June 14, 2019
The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development and 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). The individual award amount has been increased to a single funding level up to $250,000.
The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS act) provides 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. The MUMS act established the grant program.
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.
To date, the MUMS grant program has provided more than $4 million in support of 61 studies.
Applying for MUMS Grants
Only eligible applicants pursuing FDA approval of MUMS drugs for veterinary use, or their research partners, are eligible to apply for grants. Additional eligibility requirements include:
- The entity pursuing the drug approval
- must have opened an Investigational New Animal Drug (INAD) file with the FDA’s Center for Veterinary Medicine (CVM), and;
- must hold a MUMS designation granted by CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use.
- The entity or its research partner must use the funding, if awarded, to assist in defraying the costs of qualified safety and effectiveness testing associated with the development of the drug for the designated intended use; and
- CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed and accepted the study protocol prior to grant application submission.
Qualified studies include those intended to support target animal safety or effectiveness, environmental safety, or human food safety. For human food safety, a separate study to validate an analytical method prior to conduct of an in-life study is eligible for funding, if ONADE has accepted a protocol for the stand-alone method validation study. Certain manufacturing studies that are supportive of target animal safety or effectiveness are also eligible for funding.
Subject to funding availability, grants will be available for up to $250,000 per year for up to two years for routine studies. A third year of funding may be available for long-term toxicology studies. The grant program allows an indirect cost rate of 10% of modified total direct costs if the applicant does not have a negotiated Federal indirect cost rate agreement.
The complete FOA is available at https://grants.nih.gov/grants/guide/pa-files/PAR-18-827.html.
More information about the MUMS grant program and how to apply for MUMS grants is available at:
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.