Funding Wizard

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.

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.

The purpose of this funding opportunity is to develop a workflow for designing and performing a reliable virtual bioequivalence study by leveraging a physiologically-based pharmacokinetic (PBPK) model, validated for its intended purpose, to detect formulation differences between the reference standard product and a prospective generic drug product. The workflow will explore considerations and reasonable assumptions related to performing a virtual bioequivalence assessment using mechanistic modeling and simulation tools of increased complexity, such as PBPK models.

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.

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.

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.

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.

The purpose of this funding opportunity is to support research and development that will characterize the specific and unique considerations relevant to evaluating the bioequivalence (BE) of rectal and vaginal (topical) drug products. A specific emphasis of this funding opportunity involves the development of biorelevant performance tests as a component of product characterization-based BE approaches.

The FDA hosts the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to foster robust and innovative approaches to advance regulatory science, and the goal is for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the Office of Regulatory Science and Innovation (ORSI), through collaborative interactions with FDA scientific experts and funding offices. This funding opportunity will provide support, depending on availability of FDA funding, for collaborative research with FDA and regulatory science information sharing opportunities.

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetylgalactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereochemically-controlled synthesis and biological activity assessment using in vitro and animal models. The proposed studies will focus on 1) synthesis of each diastereomer of LEQVIO (Inclisiran) in stereochemically pure form; 2) assessment of the biological activity of each stereochemically pure diastereomer in inhibiting PCSK9 activity using in vitro assays and in a transgenic mouse model; 3) development of analytical methods to identify and characterize the stereochemical structure of each diastereomer in LEQVIO; and 4) assessment of the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. Tools developed in this research can also be applied to other similar GalNAc-conjugated siRNAs specifically, and other siRNAs in general. Knowledge gained from this research will also contribute to the sameness evaluation of generic siRNAs, and to the quality control of oligonucleotide drugs.