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          FDA Opening First FY2024 Grant Funding Application Period for Animal Drugs for Minor Uses and Minor SpeciesCVM Updates FDA Opening First FY2024 Grant Funding Application Period for Animal Drugs for Minor Uses and Minor Species
  
  					Sponsors with Designated MUMS animal drugs who meet the eligibility requirements or their research partners are encouraged to apply.
	
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On May 26, 2023, the U.S. Food and Drug Administration will open 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 $6.82 million in support of 65 studies. In December of 2022, the FDA awarded a new grant of $250,000 to Anivive Lifesciences, Inc., for a comparability protocol for 22.5 mg verdinexor tablets. This study will support the Chemistry, Manufacturing and Controls technical section for Laverdia-CA1 (verdinexor) for the treatment of lymphoma in dogs. The FDA conditionally approved Laverdia-CA1 for this intended use on January 11, 2021.

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 12, 2023, and applications must be submitted by July 28, 2023, 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 .

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.

**Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.**

                                                                                  Content current as of:
      05/24/2023CVM Updates
 
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