110TH CONGRESS 

2D SESSION S. 1382 

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, 
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1 SECTION 1. SHORT TITLE. 

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

3 SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

4 ACT. 

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

6 (42 U.S.C. 280g et seq.) is amended by adding at the end 

7 the following: 

8 ‘‘SEC. 399R. AMYOTROPHIC LATERAL SCLEROSIS REG9 ISTRY. 

10 ‘‘(a) ESTABLISHMENT.— 

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

12 the receipt of the report described in subsection 

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

14 of the Centers for Disease Control and Prevention, 

15 may, if scientifically advisable— 

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

17 amyotrophic lateral sclerosis (referred to in this 

18 section as ‘ALS’) and other motor neuron dis19 orders that can be confused with ALS, 

20 misdiagnosed as ALS, and in some cases 

21 progress to ALS, including information with re22 spect to the incidence and prevalence of the dis23 ease in the United States; and 

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

25 collection and storage of such data to develop 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— 

7 ‘‘(A) better describe the incidence and 

8 prevalence of ALS in the United States; 

9 ‘‘(B) examine appropriate factors, such as 

10 environmental and occupational, that may be 

11 associated with the disease; 

12 ‘‘(C) better outline key demographic fac13 tors (such as age, race or ethnicity, gender, and 

14 family history of individuals who are diagnosed 

15 with the disease) associated with the disease; 

16 ‘‘(D) better examine the connection be17 tween ALS and other motor neuron disorders 

18 that can be confused with ALS, misdiagnosed 

19 as ALS, and in some cases progress to ALS; 

20 and 

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

22 Advisory Committee established under sub23 section (b). 

24 ‘‘(b) ADVISORY COMMITTEE.— 
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1 ‘‘(1) ESTABLISHMENT.—Not later than 180 

2 days after the date of the enactment of this section, 

3 the Secretary, acting through the Director of the 

4 Centers for Disease Control and Prevention, may es5 tablish a committee to be known as the Advisory 

6 Committee on the National ALS Registry (referred 

7 to in this section as the ‘Advisory Committee’). The 

8 Advisory Committee shall be composed of not more 

9 than 27 members to be appointed by the Secretary, 

10 acting through the Centers for Disease Control and 

11 Prevention, of which— 

12 ‘‘(A) two-thirds of such members shall rep13 resent governmental agencies— 

14 ‘‘(i) including at least one member 

15 representing— 

16 ‘‘(I) the National Institutes of 

17 Health, to include, upon the rec18 ommendation of the Director of the 

19 National Institutes of Health, rep20 resentatives from the National Insti21 tute of Neurological Disorders and 

22 Stroke and the National Institute of 

23 Environmental Health Sciences; 

24 ‘‘(II) the Department of Veterans 

25 Affairs; 
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1 ‘‘(III) the Agency for Toxic Sub2 stances and Disease Registry; and 

3 ‘‘(IV) the Centers for Disease 

4 Control and Prevention; and 

5 ‘‘(ii) of which at least one such mem6 ber shall be a clinician with expertise on 

7 ALS and related diseases, an epidemiolo8 gist with experience in data registries, a 

9 statistician, an ethicist, and a privacy ex10 pert (relating to the privacy regulations 

11 under the Health Insurance Portability 

12 and Accountability Act of 1996); and 

13 ‘‘(B) one-third of such members shall be 

14 public members, including at least one member 

15 representing— 

16 ‘‘(i) national and voluntary health as17 sociations; 

18 ‘‘(ii) patients with ALS or their fam19 ily members; 

20 ‘‘(iii) clinicians with expertise on ALS 

21 and related diseases; 

22 ‘‘(iv) epidemiologists with experience 

23 in data registries; 
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1 ‘‘(v) geneticists or experts in genetics 

2 who have experience with the genetics of 

3 ALS or other neurological diseases and 

4 ‘‘(vi) other individuals with an interest 

5 in developing and maintaining the National 

6 ALS Registry. 

7 ‘‘(2) DUTIES.—The Advisory Committee may 

8 review information and make recommendations to 

9 the Secretary concerning— 

10 ‘‘(A) the development and maintenance of 

11 the National ALS Registry; 

12 ‘‘(B) the type of information to be col13 lected and stored in the Registry; 

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

15 be collected; 

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

17 including guidelines for such use; and 

18 ‘‘(E) the collection of information about 

19 diseases and disorders that primarily affect 

20 motor neurons that are considered essential to 

21 furthering the study and cure of ALS. 

22 ‘‘(3) REPORT.—Not later than 270 days after 

23 the date on which the Advisory Committee is estab24 lished, the Advisory Committee may submit a report 

25 to the Secretary concerning the review conducted 
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1 under paragraph (2) that contains the recommenda2 tions of the Advisory Committee with respect to the 

3 results of such review. 

4 ‘‘(c) GRANTS.—The Secretary, acting through the 

5 Director of the Centers for Disease Control and Preven6 tion, may award grants to, and enter into contracts and 

7 cooperative agreements with, public or private nonprofit 

8 entities for the collection, analysis, and reporting of data 

9 on ALS and other motor neuron disorders that can be con10 fused with ALS, misdiagnosed as ALS, and in some cases 

11 progress to ALS after receiving the report under sub12 section (b)(3). 

13 ‘‘(d) COORDINATION WITH STATE, LOCAL, AND FED14 ERAL REGISTRIES.— 

15 ‘‘(1) IN GENERAL.—In establishing the Na16 tional ALS Registry under subsection (a), the Sec17 retary, acting through the Director of the Centers 

18 for Disease Control and Prevention, may— 

19 ‘‘(A) identify, build upon, expand, and co20 ordinate among existing data and surveillance 

21 systems, surveys, registries, and other Federal 

22 public health and environmental infrastructure 

23 wherever possible, which may include— 
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1 ‘‘(i) any registry pilot projects pre2 viously supported by the Centers for Dis3 ease Control and Prevention; 

4 ‘‘(ii) the Department of Veterans Af5 fairs ALS Registry; 

6 ‘‘(iii) the DNA and Cell Line Reposi7 tory of the National Institute of Neuro8 logical Disorders and Stroke Human Ge9 netics Resource Center at the National In10 stitutes of Health; 

11 ‘‘(iv) Agency for Toxic Substances 

12 and Disease Registry studies, including 

13 studies conducted in Illinois, Missouri, El 

14 Paso and San Antonio, Texas, and Massa15 chusetts; 

16 ‘‘(v) State-based ALS registries; 

17 ‘‘(vi) the National Vital Statistics Sys18 tem; and 

19 ‘‘(vii) any other existing or relevant 

20 databases that collect or maintain informa21 tion on those motor neuron diseases rec22 ommended by the Advisory Committee es23 tablished in subsection (b); and 

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

25 data as recommended by the Advisory Com-
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1 mittee established in subsection (b) to the ex2 tent permitted by applicable statutes and regu3 lations and in a manner that protects personal 

4 privacy consistent with applicable privacy stat5 utes and regulations. 

6 ‘‘(2) COORDINATION WITH NIH AND DEPART7 MENT OF VETERANS AFFAIRS.—Consistent with ap8 plicable privacy statutes and regulations, the Sec9 retary may ensure that epidemiological and other 

10 types of information obtained under subsection (a) is 

11 made available to the National Institutes of Health 

12 and the Department of Veterans Affairs. 

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

14 the term ‘national voluntary health association’ means a 

15 national non-profit organization with chapters or other af16 filiated organizations in States throughout the United 

17 States with experience serving the population of individ18 uals with ALS and have demonstrated experience in ALS 

19 research, care, and patient services.’’. 

20 SEC. 3. REPORT ON REGISTRIES. 

21 Not later than 18 months after the date of enactment 

22 of this Act, the Secretary of Health and Human Services 

23 may submit to the appropriate committees of Congress a 

24 report outlining— 

25 (1) the registries currently under way; 
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1 (2) future planned registries; 

2 (3) the criteria involved in determining what 

3 registries to conduct, defer, or suspend; and 

4 (4) the scope of those registries. 

5 The report may also include a description of the activities 

6 the Secretary undertakes to establish partnerships with re7 search and patient advocacy communities to expand reg8 istries. 

Passed the Senate September 23 (legislative day, 

September 17), 2008. 

Attest: 

Secretary. 

110TH CONGRESS 

2D SESSION S. 1382 

AN ACT 

To amend the Public Health Service Act to provide 

Sclerosis Registry. for the establishment of an Amyotrophic Lateral