(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 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. 
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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 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.— 
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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 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 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 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 appro-
priated to carry out subsection (b) $4,000,000 for 
each of fiscal years 2010, 2011, 2012, and 2013. 
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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 2010, 2011, 
2012, and 2013. 
(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 2010, 2011, 
2012, and 2013. 
(3) LIMITATION.—No more than $250,000 per 
fiscal year shall be used to carry out subsection 
(a)(2). 
Æ 
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