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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required

ID: RFA-FD-21-001 • Type: Posted
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Description

The purpose of this funding opportunity announcement (FOA) is to fund well-controlled studies in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions. Through the funding of efficient and innovative clinical studies evaluating safety and/or efficacy, FDA expects to increase the number of treatments for rare diseases with an unmet medical need 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
Other (see text field entitled "Explanation of Other Category of Funding Activity" for clarification)
Funding Instruments
Cooperative Agreement
Grant Program (CFDA)
93.103 - Food and Drug Administration Research
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 2/21/20 Food and Drug Administration posted grant opportunity RFA-FD-21-001 for Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required. The grant will be issued under grant program 93.103 Food and Drug Administration Research. It is expected that 8 total grants will be made worth between $10,000 and $10.0 million.

Timing

Posted Date
Feb. 21, 2020, 12:00 a.m. EST
Closing Date
Oct. 5, 2021, 12:00 a.m. EDT Past Due
Closing Date Explanation
Two deadlines listed below:October 6, 2020,by 11:59 PM Eastern TimeOctober 5, 2021; by 11:59 PM Eastern Time.
Last Updated
Feb. 21, 2020, 9:47 a.m. EST
Version
2
Archive Date
Nov. 4, 2021

Eligibility

Eligible Applicants
County governments
Public housing authorities/Indian housing authorities
Native American tribal governments (Federally recognized)
For profit organizations other than small businesses
State governments
City or township governments
Independent school districts
Private institutions of higher education
Special district governments
Public and State controlled institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education

Award Sizing

Ceiling
$10,000,000
Floor
$10,000
Estimated Program Funding
Not Provided
Estimated Number of Grants
8

Contacts

Contact
Daniel Lukash Grants Management Specialist
Contact Email
daniel.lukash@fda.hhs.gov   Profile
Email Description
work email
Contact Phone
(240) 402-7596
Additional Information
full announcement
Additional Information Site
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-21-001.html

Documents

Posted documents for RFA-FD-21-001

Grant Awards

Grants awarded through RFA-FD-21-001

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