[110th Congress Public Law 373]
[From the U.S. Government Printing Office]
[DOCID: f:publ373.110]
[[Page 122 STAT. 4047]]
Public Law 110-373
110th Congress
An Act
To amend the Public Health Service Act to provide for the establishment
of an Amyotrophic Lateral Sclerosis Registry. <<NOTE: Oct. 8,
2008 - [S. 1382]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: ALS Registry
Act.>>
SECTION 1. <<NOTE: 42 USC 201 note.>> 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. <<NOTE: 42 USC 280g-7.>> AMYOTROPHIC LATERAL
SCLEROSIS REGISTRY.
``(a) Establishment.--
``(1) In <<NOTE: Deadline.>> 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, may, if
scientifically advisable--
``(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
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``(E) other matters as recommended by the Advisory
Committee established under subsection (b).
``(b) Advisory Committee.--
``(1) Establishment.--Not <<NOTE: Deadline.>> 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, may 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 may 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
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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 may 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, may--
``(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.
``(C) Coordination with nih and department of
veterans affairs.--Consistent with applicable privacy
statutes and regulations, the Secretary may ensure that
epidemiological and other types of information obtained
under subsection (a) is made available to the National
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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.''.
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 may 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 may also include a description of the activities the
Secretary undertakes to establish partnerships with research and patient
advocacy communities to expand registries.
Approved October 8, 2008.
LEGISLATIVE HISTORY--S. 1382 (H.R. 2295):
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HOUSE REPORTS: No. 110-379 accompanying H.R. 2295 (Comm. on Energy and
Commerce).
CONGRESSIONAL RECORD, Vol. 154 (2008):
Sept. 23, considered and passed Senate.
Sept. 25, 26, considered and passed House.
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