December 1, 2023
Today, the U.S. Food and Drug Administration 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. The available funding for this open period is limited.
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 $7.07 million in support of 66 studies. In June of 2023, the FDA awarded a new grant of $249,504 to Intervet, Inc., for its study, “Environmental Assessment for SLICE (emamectin benzoate) Type A Medicated Article for Freshwater-Reared Salmonids.” This study will support the Environmental Impact technical section for SLICE for the control of Salmincola californiensis on freshwater-reared Oncorhynchus mykiss.
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-21-179. The due date to submit an optional Letter of Intent to apply for a grant is December 15, 2023, and applications must be submitted by February 2, 2024, through the NIH ASSIST system or www.grants.gov. The complete NOFO is available at https://grants.nih.gov/grants/guide/pa-files/PAR-21-179.html.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.