I 117th CONGRESS 1st Session H. R. 5435 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 Neuroscience Translation Working Group, and for other purposes.

1. Short title This Act may be cited as the Bringing Regulatory Advances Into Neuroscience Act of 2021 or the BRAIN Act of 2021 . 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 illness, disproportionately impacting women, people reporting 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 billion 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 and are less likely to be approved than products for other disease areas. 3. Institute and advisory committee for diseases 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 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. (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 Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended by adding at the end the following: 1015. Neuroscience Translation Working Group (a) Establishment 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: (1) Issues with respect to translating neuroscience discoveries to approved treatments for diseases and conditions affecting the brain or central nervous system. (2) Activities to increase the translation of neuroscience discoveries to such approved treatments. (3) The development of guidance with respect to diseases and conditions affecting the brain or central nervous system. (4) 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. (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 members, 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 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; (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 Excellence under section 1014(e), the Neuroscience Translation 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.