FDA opens first FY2025 grant funding application period for animal drugs for minus uses and minor species

The U.S. Food and Drug Administration has opened a new period for applications for grants to support the development and potential approval or conditional approval of new animal drugs.

May 24, 2024

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The U.S. Food and Drug Administration has opened a new period for applications for grants to support the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species (MUMS drugs).

The maximum individual award amount is $250,000 per year per awardee, for up to two years for routine studies ($500,000 total) and up to three years for toxicology studies ($750,000 total). Grant amount and availability is always dependent upon available funding.

Only animal drug sponsors with Designated MUMS animal drugs or their research partners are eligible to apply. Applicants must also meet other eligibility requirements.

To date, the MUMS grant program has provided $7.48 million in support of 68 studies. In January of 2024, the FDA awarded two new grants. The first was $205,612 to Iowa State University of Science and Technology, for its study, “Analytical Method Validation to Detect and Quantify Tulathromycin Residues in Caprine Liver.” The second was $209,928 to Phibro Animal Health, for its study “Environmental Assessment for Oxytetracycline Dihydrate Administered to Shrimp.”

The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act) helps provide innovative ways to bring products to market for these small populations and is designed to help veterinary pharmaceutical companies and others overcome the financial roadblocks they face in providing animal drugs for a limited market. Before this legislation, veterinary pharmaceutical companies and others would rarely attempt to bring such drugs to market.

Grants awarded through the MUMS program support the FDA’s continuing mission to assure that safe and effective animal drugs are available for a wide range of species and conditions. MUMS grants have been awarded to support product development for a variety of indications, including the treatment and control of specific parasitic and bacterial diseases in various fish species, the treatment of particular cancers in dogs, and some uses for horses, pheasants, and goats.

This is Notice of Funding Opportunity (NOFO) Announcement Number PAR-24-216. The due date to submit an optional Letter of Intent to apply for a grant is June 21, 2024, and applications must be submitted by July 26, 2024, through the NIH ASSIST system or www.grants.gov. The complete NOFO is available at PAR-24-216: Minor Use Minor Species Development of Drugs (R01) (nih.gov).

More information about the MUMS grant program and how to apply for MUMS grants is available at Minor Use/Minor Species (MUMS) Grants and How to Apply for a MUMS Grant.

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