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

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
110th CONGRESS
  2d Session
                                S. 1382

_______________________________________________________________________

                                 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.
            ``(2) 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.

            Passed the Senate September 23 (legislative day, September 
      17), 2008.

            Attest:

                                                             Secretary.
110th CONGRESS

  2d Session

                                S. 1382

_______________________________________________________________________

                                 AN ACT

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