Grants for State governments - Consumer Protection

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.

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.

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.

The ConnectALL Initiative's Municipal Infrastructure Program (MIP) is designed to foster the development of open-access, publicly owned, and/or controlled last-mile fiber broadband infrastructure. This initiative aims to deliver reliable high-speed internet services to homes, businesses, and community anchor institutions throughout New York State. The program's mission aligns directly with the New York State Urban Development Corporation d/b/a Empire State Development ("ESD") objectives to promote a vigorous and growing state economy, encourage business investment and job creation, and support diverse, prosperous local economies across NYS. By addressing broadband access, the MIP contributes to ESD's broader strategy of using grants and other forms of assistance to facilitate economic development and improve quality of life for residents. The target beneficiaries of the MIP include communities across New York State that are currently experiencing connectivity challenges due to a lack of affordable, high-speed internet infrastructure. Specifically, the program aims to connect homes, businesses, and community anchor institutions. The primary impact goal is to improve broadband access, thereby reducing the digital divide and enabling greater participation in the digital economy. Expected outcomes include a significant increase in the availability of reliable, high-speed internet, leading to enhanced economic opportunities, improved educational access, and better access to essential services for residents and businesses in underserved areas. The program's priorities and focuses revolve around the construction of new infrastructure or the acquisition of existing infrastructure. This includes last-mile fiber connections to address last-mile infrastructure (cabling, wires, pole replacements, radios) and drops to buildings. It also emphasizes fiber connections to Internet Exchange Points or Data Centers, including middle-mile fiber and networking equipment. A key focus is on ensuring open-access and predominantly publicly controlled infrastructure, leveraging funding from the U.S. Department of Treasury Capital Projects Fund (CPF) to achieve these objectives. The ConnectALL Initiative's strategic priorities are deeply rooted in addressing fundamental connectivity gaps across the state. The theory of change posits that by investing in publicly controlled, open-access fiber broadband infrastructure, the state can stimulate economic growth, create jobs, and foster more equitable access to information and opportunities. The expected measurable results include the deployment of new fiber optic networks, the number of homes, businesses, and community anchor institutions connected, and ultimately, an improvement in the overall broadband speed and affordability available to New Yorkers. The total funding available for this program is $228 Million, with a maximum grant size of $30 million per award, indicating a significant investment to achieve these transformative goals.

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.

Youth Service America's (YSA) "We Serve to Remember 9/11 Day of Service Grants" program is designed to empower young changemakers aged 5 to 25. This initiative directly aligns with YSA's mission of engaging youth in service and fostering active citizenship. The grants support organizations, schools, and youth changemakers in planning and implementing service activities that honor and pay tribute to those affected by 9/11. The program emphasizes youth leadership, ensuring that projects are driven by the young participants themselves, thereby developing their leadership skills and sense of community responsibility. The program's target beneficiaries are primarily youth, with a strong focus on engaging those who are not typically asked to serve and face systemic barriers to participation. This includes young people of color, youth from underserved low-income families and neighborhoods, and youth who are often beneficiaries of service rather than participants. Specific groups identified include youth in rural communities, those experiencing homelessness, youth in foster care, youth with disabilities, youth in the juvenile justice system, immigrants or refugees, youth from military families, LGBTQ+ youth, and English language learners. The impact goal is to create a more inclusive service environment and empower a diverse group of young people to contribute to their communities. A key priority of this grant program is the engagement of at least 100 youth volunteers per project, with 80% of these volunteers identifying as youth facing systemic barriers to participation. Projects must include elements to honor and pay tribute to those who lost their lives on 9/11, their families, and those who responded in service. All activities must take place on or around September 11th National Day of Service and Remembrance (September 11, 2024). This specific timing reinforces the program's focus on remembrance and national service. YSA expects to award up to 100 grants of $1,000 each. The expected outcomes include a significant increase in youth engagement in service, particularly among marginalized groups, and the successful execution of service activities that commemorate 9/11. Measurable results will include the number of grants awarded, the number of youth volunteers engaged, and the percentage of those volunteers who identify as facing systemic barriers. The program also aims to foster a sense of civic duty and historical awareness among participants. The foundation's strategic priorities are centered on youth empowerment and inclusive participation in service. YSA's theory of change posits that by providing resources and opportunities, particularly to underserved youth, they can develop leadership skills, strengthen communities, and create a lasting impact. By focusing on youth-led projects and ensuring diverse representation, YSA aims to build a generation of civically engaged individuals who are committed to addressing community needs and remembering significant historical events. Applicants must be based in the United States, with activities benefiting people in the U.S., including its territories. This geographical focus ensures that the grants support local communities across the nation. The emphasis on reaching youth who face systemic barriers aligns with a broader strategic goal of promoting equity and inclusion within the service sector, demonstrating YSA's commitment to a more representative and impactful youth service movement.

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.

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 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.

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

The purpose of the SNAP Fraud Framework Implementation Grant Program is to support State agency efforts to improve and expand recipient fraud prevention, detection, and investigation efforts using the procedures, ideas and practices outlined in the SNAP Fraud Framework.Organizational Management: This objective aims to help States establish and communicate priorities, organize employees, and manage both large-scale and day-to-day processes. Many of the concepts described in this component are the foundation for successful program integrity initiatives.Performance Measurement: This objective offers recommendations encouraging States to consistently capture and analyze their own performance.Recipient Integrity Education: This objective provides targeted integrity education initiatives to help ensure recipients have the necessary information and tools to use SNAP benefits as intendedpreventing fraud before it occurs. When producing recipient integrity education materials, States are encouraged to educate the public and applicants about SNAP fraud, rather than emphasize the consequences as a deterrent to applying.Fraud Detection: Here, the SNAP Fraud Framework stresses the importance of proactively detecting fraud from the application process and continuing throughout the recipients time in the Program.Investigations and Dispositions: This objective aims to provide states with tools and suggestions to improve fraud case management from initial fraud referral through disposition.Analytics and Data Management: This objective details the necessary people, processes, and technology to launch and maintain an analytics capability. Data analytics can play a valuable role in preventing, detecting, and investigating SNAP fraud.Learning and Development: The final objective contains recommendations for States to invest in training and professional development opportunities to promote employee engagement and to ensure employees are aware of new and emerging trends in fraud.Please read the entire request for applications (RFA) for additional information.

This funding opportunity supports clinical trials aimed at developing new therapies for rare neurodegenerative diseases, such as ALS, and is open to a wide range of eligible organizations, including universities and nonprofits.

This funding opportunity provides financial support to U.S.-based organizations, including universities, nonprofits, and businesses, to help outsourcing facilities produce critical medications that are in short supply and vulnerable to fraud.

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 grant provides funding for DC-based individuals, community groups, and nonprofit organizations to create innovative public programs that showcase existing oral history collections and engage the local community.

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.

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.

This funding opportunity provides financial support to nonprofit organizations in Santa Barbara for social services, infrastructure improvements, and economic development projects that assist low- and moderate-income residents.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit grant applications from neutral, independent institutions and/or organizations to support meetings (e.g., conferences, workgroups, roundtables) that convene a broad range of multiple stakeholders, including those with relevant expertise, to explore, research, and address issues related to medical products, policy, and surveillance methods and systems. Support includes, but is not limited to the design, planning, execution, synthesis, summary, and communication of findings from these forums to a broad range of organizations and individuals.

This funding opportunity provides $1 million to various organizations to develop and implement strategies for effectively sharing clinical practice guidelines, particularly in underserved communities, to improve healthcare quality and equity.