1.This Act may be cited as the
National MS and Parkinson’s Disease
Registries Act
.
2.Congress makes the following
findings:
(1)Multiple sclerosis
(referred to in this section as MS
) is a progressive, disabling
disease that affects the brain and the spinal cord causing loss of myelin,
damage to axons, and cerebral atrophy.
(2)MS is a
prime-of-life disease with an average age of onset at 30 to 35 years of
age.
(3)More than 10,000
individuals in the United States are diagnosed with MS annually, and it is
thought that more than 400,000 individuals in the United States have MS.
(4)Parkinson’s
disease is a chronic, progressive neurological disease. The primary pathologic
feature of Parkinson’s disease is degeneration and premature death of
dopamine-producing brain cells.
(5)Parkinson’s is the
second-most common neurodegenerative disease in the United States.
(6)It is estimated
that more than 1,000,000 Americans are currently fighting Parkinson’s disease,
and 60,000 Americans are newly diagnosed every year.
(7)Although estimates
exist, there is no confirmed data regarding prevalence or diagnosed cases of
Parkinson’s disease or MS.
(8)The causes of
Parkinson’s disease and MS are not well understood.
(9)There is no known
cure for Parkinson’s disease or MS.
(10)Studies have
found relationships between both MS and Parkinson’s disease and environmental
and genetic factors, but those relationships are not well understood.
(11)Better data are
needed to understand the economic impact of Parkinson’s disease, MS, and other
neurological diseases.
(12)There are several
drugs currently approved by the Food and Drug Administration for the treatment
of MS, which have shown modest success in reducing relapses, slowing
progression of disability, and limiting the accumulation of brain
lesions.
(13)Currently,
state-of-the-art treatment for Parkinson’s disease is based on a 40-year-old
pharmaceutical therapy, which only treats some of the motor symptoms of
Parkinson’s disease. Deep brain stimulation surgery is available for certain
patients and treats some symptoms of Parkinson’s disease.
(14)No therapies
exist that will slow or stop progression of Parkinson’s disease. There is no
effective, lasting therapy for all features of Parkinson’s disease.
(15)Central nervous
system drugs, including therapies for MS, Parkinson’s disease, and other
neurological diseases, are the slowest in the drug development pipeline, taking
an average of 15 years post discovery for new therapies to reach the
market.
(16)Several small and
uncoordinated MS and Parkinson’s disease registries, surveillance systems, and
databases exist in the United States and throughout the world.
(17)A single national
system to collect and store information on the incidence and prevalence of MS,
Parkinson’s disease, or other neurological diseases in the United States does
not exist.
(18)The Agency for
Toxic Substances and Disease Registry (ATSDR) has established a series of small
pilot studies, beginning in fiscal year 2006, to evaluate the feasibility of
various methodologies to create an MS surveillance system at the national
level.
(19)The national
surveillance system methodology resulting from the MS pilot studies should be
expanded upon and developed into a national surveillance system for Parkinson’s
disease.
(20)The establishment
of separate, coordinated national surveillance systems for Parkinson’s disease
and MS will help—
(A)to identify the
incidence and prevalence of these diseases in the United States;
(B)to collect
demographic and other data important to the study of MS and Parkinson’s
disease;
(C)to produce
epidemiologically sound data that can be used to compare with cluster
information, data sets of the Department of Veterans Affairs, environmental
exposure data, and other information;
(D)to promote a
better understanding of causes, prevention, and treatment of disease;
(E)to better
understand public and private resource impact;
(F)to collect
information that is important for research into genetic and environmental risk
factors;
(G)to enhance
biomedical and clinical research by providing a basis for population
comparisons;
(H)to enhance efforts
to develop better diagnosis and progression biomarkers for MS and Parkinson’s
disease; and
(I)to enhance efforts
to find treatments and a cure for MS and Parkinson’s disease.
3.Part P of title III of
the Public Health Service Act (42 U.S.C. 280g et seq.) is amended—
(1)by redesignating
the second and third sections 399R (added by section 2 of Public Law 110–373
and section 3 of Public Law 110–374) as sections 399S and 399T, respectively;
and
(2)by adding at the
end the following:
399U.Surveillance
of neurological diseases
(a)Multiple
sclerosis national surveillance system
(1)Not later than 1 year after receipt of the report
described in subsection (c)(3), the Secretary, acting through the Director of
the Agency for Toxic Substances and Disease Registry and in consultation with a
national voluntary health organization with experience serving the population
of individuals with multiple sclerosis (referred to in this section as
MS
), shall—
(A)develop a system
to collect data on MS including information with respect to the incidence and
prevalence of the disease in the United States;
(B)establish a
national surveillance system for the collection and storage of such data to
include a population-based registry of cases of MS in the United States;
(C)assist in
application of MS national surveillance system methodologies for the
development, piloting, and implementation of a national Parkinson’s disease
national surveillance system under subsection (b); and
(D)provide analysis
regarding expansion of national disease surveillance systems for other
neurological diseases and disorders utilizing the MS and Parkinson’s disease
national surveillance systems’ process and structure.
(2)It
is the purpose of the registry established under paragraph (1)(B) to gather
available data concerning—
(A)MS, including the
incidence and prevalence of MS in the United States;
(B)the age, race or
ethnicity, gender, military service if applicable, and family history of
individuals who are diagnosed with the disease; and
(C)other matters as
recommended by the Advisory Committee established pursuant to subsection
(c).
(b)Parkinson’s
disease national surveillance system
(1)Not later than 1 year after the receipt of the report
described in subsection (c)(3), the Secretary, acting through the Director of
the Agency for Toxic Substances and Disease Registry and in consultation with a
national voluntary health organization with experience serving the population
of individuals with Parkinson’s disease, shall—
(A)develop a system
to collect data on Parkinson’s disease including information with respect to
the incidence and prevalence of the disease in the United States;
(B)establish a
national surveillance system for the collection and storage of such data to
include a population-based registry of cases of Parkinson’s disease in the
United States; and
(C)provide analysis
regarding expansion of national disease surveillance systems for other
neurological diseases utilizing the MS and Parkinson’s disease national
surveillance systems’ process and structure.
(2)It
is the purpose of the registry established under paragraph (1)(B) to gather
available data concerning—
(A)Parkinson’s
disease, including the incidence and prevalence of Parkinson’s disease in the
United States;
(B)the age, race or
ethnicity, gender, military service if applicable, and family history of
individuals who are diagnosed with the disease; and
(C)other matters as
recommended by the Advisory Committee established pursuant to subsection
(c).
(c)
(1)Not later than 180 days after the date of
the enactment of this section, the Secretary, acting through the Director of
the Agency for Toxic Substances and Disease Registry, shall establish a
committee to be known as the Advisory Committee on Neurological Disease
Registries (referred to in this section as the Advisory
Committee
). The Advisory Committee shall be composed of at least one
member, to be appointed by the Secretary, acting through the Director of the
Agency for Toxic Substances and Disease Registry, representing each of the
following:
(A)National voluntary
health associations that focus solely on MS and have demonstrated experience in
MS research, care, or patient services.
(B)National voluntary
health associations that focus solely on Parkinson’s disease and have
demonstrated experience in Parkinson’s disease public policy, research, care,
or patient services.
(C)The National
Institutes of Health, to include, upon the recommendation of the Director of
the National Institutes of Health, representatives from the Office of Portfolio
Analysis and Strategic Initiatives, the National Institute of Neurological
Disorders and Stroke, the National Institute of Environmental Health Sciences,
the National Institute on Aging, and the National Institute of Allergy and
Infectious Diseases.
(D)The Department of
Veterans Affairs, to include representatives from the Parkinson’s Disease
Research Education and Clinical Centers and the MS Centers of
Excellence.
(E)The Department of
Defense, to include representatives from the Parkinson’s disease and MS
research programs.
(F)The Food and Drug
Administration.
(G)The Centers for
Disease Control and Prevention, to include representatives from the Agency for
Toxic Substances and Disease Registry.
(H)Patients with MS
and Parkinson’s disease or their family members.
(I)Clinicians with
expertise on MS and Parkinson’s disease.
(J)Research
scientists with experience conducting translational research or creating
systems that support translating basic discoveries into treatments.
(K)Epidemiologists
with experience in data registries.
(L)Geneticists or
experts in genetics who have experience with the genetics of MS and Parkinson’s
disease.
(M)Statisticians.
(N)Bioethicists.
(O)Attorneys.
(P)Other individuals,
organizations, or agencies with an interest in developing and maintaining the
MS and Parkinson’s disease national surveillance systems.
(Q)Experts in
additional neurological diseases, as appropriate, based on development and
implementation of national surveillance systems for other neurological diseases
and disorders.
(2)The
Advisory Committee shall review information and make recommendations to the
Secretary concerning—
(A)the development
and maintenance of the MS and Parkinson’s disease national surveillance
systems;
(B)the use and
coordination of existing databases that collect or maintain information on
neurological diseases and disorders;
(C)the type of
information to be collected and stored in the systems;
(D)the manner in
which such data is to be collected;
(E)the use and
availability of such data including guidelines for such use; and
(F)the application of
MS and Parkinson’s disease registry methodologies to benefit other neurological
diseases and disorders, including analysis of how other neurological disease
surveillance systems or registries can be developed, piloted, and implemented
nationally utilizing the MS and Parkinson’s disease national surveillance
systems’ process and structure.
(3)Not
later than 1 year after the date on which the Advisory Committee is
established, the Advisory Committee shall submit a report to Congress
concerning the review conducted under paragraph (2) that contains the
recommendations of the Advisory Committee with respect to the results of such
review.
(d)Notwithstanding
the recommendations of the Advisory Committee under subsection (c), the
Secretary, acting through the Director of the Agency for Toxic Substances and
Disease Registry, may award grants to, and enter into contracts and cooperative
agreements with, public or private nonprofit entities for the collection,
analysis, and reporting of data on MS and Parkinson’s disease.
(e)Coordination
With State, local, and Federal registries
(1)In establishing the MS and Parkinson’s disease national
surveillance systems under subsections (a) and (b), the Secretary, acting
through the Director of the Agency for Toxic Substances and Disease Registry,
shall—
(A)identify, build
upon, expand, and coordinate existing data and surveillance systems, surveys,
registries, and other Federal public health and environmental infrastructure
wherever possible, including—
(i)the 2 MS
surveillance pilot studies initiated in fiscal year 2006 by the Centers for
Disease Control and Prevention and the Agency for Toxic Substances and Disease
Registry;
(ii)the Parkinson’s
disease and MS databases of the Department of Veterans Affairs;
(iii)current
Parkinson’s disease registries and surveillance systems, including the Nebraska
and California State registries;
(iv)current MS
registries, including the New York State MS Registry and the North American
Research Committee on MS (NARCOMS) Registry; and
(v)any other existing
or relevant databases that collect or maintain information on neurological
diseases and disorders identified by researchers or recommended by the Advisory
Committee pursuant to subsection (c); and
(B)provide for and
conduct outreach in support of research access to Parkinson’s disease and MS
data as recommended by the Advisory Committee established pursuant to
subsection (c) to the extent permitted by applicable statutes and regulations
and in a manner that protects personal privacy consistent with applicable
privacy statutes and regulations.
(2)Coordination
with other Federal agenciesNotwithstanding the recommendations
of the Advisory Committee established pursuant to subsection (c), and
consistent with applicable privacy statutes and regulations, the Secretary
shall ensure that epidemiological and other types of information obtained under
subsections (a) and (b) are made available to agencies such as the National
Institutes of Health, the Food and Drug Administration, the Department of
Veterans Affairs, and the Department of Defense.
(f)For
the purposes of this section, the term national voluntary health
association means a national nonprofit organization with chapters, other
affiliated organizations, or networks in States throughout the United
States.
(g)Authorization of
AppropriationsThere is authorized to be appropriated to carry
out this section $5,000,000 for each of fiscal years 2010 through
2014.
.