IB 

Union Calendar No. 236 

110TH CONGRESS 

1ST SESSION H. R. 2295 

[Report No. 110–379] 

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 

OCTOBER 15, 2007 

Additional sponsors: Ms. ESHOO, Mr. CARNEY, Mr. BOOZMAN, Mr. HAYES, 

Ms. HOOLEY, Ms. SHEA-PORTER, Mr. WATT, Mr. SESSIONS, Mrs. 

SCHMIDT, Mr. WELLER of Illinois, Mr. RAMSTAD, Mr. KING of New 

York, Mr. HOEKSTRA, Mr. JINDAL, Mr. DEFAZIO, Mr. PETERSON of 


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Pennsylvania, Mr. TAYLOR, Mr. ALTMIRE, Mr. ISRAEL, Mr. FRELINGHUYSEN, Mr. OBERSTAR, Ms. WASSERMAN SCHULTZ, Mr. MICHAUD, Mr. 

SKELTON, Mr. BONNER, Ms. SLAUGHTER, Mr. FARR, Mr. KUCINICH, Mr. 

CHANDLER, Mr. NEAL of Massachusetts, Mrs. MALONEY of New York, 

Mr. CLAY, Mr. FRANK of Massachusetts, Mr. DOOLITTLE, Mr. PAYNE, 

Mrs. BIGGERT, Mr. MILLER of North Carolina, Mr. SCHIFF, Mr. KELLER

of Florida, Mr. YOUNG of Florida, Mr. SMITH of Washington, Mr. DAVID

DAVIS of Tennessee, Mr. SIMPSON, Mr. WOLF, Mr. CALVERT, Mr. MARSHALL, Mr. LOBIONDO, Mr. COBLE, Mr. PLATTS, Ms. LINDA T. 

SA ́NCHEZ of California, Mr. RYAN of Ohio, Mr. WALZ of Minnesota, Mr. 

WALDEN of Oregon, Mr. STEARNS, Mr. PASTOR, Mr. LEWIS of Kentucky, 

Mr. LEWIS of Georgia, Mr. SENSENBRENNER, Mr. MCCOTTER, Mr. 

MCHENRY, Mr. ELLISON, Mr. ANDREWS, Mr. KLEIN of Florida, Mr. 

BRALEY of Iowa, Mr. FILNER, Mr. WILSON of South Carolina, Mr. MURPHY of Connecticut, Mr. SESTAK, Mr. EVERETT, Mr. COSTELLO, Mr. 

ACKERMAN, Mr. HINOJOSA, Mr. BLUMENAUER, Ms. MATSUI, Ms. PRYCE

of Ohio, Mr. BERRY, Mr. DAVIS of Alabama, Mr. STUPAK, Mr. AL

GREEN of Texas, Mr. SAXTON, Mr. SPACE, Mr. GRAVES, Mr. WU, Mr. 

KIRK, Mr. WELDON of Florida, Mr. CONAWAY, Mr. LAMPSON, Mr. 

WELCH of Vermont, Mr. PICKERING, Mr. GORDON of Tennessee, Ms. 

CASTOR, Mr. MCCAUL of Texas, Mr. LARSEN of Washington, Mr. CASTLE, Mr. BOREN, Mrs. CUBIN, Mr. LANGEVIN, Mr. ARCURI, Mr. JACKSON of Illinois, Mrs. GILLIBRAND, Mr. TIM MURPHY of Pennsylvania, 

Mr. WICKER, Mrs. DRAKE, Mrs. CAPITO, Mr. BAIRD, Mr. ORTIZ, Mr. 

CHABOT, Mr. DELAHUNT, Mr. YARMUTH, Mr. BUCHANAN, Ms. 

VELA ́ZQUEZ, Mr. RAHALL, Ms. BEAN, Mr. SOUDER, Mr. WEXLER, Mr. 

REICHERT, Ms. GINNY BROWN-WAITE of Florida, Mr. DENT, Mr. 

ENGLISH of Pennsylvania, Mr. PASCRELL, Ms. WATSON, Mr. ROGERS of 

Kentucky, Mr. PETERSON of Minnesota, Mr. SULLIVAN, Mr. TIBERI, Ms. 

WOOLSEY, Mrs. BLACKBURN, Mr. ALEXANDER, Mr. LUCAS, Mr. HOLT, 

Mr. CARNAHAN, Mr. THOMPSON of California, Mr. THOMPSON of Mississippi, Ms. SUTTON, Mr. KUHL of New York, Mr. SHULER, Mr. 

MELANCON, Mr. DOGGETT, Ms. HERSETH SANDLIN, Mr. JONES of North 

Carolina, Mr. MOORE of Kansas, Mr. BRADY of Pennsylvania, Mr. 

RUPPERSBERGER, Mrs. BOYDA of Kansas, Mr. DONNELLY, Mr. LEVIN, 

Mr. POMEROY, Mr. NUNES, Mr. DAVIS of Illinois, Mr. LAHOOD, Mr. 

SERRANO, Mr. RADANOVICH, Mr. BISHOP of Utah, Ms. DEGETTE, Ms. 

HARMAN, Mr. HILL, Ms. BERKLEY, Mr. BOUCHER, Mr. MCNERNEY, Mr. 

SARBANES, Mr. FORTENBERRY, Mr. CARTER, Mr. GARY G. MILLER of 

California, Mrs. EMERSON, Mr. HOLDEN, Mr. CANNON, Mr. CLEAVER, 

Mr. KILDEE, Mr. LATHAM, Mr. REYES, Mr. BAKER, Mr. FEENEY, Mr. 

ROGERS of Alabama, Mr. GEORGE MILLER of California, Mr. PUTNAM, 

Mr. MORAN of Virginia, Mr. RODRIGUEZ, Mr. CANTOR, Mrs. WILSON of 

New Mexico, Mr. HALL of New York, Mrs. DAVIS of California, Mr. 

MITCHELL, Mr. ELLSWORTH, Mr. BACHUS, Mr. MORAN of Kansas, Mr. 

LYNCH, Mr. JOHNSON of Illinois, Mrs. TAUSCHER, Ms. LEE, Mr. HELLER of Nevada, Mr. BURGESS, Ms. SCHWARTZ, and Mr. LARSON of Connecticut 


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OCTOBER 15, 2007 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on May 14, 2007] 

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. 

11 (2) The average life expectancy for a person with 

12 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 by 

15 the Food and Drug Administration for the treatment 


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1 of ALS, which has thus far shown only modest effects, 

2 prolonging life by just a few months. 

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

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

5 States are diagnosed with ALS annually and as 

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

7 in the United States today. 

8 (7) Studies have found relationships between 

9 ALS and environmental and genetic factors, but those 

10 relationships are not well understood. 

11 (8) Scientists believe that there are significant 

12 ties between ALS and other motor neuron diseases. 

13 (9) Several ALS disease registries and databases 

14 exist in the United States and throughout the world, 

15 including the SOD1 database, the National Institute 

16 of Neurological Disorders and Stroke repository, and 

17 the Department of Veterans Affairs ALS Registry. 

18 (10) A single national system to collect and store 

19 information on the prevalence and incidence of ALS 

20 in the United States does not exist. 

21 (11) In each of fiscal years 2006 and 2007, Con22 gress directed $887,000 to the Centers for Disease 

23 Control and Prevention to begin a nationwide ALS 

24 registry. 


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1 (12) The Centers for Disease Control and Preven2 tion and the Agency for Toxic Substances and Disease 

3 Registry have established three pilot projects, begin4 ning in fiscal year 2006, to evaluate the science to 

5 guide the creation of a national ALS registry. 

6 (13) The establishment of a national registry 

7 will help— 

8 (A) to identify the incidence and prevalence 

9 of ALS in the United States; 

10 (B) to collect data important to the study of 

11 ALS; 

12 (C) to promote a better understanding of 

13 ALS; 

14 (D) to collect information that is important 

15 for research into the genetic and environmental 

16 factors that cause ALS; 

17 (E) to strengthen the ability of a clearing18 house— 

19 (i) to collect and disseminate research 

20 findings on environmental, genetic, and 

21 other causes of ALS and other motor neuron 

22 disorders that can be confused with ALS, 

23 misdiagnosed as ALS, and in some cases 

24 progress to ALS; 


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1 (ii) to make available information to 

2 patients about research studies for which 

3 they may be eligible; and 

4 (iii) to maintain information about 

5 clinical specialists and clinical trials on 

6 therapies; and 

7 (F) to enhance efforts to find treatments 

8 and a cure for ALS. 

9 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT. 

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

11 (42 U.S.C. 280g et seq.) is amended by adding at the end 

12 the following: 

13 ‘‘SEC. 399R. AMYOTROPHIC LATERAL SCLEROSIS REGISTRY. 

14 ‘‘(a) ESTABLISHMENT.— 

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

16 the receipt of the report described in subsection (b)(3), 

17 the Secretary, acting through the Director of the Cen18 ters for Disease Control and Prevention and in con19 sultation with a national voluntary health organiza20 tion with experience serving the population of indi21 viduals with amyotrophic lateral sclerosis (referred to 

22 in this section as ‘ALS’), shall— 

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

24 ALS and other motor neuron disorders that can 

25 be confused with ALS, misdiagnosed as ALS, 


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1 and in some cases progress to ALS, including in2 formation with respect to the incidence and prev3 alence of the disease in the United States; and 

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

5 collection and storage of such data to include a 

6 population-based registry of cases in the United 

7 States of ALS and other motor neuron disorders 

8 that can be confused with ALS, misdiagnosed as 

9 ALS, and in some cases progress to ALS. 

10 ‘‘(2) PURPOSE.—It is the purpose of the registry 

11 established under paragraph (1)(B) to gather avail12 able data concerning— 

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

14 prevalence of ALS in the United States; 

15 ‘‘(B) the environmental and occupational 

16 factors that may be associated with the disease; 

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

18 family history of individuals who are diagnosed 

19 with the disease; 

20 ‘‘(D) other motor neuron disorders that can 

21 be confused with ALS, misdiagnosed as ALS, 

22 and in some cases progress to ALS; and 

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

24 Advisory Committee established under subsection 

25 (b). 


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1 ‘‘(b) ADVISORY COMMITTEE.— 

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

3 after the date of the enactment of this section, the Sec4 retary, acting through the Director of the Centers for 

5 Disease Control and Prevention, shall establish a 

6 committee to be known as the Advisory Committee on 

7 the National ALS Registry (referred to in this section 

8 as the ‘Advisory Committee’). The Advisory Com9 mittee shall be composed of at least one member, to 

10 be appointed by the Secretary, acting through the Di11 rector of the Centers for Disease Control and Preven12 tion, representing each of the following: 

13 ‘‘(A) National voluntary health associations 

14 that focus solely on ALS and have demonstrated 

15 experience in ALS research, care, and patient 

16 services, as well as other voluntary associations 

17 focusing on neurodegenerative diseases that rep18 resent and advocate on behalf of patients with 

19 ALS and patients with other motor neuron dis20 orders that can be confused with ALS, 

21 misdiagnosed as ALS, and in some cases 

22 progress to ALS. 

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

24 include, upon the recommendation of the Direc25 tor of the National Institutes of Health, repVerDate Aug 31 2005 04:01 Oct 16, 2007 Jkt 069200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6203 E:\BILLS\H2295.RH H2295

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1 resentatives from the National Institute of Neu2 rological Disorders and Stroke and the National 

3 Institute of Environmental Health Sciences. 

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

5 ‘‘(D) The Agency for Toxic Substances and 

6 Disease Registry. 

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

8 Prevention. 

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

10 members. 

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

12 related diseases. 

13 ‘‘(H) Epidemiologists with experience in 

14 data registries. 

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

16 have experience with the genetics of ALS or other 

17 neurological diseases. 

18 ‘‘(J) Statisticians. 

19 ‘‘(K) Ethicists. 

20 ‘‘(L) Attorneys. 

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

22 developing and maintaining the National ALS 

23 Registry. 


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1 ‘‘(2) DUTIES.—The Advisory Committee shall re2 view information and make recommendations to the 

3 Secretary concerning— 

4 ‘‘(A) the development and maintenance of 

5 the National ALS Registry; 

6 ‘‘(B) the type of information to be collected 

7 and stored in the Registry; 

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

9 be collected; 

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

11 including guidelines for such use; and 

12 ‘‘(E) the collection of information about dis13 eases and disorders that primarily affect motor 

14 neurons that are considered essential to fur15 thering the study and cure of ALS. 

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

17 date on which the Advisory Committee is established, 

18 the Advisory Committee shall submit a report con19 cerning the review conducted under paragraph (2) 

20 that contains the recommendations of the Advisory 

21 Committee with respect to the results of such review. 

22 ‘‘(c) GRANTS.—Notwithstanding the recommendations 

23 of the Advisory Committee under subsection (b), the Sec24 retary, acting through the Director of the Centers for Dis25 ease Control and Prevention, may award grants to, and 


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1 enter into contracts and cooperative agreements with, pub2 lic or private nonprofit entities for the collection, analysis, 

3 and reporting of data on ALS and other motor neuron dis4 orders that can be confused with ALS, misdiagnosed as 

5 ALS, and in some cases progress to ALS. 

6 ‘‘(d) COORDINATION WITH STATE, LOCAL, AND FED7 ERAL REGISTRIES.— 

8 ‘‘(1) IN GENERAL.—In establishing the National 

9 ALS Registry under subsection (a), the Secretary, 

10 acting through the Director of the Centers for Disease 

11 Control and Prevention, shall— 

12 ‘‘(A) identify, build upon, expand, and co13 ordinate among existing data and surveillance 

14 systems, surveys, registries, and other Federal 

15 public health and environmental infrastructure 

16 wherever possible, including— 

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

18 initiated in fiscal year 2006 by the Centers 

19 for Disease Control and Prevention and the 

20 Agency for Toxic Substances and Disease 

21 Registry at the South Carolina Office of Re22 search & Statistics; the Mayo Clinic in 

23 Rochester, Minnesota; and Emory Univer24 sity in Atlanta, Georgia; 


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1 ‘‘(ii) the Department of Veterans Af2 fairs ALS Registry; 

3 ‘‘(iii) the DNA and Cell Line Reposi4 tory of the National Institute of Neuro5 logical Disorders and Stroke Human Genet6 ics Resource Center; 

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

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

16 ‘‘(vii) 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 research access to ALS 

22 data as recommended by the Advisory Committee 

23 established in subsection (b) to the extent per24 mitted by applicable statutes and regulations 

25 and in a manner that protects personal privacy 


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1 consistent with applicable privacy statutes and 

2 regulations. 

3 ‘‘(2) COORDINATION WITH NIH AND DEPARTMENT

4 OF VETERANS AFFAIRS.—Notwithstanding the rec5 ommendations of the Advisory Committee established 

6 in subsection (b), and consistent with applicable pri7 vacy statutes and regulations, the Secretary shall en8 sure that epidemiological and other types of informa9 tion obtained under subsection (a) is made available 

10 to the National Institutes of Health and the Depart11 ment of Veterans Affairs. 

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

13 term ‘national voluntary health association’ means a na14 tional non-profit organization with chapters or other affili15 ated organizations in States throughout the United States. 

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

17 authorized to be appropriated to carry out this section, 

18 $25,000,000 for fiscal year 2008, and $16,000,000 for each 

19 of the fiscal years 2009 through 2012.’’. 


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Union Calendar No. 236 

110TH CONGRESS 

1ST SESSION H. R. 2295 

[Report No. 110

–379] 

A BILL 

To amend the Public Health Service Act to provide 

Sclerosis Registry. for the establishment of an Amyotrophic Lateral 

OCTOBER 15, 2007 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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