Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional

Archived

Food and Drug Administration

Description

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies alone or in conjunction with the development and validation of clinical outcome assessments (COAs) and/or biomarker studies to address the unmet needs in rare neurodegenerative diseases for children and adults. Through the support of studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development.

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities / Indian housing authorities
  • Native American tribal organizations (other than Federally recognized)
  • Nonprofits with 501(c)(3) status (other than higher education)
  • Nonprofits without 501(c)(3) status (other than higher education)
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others

Contact

Zahara Graves <br/>Grantor
zahara.graves@fda.hhs.gov

Key dates & funding
  • PostedDec 11, 2023
  • ClosesMay 6, 2024
  • Award ceiling$2,000,000
  • Program funding$2,000,000
  • Expected awards3
  • CFDA93.103

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