[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 957 Introduced in Senate (IS)]

  1st Session
                                 S. 957

  To provide for the collection and maintenance of amniotic fluid and 
    placental stem cells for the treatment of patients and research.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 22, 2007

 Mr. Burr (for himself and Mr. Coleman) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To provide for the collection and maintenance of amniotic fluid and 
    placental stem cells for the treatment of patients and research.

    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 ``Amniotic Fluid and Placental Stem 
Cell Banking Act of 2007''.

SEC. 2. AMNIOTIC FLUID AND PLACENTAL STEM CELL INVENTORY.

    (a) In General.--The Secretary shall enter into one-time contracts 
with qualified amniotic fluid and placental stem cell banks to assist 
in the collection and maintenance of 100,000 new units of high-quality 
amniotic fluid and placental stem cells to be made available for 
treatment through the C.W. Bill Young Cell Transplantation and 
Treatment 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 amniotic fluid and placental stem cells 
        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 amniotic fluid and placental stem cells that 
        are collected pursuant to this section or otherwise and meet 
        all applicable Federal standards available to physicians for 
        treatment;
            (4) to make amniotic fluid and placental stem cell 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 and 
        Treatment 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) Application.--To seek to enter into a contract under this 
section, a qualified amniotic fluid and placental stem cell bank shall 
submit an application to the Secretary at such time, in such manner, 
and containing such information as the Secretary may reasonably 
require. At a minimum, an application for a contract under this section 
shall include a requirement that the applicant--
            (1) will participate in the C.W. Bill Young Cell 
        Transplantation and Treatment Program for a period of at least 
        10 years;
            (2) will make amniotic fluid and placental stem cell units 
        collected pursuant to this section available through the C.W. 
        Bill Young Cell Transplantation and Treatment 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 an amniotic fluid and 
        placental stem cell 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 amniotic fluid and placental 
        stem cell bank approved by the Secretary to ensure continued 
        availability of amniotic fluid and placental stem cell units.
    (d) 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, 2012.
            (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 100,000 new units of 
                high-quality amniotic fluid and placental stem cells 
                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 
                amniotic fluid and placental stem cell bank that has 
                not previously entered into a contract under this 
                section or the Secretary determines that the 
                outstanding inventory need cannot be met by the one or 
                more qualified amniotic fluid and placental stem cell 
                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 
        amniotic fluid and placental stem cell 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.
    (e) Regulations.--The Secretary may promulgate regulations to carry 
out this section.
    (f) Definitions.--In this section:
            (1) The term ``C.W. Bill Young Cell Transplantation and 
        Treatment Program'' means the C.W. Bill Young Cell 
        Transplantation and Treatment Program under section 379 of the 
        Public Health Service Act, as amended by this Act.
            (2) The term ``amniotic fluid and placental stem cell 
        donor'' means a mother who has delivered a baby and consents to 
        donate the placental stem cells or a mother who undergoes 
        amniocentesis or placental sampling for other diagnostic 
        purposes and consents to donate the discarded amniotic fluid 
        and placental stem cells after the diagnostic analysis is 
        completed.
            (3) The term ``amniotic fluid and placental stem cell 
        unit'' means the amniotic fluid and placental stem cells 
        collected from the placenta of a single newborn baby or 
        collected from the discarded amniotic fluid or placenta after a 
        diagnostic test.
            (5) The term ``qualified amniotic fluid and placental stem 
        cell 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.
    (g) Authorization of Appropriations.--There are authorized to be 
appropriated to the Secretary $20,000,000 for each of fiscal years 2008 
through 2012, to carry out this section.

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

    Part I of title III of the Public Health Service Act (42 U.S.C. 
274k et seq.) is amended--
            (1) in the part heading by inserting ``AND TREATMENT'' 
        after ``TRANSPLANTATION'';
            (2) in section 379--
                    (A) in subsection (a)
                            (i) in paragraph (4)(A), by inserting 
                        ``representatives of amniotic fluid and 
                        placental stem cell banks and participating 
                        birthing hospitals and ob/gyn offices, 
                        recipients of an amniotic fluid and placental 
                        stem cell treatment, basic scientists with 
                        expertise in the biology of amniotic fluid and 
                        placental stem cells,'' after ``adult stem 
                        cells,'';
                            (ii) in paragraph (5)(A), by striking ``, 
                        or cord blood bank from participating in any 
                        decision that materially affects the center, 
                        recruitment organization, transplant center, or 
                        cord blood bank'' and inserting ``, cord blood 
                        bank, or amniotic fluid and placental stem cell 
                        bank from participating in any decision that 
                        materially affects the center, recruitment 
                        organization, transplant center, cord blood 
                        bank, or amniotic fluid and placental stem cell 
                        bank''; and
                            (iii) in paragraph (6)
                                    (I) in subparagraph (A), by 
                                striking ``and'' at the end.
                                    (II) in subparagraph (B), by 
                                striking the period and inserting ``; 
                                and''; and
                                    (III) by adding at the end the 
                                following:
                    ``(C) not later than 6 months after the date of 
                enactment of the Amniotic Fluid and Placental Stem Cell 
                Banking Act of 2007, a report concerning the 
                recommendations on the scientific factors necessary to 
                define an amniotic fluid and placental stem cell unit 
                as a high-quality unit.'';
                    (B) in subsection (b), by inserting ``and amniotic 
                fluid and placental stem cell banks'' before the 
                period;
                    (C) in subsection (c)--
                            (i) in the matter preceding paragraph (1), 
                        by striking ``process, examine'' and inserting 
                        the following: ``process--
            ``(1) examine'';
                            (ii) by redesignating paragraphs (1) and 
                        (2) as subparagraphs (A) and (B) and indenting 
                        accordingly;
                            (iii) by striking the first period and 
                        inserting ``; and
            ``(2) examine the informed consent procedures for cord 
        blood donation and determine appropriate informed consent 
        procedures for amniotic fluid and placental stem cell 
        donation.''; and
                            (v) by adding at the end the following: 
                        ``The Secretary shall require that the 
                        standards used by the accreditation entities 
                        recognized under subsection (b) ensures that an 
                        amniotic fluid and placental stem cell unit is 
                        acquired with the informed consent of the 
                        maternal donor.'';
                    (D) in subsection (d)--
                            (i) by redesignating paragraphs (3) and (4) 
                        as paragraphs (4) and (5), respectively; and
                            (ii) by inserting after paragraph (2), the 
                        following;
            ``(2) Amniotic fluid and placental stem cell functions.--
        With respect to amniotic fluid and placental stem cells, the 
        Program shall--
                    ``(A) operate a system for identifying, matching, 
                and facilitating the distribution of donated amniotic 
                fluid and placental stem cell units that are suitably 
                matched to candidate patients and meet all applicable 
                Federal and State regulations from a qualified amniotic 
                fluid and placental stem cell bank;
                    ``(B) consistent with paragraph (3), allow 
                treatment physicians, other appropriate health care 
                professionals, and patients to search by means of 
                electronic access all available amniotic fluid and 
                placental stem cell units made available through the 
                Program;
                    ``(C) allow treatment physicians and other 
                appropriate health care professionals to reserve, as 
                defined by the Secretary, an amniotic fluid and 
                placental stem cell unit for treatment;
                    ``(D) support studies and demonstration and 
                outreach projects for the purpose of increasing 
                amniotic fluid and placental stem cell donation to 
                ensure a genetically diverse collection of amniotic 
                fluid and placental stem cell units;
                    ``(E) provide for a system of patient advocacy 
                through the office established under subsection (h);
                    ``(F) coordinate with the qualified amniotic fluid 
                and placental stem cell banks to support informational 
                and educational activities in accordance with 
                subsection (g); and
                    ``(G) 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.'';
                            (iii) in paragraph (4) (as so 
                        redesignated)--
                                    (I) in subparagraph (A), by 
                                striking ``and (2)(A), cells from bone 
                                marrow donors and cord blood'' and 
                                inserting ``, (2)(A), and (3)(A), cells 
                                from bone marrow donors, cord blood, 
                                and amniotic fluid and placental stem 
                                cells''; and
                                    (II) in subparagraph (B), by 
                                striking ``that enables transplant,'' 
                                and inserting ``. The standardization 
                                shall enable'';
                            (iv) in paragraph (5) (as so 
                        redesignated)--
                                    (I) by redesignating subparagraphs 
                                (A) through (F) as clauses (i) through 
                                (vi), respectively, and indent 
                                accordingly;
                                    (II) by striking ``The term'' and 
                                inserting the following:
                    ``(A) The term''; and
                                    (III) by adding at the end the 
                                following:
                    ``(B) The term `qualified amniotic fluid and 
                placental stem cell bank' means a qualified amniotic 
                fluid and placental stem cell bank that--
                            ``(i) 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 an amniotic 
                        fluid and placental stem cell bank;
                            ``(ii) has implemented donor screening, 
                        amniotic fluid and placental stem cell 
                        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;
                            ``(iii) is accredited by an accreditation 
                        entity recognized by the Secretary under 
                        subsection (b);
                            ``(iv) 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;
                            ``(v) has established a system for 
                        encouraging donation by a genetically diverse 
                        group of donors; and
                            ``(vi) has established a system to 
                        confidentially maintain linkage between a 
                        amniotic fluid and placental stem cell unit and 
                        a maternal donor.'';
                    (E) by redesignating subsections (h) through (n) as 
                subsections (i) through (o), respectively;
                    (F) by inserting after subsection (g), the 
                following:
    ``(h) Amniotic Fluid and Placental Stem Cell Recruitment; 
Priorities; Information and Education.--
            ``(1) Recruitment; priorities.--The Program shall support 
        activities, in cooperation with qualified amniotic fluid and 
        placental stem cell banks, for the recruitment of amniotic 
        fluid and placental stem cell donors. Such recruitment program 
        shall identify populations that are underrepresented among 
        amniotic fluid and placental stem cell 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 amniotic fluid and 
                placental stem cell 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 amniotic fluid and 
                placental stem cell 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 amniotic fluid and 
                placental stem cells. 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 amniotic fluid and placental stem cell 
                        units.
                            ``(ii) Educating and providing information 
                        to pregnant women who are willing to donate 
                        amniotic fluid and placental stem cell units.
                            ``(iii) Training individuals in requesting 
                        pregnant women to serve as amniotic fluid and 
                        placental stem cell 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 
                amniotic fluid and placental stem cell 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 amniotic 
        fluid and placental stem cell treatments 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)(3).'';
                    (G) in subsection (i) (as so redesignated)--
                            (i) in the subsection heading by striking 
                        ``and Cord Blood'' and inserting ``, Cord 
                        Blood, and Amniotic Fluid and Placental Stem 
                        Cells'';
                            (ii) in paragraph (2)--
                                    (I) in subparagraph (B), by 
                                striking ``and cord blood therapy'' and 
                                inserting ``, cord blood, and amniotic 
                                fluid and placental stem cell therapy 
                                and treatment'';
                                    (II) in subparagraph (C), by 
                                striking ``or cord blood unit'' and 
                                inserting ``, cord blood unit, or 
                                amniotic fluid and placental stem cell 
                                unit'';
                                    (III) in subparagraph (D), by 
                                striking ``and (2) of subsection (d) to 
                                conduct an ongoing search for a bone 
                                marrow donor or cord blood unit'' and 
                                inserting ``, (2), and (3) of 
                                subsection (d) to conduct an ongoing 
                                search for a bone marrow donor, cord 
                                blood unit, or amniotic fluid and 
                                placental stem cell unit'';
                                    (IV) in subparagraph (E)--
                                            (aa) in the matter 
                                        preceding clause (i), by 
                                        striking ``(1) and (2)'' and 
                                        inserting ``(1), (2), and 
                                        (3)''; and
                                            (bb) in clause (i), by 
                                        striking ``or cord blood 
                                        units'' and inserting ``, cord 
                                        blood units, or amniotic fluid 
                                        and placental stem cell 
                                        units''; and
                                    (V) in subparagraph (F)--
                                            (aa) by redesignating 
                                        clause (v) as clause (viii); 
                                        and
                                            (bb) by inserting after 
                                        clause (iv), the following:
                            ``(v) A comparison of treatment centers 
                        with respect to search and other costs that 
                        prior to treatment are charged to patients by 
                        treatment centers.
                            ``(vi) The post-treatment outcomes for 
                        individual treatment centers.
                            ``(vii) Information concerning issues that 
                        patients may face after a treatment.''; and
                            (iii) in paragraph (3)(B), by inserting 
                        before the period the following: ``and on 
                        behalf of patients who have completed the 
                        search for an amniotic fluid and placental stem 
                        cell unit, provide information and education on 
                        the process of receiving a treatment, including 
                        the post-treatment process''; and
                    (H) in subsection (o) (as so redesignated), by 
                striking ``(d)(4)(D)'' and inserting ``(d)(5)(A)(iv)'';
            (3) in section 379A--
                    (A) in subsection (b)--
                            (i) by striking ``, results'' and inserting 
                        ``, treatments, results''; and
                            (ii) by inserting ``or treatment'' after 
                        ``transplantation'';
                    (B) in subsection (c), by inserting ``or 
                treatment'' after ``transplant''; and
                    (C) in subsection (d)
                            (i) by inserting ``treatment centers,'' 
                        after ``programs,''; and
                            (ii) by striking ``and cord blood banks'' 
                        and inserting ``cord blood banks, and amniotic 
                        fluid and placental stem cell banks''; and
            (4) in section 379A-1, in paragraph (4), by inserting ``and 
        Treatment'' after ``Transplantation''.

SEC. 4. AUTHORIZATION OF APPROPRIATIONS.

    Section 379B of the Public Health Service Act (42 U.S.C. 274m) is 
amended by striking ``2010'' and inserting ``2012''.
                                 <all>