ALS Registry Act
PL 110-373 (S.1382), enacted 10/08/2008

122 STAT. 4047 
PUBLIC LAW 110–373—OCT. 8, 2008 
Public Law 110–373 
110th Congress 
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 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 environ-
mental 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 individ-
uals 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 
Deadline. 
42 USC 280g–7. 
42 USC 201 note. 
ALS Registry 
Act. 
Oct. 8, 2008 
[S. 1382] 
VerDate Aug 31 2005 
12:51 Dec 08, 2009
Jkt 069194
PO 00003
Frm 01133
Fmt 6580
Sfmt 6581
M:\STATUTES\2008\PT3\69194PT3.001
APPS10
PsN: 69194PT3
dkrause on DSK1YNZS61 with PUBLAW
122 STAT. 4048 
PUBLIC LAW 110–373—OCT. 8, 2008 
‘‘(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, representa-
tives 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 mem-
bers, 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 reg-
istries; 
‘‘(v) geneticists or experts in genetics who have 
experience with the genetics of ALS or other neuro-
logical diseases and 
‘‘(vi) other individuals with an interest in devel-
oping and maintaining the National ALS Registry. 
‘‘(2) 
DUTIES.—The 
Advisory 
Committee 
may 
review 
information and make recommendations to the Secretary con-
cerning— 
‘‘(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 
Deadline. 
VerDate Aug 31 2005 
12:51 Dec 08, 2009
Jkt 069194
PO 00003
Frm 01134
Fmt 6580
Sfmt 6581
M:\STATUTES\2008\PT3\69194PT3.001
APPS10
PsN: 69194PT3
dkrause on DSK1YNZS61 with PUBLAW
122 STAT. 4049 
PUBLIC LAW 110–373—OCT. 8, 2008 
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 REG-
ISTRIES.— 
‘‘(1) IN GENERAL.—In establishing the National ALS Reg-
istry 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 environ-
mental 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 Reg-
istry; 
‘‘(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 Reg-
istry 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 rec-
ommended by the Advisory Committee established in sub-
section (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. 
‘‘(C) COORDINATION WITH NIH AND DEPARTMENT OF VET-
ERANS AFFAIRS.—Consistent with applicable privacy stat-
utes and regulations, the Secretary may ensure that 
epidemiological and other types of information obtained 
under subsection (a) is made available to the National 
VerDate Aug 31 2005 
12:51 Dec 08, 2009
Jkt 069194
PO 00003
Frm 01135
Fmt 6580
Sfmt 6581
M:\STATUTES\2008\PT3\69194PT3.001
APPS10
PsN: 69194PT3
dkrause on DSK1YNZS61 with PUBLAW
122 STAT. 4050 
PUBLIC LAW 110–373—OCT. 8, 2008 
LEGISLATIVE HISTORY—S. 1382 (H.R. 2295): 
HOUSE REPORTS: No. 110–379 accompanying H.R. 2295 (Comm. on Energy and 
Commerce). 
CONGRESSIONAL RECORD, Vol. 154 (2008): 
Sept. 23, considered and passed Senate. 
Sept. 25, 26, considered and passed House. 
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 popu-
lation 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. 
Approved October 8, 2008. 
VerDate Aug 31 2005 
12:51 Dec 08, 2009
Jkt 069194
PO 00003
Frm 01136
Fmt 6580
Sfmt 6580
M:\STATUTES\2008\PT3\69194PT3.001
APPS10
PsN: 69194PT3
dkrause on DSK1YNZS61 with PUBLAW