[Congressional Record Volume 154, Number 153 (Thursday, September 25, 2008)]
[House]
[Pages H9916-H9917]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                            ALS REGISTRY ACT

  Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the 
Senate bill (S. 1382) to amend the Public Health Service Act to provide 
for the establishment of an Amyotrophic Lateral Sclerosis Registry.
  The Clerk read the title of the Senate bill.
  The text of the Senate bill is 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. 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.

                              {time}  1630

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from

[[Page H9917]]

New Jersey (Mr. Pallone) and the gentleman from Nebraska (Mr. Terry) 
each will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I rise in support of S. 1382, the ALS Registry Act. 
ALS, more commonly known as Lou Gehrig's disease, is a fatal, 
progressive neurodegenerative disease affecting approximately 5,600 
Americans each year. It is estimated that as many as 30,000 Americans 
have ALS at any given time, with an average life expectancy of 2 to 5 
years from time of diagnosis.
  Today, no single national patient registry collects and stores 
information on the prevalence and incidence of ALS.
  The ALS Registry Act would create a nationwide registry at the 
Centers for Disease Control and Prevention for ALS and other related 
motor neuron disorders. The patient registry would collect data which 
is urgently needed for ALS research, disease management, and the 
development of standards of care. This will allow us to make real 
progress in better understanding ALS, and to develop measures for 
prevention, treatment, and eventually a cure for this dreaded disease.
  I would like to thank my dear friend and colleague on the Energy and 
Commerce Committee Representative Eliot Engel for his dedication to 
bringing this bill before us today. Eliot and I, along with Nita Lowey, 
started the same time in Congress, which is about 20 years now. I 
remember when we had the hearing on this. Mr. Engel is from New York 
and talked a little about Lou Gehrig. I had actually been to a Yankees' 
game just a few days before, and I saw so many people wearing Lou 
Gehrig shirts, and I was amazed after so many years that that would 
still be the case.
  On October 16 of last year, we overwhelmingly passed the House 
companion to S. 1382, and I strongly urge us to pass this bill by the 
same margin. Please join me in enacting this important legislation.
  I reserve the balance of my time.
  Mr. TERRY. Madam Speaker, I yield myself such time as I may consume.
  Madam Speaker, as one of the coauthors of this bill, I rise in 
support of Senate 1382, or at least the House version of this ALS 
Registry Act.
  ALS, sometimes called Lou Gehrig's disease, is a rapidly progressive 
and invariably fatal neurological disease that attacks the nerve cells 
responsible for controlling voluntary muscles. The disease belongs to a 
group of disorders known as motor neuron diseases, which are 
characterized by the gradual degeneration and death of motor neurons.
  As many as 20,000 Americans have ALS, and an estimated 5,000 people 
in the United States are diagnosed with the disease each year. ALS is 
one of the most common neuromuscular diseases worldwide, and people of 
all races and ethnic backgrounds are affected. ALS most commonly 
strikes people between 40 and 60 years of age, but younger and older 
people also can develop the disease.
  Constituents suffering from what used to be called Lou Gehrig's 
disease have been visiting Congress and asking for help for years. The 
disease is brutal, and I believe that establishing a registry will help 
researchers cure ALS. An ALS registry will serve as an excellent 
resource for scientists.
  I thank Mr. Engel and others like Mr. Deal who helped shepherd this 
through our subcommittee and committee and in making sure that it got 
here today.
  Madam Speaker, I urge all Members to support this legislation.
  I reserve the balance of my time.
  Mr. PALLONE. Madam Speaker, I yield 4 minutes to the sponsor of the 
bill, the gentleman from New York (Mr. Engel).
  Mr. ENGEL. I thank my good friend, the gentleman from New Jersey (Mr. 
Pallone), with whom I have worked so closely during these past 20 years 
on so many things, and he is doing a wonderful job as chairman of our 
Health Subcommittee on the Energy and Commerce Committee.
  Madam Speaker, I am so proud that through hard work and compromise 
with the Senate, that today we will take up a final version of the ALS 
Registry Act. The House has passed this bill before. It was stuck in 
the Senate. We finally have it shaken loose and it is back with the 
Senate version which we are proud to all support. Thanks to this 
legislation, we will provide for the creation and maintenance of a 
single, nationwide ALS registry at the Centers for Disease Control and 
Prevention.
  Amyotrophic lateral sclerosis, ALS, also known as Lou Gehrig's 
disease, is a fatal, progressive neurodegenerative disease that affects 
motor nerve cells in the brain and spinal cord. Approximately 5,600 
people in the U.S. are diagnosed with ALS each year, and it is 
estimated that as many as 30,000 Americans have the disease at any 
given time. The average life expectancy for a person with ALS is 2 to 5 
years from the time of diagnosis. The causes of ALS are not well 
understood, and there is no known cure.
  I first became aware of this disease through my grandmother. My 
father's mother was diagnosed with this disease. I was only 2\1/2\ when 
she passed away. As Mr. Pallone mentioned, the most famous person with 
this disease is Lou Gehrig. I come from the Bronx where the Yankees 
play, and Yankee Stadium just had its last game on Sunday evening. The 
clips that we saw were from that famous speech that Lou Gehrig made at 
Yankee Stadium. You could hear the echoes reverberating, saying that he 
felt he was the luckiest man on the face of the Earth. And it is 
fitting that today we pass this bill, just a few days after Yankee 
Stadium where Lou Gehrig toiled for so many years is closing. This is a 
fitting tribute to Lou Gehrig.
  A single national patient registry which collects and stores 
information on the prevalence and incidence of ALS does not exist in 
the United States today, believe it or not, and that is what this bill 
is going to change.
  The establishment of a national registry will help identify the 
incidence and prevalence of ALS and other motor neuron disorders in the 
United States and collect data which is urgently needed for ALS 
research, disease management and the development of standards of care 
in order to significantly enhance the Nation's efforts to find a 
treatment and cure for ALS.
  I would like to thank Steve Gibson and Pat Wildman of the ALS 
Association for their partnership on this bill. We have worked with 
them for so many years, as well as William Garner of Chairman Dingell's 
staff for his work on this bill. I would also like to thank John Ford, 
formerly of Chairman Dingell's staff and Katherine Martin, formerly of 
Ranking Member Barton's staff who worked so diligently on this bill 
prior to its original House passage in 2007.
  I thank all my colleagues for it and urge them to pass this bill. It 
has been a long time coming, but it is finally here.
  Mr. TERRY. Madam Speaker, I have no further speakers, and I yield 
back the balance of my time.
  Mr. PALLONE. Madam Speaker, I would just urge passage of this 
important legislation relevant to ALS, and I yield back the balance of 
my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the Senate bill, S. 1382.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. TERRY. Madam Speaker, I object to the vote on the ground that a 
quorum is not present and make the point of order that a quorum is not 
present.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.
  The point of no quorum is considered withdrawn.




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