[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1317 Reported in Senate (RS)]






                                                       Calendar No. 156
109th CONGRESS
  1st Session
                                S. 1317

 To provide for the collection and maintenance of cord blood units for 
the treatment of patients and research, and to amend the Public Health 
     Service Act to authorize the Bone Marrow and Cord Blood Cell 
   Transplantation Program to increase the number of transplants for 
  recipients suitably matched to donors of bone marrow and cord blood.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 27, 2005

Mr. Hatch (for himself, Mr. Dodd, Mr. Burr, Mr. Reed, Mr. Ensign, Mrs. 
Clinton, Ms. Mikulski, Mr. Frist, Mrs. Murray, Mr. Talent, Ms. Collins, 
Mr. Schumer, Mr. Voinovich, Mr. Harkin, Mr. Brownback, Mr. DeWine, Mr. 
 Roberts, Mrs. Dole, Mrs. Feinstein, Mr. Grassley, Mr. Hagel, and Mr. 
    Durbin) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

                             July 11, 2005

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

_______________________________________________________________________

                                 A BILL


 
 To provide for the collection and maintenance of cord blood units for 
the treatment of patients and research, and to amend the Public Health 
     Service Act to authorize the Bone Marrow and Cord Blood Cell 
   Transplantation Program to increase the number of transplants for 
  recipients suitably matched to donors of bone marrow and cord blood.

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

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

<DELETED>    This Act may be cited as the ``Bone Marrow and Cord Blood 
Therapy and Research Act of 2005''.</DELETED>

<DELETED>SEC. 2. CORD BLOOD INVENTORY.</DELETED>

<DELETED>    (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 150,000 new units 
of high-quality cord blood to be made available for transplantation 
through the Bone Marrow and Cord Blood Cell Transplantation Program and 
to carry out the requirements of subsection (b).</DELETED>
<DELETED>    (b) Requirements.--The Secretary shall require each 
recipient of a contract under this section--</DELETED>
        <DELETED>    (1) to acquire, tissue-type, test, cryopreserve, 
        and store donated units of cord blood acquired with the 
        informed consent of the donor in a manner that complies with 
        applicable Federal and State regulations;</DELETED>
        <DELETED>    (2) to encourage donation from a genetically 
        diverse population;</DELETED>
        <DELETED>    (3) 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 
        transplantation;</DELETED>
        <DELETED>    (4) to make cord blood units that are collected, 
        but not appropriate for clinical use, available for peer-
        reviewed research;</DELETED>
        <DELETED>    (5) to make data available, as required by the 
        Secretary and consistent with section 379(c)(3) of the Public 
        Health Service Act (42 U.S.C. 274k(c)(3)), as amended by this 
        Act, in a standardized electronic format, as determined by the 
        Secretary, for the Bone Marrow and Cord Blood Cell 
        Transplantation Program; and</DELETED>
        <DELETED>    (6) to submit data in a standardized electronic 
        format for inclusion in the stem cell therapeutic outcomes 
        database maintained under section 379A of the Public Health 
        Service Act, as amended by this Act.</DELETED>
<DELETED>    (c) Related Cord Blood Donors.--</DELETED>
        <DELETED>    (1) In general.--The Secretary shall establish a 
        3-year demonstration project under which qualified cord blood 
        banks receiving a contract under this section may use a portion 
        of the funding under such contract for the collection and 
        storage of cord blood units for a family where a first-degree 
        relative has been diagnosed with a condition that will benefit 
        from transplantation (including selected blood disorders, 
        malignancies, metabolic storage disorders, hemoglobinopathies, 
        and congenital immunodeficiencies) at no cost to such family. 
        Qualified cord blood banks collecting cord blood units under 
        this paragraph shall comply with the requirements of paragraphs 
        (1), (2), (3), and (5) of subsection (b).</DELETED>
        <DELETED>    (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 Bone Marrow and Cord Blood 
        Cell Transplantation Program in accordance with guidance or 
        regulations promulgated by the Secretary.</DELETED>
        <DELETED>    (3) Inventory.--Cord blood units collected through 
        the program under this section shall not be counted toward the 
        150,000 inventory goal under the Bone Marrow and Cord Blood 
        Cell Transplantation Program.</DELETED>
        <DELETED>    (4) Report.--Not later than 90 days after the date 
        on which the project under paragraph (1) is terminated by the 
        Secretary, the Secretary shall submit to Congress a report on 
        the outcomes of the project that shall include the 
        recommendations of the Secretary with respect to the 
        continuation of such project.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) will participate in the Bone Marrow and Cord 
        Blood Cell Transplantation Program for a period of at least 10 
        years;</DELETED>
        <DELETED>    (2) will make cord blood units collected pursuant 
        to this section available through the Bone Marrow and Cord 
        Blood Cell Transplantation Program in perpetuity; and</DELETED>
        <DELETED>    (3) 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(c)(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.</DELETED>
<DELETED>    (e) Duration of Contracts.--</DELETED>
        <DELETED>    (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. The Secretary shall 
        ensure that Federal funds provided under any such contract 
        terminate on the earlier of--</DELETED>
                <DELETED>    (A) the date that is 3 years after the 
                date on which the contract is entered into; 
                or</DELETED>
                <DELETED>    (B) September 30, 2010.</DELETED>
        <DELETED>    (2) Extensions.--Subject to paragraph (1)(B), the 
        Secretary may extend the period of funding under a contract 
        under this section to exceed a period of 3 years if--</DELETED>
                <DELETED>    (A) the Secretary finds that 150,000 new 
                units of high-quality cord blood have not yet been 
                collected pursuant to this section; and</DELETED>
                <DELETED>    (B) the Secretary does not receive an 
                application for a contract under this section 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.</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (f) Regulations.--The Secretary may promulgate regulations 
to carry out this section.</DELETED>
<DELETED>    (g) Definitions.--In this section:</DELETED>
        <DELETED>    (1) The term ``Bone Marrow and Cord Blood Cell 
        Transplantation Program'' means the Bone Marrow and Cord Blood 
        Cell Transplantation Program under section 379 of the Public 
        Health Service Act, as amended by this Act.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (3) The term ``cord blood unit'' means the 
        neonatal blood collected from the placenta and umbilical cord 
        of a single newborn baby.</DELETED>
        <DELETED>    (4) The term ``first-degree relative'' means a 
        sibling or parent who is one meiosis away from a particular 
        individual in a family.</DELETED>
        <DELETED>    (5) The term ``qualified cord blood bank'' has the 
        meaning given to that term in section 379(c)(4) of the Public 
        Health Service Act, as amended by this Act.</DELETED>
        <DELETED>    (6) The term ``Secretary'' means the Secretary of 
        Health and Human Services.</DELETED>
<DELETED>    (h) Authorization of Appropriations.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (3) Limitation.--Not to exceed 5 percent of the 
        amount appropriated under this section in each of fiscal years 
        2007 through 2009 may be used to carry out the demonstration 
        project under subsection (c).</DELETED>

<DELETED>SEC. 3. BONE MARROW AND CORD BLOOD CELL TRANSPLANTATION 
              PROGRAM.</DELETED>

<DELETED>    (a) National Program.--Section 379 of the Public Health 
Service Act (42 U.S.C. 274k) is amended to read as follows:</DELETED>

<DELETED>``SEC. 379. NATIONAL PROGRAM.</DELETED>

<DELETED>    ``(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 Bone Marrow and 
Cord Blood Cell Transplantation Program (referred to in this section as 
the `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 (c) 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:</DELETED>
        <DELETED>    ``(1) Each member of the Advisory Council shall 
        serve for a term of 2 years, and each such member may serve as 
        many as 3 consecutive 2-year terms, except that</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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 organization, 
                transplant center, or cord blood bank.</DELETED>
        <DELETED>    ``(2) A member of the Advisory Council may 
        continue to serve after the expiration of the term of such 
        member until a successor is appointed.</DELETED>
        <DELETED>    ``(3) In order to ensure the continuity of the 
        Advisory Council, the Advisory Council shall be appointed so 
        that each year the terms of approximately one-third of the 
        members of the Advisory Council expire.</DELETED>
        <DELETED>    ``(4) The membership of the Advisory Council--
        </DELETED>
                <DELETED>    ``(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 banks 
                and participating birthing hospitals, recipients of a 
                bone marrow transplant, recipients of a cord blood 
                transplant, 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 bone 
                marrow and cord blood transplantation, persons with 
                expertise in typing, matching, and transplant outcome 
                data analysis, persons with expertise in the social 
                sciences, basic scientists with expertise in the 
                biology of adult stem cells, and members of the general 
                public; and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) to prohibit any member of the 
                Advisory Council who has an employment, governance, or 
                financial affiliation with a donor center, recruitment 
                organization, transplant center, or cord blood bank 
                from participating in any decision that materially 
                affects the center, recruitment organization, 
                transplant center, or cord blood bank; and</DELETED>
                <DELETED>    ``(B) to limit the number of members of 
                the Advisory Council with any such 
                affiliation.</DELETED>
        <DELETED>    ``(6) The Secretary, acting through the Advisory 
        Council, shall submit to the Congress--</DELETED>
                <DELETED>    ``(A) an annual report on the activities 
                carried out under this section; and</DELETED>
                <DELETED>    ``(B) not later than 6 months after the 
                date of the enactment of the Bone Marrow and Cord Blood 
                Therapy 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.</DELETED>
<DELETED>    ``(b) Accreditation.--The Secretary shall, through a 
public process, recognize one or more accreditation entities for the 
accreditation of cord blood banks.</DELETED>
<DELETED>    ``(c) Functions.--</DELETED>
        <DELETED>    ``(1) Bone marrow functions.--With respect to bone 
        marrow, the Program shall--</DELETED>
                <DELETED>    ``(A) operate a system for listing, 
                searching, and facilitating the distribution of bone 
                marrow that is suitably matched to candidate 
                patients;</DELETED>
                <DELETED>    ``(B) consistent with paragraph (3), 
                permit transplant physicians, other appropriate health 
                care professionals, and patients to search by means of 
                electronic access all available bone marrow donors 
                listed in the Program;</DELETED>
                <DELETED>    ``(C) carry out a program for the 
                recruitment of bone marrow donors in accordance with 
                subsection (d), including with respect to increasing 
                the representation of racial and ethnic minority groups 
                (including persons of mixed ancestry) in the enrollment 
                of the Program;</DELETED>
                <DELETED>    ``(D) 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;</DELETED>
                <DELETED>    ``(E) carry out informational and 
                educational activities in accordance with subsection 
                (d);</DELETED>
                <DELETED>    ``(F) at least annually update information 
                to account for changes in the status of individuals as 
                potential donors of bone marrow;</DELETED>
                <DELETED>    ``(G) provide for a system of patient 
                advocacy through the office established under 
                subsection (g);</DELETED>
                <DELETED>    ``(H) 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 through the 
                office established under subsection (g);</DELETED>
                <DELETED>    ``(I) with respect to searches for 
                unrelated donors of bone marrow that are conducted 
                through the system under subparagraph (A), collect, 
                analyze, and publish data in a standardized electronic 
                format 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;</DELETED>
                <DELETED>    ``(J) 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; 
                and</DELETED>
                <DELETED>    ``(K) facilitate and support research to 
                improve the availability, efficiency, safety, and cost 
                of transplants from unrelated donors and the 
                effectiveness of Program operations.</DELETED>
        <DELETED>    ``(2) Cord blood functions.--With respect to cord 
        blood, the Program shall--</DELETED>
                <DELETED>    ``(A) operate a system for listing, 
                searching, 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;</DELETED>
                <DELETED>    ``(B) 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;</DELETED>
                <DELETED>    ``(C) allow transplant physicians and 
                other appropriate health care professionals to reserve, 
                as defined by the Secretary, a cord blood unit for 
                transplantation;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(E) provide for a system of patient 
                advocacy through the office established under 
                subsection (g);</DELETED>
                <DELETED>    ``(F) coordinate with the qualified cord 
                blood banks to carry out informational and educational 
                activities in accordance with subsection (f);</DELETED>
                <DELETED>    ``(G) 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</DELETED>
                <DELETED>    ``(H) 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.</DELETED>
        <DELETED>    ``(3) Single point of access; submission of 
        data.--</DELETED>
                <DELETED>    ``(A) Single point of access.--The 
                Secretary shall ensure that health care professionals 
                and patients are able to, at a minimum, locate, 
                consistent with the functions described in paragraphs 
                (1)(A) and (2)(A), cells from bone marrow donors and 
                cord blood units through a single electronic point of 
                access.</DELETED>
                <DELETED>    ``(B) Standard data.--The Secretary shall 
                require all recipients of contracts under this section 
                to make available a standard dataset for purposes of 
                subparagraph (A) in a standardized electronic format 
                the enables transplant physicians to compare among and 
                between bone marrow donors and cord blood units to 
                ensure the best possible match for the 
                patient.</DELETED>
        <DELETED>    ``(4) Definition.--The term `qualified cord blood 
        bank' means a cord blood bank that--</DELETED>
                <DELETED>    ``(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 bank;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(C) is accredited by an accreditation 
                entity recognized by the Secretary under subsection 
                (b);</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(E) has established a system for 
                encouraging donation by a genetically diverse group of 
                donors; and</DELETED>
                <DELETED>    ``(F) has established a system to 
                confidentially maintain linkage between a cord blood 
                unit and a maternal donor.</DELETED>
<DELETED>    ``(d) Bone Marrow Recruitment; Priorities; Information and 
Education.--</DELETED>
        <DELETED>    ``(1) Recruitment; priorities.--The Program shall 
        carry out activities for the recruitment of bone marrow donors. 
        Such recruitment program shall identify populations that are 
        underrepresented among potential donors enrolled with the 
        Program. In the case of populations that are identified under 
        the preceding sentence:</DELETED>
                <DELETED>    ``(A) The Program shall give priority to 
                carrying out activities under this part to increase 
                representation for such populations in order to enable 
                a member of such a population, to the extent 
                practicable, to have a probability of finding a 
                suitable unrelated donor that is comparable to the 
                probability that an individual who is not a member of 
                an underrepresented population would have.</DELETED>
                <DELETED>    ``(B) The Program shall consider racial 
                and ethnic minority groups (including persons of mixed 
                ancestry) to be populations that have been identified 
                for purposes of this paragraph, and shall carry out 
                subparagraph (A) with respect to such 
                populations.</DELETED>
        <DELETED>    ``(2) Information and education regarding 
        recruitment; testing and enrollment.--</DELETED>
                <DELETED>    ``(A) In general.--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 bone marrow donors. 
                Such information and educational activities shall 
                include the following:</DELETED>
                        <DELETED>    ``(i) Making information available 
                        to the general public, including information 
                        describing the needs of patients with respect 
                        to donors of bone marrow.</DELETED>
                        <DELETED>    ``(ii) Educating and providing 
                        information to individuals who are willing to 
                        serve as potential bone marrow 
                        donors.</DELETED>
                        <DELETED>    ``(iii) Training individuals in 
                        requesting individuals to serve as potential 
                        bone marrow donors.</DELETED>
                <DELETED>    ``(B) Priorities.--In carrying out 
                informational and educational activities under 
                subparagraph (A), the Program shall give priority to 
                recruiting individuals to serve as donors of bone 
                marrow for populations that are identified under 
                paragraph (1).</DELETED>
        <DELETED>    ``(3) Transplantation as treatment option.--In 
        addition to activities regarding recruitment, the recruitment 
        program under paragraph (1) shall provide information to 
        physicians, other health care professionals, and the public 
        regarding bone marrow transplants from unrelated donors as a 
        treatment option.</DELETED>
        <DELETED>    ``(4) Implementation of subsection.--The 
        requirements of this subsection shall be carried out by the 
        entity that has been awarded a contract by the Secretary under 
        subsection (a) to carry out the functions described in 
        subsection (c)(1).</DELETED>
<DELETED>    ``(e) 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--</DELETED>
        <DELETED>    ``(1) quality standards and standards for tissue 
        typing, obtaining the informed consent of donors, and providing 
        patient advocacy;</DELETED>
        <DELETED>    ``(2) donor selection criteria, based on 
        established medical criteria, to protect both the donor and the 
        recipient and to prevent the transmission of potentially 
        harmful infectious diseases such as the viruses that cause 
        hepatitis and the etiologic agent for Acquired Immune 
        Deficiency Syndrome;</DELETED>
        <DELETED>    ``(3) procedures to ensure the proper collection 
        and transportation of the marrow;</DELETED>
        <DELETED>    ``(4) standards for the system for patient 
        advocacy operated under subsection (g), including standards 
        requiring the provision of appropriate information (at the 
        start of the search process and throughout the process) to 
        patients and their families and physicians;</DELETED>
        <DELETED>    ``(5) standards that--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) prescribe the purposes for which the 
                records described in subparagraph (A) may be disclosed, 
                and the circumstances and extent of the disclosure; 
                and</DELETED>
        <DELETED>    ``(6) in the case of a marrow donor center or 
        marrow donor registry participating in the program, procedures 
        to ensure the establishment of a method for integrating donor 
        files, searches, and general procedures of the center or 
        registry with the Program.</DELETED>
<DELETED>    ``(f) Cord Blood Recruitment; Priorities; Information and 
Education.--</DELETED>
        <DELETED>    ``(1) Recruitment; priorities.--The Program shall 
        support activities, in cooperation with qualified cord blood 
        banks, for the recruitment of cord blood donors. Such 
        recruitment program shall identify populations that are 
        underrepresented among cord blood donors. In the case of 
        populations that are identified under the preceding 
        sentence:</DELETED>
                <DELETED>    ``(A) The Program shall give priority to 
                supporting activities under this part to increase 
                representation for such populations in order to enable 
                a member of such a population, to the extent 
                practicable, to have a probability of finding a 
                suitable cord blood unit that is comparable to the 
                probability that an individual who is not a member of 
                an underrepresented population would have.</DELETED>
                <DELETED>    ``(B) The Program shall consider racial 
                and ethnic minority groups (including persons of mixed 
                ancestry) to be populations that have been identified 
                for purposes of this paragraph, and shall support 
                activities under subparagraph (A) with respect to such 
                populations.</DELETED>
        <DELETED>    ``(2) Information and education regarding 
        recruitment; testing and donation.--</DELETED>
                <DELETED>    ``(A) In general.--In carrying out the 
                recruitment program under paragraph (1), the Program 
                shall support informational and educational activities 
                in coordination with qualified cord blood banks and 
                organ donation public awareness campaigns operated 
                through the Department of Health and Human Services, 
                for purposes of recruiting pregnant women to serve as 
                donors of cord blood. Such information and educational 
                activities shall include the following:</DELETED>
                        <DELETED>    ``(i) Making information available 
                        to the general public, including information 
                        describing the needs of patients with respect 
                        to cord blood units.</DELETED>
                        <DELETED>    ``(ii) Educating and providing 
                        information to pregnant women who are willing 
                        to donate cord blood units.</DELETED>
                        <DELETED>    ``(iii) Training individuals in 
                        requesting pregnant women to serve as cord 
                        blood donors.</DELETED>
                <DELETED>    ``(B) Priorities.--In carrying out 
                informational and educational activities under 
                subparagraph (A), the Program shall give priority to 
                supporting the recruitment of pregnant women to serve 
                as donors of cord blood for populations that are 
                identified under paragraph (1).</DELETED>
        <DELETED>    ``(3) Transplantation as treatment option.--In 
        addition to activities regarding recruitment, the recruitment 
        program under paragraph (1) shall provide information to 
        physicians, other health care professionals, and the public 
        regarding cord blood transplants from donors as a treatment 
        option.</DELETED>
        <DELETED>    ``(4) Implementation of subsection.--The 
        requirements of this subsection shall be carried out by the 
        entity that has been awarded a contract by the Secretary under 
        subsection (a) to carry out the functions described in 
        subsection (c)(2).</DELETED>
<DELETED>    ``(g) Patient Advocacy and Case Management for Bone Marrow 
and Cord Blood.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall establish 
        and maintain, through a contract or other means determined 
        appropriate by the Secretary, an office of patient advocacy (in 
        this subsection referred to as the `Office').</DELETED>
        <DELETED>    ``(2) General functions.--The Office shall meet 
        the following requirements:</DELETED>
                <DELETED>    ``(A) The Office shall be headed by a 
                director.</DELETED>
                <DELETED>    ``(B) The Office shall be staffed by 
                individuals with expertise in bone marrow and cord 
                blood therapy covered under the Program.</DELETED>
                <DELETED>    ``(C) The Office shall operate a system 
                for patient advocacy, which shall be separate from 
                mechanisms for donor advocacy, and which shall serve 
                patients for whom the Program is conducting, or has 
                been requested to conduct, a search for a bone marrow 
                donor or cord blood unit.</DELETED>
                <DELETED>    ``(D) In the case of such a patient, the 
                Office shall serve as an advocate for the patient by 
                directly providing to the patient (or family members, 
                physicians, or other individuals acting on behalf of 
                the patient) individualized services with respect to 
                efficiently utilizing the system under paragraphs (1) 
                and (2) of subsection (c) to conduct an ongoing search 
                for a bone marrow donor or cord blood unit and assist 
                with information regarding third party payor 
                matters.</DELETED>
                <DELETED>    ``(E) In carrying out subparagraph (D), 
                the Office shall monitor the system under paragraphs 
                (1) and (2) of subsection (c) to determine whether the 
                search needs of the patient involved are being met, 
                including with respect to the following:</DELETED>
                        <DELETED>    ``(i) Periodically providing to 
                        the patient (or an individual acting on behalf 
                        of the patient) information regarding bone 
                        marrow donors or cord blood units that are 
                        suitably matched to the patient, and other 
                        information regarding the progress being made 
                        in the search.</DELETED>
                        <DELETED>    ``(ii) Informing the patient (or 
                        such other individual) if the search has been 
                        interrupted or discontinued.</DELETED>
                        <DELETED>    ``(iii) Identifying and resolving 
                        problems in the search, to the extent 
                        practicable.</DELETED>
                <DELETED>    ``(F) The Office shall ensure that the 
                following data are made available to 
                patients:</DELETED>
                        <DELETED>    ``(i) The resources available 
                        through the Program.</DELETED>
                        <DELETED>    ``(ii) A comparison of transplant 
                        centers regarding search and other costs that 
                        prior to transplantation are charged to 
                        patients by transplant centers.</DELETED>
                        <DELETED>    ``(iii) The post-transplant 
                        outcomes for individual transplant 
                        centers.</DELETED>
                        <DELETED>    ``(iv) Information concerning 
                        issues that patients may face after a 
                        transplant.</DELETED>
                        <DELETED>    ``(v) Such other information as 
                        the Program determines to be 
                        appropriate.</DELETED>
                <DELETED>    ``(G) The Office shall conduct surveys of 
                patients (or family members, physicians, or other 
                individuals acting on behalf of patients) to determine 
                the extent of satisfaction with the system for patient 
                advocacy under this subsection, and to identify ways in 
                which the system can be improved to best meet the needs 
                of patients.</DELETED>
        <DELETED>    ``(3) Case management.--</DELETED>
                <DELETED>    ``(A) In general.--In serving as an 
                advocate for a patient under paragraph (2), the Office 
                shall provide individualized case management services 
                directly to the patient (or family members, physicians, 
                or other individuals acting on behalf of the patient), 
                including--</DELETED>
                        <DELETED>    ``(i) individualized case 
                        assessment; and</DELETED>
                        <DELETED>    ``(ii) the functions described in 
                        paragraph (2)(D) (relating to progress in the 
                        search process).</DELETED>
                <DELETED>    ``(B) Postsearch functions.--In addition 
                to the case management services described in paragraph 
                (1) for patients, the Office shall, on behalf of 
                patients who have completed the search for a bone 
                marrow donor or cord blood unit, provide information 
                and education on the process of receiving a transplant, 
                including the post-transplant process.</DELETED>
<DELETED>    ``(h) 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.</DELETED>
<DELETED>    ``(i) 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.</DELETED>
<DELETED>    ``(j) Contracts.--</DELETED>
        <DELETED>    ``(1) Application.--To be eligible to enter into a 
        contract under this section, an entity shall submit to the 
        Secretary and obtain approval of an application at such time, 
        in such manner, and containing such information as the 
        Secretary shall by regulation prescribe.</DELETED>
        <DELETED>    ``(2) Considerations.--In awarding contracts under 
        this section, the Secretary shall give consideration to the 
        continued safety of donors and patients and other factors 
        deemed appropriate by the Secretary.</DELETED>
<DELETED>    ``(k) Eligibility.--Entities eligible to receive a 
contract under this section shall include private nonprofit 
entities.</DELETED>
<DELETED>    ``(l) Records.--</DELETED>
        <DELETED>    ``(1) Recordkeeping.--Each recipient of a contract 
        or subcontract under subsection (a) shall keep such records as 
        the Secretary shall prescribe, including records that fully 
        disclose the amount and disposition by the recipient of the 
        proceeds of the contract, the total cost of the undertaking in 
        connection with which the contract was made, and the amount of 
        the portion of the cost of the undertaking supplied by other 
        sources, and such other records as will facilitate an effective 
        audit.</DELETED>
        <DELETED>    ``(2) Examination of records.--The Secretary and 
        the Comptroller General of the United States shall have access 
        to any books, documents, papers, and records of the recipient 
        of a contract or subcontract entered into under this section 
        that are pertinent to the contract, for the purpose of 
        conducting audits and examinations.</DELETED>
<DELETED>    ``(m) Penalties for Disclosure.--Any person who discloses 
the content of any record referred to in subsection (c)(4)(D) or 
(e)(5)(A) without the prior written consent of the donor or potential 
donor with respect to whom the record is maintained, or in violation of 
the standards described in subsection (e)(5)(B), shall be imprisoned 
for not more than 2 years or fined in accordance with title 18, United 
States Code, or both.''.</DELETED>
<DELETED>    (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:</DELETED>

<DELETED>``SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES 
              DATABASE.</DELETED>

<DELETED>    ``(a) Establishment.--The Secretary shall by contract 
establish and maintain a scientific database of information relating to 
patients who have been recipients of a stem cell therapeutics product 
(including bone marrow, cord blood, or other such product) from a 
donor.</DELETED>
<DELETED>    ``(b) Information.--The outcomes database shall include 
information in a standardized electronic format with respect to 
patients described in subsection (a), diagnosis, transplant procedures, 
results, long-term follow-up, 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 a stem cell therapeutics product from a 
donor.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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 
banks.''.</DELETED>
<DELETED>    (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:</DELETED>

<DELETED>``SEC. 379A-1. DEFINITIONS.</DELETED>

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

<DELETED>``SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.</DELETED>

<DELETED>    ``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.''.</DELETED>
<DELETED>    (e) Conforming Amendments.--Part I of title III of the 
Public Health Service Act (42 U.S.C. 274k et seq.) is amended in the 
part heading, by striking ``NATIONAL BONE MARROW DONOR REGISTRY'' and 
inserting ``BONE MARROW AND CORD BLOOD CELL TRANSPLANTATION 
PROGRAM''.</DELETED>

<DELETED>SEC. 4. REPORT ON LICENSURE OF CORD BLOOD UNITS.</DELETED>

<DELETED>    Not later than 90 days after the date of enactment of this 
Act, the Secretary of Health and Human Services, in consultation with 
the Commissioner of Food and Drugs, shall submit to Congress a report 
concerning the progress made by the Food and Drug Administration in 
developing requirements for the licensing of cord blood 
units.</DELETED>

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 banks to assist 
in the collection and maintenance of 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).
    (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 cord blood acquired with the informed consent 
        of the donor, as determined by the Secretary pursuant to 
        section 379(c) of the Public Health Service Act, in a manner 
        that complies with applicable Federal and State regulations;
            (2) to encourage donation from a genetically diverse 
        population;
            (3) 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 transplantation;
            (4) to make cord blood units that are collected, but not 
        appropriate for clinical use, available for peer-reviewed 
        research;
            (5) to make data available, as required by the Secretary 
        and consistent with section 379(d)(3) of the Public Health 
        Service Act (42 U.S.C. 274k(d)(3)), as amended by this Act, in 
        a standardized electronic format, as determined by the 
        Secretary, for the C.W. Bill Young Cell Transplantation 
        Program; and
            (6) to submit data in a standardized electronic format 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) Related Cord Blood Donors.--
            (1) In general.--The Secretary shall establish a 3-year 
        demonstration project under which qualified cord blood banks 
        receiving a contract under this section may use a portion of 
        the funding under such contract for the collection and storage 
        of cord blood units for a family where a first-degree relative 
        has been diagnosed with a condition that will benefit from 
        transplantation (including selected blood disorders, 
        malignancies, metabolic storage disorders, hemoglobinopathies, 
        and congenital immunodeficiencies) at no cost to such family. 
        Qualified cord blood banks collecting cord blood units under 
        this paragraph shall comply with the requirements of paragraphs 
        (1), (2), (3), and (5) of subsection (b).
            (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.
            (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.
            (4) Report.--Not later than 90 days after the date on which 
        the project under paragraph (1) is terminated by the Secretary, 
        the Secretary shall submit to Congress a report on the outcomes 
        of the project that shall include the recommendations of the 
        Secretary with respect to the continuation of such project.
    (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;
            (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) 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. 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.
            (2) Extensions.--Subject to paragraph (1)(B), the Secretary 
        may extend the period of funding under a contract under this 
        section to exceed a period of 3 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
                    (B) the Secretary does not receive an application 
                for a contract under this section 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.
            (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.
    (f) Regulations.--The Secretary may promulgate regulations to carry 
out this section.
    (g) 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 ``cord blood unit'' means the neonatal blood 
        collected from the placenta and umbilical cord of a single 
        newborn baby.
            (4) The term ``first-degree relative'' means a sibling or 
        parent who is one meiosis away from a particular individual in 
        a family.
            (5) The term ``qualified cord blood bank'' has the meaning 
        given to that term in section 379(d)(4) of the Public Health 
        Service Act, as amended by this Act.
            (6) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
    (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.
            (3) Limitation.--Not to exceed 5 percent of the amount 
        appropriated under this section in each of fiscal years 2007 
        through 2009 may be used to carry out the demonstration project 
        under subsection (c).

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 to read as follows:

``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) Each member of the Advisory Council shall serve for a 
        term of 2 years, and each such member may serve as many as 3 
        consecutive 2-year terms, 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 organization, transplant 
                center, or cord blood bank.
            ``(2) A member of the Advisory Council may continue to 
        serve after the expiration of the term of such member until a 
        successor is appointed.
            ``(3) In order to ensure the continuity of the Advisory 
        Council, the Advisory Council shall be appointed so that each 
        year the terms of approximately one-third of the members of the 
        Advisory Council expire.
            ``(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 banks and participating 
                birthing hospitals, recipients of a bone marrow 
                transplant, recipients of a cord blood transplant, 
                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 bone marrow and cord blood 
                transplantation, persons with expertise in typing, 
                matching, and transplant outcome data analysis, persons 
                with expertise in the social sciences, basic scientists 
                with expertise in the biology of adult stem cells, 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.
            ``(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 
                organization, transplant center, or cord blood bank 
                from participating in any decision that materially 
                affects the center, recruitment organization, 
                transplant center, or cord blood 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.
    ``(b) Accreditation.--The Secretary shall, through a public 
process, recognize one or more accreditation entities for the 
accreditation of cord blood banks.
    ``(c) Informed Consent.--The Secretary shall, through a public 
process, examine issues of informed consent, including--
            ``(1) the appropriate timing of such consent; and
            ``(2) the information provided to the maternal donor 
        regarding all of her medically appropriate cord blood options.
Based on such examination, the Secretary shall require that the 
standards used by the accreditation entities recognized under 
subsection (b) ensure that a cord blood unit is acquired with the 
informed consent of the maternal donor.
    ``(d) Functions.--
            ``(1) Bone marrow functions.--With respect to bone marrow, 
        the Program shall--
                    ``(A) operate a system for identifying, matching, 
                and facilitating the distribution of bone marrow that 
                is suitably matched to candidate patients;
                    ``(B) consistent with paragraph (3), permit 
                transplant physicians, other appropriate health care 
                professionals, and patients to search by means of 
                electronic access all available bone marrow donors 
                listed in the Program;
                    ``(C) carry out a program for the recruitment of 
                bone marrow donors in accordance with subsection (e), 
                including with respect to increasing the representation 
                of racial and ethnic minority groups (including persons 
                of mixed ancestry) in the enrollment of the Program;
                    ``(D) 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;
                    ``(E) carry out informational and educational 
                activities in accordance with subsection (e);
                    ``(F) at least annually update information to 
                account for changes in the status of individuals as 
                potential donors of bone marrow;
                    ``(G) provide for a system of patient advocacy 
                through the office established under subsection (h);
                    ``(H) 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 through the 
                office established under subsection (h);
                    ``(I) with respect to searches for unrelated donors 
                of bone marrow that are conducted through the system 
                under subparagraph (A), collect, analyze, and publish 
                data in a standardized electronic format 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;
                    ``(J) 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; and
                    ``(K) facilitate research with the appropriate 
                Federal agencies to improve the availability, 
                efficiency, safety, and cost of transplants from 
                unrelated donors and the effectiveness of Program 
                operations.
            ``(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 
                bank;
                    ``(B) 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) 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;
                    ``(E) provide for a system of patient advocacy 
                through the office established under subsection (h);
                    ``(F) coordinate with the qualified cord blood 
                banks to support informational and educational 
                activities in accordance with subsection (g);
                    ``(G) 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) 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.
            ``(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), cells from bone marrow 
                donors and cord blood units through a single point of 
                access.
                    ``(B) Standard data.--The Secretary shall require 
                all recipients of contracts under this section to make 
                available a standard dataset for purposes of 
                subparagraph (A) in a standardized electronic format 
                that enables transplant physicians to compare among and 
                between bone marrow donors and cord blood units to 
                ensure the best possible match for the patient.
            ``(4) Definition.--The term `qualified cord blood bank' 
        means a cord blood 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 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 entity 
                recognized by the Secretary under subsection (b);
                    ``(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;
                    ``(E) has established a system for encouraging 
                donation by a genetically diverse group of donors; and
                    ``(F) has established a system to confidentially 
                maintain linkage between a cord blood unit and a 
                maternal donor.
    ``(e) Bone Marrow Recruitment; Priorities; Information and 
Education.--
            ``(1) Recruitment; priorities.--The Program shall carry out 
        activities for the recruitment of bone marrow donors. Such 
        recruitment program shall identify populations that are 
        underrepresented among potential donors enrolled with the 
        Program. In the case of populations that are identified under 
        the preceding sentence:
                    ``(A) The Program shall give priority to carrying 
                out activities under this part to increase 
                representation for such populations in order to enable 
                a member of such a population, to the extent 
                practicable, to have a probability of finding a 
                suitable unrelated donor that is comparable to the 
                probability that an individual who is not a member of 
                an underrepresented population would have.
                    ``(B) The Program shall consider racial and ethnic 
                minority groups (including persons of mixed ancestry) 
                to be populations that have been identified for 
                purposes of this paragraph, and shall carry out 
                subparagraph (A) with respect to such populations.
            ``(2) Information and education regarding recruitment; 
        testing and enrollment.--
                    ``(A) In general.--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 bone marrow donors. 
                Such information and educational activities shall 
                include the following:
                            ``(i) Making information available to the 
                        general public, including information 
                        describing the needs of patients with respect 
                        to donors of bone marrow.
                            ``(ii) Educating and providing information 
                        to individuals who are willing to serve as 
                        potential bone marrow donors.
                            ``(iii) Training individuals in requesting 
                        individuals to serve as potential bone marrow 
                        donors.
                    ``(B) Priorities.--In carrying out informational 
                and educational activities under subparagraph (A), the 
                Program shall give priority to recruiting individuals 
                to serve as donors of bone marrow for populations that 
                are identified under paragraph (1).
            ``(3) Transplantation as treatment option.--In addition to 
        activities regarding recruitment, the recruitment program under 
        paragraph (1) shall provide information to physicians, other 
        health care professionals, and the public regarding bone marrow 
        transplants from unrelated donors as a treatment option.
            ``(4) Implementation of subsection.--The requirements of 
        this subsection shall be carried out by the entity that has 
        been awarded a contract by the Secretary under subsection (a) 
        to carry out the functions described in subsection (d)(1).
    ``(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) quality standards and standards for tissue typing, 
        obtaining the informed consent of donors, and providing patient 
        advocacy;
            ``(2) donor selection criteria, based on established 
        medical criteria, to protect both the donor and the recipient 
        and to prevent the transmission of potentially harmful 
        infectious diseases such as the viruses that cause hepatitis 
        and the etiologic agent for Acquired Immune Deficiency 
        Syndrome;
            ``(3) procedures to ensure the proper collection and 
        transportation of the marrow;
            ``(4) standards for the system for patient advocacy 
        operated under subsection (h), including standards requiring 
        the provision of appropriate information (at the start of the 
        search process and throughout the process) to patients and 
        their families and physicians;
            ``(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
                    ``(B) prescribe the purposes for which the records 
                described in subparagraph (A) may be disclosed, and the 
                circumstances and extent of the disclosure; and
            ``(6) in the case of a marrow donor center or marrow donor 
        registry participating in the program, procedures to ensure the 
        establishment of a method for integrating donor files, 
        searches, and general procedures of the center or registry with 
        the Program.
    ``(g) Cord Blood Recruitment; Priorities; Information and 
Education.--
            ``(1) Recruitment; priorities.--The Program shall support 
        activities, in cooperation with qualified cord blood banks, for 
        the recruitment of cord blood donors. Such recruitment program 
        shall identify populations that are underrepresented among cord 
        blood donors. In the case of populations that are identified 
        under the preceding sentence:
                    ``(A) The Program shall give priority to supporting 
                activities under this part to increase representation 
                for such populations in order to enable a member of 
                such a population, to the extent practicable, to have a 
                probability of finding a suitable cord blood unit that 
                is comparable to the probability that an individual who 
                is not a member of an underrepresented population would 
                have.
                    ``(B) The Program shall consider racial and ethnic 
                minority groups (including persons of mixed ancestry) 
                to be populations that have been identified for 
                purposes of this paragraph, and shall support 
                activities under subparagraph (A) with respect to such 
                populations.
            ``(2) Information and education regarding recruitment; 
        testing and donation.--
                    ``(A) In general.--In carrying out the recruitment 
                program under paragraph (1), the Program shall support 
                informational and educational activities in 
                coordination with qualified cord blood banks and organ 
                donation public awareness campaigns operated through 
                the Department of Health and Human Services, for 
                purposes of recruiting pregnant women to serve as 
                donors of cord blood. Such information and educational 
                activities shall include the following:
                            ``(i) Making information available to the 
                        general public, including information 
                        describing the needs of patients with respect 
                        to cord blood units.
                            ``(ii) Educating and providing information 
                        to pregnant women who are willing to donate 
                        cord blood units.
                            ``(iii) Training individuals in requesting 
                        pregnant women to serve as cord blood donors.
                    ``(B) Priorities.--In carrying out informational 
                and educational activities under subparagraph (A), the 
                Program shall give priority to supporting the 
                recruitment of pregnant women to serve as donors of 
                cord blood for populations that are identified under 
                paragraph (1).
            ``(3) Transplantation as treatment option.--In addition to 
        activities regarding recruitment, the recruitment program under 
        paragraph (1) shall provide information to physicians, other 
        health care professionals, and the public regarding cord blood 
        transplants from donors as a treatment option.
            ``(4) Implementation of subsection.--The requirements of 
        this subsection shall be carried out by the entity that has 
        been awarded a contract by the Secretary under subsection (a) 
        to carry out the functions described in subsection (d)(2).
    ``(h) Patient Advocacy and Case Management for Bone Marrow and Cord 
Blood.--
            ``(1) In general.--The Secretary shall establish and 
        maintain, through a contract or other means determined 
        appropriate by the Secretary, an office of patient advocacy (in 
        this subsection referred to as the `Office').
            ``(2) General functions.--The Office shall meet the 
        following requirements:
                    ``(A) The Office shall be headed by a director.
                    ``(B) The Office shall be staffed by individuals 
                with expertise in bone marrow and cord blood therapy 
                covered under the Program.
                    ``(C) The Office shall operate a system for patient 
                advocacy, which shall be separate from mechanisms for 
                donor advocacy, and which shall serve patients for whom 
                the Program is conducting, or has been requested to 
                conduct, a search for a bone marrow donor or cord blood 
                unit.
                    ``(D) In the case of such a patient, the Office 
                shall serve as an advocate for the patient by directly 
                providing to the patient (or family members, 
                physicians, or other individuals acting on behalf of 
                the patient) individualized services with respect to 
                efficiently utilizing the system under paragraphs (1) 
                and (2) of subsection (d) to conduct an ongoing search 
                for a bone marrow donor or cord blood unit and assist 
                with information regarding third party payor matters.
                    ``(E) In carrying out subparagraph (D), the Office 
                shall monitor the system under paragraphs (1) and (2) 
                of subsection (d) to determine whether the search needs 
                of the patient involved are being met, including with 
                respect to the following:
                            ``(i) Periodically providing to the patient 
                        (or an individual acting on behalf of the 
                        patient) information regarding bone marrow 
                        donors or cord blood units that are suitably 
                        matched to the patient, and other information 
                        regarding the progress being made in the 
                        search.
                            ``(ii) Informing the patient (or such other 
                        individual) if the search has been interrupted 
                        or discontinued.
                            ``(iii) Identifying and resolving problems 
                        in the search, to the extent practicable.
                    ``(F) The Office shall ensure that the following 
                data are made available to patients:
                            ``(i) The resources available through the 
                        Program.
                            ``(ii) A comparison of transplant centers 
                        regarding search and other costs that prior to 
                        transplantation are charged to patients by 
                        transplant centers.
                            ``(iii) The post-transplant outcomes for 
                        individual transplant centers.
                            ``(iv) Information concerning issues that 
                        patients may face after a transplant.
                            ``(v) Such other information as the Program 
                        determines to be appropriate.
                    ``(G) The Office shall conduct surveys of patients 
                (or family members, physicians, or other individuals 
                acting on behalf of patients) to determine the extent 
                of satisfaction with the system for patient advocacy 
                under this subsection, and to identify ways in which 
                the system can be improved to best meet the needs of 
                patients.
            ``(3) Case management.--
                    ``(A) In general.--In serving as an advocate for a 
                patient under paragraph (2), the Office shall provide 
                individualized case management services directly to the 
                patient (or family members, physicians, or other 
                individuals acting on behalf of the patient), 
                including--
                            ``(i) individualized case assessment; and
                            ``(ii) the functions described in paragraph 
                        (2)(D) (relating to progress in the search 
                        process).
                    ``(B) Postsearch functions.--In addition to the 
                case management services described in paragraph (1) for 
                patients, the Office shall, on behalf of patients who 
                have completed the search for a bone marrow donor or 
                cord blood unit, provide information and education on 
                the process of receiving a transplant, including the 
                post-transplant process.
    ``(i) 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. The Secretary may promulgate regulations under this 
section.
    ``(j) 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.
    ``(k) Contracts.--
            ``(1) Application.--To be eligible to enter into a contract 
        under this section, an entity shall submit to the Secretary and 
        obtain approval of an application at such time, in such manner, 
        and containing such information as the Secretary shall by 
        regulation prescribe.
            ``(2) Considerations.--In awarding contracts under this 
        section, the Secretary shall give consideration to the 
        continued safety of donors and patients and other factors 
        deemed appropriate by the Secretary.
    ``(l) Eligibility.--Entities eligible to receive a contract under 
this section shall include private nonprofit entities.
    ``(m) Records.--
            ``(1) Recordkeeping.--Each recipient of a contract or 
        subcontract under subsection (a) shall keep such records as the 
        Secretary shall prescribe, including records that fully 
        disclose the amount and disposition by the recipient of the 
        proceeds of the contract, the total cost of the undertaking in 
        connection with which the contract was made, and the amount of 
        the portion of the cost of the undertaking supplied by other 
        sources, and such other records as will facilitate an effective 
        audit.
            ``(2) Examination of records.--The Secretary and the 
        Comptroller General of the United States shall have access to 
        any books, documents, papers, and records of the recipient of a 
        contract or subcontract entered into under this section that 
        are pertinent to the contract, for the purpose of conducting 
        audits and examinations.
    ``(n) Penalties for Disclosure.--Any person who discloses the 
content of any record referred to in subsection (d)(4)(D) or (f)(5)(A) 
without the prior written consent of the donor or potential donor with 
respect to whom the record is maintained, or in violation of the 
standards described in subsection (f)(5)(B), shall be imprisoned for 
not more than 2 years or fined in accordance with title 18, United 
States Code, or both.''.
    (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 a stem cell therapeutics product (including 
bone marrow, cord blood, or other such product) from a donor.
    ``(b) Information.--The outcomes database shall include information 
in a standardized electronic format with respect to patients described 
in subsection (a), diagnosis, transplant procedures, results, long-term 
follow-up, 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 a stem cell 
therapeutics product from a donor.
    ``(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 
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.

    ``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.''.
    (e) Conforming Amendments.--Part I of title III of the Public 
Health Service Act (42 U.S.C. 274k et seq.) is amended in the part 
heading, by striking ``NATIONAL BONE MARROW DONOR REGISTRY'' and 
inserting ``C. W. BILL YOUNG CELL TRANSPLANTATION PROGRAM''.

SEC. 4. REPORT ON LICENSURE OF CORD BLOOD UNITS.

    Not later than 90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services, in consultation with the 
Commissioner of Food and Drugs, shall submit to Congress a report 
concerning the progress made by the Food and Drug Administration in 
developing requirements for the licensing of cord blood units.
                                                       Calendar No. 156

109th CONGRESS

  1st Session

                                S. 1317

_______________________________________________________________________

                                 A BILL

 To provide for the collection and maintenance of cord blood units for 
the treatment of patients and research, and to amend the Public Health 
     Service Act to authorize the Bone Marrow and Cord Blood Cell 
   Transplantation Program to increase the number of transplants for 
  recipients suitably matched to donors of bone marrow and cord blood.

_______________________________________________________________________

                             July 11, 2005

                       Reported with an amendment