I 

110TH CONGRESS 

1ST SESSION H. R. 2295 

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

of an Amyotrophic Lateral Sclerosis Registry. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 14, 2007 

Mr. ENGEL (for himself, Mr. TERRY, Mr. WAXMAN, Mr. UPTON, Mr. MARKEY, Mr. WHITFIELD, Mr. TOWNS, Mr. SHIMKUS, Mr. RUSH, Mr. 

FOSSELLA, Mr. WYNN, Mrs. BONO, Mr. GENE GREEN of Texas, Mr. 

FERGUSON, Mrs. CAPPS, Mrs. MYRICK, Mr. DOYLE, Mr. ALLEN, Ms. 

SCHAKOWSKY, Ms. SOLIS, Mr. GONZALEZ, Mr. INSLEE, Ms. BALDWIN, 

Mr. ROSS, Mr. WEINER, Mr. MATHESON, Mr. BUTTERFIELD, Mr. BARROW, Ms. ROS-LEHTINEN, Mr. RANGEL, Mr. MCCRERY, Mr. STARK, Mr. 

GOODE, Mr. KENNEDY, Mr. GERLACH, Mr. ROTHMAN, Mr. BURTON of 

Indiana, Mr. EMANUEL, Mr. SHAYS, Mr. HIGGINS, Ms. FALLIN, Mr. 

COHEN, Mr. BOUSTANY, Mr. PATRICK J. MURPHY of Pennsylvania, Mr. 

SMITH of New Jersey, Mr. MCDERMOTT, Mr. BROWN of South Carolina, 

Ms. NORTON, Mrs. MCMORRIS RODGERS, Mr. PRICE of North Carolina, 

Mr. MCHUGH, Mr. ABERCROMBIE, Mr. EHLERS, Mr. MCNULTY, Mr. 

GALLEGLY, Mr. MCINTYRE, Mr. PEARCE, Mr. NADLER, Ms. CARSON, 

Mr. OLVER, Mr. TIERNEY, Mr. KANJORSKI, Mr. BISHOP of New York, 

Mr. MCGOVERN, Mr. CROWLEY, Mr. GRIJALVA, Mrs. LOWEY, Mr. SHERMAN, Ms. LORETTA SANCHEZ of California, Mr. MURTHA, Mr. 

ETHERIDGE, Mr. CAPUANO, Ms. KAPTUR, Mr. VAN HOLLEN, Mrs. 

MCCARTHY of New York, Ms. MCCOLLUM of Minnesota, Mr. BERMAN, 

Mr. SIRES, Ms. ROYBAL-ALLARD, Mr. CRAMER, Ms. HIRONO, Ms. 

BORDALLO, Mr. BOSWELL, and Mr. KIND) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to provide for 

the establishment of an Amyotrophic Lateral Sclerosis 

Registry. 


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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. 

11 (2) The average life expectancy for a person 

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

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

14 (4) There is only one drug currently approved 

15 by the Food and Drug Administration for the treat16 ment of ALS, which has thus far shown only modest 

17 effects, prolonging life by just a few months. 

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

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

20 States are diagnosed with ALS annually and as 

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

22 in the United States today. 

23 (7) Studies have found relationships between 

24 ALS and environmental and genetic factors, but 

25 those relationships are not well understood. 


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1 (8) Scientists believe that there are significant 

2 ties between ALS and other motor neuron diseases. 

3 (9) Several ALS disease registries and data4 bases exist in the United States and throughout the 

5 world, including the SOD1 database, the National 

6 Institute of Neurological Disorders and Stroke re7 pository, and the Department of Veterans Affairs 

8 ALS Registry. 

9 (10) A single national system to collect and 

10 store information on the prevalence and incidence of 

11 ALS in the United States does not exist. 

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

13 Congress directed $887,000 to the Centers for Dis14 ease Control and Prevention to begin a nationwide 

15 ALS registry. 

16 (12) The Centers for Disease Control and Pre17 vention and the Agency for Toxic Substances and 

18 Disease Registry has established three pilot projects, 

19 beginning in fiscal year 2006, to evaluate the science 

20 to guide the creation of a national ALS registry. 

21 (13) The establishment of a national registry 

22 will help— 

23 (A) to identify the incidence and preva24 lence of ALS in the United States; 


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1 (B) to collect data important to the study 

2 of ALS; 

3 (C) to promote a better understanding of 

4 ALS; 

5 (D) to collect information that is impor6 tant for research into the genetic and environ7 mental factors that cause ALS; 

8 (E) to strengthen the ability of a clearing9 house— 

10 (i) to collect and disseminate research 

11 findings on environmental, genetic and 

12 other causes of ALS and other motor neu13 ron disorders that can be confused with 

14 ALS, misdiagnosed as ALS, and in some 

15 cases progress to ALS; 

16 (ii) make available information to pa17 tients about research studies for which 

18 they may be eligible; and 

19 (iii) maintain information about clin20 ical specialists and clinical trials on thera21 pies; and 

22 (F) to enhance efforts to find treatments 

23 and a cure for ALS. 


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1 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

2 ACT. 

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

4 (42 U.S.C. 280g et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘SEC. 399O. AMYOTROPHIC LATERAL SCLEROSIS REG7 ISTRY. 

8 ‘‘(a) ESTABLISHMENT.— 

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

10 the receipt of the report described in subsection 

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

12 of the Centers for Disease Control and Prevention 

13 and in consultation with a national voluntary health 

14 organization with experience serving the population 

15 of individuals with amyotrophic lateral sclerosis (re16 ferred to in this section as ‘ALS’), shall— 

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

18 ALS and other motor neuron disorders that can 

19 be confused with ALS, misdiagnosed as ALS, 

20 and in some cases progress to ALS, including 

21 information with respect to the incidence and 

22 prevalence of the disease in the United States; 

23 and 

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

25 collection and storage of such data to include a 

26 population-based registry of cases in the United 


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1 States of ALS and other motor neuron dis2 orders that can be confused with ALS, 

3 misdiagnosed as ALS, and in some cases 

4 progress to ALS. 

5 ‘‘(2) PURPOSE.—It is the purpose of the reg6 istry established under paragraph (1)(B) to gather 

7 available data concerning— 

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

9 prevalence of ALS in the United States; 

10 ‘‘(B) the environmental and occupational 

11 factors that may be associated with the disease; 

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

13 family history of individuals who are diagnosed 

14 with the disease; 

15 ‘‘(D) other motor neuron disorders that 

16 can be confused with ALS, misdiagnosed as 

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

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

19 Advisory Committee established under sub20 section (b). 

21 ‘‘(b) ADVISORY COMMITTEE.— 

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

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

24 Secretary, acting through the Director of the Cen25 ters for Disease Control and Prevention, shall estabVerDate Aug 31 2005 06:14 May 15, 2007 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2295.IH H2295

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1 lish a committee to be known as the Advisory Com2 mittee on the National ALS Registry (referred to in 

3 this section as the ‘Advisory Committee’). The Advi4 sory Committee shall be composed of at least one 

5 member, to be appointed by the Secretary, acting 

6 through the Director of the Centers for Disease 

7 Control and Prevention, representing each of the fol8 lowing: 

9 ‘‘(A) National voluntary health associa10 tions that focus solely on ALS and have dem11 onstrated experience in ALS research, care, and 

12 patient services, as well as other voluntary asso13 ciations focusing on neurodegenerative diseases 

14 that represent and advocate on behalf of pa15 tients with ALS and patients with other motor 

16 neuron disorders that can be confused with 

17 ALS, misdiagnosed as ALS, and in some cases 

18 progress to ALS. 

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

20 include, upon the recommendation of the Direc21 tor of the National Institutes of Health, rep22 resentatives from the National Institute of Neu23 rological Disorders and Stroke and the National 

24 Institute of Environmental Health Sciences. 

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


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1 ‘‘(D) The Agency for Toxic Substances 

2 and Disease Registry. 

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

4 Prevention. 

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

6 members. 

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

8 related diseases. 

9 ‘‘(H) Epidemiologists with experience in 

10 data registries. 

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

12 have experience with the genetics of ALS or 

13 other neurological diseases. 

14 ‘‘(J) Statisticians. 

15 ‘‘(K) Ethicists. 

16 ‘‘(L) Attorneys. 

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

18 developing and maintaining the National ALS 

19 Registry. 

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

21 review information and make recommendations to 

22 the Secretary concerning— 

23 ‘‘(A) the development and maintenance of 

24 the National ALS Registry; 


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1 ‘‘(B) the type of information to be col2 lected and stored in the Registry; 

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

4 be collected; 

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

6 including guidelines for such use; and 

7 ‘‘(E) the collection of information about 

8 diseases and disorders that primarily affect 

9 motor neurons that are considered essential to 

10 furthering the study and cure of ALS. 

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

12 date on which the Advisory Committee is estab13 lished, the Advisory Committee shall submit a report 

14 concerning the review conducted under paragraph 

15 (2) that contains the recommendations of the Advi16 sory Committee with respect to the results of such 

17 review. 

18 ‘‘(c) GRANTS.—Notwithstanding the recommenda19 tions of the Advisory Committee under subsection (b), the 

20 Secretary, acting through the Director of the Centers for 

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

22 enter into contracts and cooperative agreements with, pub23 lic or private nonprofit entities for the collection, analysis, 

24 and reporting of data on ALS and other motor neuron 


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1 disorders that can be confused with ALS, misdiagnosed 

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

3 ‘‘(d) COORDINATION WITH STATE, LOCAL, AND FED4 ERAL REGISTRIES.— 

5 ‘‘(1) IN GENERAL.—In establishing the Na6 tional ALS Registry under subsection (a), the Sec7 retary, acting through the Director of the Centers 

8 for Disease Control and Prevention, shall— 

9 ‘‘(A) identify, build upon, expand, and co10 ordinate among existing data and surveillance 

11 systems, surveys, registries, and other Federal 

12 public health and environmental infrastructure 

13 wherever possible, including— 

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

15 initiated in fiscal year 2006 by the Centers 

16 for Disease Control and Prevention and 

17 the Agency for Toxic Substances and Dis18 ease Registry at the South Carolina Office 

19 of Research & Statistics; the Mayo Clinic 

20 in Rochester, Minnesota; and Emory Uni21 versity in Atlanta, Georgia; 

22 ‘‘(ii) the Department of Veterans Af23 fairs ALS Registry; 

24 ‘‘(iii) the DNA and Cell Line Reposi25 tory of the National Institute of NeuroVerDate Aug 31 2005 06:14 May 15, 2007 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2295.IH H2295

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1 logical Disorders and Stroke Human Ge2 netics Resource Center; 

3 ‘‘(iv) Agency for Toxic Substances 

4 and Disease Registry studies, including 

5 studies conducted in Illinois, Missouri, El 

6 Paso and San Antonio, Texas, and Massa7 chusetts; 

8 ‘‘(v) State-based ALS registries, in9 cluding the Massachusetts ALS Registry; 

10 ‘‘(vi) the National Vital Statistics Sys11 tem; and 

12 ‘‘(vii) any other existing or relevant 

13 databases that collect or maintain informa14 tion on those motor neuron diseases rec15 ommended by the Advisory Committee es16 tablished in subsection (b); and 

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

18 data as recommended by the Advisory Com19 mittee established in subsection (b) to the ex20 tent permitted by applicable statutes and regu21 lations and in a manner that protects personal 

22 privacy consistent with applicable privacy stat23 utes and regulations. 

24 ‘‘(2) COORDINATION WITH NIH AND DEPART25 MENT OF VETERANS AFFAIRS.—Notwithstanding the 


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1 recommendations of the Advisory Committee estab2 lished in subsection (b), and consistent with applica3 ble privacy statutes and regulations, the Secretary 

4 shall ensure that epidemiological and other types of 

5 information obtained under subsection (a) is made 

6 available to the National Institutes of Health and 

7 the Department of Veterans Affairs. 

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

9 the term ‘national voluntary health association’ means a 

10 national non-profit organization with chapters or other af11 filiated organizations in States throughout the United 

12 States. 

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

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

15 $25,000,000 for fiscal year 2008, and such sums as may 

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

Æ 


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