A bill to amend the Public Health Service Act to provide for the establishment of an Amyotrophic Lateral Sclerosis Registry.

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.

Summary: ALS Registry Act - Amends the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), if scientifically advisable, to: (1) develop a system to collect data on amyotrophic lateral sclerosis (ALS) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, or progress to ALS. And (2) establish a national registry for the collection and storage of such data to develop a population-based registry of cases. Authorizes the Secretary, acting through the Director, to establish the Advisory Committee on the National ALS Registry, which may review information and make recommendations to the Secretary concerning: (1) the development and maintenance of the registry, (2) the type of information to be included, (3) the manner in which data is to be collected, (4) the use and availability of such data. And (5) 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. Allows the Secretary, acting through the Director, to 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. Authorizes the Secretary, acting through the Director, to: (1) identify, build upon, expand, and coordinate among existing data and surveillance systems, surveys, registries, and other federal public health and environmental infrastructure wherever possible. And (2) provide for research access to ALS data as recommended by the Advisory Committee in a manner that protects personal privacy. Allows the Secretary to ensure that epidemiological and other types of information is made available to the National Institutes of Health (NIH) and the Department of Veterans Affairs (VA). Authorizes the Secretary to report to the appropriate congressional committees on ALS registries, including: (1) the registries currently under way and future planned registries. (2) the criteria involved in determining what registries to conduct, defer, or suspend, (3) the scope of those registries. And (4) the activities the Secretary undertakes to establish partnerships with research and patient advocacy communities to expand registries.