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[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1382 Introduced in Senate (IS)]

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 introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``ALS Registry Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (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.
            (2) The average life expectancy for a person with ALS is 2 
        to 5 years from the time of diagnosis.
            (3) The cause of ALS is not well understood.
            (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.
            (5) There is no known cure for ALS.
            (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.
            (7) Studies have found relationships between ALS and 
        environmental and genetic factors, but those relationships are 
        not well understood.
            (8) Scientists believe that there are significant ties 
        between ALS and other motor neuron diseases.
            (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.
            (10) A single national system to collect and store 
        information on the prevalence and incidence of ALS in the 
        United States does not exist.
            (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.
            (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.
            (13) The establishment of a national registry will help--
                    (A) to identify the incidence and prevalence of ALS 
                in the United States;
                    (B) to collect data important to the study of ALS;
                    (C) to promote a better understanding of ALS;
                    (D) to collect information that is important for 
                research into the genetic and environmental factors 
                that cause ALS;
                    (E) to strengthen the ability of a clearinghouse--
                            (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;
                            (ii) make available information to patients 
                        about research studies for which they may be 
                        eligible; and
                            (iii) maintain information about clinical 
                        specialists and clinical trials on therapies; 
                        and
                    (F) to enhance efforts to find treatments and a 
                cure for ALS.

SEC. 3. 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 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--
                    ``(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
                    ``(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.
            ``(2) Purpose.--It is the purpose of the registry 
        established under paragraph (1)(B) to gather available data 
        concerning--
                    ``(A) ALS, including the incidence and prevalence 
                of ALS in the United States;
                    ``(B) the environmental and occupational factors 
                that may be associated with the disease;
                    ``(C) the age, race or ethnicity, gender, and 
                family history of individuals who are diagnosed with 
                the disease;
                    ``(D) 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 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:
                    ``(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.
                    ``(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.
                    ``(C) The Department of Veterans Affairs.
                    ``(D) The Agency for Toxic Substances and Disease 
                Registry.
                    ``(E) The Centers for Disease Control and 
                Prevention.
                    ``(F) Patients with ALS or their family members.
                    ``(G) Clinicians with expertise on ALS and related 
                diseases.
                    ``(H) Epidemiologists with experience in data 
                registries.
                    ``(I) Geneticists or experts in genetics who have 
                experience with the genetics of ALS or other 
                neurological diseases.
                    ``(J) Statisticians.
                    ``(K) Ethicists.
                    ``(L) Attorneys.
                    ``(M) 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 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.
    ``(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.
    ``(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, 
                including--
                            ``(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;
                            ``(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;
                            ``(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, including 
                        the Massachusetts ALS Registry;
                            ``(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.--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.
    ``(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.
    ``(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.''.
                                 <all>
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