[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1382 Enrolled Bill (ENR)]
S.1382
One Hundred Tenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and eight
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.
``(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 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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.