I 
109TH CONGRESS 
1ST SESSION H. R. 4033 
To amend the Public Health Service Act to provide for the establishment 
of an Amyotrophic Lateral Sclerosis Registry. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 7, 2005 
Mr. ENGEL (for himself, Mr. TERRY, Mr. SHIMKUS, Mr. WAXMAN, Mr. 
WHITFIELD, Mr. BROWN of Ohio, Ms. ESHOO, Mr. TOWNS, Mr. RUSH, 
Mrs. CAPPS, Mr. ALLEN, Mr. RANGEL, Mr. FOLEY, Mr. MCNULTY, Mr. 
MCHUGH, Ms. ROS-LEHTINEN, Mr. MCDERMOTT, Ms. DELAURO, Mr. 
SHAYS, Mr. JEFFERSON, Mr. GOODE, Mr. LANTOS, Ms. BERKLEY, Mr. 
CALVERT, Ms. BORDALLO, Mr. BRADY of Pennsylvania, Mr. MOORE of 
Kansas, Ms. JACKSON-LEE of Texas, Mr. ABERCROMBIE, Ms. CARSON, 
Mr. CROWLEY, Mr. FILNER, Mr. GRIJALVA, Mr. HIGGINS, Mr. HINCHEY, 
Mr. KUCINICH, Mr. LYNCH, Mr. RUPPERSBERGER, Mr. SANDERS, Mr. 
SCHIFF, Mr. SCOTT of Georgia, Mr. VAN HOLLEN, Ms. WASSERMAN 
SCHULTZ, Mr. WEINER, Mr. WEXLER, Mr. CAPUANO, and Mr. OWENS) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
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 Representa-
tives 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 treat-
ment 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 factors, but 
those relationships are not well understood. 
(8) Scientists believe that there are significant 
ties between ALS and any motor neuron diseases. 
(9) Several ALS disease registries and data-
bases exist in the United States and throughout the 
world, including the SOD1 database, the National
Institute of Neurological Disorders and Stroke re-
pository, 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) The establishment of a national registry 
will help— 
(A) identify the incidence and prevalence 
of ALS in the United States; 
(B) collect data important to the study of 
ALS; 
(C) promote a better understanding of 
ALS; 
(D) promote research into the genetic and 
environmental factors that cause ALS; 
(E) provide a means for patients to contact 
scientists researching the environmental and ge-
netic factors that cause ALS as well as those 
engaged in clinical trials; and 
(F) 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. 399O. AMYOTROPHIC LATERAL SCLEROSIS REG-
ISTRY. 
‘‘(a) ESTABLISHMENT.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the receipt of the report described in sub-
section (b)(2)(A), the Secretary, acting through the 
Director of the Centers for Disease Control and Pre-
vention and in consultation with a national voluntary 
health organization with experience serving the pop-
ulation of individuals with amyotrophic lateral scle-
rosis (referred to in this section as ‘ALS’), shall— 
‘‘(A) develop a system to collect data on 
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 of ALS in 
the United States. 
‘‘(2) PURPOSE.—It is the purpose of the reg-
istry established under paragraph (1)(B) to—
‘‘(A) gather data concerning— 
‘‘(i) ALS, including the incidence and 
prevalence of ALS in the United States; 
‘‘(ii) the environmental and occupa-
tional factors that may be associated with 
the disease; 
‘‘(iii) the age, race or ethnicity, gen-
der, and family history of individuals who 
are diagnosed with the disease; and 
‘‘(iv) other matters as recommended 
by the Advisory Committee established 
under subsection (b); and 
‘‘(B) establish a secure method to put pa-
tients in contact with scientists studying the en-
vironmental, and genetic causes of motor neu-
ron disease or conducting clinical trials on 
therapies for motor neuron disease. 
‘‘(b) ADVISORY COMMITTEE.— 
‘‘(1) ESTABLISHMENT.—Not later than 60 days 
after the date of the enactment of this section, the 
Secretary, acting through the Director of the Cen-
ters for Disease Control and Prevention, shall estab-
lish a committee to be known as the Advisory Com-
mittee on the National ALS Registry (referred to in 
this section as the ‘Advisory Committee’). The Advi-
sory 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 fol-
lowing: 
‘‘(A) National voluntary health associa-
tions that focus solely on ALS that have a dem-
onstrated experience in ALS research, care, and 
patient services. 
‘‘(B) The National Institutes of Health, to 
include, upon the recommendation of the Direc-
tor of the National Institutes of Health, rep-
resentatives from the National Institute of Neu-
rological 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 who have worked with data 
registries.
‘‘(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 
conduct a study and make recommendations to the 
Secretary concerning— 
‘‘(A) the development and maintenance of 
the National ALS Registry; 
‘‘(B) the type of information to be col-
lected 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 6 months after 
the date on which the Advisory Committee is estab-
lished, the Advisory Committee shall submit a report 
concerning the study conducted under paragraph (2) 
that contains the recommendations of the Advisory 
Committee with respect to the results of such study. 
‘‘(c) GRANTS.—Notwithstanding the recommenda-
tions 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, pub-
lic or private nonprofit entities for the collection, analysis, 
and reporting of data on ALS. 
‘‘(d) COORDINATION WITH STATE, LOCAL, AND FED-
ERAL REGISTRIES.— 
‘‘(1) IN
GENERAL.—In establishing the Na-
tional ALS Registry under subsection (a), the Sec-
retary, acting through the Director of the Centers 
for Disease Control and Prevention, shall— 
‘‘(A) identify, build upon, expand, and co-
ordinate among existing data and surveillance 
systems, surveys, registries, and other Federal
public health and environmental infrastructure 
wherever possible, including— 
‘‘(i) the Department of Veterans Af-
fairs ALS Registry; 
‘‘(ii) the DNA and Cell Line Reposi-
tory of the National Institute of Neuro-
logical Disorders and Stroke Human Ge-
netics Resource Center; 
‘‘(iii) Agency for Toxic Substances 
and Disease Registry studies, including 
studies conducted in Illinois, Missouri, El 
Paso and San Antonio Texas, and Massa-
chusetts; 
‘‘(iv) State-based ALS registries, in-
cluding the Massachusetts ALS Registry; 
‘‘(v) the National Vital Statistics Sys-
tem; and 
‘‘(vi) any other existing or relevant 
databases that collect or maintain informa-
tion on those motor neuron diseases rec-
ommended by the Advisory Committee es-
tablished in subsection (b); and 
‘‘(B) provide for public access to an elec-
tronic national database that accepts data from 
State-based registries, health care professionals,
and others as recommended by the Advisory 
Committee established in subsection (b) in a 
manner that protects personal privacy con-
sistent with medical privacy regulations. 
‘‘(2) COORDINATION WITH NIH AND DEPART-
MENT OF VETERANS AFFAIRS.—Notwithstanding the 
recommendations of the Advisory Committee estab-
lished in subsection (b), 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 Depart-
ment 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 af-
filiated 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 2006, and such sums as may 
be necessary for each of fiscal years 2007 through 2010.’’. 
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