S. 1382 

One Hundred Tenth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Thursday, 

the third day of January, two thousand and eight 

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 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 
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‘‘(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 
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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. 

‘‘(C) 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 
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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. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.