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Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required

ID: RFA-FD-22-001 • Type: Posted
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Description

The purpose of this funding opportunity announcement (FOA) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history 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 disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.

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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Category of Funding
Health
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 2/17/21 Food and Drug Administration posted grant opportunity RFA-FD-22-001 for Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required. The grant will be issued under grant program 93.103 Food and Drug Administration Research. It is expected that 5 total grants will be made worth between $150,000 and $2.5 million.

Timing

Posted Date
Feb. 17, 2021, 12:00 a.m. EST
Closing Date
March 11, 2024, 12:00 a.m. EDT Past Due
Closing Date Explanation
This FOA has multiple close dates. February 15, 2022, by 11:59 PM Eastern Time and March 11, 2024, by 11:59 PM Eastern Time.
Last Updated
March 7, 2024, 1:51 p.m. EST
Version
3

Eligibility

Eligible Applicants
Public and State controlled institutions of higher education
Independent school districts
Private institutions of higher education
Native American tribal governments (Federally recognized)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
For profit organizations other than small businesses
City or township governments
Native American tribal organizations (other than Federally recognized tribal governments)
Special district governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
State governments
Small businesses
Public housing authorities/Indian housing authorities
Additional Info
Eligible OrganizationsHigher Education InstitutionsPublic/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 OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) 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) U.S. Territory or PossessionOtherIndependent School DistrictsPublic 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)

Award Sizing

Ceiling
$2,500,000
Floor
$150,000
Estimated Program Funding
Not Provided
Estimated Number of Grants
5

Contacts

Contact
Shashi Malhotra Grants Management Specialist
Contact Email
shashi.malhotra@fda.hhs.gov   Profile
Contact Phone
(240) 402-7592
Additional Information
Full Announcement
Additional Information Site
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-22-001.html

Documents

Posted documents for RFA-FD-22-001

Grant Awards

Grants awarded through RFA-FD-22-001

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