110th CONGRESS
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
(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';
(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
(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;
(i) in the matter preceding paragraph (1), by striking `process, examine'
and inserting the following: `process--
(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.';
(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:
(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';
(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)';
(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
(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'.
END
