Consumer Protection for State governments Grants

Notice of Funding Opportunity Description The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)is announcing the availability of up to $1,125,000 in FY 2024 to be awarded under Limited Competition to State animal food regulatory programs. The intended outcome of this NOFO is to advance efforts for a nationally integrated animal food safety system through the implementation and advancement of the Animal Food Regulatory Program Standards (AFRPS) by State animal food regulatory programs. Applicants must refer to the Eligibility section of this NOFO to determine which funding track they should apply for: AFRPS Development or AFRPS Maintenance. Applicants should take sustainability into account when designing projects proposed under this cooperative agreement to maximize the longevity of resulting outcomes, resources, and program infrastructure beyond the end of the project period. The AFRPS allows for the development of risk-based animal food safety programs by establishing a uniform basis for measuring, evaluating, and improving the performance of State animal food regulatory programs in the Unites States. By achieving and maintaining implementation of these program Standards, Federal and State food regulatory programs can better direct their regulatory activities toward preventing animal food safety hazards, that can cause illness or injury to animals or humans, in facilities that manufacture, process, pack, or hold animal food materials/supplies. Consequently, the safety and security of the United States animal food supply and protection of human public health will improve. The AFRPS are comprised of eleven Standards (See link below in Program Goals Section) which establish foundations for the critical elements that serve as an objective framework to evaluate and improve components of a State animal food program. These elements cover the State animal food program's regulatory foundation, training, inspection program, auditing, animal food-related illness or death and emergency response, enforcement program, outreach activities, planning and resources, laboratory services, sampling program, and assessment and improvement of Standard implementation. Achieving and maintaining implementation of the program Standards will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation. FDA recognizes that the time required for achieving full implementation of the AFRPS will vary between States. However, all State animal food regulatory programs will be expected to implement improvement plans to ensure continuous improvement and demonstrate that they are moving towards full implementation. State animal food regulatory programs receiving funds under this cooperative agreement will be expected to achieve and maintain full implementation within 5 total year or less of funding under an AFRPS Cooperative Agreement(s). Grantees will achieve and maintain implementation with the AFRPS (most recent published version). For the purpose of this funding opportunity, "full implementation" is defined as the State animal food regulatory program having all elements, systems, and programs, as required in the Program Elements and Documentation sections of the AFRPS; and can demonstrate the use of those elements, systems, or programs. If implementation is not achieved by the end of funding year 5, the State program will provide a detailed improvement plan on how the remaining AFRPS elements and documentation requirements will be fully implemented and demonstrated. The improvement plan will include: A detailed timeline including what needs to be accomplished to implement the element and/or documentation requirement, and when the work will be completed. The outcomes of the work provided under this cooperative agreement are as follows: 1. State animal food regulatory programs will take significant steps to achieve and maintain implementation of the AFRPS, which is recognized as a critical element to creating a national, fully integrated food safety system. 2. State animal food regulatory programs will contribute to the continuous improvement of the AFRPS through attendance at an annual face-to-face meeting, active participation in committees, and other initiatives supporting the AFRPS. 3. Develop strategies for achieving and maintaining implementation of the AFRPS that can be replicated or leveraged across state programs to promote national consistency. 4. Provide a foundation for supporting advisory/regulatory action based upon findings of regulatory activities conducted by State animal food regulatory programs. Only the following State animal food programs will be eligible to apply: State animal food regulatory programs with current FDA animal food safety inspection contracts (providing funding to State animal food regulatory programs) and are also enrolled in the AFRPS, or those that apply for an FDA animal food safety inspection contract and enroll in the AFRPS, are eligible to apply for funding under this cooperative agreement. An animal food safety inspection contract must be executed prior to this cooperative agreement being awarded. A condition of the award will be maintaining a current FDA animal food safety inspection contract in satisfactory condition throughout the cooperative agreement project period. The FDA will provide one year of funding for this project with the hopes of making another NOFO in FY 2025 to help align project objectives, outputs, reporting, terms and conditions, and project periods for all AFRPS project awardees, and to provide continued funding for awardees under this project to achieve the objectives of the project. The anticipated release of another NOFO in FY2025 will also help align project periods for awardees under this NOFO as well as those currently awarded under PAR-20-132 (for which the project period and funding will end on 6/30/2025). For AFRPS, it is anticipated that full implementation of the AFRPS will be achieved within 5 total funding years under an AFRPS Cooperative Agreement(s), based on a verification audit of your program to ensure the elements have been implemented.

FDA announces the availability of fiscal year (FY) 2024 funds to support one or more projects to 1) collect antimicrobial use data from diverse animal sectors, including domestic livestock, poultry, companion animals (dogs, cats, and horses), and minor species (e.g., fish, sheep, goats) and 2) contribute to the development of data collection frameworks, including providing data and expertise as resources and a public-private partnership frameworks are established. This grant will support the continued advancement of FDA;apos;s initiatives to support antimicrobial stewardship in veterinary settings. It will also support the National Action Plan objectives to engage the animal health community and relevant stakeholders to advance strategies intended to improve understanding of antimicrobial use and foster antimicrobial stewardship in animal agriculture.

This funding opportunity supports researchers in developing innovative tools that can speed up drug development and improve regulatory processes, ultimately enhancing public health by facilitating faster access to effective treatments.

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 potential risks from skin lightening products containing hydroquinone and/or mercury.Applicants will research and 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 over-the-counter (OTC) skin lightening products.

The purpose of this funding opportunity announcement (FOA) is to support efficient natural history studies alone or in conjunction with the development and validation of clinical outcome assessments (COAs) and/or biomarker studies to address the unmet needs in rare neurodegenerative diseases for children and adults. Through the support of 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.

The purpose of this funding opportunity announcement (FOA) is to fund innovative research that will strengthen and advance minority health and health equity objectives.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.

This Notice of Funding Opportunity (NOFO) invites applications for a cooperative agreement to support, manage and facilitate Public-Private Partnerships and Collaborative activities as part of the Critical Path Initiative and to support regulatory science efforts. FDA and grantees will work together to develop innovative, collaborative projects in research, education, and outreach. These projects can help foster drug product innovation to 1) support efforts to accelerate drug product development; 2) support approaches to advanced manufacturing; 3) facilitate translation of basic science discoveries into therapeutics; and 4) facilitate approaches to enhance the safety, efficacy, quality, and performance of drug products. Projects are identified by FDA. Multiple awards may be funded under this NOFO and are directly dependent on drug development priorities and subject to the availability of funding.

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.

This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs.Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants.The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516.FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application.

The U.S. Food and Drug Administration (FDA) seeks applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. FDA has previously warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at receptor sites known to be associated with abuse, such as mu opioid receptors. Although Kratom use is prevalent, to date, clinical evaluations of its abuse potential have been limited. The proposed HAP study should be performed in accordance with the guidance for industry, "Assessment of Abuse Potential of Drugs," including (but not limited to) the selection of an appropriate comparator(s) and outcome measures, statistical analyses etc. Interested parties, will also complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.

The intended outcome of this Notice of Funding Opportunity (NOFO) 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 NOFO, the term state encompasses all eligible organizations as defined in Section 3. MFRPS Development or Maintenance: The purpose of this Notice of Funding Opportunity (NOFO) section is to advance efforts for a nationally Integrated Food Safety System (IFSS) 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 dietary supplement 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 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 Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement. The proposed work directly supports the U.S. FDAs stated goal of protecting public health from unacceptable risks from nitrosamine impurities in human drugs. Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs. The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities. In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereo chemically 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 stereo chemically pure form; 2) assessment of the biological activity of each stereo chemically 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.

Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time. Accidental exposure of these products to alcohol can result in the relatively rapid release of large quantities of drug with severe side effects, including death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products. To date, ADD assessments have not been harmonized globally. For instance, the U.S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media. This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations. In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior. The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.

This funding opportunity provides financial support to various organizations, including universities and non-profits, to improve veterinary diagnostic capabilities and address public health issues related to animal food safety and antimicrobial resistance.

The "Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required" grant aims to fund clinical trials that test the effectiveness and safety of new treatments for rare diseases, with the goal of increasing the number of approved treatments for these conditions.