I 

111TH CONGRESS 

1ST SESSION H. R. 1362 

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

of permanent national surveillance systems for multiple sclerosis, Parkinson’s disease, and other neurological diseases and disorders. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 5, 2009 

Mr. VAN HOLLEN (for himself, Mr. BURGESS, Mrs. MALONEY, Mr. UPTON, 

Mr. CARNAHAN, and Mr. KING of New York) 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 permanent national surveillance systems for multiple sclerosis, Parkinson’s disease, and 

other neurological diseases and disorders. 

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 ‘‘National MS and Par5 kinson’s Disease Registries Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 


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1 (1) Multiple sclerosis (referred to in this section 

2 as ‘‘MS’’) is a progressive, disabling disease that af3 fects the brain and the spinal cord causing loss of 

4 myelin, damage to axons, and cerebral atrophy. 

5 (2) MS is a prime-of-life disease with an aver6 age age of onset at 30 to 35 years of age. 

7 (3) More than 10,000 individuals in the United 

8 States are diagnosed with MS annually, and it is 

9 thought that more than 400,000 individuals in the 

10 United States have MS. 

11 (4) Parkinson’s disease is a chronic, progressive 

12 neurological disease. The primary pathologic feature 

13 of Parkinson’s disease is degeneration and pre14 mature death of dopamine-producing brain cells. 

15 (5) Parkinson’s is the second-most common 

16 neurodegenerative disease in the United States. 

17 (6) It is estimated that more than 1,000,000 

18 Americans are currently fighting Parkinson’s dis19 ease, and 60,000 Americans are newly diagnosed 

20 every year. 

21 (7) Although estimates exist, there is no con22 firmed data regarding prevalence or diagnosed cases 

23 of Parkinson’s disease or MS. 

24 (8) The causes of Parkinson’s disease and MS 

25 are not well understood. 


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1 (9) There is no known cure for Parkinson’s dis2 ease or MS. 

3 (10) Studies have found relationships between 

4 both MS and Parkinson’s disease and environmental 

5 and genetic factors, but those relationships are not 

6 well understood. 

7 (11) Better data are needed to understand the 

8 economic impact of Parkinson’s disease, MS, and 

9 other neurological diseases. 

10 (12) There are several drugs currently approved 

11 by the Food and Drug Administration for the treat12 ment of MS, which have shown modest success in re13 ducing relapses, slowing progression of disability, 

14 and limiting the accumulation of brain lesions. 

15 (13) Currently, state-of-the-art treatment for 

16 Parkinson’s disease is based on a 40-year-old phar17 maceutical therapy, which only treats some of the 

18 motor symptoms of Parkinson’s disease. Deep brain 

19 stimulation surgery is available for certain patients 

20 and treats some symptoms of Parkinson’s disease. 

21 (14) No therapies exist that will slow or stop 

22 progression of Parkinson’s disease. There is no ef23 fective, lasting therapy for all features of Parkin24 son’s disease. 


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1 (15) Central nervous system drugs, including 

2 therapies for MS, Parkinson’s disease, and other 

3 neurological diseases, are the slowest in the drug de4 velopment pipeline, taking an average of 15 years 

5 post discovery for new therapies to reach the mar6 ket. 

7 (16) Several small and uncoordinated MS and 

8 Parkinson’s disease registries, surveillance systems, 

9 and databases exist in the United States and 

10 throughout the world. 

11 (17) A single national system to collect and 

12 store information on the incidence and prevalence of 

13 MS, Parkinson’s disease, or other neurological dis14 eases in the United States does not exist. 

15 (18) The Agency for Toxic Substances and Dis16 ease Registry (ATSDR) has established a series of 

17 small pilot studies, beginning in fiscal year 2006, to 

18 evaluate the feasibility of various methodologies to 

19 create an MS surveillance system at the national 

20 level. 

21 (19) The national surveillance system method22 ology resulting from the MS pilot studies should be 

23 expanded upon and developed into a national surveil24 lance system for Parkinson’s disease. 


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1 (20) The establishment of separate, coordinated 

2 national surveillance systems for Parkinson’s disease 

3 and MS will help— 

4 (A) to identify the incidence and preva5 lence of these diseases in the United States; 

6 (B) to collect demographic and other data 

7 important to the study of MS and Parkinson’s 

8 disease; 

9 (C) to produce epidemiologically sound 

10 data that can be used to compare with cluster 

11 information, data sets of the Department of 

12 Veterans Affairs, environmental exposure data, 

13 and other information; 

14 (D) to promote a better understanding of 

15 causes, prevention, and treatment of disease; 

16 (E) to better understand public and pri17 vate resource impact; 

18 (F) to collect information that is important 

19 for research into genetic and environmental risk 

20 factors; 

21 (G) to enhance biomedical and clinical re22 search by providing a basis for population com23 parisons; 


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1 (H) to enhance efforts to develop better di2 agnosis and progression biomarkers for MS and 

3 Parkinson’s disease; and 

4 (I) to enhance efforts to find treatments 

5 and a cure for MS and Parkinson’s disease. 

6 SEC. 3. SURVEILLANCE SYSTEMS. 

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

8 (42 U.S.C. 280g et seq.) is amended— 

9 (1) by redesignating the second and third sec10 tions 399R (added by section 2 of Public Law 110– 

11 373 and section 3 of Public Law 110–374) as sec12 tions 399S and 399T, respectively; and 

13 (2) by adding at the end the following: 

14 ‘‘SEC. 399U. SURVEILLANCE OF NEUROLOGICAL DISEASES. 

15 ‘‘(a) MULTIPLE SCLEROSIS NATIONAL SURVEIL16 LANCE SYSTEM.— 

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

18 receipt of the report described in subsection (c)(3), 

19 the Secretary, acting through the Director of the 

20 Agency for Toxic Substances and Disease Registry 

21 and in consultation with a national voluntary health 

22 organization with experience serving the population 

23 of individuals with multiple sclerosis (referred to in 

24 this section as ‘MS’), shall— 


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

2 MS including information with respect to the 

3 incidence and prevalence of the disease in the 

4 United States; 

5 ‘‘(B) establish a national surveillance sys6 tem for the collection and storage of such data 

7 to include a population-based registry of cases 

8 of MS in the United States; 

9 ‘‘(C) assist in application of MS national 

10 surveillance system methodologies for the devel11 opment, piloting, and implementation of a na12 tional Parkinson’s disease national surveillance 

13 system under subsection (b); and 

14 ‘‘(D) provide analysis regarding expansion 

15 of national disease surveillance systems for 

16 other neurological diseases and disorders uti17 lizing the MS and Parkinson’s disease national 

18 surveillance systems’ process and structure. 

19 ‘‘(2) PURPOSE.—It is the purpose of the reg20 istry established under paragraph (1)(B) to gather 

21 available data concerning— 

22 ‘‘(A) MS, including the incidence and prev23 alence of MS in the United States; 

24 ‘‘(B) the age, race or ethnicity, gender, 

25 military service if applicable, and family history 


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1 of individuals who are diagnosed with the dis2 ease; and 

3 ‘‘(C) other matters as recommended by the 

4 Advisory Committee established pursuant to 

5 subsection (c). 

6 ‘‘(b) PARKINSON’S DISEASE NATIONAL SURVEIL7 LANCE SYSTEM.— 

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

9 the receipt of the report described in subsection 

10 (c)(3), the Secretary, acting through the Director of 

11 the Agency for Toxic Substances and Disease Reg12 istry and in consultation with a national voluntary 

13 health organization with experience serving the pop14 ulation of individuals with Parkinson’s disease, 

15 shall— 

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

17 Parkinson’s disease including information with 

18 respect to the incidence and prevalence of the 

19 disease in the United States; 

20 ‘‘(B) establish a national surveillance sys21 tem for the collection and storage of such data 

22 to include a population-based registry of cases 

23 of Parkinson’s disease in the United States; 

24 and 


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1 ‘‘(C) provide analysis regarding expansion 

2 of national disease surveillance systems for 

3 other neurological diseases utilizing the MS and 

4 Parkinson’s disease national surveillance sys5 tems’ process and structure. 

6 ‘‘(2) PURPOSE.—It is the purpose of the reg7 istry established under paragraph (1)(B) to gather 

8 available data concerning— 

9 ‘‘(A) Parkinson’s disease, including the in10 cidence and prevalence of Parkinson’s disease in 

11 the United States; 

12 ‘‘(B) the age, race or ethnicity, gender, 

13 military service if applicable, and family history 

14 of individuals who are diagnosed with the dis15 ease; and 

16 ‘‘(C) other matters as recommended by the 

17 Advisory Committee established pursuant to 

18 subsection (c). 

19 ‘‘(c) ADVISORY COMMITTEE.— 

20 ‘‘(1) ESTABLISHMENT.—Not later than 180 

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

22 the Secretary, acting through the Director of the 

23 Agency for Toxic Substances and Disease Registry, 

24 shall establish a committee to be known as the Advi25 sory Committee on Neurological Disease Registries 


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1 (referred to in this section as the ‘Advisory Com2 mittee’). The Advisory Committee shall be composed 

3 of at least one member, to be appointed by the Sec4 retary, acting through the Director of the Agency 

5 for Toxic Substances and Disease Registry, rep6 resenting each of the following: 

7 ‘‘(A) National voluntary health associa8 tions that focus solely on MS and have dem9 onstrated experience in MS research, care, or 

10 patient services. 

11 ‘‘(B) National voluntary health associa12 tions that focus solely on Parkinson’s disease 

13 and have demonstrated experience in Parkin14 son’s disease public policy, research, care, or 

15 patient services. 

16 ‘‘(C) The National Institutes of Health, to 

17 include, upon the recommendation of the Direc18 tor of the National Institutes of Health, rep19 resentatives from the Office of Portfolio Anal20 ysis and Strategic Initiatives, the National In21 stitute of Neurological Disorders and Stroke, 

22 the National Institute of Environmental Health 

23 Sciences, the National Institute on Aging, and 

24 the National Institute of Allergy and Infectious 

25 Diseases. 


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1 ‘‘(D) The Department of Veterans Affairs, 

2 to include representatives from the Parkinson’s 

3 Disease Research Education and Clinical Cen4 ters and the MS Centers of Excellence. 

5 ‘‘(E) The Department of Defense, to in6 clude representatives from the Parkinson’s dis7 ease and MS research programs. 

8 ‘‘(F) The Food and Drug Administration. 

9 ‘‘(G) The Centers for Disease Control and 

10 Prevention, to include representatives from the 

11 Agency for Toxic Substances and Disease Reg12 istry. 

13 ‘‘(H) Patients with MS and Parkinson’s 

14 disease or their family members. 

15 ‘‘(I) Clinicians with expertise on MS and 

16 Parkinson’s disease. 

17 ‘‘(J) Research scientists with experience 

18 conducting translational research or creating 

19 systems that support translating basic discov20 eries into treatments. 

21 ‘‘(K) Epidemiologists with experience in 

22 data registries. 

23 ‘‘(L) Geneticists or experts in genetics who 

24 have experience with the genetics of MS and 

25 Parkinson’s disease. 


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1 ‘‘(M) Statisticians. 

2 ‘‘(N) Bioethicists. 

3 ‘‘(O) Attorneys. 

4 ‘‘(P) Other individuals, organizations, or 

5 agencies with an interest in developing and 

6 maintaining the MS and Parkinson’s disease 

7 national surveillance systems. 

8 ‘‘(Q) Experts in additional neurological 

9 diseases, as appropriate, based on development 

10 and implementation of national surveillance sys11 tems for other neurological diseases and dis12 orders. 

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

14 review information and make recommendations to 

15 the Secretary concerning— 

16 ‘‘(A) the development and maintenance of 

17 the MS and Parkinson’s disease national sur18 veillance systems; 

19 ‘‘(B) the use and coordination of existing 

20 databases that collect or maintain information 

21 on neurological diseases and disorders; 

22 ‘‘(C) the type of information to be collected 

23 and stored in the systems; 

24 ‘‘(D) the manner in which such data is to 

25 be collected; 


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

2 including guidelines for such use; and 

3 ‘‘(F) the application of MS and Parkin4 son’s disease registry methodologies to benefit 

5 other neurological diseases and disorders, in6 cluding analysis of how other neurological dis7 ease surveillance systems or registries can be 

8 developed, piloted, and implemented nationally 

9 utilizing the MS and Parkinson’s disease na10 tional surveillance systems’ process and struc11 ture. 

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

13 date on which the Advisory Committee is estab14 lished, the Advisory Committee shall submit a report 

15 to Congress concerning the review conducted under 

16 paragraph (2) that contains the recommendations of 

17 the Advisory Committee with respect to the results 

18 of such review. 

19 ‘‘(d) GRANTS.—Notwithstanding the recommenda20 tions of the Advisory Committee under subsection (c), the 

21 Secretary, acting through the Director of the Agency for 

22 Toxic Substances and Disease Registry, may award grants 

23 to, and enter into contracts and cooperative agreements 

24 with, public or private nonprofit entities for the collection, 


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1 analysis, and reporting of data on MS and Parkinson’s 

2 disease. 

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

5 ‘‘(1) IN GENERAL.—In establishing the MS and 

6 Parkinson’s disease national surveillance systems 

7 under subsections (a) and (b), the Secretary, acting 

8 through the Director of the Agency for Toxic Sub9 stances and Disease Registry, shall— 

10 ‘‘(A) identify, build upon, expand, and co11 ordinate existing data and surveillance systems, 

12 surveys, registries, and other Federal public 

13 health and environmental infrastructure wher14 ever possible, including— 

15 ‘‘(i) the 2 MS surveillance pilot stud16 ies initiated in fiscal year 2006 by the Cen17 ters for Disease Control and Prevention 

18 and the Agency for Toxic Substances and 

19 Disease Registry; 

20 ‘‘(ii) the Parkinson’s disease and MS 

21 databases of the Department of Veterans 

22 Affairs; 

23 ‘‘(iii) current Parkinson’s disease reg24 istries and surveillance systems, including 


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1 the Nebraska and California State reg2 istries; 

3 ‘‘(iv) current MS registries, including 

4 the New York State MS Registry and the 

5 North American Research Committee on 

6 MS (NARCOMS) Registry; and 

7 ‘‘(v) any other existing or relevant 

8 databases that collect or maintain informa9 tion on neurological diseases and disorders 

10 identified by researchers or recommended 

11 by the Advisory Committee pursuant to 

12 subsection (c); and 

13 ‘‘(B) provide for and conduct outreach in 

14 support of research access to Parkinson’s dis15 ease and MS data as recommended by the Advi16 sory Committee established pursuant to sub17 section (c) to the extent permitted by applicable 

18 statutes and regulations and in a manner that 

19 protects personal privacy consistent with appli20 cable privacy statutes and regulations. 

21 ‘‘(2) COORDINATION WITH OTHER FEDERAL

22 AGENCIES.—Notwithstanding the recommendations 

23 of the Advisory Committee established pursuant to 

24 subsection (c), and consistent with applicable privacy 

25 statutes and regulations, the Secretary shall ensure 


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1 that epidemiological and other types of information 

2 obtained under subsections (a) and (b) are made 

3 available to agencies such as the National Institutes 

4 of Health, the Food and Drug Administration, the 

5 Department of Veterans Affairs, and the Depart6 ment of Defense. 

7 ‘‘(f) DEFINITION.—For the purposes of this section, 

8 the term ‘national voluntary health association’ means a 

9 national nonprofit organization with chapters, other affili10 ated organizations, or networks in States throughout the 

11 United States. 

12 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

13 is authorized to be appropriated to carry out this section 

14 $5,000,000 for each of fiscal years 2010 through 2014.’’. 

Æ 


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