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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3427 Introduced in Senate (IS)]

<DOC>

117th CONGRESS
  1st Session
                                S. 3427

To authorize the Secretary of Health and Human Services to establish a 
                   Neuroscience Center of Excellence.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           December 16, 2021

Ms. Collins (for herself and Mr. Lujan) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
To authorize the Secretary of Health and Human Services to establish a 
                   Neuroscience Center of Excellence.

    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 ``Neuroscience Center of Excellence 
Act of 2021''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Neuroscience at the Food and Drug Administration 
        encompasses a broad range of neurological and psychiatric 
        diseases and disorders, including--
                    (A) addiction;
                    (B) Alzheimer's disease and other neurodegenerative 
                conditions that cause dementia;
                    (C) amyotrophic lateral sclerosis;
                    (D) autism spectrum disorder, Down syndrome, and 
                other neurodevelopmental disorders;
                    (E) bipolar disorder;
                    (F) brain aneurysms;
                    (G) brain tumors;
                    (H) cerebral palsy;
                    (I) anxiety and depression;
                    (J) dyspraxia;
                    (K) dystonia;
                    (L) epilepsy and other seizure disorders;
                    (M) hereditary brain and central nervous system 
                diseases;
                    (N) headaches and migraine disease;
                    (O) Huntington's disease;
                    (P) multiple sclerosis;
                    (Q) pain;
                    (R) Parkinson's disease and other movement 
                disorders, including parkinsonisms;
                    (S) personality disorders;
                    (T) psychotic disorders;
                    (U) traumatic brain injury and chronic traumatic 
                encephalopathy; and
                    (V) rare diseases that impact the brain and central 
                nervous system.
            (2) Neurological and psychiatric diseases and disorders are 
        highly prevalent. According to the National Institutes of 
        Health, neurological disorders affect an estimated 50,000,000 
        people in the United States each year, and 51,500,000 adults in 
        the United States live with a mental illness.
            (3) The prevalence of neuroscience diseases and disorders 
        continues to grow. The Centers for Disease Control and 
        Prevention forecasts that the burden of dementias in the United 
        States will double by 2060 to 13,900,000 people, which will be 
        3.3 percent of the population.
            (4) Neurological and psychiatric diseases and disorders 
        have a significant impact on health care expenditures and the 
        United States economy as a whole. The impact of common 
        neurological diseases, including Alzheimer's disease and 
        Parkinson's disease, on the United States economy is estimated 
        by the American Neurological Association at over 
        $789,000,000,000.
            (5) Factors associated with the COVID-19 pandemic, 
        including job loss and social isolation, have exacerbated the 
        prevalence and impact of psychiatric diseases and disorders. 
        According to the Centers for Disease Control and Prevention, 
        during the pandemic, more than one-third of adults in the 
        United States reported symptoms of anxiety or depression.
            (6) The National Institute of Neurological Disorders and 
        Stroke has recognized that the SARS-CoV-2 virus can lead to 
        serious neurological complications, such as anosmia, headache, 
        impaired consciousness, and stroke, which may affect 
        individuals' ability to function or work after the pandemic 
        ends.
            (7) Despite the large societal need, medical products for 
        neurological and psychiatric diseases and disorders are 
        approved by the Food and Drug Administration at a much lower 
        rate than products for other disease areas. According to a 2018 
        study conducted by the Tufts Center for the Study of Drug 
        Development, central nervous system drugs take 20 percent 
        longer to develop and approve than non-central nervous system 
        drugs.

SEC. 3. ESTABLISHMENT OF A NEUROSCIENCE CENTER OF EXCELLENCE.

    (a) Establishment Required.--The first sentence of section 1014(a) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399g(a)) is 
amended by inserting ``, at least 1 of which shall be focused on 
neuroscience diseases and disorders (as defined in section 1015)'' 
before the period at the end.
    (b) Timing of Establishment.--Subsection (c) of section 1014 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399g(c)) is amended to 
read as follows:
    ``(c) Timing.--Not later than 1 year after the date of enactment of 
the Neuroscience Center of Excellence Act of 2021, the Secretary shall 
establish, in accordance with this section and section 1015, an 
Institute under subsection (a) focused on neuroscience diseases and 
disorders, to be known as the Neuroscience Center of Excellence.''.
    (c) Activities.--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 CENTER OF EXCELLENCE.

    ``(a) Activities.--The Neuroscience Center of Excellence 
established under section 1014(a), shall--
            ``(1) carry out the activities described in section 
        1014(a);
            ``(2) coordinate collaborations among the Centers (within 
        the meaning of section 1014(a)) and stakeholders to support the 
        development of medical products for neuroscience diseases and 
        disorders;
            ``(3) establish and carry out the programs described in 
        subsection (c); and
            ``(4) issue reports to Congress on the activities of the 
        Neuroscience Center of Excellence, as described in subsection 
        (d).
    ``(b) Definitions.--In this section:
            ``(1) Neuroscience diseases and disorders.--The term 
        `neuroscience diseases and disorders' means--
                    ``(A) addiction;
                    ``(B) Alzheimer's disease and other 
                neurodegenerative conditions that cause dementia;
                    ``(C) amyotrophic lateral sclerosis;
                    ``(D) autism spectrum disorder, Down syndrome, and 
                other neurodevelopmental disorders;
                    ``(E) bipolar disorder;
                    ``(F) brain aneurysms;
                    ``(G) brain tumors;
                    ``(H) cerebral palsy;
                    ``(I) anxiety and depression;
                    ``(J) dyspraxia;
                    ``(K) dystonia;
                    ``(L) epilepsy and other seizure disorders;
                    ``(M) hereditary brain and central nervous system 
                diseases;
                    ``(N) headaches and migraine disease;
                    ``(O) Huntington's disease;
                    ``(P) multiple sclerosis;
                    ``(Q) pain;
                    ``(R) Parkinson's disease and other movement 
                disorders, including parkinsonisms;
                    ``(S) personality disorders;
                    ``(T) psychotic disorders;
                    ``(U) traumatic brain injury and chronic traumatic 
                encephalopathy; and
                    ``(V) rare diseases that impact the brain and 
                central nervous system.
            ``(2) Medical product.--The term `medical product' means a 
        drug, biological product, or device, or a combination product 
        described in section 503(g).
            ``(3) Patient experience data.--The term `patient 
        experience data' has the meaning given such term in section 
        569C(c).
    ``(c) Programs.--The Neuroscience Center of Excellence shall 
establish and implement the following programs:
            ``(1) Neuroscience therapeutics program.--
                    ``(A) Public engagement.--
                            ``(i) Public meeting.--Not later than 2 
                        years after the date of enactment of the 
                        Neuroscience Center of Excellence Act of 2021, 
                        and not less than once per year thereafter, the 
                        Secretary shall convene a public meeting of 
                        stakeholders (including scientists, 
                        researchers, patient advocacy organizations, 
                        disease research foundations, and 
                        representatives of the drug and device 
                        industries) to identify and make 
                        recommendations to address current and emerging 
                        regulatory science and public policy challenges 
                        associated with developing medical products for 
                        neuroscience diseases and disorders. Issues 
                        addressed during such meetings shall include--
                                    ``(I) methods to support the 
                                accelerated qualification of 
                                appropriate biomarkers and endpoints, 
                                including predictive biomarkers and 
                                endpoints, for neuroscience diseases 
                                and disorders; and
                                    ``(II) novel drug development 
                                methodologies and study designs to 
                                better support the rapid development 
                                and approval of medical products for 
                                neuroscience diseases and disorders.
                            ``(ii) Report.--Not later than 3 months 
                        after the conclusion of each public meeting 
                        under clause (i), the Secretary shall publish a 
                        report identifying the challenges and 
                        opportunities for rapid improvement discussed 
                        during such public meeting, and as applicable, 
                        any recommendations to Congress regarding how 
                        to address such challenges and ensure that 
                        patients benefit from optimizing development of 
                        medical products for neurosciences diseases and 
                        disorders. The Secretary shall make such report 
                        public on the website of the Department of 
                        Health and Human Services.
                    ``(B) Guidance.--Not later than 2 years after the 
                date of enactment of the Neuroscience Center of 
                Excellence Act of 2021, the Secretary shall issue one 
                or more final guidances that address--
                            ``(i) recommendations to sponsors of 
                        medical products for neuroscience diseases and 
                        disorders regarding master protocols to 
                        simultaneously evaluate more than 1 
                        investigational medical product or more than 1 
                        type of disease or disorder within the same 
                        overall trial structure, as well as other novel 
                        or collaborative study designs and approaches; 
                        and
                            ``(ii) approaches that may be used to 
                        incorporate clinical outcome assessments, 
                        including patient-reported outcomes, into 
                        endpoints for the development of medical 
                        products for neuroscience diseases and 
                        disorders.
            ``(2) Neuroscience patient-focused drug development 
        program.--
                    ``(A) In general.--The Secretary shall establish, 
                within the Neuroscience Center of Excellence, a program 
                to facilitate the collection of patient experience 
                data, and the systematic use of such data and related 
                information, in the development of medical products for 
                neuroscience diseases and disorders.
                    ``(B) Public engagement.--Not later than 2 years 
                after the date of enactment of the Neuroscience Center 
                of Excellence Act of 2021, and not less than once per 
                year thereafter, the Secretary shall convene 
                stakeholders (including patient advocacy groups and 
                disease research foundations) for a public workshop. 
                Such workshop shall--
                            ``(i) educate stakeholders on current 
                        initiatives and activities at the Neuroscience 
                        Center of Excellence;
                            ``(ii) solicit feedback from stakeholders 
                        on ongoing initiatives and activities at the 
                        Neuroscience Center of Excellence; and
                            ``(iii) provide an opportunity for 
                        stakeholders to discuss their personal 
                        experiences, including with respect to 
                        symptoms, daily impact, and current approaches 
                        to treatment for neuroscience diseases and 
                        disorders.
                    ``(C) Study.--Not later than 2 years after the date 
                of enactment of the Neuroscience Center of Excellence 
                Act of 2021, the Secretary shall conduct a study on 
                methods to assess the patient experience in the 
                development of medical products for neuroscience 
                diseases and disorders. The Secretary shall make a 
                report summarizing the results of such study public on 
                the website of the Department of Health and Human 
                Services.
                    ``(D) Guidance.--Not later than 2 years after the 
                date of enactment of the Neuroscience Center of 
                Excellence Act of 2021, the Secretary shall issue final 
                guidance with recommendations on the collection of 
                patient experience data (as defined in section 569C of 
                the Federal Food, Drug, and Cosmetic Act), and the use 
                of such data and related information, in the 
                development of medical products for neuroscience 
                diseases and disorders.
            ``(3) Neuroscience natural history studies program.--
                    ``(A) Guidance.--Not later than 2 years after the 
                date of enactment of the Neuroscience Center of 
                Excellence Act of 2021, the Secretary shall issue final 
                guidance with recommendations for sponsors on 
                implementing natural history studies that can be used 
                to support the development of medical products for 
                neuroscience diseases and disorders.
                    ``(B) Definition.--In this paragraph, the term 
                `natural history study' means a preplanned 
                observational study intended to track the course of the 
                disease.
            ``(4) Digital health technologies program.--
                    ``(A) Guidance.--Not later than 2 years after the 
                date of enactment of the Neuroscience Center of 
                Excellence Act of 2021, the Secretary shall issue final 
                guidance addressing approaches to--
                            ``(i) using digital technologies and 
                        digital endpoints in clinical trials evaluating 
                        medical products for neuroscience diseases and 
                        disorders; and
                            ``(ii) using digital technologies for the 
                        treatment of such diseases and disorders.
            ``(5) COVID-19 impacts program.--
                    ``(A) Public meeting.--
                            ``(i) In general.--Not later than 2 years 
                        after the date of enactment of the Neuroscience 
                        Center of Excellence Act of 2021, the Secretary 
                        shall convene not fewer than 2 public meetings 
                        for stakeholders (including scientists, 
                        researchers, health care providers, academics, 
                        members of the regulated industry, patient 
                        advocacy organizations, and disease research 
                        foundations) to discuss the impact of COVID-19 
                        on neuroscience diseases and disorders.
                            ``(ii) Topics.--The topics discussed at the 
                        meeting under clause (i) shall include--
                                    ``(I) the impact of the SARS-CoV-2 
                                virus on patients diagnosed with such 
                                diseases and disorders, without regard 
                                to whether such diagnoses occurred 
                                before or after such patient contracted 
                                the SARS-CoV-2 virus;
                                    ``(II) the indirect impact of the 
                                COVID-19 pandemic on such diseases and 
                                disorders, including the effects of 
                                social isolation and heightened levels 
                                of stress and anxiety for those with 
                                neuroscience disease and disorder 
                                diagnoses; and
                                    ``(III) strategies for the rapid 
                                development of medical products to 
                                address the direct and indirect impacts 
                                of COVID-19 on such diseases and 
                                disorders, including real-world data 
                                collection and real-world evidence 
                                development.
                    ``(B) Report.--Not later than 1 year after the date 
                of enactment of the Neuroscience Center of Excellence 
                Act of 2021, the Secretary shall publish a report on 
                the direct and indirect impacts of COVID-19 on 
                neuroscience diseases and disorders including, as 
                applicable, any recommendations to Congress on the 
                development of medical products intended to address the 
                impact of COVID-19 for individuals with such 
                conditions. The Secretary shall make such report public 
                on the website of the Department of Health and Human 
                Services.
            ``(6) Ensuring equity in neuroscience program.--
                    ``(A) Public meeting.--Not later than 2 years after 
                the date of enactment of the Neuroscience Center of 
                Excellence Act of 2021, the Secretary shall convene a 
                public meeting of stakeholders whose experience 
                directly relates to patients with neuroscience diseases 
                and disorders (including scientists, health care 
                providers, academics, members of the regulated 
                industry, patient advocacy organizations, and disease 
                research foundations) to discuss how to promote equity 
                and inclusion of traditionally underrepresented 
                populations in the research and development of medical 
                products for neuroscience diseases and disorders.
                    ``(B) Guidance.--Not later than 2 years after the 
                date of enactment of the Neuroscience Center of 
                Excellence Act of 2021, the Secretary shall issue 
                guidance for industry on how to ensure greater 
                diversity in clinical trials for neuroscience diseases 
                and disorders medical products. Such guidance shall 
                consider the feedback and recommendations from the 
                public meeting under subparagraph (A) the study under 
                section 3(d) of the Neuroscience Center of Excellence 
                Act of 2021.
    ``(d) Report.--Not later than 1 year after the date of enactment of 
the Neuroscience Center of Excellence Act of 2021, and annually 
thereafter, the Secretary shall submit a report to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives on the 
activities of the Neuroscience Center of Excellence. Such report shall 
include--
            ``(1) the number of medical products for neuroscience 
        diseases and disorders that were approved by the Food and Drug 
        Administration in the previous 5 calendar years;
            ``(2) a summary of challenges to developing medical 
        products for neuroscience diseases and disorders, and as 
        applicable, recommendations to Congress on how to address such 
        challenges; and
            ``(3) the direct and indirect impacts of the COVID-19 
        pandemic on neuroscience diseases and disorders.
    ``(e) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $25,000,000 for the period of 
fiscal years 2023 through 2027.''.
    (d) GAO Study.--Not later than 2 years after the date of enactment 
of this Act, the Comptroller General of the United States shall--
            (1) complete a study that reviews the participation of 
        traditionally underrepresented populations in clinical trials 
        for medical products (as defined in section 1015 of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 3) for the 
        treatment or diagnosis of neuroscience diseases and disorders 
        (as defined in such section 1015); and
            (2) submit a report to Congress on the results of such 
        study, including recommendations on potential changes in 
        practices and policies to improve participation by populations 
        that have been traditionally underrepresented in such trials.
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