Sec. 3. Establishment of a Neuroscience Center of Excellence
1,759 words·~8 min read·
/bill/117/s/3427/is/section-3·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. 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: 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. . 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 Neuroscience Center of Excellence established under section 1014(a), shall— carry out the activities described in section 1014(a); 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; establish and carry out the programs described in subsection (c); and issue reports to Congress on the activities of the Neuroscience Center of Excellence, as described in subsection (d). In this section: The term neuroscience diseases and disorders means— addiction; Alzheimer’s disease and other neurodegenerative conditions that cause dementia; amyotrophic lateral sclerosis; autism spectrum disorder, Down syndrome, and other neurodevelopmental disorders; bipolar disorder; brain aneurysms; brain tumors; cerebral palsy; anxiety and depression; dyspraxia; dystonia; epilepsy and other seizure disorders; hereditary brain and central nervous system diseases; headaches and migraine disease; Huntington’s disease; multiple sclerosis; pain; Parkinson’s disease and other movement disorders, including parkinsonisms; personality disorders; psychotic disorders; traumatic brain injury and chronic traumatic encephalopathy; and rare diseases that impact the brain and central nervous system. The term medical product means a drug, biological product, or device, or a combination product described in section 503(g). The term patient experience data has the meaning given such term in section 569C(c). The Neuroscience Center of Excellence shall establish and implement the following programs: 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— methods to support the accelerated qualification of appropriate biomarkers and endpoints, including predictive biomarkers and endpoints, for neuroscience diseases and disorders; and novel drug development methodologies and study designs to better support the rapid development and approval of medical products for neuroscience diseases and disorders. 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. 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— 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 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. 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. 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— educate stakeholders on current initiatives and activities at the Neuroscience Center of Excellence; solicit feedback from stakeholders on ongoing initiatives and activities at the Neuroscience Center of Excellence; and 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. 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. 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. 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. In this paragraph, the term natural history study means a preplanned observational study intended to track the course of the disease. 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— using digital technologies and digital endpoints in clinical trials evaluating medical products for neuroscience diseases and disorders; and using digital technologies for the treatment of such diseases and disorders. 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. The topics discussed at the meeting under clause
(i)shall include— 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; 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 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. 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. 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. 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 . 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— 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; 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 the direct and indirect impacts of the COVID–19 pandemic on neuroscience diseases and disorders. To carry out this section, there are authorized to be appropriated $25,000,000 for the period of fiscal years 2023 through 2027. . Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall— 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 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.
Connectionstraces to 2
Traces to 2 documents
Citation graph
cites case law
Cites 2Cited by 0 across 0 sources