[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1382 Engrossed in Senate (ES)]
110th CONGRESS
2d Session
S. 1382
_______________________________________________________________________
AN ACT
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. 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, 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
``(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, 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 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.
``(2) 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 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.
Passed the Senate September 23 (legislative day, September
17), 2008.
Attest:
Secretary.
110th CONGRESS
2d Session
S. 1382
_______________________________________________________________________
AN ACT
To amend the Public Health Service Act to provide for the establishment
of an Amyotrophic Lateral Sclerosis Registry.