[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