[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 849 Reported in Senate (RS)]

<DOC>





                                                       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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Advancing Research for 
Neurological Diseases Act of 2015''.</DELETED>

<DELETED>SEC. 2. NATIONAL NEUROLOGICAL DISEASES SURVEILLANCE 
              SYSTEM.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 399V-6 SURVEILLANCE OF NEUROLOGICAL DISEASES.</DELETED>

<DELETED>    ``(a) In General.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall--
</DELETED>
        <DELETED>    ``(1) enhance and expand infrastructure and 
        activities to track the epidemiology of neurological diseases, 
        including multiple sclerosis and Parkinson's disease; 
        and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Content.--In carrying out subsection (a), the 
Secretary--</DELETED>
        <DELETED>    ``(1) shall provide for the collection and storage 
        of information on the incidence and prevalence of neurological 
        diseases in the United States;</DELETED>
        <DELETED>    ``(2) to the extent practicable, shall provide for 
        the collection and storage of other available information on 
        neurological diseases, such as information concerning--
        </DELETED>
                <DELETED>    ``(A) demographics and other information 
                associated or possibly associated with neurological 
                diseases, such as age, race, ethnicity, sex, geographic 
                location, and family history;</DELETED>
                <DELETED>    ``(B) risk factors associated or possibly 
                associated with neurological diseases, including 
                genetic and environmental risk factors; and</DELETED>
                <DELETED>    ``(C) diagnosis and progression 
                markers;</DELETED>
        <DELETED>    ``(3) may provide for the collection and storage 
        of information relevant to analysis on neurological diseases, 
        such as information concerning--</DELETED>
                <DELETED>    ``(A) the epidemiology of the 
                diseases;</DELETED>
                <DELETED>    ``(B) the natural history of the 
                diseases;</DELETED>
                <DELETED>    ``(C) the prevention of the 
                diseases;</DELETED>
                <DELETED>    ``(D) the detection, management, and 
                treatment approaches for the diseases; and</DELETED>
                <DELETED>    ``(E) the development of outcomes 
                measures; and</DELETED>
        <DELETED>    ``(4) may address issues identified during the 
        consultation process under subsection (d).</DELETED>
<DELETED>    ``(d) Consultation.--In carrying out this section, the 
Secretary shall consult with individuals with appropriate expertise, 
including--</DELETED>
        <DELETED>    ``(1) epidemiologists with experience in disease 
        surveillance or registries;</DELETED>
        <DELETED>    ``(2) representatives of national voluntary health 
        associations that--</DELETED>
                <DELETED>    ``(A) focus on neurological diseases, 
                including multiple sclerosis and Parkinson's disease; 
                and</DELETED>
                <DELETED>    ``(B) have demonstrated experience in 
                research, care, or patient services;</DELETED>
        <DELETED>    ``(3) health information technology experts or 
        other information management specialists;</DELETED>
        <DELETED>    ``(4) clinicians with expertise in neurological 
        diseases; and</DELETED>
        <DELETED>    ``(5) research scientists with experience 
        conducting translational research or utilizing surveillance 
        systems for scientific research purposes.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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)).</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) the development and maintenance of the 
        National Neurological Diseases Surveillance System;</DELETED>
        <DELETED>    ``(2) the type of information collected and stored 
        in the System;</DELETED>
        <DELETED>    ``(3) the use and availability of such 
        information, including guidelines for such use; and</DELETED>
        <DELETED>    ``(4) the use and coordination of databases that 
        collect or maintain information on neurological 
        diseases.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Advancing Research for Neurological 
Diseases Act of 2016''.

SEC. 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:

``SEC. 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.''.
                                                       Calendar No. 408

114th CONGRESS

  2d Session

                                 S. 849

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             April 4, 2016

                       Reported with an amendment