[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4033 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4033

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 7, 2005

    Mr. Engel (for himself, Mr. Terry, Mr. Shimkus, Mr. Waxman, Mr. 
  Whitfield, Mr. Brown of Ohio, Ms. Eshoo, Mr. Towns, Mr. Rush, Mrs. 
 Capps, Mr. Allen, Mr. Rangel, Mr. Foley, Mr. McNulty, Mr. McHugh, Ms. 
Ros-Lehtinen, Mr. McDermott, Ms. DeLauro, Mr. Shays, Mr. Jefferson, Mr. 
Goode, Mr. Lantos, Ms. Berkley, Mr. Calvert, Ms. Bordallo, Mr. Brady of 
   Pennsylvania, Mr. Moore of Kansas, Ms. Jackson-Lee of Texas, Mr. 
  Abercrombie, Ms. Carson, Mr. Crowley, Mr. Filner, Mr. Grijalva, Mr. 
 Higgins, Mr. Hinchey, Mr. Kucinich, Mr. Lynch, Mr. Ruppersberger, Mr. 
    Sanders, Mr. Schiff, Mr. Scott of Georgia, Mr. Van Hollen, Ms. 
Wasserman Schultz, Mr. Weiner, Mr. Wexler, Mr. Capuano, and Mr. Owens) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 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 any 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) The establishment of a national registry will help--
                    (A) identify the incidence and prevalence of ALS in 
                the United States;
                    (B) collect data important to the study of ALS;
                    (C) promote a better understanding of ALS;
                    (D) promote research into the genetic and 
                environmental factors that cause ALS;
                    (E) provide a means for patients to contact 
                scientists researching the environmental and genetic 
                factors that cause ALS as well as those engaged in 
                clinical trials; and
                    (F) 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. 399O. AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.

    ``(a) Establishment.--
            ``(1) In general.--Not later than 6 months 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, 
                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 of ALS in the United 
                States.
            ``(2) Purpose.--It is the purpose of the registry 
        established under paragraph (1)(B) to--
                    ``(A) gather data concerning--
                            ``(i) ALS, including the incidence and 
                        prevalence of ALS in the United States;
                            ``(ii) the environmental and occupational 
                        factors that may be associated with the 
                        disease;
                            ``(iii) the age, race or ethnicity, gender, 
                        and family history of individuals who are 
                        diagnosed with the disease; and
                            ``(iv) other matters as recommended by the 
                        Advisory Committee established under subsection 
                        (b); and
                    ``(B) establish a secure method to put patients in 
                contact with scientists studying the environmental, and 
                genetic causes of motor neuron disease or conducting 
                clinical trials on therapies for motor neuron disease.
    ``(b) Advisory Committee.--
            ``(1) Establishment.--Not later than 60 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 that have a demonstrated experience 
                in ALS research, care, and patient services.
                    ``(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 who have worked with data 
                registries.
                    ``(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 conduct a study 
        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 6 months after the date on 
        which the Advisory Committee is established, the Advisory 
        Committee shall submit a report concerning the study conducted 
        under paragraph (2) that contains the recommendations of the 
        Advisory Committee with respect to the results of such study.
    ``(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.
    ``(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 Department of Veterans Affairs 
                        ALS Registry;
                            ``(ii) the DNA and Cell Line Repository of 
                        the National Institute of Neurological 
                        Disorders and Stroke Human Genetics Resource 
                        Center;
                            ``(iii) Agency for Toxic Substances and 
                        Disease Registry studies, including studies 
                        conducted in Illinois, Missouri, El Paso and 
                        San Antonio Texas, and Massachusetts;
                            ``(iv) State-based ALS registries, 
                        including the Massachusetts ALS Registry;
                            ``(v) the National Vital Statistics System; 
                        and
                            ``(vi) 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 public access to an electronic 
                national database that accepts data from State-based 
                registries, health care professionals, and others as 
                recommended by the Advisory Committee established in 
                subsection (b) in a manner that protects personal 
                privacy consistent with medical privacy regulations.
            ``(2) Coordination with nih and department of veterans 
        affairs.--Notwithstanding the recommendations of the Advisory 
        Committee established in subsection (b), 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 
2006, and such sums as may be necessary for each of fiscal years 2007 
through 2010.''.
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