Grants for Public housing authorities - Agriculture

Federal Awarding Agency Name: U.S. Department of Agriculture (USDA), Natural Resources Conservation Service (NRCS), Commodity Credit Corporation (CCC) Funding Opportunity Title: Regional Conservation Partnership Program (RCPP) Classic for Federal fiscal year (FY) 2024 Funding Opportunity Number: USDA-NRCS-NHQ-RCPP-24-NOFO0001354 Assistance Listing: 10.932, Regional Conservation Partnership Program (RCPP) Due Date: NRCS must receive proposals by 4:59 p.m. Eastern Time on July 2, 2024. Note: The RCPP Classic and Alternative Funding Arrangement (AFA) FY 2024 notices of funding opportunity (NFO) will run concurrently. For information on AFA proposals please see Funding Opportunity Number USDA-NRCS-NHQ-RCPPAFA-24-NOFO0001355. The RCPP promotes the coordination of NRCS conservation activities with partners that offer value-added contributions to expand our ability to address on-farm, watershed, and regional natural resource concerns. Through the RCPP, NRCS seeks to co-invest with partners to implement projects that provide solutions to conservation challenges thereby measurably improving the resource concerns they seek to address. RCPP promotes collaboration with partners, stakeholders, and various communities, which is paramount to achieving equity in NRCS programs and services. Using guidance contained in this notice, partners propose projects that generate conservation benefits by addressing specific natural resource concerns in a state or multistate area by addressing one or more priority resource concerns within an NRCS-designated critical conservation area (CCA). NRCS and partners collaborate to design, promote, and implement RCPP projects on agricultural and nonindustrial private forest land. Through RCPP, NRCS may provide both financial assistance (FA) and technical assistance (TA) funds to project partners and agricultural producers for implementing projects. RCPP proposals are evaluated through a competitive proposal process based on three criteria: impact, partner contributions, and partnership and management. Up to $1.5 billion is available for RCPP projects through this announcement and the FY 2024 AFA announcement, which includes $300 million of the Agriculture Improvement Act of 2018 (2018 Farm Bill) funding and $1.2 billion of Inflation Reduction Act (IRA) funding. Proposals are accepted from all 50 States, the Caribbean Area (Puerto Rico and the U.S. Virgin Islands), and U.S. territories in the Pacific Island Areas (Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands). NRCS will prioritize using IRA funds for projects that will implement climate-smart agriculture and forestry conservation activities as described in section F.(3)a. of this announcement. Up to $100 million is being made available specifically for NRCS to enter into programmatic partnership agreements with Indian tribes. This set aside will be shared by this announcement and the FY 2024 AFA announcement. Any unused funds may be available for other partnership agreements. Submissions: Proposals must be submitted through the RCPP portal. See section E of this announcement for information on using the RCPP portal to submit proposals. Access to the RCPP portal requires a level 2 eAuthentication credential or a Login.gov credential. Obtaining a new Login.gov credential involves multiple steps and can take several days to complete. Instructions are posted on the How to Apply to RCPP web page listed below. For More Information: Applicants are expected to contact the appropriate State Conservationists and state RCPP coordinators prior to submitting a proposal. NRCS will use a state conservation questionnaire to record the results of this conversation. Proposals without a completed questionnaire may have their score and ranking reduced. A list of state RCPP coordinators (as of the date of this announcements posting) is on the NRCS How to Apply to RCPP web page. Applicants can also email the RCPP inbox ([email protected]) with any questions about the announcement. The RCPP website is also a great source of current information about the program. Interested applicants are encouraged to participate in one or more of the webinars below to learn about the program and how to apply. 2024 RCPP NFO Applicant Outreach Webinar This webinar will provide general information for applicants submitting proposals for the Regional Conservation Partnership Program (RCPP). The same material will be covered at both webinars followed by a question-and-answer section. Please refer to the RCPP website for more information. Regional Conservation Partnership Program Natural Resources Conservation Service (usda.gov) April 23, 2024, RCPP Applicant Outreach Webinar Registration Link 2pm to 4pm EDT - https://events.gcc.teams.microsoft.com/event/e2f45f75-7ea4-410b-b1c9-567537cd2454@ed5b36e7-01ee-4ebc-867e-e03cfa0d4697 May 30, 2024, RCPP Applicant Outreach Webinar Registration Link 2pm to 4pm EDT - https://events.gcc.teams.microsoft.com/event/226dcb51-0b57-43b1-b340-95e535238713@ed5b36e7-01ee-4ebc-867e-e03cfa0d4697 NRCS will schedule additional webinars on RCPP easements and providing outreach to tribal applicants. Information on all webinars will be posted to the RCPP how to apply page.

Federal Awarding Agency Name: U.S. Department of Agriculture (USDA), Natural Resources Conservation Service (NRCS), Commodity Credit Corporation (CCC) Funding Opportunity Title: Regional Conservation Partnership Program (RCPP) Alternative Funding Arrangements (AFA) for fiscal year (FY) 2024 Funding Opportunity Number: USDA-NRCS-NHQ-RCPPAFA-24-NOFO0001355 Assistance Listing: 10.932, Regional Conservation Partnership Program (RCPP) Due Date: NRCS must receive proposals by 4:59 p.m. Eastern Time on July 2, 2024. Note: The RCPP AFA and Classic FY 2024 notices of funding opportunity (NFO) will run concurrently. For information on Classic proposals please see USDA-NRCS-NHQ-RCPP-24-NOFO0001354. The RCPP promotes the coordination of NRCS conservation activities with partners that offer valueadded contributions to expand our ability to address on-farm, watershed, and regional natural resource concerns. Through the RCPP, NRCS seeks to co-invest with partners to implement projects that provide solutions to conservation challenges thereby measurably improving the resource concerns they seek to address. RCPP promotes collaboration with partners, stakeholders, and various communities, which is paramount to achieving equity in NRCS programs and services. Using guidance contained in this notice, partners propose projects that generate conservation benefits by addressing specific natural resource concerns in a state or multistate area or by addressing one or more priority resource concerns within an NRCS-designated critical conservation area (CCA). RCPP proposals are evaluated through a competitive proposal process based on three criteria: impact, partner contributions, and partnership and management. Up to $1.5 billion is available for RCPP projects through this announcement and the FY 2024 Classic announcement, which includes $300 million of the Agriculture Improvement Act of 2018 (2018 Farm Bill) funding and $1.2 billion of Inflation Reduction Act (IRA) funding. Proposals will be accepted from all 50 States, the Caribbean Area (Puerto Rico and the U.S. Virgin Islands), and U.S. territories in the Pacific Island Areas (Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands). NRCS will prioritize using IRA funds for projects that will implement climate-smart agriculture and forestry conservation activities as described in section F.3.a. of this announcement. Up to $100 million is being made available specifically for NRCS to enter into programmatic partnership agreements with Indian tribes. This set aside will be shared by this announcement and the FY 2024 Classic announcement. Any unused funds may be available for other partnership agreements. RCPP AFAs are intended to support project structures and approaches that cannot be carried out as effectively through the RCPP Classic NFO. RCPP AFA applicants must describe the innovative nature of the conservation approach they are proposing to justify potential funding through an RCPP AFA NFO rather than an RCPP Classic NFO. Moreover, applicants should consider the additional administrative and technical assistance responsibilities that accompany receipt of an RCPP AFA award. The 2018 Farm Bill provides the following examples of project types that might be implemented through RCPP AFA: projects that use innovative approaches to leverage the Federal investment in conservation; projects that deploy a pay-for-performance conservation approach; and projects that seek large-scale infrastructure investments that generate conservation benefits for agricultural producers and nonindustrial private forest owners. Although RCPP AFA provides flexibilities to partners, these projects share the overarching focus of RCPP, which is to engage with producers and landowners to implement conservation practices, systems, and approaches on (or for the benefit of) agricultural and nonindustrial private forest lands. NRCS can make up to 15 awards through this funding opportunity through Farm Bill funding. This limit does not apply to projects funded through the Inflation Reduction Act. Submissions: Proposals must be submitted through the RCPP portal. See section E of this announcement for information on using the RCPP portal to submit proposals. Access to the RCPP portal requires a level 2 eAuthentication credential or a Login.gov credential. Obtaining a new Login.gov credential involves multiple steps and can take several days to complete. Instructions are posted on the How to Apply to RCPP web page listed below. For More Information: Applicants are expected to contact the appropriate state conservationists and state RCPP coordinators prior to submitting a proposal. NRCS will use a state conservation questionnaire to record the results of these conversations. Proposals without a completed questionnaire may have their score and ranking reduced. A list of state RCPP coordinators (as of the date of this announcements posting) is on the NRCS How to Apply to RCPP web page. Applicants can also email the RCPP inbox ([email protected]) with any questions about the announcement. The NRCS RCPP website is also a great source of current information about the program. Interested applicants are encouraged to participate in one or more of the webinars below to learn about the program and how to apply. 2024 RCPP NFO Applicant Outreach Webinar This webinar will provide general information for applicants submitting proposals for the Regional Conservation Partnership Program (RCPP). The same material will be covered at both webinars followed by a question-and-answer section. Please refer to the RCPP website for more information. Regional Conservation Partnership Program Natural Resources Conservation Service (usda.gov) April 23, 2024, RCPP Applicant Outreach Webinar Registration Link 2pm to 4pm EDT - https://events.gcc.teams.microsoft.com/event/e2f45f75-7ea4-410b-b1c9-567537cd2454@ed5b36e7-01ee-4ebc-867e-e03cfa0d4697 May 30, 2024, RCPP Applicant Outreach Webinar Registration Link 2pm to 4pm EDT - https://events.gcc.teams.microsoft.com/event/226dcb51-0b57-43b1-b340-95e535238713@ed5b36e7-01ee-4ebc-867e-e03cfa0d4697 NRCS will schedule additional webinars on RCPP easements and providing outreach to tribal applicants. Information on all webinars will be posted to the RCPP how to apply page.

Notice of Funding Opportunity SummaryThe Natural Resources Conservation Service (NRCS) is directing resources toward climate-smart agriculture and forestry (CSAF) conservation practices, including those for energy efficiency. NRCS is providing funding for a partnership to provide technical assistance to NRCS and producers on energy practices. Information related to NRCS CSAF practices can be found at the following web address: https://www.nrcs.usda.gov/sites/default/files/2023-10/NRCS-CSAF-Mitigation-Activities-List.pdf.A total of up to $1,500,000 is available in fiscal year 2024. All agreements will be five years in duration. Additional funds may be added to agreement in later years as funds become available. Total funding is dependent on the Federal Budget and technical workload in Ohio. For new users of Grants.gov, see Section D. of the full Notice of Funding Opportunity for information about steps required before submitting an application via Grants.gov.Key DatesApplicants must submit their applications via Grants.gov by 11:59 pm Eastern Time on May 22, 2024. For technical issues with Grants.gov, contact Grants.gov Applicant Support at 1-800-518-4726 or [email protected]. Awarding agency staff cannot support applicants regarding Grants.gov accounts.For inquiries specific to the content of the NFO requirements, contact the federal awarding agency contact (section G of this NFO). Please limit questions to those regarding specific information contained in this NFO (such as dates, page numbers, clarification of discrepancies, etc.). Questions related to eligibility or the merits of a specific proposal will not be addressed. The agency anticipates making selections by June 22, 2024 and expects to execute awards by July 22, 2024. These dates are estimates and are subject to change.

This Notice of Funding Opportunity (NFO) is being released prior to appropriation and/or apportionment of funds for fiscal year 2024. Enactment of additional continuing resolutions or an appropriations act may affect the availability or level of funding for this program. The purpose of this NFO is to encourage and promote conservation planning and conservation practice implementation in urban, suburban, and other small-scale type agricultural operations. Emphasis will be placed on projects that establish new demonstration community gardens, or enhance and expand existing community agriculture projects. Proposals should seek to: 1. Provide conservation learning experiences to urban, suburban, and Tribal communities. 2. Address concerns regarding food deserts. 3. Advance Tribal food sovereignty. 4. Achieve positive and measurable natural resources conservation outcomes. For new users of Grants.gov, see Section D. of the full Notice of Funding Opportunity for information about steps required before submitting an application via Grants.gov. Key Dates Applicants must submit their applications via Grants.gov by 11:59 pm Eastern Time on May 22, 2024. For technical issues with Grants.gov, contact Grants.gov Applicant Support at 1-800-518-4726 or [email protected]. Awarding agency staff cannot support applicants regarding Grants.gov accounts. For inquiries specific to the content of the NFO requirements, contact the federal awarding agency contact (section G of this NFO). Please limit questions to those regarding specific information contained in this NFO (such as dates, page numbers, clarification of discrepancies, etc.). Questions related to eligibility or the merits of a specific proposal will not be addressed. The agency anticipates making selections by June 21, 2024 and expects to execute awards by September 1, 2024. These dates are estimates and are subject to change.

Notice of Funding Opportunity Description Background The Food and Drug Administration (FDA) protects the public health by ensuring that medical products intended to be marketed in the United States are safe and effective for their intended use. FDA stakeholders are exploring innovative ways to produce scientific evidence in support of regulatory submissions, including the development of new data sources, study designs, methodologies, and technologies. FDA encourages and facilitates the use of such innovative approaches while ensuring that the scientific evidence supporting marketing approvals meet our high evidentiary standards. The Prescription Drug User Fee Act VII (PDUFA VII) commitment letter represents the product of discussions between the FDA, regulated industry, and public stakeholders, as mandated by Congress. The performance and procedural goals and other commitments specified in the PDUFA VII commitment letter apply to aspects of the human drug review program that are important for facilitating timely access to safe, effective, and innovative new medicines for patients. The commitment letter includes goals relating to the use of digital health technologies (DHTs) to support drug development and review. A DHT is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. DHTs may rely on or work with other technologies that support their operation, such as general-purpose computing platforms (e.g., smartphones) and communication networks. Among other activities relating to the use of DHTs, FDA has established a Framework for the Use of DHTs in Drug and Biological Product Development to guide the use of DHT-derived data in regulatory decision-making for drugs (hereinafter Framework ). The Framework highlights FDA’s DHT efforts including workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents. In addition, FDA’s webpage DHTs for Drug Development (available at: https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development) provides an overview of the ongoing DHT efforts, including demonstration projects. A variety of project types are welcomed under this NOFO, applicable to drugs and biologics (not devices). FDA is particularly interested in projects that evaluate the use of DHTs in drug development. Project Objectives The overarching goal of this notice of funding opportunity (NOFO) is to explore the role of DHTs (e.g., actigraphy, photography, environmental sensors) in the evaluation of new drugs. These projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders. The objectives of these projects are to advance DHTs for clinical drug development, expand the ability to capture early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs and enhance convenience for trial participants by allowing for remote data acquisition in clinical investigations. The scope includes, but is not limited to, projects that focus on: Comparing digital measurements to traditional measurements in clinical trials to evaluate drugs Developing and evaluating novel endpoints using DHTs to address unmet needs for drug clinical trials (e.g., use of environmental sensors to capture apnea in pediatric patients) Comparing metrics to evaluate continuous measurements (e.g., maximum activity and stamina) Capturing early manifestations of chronic diseases (e.g., dementia) through the use of DHTs

Notice of Funding Opportunity SummaryNRCS is announcing the availability of Conservation Innovation Grants (CIG) Caribbean Area Program funding to stimulate the development and adoption of innovative conservation approaches and technologies. Applications are accepted from eligible entities (Section C) for projects carried out in the Caribbean Area (Puerto Rico (PR) and the U.S. Virgin Islands (USVI)). A total of up to $500,000 is available for the Caribbean Area CIG competition in FY 2024. All non-Foreign, non-federal entities (NFE) and individuals are invited to apply, with the sole exception of federal agencies. Projects may be between one and three years in duration. The maximum award amount for a single award in FY 2024 is $100,000. For new users of Grants.gov, see Section D. of the full Notice of Funding Opportunity for information about steps required before submitting an application via Grants.gov. Completing all steps required to start an application can take a significant amount of time, plan accordingly.Key DatesApplicants must submit their applications via Grants.gov by 11:59 pm Eastern Time on May 15, 2024 For technical issues with Grants.gov, contact Grants.gov Applicant Support at 1-800-518-4726 or [email protected]. Awarding agency staff cannot support applicants regarding Grants.gov accounts. For inquiries specific to the content of the NFO requirements, contact the federal awarding agency contact (section G of this NFO). Please limit questions to those regarding specific information contained in this NFO (such as dates, page numbers, clarification of discrepancies, etc.). Questions related to eligibility, or the merits of a specific proposal will not be addressed.A webinar for CIG applicants is scheduled for April 9, 2024 at 9 a.m. Atlantic Standard Time. Information on how to participate in the webinar will be posted to the HYPERLINK website. Applicants are encouraged to visit the Caribbean Area CIG website to learn more about the CIG program.The agency anticipates making selections by June 30, 2024 and expects to execute awards by July 30, 2024. These dates are estimates and are subject to change.

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.

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 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.