Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities
ID: 360124Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $3M

Eligible Applicants

Others

Funding Category

Food and Nutrition

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The Food and Drug Administration (FDA) is offering a grant opportunity titled "Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities." This initiative aims to enhance understanding of drug shortages and identify vulnerable products, particularly those prone to health fraud, while supporting outsourcing facilities in the development of critical medications. The FDA plans to allocate up to $3 million to fund two research projects over a maximum period of three years, with applications due by August 8, 2025. Interested applicants can reach out to Patrick Johnson at patrick.johnson@fda.hhs.gov for further information and are encouraged to review the detailed funding announcement available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-023.html.

    Point(s) of Contact
    Files
    Title
    Posted
    The U.S. Food and Drug Administration (FDA) announces funding opportunities aimed at understanding and addressing drug shortages and their susceptibility to fraud. The primary goal is to identify vulnerable drug products, especially those regularly in shortage or historically associated with fraudulent activities, and to support outsourcing facilities in developing these drugs. This initiative seeks to strengthen the pharmaceutical supply chain and mitigate public health risks associated with inadequate access to essential medications. The FDA plans to allocate $3 million to support up to two research projects through the R01 Research Project Grant mechanism. Eligible applicants include various organizations such as higher education institutions and nonprofit organizations. Funding will be available for a maximum of three years, with an application due date of August 8, 2025. The successful applicants will conduct research to identify drugs that are at risk for shortages or fraud, collaborate with healthcare providers to determine needs, and manage a sub-grant program to facilitate outsourcing facilities' research and production efforts. This initiative underscores the FDA's commitment to promoting drug quality, increasing supply, and protecting public health by reducing vulnerabilities to health fraud.
    Similar Opportunities
    Collaborations to Enhance Drug Development and Regulatory Science
    Food and Drug Administration
    The Food and Drug Administration (FDA) is inviting applications for a federal grant titled "Collaborations to Enhance Drug Development and Regulatory Science." This opportunity aims to establish cooperative agreements that support Public-Private Partnerships and collaborative activities under the Critical Path Initiative, focusing on innovative projects that enhance drug product development, advanced manufacturing, and the translation of scientific discoveries into therapeutics. The initiative is crucial for fostering innovation in drug safety, efficacy, quality, and performance, with a total funding ceiling of $5 million available for six expected awards in fiscal year 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information.
    Center for Research on Complex Generics (U18) Clinical Trials Optional
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the establishment of a Center for Research on Complex Generics through a cooperative agreement. This initiative aims to enhance collaboration with the generic drug industry, focusing on identifying scientific challenges in generic product development and facilitating research that supports the FDA's mission to improve patient access to high-quality, safe, and effective generic drugs. The Center will serve as a hub for coordination among FDA, academia, and industry stakeholders, conducting research, hosting workshops, and providing public access to research outcomes. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610. The funding amount is set at $1.5 million, with one award anticipated for the fiscal year 2025.
    Manufactured Foods Flexible Funding Model (MF-FFM)
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Manufactured Foods Flexible Funding Model (MF-FFM)" aimed at advancing a nationally integrated food safety system. This cooperative agreement seeks to support initiatives related to Manufactured Food Regulatory Program Standards (MFRPS), dietary supplement safety, and state compliance and enforcement infrastructure, with a focus on enhancing food safety practices across jurisdictions. The program is critical for ensuring that state regulatory programs maintain high-quality standards and best practices in food safety. Interested applicants, which include state, local, territorial, and tribal agencies, as well as non-profit training entities collaborating with higher education institutions, can reach out to Gordana Zuber at gordana.zuber@fda.hhs.gov or by phone at 301-348-1747 for further details. The estimated project start date is July 1, 2023, with approximately 50 awards expected under this discretionary funding opportunity.
    Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
    Food and Drug Administration
    The Food and Drug Administration (FDA) is announcing a funding opportunity for a Cooperative Agreement titled "Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)." This initiative aims to support research and development of practices that mitigate risks associated with nitrosamine impurities in human drugs, thereby enhancing public health safety while ensuring access to essential therapeutic drugs. The FDA seeks to fund one award with a total funding amount of $350,000, with no cost-sharing or matching requirements. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information. The opportunity is forecasted for fiscal year 2024, and applicants may submit multiple distinct applications, adhering to guidelines regarding overlapping submissions.
    Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F)," aimed at enhancing state manufactured food regulatory programs. This cooperative agreement seeks to support the development and maintenance of Manufactured Food Regulatory Program Standards (MFRPS) to ensure high-quality regulatory frameworks that improve food safety and reduce foodborne illness hazards. Eligible applicants include state, tribal, and territorial food safety programs with existing FDA food safety inspection contracts or those willing to enter into such contracts, with funding amounts ranging from $340,000 to $1,285,000 per year. Interested parties can contact Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information, with applications expected to align with the fiscal year 2024 timeline.
    Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a federal grant opportunity titled "Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)." This grant aims to fund clinical trials that evaluate the efficacy and safety of products intended to address unmet needs in rare diseases or conditions, with the goal of increasing the number of approved treatments in this area. The initiative is crucial for enhancing drug development for rare diseases, thereby potentially improving patient outcomes. Interested applicants, including higher education institutions, nonprofits, for-profit organizations, and various levels of government, can reach out to Kimberly Pendleton at Kimberly.Pendleton@fda.hhs.gov or call 240-402-7610 for more information. The opportunity is currently posted for the fiscal year 2025, with no cost-sharing or matching requirements.
    Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01)," aimed at advancing research in Anesthesia, Addiction Medicine, and Pain Medicine. Applicants are required to propose comprehensive, evidence-based plans that focus on critical areas such as clinical trial endpoints for chronic pain, outcome measures for stimulant use disorders, and assessments of opioid clinical trials, among others. This initiative is vital for enhancing the understanding and management of analgesics and anesthetics, particularly in vulnerable populations. The FDA anticipates awarding five grants, each with a funding ceiling and floor of $2 million, with applications due for the fiscal year 2025. Interested parties can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information.
    OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a grant opportunity titled "OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed." This initiative aims to enhance the FDA's Office of Minority Health and Health Equity (OMHHE) efforts by funding research and community-based strategies that promote education and public awareness regarding the risks associated with over-the-counter skin lightening products containing hydroquinone and/or mercury. The grant, which has a fixed award amount of $250,000, is open to unrestricted applicants and is part of the fiscal year 2024 funding cycle. Interested parties can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information.
    Laboratory Flexible Funding Model (LFFM)
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled the Laboratory Flexible Funding Model (LFFM) aimed at enhancing the capacities of state human and animal food testing laboratories to support an integrated food safety system. This cooperative agreement focuses on prioritized sample testing and method development in microbiology, chemistry, and radiochemistry, with the goal of improving food safety and defense capabilities. The program is crucial for preventing foodborne illnesses and ensuring the safety of food in the U.S., with approximately $25 million in funding anticipated for fiscal year 2025 and a total of 75 awards expected. Eligible applicants include accredited private institutions of higher education and government entities, with key deadlines starting with letters of intent due on January 17, 2025. For further details, interested parties can contact Lisa Pendleton at lisa.pendleton@fda.hhs.gov or refer to the funding announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-007.html.
    Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
    Food and Drug Administration
    The U.S. Food and Drug Administration (FDA) has announced a Notice of Funding Opportunity (NOFO) titled "Reissue of RFA-FD-23-001 - Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)." This initiative aims to fund clinical trials that evaluate the efficacy and safety of orphan products for rare diseases, with the goal of addressing unmet medical needs and increasing the number of approved treatments in this area. The funding opportunity encourages innovative trial designs and collaboration among various stakeholders, emphasizing the importance of patient engagement throughout the research process. Eligible applicants include a wide range of organizations, with funding amounts reaching up to $900,000 per year, and applications are due by May 16, 2028. For further inquiries, interested parties can contact Kimberly Pendleton at Kimberly.Pendleton@fda.hhs.gov.