Sec. 3. Institute and advisory committee for diseases affecting the brain or central nervous system
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Section 1014 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399g ) is amended by adding at the end the following: The Secretary shall establish 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. There are authorized to be appropriated to carry out this subsection $25,000,000 for each of fiscal years 2023 through 2027. . Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended by adding at the end the following: The Secretary shall establish 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: Issues with respect to translating neuroscience discoveries to approved treatments for diseases and conditions affecting the brain or central nervous system. Activities to increase the translation of neuroscience discoveries to such approved treatments. The development of guidance with respect to diseases and conditions affecting the brain or central nervous system. Funding, collaboration, and other opportunities within the National Institute of Neurological Disorders and Stroke, National Center for Advancing Translational Sciences, or other Government entities to increase the translation of neuroscience discoveries to such approved treatments. The incorporation of patient preferences, patient-reported outcomes, and real-world data in the development of regulations. The Neuroscience Translation Working Group shall consist of not more than eight members, including— the Director of the National Institute of Neurological Disorders and Stroke (or designee); the Director of the National Center for Advancing Translational Sciences (or designee); three representatives from patient advocacy or national organizations that focus on injuries, diseases, or disorders affecting the brain or central nervous system, including organizations that represent service delivery for patients; two experts with experience conducting clinical trials with respect to diseases and conditions affecting the brain or central nervous system; and one expert with expertise in the regulation of drugs, devices, and biological products. If the Secretary, pursuant to section 1014(d), terminates the Neuroscience Center of Excellence under section 1014(e), the Neuroscience Translation Working Group shall advise the Commissioner of Food and Drugs. . 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.
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Sec. 3
Institute and advisory committee for diseases affecting the brain or central nervous system
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