[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 586 Introduced in Senate (IS)]
111th CONGRESS
1st Session
S. 586
To direct the Secretary of Health and Human Services to implement a
National Neurotechnology Initiative, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 12, 2009
Mrs. Murray introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To direct the Secretary of Health and Human Services to implement a
National Neurotechnology Initiative, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Neurotechnology Initiative
Act''.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) While the field of neuroscience is highly advanced, our
understanding of how the brain works still has many gaps and
our ability to repair damage remains limited.
(2) Nearly 100,000,000 Americans suffer from a brain or
nervous system disease, injury, or disorder, and the national
economic burden of such brain-related illnesses has reached
more than $1,000,000,000,000 per year and is growing alarmingly
due to an aging population.
(3) Critical unmet medical needs exist in almost every area
of brain and nervous system disorders, including Alzheimer's
disease, addiction, anxiety, chronic pain, depression,
epilepsy, hearing loss, multiple sclerosis, obesity,
Parkinson's disease, schizophrenia, sleep, spinal cord injury,
stroke, traumatic brain injury, and more.
(4) While the science of the brain is moving forward more
rapidly than any other science today, we must ensure these
discoveries quickly become tools to improve the human
condition.
(5) Neurotechnology has the potential to transform nearly
every aspect of our lives from medicine to defense to education
to computing, as well as our conception of the human mind.
(6) A global race is underway to determine the country that
will lead the neurotechnology economy, which will have long-
lasting implications for employment, infrastructure
development, and regional competitiveness.
(7) Federal leadership is needed to accelerate and
coordinate the development of neurotechnology and bring the
benefits to those in need across the Nation.
(8) Therefore, it is in the national interest for the
Federal Government to increase investment and interagency
coordination of Federal neurotechnology research, development,
and commercialization programs.
SEC. 3. DEFINITIONS.
In this Act:
(1) Initiative.--The term ``Initiative'' means the National
Neurotechnology Initiative implemented under section 4.
(2) Neurotechnology.--The term ``neurotechnology'' means
the science and technology that allows an individual to
analyze, understand, treat, and heal the brain and nervous
system.
(3) Qualified staff.--The term ``qualified staff'' means a
Food and Drug Administration employee who has academic training
or significant experience in neurotechnology or related fields,
or who has satisfactorily completed a Food and Drug
Administration neuroscience training course.
(4) Related fields.--The term ``related fields'' means
neuroscience, neuromedicine, cognitive science, behavioral
psychology, neuropharmacology, neuropsychiatry, neuroimaging,
neuroregeneration, neurorehabilitation, neuromodulation,
neurostimulation, biomedical engineering, bioengineering,
molecular biology, computer science, robotics, and such other
fields as the Director of the National Neurotechnology
Coordinating Office determines to be related to
neurotechnology.
(5) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(6) Translational.--The term ``translational'' means
relating to research that is focused on converting laboratory
findings into patient treatments.
SEC. 4. NATIONAL NEUROTECHNOLOGY INITIATIVE.
(a) In General.--The Secretary shall implement a National
Neurotechnology Initiative under which, acting through appropriate
agencies, councils, and the National Neurotechnology Coordination
Office established pursuant to section 5, the Secretary shall--
(1) establish goals, priorities, and metrics for evaluation
for Federal neurotechnology research, development,
commercialization, and other activities;
(2) increase the investment in Federal research,
development, and translational programs in neurotechnology, and
related fields as appropriate, to achieve the goals described
in paragraph (1); and
(3) increase interagency coordination of Federal
neurotechnology research, development, and other activities
undertaken pursuant to the Initiative.
(b) Areas of Concentration.--The Initiative shall--
(1) coordinate, support, and extend the neurotechnology-
related activities of the National Institutes of Health and the
work of the Blueprint for Neuroscience Research developed under
section 6(a);
(2) coordinate and promote neuroscience small business
innovation research programs;
(3) facilitate testing and evaluation of advances in
neuromedicine, including drugs, diagnostics, and devices; and
(4) coordinate and promote the study of the social,
ethical, and legal aspects of neurotechnology.
SEC. 5. COORDINATION.
(a) In General.--The Secretary shall establish a National
Neurotechnology Coordination Office, to be headed by a director to be
appointed by the Secretary, that shall--
(1) coordinate Federal neurotechnology activities among the
Department of Health and Human Services, the National
Institutes of Health, the Food and Drug Administration, the
Department of Defense, the Department of Veterans Affairs, and
other Federal agencies;
(2) serve as the point of contact on Federal
neurotechnology activities for academia, industry, professional
societies, State neurotechnology programs, interested citizen
groups, and others to facilitate the exchange of technical and
programmatic information;
(3) conduct public outreach, including dissemination of
findings and recommendations of the National Neurotechnology
Advisory Council established under subsection (c), as
appropriate;
(4) promote access to, and the early application of, the
technologies, innovations, and expertise derived from
activities conducted under the Initiative by agencies and
systems across the Federal Government, and by United States
industry, including start-up companies; and
(5) provide technical and administrative support to the
National Neurotechnology Advisory Council.
(b) Report.--The Director of the National Neurotechnology
Coordination Office shall annually submit to the Secretary a report on
the status of the Initiative. Such reports shall contain the results of
an evaluation of the effectiveness of the Initiative in the year for
which the report is being prepared and the goals and benchmarks for the
following year. The Secretary shall transmit a copy of each report
under this subsection to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate.
(c) Advisory Council.--
(1) In general.--The Secretary shall establish, or
designate an existing entity as, a National Neurotechnology
Advisory Council.
(2) Qualifications.--
(A) In general.--The Advisory Council shall consist
primarily of members from academic institutions, not-
for-profit organizations, and industry.
(B) Requirements.--Members of the Advisory Council
shall be qualified to provide advice and information on
neurotechnology research, development, demonstrations,
education, technology transfer, commercial application,
delivery, access, or ethical, legal, and social issues
related to neurotechnology.
(C) Recommendations.--In appointing members to, or
designating an entity as, an Advisory Council, the
Secretary may seek and give consideration to
recommendations from the Congress, industry, the
scientific and medical communities (including the
National Academy of Sciences, scientific and medical
professional societies, not-for-profit organizations,
and academia), the defense community, State and local
governments, regional neurotechnology programs, and
other appropriate organizations.
(3) Duties.--The Advisory Council shall provide advice to
the Director of the National Neurotechnology Coordination
Office on matters relating to the Initiative, including
assessing--
(A) trends and developments in neurotechnology and
related fields;
(B) progress made in implementing the Initiative;
(C) the need to revise the Initiative;
(D) the balance among the components of the
Initiative, including funding levels for the program
component areas;
(E) whether the program component areas,
priorities, and technical goals developed by the
Council are helping to maintain United States
leadership in neurotechnology and related fields;
(F) the management, coordination, implementation,
and activities of the Initiative; and
(G) whether ethical, legal, and social issues are
adequately addressed by the Initiative.
(d) Authorization of Appropriations.--
(1) Office.--There is authorized to be appropriated to
carry out subsections (a) and (b) $4,000,000 for each of fiscal
years 2010, 2011, 2012, and 2013.
(2) Advisory council.--There is authorized to be
appropriated to carry out subsection (c) $1,000,000 for each of
fiscal years 2010, 2011, 2012, and 2013.
SEC. 6. PROGRAMS RELATED TO THE NATIONAL INSTITUTES OF HEALTH.
(a) Blueprint for Neuroscience Research.--The Director of the
National Institutes of Health shall develop a program or designate an
existing program, to be known as the Blueprint for Neuroscience
Research, for collaboration among the institutes, centers, and offices
of the National Institutes of Health that support neuroscience research
within the National Institutes of Health. Such program shall--
(1) identify pervasive challenges in neuroscience and any
technological barriers to solving such challenges; and
(2) support the development of new tools, training
opportunities, and other resources to assist neuroscientists in
both basic and clinical research.
(b) Small Business Innovation Research.--In carrying out their
duties under the Small Business Innovation Research Program, the
directors of each of the institutes of the National Institutes of
Health shall--
(1) where appropriate, give high priority to small business
concerns that participate in or conduct neurotechnology
research and development projects; and
(2) annually report to the Director of the National
Neurotechnology Coordination Office concerning the percentage
of Small Business Innovation Research funding being used for
such projects.
(c) Small Business Technology Transfer.--In carrying out their
duties under the Small Business Technology Transfer Program, the
directors of each of the institutes of the National Institutes of
Health shall--
(1) where appropriate, give high priority to small business
concerns that participate in or conduct neurotechnology
research and development projects; and
(2) annually report to the Director of the National
Neurotechnology Coordination Office concerning the percentage
of Small Business Technology Transfer funding being used for
such projects.
(d) Authorization of Appropriations.--
(1) Blueprint for neuroscience research.--There are
authorized to be appropriated to carry out subsection (a)--
(A) $80,000,000 for fiscal year 2010;
(B) $88,000,000 for fiscal year 2011;
(C) $96,800,000 for fiscal year 2012; and
(D) $106,480,000 for fiscal year 2013.
(2) Small business innovation research and small business
technology transfer.--
(A) In general.--There are authorized to be
appropriated to carry out subsections (b) and (c)--
(i) $75,000,000 for fiscal year 2010;
(ii) $82,500,000 for fiscal year 2011;
(iii) $90,750,000 for fiscal year 2012; and
(iv) $99,825,000 for fiscal year 2013.
(B) Limitation.--None of the funding authorized by
this paragraph may be counted toward the expenditure
amounts required by subsections (f) and (n) of section
9 of the Small Business Act (15 U.S.C. 638).
SEC. 7. PROGRAMS RELATED TO THE FOOD AND DRUG ADMINISTRATION.
(a) FDA Review.--The Commissioner of Food and Drugs shall direct
the Director of the Center for Drug Evaluation and Research, the
Director of the Center for Biologics Evaluation and Research, and the
Director of the Center for Devices and Radiological Health to improve
the timeliness of the review process for neurology and psychiatry by--
(1) increasing, through recruitment and training, the
number of qualified staff within such Centers; and
(2) improving the processes for creating guidelines with
respect to neurology and psychiatry and communicating those
guidelines to industry.
(b) Neurotechnology Standards Workgroups.--The Commissioner of Food
and Drugs shall sponsor workgroups including academic and industry
representatives to develop standards for preclinical testing and
clinical trial endpoints for emerging brain and nervous system
indications for which clear and achievable standards do not otherwise
exist on the date of the enactment of this Act.
(c) Authorization of Appropriations.--
(1) FDA review.--There are authorized to be appropriated to
carry out subsection (a)--
(A) $26,000,000 for fiscal year 2010;
(B) $28,600,000 for fiscal year 2011;
(C) $31,460,000 for fiscal year 2012; and
(D) $34,606,000 for fiscal year 2013.
(2) Neurotechnology standards workgroups.--There is
authorized to be appropriated to carry out subsection (b)
$4,000,000 for each of fiscal years 2010, 2011, 2012, and 2013.
SEC. 8. PROGRAMS RELATED TO ETHICAL, LEGAL, AND SOCIAL ISSUES.
(a) American Neurotechnology Study Center.--The Director of the
National Neurotechnology Coordination Office shall--
(1) provide for the establishment, on a merit-reviewed and
competitive basis, of an American Neurotechnology Study Center
that shall--
(A) establish a research program to identify
ethical, legal, and social issues related to
neurotechnology and related fields, and ensure that the
results of such research are widely disseminated; and
(B) conduct, coordinate, collect, and disseminate
studies on such issues; and
(2) provide for public input and outreach to be integrated
into the Initiative by the convening of regular and ongoing
public discussions, through mechanisms such as citizens'
panels, consensus conferences, and educational events, as
appropriate.
(b) Study on the Responsible Development of Neurotechnology.--The
American Neurotechnology Study Center established under subsection (a)
shall conduct a study to assess the need for standards, guidelines, or
strategies for ensuring the responsible development of neurotechnology,
including--
(1) the safety of use of brain interface devices;
(2) human subject guidelines for research and development
of neurotechnology;
(3) the use of neurotechnology in the enhancement of human
intelligence;
(4) the development of defensive technologies relating to
neurotechnology;
(5) the use of neurotechnology in developing artificial
intelligence;
(6) the potential to ease the health care burden through
use of neurotechnology; and
(7) the development of appropriate ethical standards and
guidelines for research and development in neurotechnology.
(c) Study on the Economic Impact of Neurotechnology.--The Director
of the National Neurotechnology Coordination Office shall, on a merit-
reviewed and competitive basis, provide for the conduct of an annual
study to assess the need for analyses, programs, reports, or strategies
for ensuring the development of neurotechnology, including analyzing--
(1) the economic burden of brain and nervous system
disorders and illness;
(2) the economic growth potential of neurotechnology;
(3) national and regional neurotechnology assets; and
(4) global neurotechnology assets.
(d) Authorization of Appropriations.--
(1) In general.--There is authorized to be appropriated to
carry out subsections (a) and (b) $8,000,000 for each of fiscal
years 2010, 2011, 2012, and 2013.
(2) Study on the responsible development of
neurotechnology.--There is authorized to be appropriated to
carry out subsection (c) $2,000,000 for each of fiscal years
2010, 2011, 2012, and 2013.
(3) Limitation.--No more than $250,000 per fiscal year
shall be used to carry out subsection (a)(2).
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