I 
117TH CONGRESS 
1ST SESSION H. R. 5435 
To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary 
of Health and Human Services to establish a Neuroscience Center of 
Excellence and a Neuroscience Translation Working Group, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 30, 2021 
Mr. BLUMENAUER (for himself, Mr. PASCRELL, and Mr. BACON) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
direct the Secretary of Health and Human Services to 
establish a Neuroscience Center of Excellence and a Neu-
roscience Translation Working Group, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Bringing Regulatory 
Advances Into Neuroscience Act of 2021’’ or the ‘‘BRAIN 
Act of 2021’’. 
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SEC. 2. FINDINGS. 
Congress finds the following: 
(1) The brain and central nervous system make 
up the body’s most complex organ system. 
(2) Nearly one in five adults in the United 
States (more than 50 million) live with a mental ill-
ness, disproportionately impacting women, people re-
porting two or more races, and individuals under age 
fifty. 
(3) Neuropsychiatric disorders are the leading 
cause of disability in the Nation, making up 18.7 
percent of years lost to disability and premature 
death. 
(4) Brain disorders, injuries, and diseases are 
estimated to cost the United States more than $1.5 
trillion per year. 
(5) Mental health and substance use disorder 
treatment spending is expected to total $280.5 bil-
lion in 2020. 
(6) The SARS–CoV–2 virus can cause serious 
psychiatric and neurologic effects and the COVID– 
19 pandemic has exacerbated the burden of brain 
and central nervous system conditions. 
(7) Products targeting the brain and central 
nervous system, including those conditions with few 
or no approved treatments, take longer to develop 
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and are less likely to be approved than products for 
other disease areas. 
SEC. 3. INSTITUTE AND ADVISORY COMMITTEE FOR DIS-
EASES AFFECTING THE BRAIN OR CENTRAL 
NERVOUS SYSTEM. 
(a) ESTABLISHMENT OF NEUROSCIENCE CENTER OF 
EXCELLENCE.—Section 1014 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 399g) is amended by adding 
at the end the following: 
‘‘(e) NEUROSCIENCE CENTER OF EXCELLENCE.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish an institute under subsection (a) to be known as 
the Neuroscience Center of Excellence to carry out 
activities under such subsection with respect to a 
major disease area or areas affecting the brain or 
central nervous system. 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection $25,000,000 for each of fiscal years 
2023 through 2027.’’. 
(b) 
NEUROSCIENCE
TRANSLATION
WORKING 
GROUP.—Chapter X of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 391 et seq.) is amended by adding 
at the end the following: 
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‘‘SEC. 
1015. 
NEUROSCIENCE 
TRANSLATION 
WORKING 
GROUP. 
‘‘(a) ESTABLISHMENT.—The Secretary shall estab-
lish and maintain an advisory board to be known as the 
Neuroscience Translation Working Group to advise the 
Director of the Neuroscience Center of Excellence under 
section 1014(e) (or the Commissioner of Food and Drugs 
in accordance with subsection (c)) on the following: 
‘‘(1) Issues with respect to translating neuro-
science discoveries to approved treatments for dis-
eases and conditions affecting the brain or central 
nervous system. 
‘‘(2) Activities to increase the translation of 
neuroscience discoveries to such approved treat-
ments. 
‘‘(3) The development of guidance with respect 
to diseases and conditions affecting the brain or cen-
tral nervous system. 
‘‘(4) Funding, collaboration, and other opportu-
nities within the National Institute of Neurological 
Disorders and Stroke, National Center for Advanc-
ing Translational Sciences, or other Government en-
tities to increase the translation of neuroscience dis-
coveries to such approved treatments. 
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‘‘(5) The incorporation of patient preferences, 
patient-reported outcomes, and real-world data in 
the development of regulations. 
‘‘(b) MEMBERSHIP.—The Neuroscience Translation 
Working Group shall consist of not more than eight mem-
bers, including— 
‘‘(1) the Director of the National Institute of 
Neurological Disorders and Stroke (or designee); 
‘‘(2) the Director of the National Center for 
Advancing Translational Sciences (or designee); 
‘‘(3) three representatives from patient advo-
cacy or national organizations that focus on injuries, 
diseases, or disorders affecting the brain or central 
nervous system, including organizations that rep-
resent service delivery for patients; 
‘‘(4) two experts with experience conducting 
clinical trials with respect to diseases and conditions 
affecting the brain or central nervous system; and 
‘‘(5) one expert with expertise in the regulation 
of drugs, devices, and biological products. 
‘‘(c) TERMINATION OF NEUROSCIENCE CENTER OF 
EXCELLENCE.—If the Secretary, pursuant to section 
1014(d), terminates the Neuroscience Center of Excel-
lence under section 1014(e), the Neuroscience Translation 
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Working Group shall advise the Commissioner of Food 
and Drugs.’’. 
(c) APPLICABILITY.—Sections 1014(e) and 1015 of 
the Federal Food, Drug, and Cosmetic Act, as added by 
this section, shall apply on the date that is not later than 
one year after the date of the enactment of this Act. 
Æ 
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