II 

110TH CONGRESS 

1ST SESSION S. 1382 

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 

MAY 14, 2007 

Mr. REID 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 in 

8 this section as ‘‘ALS’’) is a fatal, progressive 

9 neurodegenerative disease that affects motor nerve 

10 cells in the brain and the spinal cord. 


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1 (2) The average life expectancy for a person 

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

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

4 (4) There is only one drug currently approved 

5 by the Food and Drug Administration for the treat6 ment of ALS, which has thus far shown only modest 

7 effects, prolonging life by just a few months. 

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

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

10 States are diagnosed with ALS annually and as 

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

12 in the United States today. 

13 (7) Studies have found relationships between 

14 ALS and environmental and genetic factors, but 

15 those relationships are not well understood. 

16 (8) Scientists believe that there are significant 

17 ties between ALS and other motor neuron diseases. 

18 (9) Several ALS disease registries and data19 bases exist in the United States and throughout the 

20 world, including the SOD1 database, the National 

21 Institute of Neurological Disorders and Stroke re22 pository, and the Department of Veterans Affairs 

23 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) In each of fiscal years 2006 and 2007, 

5 Congress directed $887,000 to the Centers for Dis6 ease Control and Prevention to begin a nationwide 

7 ALS registry. 

8 (12) The Centers for Disease Control and Pre9 vention and the Agency for Toxic Substances and 

10 Disease Registry has established three pilot projects, 

11 beginning in fiscal year 2006, to evaluate the science 

12 to guide the creation of a national ALS registry. 

13 (13) The establishment of a national registry 

14 will help— 

15 (A) to identify the incidence and preva16 lence of ALS in the United States; 

17 (B) to collect data important to the study 

18 of ALS; 

19 (C) to promote a better understanding of 

20 ALS; 

21 (D) to collect information that is impor22 tant for research into the genetic and environ23 mental factors that cause ALS; 

24 (E) to strengthen the ability of a clearing25 house— 


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1 (i) to collect and disseminate research 

2 findings on environmental, genetic and 

3 other causes of ALS and other motor neu4 ron disorders that can be confused with 

5 ALS, misdiagnosed as ALS, and in some 

6 cases progress to ALS; 

7 (ii) make available information to pa8 tients about research studies for which 

9 they may be eligible; and 

10 (iii) maintain information about clin11 ical specialists and clinical trials on thera12 pies; and 

13 (F) to enhance efforts to find treatments 

14 and a cure for ALS. 

15 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

16 ACT. 

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

18 (42 U.S.C. 280g et seq.) is amended by adding at the end 

19 the following: 

20 ‘‘SEC. 399R. AMYOTROPHIC LATERAL SCLEROSIS REG21 ISTRY. 

22 ‘‘(a) ESTABLISHMENT.— 

23 ‘‘(1) IN GENERAL.—Not later than 1 year after 

24 the receipt of the report described in subsection 

25 (b)(2)(A), the Secretary, acting through the Director 


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1 of the Centers for Disease Control and Prevention 

2 and in consultation with a national voluntary health 

3 organization with experience serving the population 

4 of individuals with amyotrophic lateral sclerosis (re5 ferred to in this section as ‘ALS’), shall— 

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

7 ALS and other motor neuron disorders that can 

8 be confused with ALS, misdiagnosed as ALS, 

9 and in some cases progress to ALS, including 

10 information with respect to the incidence and 

11 prevalence of the disease in the United States; 

12 and 

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

14 collection and storage of such data to include a 

15 population-based registry of cases in the United 

16 States of ALS and other motor neuron dis17 orders that can be confused with ALS, 

18 misdiagnosed as ALS, and in some cases 

19 progress to ALS. 

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

22 available data concerning— 

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

24 prevalence of ALS in the United States; 


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1 ‘‘(B) the environmental and occupational 

2 factors that may be associated with the disease; 

3 ‘‘(C) the age, race or ethnicity, gender, and 

4 family history of individuals who are diagnosed 

5 with the disease; 

6 ‘‘(D) other motor neuron disorders that 

7 can be confused with ALS, misdiagnosed as 

8 ALS, and in some cases progress to ALS; and 

9 ‘‘(E) other matters as recommended by the 

10 Advisory Committee established under sub11 section (b). 

12 ‘‘(b) ADVISORY COMMITTEE.— 

13 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

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

15 Secretary, acting through the Director of the Cen16 ters for Disease Control and Prevention, shall estab17 lish a committee to be known as the Advisory Com18 mittee on the National ALS Registry (referred to in 

19 this section as the ‘Advisory Committee’). The Advi20 sory Committee shall be composed of at least one 

21 member, to be appointed by the Secretary, acting 

22 through the Director of the Centers for Disease 

23 Control and Prevention, representing each of the fol24 lowing: 


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1 ‘‘(A) National voluntary health associa2 tions that focus solely on ALS and have dem3 onstrated experience in ALS research, care, and 

4 patient services, as well as other voluntary asso5 ciations focusing on neurodegenerative diseases 

6 that represent and advocate on behalf of pa7 tients with ALS and patients with other motor 

8 neuron disorders that can be confused with 

9 ALS, misdiagnosed as ALS, and in some cases 

10 progress to ALS. 

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

12 include, upon the recommendation of the Direc13 tor of the National Institutes of Health, rep14 resentatives from the National Institute of Neu15 rological Disorders and Stroke and the National 

16 Institute of Environmental Health Sciences. 

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

18 ‘‘(D) The Agency for Toxic Substances 

19 and Disease Registry. 

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

21 Prevention. 

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

23 members. 

24 ‘‘(G) Clinicians with expertise on ALS and 

25 related diseases. 


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1 ‘‘(H) Epidemiologists with experience in 

2 data registries. 

3 ‘‘(I) Geneticists or experts in genetics who 

4 have experience with the genetics of ALS or 

5 other neurological diseases. 

6 ‘‘(J) Statisticians. 

7 ‘‘(K) Ethicists. 

8 ‘‘(L) Attorneys. 

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

10 developing and maintaining the National ALS 

11 Registry. 

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

13 review information and make recommendations to 

14 the Secretary concerning— 

15 ‘‘(A) the development and maintenance of 

16 the National ALS Registry; 

17 ‘‘(B) the type of information to be col18 lected and stored in the Registry; 

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

20 be collected; 

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

22 including guidelines for such use; and 

23 ‘‘(E) the collection of information about 

24 diseases and disorders that primarily affect 


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1 motor neurons that are considered essential to 

2 furthering the study and cure of ALS. 

3 ‘‘(3) REPORT.—Not later than 1 years after the 

4 date on which the Advisory Committee is estab5 lished, the Advisory Committee shall submit a report 

6 concerning the review conducted under paragraph 

7 (2) that contains the recommendations of the Advi8 sory Committee with respect to the results of such 

9 review. 

10 ‘‘(c) GRANTS.—Notwithstanding the recommenda11 tions of the Advisory Committee under subsection (b), the 

12 Secretary, acting through the Director of the Centers for 

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

14 enter into contracts and cooperative agreements with, pub15 lic or private nonprofit entities for the collection, analysis, 

16 and reporting of data on ALS and other motor neuron 

17 disorders that can be confused with ALS, misdiagnosed 

18 as ALS, and in some cases progress to ALS. 

19 ‘‘(d) COORDINATION WITH STATE, LOCAL, AND FED20 ERAL REGISTRIES.— 

21 ‘‘(1) IN GENERAL.—In establishing the Na22 tional ALS Registry under subsection (a), the Sec23 retary, acting through the Director of the Centers 

24 for Disease Control and Prevention, shall— 


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1 ‘‘(A) identify, build upon, expand, and co2 ordinate among existing data and surveillance 

3 systems, surveys, registries, and other Federal 

4 public health and environmental infrastructure 

5 wherever possible, including— 

6 ‘‘(i) the 3 ALS registry pilot projects 

7 initiated in fiscal year 2006 by the Centers 

8 for Disease Control and Prevention and 

9 the Agency for Toxic Substances and Dis10 ease Registry at the South Carolina Office 

11 of Research & Statistics; the Mayo Clinic 

12 in Rochester, Minnesota; and Emory Uni13 versity in Atlanta, Georgia; 

14 ‘‘(ii) the Department of Veterans Af15 fairs ALS Registry; 

16 ‘‘(iii) the DNA and Cell Line Reposi17 tory of the National Institute of Neuro18 logical Disorders and Stroke Human Ge19 netics Resource Center; 

20 ‘‘(iv) Agency for Toxic Substances 

21 and Disease Registry studies, including 

22 studies conducted in Illinois, Missouri, El 

23 Paso and San Antonio, Texas, and Massa24 chusetts; 


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1 ‘‘(v) State-based ALS registries, in2 cluding the Massachusetts ALS Registry; 

3 ‘‘(vi) the National Vital Statistics Sys4 tem; and 

5 ‘‘(vii) any other existing or relevant 

6 databases that collect or maintain informa7 tion on those motor neuron diseases rec8 ommended by the Advisory Committee es9 tablished in subsection (b); and 

10 ‘‘(B) provide for research access to ALS 

11 data as recommended by the Advisory Com12 mittee established in subsection (b) to the ex13 tent permitted by applicable statutes and regu14 lations and in a manner that protects personal 

15 privacy consistent with applicable privacy stat16 utes and regulations. 

17 ‘‘(2) COORDINATION WITH NIH AND DEPART18 MENT OF VETERANS AFFAIRS.—Notwithstanding the 

19 recommendations of the Advisory Committee estab20 lished in subsection (b), and consistent with applica21 ble privacy statutes and regulations, the Secretary 

22 shall ensure that epidemiological and other types of 

23 information obtained under subsection (a) is made 

24 available to the National Institutes of Health and 

25 the Department of Veterans Affairs. 


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

2 the term ‘national voluntary health association’ means a 

3 national non-profit organization with chapters or other af4 filiated organizations in States throughout the United 

5 States. 

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

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

8 $25,000,000 for fiscal year 2008, and such sums as may 

9 be necessary for each of fiscal years 2009 through 2012.’’. 

Æ 


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