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forecasted

Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required

Food and Drug Administration · FOR-FD-25-001

Award range

$650,000 – $900,000

Deadline

Not specified

Eligible applicants

Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility", County governments, Public and State controlled institutions of higher education, For profit organizations other than small businesses, Small businesses, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, State governments, Native American tribal governments (Federally recognized), Independent school districts, City or township governments, Special district governments, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments)

Geographic eligibility and all attachment-specific conditions require review of the original announcement.

Matching funds & resources

Source matching-funds field: Not Required.

Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.

About this opportunity

The purpose is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare neurodegenerative diseases for children and adults. Through the support of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare neurodegenerative diseases and exert a broad and positive impact on rare disease drug development.

Funding geography: Not specified — review source. A funder’s address does not establish eligibility.

Review original source ↗

Funding instrument: Grant. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.

Source fields and evidence

id: 356054
Source ↗ · id

opportunityNumber: FOR-FD-25-001
Source ↗ · opportunityNumber

opportunityTitle: Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
Source ↗ · opportunityTitle

revision: 0
Source ↗ · revision

agencyDetails: {"code":"FDA","seed":"HHS-FDA","agencyName":"Food and Drug Administration","agencyCode":"HHS-FDA","topAgencyCode":"HHS"}
Source ↗ · agencyDetails

owningAgencyCode: HHS-FDA
Source ↗ · owningAgencyCode

cfdas: [{"id":423141,"opportunityId":356054,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
Source ↗ · cfdas

forecastDesc: <p>The purpose is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare neurodegenerative diseases for children and adults.&nbsp;Through the support of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare neurodegenerative diseases and exert a broad and positive impact on rare disease drug development.</p>
Source ↗ · forecastDesc

applicantTypes: [{"id":"99","description":"Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled \"Additional Information on Eligibility\""},{"id":"01","description":"County governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"23","description":"Small businesses"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"20","description":"Private institutions of higher education"},{"id":"00","description":"State governments"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"05","description":"Independent school districts"},{"id":"02","description":"City or township governments"},{"id":"04","description":"Special district governments"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"}]
Source ↗ · applicantTypes

fundingInstruments: [{"id":"G","description":"Grant"}]
Source ↗ · fundingInstruments

fundingActivityCategories: [{"id":"AG","description":"Agriculture"},{"id":"CP","description":"Consumer Protection"},{"id":"FN","description":"Food and Nutrition"}]
Source ↗ · fundingActivityCategories

awardFloor: 650000
Source ↗ · awardFloor

awardCeiling: 900000
Source ↗ · awardCeiling

costSharing: false
Source ↗ · costSharing

lastUpdatedDate: Aug 14, 2024 10:50:55 PM EDT
Source ↗ · lastUpdatedDate

status: forecasted
Source ↗ · oppHits[id=356054].oppStatus

Source retrieved 10/15/2026 · Revision 0. Always confirm current requirements and dates with the funder. Structured source fields are checked; this is not a determination that every applicant qualifies.

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