 2010.
    ``(b) Emergency Contingency Response Capabilities.--In addition to 
the amounts authorized to be appropriated under subsection (a), there 
is authorized to be appropriated $2,000,000 for the maintenance and 
expansion of emergency contingency response capabilities under section 
379(b)(1)(C).''.
    (e) Conforming Amendments.--Part I of title III of the Public 
Health Service Act (42 U.S.C. 274k et seq.) is amended--
            (1) in the title heading, by striking ``NATIONAL BONE 
        MARROW DONOR REGISTRY'' and inserting ``C.W. BILL YOUNG CELL 
        TRANSPLANTATION PROGRAM''; and
            (2) in section 379, as amended by this section--
                    (A) in subsection (a), by striking the term 
                ``board'' each place such term appears and inserting 
                ``Advisory Council'';
                    (B) in subection (c)--
                            (i) in the matter preceding subparagraph 
                        (A) in paragraph (1), by striking ``Such 
                        program'' and inserting ``Such recruitment 
                        program'';
                            (ii) in paragraph (2), by striking 
                        ``program under paragraph (1)'' and inserting 
                        ``recruitment program under paragraph (1)''; 
                        and
                            (iii) in paragraph (3), by striking 
                        ``program under paragraph (1)'' and inserting 
                        ``recruitment program under paragraph (1)'';
                    (C) in subsection (d)(2)(E), by striking ``Registry 
                program'' and inserting ``Program'';
                    (D) in subsection (e)--
                            (i) in the matter preceding paragraph (1), 
                        by striking ``participating in the program, 
                        including the Registry,'' and inserting 
                        ``participating in the Program, including''; 
                        and
                            (ii) in paragraph (6), by striking ``the 
                        program'' and inserting ``the Program''; and
                    (E) by striking the term ``Registry'' each place 
                such term appears and inserting ``Program''.

            Passed the House of Representatives May 24, 2005.

            Attest:

                                                                 Clerk.
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