[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1382 Introduced in Senate (IS)]
110th CONGRESS
1st Session
S. 1382
To amend the Public Health Service Act to provide for the establishment
of an Amyotrophic Lateral Sclerosis Registry.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 14, 2007
Mr. Reid introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for the establishment
of an Amyotrophic Lateral Sclerosis Registry.
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 ``ALS Registry Act''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Amyotrophic lateral sclerosis (referred to in this
section as ``ALS'') is a fatal, progressive neurodegenerative
disease that affects motor nerve cells in the brain and the
spinal cord.
(2) The average life expectancy for a person with ALS is 2
to 5 years from the time of diagnosis.
(3) The cause of ALS is not well understood.
(4) There is only one drug currently approved by the Food
and Drug Administration for the treatment of ALS, which has
thus far shown only modest effects, prolonging life by just a
few months.
(5) There is no known cure for ALS.
(6) More than 5,000 individuals in the United States are
diagnosed with ALS annually and as many as 30,000 individuals
may be living with ALS in the United States today.
(7) Studies have found relationships between ALS and
environmental and genetic factors, but those relationships are
not well understood.
(8) Scientists believe that there are significant ties
between ALS and other motor neuron diseases.
(9) Several ALS disease registries and databases exist in
the United States and throughout the world, including the SOD1
database, the National Institute of Neurological Disorders and
Stroke repository, and the Department of Veterans Affairs ALS
Registry.
(10) A single national system to collect and store
information on the prevalence and incidence of ALS in the
United States does not exist.
(11) In each of fiscal years 2006 and 2007, Congress
directed $887,000 to the Centers for Disease Control and
Prevention to begin a nationwide ALS registry.
(12) The Centers for Disease Control and Prevention and the
Agency for Toxic Substances and Disease Registry has
established three pilot projects, beginning in fiscal year
2006, to evaluate the science to guide the creation of a
national ALS registry.
(13) The establishment of a national registry will help--
(A) to identify the incidence and prevalence of ALS
in the United States;
(B) to collect data important to the study of ALS;
(C) to promote a better understanding of ALS;
(D) to collect information that is important for
research into the genetic and environmental factors
that cause ALS;
(E) to strengthen the ability of a clearinghouse--
(i) to collect and disseminate research
findings on environmental, genetic and other
causes of ALS and other motor neuron disorders
that can be confused with ALS, misdiagnosed as
ALS, and in some cases progress to ALS;
(ii) make available information to patients
about research studies for which they may be
eligible; and
(iii) maintain information about clinical
specialists and clinical trials on therapies;
and
(F) to enhance efforts to find treatments and a
cure for ALS.
SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399R. AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.
``(a) Establishment.--
``(1) In general.--Not later than 1 year after the receipt
of the report described in subsection (b)(2)(A), the Secretary,
acting through the Director of the Centers for Disease Control
and Prevention and in consultation with a national voluntary
health organization with experience serving the population of
individuals with amyotrophic lateral sclerosis (referred to in
this section as `ALS'), shall--
``(A) develop a system to collect data on ALS and
other motor neuron disorders that can be confused with
ALS, misdiagnosed as ALS, and in some cases progress to
ALS, including information with respect to the
incidence and prevalence of the disease in the United
States; and
``(B) establish a national registry for the
collection and storage of such data to include a
population-based registry of cases in the United States
of ALS and other motor neuron disorders that can be
confused with ALS, misdiagnosed as ALS, and in some
cases progress to ALS.
``(2) Purpose.--It is the purpose of the registry
established under paragraph (1)(B) to gather available data
concerning--
``(A) ALS, including the incidence and prevalence
of ALS in the United States;
``(B) the environmental and occupational factors
that may be associated with the disease;
``(C) the age, race or ethnicity, gender, and
family history of individuals who are diagnosed with
the disease;
``(D) other motor neuron disorders that can be
confused with ALS, misdiagnosed as ALS, and in some
cases progress to ALS; and
``(E) other matters as recommended by the Advisory
Committee established under subsection (b).
``(b) Advisory Committee.--
``(1) Establishment.--Not later than 90 days after the date
of the enactment of this section, the Secretary, acting through
the Director of the Centers for Disease Control and Prevention,
shall establish a committee to be known as the Advisory
Committee on the National ALS Registry (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 Centers for
Disease Control and Prevention, representing each of the
following:
``(A) National voluntary health associations that
focus solely on ALS and have demonstrated experience in
ALS research, care, and patient services, as well as
other voluntary associations focusing on
neurodegenerative diseases that represent and advocate
on behalf of patients with ALS and patients with other
motor neuron disorders that can be confused with ALS,
misdiagnosed as ALS, and in some cases progress to ALS.
``(B) The National Institutes of Health, to
include, upon the recommendation of the Director of the
National Institutes of Health, representatives from the
National Institute of Neurological Disorders and Stroke
and the National Institute of Environmental Health
Sciences.
``(C) The Department of Veterans Affairs.
``(D) The Agency for Toxic Substances and Disease
Registry.
``(E) The Centers for Disease Control and
Prevention.
``(F) Patients with ALS or their family members.
``(G) Clinicians with expertise on ALS and related
diseases.
``(H) Epidemiologists with experience in data
registries.
``(I) Geneticists or experts in genetics who have
experience with the genetics of ALS or other
neurological diseases.
``(J) Statisticians.
``(K) Ethicists.
``(L) Attorneys.
``(M) Other individuals with an interest in
developing and maintaining the National ALS Registry.
``(2) Duties.--The Advisory Committee shall review
information and make recommendations to the Secretary
concerning--
``(A) the development and maintenance of the
National ALS Registry;
``(B) the type of information to be collected and
stored in the Registry;
``(C) the manner in which such data is to be
collected;
``(D) the use and availability of such data
including guidelines for such use; and
``(E) the collection of information about diseases
and disorders that primarily affect motor neurons that
are considered essential to furthering the study and
cure of ALS.
``(3) Report.--Not later than 1 years after the date on
which the Advisory Committee is established, the Advisory
Committee shall submit a report concerning the review conducted
under paragraph (2) that contains the recommendations of the
Advisory Committee with respect to the results of such review.
``(c) Grants.--Notwithstanding the recommendations of the Advisory
Committee under subsection (b), the Secretary, acting through the
Director of the Centers for Disease Control and Prevention, 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 ALS and other motor neuron disorders that can be
confused with ALS, misdiagnosed as ALS, and in some cases progress to
ALS.
``(d) Coordination With State, Local, and Federal Registries.--
``(1) In general.--In establishing the National ALS
Registry under subsection (a), the Secretary, acting through
the Director of the Centers for Disease Control and Prevention,
shall--
``(A) identify, build upon, expand, and coordinate
among existing data and surveillance systems, surveys,
registries, and other Federal public health and
environmental infrastructure wherever possible,
including--
``(i) the 3 ALS registry pilot projects
initiated in fiscal year 2006 by the Centers
for Disease Control and Prevention and the
Agency for Toxic Substances and Disease
Registry at the South Carolina Office of
Research & Statistics; the Mayo Clinic in
Rochester, Minnesota; and Emory University in
Atlanta, Georgia;
``(ii) the Department of Veterans Affairs
ALS Registry;
``(iii) the DNA and Cell Line Repository of
the National Institute of Neurological
Disorders and Stroke Human Genetics Resource
Center;
``(iv) Agency for Toxic Substances and
Disease Registry studies, including studies
conducted in Illinois, Missouri, El Paso and
San Antonio, Texas, and Massachusetts;
``(v) State-based ALS registries, including
the Massachusetts ALS Registry;
``(vi) the National Vital Statistics
System; and
``(vii) any other existing or relevant
databases that collect or maintain information
on those motor neuron diseases recommended by
the Advisory Committee established in
subsection (b); and
``(B) provide for research access to ALS data as
recommended by the Advisory Committee established in
subsection (b) 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 nih and department of veterans
affairs.--Notwithstanding the recommendations of the Advisory
Committee established in subsection (b), and consistent with
applicable privacy statutes and regulations, the Secretary
shall ensure that epidemiological and other types of
information obtained under subsection (a) is made available to
the National Institutes of Health and the Department of
Veterans Affairs.
``(e) Definition.--For the purposes of this section, the term
`national voluntary health association' means a national non-profit
organization with chapters or other affiliated organizations in States
throughout the United States.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $25,000,000 for fiscal year
2008, and such sums as may be necessary for each of fiscal years 2009
through 2012.''.
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