II 

109TH CONGRESS 

1ST SESSION S. 1353 

To amend the Public Health Service Act to provide for the establishment 

of an Amyotrophic Lateral Sclerosis Registry. 

IN THE SENATE OF THE UNITED STATES 

JUNE 30, 2005 

Mr. REID (for himself, Mr. WARNER, Ms. MURKOWSKI, Mr. COCHRAN, Mr. 

CORZINE, Ms. STABENOW, Mr. BINGAMAN, Mr. DURBIN, and Mr. 

VITTER) introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL

To amend the Public Health Service Act to provide for 

the establishment of an Amyotrophic Lateral Sclerosis 

Registry.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘ALS Registry Act’’. 

5 SEC. 2. FINDINGS. 

6 Congress makes the following findings: 

7 (1) Amyotrophic Lateral Sclerosis (referred to 

8 in this section as ‘‘ALS’’) is a fatal, progressive 
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1 neurodegenerative disease that affects motor nerve 

2 cells in the brain and the spinal cord. 

3 (2) The average life expectancy for a person 

4 with ALS is 2 to 5 years from the time of diagnosis. 

5 (3) The cause of ALS is not well understood. 

6 (4) There is only one drug currently approved 

7 by the Food and Drug Administration for the treat8 ment of ALS, which has thus far shown only modest 

9 effects, prolonging life by just a few months. 

10 (5) There is no known cure for ALS. 

11 (6) More than 5,000 individuals in the United 

12 States are diagnosed with ALS annually and as 

13 many as 30,000 individuals may be living with ALS 

14 in the United States today. 

15 (7) Studies have found relationships between 

16 ALS and environmental and genetic factors, but 

17 those relationships are not well understood. 

18 (8) Scientists believe that there are significant 

19 ties between ALS and any motor neuron diseases. 

20 (9) Several ALS disease registries and data21 bases exist in the United States and throughout the 

22 world, including the SOD1 database, the National 

23 Institute of Neurological Disorders and Stroke re24 pository, and the Department of Veterans Affairs 

25 ALS Registry. 
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1 (10) A single national system to collect and 

2 store information on the prevalence and incidence of 

3 ALS in the United States does not exist. 

4 (11) The establishment of a national registry 

5 will help— 

6 (A) identify the incidence and prevalence 

7 of ALS in the United States; 

8 (B) collect data important to the study of 

9 ALS; 

10 (C) promote a better understanding of 

11 ALS; 

12 (D) promote research into the genetic and 

13 environmental factors that cause ALS; 

14 (E) provide a means for patients to contact 

15 scientists researching the environmental and ge16 netic factors that cause ALS as well as those 

17 engaged in clinical trials; and 

18 (F) enhance efforts to find treatments and 

19 a cure for ALS. 

20 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

21 ACT. 

22 Part P of title III of the Public Health Service Act 

23 (42 U.S.C. 280g et seq.) is amended by adding at the end 

24 the following: 
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1 ‘‘SEC. 399O. AMYOTROPHIC LATERAL SCLEROSIS REG2 ISTRY. 

3 ‘‘(a) ESTABLISHMENT.— 

4 ‘‘(1) IN GENERAL.—Not later than 6 months 

5 after the receipt of the report described in sub6 section (b)(2)(A), the Secretary, acting through the 

7 Director of the Centers for Disease Control and Pre8 vention and in consultation with a national voluntary 

9 health organization with experience serving the pop10 ulation of individuals with amyotrophic lateral scle11 rosis (referred to in this section as ‘ALS’), shall— 

12 ‘‘(A) develop a system to collect data on 

13 ALS, including information with respect to the 

14 incidence and prevalence of the disease in the 

15 United States; and 

16 ‘‘(B) establish a national registry for the 

17 collection and storage of such data to include a 

18 population-based registry of cases of ALS in 

19 the United States. 

20 ‘‘(2) PURPOSE.—It is the purpose of the reg21 istry established under paragraph (1)(B) to— 

22 ‘‘(A) gather data concerning— 

23 ‘‘(i) ALS, including the incidence and 

24 prevalence of ALS in the United States; 
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1 ‘‘(ii) the environmental and occupa2 tional factors that may be associated with 

3 the disease; 

4 ‘‘(iii) the age, race or ethnicity, gen5 der, and family history of individuals who 

6 are diagnosed with the disease; and 

7 ‘‘(iv) other matters as recommended 

8 by the Advisory Committee established 

9 under subsection (b); and 

10 ‘‘(B) establish a secure method to put pa11 tients in contact with scientists studying the en12 vironmental, and genetic causes of motor neu13 ron disease or conducting clinical trials on 

14 therapies for motor neuron disease. 

15 ‘‘(b) ADVISORY COMMITTEE.— 

16 ‘‘(1) ESTABLISHMENT.—Not later than 60 days 

17 after the date of the enactment of this section, the 

18 Secretary, acting through the Director of the Cen19 ters for Disease Control and Prevention, shall estab20 lish a committee to be known as the Advisory Com21 mittee on the National ALS Registry (referred to in 

22 this section as the ‘Advisory Committee’). The Advi23 sory Committee shall be composed of at least one 

24 member, to be appointed by the Secretary, acting 

25 through the Director of the Centers for Disease 
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1 Control and Prevention, representing each of the fol2 lowing: 

3 ‘‘(A) National voluntary health associa4 tions that focus solely on ALS that have a dem5 onstrated experience in ALS research, care, and 

6 patient services. 

7 ‘‘(B) The National Institutes of Health, to 

8 include, upon the recommendation of the Direc9 tor of the National Institutes of Health, rep10 resentatives from the National Institute of Neu11 rological Disorders and Stroke and the National 

12 Institute of Environmental Health Sciences. 

13 ‘‘(C) The Department of Veterans Affairs. 

14 ‘‘(D) The Agency for Toxic Substances 

15 and Disease Registry. 

16 ‘‘(E) The Centers for Disease Control and 

17 Prevention. 

18 ‘‘(F) Patients with ALS or their family 

19 members. 

20 ‘‘(G) Clinicians who have worked with data 

21 registries. 

22 ‘‘(H) Epidemiologists with experience in 

23 data registries. 
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1 ‘‘(I) Geneticists or experts in genetics who 

2 have experience with the genetics of ALS or 

3 other neurological diseases. 

4 ‘‘(J) Statisticians. 

5 ‘‘(K) Ethicists. 

6 ‘‘(L) Attorneys. 

7 ‘‘(M) Other individuals with an interest in 

8 developing and maintaining the National ALS 

9 Registry. 

10 ‘‘(2) DUTIES.—The Advisory Committee shall 

11 conduct a study and make recommendations to the 

12 Secretary concerning— 

13 ‘‘(A) the development and maintenance of 

14 the National ALS Registry; 

15 ‘‘(B) the type of information to be col16 lected and stored in the Registry; 

17 ‘‘(C) the manner in which such data is to 

18 be collected; 

19 ‘‘(D) the use and availability of such data 

20 including guidelines for such use; and 

21 ‘‘(E) the collection of information about 

22 diseases and disorders that primarily affect 

23 motor neurons that are considered essential to 

24 furthering the study and cure of ALS. 
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1 ‘‘(3) REPORT.—Not later than 6 months after 

2 the date on which the Advisory Committee is estab3 lished, the Advisory Committee shall submit a report 

4 concerning the study conducted under paragraph (2) 

5 that contains the recommendations of the Advisory 

6 Committee with respect to the results of such study. 

7 ‘‘(c) GRANTS.—Notwithstanding the recommenda8 tions of the Advisory Committee under subsection (b), the 

9 Secretary, acting through the Director of the Centers for 

10 Disease Control and Prevention, may award grants to, and 

11 enter into contracts and cooperative agreements with, pub12 lic or private nonprofit entities for the collection, analysis, 

13 and reporting of data on ALS. 

14 ‘‘(d) COORDINATION WITH STATE, LOCAL, AND FED15 ERAL REGISTRIES.— 

16 ‘‘(1) IN GENERAL.—In establishing the Na17 tional ALS Registry under subsection (a), the Sec18 retary, acting through the Director of the Centers 

19 for Disease Control and Prevention, shall— 

20 ‘‘(A) identify, build upon, expand, and co21 ordinate among existing data and surveillance 

22 systems, surveys, registries, and other Federal 

23 public health and environmental infrastructure 

24 wherever possible, including— 
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1 ‘‘(i) the Department of Veterans Af2 fairs ALS Registry; 

3 ‘‘(ii) the DNA and Cell Line Reposi4 tory of the National Institute of Neuro5 logical Disorders and Stroke Human Ge6 netics Resource Center; 

7 ‘‘(iii) Agency for Toxic Substances 

8 and Disease Registry studies, including 

9 studies conducted in Illinois, Missouri, El 

10 Paso and San Antonio Texas, and Massa11 chusetts; 

12 ‘‘(iv) State-based ALS registries, in13 cluding the Massachusetts ALS Registry; 

14 ‘‘(v) the National Vital Statistics Sys15 tem; and 

16 ‘‘(vi) any other existing or relevant 

17 databases that collect or maintain informa18 tion on those motor neuron diseases rec19 ommended by the Advisory Committee es20 tablished in subsection (b); and 

21 ‘‘(B) provide for public access to an elec22 tronic national database that accepts data from 

23 State-based registries, health care professionals, 

24 and others as recommended by the Advisory 

25 Committee established in subsection (b) in a 
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1 manner that protects personal privacy con2 sistent with medical privacy regulations. 

3 ‘‘(2) COORDINATION WITH NIH AND DEPART4 MENT OF VETERANS AFFAIRS.—Notwithstanding the 

5 recommendations of the Advisory Committee estab6 lished in subsection (b), the Secretary shall ensure 

7 that epidemiological and other types of information 

8 obtained under subsection (a) is made available to 

9 the National Institutes of Health and the Depart10 ment of Veterans Affairs. 

11 ‘‘(e) DEFINITION.—For the purposes of this section, 

12 the term ‘national voluntary health association’ means a 

13 national non-profit organization with chapters or other af14 filiated organizations in States throughout the United 

15 States. 

16 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

17 are authorized to be appropriated to carry out this section, 

18 $25,000,000 for fiscal year 2006, and such sums as may 

19 be necessary for each of fiscal years 2007 through 2010.’’.

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