II Calendar No. 408 114th CONGRESS 2d Session S. 849 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. Short title This Act may be cited as the Advancing Research for Neurological Diseases Act of 2015 . 2. National neurological diseases surveillance system Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. ) is amended by adding at the end the following: 399V–6 Surveillance of neurological diseases (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall— (1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases, including multiple sclerosis and Parkinson’s disease; and (2) incorporate information obtained through such activities into a statistically sound, scientifically credible, integrated surveillance system, to be known as the National Neurological Diseases Surveillance System. (b) Research The Secretary shall ensure that the National Neurological Diseases Surveillance System is designed in a manner that facilitates further research on neurological diseases. (c) Content In carrying out subsection (a), the Secretary— (1) shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases in the United States; (2) to the extent practicable, shall provide for the collection and storage of other available information on neurological diseases, such as information concerning— (A) demographics and other information associated or possibly associated with neurological diseases, such as age, race, ethnicity, sex, geographic location, and family history; (B) risk factors associated or possibly associated with neurological diseases, including genetic and environmental risk factors; and (C) diagnosis and progression markers; (3) may provide for the collection and storage of information relevant to analysis on neurological diseases, such as information concerning— (A) the epidemiology of the diseases; (B) the natural history of the diseases; (C) the prevention of the diseases; (D) the detection, management, and treatment approaches for the diseases; and (E) the development of outcomes measures; and (4) may address issues identified during the consultation process under subsection (d). (d) Consultation In carrying out this section, the Secretary shall consult with individuals with appropriate expertise, including— (1) epidemiologists with experience in disease surveillance or registries; (2) representatives of national voluntary health associations that— (A) focus on neurological diseases, including multiple sclerosis and Parkinson’s disease; and (B) have demonstrated experience in research, care, or patient services; (3) health information technology experts or other information management specialists; (4) clinicians with expertise in neurological diseases; and (5) research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes. (e) Grants The Secretary may award grants to, or enter into contracts or cooperative agreements with, public or private nonprofit entities to carry out activities under this section. (f) Coordination with other Federal agencies Subject to subsection (h), the Secretary shall make information and analysis in the National Neurological Diseases Surveillance System available, as appropriate, to Federal departments and agencies, such as the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Veterans Affairs, and the Department of Defense. (g) Public access Subject to subsection (h), the Secretary shall make information and analysis in the National Neurological Diseases Surveillance System available, as appropriate, to the public, including researchers. (h) Privacy The Secretary shall ensure that privacy and security protections applicable to the National Neurological Diseases Surveillance System are at least as stringent as the privacy and security protections under HIPAA privacy and security law (as defined in section 3009(a)(2)). (i) Report Not later than 4 years after the date of the enactment of this section, the Secretary shall submit a report to the Congress concerning the implementation of this section. Such report shall include information on— (1) the development and maintenance of the National Neurological Diseases Surveillance System; (2) the type of information collected and stored in the System; (3) the use and availability of such information, including guidelines for such use; and (4) the use and coordination of databases that collect or maintain information on neurological diseases. (j) Definition In this section, the term national voluntary health association means a national nonprofit organization with chapters, other affiliated organizations, or networks in States throughout the United States. (k) Authorization of appropriations To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2015 through 2019. .

1. Short title This Act may be cited as the Advancing Research for Neurological Diseases Act of 2016 . 2. Advancing research for neurological diseases Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. ) is amended by inserting after section 399S, the following: 399S-1. Advancing research for neurological diseases (a) In general The Secretary may improve the collection of epidemiological and surveillance data on neurological diseases (including, for purposes of this section, both neurological diseases and neurological conditions), which may include the incorporation of such data into a registry, to facilitate research and improve public health, including, as appropriate, by leveraging existing surveillance activities and registries established under this Act. (b) Content In carrying out subsection (a), the Secretary— (1) shall provide for the collection and storage of information to better describe the incidence and prevalence of neurological diseases in the United States identified under paragraph (2); (2) shall initially identify and focus on up to five neurological diseases that available data indicate are the most prevalent or present a significant public health burden; (3) shall identify, build upon, leverage, and coordinate among existing data and surveillance systems, surveys, registries, and other existing Federal public health and infrastructure wherever possible; (4) shall ensure that any neurological disease surveillance activities conducted pursuant to this section, including any such registry, are designed in a manner that facilitates research on neurological diseases; (5) shall, to the extent practicable, provide for the collection and storage of information relevant to the identified neurological diseases, such as— (A) demographics, such as age, race, ethnicity, sex, geographic location, and family history, and other information, as appropriate; (B) risk factors that may be associated with certain neurological diseases; and (C) diagnosis and progression markers; (6) may provide for the collection and storage of additional information relevant to analysis on neurological diseases, such as information regarding— (A) the natural history of the diseases; (B) the prevention, detection, management, and treatments or treatment approaches for the diseases; and (C) the development of outcomes measures; and (7) may address issues identified during the consultation process described in subsection (c). (c) Consultation In carrying out this section, the Secretary shall consult with experts, who may include— (1) epidemiologists with experience in disease surveillance or registries; (2) representatives of national and voluntary health associations that focus on neurological diseases and have demonstrated experience in research, care, or patient services; (3) health information technology experts or other information management specialists; (4) clinicians with expertise in neurological diseases; and (5) research scientists with experience conducting translational research or utilizing surveillance systems or registries for scientific research purposes. (d) Grants The Secretary may award grants to, or enter into contracts or cooperative agreements with, public or private nonprofit entities to carry out activities under this section. (e) Coordination with other federal agencies Consistent with applicable privacy laws, the Secretary shall make information and analysis pertaining to information collected under this section available, as appropriate, to relevant Federal departments and agencies. (f) Access for biomedical research The Secretary shall make data collected under this section available for purposes of biomedical research as determined appropriate by the Secretary, to the extent permitted by applicable laws, and in a manner that protects personal privacy. (g) Reports (1) Interim report Not later than 1 year after the date on which any registry is established and operational under this section, the Secretary shall submit an interim report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding aggregate information collected pursuant to this section and epidemiological analyses, as appropriate. Such report shall be posted on the Internet website of the Department of Health and Human Services and shall be updated biennially thereafter. (2) Implementation report Not later than 4 years after the date of the enactment of this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding the implementation of this section. Such report shall include information on— (A) the development and maintenance of any means of collecting neurological disease surveillance information gathered pursuant to this section; (B) the type of information collected and stored; (C) the use and availability of such information, including guidelines for such use; and (D) the use and coordination of databases that collect or maintain information on neurological diseases. .

April 4, 2016 Reported with an amendment