[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5989 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 5989

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 7, 2008

Mr. Kennedy (for himself and Ms. Ros-Lehtinen) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 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 
        over $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 the brain and nervous system, 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 holds 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 on 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 2009, 2010, 2011, and 2012.
            (2) Advisory council.--There is authorized to be 
        appropriated to carry out subsection (c) $1,000,000 for each of 
        fiscal years 2009, 2010, 2011, and 2012.

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 2009;
                    (B) $88,000,000 for fiscal year 2010;
                    (C) $96,800,000 for fiscal year 2011; and
                    (D) $106,480,000 for fiscal year 2012.
            (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 2009;
                            (ii) $82,500,000 for fiscal year 2010;
                            (iii) $90,750,000 for fiscal year 2011; and
                            (iv) $99,825,000 for fiscal year 2012.
                    (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 2009;
                    (B) $28,600,000 for fiscal year 2010;
                    (C) $31,460,000 for fiscal year 2011; and
                    (D) $34,606,000 for fiscal year 2012.
            (2) Neurotechnology standards workgroups.--There is 
        authorized to be appropriated to carry out subsection (b) 
        $4,000,000 for each of fiscal years 2009, 2010, 2011, and 2012.

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 subsection (a) and (b) $8,000,000 for each of fiscal 
        years 2009, 2010, 2011, and 2012.
            (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 
        2009, 2010, 2011, and 2012.
            (3) Limitation.--No more than $250,000 per fiscal year 
        shall be used to carry out subsection (a)(2).
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