S AMDT 586

S 586 IS

To direct the Secretary of Health and Human Services to implement a National Neurotechnology Initiative, and for other purposes.

March 12, 2009

Mrs. MURRAY introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

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.