110 HR 7153 IH: To amend title IV of the Public Health Service Act to
U.S. House of Representatives
2008-09-26
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.This Act may be cited as the National
Childhood Brain Tumor Prevention Network Act of 2008
.
2.Congress finds the following:
(1)Tumors kill more
children than any other disease and brain tumors are the second most common
type of cancer in children.
(2)Childhood brain
tumors are the leading cause of death from solid tumors in children.
(3)There are newly
recognized types of brain tumors, as defined by the World Health Organization,
and many of these newly recognized types occur in children.
(4)The causes of the
overwhelming majority of childhood brain tumors are unknown.
(5)Brain tumors have
substantial costs for affected children, the families of such children, and
society.
(6)Childhood brain
tumors cause significant morbidity and the loss of many years of potential
life.
(7)The prognosis for
most childhood brain tumors is dismal and survivors face lasting adverse health
effects.
(8)Because of the relatively low overall
incidence of childhood brain tumors, such tumors frequently do not receive
sufficient attention and research funding.
(9)No
single institution has a sufficient number of patients to independently conduct
research that will adequately address the causes of childhood brain
tumors.
(10)There has been no
comprehensive study analyzing all relevant clinical, biological, and
epidemiological aspects of childhood brain tumors to identify potential risk
factors and determine the cause of such tumors.
(11)Existing national cooperative clinical
oncology groups primarily investigate treatment options and prognosis and do
not typically examine the origins of childhood brain tumors or the risk factors
associated with such tumors. A significant majority of children with brain
tumors are first treated by neurosurgeons and not by oncologists typically
involved in such groups.
3.It is the sense of
Congress that—
(1)there is a need to
establish a multi-center research effort based on collaboration between
regional consortia in order to comprehensively study the causes of childhood
brain tumors and identify potential risk factors;
(2)there is a need to
encourage a collaborative effort among surgical and medical centers with
epidemiological study groups to gather comprehensive and detailed information
for each child enrolled in those groups, in order to investigate environmental,
nutritional, genetic, and developmental factors with respect to, and the
pathological and epidemiological characteristics of, childhood brain tumors;
and
(3)there is a need to
authorize the Director of the National Institutes of Health to coordinate
national research efforts of governmental and nongovernmental entities with
respect to childhood brain tumors.
4.Establishment of
the National Childhood Brain Tumor Prevention
Network
(a)Subpart 1 of part C
of title IV of the Public Health Service Act (42 U.S.C. 285 et seq.) is amended
by adding at the end the following:
417F.National
Childhood Brain Tumor Prevention Network
(a)Establishment of
the National Childhood Brain Tumor Prevention Network
(1)Not later than one
year after the date of the enactment of this section, the Director of NIH,
acting through the Director of the National Cancer Institute, shall establish,
administer, and coordinate a National Childhood Brain Tumor Prevention Network
(hereinafter referred to in this section as the Network
) for the
purposes described in paragraph (2).
(2)The
purposes of the Network shall be the following:
(A)Providing grants
of not fewer than five years duration to eligible consortia for the purpose of
conducting research with respect to the causes of and risk factors associated
with childhood brain tumors.
(B)Assembling a panel of experts, including
members of the Brain Tumor Epidemiology Consortium and survivors of brain
tumors, to provide ongoing guidance and recommendations for, with respect to
research funded by the Network, the development of the following:
(i)A
common study design.
(ii)Standard protocols, methods, procedures,
and assays for collecting from individuals enrolled as study participants, and
the parents of such individuals, a minimum data set that includes the
following:
(I)Environmental
exposure data.
(II)Nutritional
data.
(III)Biospecimens,
including genomic data.
(IV)Histopathological and molecular
pathological data and specimens.
(V)Clinical and
radiological data.
(iii)Specific
analytical methods for examining data.
(iv)Provisions for
consensus review of enrolled cases.
(v)An
integrated data collection network.
(C)Designating a
central laboratory to collect, analyze, and aggregate data with respect to
research funded by the Network and to make such data and analysis available to
researchers.
(3)To be eligible for a grant under this section, a
consortium shall demonstrate the following:
(A)The capability to
annually enroll as research participants a minimum of 100 individuals with a
newly diagnosed childhood brain tumor from the designated catchment area of
such consortium.
(B)The capability to
form a control group by enrolling as research participants, for each enrolled
individual with a childhood brain tumor, at least two individuals without a
childhood brain tumor, who are matched demographically to such enrolled
individual with a childhood brain tumor.
(C)That the
designated catchment area of such consortium does not overlap with the
designated catchment area of a consortium already receiving a grant under this
section.
(4)Not later than one year after the date of
the enactment of this section and annually thereafter, the Director of NIH
shall submit to Congress a report with respect to the Network, to be made
publicly available, including a summary of research funded by the Network and a
list of consortia receiving grants under the Network. At the discretion of the
Director of NIH, such report may be combined with other similar or existing
reports.
(5)Authorization of
appropriations
(A)There is authorized
to be appropriated $25,000,000 for each of fiscal years 2010 through 2014, to
remain available until expended, to carry out this section.
(B)It is the sense of Congress that funds appropriated to
carry out this section should be in addition to the funds already appropriated
to carry out the functions of the National Institutes of Health.
(b)For
purposes of this section, the following definitions apply:
(1)Brain Tumor
Epidemiology ConsortiumThe term Brain Tumor Epidemiology
Consortium means the organization with such name formed in 2003 after an
initial meeting sponsored by the National Cancer Institute’s Division of Cancer
Epidemiology and Genetics.
(2)The term catchment area means a defined area
for which population data are available.
(3)The term childhood brain tumor means an
intracranial or spinal cord tumor occurring in an individual under 20 years of
age.
(4)The
term consortium means a partnership of two or more universities,
health care organizations, or government agencies, or any combination of such
entities, serving a designated catchment
area.
.
(b)
(1)Section 3 of the Hematological Cancer Research Investment
and Education Act of 2002 (Public Law 107–172; 116 Stat. 541) is amended by
striking 419C
and inserting 417C
.
(2)The amendment made by
paragraph (1) shall take effect as if included in the enactment of the Act
referred to in such paragraph.