S 957 ISCommentsClose CommentsPermalink

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

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 PensionsCommentsClose CommentsPermalink

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

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

SECTION 1. SHORT TITLE.

This Act may be cited as the `Amniotic Fluid and Placental Stem Cell Banking Act of 2007'.CommentsClose CommentsPermalink

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).CommentsClose CommentsPermalink





(b) Requirements- The Secretary shall require each recipient of a contract under this section--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(2) to encourage donation from a genetically diverse population;CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(4) to make amniotic fluid and placental stem cell units that are collected, but not appropriate for clinical use, available for peer-reviewed research;CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(1) will participate in the C.W. Bill Young Cell Transplantation and Treatment Program for a period of at least 10 years;CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(d) Duration of Contracts-CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) the date that is 3 years after the date on which the contract is entered into; orCommentsClose CommentsPermalink





(B) September 30, 2012.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(e) Regulations- The Secretary may promulgate regulations to carry out this section.CommentsClose CommentsPermalink





(f) Definitions- In this section:CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(6) The term `Secretary' means the Secretary of Health and Human Services.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) in the part heading by inserting `AND TREATMENT' after `TRANSPLANTATION';CommentsClose CommentsPermalink





(2) in section 379--CommentsClose CommentsPermalink





(A) in subsection (a)CommentsClose CommentsPermalink





(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,';CommentsClose CommentsPermalink





(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'; andCommentsClose CommentsPermalink





(iii) in paragraph (6)CommentsClose CommentsPermalink





(I) in subparagraph (A), by striking `and' at the end.CommentsClose CommentsPermalink





(II) in subparagraph (B), by striking the period and inserting `; and'; andCommentsClose CommentsPermalink





(III) by adding at the end the following:CommentsClose CommentsPermalink





`(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.';CommentsClose CommentsPermalink





(B) in subsection (b), by inserting `and amniotic fluid and placental stem cell banks' before the period;CommentsClose CommentsPermalink





(C) in subsection (c)--CommentsClose CommentsPermalink





(i) in the matter preceding paragraph (1), by striking `process, examine' and inserting the following: `process--CommentsClose CommentsPermalink





`(1) examine';CommentsClose CommentsPermalink





(ii) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B) and indenting accordingly;CommentsClose CommentsPermalink





(iii) by striking the first period and inserting `; andCommentsClose CommentsPermalink





`(2) examine the informed consent procedures for cord blood donation and determine appropriate informed consent procedures for amniotic fluid and placental stem cell donation.'; andCommentsClose CommentsPermalink





(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.';CommentsClose CommentsPermalink





(D) in subsection (d)--CommentsClose CommentsPermalink





(i) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; andCommentsClose CommentsPermalink





(ii) by inserting after paragraph (2), the following;CommentsClose CommentsPermalink





`(2) AMNIOTIC FLUID AND PLACENTAL STEM CELL FUNCTIONS- With respect to amniotic fluid and placental stem cells, the Program shall--CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(E) provide for a system of patient advocacy through the office established under subsection (h);CommentsClose CommentsPermalink





`(F) coordinate with the qualified amniotic fluid and placental stem cell banks to support informational and educational activities in accordance with subsection (g); andCommentsClose CommentsPermalink





`(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.';CommentsClose CommentsPermalink





(iii) in paragraph (4) (as so redesignated)--CommentsClose CommentsPermalink





(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'; andCommentsClose CommentsPermalink





(II) in subparagraph (B), by striking `that enables transplant,' and inserting `. The standardization shall enable';CommentsClose CommentsPermalink





(iv) in paragraph (5) (as so redesignated)--CommentsClose CommentsPermalink





(I) by redesignating subparagraphs (A) through (F) as clauses (i) through (vi), respectively, and indent accordingly;CommentsClose CommentsPermalink





(II) by striking `The term' and inserting the following:CommentsClose CommentsPermalink





`(A) The term'; andCommentsClose CommentsPermalink





(III) by adding at the end the following:CommentsClose CommentsPermalink





`(B) The term `qualified amniotic fluid and placental stem cell bank' means a qualified amniotic fluid and placental stem cell bank that--CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(iii) is accredited by an accreditation entity recognized by the Secretary under subsection (b);CommentsClose CommentsPermalink





`(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;CommentsClose CommentsPermalink





`(v) has established a system for encouraging donation by a genetically diverse group of donors; andCommentsClose CommentsPermalink





`(vi) has established a system to confidentially maintain linkage between a amniotic fluid and placental stem cell unit and a maternal donor.';CommentsClose CommentsPermalink





(E) by redesignating subsections (h) through (n) as subsections (i) through (o), respectively;CommentsClose CommentsPermalink





(F) by inserting after subsection (g), the following:CommentsClose CommentsPermalink





`(h) Amniotic Fluid and Placental Stem Cell Recruitment; Priorities; Information and Education-CommentsClose CommentsPermalink





`(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:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(2) INFORMATION AND EDUCATION REGARDING RECRUITMENT; TESTING AND DONATION-CommentsClose CommentsPermalink





`(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:CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(ii) Educating and providing information to pregnant women who are willing to donate amniotic fluid and placental stem cell units.CommentsClose CommentsPermalink





`(iii) Training individuals in requesting pregnant women to serve as amniotic fluid and placental stem cell donors.CommentsClose CommentsPermalink





`(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).CommentsClose CommentsPermalink





`(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.CommentsClose CommentsPermalink





`(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).';CommentsClose CommentsPermalink





(G) in subsection (i) (as so redesignated)--CommentsClose CommentsPermalink





(i) in the subsection heading by striking `AND CORD BLOOD' and inserting `, Cord Blood, and Amniotic Fluid and Placental Stem Cells';CommentsClose CommentsPermalink





(ii) in paragraph (2)--CommentsClose CommentsPermalink





(I) in subparagraph (B), by striking `and cord blood therapy' and inserting `, cord blood, and amniotic fluid and placental stem cell therapy and treatment';CommentsClose CommentsPermalink





(II) in subparagraph (C), by striking `or cord blood unit' and inserting `, cord blood unit, or amniotic fluid and placental stem cell unit';CommentsClose CommentsPermalink





(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';CommentsClose CommentsPermalink





(IV) in subparagraph (E)--CommentsClose CommentsPermalink

(aa) in the matter preceding clause (i), by striking `(1) and (2)' and inserting `(1), (2), and (3)'; andCommentsClose CommentsPermalink

(bb) in clause (i), by striking `or cord blood units' and inserting `, cord blood units, or amniotic fluid and placental stem cell units'; andCommentsClose CommentsPermalink

(V) in subparagraph (F)--CommentsClose CommentsPermalink

(aa) by redesignating clause (v) as clause (viii); andCommentsClose CommentsPermalink

(bb) by inserting after clause (iv), the following:CommentsClose CommentsPermalink

`(v) A comparison of treatment centers with respect to search and other costs that prior to treatment are charged to patients by treatment centers.CommentsClose CommentsPermalink





`(vi) The post-treatment outcomes for individual treatment centers.CommentsClose CommentsPermalink





`(vii) Information concerning issues that patients may face after a treatment.'; andCommentsClose CommentsPermalink





(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'; andCommentsClose CommentsPermalink





(H) in subsection (o) (as so redesignated), by striking `(d)(4)(D)' and inserting `(d)(5)(A)(iv)';CommentsClose CommentsPermalink





(3) in section 379A--CommentsClose CommentsPermalink





(A) in subsection (b)--CommentsClose CommentsPermalink





(i) by striking `, results' and inserting `, treatments, results'; andCommentsClose CommentsPermalink





(ii) by inserting `or treatment' after `transplantation';CommentsClose CommentsPermalink





(B) in subsection (c), by inserting `or treatment' after `transplant'; andCommentsClose CommentsPermalink





(C) in subsection (d)CommentsClose CommentsPermalink





(i) by inserting `treatment centers,' after `programs,'; andCommentsClose CommentsPermalink





(ii) by striking `and cord blood banks' and inserting `cord blood banks, and amniotic fluid and placental stem cell banks'; andCommentsClose CommentsPermalink





(4) in section 379A-1, in paragraph (4), by inserting `and Treatment' after `Transplantation'.CommentsClose CommentsPermalink

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'.CommentsClose CommentsPermalink