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[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2520 Enrolled Bill (ENR)]

        H.R.2520

                       One Hundred Ninth Congress

                                 of the

                        United States of America

                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
            the fourth day of January, two thousand and five

                                 An Act

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

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Stem Cell Therapeutic and Research 
Act of 2005''.

SEC. 2. CORD BLOOD INVENTORY.

    (a) In General.--The Secretary of Health and Human Services shall 
enter into one-time contracts with qualified cord blood 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) one 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```