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[109th Congress Public Law 129]
[From the U.S. Government Printing Office]

[DOCID: f:publ129.109]

[[Page 2549]]

             STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005

[[Page 119 STAT. 2550]]

Public Law 109-129
109th Congress

                                 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. <<NOTE: Dec. 20, 2005 -  [H.R. 2520]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Stem Cell 
Therapeutic and Research Act of 2005.>> 

SECTION 1. <<NOTE: 42 USC 201 note.>> SHORT TITLE.

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

SEC. 2. <<NOTE: 42 USC 274k note.>> CORD BLOOD INVENTORY.

    (a) <<NOTE: Contracts.>>  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) <<NOTE: Records.>> 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) <<NOTE: Records.>> 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.--

[[Page 119 STAT. 2551]]

            (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) <<NOTE: Regulations.>> 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--

[[Page 119 STAT. 2552]]

                    (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).

[[Page 119 STAT. 2553]]

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) <<NOTE: Contracts.>> 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

[[Page 119 STAT. 2554]]

                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) <<NOTE: Reports.>> 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) <<NOTE: Deadline.>> 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

[[Page 119 STAT. 2555]]

                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) <<NOTE: Records.>> 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;

[[Page 119 STAT. 2556]]

                    ``(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) <<NOTE: Publication. Records.>> 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;

[[Page 119 STAT. 2557]]

                    ``(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) <<NOTE: Minorities.>> 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).

[[Page 119 STAT. 2558]]

    ``(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) <<NOTE: Records.>> standards that--
                    ``(A) <<NOTE: Confidentiality.>> 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) <<NOTE: Minorities.>> 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

[[Page 119 STAT. 2559]]

                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) <<NOTE: Establishment.>> 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

[[Page 119 STAT. 2560]]

                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) <<NOTE: Surveys.>> 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) <<NOTE: Public information.>> 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.

[[Page 119 STAT. 2561]]

    ``(k) Contracts.--
            ``(1) <<NOTE: Regulations.>> 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) <<NOTE: Contracts.>> 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.

[[Page 119 STAT. 2562]]

    ``(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. <<NOTE: 42 USC 274l-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, <<NOTE: 42 USC prec. 274k.>> 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

[[Page 119 STAT. 2563]]

Administration in developing requirements for the licensing of cord 
blood units.

    Approved December 20, 2005.

LEGISLATIVE HISTORY--H.R. 2520 (S. 1317):
---------------------------------------------------------------------------

SENATE REPORTS: No. 109-129 accompanying S. 1317 (Comm. on Health, 
Education, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 151 (2005):
            May 24, considered and passed House.
            Dec. 16, considered and passed Senate, amended.
            Dec. 17, House concurred in Senate amendment.

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