110TH CONGRESS 
1ST SESSION H. R. 2295 
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 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 other 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) In each of fiscal years 2006 and 2007, 
Congress directed $887,000 to the Centers for Dis-
ease Control and Prevention to begin a nationwide 
ALS registry. 
(12) The Centers for Disease Control and Pre-
vention and the Agency for Toxic Substances and 
Disease Registry have 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 preva-
lence 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 impor-
tant for research into the genetic and environ-
mental factors that cause ALS; 
(E) to strengthen the ability of a clearing-
house— 
(i) to collect and disseminate research 
findings on environmental, genetic, and 
other causes of ALS and other motor neu-
ron disorders that can be confused with 
ALS, misdiagnosed as ALS, and in some 
cases progress to ALS; 
(ii) to make available information to 
patients about research studies for which 
they may be eligible; and 
(iii) to 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 REG-
ISTRY. 
‘‘(a) ESTABLISHMENT.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the receipt of the report described in subsection 
(b)(3), the Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and 
in consultation with a national voluntary health or-
ganization with experience serving the population of 
individuals with amyotrophic lateral sclerosis (re-
ferred 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 dis-
orders that can be confused with ALS, 
misdiagnosed as ALS, and in some cases 
progress to ALS. 
‘‘(2) PURPOSE.—It is the purpose of the reg-
istry 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 sub-
section (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 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 and have dem-
onstrated experience in ALS research, care, and 
patient services, as well as other voluntary asso-
ciations focusing on neurodegenerative diseases 
that represent and advocate on behalf of pa-
tients 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 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 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 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 1 year after the 
date on which the Advisory Committee is estab-
lished, the Advisory Committee shall submit a report 
concerning the review conducted under paragraph 
(2) that contains the recommendations of the Advi-
sory Committee with respect to the results of such 
review. 
‘‘(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 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 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 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 Dis-
ease Registry at the South Carolina Office 
of Research & Statistics; the Mayo Clinic 
in Rochester, Minnesota; and Emory Uni-
versity in Atlanta, Georgia; 
‘‘(ii) the Department of Veterans Af-
fairs ALS Registry; 
‘‘(iii) the DNA and Cell Line Reposi-
tory of the National Institute of Neuro-
logical Disorders and Stroke Human Ge-
netics Resource Center; 
‘‘(iv) the Agency for Toxic Substances 
and Disease Registry studies, including 
studies conducted in Illinois, Missouri, El 
Paso and San Antonio, Texas, and Massa-
chusetts; 
‘‘(v) State-based ALS registries, in-
cluding the Massachusetts ALS Registry; 
‘‘(vi) the National Vital Statistics Sys-
tem; and 
‘‘(vii) 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 research access to ALS 
data as recommended by the Advisory Com-
mittee established in subsection (b) to the ex-
tent permitted by applicable statutes and regu-
lations and in a manner that protects personal 
privacy consistent with applicable privacy stat-
utes and regulations. 
‘‘(2) COORDINATION WITH NIH AND DEPART-
MENT OF VETERANS AFFAIRS.—Notwithstanding the
recommendations of the Advisory Committee estab-
lished in subsection (b), and consistent with applica-
ble 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 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 2008, and $16,000,000 for 
each of the fiscal years 2009 through 2012.’’. 
Passed the House of Representatives October 16, 
2007. 
Attest: 
Clerk.
110TH CONGRESS 
1ST SESSION 
H. R. 2295 
AN ACT 
To amend the Public Health Service Act to provide 
for the establishment of an Amyotrophic Lateral 
Sclerosis Registry.