May 31, 2022
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). 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 more than $5.86 million in support of 64 studies. In January 2022, the FDA awarded a new grant to AQUI-S New Zealand, Ltd. for $250,000, for an oral two-generation reproductive toxicity study of eugenol in rats. This study is intended to support the human food safety technical section needed for approval of eugenol to sedate freshwater finfish to handleable condition.
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 June 13, 2022, and applications must be submitted by July 29, 2022, through www.grants.gov or the NIH ASSIST system. 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.