Neuroscience Center of Excellence Act of 2021

Summary

Neuroscience Center of Excellence Act of 2021 This bill requires the Food and Drug Administration (FDA) to establish the Neuroscience Center of Excellence to address neuroscience diseases and disorders (e.g., addiction, Alzheimer's disease, and psychotic disorders). The center must carry out various activities, including (1) coordinating with FDA programs that focus on certain areas, such as drug evaluation; (2) convening periodic public meetings to engage with stakeholders to address challenges associated with developing medical products for neuroscience diseases and disorders; (3) establishing a program to facilitate the collection and systemic use of patient experience data to develop such medical products; and (4) convening a public meeting to discuss how to promote equity and the inclusion of traditionally underrepresented populations in the development of such medical products. The FDA must take actions related to these issues, such as issuing final guidance with recommendations on the collection and use of patient experience data for developing such medical products. The Government Accountability Office must report to Congress a study that (1) reviews the participation of traditionally underrepresented populations in clinical trials for such medical products, and (2) provides recommendations for improving the participation of these populations.

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Timeline

1. 16 December 2021

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S9263-9264)

   Source: IntroReferral

2. 16 December 2021

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 16 December 2021 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 16 December 2021

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 16 December 2021

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 16 December 2021

  Open at official source

Sponsors

• Susan Collins · R · Sponsor
• Ben Luján · D · Sponsor
• · sshr00 · Standing

Related records

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