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

ID: RFA-FD-25-001 • Type: Posted
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Description

The purpose of this Notice of Funding Opportunity (NOFO) 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.

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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Category of Funding
Agriculture
Consumer Protection
Food and Nutrition
Funding Instruments
Grant
Grant Program (CFDA)
93.103 - Food and Drug Administration Research
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 8/23/24 Food and Drug Administration posted grant opportunity RFA-FD-25-001 for Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required with funding of $900,000. The grant will be issued under grant program 93.103 Food and Drug Administration Research.

Timing

Posted Date
Aug. 23, 2024, 12:00 a.m. EDT
Closing Date
Oct. 21, 2025, 12:00 a.m. EDT Past Due
Last Updated
Oct. 24, 2024, 12:40 p.m. EDT
Version
2
Archive Date
Nov. 20, 2025

Eligibility

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

Award Sizing

Ceiling
$650,000
Floor
Not Listed
Estimated Program Funding
$900,000
Estimated Number of Grants
Not Listed

Contacts

Contact
Terrin Brown Grantor
Contact Email
terrin.brown@fda.hhs.gov   Profile
Contact Phone
(240) 402-7610
Additional Information
RFA-FD-25-001 Funding Opportunity Announcement
Additional Information Site
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-001.html

Documents

Posted documents for RFA-FD-25-001

Grant Awards

Grants awarded through RFA-FD-25-001

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