IB 
Union Calendar No. 236 
110TH CONGRESS 
1ST SESSION H. R. 2295 
[Report No. 110–379] 
To amend the Public Health Service Act to provide for the establishment 
of an Amyotrophic Lateral Sclerosis Registry. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 14, 2007 
Mr. ENGEL (for himself, Mr. TERRY, Mr. WAXMAN, Mr. UPTON, Mr. MAR-
KEY, Mr. WHITFIELD, Mr. TOWNS, Mr. SHIMKUS, Mr. RUSH, Mr. 
FOSSELLA, Mr. WYNN, Mrs. BONO, Mr. GENE GREEN of Texas, Mr. 
FERGUSON, Mrs. CAPPS, Mrs. MYRICK, Mr. DOYLE, Mr. ALLEN, Ms. 
SCHAKOWSKY, Ms. SOLIS, Mr. GONZALEZ, Mr. INSLEE, Ms. BALDWIN, 
Mr. ROSS, Mr. WEINER, Mr. MATHESON, Mr. BUTTERFIELD, Mr. BAR-
ROW, Ms. ROS-LEHTINEN, Mr. RANGEL, Mr. MCCRERY, Mr. STARK, Mr. 
GOODE, Mr. KENNEDY, Mr. GERLACH, Mr. ROTHMAN, Mr. BURTON of 
Indiana, Mr. EMANUEL, Mr. SHAYS, Mr. HIGGINS, Ms. FALLIN, Mr. 
COHEN, Mr. BOUSTANY, Mr. PATRICK J. MURPHY of Pennsylvania, Mr. 
SMITH of New Jersey, Mr. MCDERMOTT, Mr. BROWN of South Carolina, 
Ms. NORTON, Mrs. MCMORRIS RODGERS, Mr. PRICE of North Carolina, 
Mr. MCHUGH, Mr. ABERCROMBIE, Mr. EHLERS, Mr. MCNULTY, Mr. 
GALLEGLY, Mr. MCINTYRE, Mr. PEARCE, Mr. NADLER, Ms. CARSON, 
Mr. OLVER, Mr. TIERNEY, Mr. KANJORSKI, Mr. BISHOP of New York, 
Mr. MCGOVERN, Mr. CROWLEY, Mr. GRIJALVA, Mrs. LOWEY, Mr. SHER-
MAN, Ms. LORETTA
SANCHEZ
of California, Mr. MURTHA, Mr. 
ETHERIDGE, Mr. CAPUANO, Ms. KAPTUR, Mr. VAN HOLLEN, Mrs. 
MCCARTHY of New York, Ms. MCCOLLUM of Minnesota, Mr. BERMAN, 
Mr. SIRES, Ms. ROYBAL-ALLARD, Mr. CRAMER, Ms. HIRONO, Ms. 
BORDALLO, Mr. BOSWELL, and Mr. KIND) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
OCTOBER 15, 2007 
Additional sponsors: Ms. ESHOO, Mr. CARNEY, Mr. BOOZMAN, Mr. HAYES, 
Ms. HOOLEY, Ms. SHEA-PORTER, Mr. WATT, Mr. SESSIONS, Mrs. 
SCHMIDT, Mr. WELLER of Illinois, Mr. RAMSTAD, Mr. KING of New 
York, Mr. HOEKSTRA, Mr. JINDAL, Mr. DEFAZIO, Mr. PETERSON of 
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Pennsylvania, Mr. TAYLOR, Mr. ALTMIRE, Mr. ISRAEL, Mr. FRELING-
HUYSEN, Mr. OBERSTAR, Ms. WASSERMAN SCHULTZ, Mr. MICHAUD, Mr. 
SKELTON, Mr. BONNER, Ms. SLAUGHTER, Mr. FARR, Mr. KUCINICH, Mr. 
CHANDLER, Mr. NEAL of Massachusetts, Mrs. MALONEY of New York, 
Mr. CLAY, Mr. FRANK of Massachusetts, Mr. DOOLITTLE, Mr. PAYNE, 
Mrs. BIGGERT, Mr. MILLER of North Carolina, Mr. SCHIFF, Mr. KELLER 
of Florida, Mr. YOUNG of Florida, Mr. SMITH of Washington, Mr. DAVID 
DAVIS of Tennessee, Mr. SIMPSON, Mr. WOLF, Mr. CALVERT, Mr. MAR-
SHALL, Mr. LOBIONDO, Mr. COBLE, Mr. PLATTS, Ms. LINDA T. 
SA´NCHEZ of California, Mr. RYAN of Ohio, Mr. WALZ of Minnesota, Mr. 
WALDEN of Oregon, Mr. STEARNS, Mr. PASTOR, Mr. LEWIS of Kentucky, 
Mr. LEWIS of Georgia, Mr. SENSENBRENNER, Mr. MCCOTTER, Mr. 
MCHENRY, Mr. ELLISON, Mr. ANDREWS, Mr. KLEIN of Florida, Mr. 
BRALEY of Iowa, Mr. FILNER, Mr. WILSON of South Carolina, Mr. MUR-
PHY of Connecticut, Mr. SESTAK, Mr. EVERETT, Mr. COSTELLO, Mr. 
ACKERMAN, Mr. HINOJOSA, Mr. BLUMENAUER, Ms. MATSUI, Ms. PRYCE 
of Ohio, Mr. BERRY, Mr. DAVIS of Alabama, Mr. STUPAK, Mr. AL 
GREEN of Texas, Mr. SAXTON, Mr. SPACE, Mr. GRAVES, Mr. WU, Mr. 
KIRK, Mr. WELDON of Florida, Mr. CONAWAY, Mr. LAMPSON, Mr. 
WELCH of Vermont, Mr. PICKERING, Mr. GORDON of Tennessee, Ms. 
CASTOR, Mr. MCCAUL of Texas, Mr. LARSEN of Washington, Mr. CAS-
TLE, Mr. BOREN, Mrs. CUBIN, Mr. LANGEVIN, Mr. ARCURI, Mr. JACK-
SON of Illinois, Mrs. GILLIBRAND, Mr. TIM MURPHY of Pennsylvania, 
Mr. WICKER, Mrs. DRAKE, Mrs. CAPITO, Mr. BAIRD, Mr. ORTIZ, Mr. 
CHABOT, Mr. DELAHUNT, Mr. YARMUTH, Mr. BUCHANAN, Ms. 
VELA´ZQUEZ, Mr. RAHALL, Ms. BEAN, Mr. SOUDER, Mr. WEXLER, Mr. 
REICHERT, Ms. GINNY BROWN-WAITE of Florida, Mr. DENT, Mr. 
ENGLISH of Pennsylvania, Mr. PASCRELL, Ms. WATSON, Mr. ROGERS of 
Kentucky, Mr. PETERSON of Minnesota, Mr. SULLIVAN, Mr. TIBERI, Ms. 
WOOLSEY, Mrs. BLACKBURN, Mr. ALEXANDER, Mr. LUCAS, Mr. HOLT, 
Mr. CARNAHAN, Mr. THOMPSON of California, Mr. THOMPSON of Mis-
sissippi, Ms. SUTTON, Mr. KUHL of New York, Mr. SHULER, Mr. 
MELANCON, Mr. DOGGETT, Ms. HERSETH SANDLIN, Mr. JONES of North 
Carolina, Mr. MOORE of Kansas, Mr. BRADY of Pennsylvania, Mr. 
RUPPERSBERGER, Mrs. BOYDA of Kansas, Mr. DONNELLY, Mr. LEVIN, 
Mr. POMEROY, Mr. NUNES, Mr. DAVIS of Illinois, Mr. LAHOOD, Mr. 
SERRANO, Mr. RADANOVICH, Mr. BISHOP of Utah, Ms. DEGETTE, Ms. 
HARMAN, Mr. HILL, Ms. BERKLEY, Mr. BOUCHER, Mr. MCNERNEY, Mr. 
SARBANES, Mr. FORTENBERRY, Mr. CARTER, Mr. GARY G. MILLER of 
California, Mrs. EMERSON, Mr. HOLDEN, Mr. CANNON, Mr. CLEAVER, 
Mr. KILDEE, Mr. LATHAM, Mr. REYES, Mr. BAKER, Mr. FEENEY, Mr. 
ROGERS of Alabama, Mr. GEORGE MILLER of California, Mr. PUTNAM, 
Mr. MORAN of Virginia, Mr. RODRIGUEZ, Mr. CANTOR, Mrs. WILSON of 
New Mexico, Mr. HALL of New York, Mrs. DAVIS of California, Mr. 
MITCHELL, Mr. ELLSWORTH, Mr. BACHUS, Mr. MORAN of Kansas, Mr. 
LYNCH, Mr. JOHNSON of Illinois, Mrs. TAUSCHER, Ms. LEE, Mr. HELL-
ER of Nevada, Mr. BURGESS, Ms. SCHWARTZ, and Mr. LARSON of Con-
necticut 
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OCTOBER 15, 2007 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on May 14, 2007] 
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 treatment 
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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 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, Con-
gress directed $887,000 to the Centers for Disease 
Control and Prevention to begin a nationwide ALS 
registry. 
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(12) The Centers for Disease Control and Preven-
tion and the Agency for Toxic Substances and Disease 
Registry have established three pilot projects, begin-
ning 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 clearing-
house— 
(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; 
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(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 REGISTRY. 
‘‘(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 Cen-
ters for Disease Control and Prevention and in con-
sultation with a national voluntary health organiza-
tion with experience serving the population of indi-
viduals 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, 
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and in some cases progress to ALS, including in-
formation with respect to the incidence and prev-
alence 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 avail-
able 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). 
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‘‘(b) ADVISORY COMMITTEE.— 
‘‘(1) ESTABLISHMENT.—Not later than 90 days 
after the date of the enactment of this section, the Sec-
retary, 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 Com-
mittee shall be composed of at least one member, to 
be appointed by the Secretary, acting through the Di-
rector of the Centers for Disease Control and Preven-
tion, 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 rep-
resent and advocate on behalf of patients with 
ALS and patients with other motor neuron dis-
orders 
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-
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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. 
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‘‘(2) DUTIES.—The Advisory Committee shall re-
view 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 dis-
eases and disorders that primarily affect motor 
neurons that are considered essential to fur-
thering the study and cure of ALS. 
‘‘(3) REPORT.—Not later than 1 year after the 
date on which the Advisory Committee is established, 
the Advisory Committee shall submit a report con-
cerning 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 Sec-
retary, acting through the Director of the Centers for Dis-
ease Control and Prevention, may award grants to, and 
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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 dis-
orders 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 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 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 Disease 
Registry at the South Carolina Office of Re-
search & Statistics; the Mayo Clinic in 
Rochester, Minnesota; and Emory Univer-
sity in Atlanta, Georgia; 
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‘‘(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 Genet-
ics 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 Committee 
established in subsection (b) to the extent per-
mitted by applicable statutes and regulations 
and in a manner that protects personal privacy 
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consistent with applicable privacy statutes and 
regulations. 
‘‘(2) COORDINATION WITH NIH AND DEPARTMENT 
OF
VETERANS
AFFAIRS.—Notwithstanding the rec-
ommendations of the Advisory Committee established 
in subsection (b), and consistent with applicable pri-
vacy statutes and regulations, the Secretary shall en-
sure that epidemiological and other types of informa-
tion 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 na-
tional non-profit organization with chapters or other affili-
ated 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.’’. 
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Union Calendar No. 236 
110TH CONGRESS 
1ST SESSION 
H. R. 2295 
[Report No. 110–379] 
A BILL 
To amend the Public Health Service Act to provide 
for the establishment of an Amyotrophic Lateral 
Sclerosis Registry. 
OCTOBER 15, 2007 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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