II 

Calendar No. 457 

110TH CONGRESS 

1ST SESSION H. R. 2295 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 17, 2007 

Received 

OCTOBER 30, 2007 

Read the first time 

OCTOBER 31, 2007 

Read the second time and placed on the calendar 

AN ACT 

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: 


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1 (1) Amyotrophic lateral sclerosis (referred to in 

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

3 neurodegenerative disease that affects motor nerve 

4 cells in the brain and the spinal cord. 

5 (2) The average life expectancy for a person 

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

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

8 (4) There is only one drug currently approved 

9 by the Food and Drug Administration for the treat10 ment of ALS, which has thus far shown only modest 

11 effects, prolonging life by just a few months. 

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

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

14 States are diagnosed with ALS annually and as 

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

16 in the United States today. 

17 (7) Studies have found relationships between 

18 ALS and environmental and genetic factors, but 

19 those relationships are not well understood. 

20 (8) Scientists believe that there are significant 

21 ties between ALS and other motor neuron diseases. 

22 (9) Several ALS disease registries and data23 bases exist in the United States and throughout the 

24 world, including the SOD1 database, the National 

25 Institute of Neurological Disorders and Stroke reVerDate Aug 31 2005 21:30 Oct 31, 2007 Jkt 069200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2295.PCS H2295

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1 pository, and the Department of Veterans Affairs 

2 ALS Registry. 

3 (10) A single national system to collect and 

4 store information on the prevalence and incidence of 

5 ALS in the United States does not exist. 

6 (11) In each of fiscal years 2006 and 2007, 

7 Congress directed $887,000 to the Centers for Dis8 ease Control and Prevention to begin a nationwide 

9 ALS registry. 

10 (12) The Centers for Disease Control and Pre11 vention and the Agency for Toxic Substances and 

12 Disease Registry have established three pilot 

13 projects, beginning in fiscal year 2006, to evaluate 

14 the science to guide the creation of a national ALS 

15 registry. 

16 (13) The establishment of a national registry 

17 will help— 

18 (A) to identify the incidence and preva19 lence of ALS in the United States; 

20 (B) to collect data important to the study 

21 of ALS; 

22 (C) to promote a better understanding of 

23 ALS; 


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1 (D) to collect information that is impor2 tant for research into the genetic and environ3 mental factors that cause ALS; 

4 (E) to strengthen the ability of a clearing5 house— 

6 (i) to collect and disseminate research 

7 findings on environmental, genetic, and 

8 other causes of ALS and other motor neu9 ron disorders that can be confused with 

10 ALS, misdiagnosed as ALS, and in some 

11 cases progress to ALS; 

12 (ii) to make available information to 

13 patients about research studies for which 

14 they may be eligible; and 

15 (iii) to maintain information about 

16 clinical specialists and clinical trials on 

17 therapies; and 

18 (F) to enhance efforts to find treatments 

19 and 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. 399R. AMYOTROPHIC LATERAL SCLEROSIS REG2 ISTRY. 

3 ‘‘(a) ESTABLISHMENT.— 

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

5 the receipt of the report described in subsection 

6 (b)(3), the Secretary, acting through the Director of 

7 the Centers for Disease Control and Prevention and 

8 in consultation with a national voluntary health or9 ganization with experience serving the population of 

10 individuals with amyotrophic lateral sclerosis (re11 ferred to in this section as ‘ALS’), shall— 

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

13 ALS and other motor neuron disorders that can 

14 be confused with ALS, misdiagnosed as ALS, 

15 and in some cases progress to ALS, including 

16 information with respect to the incidence and 

17 prevalence of the disease in the United States; 

18 and 

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

20 collection and storage of such data to include a 

21 population-based registry of cases in the United 

22 States of ALS and other motor neuron dis23 orders that can be confused with ALS, 

24 misdiagnosed as ALS, and in some cases 

25 progress to ALS. 


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1 ‘‘(2) PURPOSE.—It is the purpose of the reg2 istry established under paragraph (1)(B) to gather 

3 available data concerning— 

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

5 prevalence of ALS in the United States; 

6 ‘‘(B) the environmental and occupational 

7 factors that may be associated with the disease; 

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

9 family history of individuals who are diagnosed 

10 with the disease; 

11 ‘‘(D) other motor neuron disorders that 

12 can be confused with ALS, misdiagnosed as 

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

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

15 Advisory Committee established under sub16 section (b). 

17 ‘‘(b) ADVISORY COMMITTEE.— 

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

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

20 Secretary, acting through the Director of the Cen21 ters for Disease Control and Prevention, shall estab22 lish a committee to be known as the Advisory Com23 mittee on the National ALS Registry (referred to in 

24 this section as the ‘Advisory Committee’). The Advi25 sory Committee shall be composed of at least one 


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1 member, to be appointed by the Secretary, acting 

2 through the Director of the Centers for Disease 

3 Control and Prevention, representing each of the fol4 lowing: 

5 ‘‘(A) National voluntary health associa6 tions that focus solely on ALS and have dem7 onstrated experience in ALS research, care, and 

8 patient services, as well as other voluntary asso9 ciations focusing on neurodegenerative diseases 

10 that represent and advocate on behalf of pa11 tients with ALS and patients with other motor 

12 neuron disorders that can be confused with 

13 ALS, misdiagnosed as ALS, and in some cases 

14 progress to ALS. 

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

16 include, upon the recommendation of the Direc17 tor of the National Institutes of Health, rep18 resentatives from the National Institute of Neu19 rological Disorders and Stroke and the National 

20 Institute of Environmental Health Sciences. 

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

22 ‘‘(D) The Agency for Toxic Substances 

23 and Disease Registry. 

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

25 Prevention. 


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

2 members. 

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

4 related diseases. 

5 ‘‘(H) Epidemiologists with experience in 

6 data registries. 

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

8 have experience with the genetics of ALS or 

9 other neurological diseases. 

10 ‘‘(J) Statisticians. 

11 ‘‘(K) Ethicists. 

12 ‘‘(L) Attorneys. 

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

14 developing and maintaining the National ALS 

15 Registry. 

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

17 review information and make recommendations to 

18 the Secretary concerning— 

19 ‘‘(A) the development and maintenance of 

20 the National ALS Registry; 

21 ‘‘(B) the type of information to be col22 lected and stored in the Registry; 

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

24 be collected; 


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

2 including guidelines for such use; and 

3 ‘‘(E) the collection of information about 

4 diseases and disorders that primarily affect 

5 motor neurons that are considered essential to 

6 furthering the study and cure of ALS. 

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

8 date on which the Advisory Committee is estab9 lished, the Advisory Committee shall submit a report 

10 concerning the review conducted under paragraph 

11 (2) that contains the recommendations of the Advi12 sory Committee with respect to the results of such 

13 review. 

14 ‘‘(c) GRANTS.—Notwithstanding the recommenda15 tions of the Advisory Committee under subsection (b), the 

16 Secretary, acting through the Director of the Centers for 

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

18 enter into contracts and cooperative agreements with, pub19 lic or private nonprofit entities for the collection, analysis, 

20 and reporting of data on ALS and other motor neuron 

21 disorders that can be confused with ALS, misdiagnosed 

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

23 ‘‘(d) COORDINATION WITH STATE, LOCAL, AND FED24 ERAL REGISTRIES.— 


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1 ‘‘(1) IN GENERAL.—In establishing the Na2 tional ALS Registry under subsection (a), the Sec3 retary, acting through the Director of the Centers 

4 for Disease Control and Prevention, shall— 

5 ‘‘(A) identify, build upon, expand, and co6 ordinate among existing data and surveillance 

7 systems, surveys, registries, and other Federal 

8 public health and environmental infrastructure 

9 wherever possible, including— 

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

11 initiated in fiscal year 2006 by the Centers 

12 for Disease Control and Prevention and 

13 the Agency for Toxic Substances and Dis14 ease Registry at the South Carolina Office 

15 of Research & Statistics; the Mayo Clinic 

16 in Rochester, Minnesota; and Emory Uni17 versity in Atlanta, Georgia; 

18 ‘‘(ii) the Department of Veterans Af19 fairs ALS Registry; 

20 ‘‘(iii) the DNA and Cell Line Reposi21 tory of the National Institute of Neuro22 logical Disorders and Stroke Human Ge23 netics Resource Center; 

24 ‘‘(iv) the Agency for Toxic Substances 

25 and Disease Registry studies, including 


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1 studies conducted in Illinois, Missouri, El 

2 Paso and San Antonio, Texas, and Massa3 chusetts; 

4 ‘‘(v) State-based ALS registries, in5 cluding the Massachusetts ALS Registry; 

6 ‘‘(vi) the National Vital Statistics Sys7 tem; and 

8 ‘‘(vii) any other existing or relevant 

9 databases that collect or maintain informa10 tion on those motor neuron diseases rec11 ommended by the Advisory Committee es12 tablished in subsection (b); and 

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

14 data as recommended by the Advisory Com15 mittee established in subsection (b) to the ex16 tent permitted by applicable statutes and regu17 lations and in a manner that protects personal 

18 privacy consistent with applicable privacy stat19 utes and regulations. 

20 ‘‘(2) COORDINATION WITH NIH AND DEPART21 MENT OF VETERANS AFFAIRS.—Notwithstanding the 

22 recommendations of the Advisory Committee estab23 lished in subsection (b), and consistent with applica24 ble privacy statutes and regulations, the Secretary 

25 shall ensure that epidemiological and other types of 


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1 information obtained under subsection (a) is made 

2 available to the National Institutes of Health and 

3 the Department of Veterans Affairs. 

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

5 the term ‘national voluntary health association’ means a 

6 national non-profit organization with chapters or other af7 filiated organizations in States throughout the United 

8 States. 

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

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

11 $25,000,000 for fiscal year 2008, and $16,000,000 for 

12 each of the fiscal years 2009 through 2012.’’. 

Passed the House of Representatives October 16, 

2007. 

Attest: LORRAINE C. MILLER, 

Clerk. 


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Calendar No. 457 

110TH CONGRESS 

1ST SESSION H. R. 2295 

AN ACT 

To amend the Public Health Service Act to provide 

Sclerosis Registry. for the establishment of an Amyotrophic Lateral 

OCTOBER 31, 2007 

Read the second time and placed on the calendar 


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