Minor Use Minor Species Development of Drugs (R01)
ID: 354573Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $250K

Eligible Applicants

Others

Funding Category

Food and Nutrition

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/354573

Additional Information

https://grants.nih.gov/grants/guide/pa-files/PAR-24-216.html
Timeline
    Description

    The Food and Drug Administration (FDA) is inviting applications for the Minor Use Minor Species Development of Drugs (R01) grant, aimed at supporting the development of new animal drugs for minor uses in major species or any uses in minor species. Eligible applicants must have an active Investigational New Animal Drug (INAD) file with the FDA and must hold a minor use or minor species designation for the drug under investigation, ensuring compliance with regulatory standards. This initiative underscores the FDA's commitment to enhancing veterinary drug development for underserved markets, with grants providing up to $250,000 annually for one-year projects, potentially extendable for long-term studies. Interested parties should submit their applications by the specified deadlines, with the next due date on July 29, 2024, and can contact Terrin Brown at terrin.brown@fda.hhs.gov for further information.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    PAR-24-216.html
    The Notice of Funding Opportunity (NOFO) from the Department of Health and Human Services, specifically from the U.S. Food and Drug Administration (FDA), invites applications for the development of new animal drugs under the Minor Use Minor Species (MUMS) program. This program aims to support research through R01 Research Project Grants for drugs intended for minor uses in major species or any uses in minor species. Eligible applicants must have an active Investigational New Animal Drug (INAD) file with the FDA and meet designated requirements prior to application submission. The funding opportunity spans from May 3, 2024, with application due dates extending into 2027. Each grant may support one-year projects with direct costs not exceeding $250,000 annually, potentially extending to three years for long-term studies. A thorough review will evaluate the scientific merit of proposals based on significance, investigator capabilities, methodology, and environment of the proposed research. Compliance with regulatory standards and submission requirements is mandatory, ensuring rigorous oversight for research involving animal subjects. The initiative signifies the FDA's commitment to enhancing veterinary drug development for underserved markets while adhering to comprehensive safety and efficacy evaluations.
    Similar Opportunities
    Minor Use Minor Species Development of Drugs (R01)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the development of drugs for minor uses in major species or for use in minor species through its Minor Use Minor Species Development of Drugs (R01) grant program. This initiative aims to support research projects that assist in the safety and effectiveness testing of new animal drugs designated for minor uses, with a focus on entities that have opened an Investigational New Animal Drug (INAD) file and received the necessary designations from the FDA's Office of Minor Use and Minor Species Animal Drug Development. The program is crucial for enhancing veterinary care options for less common animal species, ensuring that these drugs meet FDA approval standards. Interested applicants can apply for grants with a funding ceiling of $250,000, with an expected six awards available for the fiscal year 2025. For further inquiries, applicants may contact Terrin Brown at terrin.brown@fda.hhs.gov or by phone at (240) 402-7610.
    Animal and Veterinary Innovation Centers (U18)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is inviting applications for the Animal and Veterinary Innovation Centers (U18) funding opportunity, aimed at establishing long-term partnerships to address critical research areas in veterinary medicine. This initiative focuses on driving research to prevent and control Highly Pathogenic Avian Influenza (HPAI), advancing regulatory science for intentional genomic alterations in animals, and developing veterinary products for underrepresented species and conditions. With an estimated total program funding of $3 million and awards of up to $1.25 million available, applications are due by August 5, 2024. Interested applicants, particularly higher education institutions serving minority populations, can find more information and submission guidelines at the provided link or contact Terrin Brown at terrin.brown@fda.hhs.gov.
    Vet-LIRN Capacity-Building Project and Equipment Grants (U18)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering the Vet-LIRN Capacity-Building Project and Equipment Grants (U18) to enhance the capabilities of veterinary diagnostic laboratories within the Vet-LIRN network. This funding opportunity aims to support projects focused on animal food safety, antimicrobial resistance, and surveillance efforts related to foodborne illnesses and emerging diseases, including COVID-19. The initiative is part of the FDA's commitment to improving food safety standards and aligns with the Food Safety Modernization Act, emphasizing the importance of federal involvement in bolstering food safety and containment capabilities. Interested applicants, including small businesses and various institutions, can apply for grants ranging from $225,000 to $2.5 million, with applications accepted annually until September 4, 2028. For further details, contact Kimberly Pendleton at kimberly.pendleton@fda.hhs.gov or visit the full announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-23-202.html.
    Drug Development Tools Research Grants (U01) Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) to support research aimed at advancing drug development tools (DDTs) that have an accepted or reviewable Letter of Intent within the FDA's qualification program. These grants are intended for developers working towards their qualification plan or full qualification package, focusing on tools that can enhance public health by optimizing the drug development process, such as biomarkers or animal models. The funding opportunity provides up to $500,000 for a maximum two-year period, with applications due by May 13, 2024, and May 13, 2025. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information and are encouraged to review the detailed announcement available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html.
    Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives." This cooperative agreement aims to enhance the capabilities of State animal food regulatory programs to fully implement the Animal Feed Regulatory Program Standards (AFRPS) and to develop standardized processes that promote mutual reliance between federal and state regulatory efforts. The initiative is crucial for establishing a nationally integrated animal food safety system, ensuring that state programs can effectively manage animal food safety regulations. Interested organizations must meet specific eligibility criteria, including the ability to enter into a 20.88 information disclosure agreement with the FDA, and the funding amount is set at $10.6 million, with approximately 30 awards expected. For further inquiries, applicants can contact Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610.
    Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity for the collection of long-term data on antimicrobial use in animals, with a focus on diverse sectors such as livestock, poultry, and companion animals. The primary objectives of this initiative are to gather comprehensive antimicrobial use data and to contribute to the development of data collection frameworks that support antimicrobial stewardship in veterinary settings. This funding is crucial for advancing the FDA's initiatives and the National Action Plan's goals to enhance understanding and management of antimicrobial use in animal agriculture. Interested small businesses can apply for a total estimated funding of $600,000, with an award ceiling of $200,000 per project, and are encouraged to contact Janelle Fundersburg at janelle.fundersburg@fda.hhs.gov or 301-798-2533 for further information.
    Collaborations to Enhance Drug Development and Regulatory Science
    Active
    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.
    Animal Food Regulatory Program Alliance
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Animal Food Regulatory Program Alliance," aimed at enhancing the national food safety system through improved collaboration among federal and state agencies. The primary objective of this program is to support the development of a national integrated animal food safety system, which includes sharing best practices, conducting training programs, and advancing the Animal Food Regulatory Program Standards (AFRPS). This initiative is crucial for ensuring public health and consumer protection in the regulation of manufactured foods. Interested national associations or organizations that represent state animal food regulatory programs can apply for funding, with a total award amount of $600,000. For further inquiries, applicants may contact Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610. The fiscal year for this opportunity is 2025.
    Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
    Active
    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.
    Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional." This initiative aims to develop and validate an in vitro mechanistic methodology to assess the performance of amorphous solid dispersion (ASD) drug products under various clinically relevant conditions, ultimately enhancing the understanding of how food and acid-reducing agents affect drug absorption. The funding, which ranges from $250,000 to $500,000, is intended to support research that correlates in vitro observations with in vivo outcomes, thereby informing regulatory decisions for high-risk generic oral drug products. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information, with applications being accepted for the fiscal year 2024.