[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1382 Reported in Senate (RS)]
Calendar No. 518
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 (for himself, Mrs. Murray, Mrs. Boxer, Mr. Harkin, Mr. Brown,
Mr. Isakson, Mr. Inouye, Mr. Durbin, Mr. Sanders, Mr. Craig, Mr.
Baucus, Mr. Reed, Mrs. Feinstein, Mr. Coleman, Mr. Cochran, Mr. Conrad,
Mrs. Clinton, Mr. Menendez, Mr. Thune, Mr. Bunning, Ms. Murkowski, Mrs.
Dole, Mr. Johnson, Ms. Klobuchar, Mr. Burr, Mr. Dodd, Mr. Nelson of
Florida, Mr. Bayh, Mr. Hagel, Mr. Lautenberg, Mr. Vitter, Mr. Warner,
Mr. Schumer, Mr. Bingaman, Mr. Lott, Mr. DeMint, Mr. Bennett, Ms.
Snowe, Mr. Dorgan, Ms. Stabenow, Mr. Martinez, Mr. Casey, Mr. Graham,
Mr. Tester, Mr. Smith, Mr. Lieberman, Mr. Whitehouse, Mr. Cardin, Mr.
Akaka, Mr. Grassley, Ms. Cantwell, Ms. Collins, Ms. Landrieu, Mr.
Wyden, Ms. Mikulski, Mr. Brownback, Mr. Sessions, Mr. Biden, Mr. Kerry,
Mr. Leahy, Mr. Chambliss, Mrs. McCaskill, Mr. Levin, Mr. Carper, Mr.
Pryor, Mr. Sununu, and Mrs. Lincoln) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
December 4, 2007
Reported by Mr. Kennedy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``ALS Registry
Act''.</DELETED>
<DELETED>SEC. 2. FINDINGS.</DELETED>
<DELETED> Congress makes the following findings:</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (2) The average life expectancy for a person with
ALS is 2 to 5 years from the time of diagnosis.</DELETED>
<DELETED> (3) The cause of ALS is not well
understood.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (5) There is no known cure for ALS.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (7) Studies have found relationships between ALS
and environmental and genetic factors, but those relationships
are not well understood.</DELETED>
<DELETED> (8) Scientists believe that there are significant
ties between ALS and other motor neuron diseases.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (10) A single national system to collect and store
information on the prevalence and incidence of ALS in the
United States does not exist.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (13) The establishment of a national registry will
help--</DELETED>
<DELETED> (A) to identify the incidence and
prevalence of ALS in the United States;</DELETED>
<DELETED> (B) to collect data important to the study
of ALS;</DELETED>
<DELETED> (C) to promote a better understanding of
ALS;</DELETED>
<DELETED> (D) to collect information that is
important for research into the genetic and
environmental factors that cause ALS;</DELETED>
<DELETED> (E) to strengthen the ability of a
clearinghouse--</DELETED>
<DELETED> (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;</DELETED>
<DELETED> (ii) make available information to
patients about research studies for which they
may be eligible; and</DELETED>
<DELETED> (iii) maintain information about
clinical specialists and clinical trials on
therapies; and</DELETED>
<DELETED> (F) to enhance efforts to find treatments
and a cure for ALS.</DELETED>
<DELETED>SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 399R. AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.</DELETED>
<DELETED> ``(a) Establishment.--</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Purpose.--It is the purpose of the registry
established under paragraph (1)(B) to gather available data
concerning--</DELETED>
<DELETED> ``(A) ALS, including the incidence and
prevalence of ALS in the United States;</DELETED>
<DELETED> ``(B) the environmental and occupational
factors that may be associated with the
disease;</DELETED>
<DELETED> ``(C) the age, race or ethnicity, gender,
and family history of individuals who are diagnosed
with the disease;</DELETED>
<DELETED> ``(D) other motor neuron disorders that
can be confused with ALS, misdiagnosed as ALS, and in
some cases progress to ALS; and</DELETED>
<DELETED> ``(E) other matters as recommended by the
Advisory Committee established under subsection
(b).</DELETED>
<DELETED> ``(b) Advisory Committee.--</DELETED>
<DELETED> ``(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:</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(C) The Department of Veterans
Affairs.</DELETED>
<DELETED> ``(D) The Agency for Toxic Substances and
Disease Registry.</DELETED>
<DELETED> ``(E) The Centers for Disease Control and
Prevention.</DELETED>
<DELETED> ``(F) Patients with ALS or their family
members.</DELETED>
<DELETED> ``(G) Clinicians with expertise on ALS and
related diseases.</DELETED>
<DELETED> ``(H) Epidemiologists with experience in
data registries.</DELETED>
<DELETED> ``(I) Geneticists or experts in genetics
who have experience with the genetics of ALS or other
neurological diseases.</DELETED>
<DELETED> ``(J) Statisticians.</DELETED>
<DELETED> ``(K) Ethicists.</DELETED>
<DELETED> ``(L) Attorneys.</DELETED>
<DELETED> ``(M) Other individuals with an interest
in developing and maintaining the National ALS
Registry.</DELETED>
<DELETED> ``(2) Duties.--The Advisory Committee shall review
information and make recommendations to the Secretary
concerning--</DELETED>
<DELETED> ``(A) the development and maintenance of
the National ALS Registry;</DELETED>
<DELETED> ``(B) the type of information to be
collected and stored in the Registry;</DELETED>
<DELETED> ``(C) the manner in which such data is to
be collected;</DELETED>
<DELETED> ``(D) the use and availability of such
data including guidelines for such use; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Coordination With State, Local, and Federal
Registries.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(ii) the Department of Veterans
Affairs ALS Registry;</DELETED>
<DELETED> ``(iii) the DNA and Cell Line
Repository of the National Institute of
Neurological Disorders and Stroke Human
Genetics Resource Center;</DELETED>
<DELETED> ``(iv) Agency for Toxic Substances
and Disease Registry studies, including studies
conducted in Illinois, Missouri, El Paso and
San Antonio, Texas, and
Massachusetts;</DELETED>
<DELETED> ``(v) State-based ALS registries,
including the Massachusetts ALS
Registry;</DELETED>
<DELETED> ``(vi) the National Vital
Statistics System; and</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``ALS Registry Act''.
SEC. 2. 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, shall--
``(A) develop a system to collect data on
amyotrophic lateral sclerosis (referred to in this
section as `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 develop 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--
``(A) better describe the incidence and prevalence
of ALS in the United States;
``(B) examine appropriate factors, such as
environmental and occupational, that may be associated
with the disease;
``(C) better outline key demographic factors (such
as age, race or ethnicity, gender, and family history
of individuals who are diagnosed with the disease)
associated with the disease;
``(D) better examine the connection between ALS and
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 180 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 not more than 27 members to be
appointed by the Secretary, acting through the Centers for
Disease Control and Prevention, of which--
``(A) two-thirds of such members shall represent
governmental agencies--
``(i) including at least one member
representing--
``(I) 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;
``(II) the Department of Veterans
Affairs;
``(III) the Agency for Toxic
Substances and Disease Registry; and
``(IV) the Centers for Disease
Control and Prevention; and
``(ii) of which at least one such member
shall be a clinician with expertise on ALS and
related diseases, an epidemiologist with
experience in data registries, a statistician,
an ethicist, and a privacy expert (relating to
the privacy regulations under the Health
Insurance Portability and Accountability Act of
1996); and
``(B) one-third of such members shall be public
members, including at least one member representing--
``(i) national and voluntary health
associations;
``(ii) patients with ALS or their family
members;
``(iii) clinicians with expertise on ALS
and related diseases;
``(iv) epidemiologists with experience in
data registries;
``(v) geneticists or experts in genetics
who have experience with the genetics of ALS or
other neurological diseases and
``(vi) 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 270 days after the date on
which the Advisory Committee is established, the Advisory
Committee shall submit a report to the Secretary 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.--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 after receiving
the report under subsection (b)(3).
``(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, which
may include--
``(i) any registry pilot projects
previously supported by the Centers for Disease
Control and Prevention;
``(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 at the National Institutes of Health;
``(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;
``(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.--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 with experience serving the population of
individuals with ALS and have demonstrated experience in ALS research,
care, and patient services.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $2,000,000 for fiscal year
2008, $25,000,000 for fiscal year 2009, and $16,000,000 for each of
fiscal years 2010 through 2012.''.
SEC. 3. REPORT ON REGISTRIES.
Not later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall submit to the
appropriate committees of Congress a report outlining--
(1) the registries currently under way;
(2) future planned registries;
(3) the criteria involved in determining what registries to
conduct, defer, or suspend; and
(4) the scope of those registries.
The report shall also include a description of the activities the
Secretary undertakes to establish partnerships with research and
patient advocacy communities to expand registries.
Calendar No. 518
110th CONGRESS
1st Session
S. 1382
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for the establishment
of an Amyotrophic Lateral Sclerosis Registry.
_______________________________________________________________________
December 4, 2007
Reported with an amendment