(1) establish goals, priorities, and metrics for 
evaluation for Federal neurotechnology research, de-
velopment, 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 In-
stitutes 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 so-
cial, ethical, and legal aspects of neurotechnology. 
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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 activi-
ties among the Department of Health and Human 
Services, the National Institutes of Health, the Food 
and Drug Administration, the Department of De-
fense, 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 pro-
grams, interested citizen groups, and others to facili-
tate the exchange of technical and programmatic in-
formation; 
(3) conduct public outreach, including dissemi-
nation of findings and recommendations of the Na-
tional Neurotechnology Advisory Council established 
under subsection (c), as appropriate; 
(4) promote access to, and the early application 
of, the technologies, innovations, and expertise de-
rived from activities conducted under the Initiative 
by agencies and systems across the Federal Govern-
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ment, 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 sub-
mit to the Secretary a report on the status of the Initia-
tive. 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 bench-
marks for the following year. The Secretary shall transmit 
a copy of each report under this subsection to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate. 
(c) ADVISORY COUNCIL.— 
(1) IN GENERAL.—The Secretary shall estab-
lish, 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 aca-
demic institutions, not-for-profit organizations, 
and industry. 
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(B) REQUIREMENTS.—Members of the Ad-
visory Council shall be qualified to provide ad-
vice and information on neurotechnology re-
search, development, demonstrations, education, 
technology transfer, commercial application, de-
livery, access, or ethical, legal, and social issues 
related to neurotechnology. 
(C) RECOMMENDATIONS.—In appointing 
members to, or designating an entity as, an Ad-
visory 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 aca-
demia), the defense community, State and local 
governments, regional neurotechnology pro-
grams, and other appropriate organizations. 
(3) DUTIES.—The Advisory Council shall pro-
vide advice to the Director of the National 
Neurotechnology Coordination Office on matters re-
lating to the Initiative, including assessing— 
(A) 
trends 
and 
developments 
in 
neurotechnology and related fields; 
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(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, imple-
mentation, 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 appro-
priated 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. 
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SEC. 6. PROGRAMS RELATED TO THE NATIONAL INSTI-
TUTES 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 neuro-
science research within the National Institutes of Health. 
Such program shall— 
(1) identify pervasive challenges in neuroscience 
and any technological barriers to solving such chal-
lenges; and 
(2) support the development of new tools, train-
ing 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 Inno-
vation Research Program, the directors of each of the in-
stitutes of the National Institutes of Health shall— 
(1) where appropriate, give high priority to 
small business concerns that participate in or con-
duct neurotechnology research and development 
projects; and 
(2) annually report to the Director of the Na-
tional Neurotechnology Coordination Office con-
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cerning 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 Tech-
nology Transfer Program, the directors of each of the in-
stitutes of the National Institutes of Health shall— 
(1) where appropriate, give high priority to 
small business concerns that participate in or con-
duct neurotechnology research and development 
projects; and 
(2) annually report to the Director of the Na-
tional Neurotechnology Coordination Office con-
cerning the percentage of Small Business Tech-
nology Transfer funding being used for such 
projects. 
(d) AUTHORIZATION OF APPROPRIATIONS.— 
(1) 
BLUEPRINT
FOR
NEUROSCIENCE
RE-
SEARCH.—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.— 
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(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 au-
thorized by this paragraph may be counted to-
ward the expenditure amounts required by sub-
sections (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 AD-
MINISTRATION. 
(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 psy-
chiatry by— 
(1) increasing, through recruitment and train-
ing, the number of qualified staff within such Cen-
ters; and 
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(2) improving the processes for creating guide-
lines 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 stand-
ards 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 appro-
priated to carry out subsection (b) $4,000,000 for 
each of fiscal years 2009, 2010, 2011, and 2012. 
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SEC. 8. PROGRAMS RELATED TO ETHICAL, LEGAL, AND SO-
CIAL ISSUES. 
(a) AMERICAN NEUROTECHNOLOGY STUDY CEN-
TER.—The Director of the National Neurotechnology Co-
ordination Office shall— 
(1) provide for the establishment, on a merit-re-
viewed and competitive basis, of an American 
Neurotechnology Study Center that shall— 
(A) establish a research program to iden-
tify ethical, legal, and social issues related to 
neurotechnology and related fields, and ensure 
that the results of such research are widely dis-
seminated; and 
(B) conduct, coordinate, collect, and dis-
seminate 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 con-
ferences, and educational events, as appropriate. 
(b) STUDY ON THE RESPONSIBLE DEVELOPMENT OF 
NEUROTECHNOLOGY.—The American Neurotechnology 
Study Center established under subsection (a) shall con-
duct a study to assess the need for standards, guidelines, 
or strategies for ensuring the responsible development of 
neurotechnology, including— 
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(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 enhance-
ment of human intelligence; 
(4) the development of defensive technologies 
relating to neurotechnology; 
(5) the use of neurotechnology in developing ar-
tificial 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 develop-
ment in neurotechnology. 
(c) 
STUDY
ON
THE
ECONOMIC
IMPACT
OF 
NEUROTECHNOLOGY.—The Director of the National 
Neurotechnology Coordination Office shall, on a merit-re-
viewed 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; 
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(3) national and regional neurotechnology as-
sets; 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
DEVELOP-
MENT 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). 
Æ 
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