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

Due: May 6, 2024

$2,000,000

DescriptionThe 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...

Estimated Total Program Funding$2,000,000Expected Number of Awards3Award Ceiling$2,000,000

Eligible Applicants- 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 tribal governments)- Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education- Private institutions of higher education- For-profit organizations other than small businesses- Small businesses- Others

Additional Eligibility Information

Eligible OrganizationsHigher Education Institutions• Public/State Controlled Institutions of Higher Education • 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 Americ...

Funding TypeCooperative AgreementCategories of Funding Activity- Agriculture- Consumer Protection- Food and NutritionOpportunity TypeDiscretionary

Grantor Contact InformationWorkGrantor Emailzahara.graves@fda.hhs.govOther Grantor InformaitonZahara Graves Grantor

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

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