OpportunityTitle: Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional
AdditionalInformationOnEligibility: Eligible OrganizationsHigher Education Institutions&#8226; Public/State Controlled Institutions of Higher Education &#8226; Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education&#8226; Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) &#8226; Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations&#8226; Small Businesses&#8226; For-Profit Organizations (Other than Small Businesses)Local Governments&#8226; State Governments &#8226; County Governments&#8226; City or Township Governments&#8226; Special District Governments&#8226; Indian/Native American Tribal Governments (Federally Recognized) &#8226; Indian/Native American Tribal Governments (Other than Federally Recognized)Other&#8226; Independent School Districts&#8226; Public Housing Authorities/Indian Housing Authorities&#8226; Native American Tribal Organizations (other than Federally recognized tribal governments)&#8226; Faith-based or Community-based Organizations&#8226; Regional Organizations&#8226; Non-domestic (non-U.S.) Entities (Foreign Institutions) Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
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.
GrantorContactEmailDescription: Work
GrantorContactText: Zahara Graves &lt;br/&gt;Grantor