Funding Wizard

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

The U.S. Food and Drug Administration (FDA) seeks applications to develop, disseminate, implement, and evaluate an evidence-based Clinical Practice Guideline (CPG) for the safe tapering of benzodiazepines. Applicants must propose a comprehensive evidence-based plan that advances safe tapering of benzodiazepines.

The U.S. Food and Drug Administration (FDA) seeks applications to develop, disseminate, implement, and evaluate an evidence-based Clinical Practice Guideline (CPG) for the management of postoperative pain in obstetric patients who have undergone surgeries, including but not limited to cesarean delivery, vaginal delivery, and appendectomy during pregnancy. Applicants must propose a comprehensive evidence-based plan that advances safe prescribing of opioid analgesics for obstetric patients with postoperative pain.

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.

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 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.

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 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 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.

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.