Grants for Special district governments - Consumer Protection

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

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.

The Tobacco Grant Program, administered by the Office of the Attorney General, California Department of Justice, aims to foster a healthier California by curtailing illegal cigarette and tobacco sales and marketing to minors. This highly competitive program, enabled by Proposition 56, allocates funds to applicants with robust enforcement capabilities. Funded agencies will focus on enforcing tobacco-related laws, conducting retailer and online inspections, and enhancing local coordination and education efforts.

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.

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 grant provides funding to organizations in Texas that promote financial literacy and consumer credit education, helping communities improve their financial stability at little or no cost.

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

This funding opportunity provides up to $1.5 million to organizations that can foster collaboration between the FDA and the generic drug industry, focusing on research and development of complex generics to improve access to safe and effective medications.

This funding opportunity supports innovative research and collaboration to develop therapies for ultra-rare cancers, targeting both pediatric and adult populations, and is open to a diverse range of applicants including nonprofits, educational institutions, and businesses.

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.

This funding opportunity provides $1.5 million to state, local, territorial, or tribal agencies and nonprofit training organizations partnering with accredited colleges to create a centralized training system for food safety regulation and laboratory education.

This funding opportunity supports research aimed at developing innovative medical products for the prevention, diagnosis, and treatment of ALS and other rare neurodegenerative diseases, welcoming applications from a diverse range of organizations.

This funding opportunity supports a wide range of organizations in researching and developing standardized methods to evaluate and treat heart-related side effects caused by cancer therapies.

This funding opportunity provides $1 million to various organizations to develop innovative strategies that promote health equity and increase participation from underrepresented groups in clinical research.

This funding opportunity provides financial support for organizations to develop innovative educational programs that raise awareness about the risks associated with skin lightening products, particularly for minority communities.

This funding opportunity provides financial support for clinical trials aimed at developing new treatments for rare neurodegenerative diseases, benefiting a wide range of organizations including universities, nonprofits, and businesses across the country.

This funding opportunity provides financial support to a wide range of organizations, including governments, educational institutions, and nonprofits, to enhance surveillance and detection of antibiotic resistance in food products, ultimately improving public health and food safety.