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






                                                       Calendar No. 518
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 (for himself, Mrs. Murray, Mrs. Boxer, Mr. Harkin, Mr. Brown, 
   Mr. Isakson, Mr. Inouye, Mr. Durbin, Mr. Sanders, Mr. Craig, Mr. 
Baucus, Mr. Reed, Mrs. Feinstein, Mr. Coleman, Mr. Cochran, Mr. Conrad, 
Mrs. Clinton, Mr. Menendez, Mr. Thune, Mr. Bunning, Ms. Murkowski, Mrs. 
  Dole, Mr. Johnson, Ms. Klobuchar, Mr. Burr, Mr. Dodd, Mr. Nelson of 
 Florida, Mr. Bayh, Mr. Hagel, Mr. Lautenberg, Mr. Vitter, Mr. Warner, 
   Mr. Schumer, Mr. Bingaman, Mr. Lott, Mr. DeMint, Mr. Bennett, Ms. 
 Snowe, Mr. Dorgan, Ms. Stabenow, Mr. Martinez, Mr. Casey, Mr. Graham, 
 Mr. Tester, Mr. Smith, Mr. Lieberman, Mr. Whitehouse, Mr. Cardin, Mr. 
   Akaka, Mr. Grassley, Ms. Cantwell, Ms. Collins, Ms. Landrieu, Mr. 
Wyden, Ms. Mikulski, Mr. Brownback, Mr. Sessions, Mr. Biden, Mr. Kerry, 
 Mr. Leahy, Mr. Chambliss, Mrs. McCaskill, Mr. Levin, Mr. Carper, Mr. 
  Pryor, Mr. Sununu, and Mrs. Lincoln) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                            December 4, 2007

               Reported by Mr. Kennedy, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``ALS Registry 
Act''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

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

<DELETED>SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 399R. AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.</DELETED>

<DELETED>    ``(a) Establishment.--</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Purpose.--It is the purpose of the registry 
        established under paragraph (1)(B) to gather available data 
        concerning--</DELETED>
                <DELETED>    ``(A) ALS, including the incidence and 
                prevalence of ALS in the United States;</DELETED>
                <DELETED>    ``(B) the environmental and occupational 
                factors that may be associated with the 
                disease;</DELETED>
                <DELETED>    ``(C) the age, race or ethnicity, gender, 
                and family history of individuals who are diagnosed 
                with the disease;</DELETED>
                <DELETED>    ``(D) other motor neuron disorders that 
                can be confused with ALS, misdiagnosed as ALS, and in 
                some cases progress to ALS; and</DELETED>
                <DELETED>    ``(E) other matters as recommended by the 
                Advisory Committee established under subsection 
                (b).</DELETED>
<DELETED>    ``(b) Advisory Committee.--</DELETED>
        <DELETED>    ``(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:</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(C) The Department of Veterans 
                Affairs.</DELETED>
                <DELETED>    ``(D) The Agency for Toxic Substances and 
                Disease Registry.</DELETED>
                <DELETED>    ``(E) The Centers for Disease Control and 
                Prevention.</DELETED>
                <DELETED>    ``(F) Patients with ALS or their family 
                members.</DELETED>
                <DELETED>    ``(G) Clinicians with expertise on ALS and 
                related diseases.</DELETED>
                <DELETED>    ``(H) Epidemiologists with experience in 
                data registries.</DELETED>
                <DELETED>    ``(I) Geneticists or experts in genetics 
                who have experience with the genetics of ALS or other 
                neurological diseases.</DELETED>
                <DELETED>    ``(J) Statisticians.</DELETED>
                <DELETED>    ``(K) Ethicists.</DELETED>
                <DELETED>    ``(L) Attorneys.</DELETED>
                <DELETED>    ``(M) Other individuals with an interest 
                in developing and maintaining the National ALS 
                Registry.</DELETED>
        <DELETED>    ``(2) Duties.--The Advisory Committee shall review 
        information and make recommendations to the Secretary 
        concerning--</DELETED>
                <DELETED>    ``(A) the development and maintenance of 
                the National ALS Registry;</DELETED>
                <DELETED>    ``(B) the type of information to be 
                collected and stored in the Registry;</DELETED>
                <DELETED>    ``(C) the manner in which such data is to 
                be collected;</DELETED>
                <DELETED>    ``(D) the use and availability of such 
                data including guidelines for such use; and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(d) Coordination With State, Local, and Federal 
Registries.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(ii) the Department of Veterans 
                        Affairs ALS Registry;</DELETED>
                        <DELETED>    ``(iii) the DNA and Cell Line 
                        Repository of the National Institute of 
                        Neurological Disorders and Stroke Human 
                        Genetics Resource Center;</DELETED>
                        <DELETED>    ``(iv) Agency for Toxic Substances 
                        and Disease Registry studies, including studies 
                        conducted in Illinois, Missouri, El Paso and 
                        San Antonio, Texas, and 
                        Massachusetts;</DELETED>
                        <DELETED>    ``(v) State-based ALS registries, 
                        including the Massachusetts ALS 
                        Registry;</DELETED>
                        <DELETED>    ``(vi) the National Vital 
                        Statistics System; and</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

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, shall--
                    ``(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, 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 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 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 270 days after the date on 
        which the Advisory Committee is established, the Advisory 
        Committee shall 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, 
        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, 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 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 with experience serving the population of 
individuals with ALS and have demonstrated experience in ALS research, 
care, and patient services.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $2,000,000 for fiscal year 
2008, $25,000,000 for fiscal year 2009, and $16,000,000 for each of 
fiscal years 2010 through 2012.''.

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 shall 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 shall also include a description of the activities the 
Secretary undertakes to establish partnerships with research and 
patient advocacy communities to expand registries.
                                                       Calendar No. 518

110th CONGRESS

  1st Session

                                S. 1382

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                            December 4, 2007

                       Reported with an amendment