Food and Drug Administration

Title Due Date Maximum Award Amount Description
Systematic Review of Clinical Outcome Assessments (COAs) for Communication Brain-Computer Interface Devices (cBCIs) in Amyotrophic Lateral Sclerosis (ALS) (UH2/UH3) Clinical Trials Not Allowed $500,000.00

The purpose of this funding opportunity is to solicit applications for UH2/UH3 cooperative agreements to support and inform the future development and use of COAs for cBCIs in patients with amyotrophic lateral sclerosis (ALS). The UH2/UH3 cooperative agreement involves two milestone driven phases: 1) the UH2 Phase will include a systematic landscape analysis of the available literature, relevant data sources, and interviews with key opinion leaders (KOLs) to document COAs for cBCIs used clinically and identify gaps between current COAs used in cBCI studies and other outcome measures that could demonstrate functional benefits for ALS patients with severe communication limitations; 2) the UH3 phase will consist of patient and caregiver focus groups to collect information about symptoms, functional status, and perceived benefits/risks of cBCIs.Each phase will have a limit of 1 year for a total award period of 2 years. The UH2/UH3 application must be submitted as a single application, and applicants should note specific instructions for each phase in this FOA.
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.
Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional $2,000,000.00

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies and/or biomarker studies that fill unmet needs for rare neurodegenerative diseases for children and adults. Through the support of prospective natural history and/or biomarker 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 neurodegenerative disease or multiple rare neurodegenerative diseases with similar pathophysiology, and facilitate rare disease product development.
Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional $2,000,000.00

The purpose of this Funding Opportunity Announcement (FOA) is to support research projects that enhance biosimilar and interchangeable product development and regulatory science.
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.
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.
Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional $5,000,000.00

The intended goal of this FOA is to facilitate the development, production, and distribution of pediatric medical devices. Although the FOA is issued by the FDA's Office of Orphan Products Development, the grant application is intended to encompass devices for all pediatric diseases and conditions, not just those that are rare. Applicants will request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices. The advising and services will focus on the total product life cycle for medical devices from concept, through pre-market development, to commercialization, and replacement by subsequent generations of devices. In addition, consortia should also provide expertise on evidence generation, including use of real-world evidence (RWE), for pediatric device development. As the consortia execute their mission, they are encouraged to collaborate with each other and the broader community and to maintain a commitment to health equity, diversity, and inclusion to foster innovation, development, and improve access to medical devices for all pediatric patients.Pediatric medical devices treat or diagnose diseases and conditions in individuals who are 21 years of age or younger (that is, up to but not including the 22nd birthday) at the time of diagnosis or treatment (21 CFR 814.3(s)).
Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed $565,000.00

The intended outcome of this FOA is to advance efforts for a nationally integrated food safety system (IFSS) by supporting Manufactured Food Regulatory Program Standards (MFRPS), Food Protection Task Force (FPTF) programs, Dietary Supplement (DS) programs, and special projects. For the purposes of this FOA, the term State encompasses all eligible organizations as defined in Section 3.MFRPS Development or Maintenance:The purpose of this FOA section is to advance efforts for a nationally integrated food safety system by assisting State manufactured food regulatory programs to achieve and maintain conformance with the most current version of the Manufactured Food Regulatory Program Standards (MFRPS). The MFRPS are intended to ensure that State manufactured food regulatory programs implement a high-quality regulatory program through the development and maintenance of a regulatory framework that builds on and emphasizes mutual reliance with all programs. Also, the program standards are intended to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. Conformance with these program standards will help Federal and State programs better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods.Food Protection Task Force (FPTF):The purpose of this funding option is to establish and/or support a Food Protection Task Force (FPTF) with diverse membership representative of stakeholders across the state that is responsible for promoting the integration of an efficient statewide human and animal food (HAF) protection system that addresses state and region-specific needs and that maximize the protection of the public health. These efforts include: establishing a food safety/protection network of subject matter experts, fostering educational opportunities, developing replicable resources and systematically fostering communication, education, outreach, cooperation and collaboration within the states among federal, state, local, tribal and territorial HAF protection, public health, agriculture, and regulatory agencies, industry, academia, and consumers to initiate and/or support HAF protection activities to improve public health.A strong FPTF can also help improve human and animal food emergency surveillance, response, and post-response systems by focusing on preparedness, building strong communication channels, and establishing relationships with key players before food-related incidents occur.Dietary Supplements:The goal of this funding option is to facilitate the development of state driven dietary supplement regulatory framework and programs. The overall objective of this funding opportunity is to advance the adoption and implementation of the cGMPs for Dietary Supplements Rule codified at 21 CFR Part 111. Specifically, this track will provide funding support for training and program development activities.Special Projects:The purpose of this funding option is to develop and implement special projects that support innovation and integration in a nationally Integrated Food Safety System (IFSS) using the MFRPS framework. This track will support other emerging food safety priorities that develop over the lifespan of the project. State programs will be expected to share project deliverables and resources developed with other programs.
Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Clinical Trials Not Allowed $750,000.00

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for award of a cooperative agreement in fiscal year 2023 (FY23) to the Food and Agriculture Organization (FAO) of the United Nations to support global strategies that address food safety and public health.The purpose of this Cooperative Agreement is to:1. Contribute to the knowledge base of and development of food safety systems globally due to the increasingly diverse and complex food supply.2. Enhance and broaden FDA’s ability to address global food safety and public health issues associated with food.3. Provide opportunities to leverage additional resources of other countries.4. Support implementation of the FDA Food Safety Modernization Act (FSMA) and FDA's International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety-related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety.5. Support food safety, nutrition and public health programs that align with FDA’s mission.
Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional $750,000.00

The purpose of this funding opportunity is to develop and validate an enhanced mechanistic PBPK model to reliably describe the skin permeation of active pharmaceutical ingredients in topical drug products applied on the skin surface of virtual subjects by accounting for the drug product quality attributes and the metamorphosis these products undergo post application. The goal is to develop an in silico tool and to assess its capability to predict skin absorption for reference listed drug and test drug products considering their potentially different formulation compositions and quality attributes and the dynamic changes they undergo post application. This in silico tool (validated using appropriate datasets) is intended to identify parameters that may impact therapeutic equivalence between a reference listed drug and a test drug product applied on the skin and to inform decisions on generic drug development for these products.