Food and Drug Administration

Title Due Date Maximum Award Amount Sort descending Description
OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed $250,000.00

The purpose of the funding opportunity is to expand and advance FDA's Office of Minority Health and Health Equity (OMHHE) work with stakeholders and partners for education, outreach, and public awareness activities on the use of and potential risks from skin lightening products (e.g., hydroquinone).Applicants will propose innovative and community-based strategies and activities that have the potential to strengthen the science base for education and public health awareness on the use of and potential risks from skin lightening products.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341831
FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed $250,000.00

The purpose of this funding opportunity announcement (FOA) is to fund innovative research that will strengthen and advance minority health and health equity research.Areas of interest include:Proposals that focus on advancing equity in clinical trials by supporting efforts to advance diversity in clinical trials, equitable data efforts by increasing data available on diverse groups including, but not limited to, ethnicity, race, age, disability and geography, and equity of voices by increasing understanding of diverse patient perspectives, preferences, and unmet needs.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341829
Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. $300,000.00

The purpose of this FOA is to support a series of conferences and workshops developed with substantial FDA input to explore challenges regarding site selection of clinical trials sites in studies that are submitted to FDA for regulatory approval of oncology indications.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341838
Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed $360,000.00

The purpose of this FOA is to develop and maintain Rapid Response Teams (RRTs) to facilitate long-term improvements and innovation to the national integrated food safety system by unifying and coordinating federal/state/local human and animal food (HAF) emergency response efforts including:1) Strengthening the link among epidemiology, lab and environmental health/regulatory components;2) Improving States' regulatory and surveillance HAF protection programs to include using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards HAF emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts; and3) Addressing supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national response capacity/capability development.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=345381
Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Clinical Trials Not Allowed $400,000.00

FDA seeks to continue a robust, collaborative, and educational program using problem-based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives. This program consists of the continued development and implementation of a certified, academic training course for instruction in Good Laboratory Practices (GLP) in a Biosafety Level (BSL) 4 High Containment Environment.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=334156
Building Research Capacity in Global Tobacco Product Regulation Program (U18) Clinical Trials Not Allowed $400,000.00

The following organization is eligible to apply:The World Health Organization (WHO)As FDA seeks to proactively work with other countries and identify research and evaluation opportunities that will impact FDA’s ability to successfully implement the Tobacco Control Act, further collaboration with WHO is anticipated. With the financial support from the U.S. FDA, WHO is uniquely qualified to undertake these activities, given its mandate, wide access to data, participation of member states, and access to worldwide regulatory expertise.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=344353
Evaluation of oral modified release drug tablet to support the approval of additional strengths $450,000.00

The FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (Aug 2021), provides recommendations for demonstrating the bioequivalence of additional strengths of a proposed modified release drug product. The recommendations involve evidence to demonstrate the same drug release mechanism and similar dissolution profiles across strengths, as well as ratios of drug excipients across strengths that are appropriate for the drug release mechanism. The purpose of this project is to determine the critical quality attributes for different release controlling platform technologies and to determine the appropriate factors to scale the formulation for additional strengths. The outcomes of this research are intended to support generic drug development and regulatory decision making.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=344256
Research to support the development of alternatives to antimicrobials for use in food-producing animals $500,000.00

FDA announces the availability of fiscal year (FY) 2022 funds to support studies that identify the most common drivers for antimicrobial use in animal agriculture and identify potential alternatives to antimicrobials that may reduce the need for antimicrobial use. The funded studies are intended to 1) provide information about animal diseases that are the most significant drivers for antimicrobial use in various animal production settings (i.e., cattle, swine, turkeys, and chickens), and 2) provide information about alternative practices that may help reduce the reliance on such drugs while addressing animal health needs. Such alternatives can include changes in husbandry, biosecurity, vaccination, and other practices. This grant will support the continued advancement of FDA's initiatives related to supporting antimicrobial stewardship in veterinary settings and will support the National Action Plan objectives to engage the animal health community and relevant stakeholders to advance strategies intended to foster antimicrobial stewardship and to improve understanding of antimicrobial use practices in animal agriculture

https://www.grants.gov/web/grants/view-opportunity.html?oppId=336241
FDA OMHHE Racial & Ethnic minority Acceleration Consortium for Health Equity (REACH) $500,000.00

This Funding Opportunity Announcement (FOA) is for FDA Office of Minority Health and Health Equity's (OMHHE) Health Equity Innovation Award: Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH). The consortium will consist of multiple cooperative agreement (U01) recipients that will strengthen and advance minority health and health equity focused research, outreach, and communications as well as support training and mentoring of diverse students, fellows, and/or researchers.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341833
Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Not Allowed $500,000.00

The purpose of this funding opportunity announcement (FOA) is to fund COVID research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making.The FDA Office of Minority Health and Health Equity (OMHHE) is interested in research proposals that will contribute to advancing understanding of COVID and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19. These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=341830