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  1. CVM Updates

FDA Announces Minor Use/Minor Species (MUMS) Grant Application Period Due January 12, 2018

November 16, 2017

The Food and Drug Administration (FDA) announced an open period for applications for grants to support the development of new animal drugs intended for minor species or minor uses (MUMS) in major species (major species are horses, dogs, cats, cattle, pigs, turkeys and chickens). This is Funding Opportunity Announcement #RFA-FD-15-004. Applications must be submitted electronically by January 12, 2018, through www.grants.gov.

The grant program was established by the Minor Use and Minor Species Animal Health Act of 2004, and funding was authorized to start after finalization of regulations to implement the Designation provisions of Section 573 of the Federal Food, Drug & Cosmetic Act.

Eligibility requirements to apply for a MUMS grant include: 1) the drug must be “designated” by the FDA Center for Veterinary Medicine’s (CVM) Office of Minor Use and Minor Species Animal Drug Development (OMUMS) under the MUMS Act (Designations List); 2) the grant funding must be used to defray the costs of qualified safety and effectiveness testing expenses associated with the development of the drug for the designated intended use; and 3) interested parties must have a study protocol that has been accepted by FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) prior to submitting the grant application.

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 a protocol for the stand-alone method validation study has been accepted by ONADE. Certain manufacturing studies as described in the FOA that are supportive of target animal safety or effectiveness are also eligible for funding, with an ONADE-accepted protocol.

Subject to the availability of funds, grants will be available for up to $100,000 per year for up to two years for routine studies; and up to $150,000 per year for up to two years for studies of unusual complexity, duration or size. A third year of funding may be available for long-term toxicology studies. Therefore, grants could range from under $100,000 for a routine study that could be completed in less than a year, to $300,000 for a complex study requiring two years for completion, to $450,000 for a long-term toxicology study. An indirect cost rate of 10% of modified total direct costs will be allowed if the applicant organization does not have a negotiated Federal indirect cost rate agreement.

The complete Request for Applications is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-004.html.