Minor Use Minor Species Development of Drugs (R01)

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Description

This opportunity, issued by the FDA Center for Veterinary Medicine (CVM), supports research projects (R01) focused on the development of new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The grant aims to defray the costs of qualified safety and effectiveness testing required for FDA approval of MUMS-designated drugs. Projects must be directly related to the development of drugs for veterinary use in these specific contexts.

Applicants must be actively developing a drug for veterinary use or be a research partner with such an entity. The drug under investigation must have an open Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" from the FDA/CVM Office of Minor Use and Minor Species Animal Drug Development (OMUMS). Additionally, the proposed study protocol must be reviewed and concurred with by the FDA/CVM Office of New Animal Drug Evaluation (ONADE) prior to application submission.

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Due Dates

• Forecasted for Fiscal Year 2025
• Exact application due date has not yet been announced; monitor Grants.gov opportunity page for updates.

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Funding Amount

• Award ceiling: $250,000 per project
• Award floor: $250,000 per project
• Expected number of awards: 6
• Single-year funding; no cost sharing or matching required

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Eligibility

Eligible applicants include:

• State, county, city, or township governments
• Special district governments
• Independent school districts
• Public and state-controlled institutions of higher education
• Private institutions of higher education
• Native American tribal governments (federally recognized and other)
• Public housing authorities/Indian housing authorities
• Nonprofits (with or without 501(c)(3) status, excluding higher education institutions)
• For-profit organizations (including small businesses)
• Unrestricted (open to any type of entity listed above)

Additional requirements:

• The applicant must be developing a drug for veterinary use or be a research partner with such an entity.
• The drug must have an open INAD file and a MUMS designation for the specified intended use.
• The study protocol must be reviewed and concurred with by FDA/CVM ONADE before application.

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Application Process

1. Ensure your project meets all eligibility requirements, including INAD file, MUMS designation, and ONADE protocol concurrence.
2. Prepare your application according to the R01 grant guidelines.
3. Submit your application via Grants.gov once the opportunity is officially posted and the due date is announced.
4. Monitor the opportunity page for updates regarding deadlines and application instructions.

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Additional Information

• No cost sharing or matching is required.
• The grant is intended to support safety and effectiveness testing for drugs that could satisfy FDA approval requirements for MUMS-designated drugs.
• Only projects with prior FDA protocol concurrence are eligible.

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External Links

• FDA Home Page
• Grants.gov Opportunity Page (FOR-FD-24-013)
• FDA Contact Page

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Contact Information