I 

111TH CONGRESS 

1ST SESSION H. R. 1483 

To direct the Secretary of Health and Human Services to implement a 

National Neurotechnology Initiative, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 12, 2009 

Mr. KENNEDY (for himself, Ms. ROS-LEHTINEN, Mr. FILNER, and Mr. WU) 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National 

5 Neurotechnology Initiative Act’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 

8 (1) While the field of neuroscience is highly ad9 vanced, our understanding of how the brain works 


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1 still has many gaps and our ability to repair damage 

2 remains limited. 

3 (2) Nearly 100,000,000 Americans suffer from 

4 a brain or nervous system disease, injury, or dis5 order, and the national economic burden of such 

6 brain-related illnesses has reached over 

7 $1,000,000,000,000 per year and is growing alarm8 ingly due to an aging population. 

9 (3) Critical unmet medical needs exist in almost 

10 every area of the brain and nervous system, includ11 ing Alzheimer’s disease, addiction, anxiety, chronic 

12 pain, depression, epilepsy, hearing loss, multiple 

13 sclerosis, obesity, Parkinson’s disease, schizophrenia, 

14 sleep, spinal cord injury, stroke, traumatic brain in15 jury, and more. 

16 (4) While the science of the brain is moving for17 ward more rapidly than any other science today, we 

18 must ensure these discoveries quickly become tools 

19 to improve the human condition. 

20 (5) Neurotechnology holds the potential to 

21 transform nearly every aspect of our lives from med22 icine to defense to education to computing, as well 

23 as our conception of the human mind. 

24 (6) A global race is underway to determine the 

25 country that will lead the neurotechnology economy, 


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1 which will have long-lasting implications on employ2 ment, infrastructure development, and regional com3 petitiveness. 

4 (7) Federal leadership is needed to accelerate 

5 and coordinate the development of neurotechnology 

6 and bring the benefits to those in need across the 

7 Nation. 

8 (8) Therefore, it is in the national interest for 

9 the Federal Government to increase investment and 

10 interagency coordination of Federal neurotechnology 

11 research, development, and commercialization pro12 grams. 

13 SEC. 3. DEFINITIONS. 

14 In this Act: 

15 (1) INITIATIVE.—The term ‘‘Initiative’’ means 

16 the National Neurotechnology Initiative implemented 

17 under section 4. 

18 (2) NEUROTECHNOLOGY.—The term ‘‘neuro19 technology’’ means the science and technology that 

20 allows an individual to analyze, understand, treat, 

21 and heal the brain and nervous system. 

22 (3) QUALIFIED STAFF.—The term ‘‘qualified 

23 staff’’ means a Food and Drug Administration em24 ployee who has academic training or significant ex25 perience in neurotechnology or related fields, or who 


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1 has satisfactorily completed a Food and Drug Ad2 ministration neuroscience training course. 

3 (4) RELATED FIELDS.—The term ‘‘related 

4 fields’’ means neuroscience, neuromedicine, cognitive 

5 science, behavioral psychology, neuropharmacology, 

6 neuropsychiatry, neuroimaging, neuroregeneration, 

7 neurorehabilitation, neuromodulation, neurostimula8 tion, biomedical engineering, bioengineering, molec9 ular biology, computer science, robotics, and such 

10 other fields as the Director of the National Neuro11 technology Coordinating Office determines to be re12 lated to neurotechnology. 

13 (5) SECRETARY.—The term ‘‘Secretary’’ means 

14 the Secretary of Health and Human Services. 

15 (6) TRANSLATIONAL.—The term ‘‘translation16 al’’ means relating to research that is focused on 

17 converting laboratory findings into patient treat18 ments. 

19 SEC. 4. NATIONAL NEUROTECHNOLOGY INITIATIVE. 

20 (a) IN GENERAL.—The Secretary shall implement a 

21 National Neurotechnology Initiative under which, acting 

22 through appropriate agencies, councils, and the National 

23 Neurotechnology Coordination Office established pursuant 

24 to section 5, the Secretary shall— 


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1 (1) establish goals, priorities, and metrics for 

2 evaluation for Federal neurotechnology research, de3 velopment, commercialization, and other activities; 

4 (2) increase the investment in Federal research, 

5 development, and translational programs in 

6 neurotechnology, and related fields as appropriate, 

7 to achieve the goals described in paragraph (1); and 

8 (3) increase interagency coordination of Federal 

9 neurotechnology research, development, and other 

10 activities undertaken pursuant to the Initiative. 

11 (b) AREAS OF CONCENTRATION.—The Initiative 

12 shall— 

13 (1) coordinate, support, and extend the 

14 neurotechnology-related activities of the National In15 stitutes of Health and the work of the Blueprint for 

16 Neuroscience Research developed under section 6(a); 

17 (2) coordinate and promote neuroscience small 

18 business innovation research programs; 

19 (3) facilitate testing and evaluation of advances 

20 in neuromedicine, including drugs, diagnostics, and 

21 devices; and 

22 (4) coordinate and promote the study of the so23 cial, ethical, and legal aspects of neurotechnology. 


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1 SEC. 5. COORDINATION. 

2 (a) IN GENERAL.—The Secretary shall establish a 

3 National Neurotechnology Coordination Office, to be 

4 headed by a director to be appointed by the Secretary, 

5 that shall— 

6 (1) coordinate Federal neurotechnology activi7 ties among the Department of Health and Human 

8 Services, the National Institutes of Health, the Food 

9 and Drug Administration, the Department of De10 fense, the Department of Veterans Affairs, and 

11 other Federal agencies; 

12 (2) serve as the point of contact on Federal 

13 neurotechnology activities for academia, industry, 

14 professional societies, State neurotechnology pro15 grams, interested citizen groups, and others to facili16 tate the exchange of technical and programmatic in17 formation; 

18 (3) conduct public outreach, including dissemi19 nation of findings and recommendations of the Na20 tional Neurotechnology Advisory Council established 

21 under subsection (c), as appropriate; 

22 (4) promote access to, and the early application 

23 of, the technologies, innovations, and expertise de24 rived from activities conducted under the Initiative 

25 by agencies and systems across the Federal GovernVerDate Nov 24 2008 02:24 Mar 14, 2009 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1483.IH H1483

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1 ment, and by United States industry, including 

2 start-up companies; and 

3 (5) provide technical and administrative support 

4 to the National Neurotechnology Advisory Council. 

5 (b) REPORT.—The Director of the National 

6 Neurotechnology Coordination Office shall annually sub7 mit to the Secretary a report on the status of the Initia8 tive. Such reports shall contain the results of an evaluation 

9 of the effectiveness of the Initiative in the year for which 

10 the report is being prepared and the goals and bench11 marks for the following year. The Secretary shall transmit 

12 a copy of each report under this subsection to the Com13 mittee on Energy and Commerce of the House of Rep14 resentatives and the Committee on Health, Education, 

15 Labor, and Pensions of the Senate. 

16 (c) ADVISORY COUNCIL.— 

17 (1) IN GENERAL.—The Secretary shall estab18 lish, or designate an existing entity as, a National 

19 Neurotechnology Advisory Council. 

20 (2) QUALIFICATIONS.— 

21 (A) IN GENERAL.—The Advisory Council 

22 shall consist primarily of members from aca23 demic institutions, not-for-profit organizations, 

24 and industry. 


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1 (B) REQUIREMENTS.—Members of the Ad2 visory Council shall be qualified to provide ad3 vice and information on neurotechnology re4 search, development, demonstrations, education, 

5 technology transfer, commercial application, de6 livery, access, or ethical, legal, and social issues 

7 related to neurotechnology. 

8 (C) RECOMMENDATIONS.—In appointing 

9 members to, or designating an entity as, an Ad10 visory Council, the Secretary may seek and give 

11 consideration to recommendations from the 

12 Congress, industry, the scientific and medical 

13 communities (including the National Academy 

14 of Sciences, scientific and medical professional 

15 societies, not-for-profit organizations, and aca16 demia), the defense community, State and local 

17 governments, regional neurotechnology pro18 grams, and other appropriate organizations. 

19 (3) DUTIES.—The Advisory Council shall pro20 vide advice to the Director of the National 

21 Neurotechnology Coordination Office on matters re22 lating to the Initiative, including assessing— 

23 (A) trends and developments in 

24 neurotechnology and related fields; 


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1 (B) progress made in implementing the 

2 Initiative; 

3 (C) the need to revise the Initiative; 

4 (D) the balance among the components of 

5 the Initiative, including funding levels for the 

6 program component areas; 

7 (E) whether the program component areas, 

8 priorities, and technical goals developed by the 

9 Council are helping to maintain United States 

10 leadership in neurotechnology and related fields; 

11 (F) the management, coordination, imple12 mentation, and activities of the Initiative; and 

13 (G) whether ethical, legal, and social issues 

14 are adequately addressed by the Initiative. 

15 (d) AUTHORIZATION OF APPROPRIATIONS.— 

16 (1) OFFICE.—There is authorized to be appro17 priated to carry out subsections (a) and (b) 

18 $4,000,000 for each of fiscal years 2010, 2011, 

19 2012, and 2013. 

20 (2) ADVISORY COUNCIL.—There is authorized 

21 to be appropriated to carry out subsection (c) 

22 $1,000,000 for each of fiscal years 2010, 2011, 

23 2012, and 2013. 


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1 SEC. 6. PROGRAMS RELATED TO THE NATIONAL INSTI2 TUTES OF HEALTH. 

3 (a) BLUEPRINT FOR NEUROSCIENCE RESEARCH.— 

4 The Director of the National Institutes of Health shall 

5 develop a program or designate an existing program, to 

6 be known as the Blueprint for Neuroscience Research, for 

7 collaboration among the institutes, centers, and offices of 

8 the National Institutes of Health that support neuro9 science research within the National Institutes of Health. 

10 Such program shall— 

11 (1) identify pervasive challenges in neuroscience 

12 and any technological barriers to solving such chal13 lenges; and 

14 (2) support the development of new tools, train15 ing opportunities, and other resources to assist 

16 neuroscientists in both basic and clinical research. 

17 (b) SMALL BUSINESS INNOVATION RESEARCH.—In 

18 carrying out their duties under the Small Business Inno19 vation Research Program, the directors of each of the in20 stitutes of the National Institutes of Health shall— 

21 (1) where appropriate, give high priority to 

22 small business concerns that participate in or con23 duct neurotechnology research and development 

24 projects; and 

25 (2) annually report to the Director of the Na26 tional Neurotechnology Coordination Office conVerDate Nov 24 2008 02:24 Mar 14, 2009 Jkt 079200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1483.IH H1483

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1 cerning the percentage of Small Business Innovation 

2 Research funding being used for such projects. 

3 (c) SMALL BUSINESS TECHNOLOGY TRANSFER.—In 

4 carrying out their duties under the Small Business Tech5 nology Transfer Program, the directors of each of the in6 stitutes of the National Institutes of Health shall— 

7 (1) where appropriate, give high priority to 

8 small business concerns that participate in or con9 duct neurotechnology research and development 

10 projects; and 

11 (2) annually report to the Director of the Na12 tional Neurotechnology Coordination Office con13 cerning the percentage of Small Business Tech14 nology Transfer funding being used for such 

15 projects. 

16 (d) AUTHORIZATION OF APPROPRIATIONS.— 

17 (1) BLUEPRINT FOR NEUROSCIENCE RE18 SEARCH.—There are authorized to be appropriated 

19 to carry out subsection (a)— 

20 (A) $80,000,000 for fiscal year 2010; 

21 (B) $88,000,000 for fiscal year 2011; 

22 (C) $96,800,000 for fiscal year 2012; and 

23 (D) $106,480,000 for fiscal year 2013. 

24 (2) SMALL BUSINESS INNOVATION RESEARCH

25 AND SMALL BUSINESS TECHNOLOGY TRANSFER.— 


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1 (A) IN GENERAL.—There are authorized to 

2 be appropriated to carry out subsections (b) 

3 and (c)— 

4 (i) $75,000,000 for fiscal year 2010; 

5 (ii) $82,500,000 for fiscal year 2011; 

6 (iii) $90,750,000 for fiscal year 2012; 

7 and 

8 (iv) $99,825,000 for fiscal year 2013. 

9 (B) LIMITATION.—None of the funding au10 thorized by this paragraph may be counted to11 ward the expenditure amounts required by sub12 sections (f) and (n) of section 9 of the Small 

13 Business Act (15 U.S.C. 638). 

14 SEC. 7. PROGRAMS RELATED TO THE FOOD AND DRUG AD15 MINISTRATION. 

16 (a) FDA REVIEW.—The Commissioner of Food and 

17 Drugs shall direct the Director of the Center for Drug 

18 Evaluation and Research, the Director of the Center for 

19 Biologics Evaluation and Research, and the Director of 

20 the Center for Devices and Radiological Health to improve 

21 the timeliness of the review process for neurology and psy22 chiatry by— 

23 (1) increasing, through recruitment and train24 ing, the number of qualified staff within such Cen25 ters; and 


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1 (2) improving the processes for creating guide2 lines with respect to neurology and psychiatry and 

3 communicating those guidelines to industry. 

4 (b) NEUROTECHNOLOGY STANDARDS

5 WORKGROUPS.—The Commissioner of Food and Drugs 

6 shall sponsor workgroups including academic and industry 

7 representatives to develop standards for preclinical testing 

8 and clinical trial endpoints for emerging brain and nervous 

9 system indications for which clear and achievable stand10 ards do not otherwise exist on the date of the enactment 

11 of this Act. 

12 (c) AUTHORIZATION OF APPROPRIATIONS.— 

13 (1) FDA REVIEW.—There are authorized to be 

14 appropriated to carry out subsection (a)— 

15 (A) $26,000,000 for fiscal year 2010; 

16 (B) $28,600,000 for fiscal year 2011; 

17 (C) $31,460,000 for fiscal year 2012; and 

18 (D) $34,606,000 for fiscal year 2013. 

19 (2) NEUROTECHNOLOGY STANDARDS

20 WORKGROUPS.—There is authorized to be appro21 priated to carry out subsection (b) $4,000,000 for 

22 each of fiscal years 2010, 2011, 2012, and 2013. 


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1 SEC. 8. PROGRAMS RELATED TO ETHICAL, LEGAL, AND SO2 CIAL ISSUES. 

3 (a) AMERICAN NEUROTECHNOLOGY STUDY CEN4 TER.—The Director of the National Neurotechnology Co5 ordination Office shall— 

6 (1) provide for the establishment, on a merit-re7 viewed and competitive basis, of an American 

8 Neurotechnology Study Center that shall— 

9 (A) establish a research program to iden10 tify ethical, legal, and social issues related to 

11 neurotechnology and related fields, and ensure 

12 that the results of such research are widely dis13 seminated; and 

14 (B) conduct, coordinate, collect, and dis15 seminate studies on such issues; and 

16 (2) provide for public input and outreach to be 

17 integrated into the Initiative by the convening of 

18 regular and ongoing public discussions, through 

19 mechanisms such as citizens’ panels, consensus con20 ferences, and educational events, as appropriate. 

21 (b) STUDY ON THE RESPONSIBLE DEVELOPMENT OF

22 NEUROTECHNOLOGY.—The American Neurotechnology 

23 Study Center established under subsection (a) shall con24 duct a study to assess the need for standards, guidelines, 

25 or strategies for ensuring the responsible development of 

26 neurotechnology, including— 


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1 (1) the safety of use of brain interface devices; 

2 (2) human subject guidelines for research and 

3 development of neurotechnology; 

4 (3) the use of neurotechnology in the enhance5 ment of human intelligence; 

6 (4) the development of defensive technologies 

7 relating to neurotechnology; 

8 (5) the use of neurotechnology in developing ar9 tificial intelligence; 

10 (6) the potential to ease the health care burden 

11 through use of neurotechnology; and 

12 (7) the development of appropriate ethical 

13 standards and guidelines for research and develop14 ment in neurotechnology. 

15 (c) STUDY ON THE ECONOMIC IMPACT OF

16 NEUROTECHNOLOGY.—The Director of the National 

17 Neurotechnology Coordination Office shall, on a merit-re18 viewed and competitive basis, provide for the conduct of 

19 an annual study to assess the need for analyses, programs, 

20 reports, or strategies for ensuring the development of 

21 neurotechnology, including analyzing— 

22 (1) the economic burden of brain and nervous 

23 system disorders and illness; 

24 (2) the economic growth potential of 

25 neurotechnology; 


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1 (3) national and regional neurotechnology as2 sets; and 

3 (4) global neurotechnology assets. 

4 (d) AUTHORIZATION OF APPROPRIATIONS.— 

5 (1) IN GENERAL.—There is authorized to be 

6 appropriated to carry out subsection (a) and (b) 

7 $8,000,000 for each of fiscal years 2010, 2011, 

8 2012, and 2013. 

9 (2) STUDY ON THE RESPONSIBLE DEVELOP10 MENT OF NEUROTECHNOLOGY.—There is authorized 

11 to be appropriated to carry out subsection (c) 

12 $2,000,000 for each of fiscal years 2010, 2011, 

13 2012, and 2013. 

14 (3) LIMITATION.—No more than $250,000 per 

15 fiscal year shall be used to carry out subsection 

16 (a)(2). 

Æ 


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