,,ii #aagth ,,congress #ast ,session ,s4 #cdbg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #af1 #bjba,ms4 ,collins 7for herself and ,mr4 ,lujn7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to authorize the ,secretary of ,health and ,human ,services to establish a ,neuroscience ,center of ,excellence4 #a4 ,short title ,this ,act may be cited as the ,neuroscience ,center of ,excellence ,act of #bjba4 #b4 ,findings ,congress finds the following3 7#a7 ,neuroscience at the ,food and ,drug ,administration encompasses a broad range of neurological and psychiatric diseases and disorders1 including-- 7,a7 addiction2 7,b7 ,alzheimer's disease and other neurodegenerative conditions that cause dementia2 7,c7 amyotrophic lateral sclerosis2 7,d7 autism spectrum disorder1 ,down syndrome1 and other neurodevelopmental disorders2 7,e7 bipolar disorder2 7,f7 brain aneurysms2 7,g7 brain tumors2 7,h7 cerebral palsy2 7,i7 anxiety and depression2 7,j7 dyspraxia2 7,k7 dystonia2 7,l7 epilepsy and other seizure disorders2 7,m7 hereditary brain and central nervous system diseases2 7,n7 headaches and migraine disease2 7,o7 ,huntington's disease2 7,p7 multiple sclerosis2 7,q7 pain2 7,r7 ,parkinson's disease and other movement disorders1 including parkinsonisms2 7,s7 personality disorders2 7,t7 psychotic disorders2 7,u7 traumatic brain injury and chronic traumatic encephalopathy2 and 7,v7 rare diseases that impact the brain and central nervous system4 7#b7 ,neurological and psychiatric diseases and disorders are highly prevalent4 ,according to the ,national ,institutes of ,health1 neurological disorders affect an estimated #ej1jjj1jjj people in the ,united ,states each year1 and #ea1ejj1jjj adults in the ,united ,states live with a mental illness4 7#c7 ,the prevalence of neuroscience diseases and disorders continues to grow4 ,the ,centers for ,disease ,control and ,prevention forecasts that the burden of dementias in the ,united ,states will double by #bjfj to #ac1ijj1jjj people1 which will be #c4c percent of the population4 7#d7 ,neurological and psychiatric diseases and disorders have a significant impact on health care expenditures and the ,united ,states economy as a whole4 ,the impact of common neurological diseases1 including ,alzheimer's disease and ,parkinson's disease1 on the ,united ,states economy is estimated by the ,american ,neurological ,association at over #ghi1jjj1jjj1jjj4 7#e7 ,factors associated with the ,,covid-#ai pandemic1 including job loss and social isolation1 have exacerbated the prevalence and impact of psychiatric diseases and disorders4 ,according to the ,centers for ,disease ,control and ,prevention1 during the pandemic1 more than one-third of adults in the ,united ,states reported symptoms of anxiety or depression4 7#f7 ,the ,national ,institute of ,neurological ,disorders and ,stroke has recognized that the ,,sars-,co,v-#b virus can lead to serious neurological complications1 such as anosmia1 headache1 impaired consciousness1 and stroke1 which may affect individuals' ability to function or work after the pandemic ends4 7#g7 ,despite the large societal need1 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 areas4 ,according to a #bjah study conducted by the ,tufts ,center for the ,study of ,drug ,development1 central nervous system drugs take #bj percent longer to develop and approve than non-central nervous system drugs4 #c4 ,establishment of a ,neuroscience ,center of ,excellence 7a7 ,establishment required ,the first sentence of section #ajad7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;g7a77 is amended by inserting 1 at least #a of which shall be focused on neuroscience diseases and disorders 7as defined in section #ajae7 before the period at the end4 7b7 ,timing of establishment ,subsection 7c7 of section #ajad of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;g7c77 is amended to read as follows3 7c7 ,timing ,not later than #a year after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall establish1 in accordance with this section and section #ajae1 an ,institute under subsection 7a7 focused on neuroscience diseases and disorders1 to be known as the ,neuroscience ,center of ,excellence4 4 7c7 ,activities ,chapter ,x of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is amended by adding at the end the following3 #ajae4 ,neuroscience ,center of ,excellence 7a7 ,activities ,the ,neuroscience ,center of ,excellence established under section #ajad7;a71 shall-- 7#a7 carry out the activities described in section #ajad7;a72 7#b7 coordinate collaborations among the ,centers 7within the meaning of section #ajad7;a77 and stakeholders to support the development of medical products for neuroscience diseases and disorders2 7#c7 establish and carry out the programs described in subsection 7c72 and 7#d7 issue reports to ,congress on the activities of the ,neuroscience ,center of ,excellence1 as described in subsection 7d74 7b7 ,definitions ,in this section3 7#a7 ,neuroscience diseases and disorders ,the term neuroscience diseases and disorders means-- 7,a7 addiction2 7,b7 ,alzheimer's disease and other neurodegenerative conditions that cause dementia2 7,c7 amyotrophic lateral sclerosis2 7,d7 autism spectrum disorder1 ,down syndrome1 and other neurodevelopmental disorders2 7,e7 bipolar disorder2 7,f7 brain aneurysms2 7,g7 brain tumors2 7,h7 cerebral palsy2 7,i7 anxiety and depression2 7,j7 dyspraxia2 7,k7 dystonia2 7,l7 epilepsy and other seizure disorders2 7,m7 hereditary brain and central nervous system diseases2 7,n7 headaches and migraine disease2 7,o7 ,huntington's disease2 7,p7 multiple sclerosis2 7,q7 pain2 7,r7 ,parkinson's disease and other movement disorders1 including parkinsonisms2 7,s7 personality disorders2 7,t7 psychotic disorders2 7,u7 traumatic brain injury and chronic traumatic encephalopathy2 and 7,v7 rare diseases that impact the brain and central nervous system4 7#b7 ,medical product ,the term medical product means a drug1 biological product1 or device1 or a combination product described in section #ejc7;g74 7#c7 ,patient experience data ,the term patient experience data has the meaning given such term in section #efi;,c7c74 7c7 ,programs ,the ,neuroscience ,center of ,excellence shall establish and implement the following programs3 7#a7 ,neuroscience therapeutics program 7,a7 ,public engagement 7i7 ,public meeting ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 and not less than once per year thereafter1 the ,secretary shall convene a public meeting of stakeholders 7including scientists1 researchers1 patient advocacy organizations1 disease research foundations1 and representatives of the drug and device industries7 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 disorders4 ,issues addressed during such meetings shall include-- 7,i7 methods to support the accelerated qualification of appropriate biomarkers and endpoints1 including predictive biomarkers and endpoints1 for neuroscience diseases and disorders2 and 7,,ii7 novel drug development methodologies and study designs to better support the rapid development and approval of medical products for neuroscience diseases and disorders4 7ii7 ,report ,not later than #c months after the conclusion of each public meeting under clause 7i71 the ,secretary shall publish a report identifying the challenges and opportunities for rapid improvement discussed during such public meeting1 and as applicable1 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 disorders4 ,the ,secretary shall make such report public on the website of the ,department of ,health and ,human ,services4 7,b7 ,guidance ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall issue one or more final guidances that address-- 7i7 recommendations to sponsors of medical products for neuroscience diseases and disorders regarding master protocols to simultaneously evaluate more than #a investigational medical product or more than #a type of disease or disorder within the same overall trial structure1 as well as other novel or collaborative study designs and approaches2 and 7ii7 approaches that may be used to incorporate clinical outcome assessments1 including patient-reported outcomes1 into endpoints for the development of medical products for neuroscience diseases and disorders4 7#b7 ,neuroscience patient-focused drug development program 7,a7 ,in general ,the ,secretary shall establish1 within the ,neuroscience ,center of ,excellence1 a program to facilitate the collection of patient experience data1 and the systematic use of such data and related information1 in the development of medical products for neuroscience diseases and disorders4 7,b7 ,public engagement ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 and not less than once per year thereafter1 the ,secretary shall convene stakeholders 7including patient advocacy groups and disease research foundations7 for a public workshop4 ,such workshop shall-- 7i7 educate stakeholders on current initiatives and activities at the ,neuroscience ,center of ,excellence2 7ii7 solicit feedback from stakeholders on ongoing initiatives and activities at the ,neuroscience ,center of ,excellence2 and 7iii7 provide an opportunity for stakeholders to discuss their personal experiences1 including with respect to symptoms1 daily impact1 and current approaches to treatment for neuroscience diseases and disorders4 7,c7 ,study ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall conduct a study on methods to assess the patient experience in the development of medical products for neuroscience diseases and disorders4 ,the ,secretary shall make a report summarizing the results of such study public on the website of the ,department of ,health and ,human ,services4 7,d7 ,guidance ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall issue final guidance with recommendations on the collection of patient experience data 7as defined in section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 and the use of such data and related information1 in the development of medical products for neuroscience diseases and disorders4 7#c7 ,neuroscience natural history studies program 7,a7 ,guidance ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 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 disorders4 7,b7 ,definition ,in this paragraph1 the term natural history study means a preplanned observational study intended to track the course of the disease4 7#d7 ,digital health technologies program 7,a7 ,guidance ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall issue final guidance addressing approaches to-- 7i7 using digital technologies and digital endpoints in clinical trials evaluating medical products for neuroscience diseases and disorders2 and 7ii7 using digital technologies for the treatment of such diseases and disorders4 7#e7 ,,covid-#ai impacts program 7,a7 ,public meeting 7i7 ,in general ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall convene not fewer than #b public meetings for stakeholders 7including scientists1 researchers1 health care providers1 academics1 members of the regulated industry1 patient advocacy organizations1 and disease research foundations7 to discuss the impact of ,,covid-#ai on neuroscience diseases and disorders4 7ii7 ,topics ,the topics discussed at the meeting under clause 7i7 shall include-- 7,i7 the impact of the ,,sars-,co,v-#b virus on patients diagnosed with such diseases and disorders1 without regard to whether such diagnoses occurred before or after such patient contracted the ,,sars-,co,v-#b virus2 7,,ii7 the indirect impact of the ,,covid-#ai pandemic on such diseases and disorders1 including the effects of social isolation and heightened levels of stress and anxiety for those with neuroscience disease and disorder diagnoses2 and 7,,iii7 strategies for the rapid development of medical products to address the direct and indirect impacts of ,,covid-#ai on such diseases and disorders1 including real-world data collection and real-world evidence development4 7,b7 ,report ,not later than #a year after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall publish a report on the direct and indirect impacts of ,,covid-#ai on neuroscience diseases and disorders including1 as applicable1 any recommendations to ,congress on the development of medical products intended to address the impact of ,,covid-#ai for individuals with such conditions4 ,the ,secretary shall make such report public on the website of the ,department of ,health and ,human ,services4 7#f7 ,ensuring equity in neuroscience program 7,a7 ,public meeting ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall convene a public meeting of stakeholders whose experience directly relates to patients with neuroscience diseases and disorders 7including scientists1 health care providers1 academics1 members of the regulated industry1 patient advocacy organizations1 and disease research foundations7 to discuss how to promote equity and inclusion of traditionally underrepresented populations in the research and development of medical products for neuroscience diseases and disorders4 7,b7 ,guidance ,not later than #b years after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 the ,secretary shall issue guidance for industry on how to ensure greater diversity in clinical trials for neuroscience diseases and disorders medical products4 ,such guidance shall consider the feedback and recommendations from the public meeting under subparagraph 7,a7 the study under section #c7;d7 of the ,neuroscience ,center of ,excellence ,act of #bjba4 7d7 ,report ,not later than #a year after the date of enactment of the ,neuroscience ,center of ,excellence ,act of #bjba1 and annually thereafter1 the ,secretary shall submit a report to the ,committee on ,health1 ,education1 ,labor1 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 ,excellence4 ,such report shall include-- 7#a7 the number of medical products for neuroscience diseases and disorders that were approved by the ,food and ,drug ,administration in the previous #e calendar years2 7#b7 a summary of challenges to developing medical products for neuroscience diseases and disorders1 and as applicable1 recommendations to ,congress on how to address such challenges2 and 7#c7 the direct and indirect impacts of the ,,covid-#ai pandemic on neuroscience diseases and disorders4 7e7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #be1jjj1jjj for the period of fiscal years #bjbc through #bjbg4 4 7d7 ,,gao study ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 complete a study that reviews the participation of traditionally underrepresented populations in clinical trials for medical products 7as defined in section #ajae of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #c7 for the treatment or diagnosis of neuroscience diseases and disorders 7as defined in such section #ajae72 and 7#b7 submit a report to ,congress on the results of such study1 including recommendations on potential changes in practices and policies to improve participation by populations that have been traditionally underrepresented in such trials4