[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1362 Introduced in House (IH)]
111th CONGRESS
1st Session
H. R. 1362
To amend the Public Health Service Act to provide for the establishment
of permanent national surveillance systems for multiple sclerosis,
Parkinson's disease, and other neurological diseases and disorders.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 5, 2009
Mr. Van Hollen (for himself, Mr. Burgess, Mrs. Maloney, Mr. Upton, Mr.
Carnahan, and Mr. King of New York) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for the establishment
of permanent national surveillance systems for multiple sclerosis,
Parkinson's disease, and other neurological diseases and disorders.
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 ``National MS and Parkinson's Disease
Registries Act''.
SEC. 2. FINDINGS.
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.
SEC. 3. SURVEILLANCE SYSTEMS.
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:
``SEC. 399U. SURVEILLANCE OF NEUROLOGICAL DISEASES.
``(a) Multiple Sclerosis National Surveillance System.--
``(1) In general.--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) Purpose.--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) In general.--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) Purpose.--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) Advisory Committee.--
``(1) Establishment.--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) Duties.--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) Report.--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) Grants.--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 general.--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 agencies.--
Notwithstanding 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) Definition.--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 Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2010 through 2014.''.
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