II 

Calendar No. 408 

114TH CONGRESS 

2D SESSION S. 849 

To amend the Public Health Service Act to provide for systematic data 

collection and analysis and epidemiological research regarding Multiple 

Sclerosis (MS), Parkinson’s disease, and other neurological diseases. 

IN THE SENATE OF THE UNITED STATES 

MARCH 24, 2015 

Mr. ISAKSON (for himself, Mr. MURPHY, Mr. VITTER, Mr. CASEY, Mr. 

WICKER, Ms. BALDWIN, Mr. COONS, Mrs. BOXER, Mr. CASSIDY, Ms. 

STABENOW, Mrs. FEINSTEIN, Mr. KIRK, Mr. MENENDEZ, Mr. CARPER, 

Mr. REED, Mr. MARKEY, Mr. PETERS, Mrs. GILLIBRAND, Ms. MURKOWSKI, Ms. KLOBUCHAR, Mr. BOOKER, Mr. ALEXANDER, Mr. NELSON, 

and Mr. BOOZMAN) introduced the following bill; which was read twice 

and referred to the Committee on Health, Education, Labor, and Pensions 

APRIL 4, 2016 

Reported by Mr. ALEXANDER, with an amendment 

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

A BILL 

To amend the Public Health Service Act to provide for 

systematic data collection and analysis and epidemiological research regarding Multiple Sclerosis (MS), Parkinson’s disease, and other neurological diseases. 

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 ‘‘Advancing Research 

3 for Neurological Diseases Act of 2015’’. 

4 SEC. 2. NATIONAL NEUROLOGICAL DISEASES SURVEIL5 LANCE SYSTEM. 

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

7 (42 U.S.C. 280g et seq.) is amended by adding at the end 

8 the following: 

9 ‘‘SEC. 399V–6 SURVEILLANCE OF NEUROLOGICAL DISEASES. 

10 ‘‘(a) IN GENERAL.—The Secretary, acting through 

11 the Director of the Centers for Disease Control and Pre12 vention, shall— 

13 ‘‘(1) enhance and expand infrastructure and ac14 tivities to track the epidemiology of neurological dis15 eases, including multiple sclerosis and Parkinson’s 

16 disease; and 

17 ‘‘(2) incorporate information obtained through 

18 such activities into a statistically sound, scientifically 

19 credible, integrated surveillance system, to be known 

20 as the National Neurological Diseases Surveillance 

21 System. 

22 ‘‘(b) RESEARCH.—The Secretary shall ensure that 

23 the National Neurological Diseases Surveillance System is 

24 designed in a manner that facilitates further research on 

25 neurological diseases. 


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1 ‘‘(c) CONTENT.—In carrying out subsection (a), the 

2 Secretary— 

3 ‘‘(1) shall provide for the collection and storage 

4 of information on the incidence and prevalence of 

5 neurological diseases in the United States; 

6 ‘‘(2) to the extent practicable, shall provide for 

7 the collection and storage of other available informa8 tion on neurological diseases, such as information 

9 concerning— 

10 ‘‘(A) demographics and other information 

11 associated or possibly associated with neuro12 logical diseases, such as age, race, ethnicity, 

13 sex, geographic location, and family history; 

14 ‘‘(B) risk factors associated or possibly as15 sociated with neurological diseases, including 

16 genetic and environmental risk factors; and 

17 ‘‘(C) diagnosis and progression markers; 

18 ‘‘(3) may provide for the collection and storage 

19 of information relevant to analysis on neurological 

20 diseases, such as information concerning— 

21 ‘‘(A) the epidemiology of the diseases; 

22 ‘‘(B) the natural history of the diseases; 

23 ‘‘(C) the prevention of the diseases; 

24 ‘‘(D) the detection, management, and 

25 treatment approaches for the diseases; and 


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1 ‘‘(E) the development of outcomes meas2 ures; and 

3 ‘‘(4) may address issues identified during the 

4 consultation process under subsection (d). 

5 ‘‘(d) CONSULTATION.—In carrying out this section, 

6 the Secretary shall consult with individuals with appro7 priate expertise, including— 

8 ‘‘(1) epidemiologists with experience in disease 

9 surveillance or registries; 

10 ‘‘(2) representatives of national voluntary 

11 health associations that— 

12 ‘‘(A) focus on neurological diseases, includ13 ing multiple sclerosis and Parkinson’s disease; 

14 and 

15 ‘‘(B) have demonstrated experience in re16 search, care, or patient services; 

17 ‘‘(3) health information technology experts or 

18 other information management specialists; 

19 ‘‘(4) clinicians with expertise in neurological 

20 diseases; and 

21 ‘‘(5) research scientists with experience con22 ducting translational research or utilizing surveil23 lance systems for scientific research purposes. 

24 ‘‘(e) GRANTS.—The Secretary may award grants to, 

25 or enter into contracts or cooperative agreements with, 


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1 public or private nonprofit entities to carry out activities 

2 under this section. 

3 ‘‘(f) COORDINATION WITH OTHER FEDERAL AGEN4 CIES.—Subject to subsection (h), the Secretary shall make 

5 information and analysis in the National Neurological Dis6 eases Surveillance System available, as appropriate, to 

7 Federal departments and agencies, such as the National 

8 Institutes of Health, the Food and Drug Administration, 

9 the Centers for Medicare & Medicaid Services, the Agency 

10 for Healthcare Research and Quality, the Department of 

11 Veterans Affairs, and the Department of Defense. 

12 ‘‘(g) PUBLIC ACCESS.—Subject to subsection (h), the 

13 Secretary shall make information and analysis in the Na14 tional Neurological Diseases Surveillance System avail15 able, as appropriate, to the public, including researchers. 

16 ‘‘(h) PRIVACY.—The Secretary shall ensure that pri17 vacy and security protections applicable to the National 

18 Neurological Diseases Surveillance System are at least as 

19 stringent as the privacy and security protections under 

20 HIPAA privacy and security law (as defined in section 

21 3009(a)(2)). 

22 ‘‘(i) REPORT.—Not later than 4 years after the date 

23 of the enactment of this section, the Secretary shall sub24 mit a report to the Congress concerning the implementaVerDate Sep 11 2014 22:17 Apr 04, 2016 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6401 E:\BILLS\S849.RS S849

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1 tion of this section. Such report shall include information 

2 on— 

3 ‘‘(1) the development and maintenance of the 

4 National Neurological Diseases Surveillance System; 

5 ‘‘(2) the type of information collected and 

6 stored in the System; 

7 ‘‘(3) the use and availability of such informa8 tion, including guidelines for such use; and 

9 ‘‘(4) the use and coordination of databases that 

10 collect or maintain information on neurological dis11 eases. 

12 ‘‘(j) DEFINITION.—In this section, the term ‘national 

13 voluntary health association’ means a national nonprofit 

14 organization with chapters, other affiliated organizations, 

15 or networks in States throughout the United States. 

16 ‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—To 

17 carry out this section, there is authorized to be appro18 priated $5,000,000 for each of fiscal years 2015 through 

19 2019.’’. 

20 SECTION 1. SHORT TITLE. 

21 This Act may be cited as the ‘‘Advancing Research for 

22 Neurological Diseases Act of 2016’’. 


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1 SEC. 2. ADVANCING RESEARCH FOR NEUROLOGICAL DIS2 EASES. 

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

4 (42 U.S.C. 280g et seq.) is amended by inserting after sec5 tion 399S, the following: 

6 ‘‘SEC. 399S-1. ADVANCING RESEARCH FOR NEUROLOGICAL 

7 DISEASES. 

8 ‘‘(a) IN GENERAL.—The Secretary may improve the 

9 collection of epidemiological and surveillance data on neu10 rological diseases (including, for purposes of this section, 

11 both neurological diseases and neurological conditions), 

12 which may include the incorporation of such data into a 

13 registry, to facilitate research and improve public health, 

14 including, as appropriate, by leveraging existing surveil15 lance activities and registries established under this Act. 

16 ‘‘(b) CONTENT.—In carrying out subsection (a), the 

17 Secretary— 

18 ‘‘(1) shall provide for the collection and storage 

19 of information to better describe the incidence and 

20 prevalence of neurological diseases in the United 

21 States identified under paragraph (2); 

22 ‘‘(2) shall initially identify and focus on up to 

23 five neurological diseases that available data indicate 

24 are the most prevalent or present a significant public 

25 health burden; 


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1 ‘‘(3) shall identify, build upon, leverage, and co2 ordinate among existing data and surveillance sys3 tems, surveys, registries, and other existing Federal 

4 public health and infrastructure wherever possible; 

5 ‘‘(4) shall ensure that any neurological disease 

6 surveillance activities conducted pursuant to this sec7 tion, including any such registry, are designed in a 

8 manner that facilitates research on neurological dis9 eases; 

10 ‘‘(5) shall, to the extent practicable, provide for 

11 the collection and storage of information relevant to 

12 the identified neurological diseases, such as— 

13 ‘‘(A) demographics, such as age, race, eth14 nicity, sex, geographic location, and family his15 tory, and other information, as appropriate; 

16 ‘‘(B) risk factors that may be associated 

17 with certain neurological diseases; and 

18 ‘‘(C) diagnosis and progression markers; 

19 ‘‘(6) may provide for the collection and storage 

20 of additional information relevant to analysis on neu21 rological diseases, such as information regarding— 

22 ‘‘(A) the natural history of the diseases; 

23 ‘‘(B) the prevention, detection, management, 

24 and treatments or treatment approaches for the 

25 diseases; and 


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1 ‘‘(C) the development of outcomes measures; 

2 and 

3 ‘‘(7) may address issues identified during the 

4 consultation process described in subsection (c). 

5 ‘‘(c) CONSULTATION.—In carrying out this section, the 

6 Secretary shall consult with experts, who may include— 

7 ‘‘(1) epidemiologists with experience in disease 

8 surveillance or registries; 

9 ‘‘(2) representatives of national and voluntary 

10 health associations that focus on neurological diseases 

11 and have demonstrated experience in research, care, 

12 or patient services; 

13 ‘‘(3) health information technology experts or 

14 other information management specialists; 

15 ‘‘(4) clinicians with expertise in neurological 

16 diseases; and 

17 ‘‘(5) research scientists with experience con18 ducting translational research or utilizing surveil19 lance systems or registries for scientific research pur20 poses. 

21 ‘‘(d) GRANTS.—The Secretary may award grants to, 

22 or enter into contracts or cooperative agreements with, pub23 lic or private nonprofit entities to carry out activities under 

24 this section. 


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1 ‘‘(e) COORDINATION WITH OTHER FEDERAL AGEN2 CIES.—Consistent with applicable privacy laws, the Sec3 retary shall make information and analysis pertaining to 

4 information collected under this section available, as appro5 priate, to relevant Federal departments and agencies. 

6 ‘‘(f) ACCESS FOR BIOMEDICAL RESEARCH.—The Sec7 retary shall make data collected under this section available 

8 for purposes of biomedical research as determined appro9 priate by the Secretary, to the extent permitted by applica10 ble laws, and in a manner that protects personal privacy. 

11 ‘‘(g) REPORTS.— 

12 ‘‘(1) INTERIM REPORT.—Not later than 1 year 

13 after the date on which any registry is established 

14 and operational under this section, the Secretary shall 

15 submit an interim report to the Committee on Health, 

16 Education, Labor, and Pensions of the Senate and the 

17 Committee on Energy and Commerce of the House of 

18 Representatives regarding aggregate information col19 lected pursuant to this section and epidemiological 

20 analyses, as appropriate. Such report shall be posted 

21 on the Internet website of the Department of Health 

22 and Human Services and shall be updated biennially 

23 thereafter. 

24 ‘‘(2) IMPLEMENTATION REPORT.—Not later than 

25 4 years after the date of the enactment of this section, 


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1 the Secretary shall submit a report to the Committee 

2 on Health, Education, Labor, and Pensions of the 

3 Senate and the Committee on Energy and Commerce 

4 of the House of Representatives regarding the imple5 mentation of this section. Such report shall include 

6 information on— 

7 ‘‘(A) the development and maintenance of 

8 any means of collecting neurological disease sur9 veillance information gathered pursuant to this 

10 section; 

11 ‘‘(B) the type of information collected and 

12 stored; 

13 ‘‘(C) the use and availability of such infor14 mation, including guidelines for such use; and 

15 ‘‘(D) the use and coordination of databases 

16 that collect or maintain information on neuro17 logical diseases.’’. 


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Calendar No. 408 

114TH CONGRESS 

2D SESSION S. 849 

A BILL 

To amend the Public Health Service Act to provide 

logical diseases. rosis (MS), Parkinson’s disease, and other neuroepidemiological research regarding Multiple Sclefor systematic data collection and analysis and 

APRIL 4, 2016 

Reported with an amendment 


sradovich on DSK3TPTVN1PROD with BILLS