[Congressional Record Volume 153, Number 79 (Monday, May 14, 2007)]
[Senate]
[Pages S6062-S6063]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REID:
  S. 1382. A bill to amend the Public Health Service Act to provide the 
establishment of an Amyotrophic Lateral Sclerosis Registry; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. REID. Mr. President, I rise to introduce the ALS Registry Act.
  Lou Gehrig brought Amyotrophic Lateral Sclerosis, ALS, to the 
public's attention more than 65 years ago and his courage put a human 
face' on this terrible disease. Each of us has a Lou Gehrig back in our 
home State, someone who shows great tremendous courage and grace as 
they wrestle with ALS.
  Over the years, I have worked closely with the Nevada ALS Association 
and have met with many Nevadans who have been touched by this 
devastating illness. One of these Nevadans was a man by the name of 
Steve Rigazio who was invited to testify before the Labor/HHS/Education 
Appropriations Subcommittee in May of 2000. Steve was at the height of 
his career when he was diagnosed with ALS. He worked through the ranks 
of the Nevada Power Company, the largest utility company in the State, 
for 16 years until he became president. He played semi-professional 
baseball. He also played and coached recreational hockey.
  After his diagnosis, Steve continued to show up for work at 6 a.m. 
for as long as he could. Sadly just 20 months after he testified so 
movingly before Congress, Steve Rigazio died of ALS on December 27, 
2001 at the age of 47. He left behind a family that included a wife, 
two children and hundreds of friends. The ALS Steve Rigazio Voice of 
Courage Award was named in his honor as a living testimony to the life 
of this special man.
  Every year approximately 5,600 Americans will learn they have ALS. 
There is no cure for ALS and there is only one FDA approved drug to 
specifically treat ALS. That drug only works for 20 percent of 
patients, and even for them, it merely extends life for a few months.
  ALS has proven particularly hard for scientists and doctors to tackle 
for a number of reasons. One of those reasons is there is not a 
centralized place where data on the disease is collected. Currently, 
there is only a patchwork of data about ALS that does not include the 
entire U.S. population and only includes limited data for specific 
purposes, such as to determine the relationship between military 
service and the disease. Perhaps the most obvious example of the 
limitations of current surveillance systems and registries is that we 
do not know with certainty how many people are living with ALS in the 
United States today. Over 136 years after the discovery of ALS, 
estimates on its prevalence still vary by as much as 100 percent, from 
a low of about 15,000 patients to as many as thirty 30,000.
  The legislation I am introducing today would create an ALS registry 
at the Centers for Disease Control and Prevention, CDC, and will aid in 
the search for a cure to this devastating disease. The registry will 
collect data concerning: the incidence and prevalence of ALS in the 
U.S.; the environmental and occupational factors that may contribute to 
the disease; the age, race or ethnicity, gender and family history of 
individuals diagnosed; and other information essential to the study of 
ALS.

  A national registry will help arm our Nation's researchers and 
clinicians with the tools and information they need to make progress in 
the fight against ALS. The data made available by a registry will 
potentially allow scientists to identify causes of the disease, and 
maybe even lead to the discovery of new treatment, a cure for ALS, or 
even a way to prevent the disease in the first place.
  I first introduced this legislation in 2005. Since that time, we have 
appropriated funding to begin work on the development of a National ALS 
Registry at the CDC. As a result, the CDC has begun pilot proams that 
will: Develop and test strategies to efficiently identify ALS patients, 
and (2) determine how to obtain data from existing registries and 
databases. These pilot programs will help to expedite the development 
of the registry established by this legislation. This is especially 
important considering the life expectancy for a person with ALS is 2 to 
5 years from the time of diagnosis.
  The establishment of a registry will bring new hope to tens of 
thousands of patients and their families that ALS will no longer be a 
death sentence. No one wants to wait another 136 years before a cure is 
found. I urge my colleagues to support the swift passage of the ALS 
Registry Act.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1382

       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

[[Page S6063]]

     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.''.
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