BRAIN Act of 2021
Bill: H.R.5435 | Sponsor: Rep. Blumenauer, Earl (D-OR)
Policy area: Health

Summary:
Bringing Regulatory Advances Into Neuroscience Act of 2021 or the BRAIN Act of 2021
This bill requires the Food and Drug Administration (FDA) to establish the Neuroscience Center of Excellence.
The center must develop and implement processes to coordinate FDA activities related to a major disease area or areas affecting the brain or central nervous system.
The FDA must also establish and maintain the Neuroscience Translation Working Group to advise the center. If the FDA terminates the center, the working group shall advise the FDA.

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.

    Be it enacted by the Senate and House of Representatives 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''.

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 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.

SEC. 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:

``SEC. 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.
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