Key Dates

Related Announcements

• February 6, 2024 - Drug Development Tools Research Grants (U01) Clinical Trials Optional. See NOFO RFA-FD-24-030.

Issued by

FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

The purpose of this Notice is to add additional verbiage under the section of the NOFO titled, Eligible Organizations.

Currently reads:

Eligible Organizations

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
• 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)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• 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)
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

These grants will be used to provide funding to developers of drug development tools that have an accepted or a reviewable Letter of Intent (LOI) within a CDER/CBER's Drug Development Tool Qualification Program and are working towards their qualification plan (QP) or full qualification package (FQP).

If you received DDT research grant support from FDA-CDER/CBER in previous years, you are eligible to apply provided that you have successfully progressed to the next submission milestone (e.g., Accepted LOI to Accepted QP) and are requesting additional funding for new DDT project needs addressing different aspects of the project.

Modified to read:

Eligible Organizations

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
• 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)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• 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)
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

These grants will be used to provide funding to developers of drug development tools that have an accepted or a reviewable Letter of Intent (LOI) within a CDER/CBER's Drug Development Tool Qualification Program and are working towards their qualification plan (QP) or full qualification package (FQP).

If you received DDT research grant support from FDA-CD ER/CBER in previous years, you are eligible to apply provided that you have successfully progressed to the next submission milestone (e.g., Accepted LOI to Accepted QP) and are requesting additional funding for new DDT project needs addressing different aspects of the project.

In recognition of the significant amount of work and time commitment that may be required to complete the full qualification package (FQP) stage of qualification, you are eligible to apply for the DDT research grant program both during the transition period to FQP from QP and during the FQP stage if substantial addition work is required. If you are interested in this eligibility criteria, provide justifications such as public health impact of qualifying your drug development tool, and the differentiation and needs of the new request compared with the previously funded work.   

 All other aspects of this NOFO remain unchanged.

Inquiries

Please direct all inquiries to:

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov