[110th Congress Public Law 373]
[From the U.S. Government Printing Office]


[DOCID: f:publ373.110]

[[Page 122 STAT. 4047]]

Public Law 110-373
110th Congress

                                 An Act


 
To amend the Public Health Service Act to provide for the establishment 
     of an Amyotrophic Lateral Sclerosis Registry. <<NOTE: Oct. 8, 
                          2008 -  [S. 1382]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: ALS Registry 
Act.>> 
SECTION 1. <<NOTE: 42 USC 201 note.>> 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. <<NOTE: 42 USC 280g-7.>> AMYOTROPHIC LATERAL 
                          SCLEROSIS REGISTRY.

    ``(a) Establishment.--
            ``(1) In <<NOTE: Deadline.>> 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

[[Page 122 STAT. 4048]]

                    ``(E) other matters as recommended by the Advisory 
                Committee established under subsection (b).

    ``(b) Advisory Committee.--
            ``(1) Establishment.--Not <<NOTE: Deadline.>> 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

[[Page 122 STAT. 4049]]

                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

[[Page 122 STAT. 4050]]

                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.

    Approved October 8, 2008.

LEGISLATIVE HISTORY--S. 1382 (H.R. 2295):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 110-379 accompanying H.R. 2295 (Comm. on Energy and 
Commerce).
CONGRESSIONAL RECORD, Vol. 154 (2008):
            Sept. 23, considered and passed Senate.
            Sept. 25, 26, considered and passed House.

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