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

ID: RFA-FD-23-001 • Type: Posted
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Description

The purpose of this funding opportunity announcement (FOA) 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 diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

Overview

Category of Funding
Health
Funding Instruments
Grant
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 6/30/22 the National Institutes of Health posted grant opportunity RFA-FD-23-001 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.

Timing

Posted Date
June 30, 2022, 12:00 a.m. EDT
Closing Date
Oct. 22, 2024, 12:00 a.m. EDT Past Due
Last Updated
June 30, 2022, 4:39 p.m. EDT
Version
1
Archive Date
Nov. 27, 2024

Eligibility

Eligible Applicants
Public housing authorities/Indian housing authorities
Special district 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
Native American tribal organizations (other than Federally recognized tribal governments)
County governments
For profit organizations other than small businesses
Native American tribal governments (Federally recognized)
State governments
City or township governments
Public and State controlled institutions of higher education
Small businesses
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Independent school districts
Private institutions of higher education
Additional Info
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Award Sizing

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

Contacts

Contact
National Institutes of Health
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541

Documents

Posted documents for RFA-FD-23-001

Grant Awards

Grants awarded through RFA-FD-23-001

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