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

The summary for the Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

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

Federal Grant Title:	Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional
Federal Agency Name:	Food and Drug Administration (HHS-FDA)
Grant Categories:	Agriculture Consumer Protection Food and Nutrition
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-24-024
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	May 6th, 2024
Original Application Deadline:	May 6th, 2024
Posted Date:	December 11th, 2023
Creation Date:	December 11th, 2023
Archive Date:	June 5th, 2024
Total Program Funding:	$2,000,000
Maximum Federal Grant Award:	$2,000,000
Minimum Federal Grant Award:
Expected Number of Awards:	3
Cost Sharing or Matching:	No
Last Updated:	December 11th, 2023

Applicants Eligible for this Grant: 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 (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility: 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 American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations• Small Businesses• For-Profit Organizations (Other than Small Businesses)Local Governments• State Governments • County Governments• City or Township Governments• Special District Governments• Indian/Native American Tribal Governments (Federally Recognized) • Indian/Native American Tribal Governments (Other than Federally Recognized)Other• Independent School Districts• Public Housing Authorities/Indian Housing Authorities• Native American Tribal Organizations (other than Federally recognized tribal governments)• Faith-based or Community-based Organizations• Regional Organizations• 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.
Grant Announcement Contact: Zahara Graves
Grantor
Work
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