USA - FDA Announces Minor Use/Minor Species Grant Program Request for Applications

The Food and Drug Administration announced the publication of a Request for Applications for a grant program to support the development of new animal drugs intended for minor species or minor uses in major species. (Major species are horses, dogs, cats, cattle, pigs, turkeys and chickens.)

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 the statute. (Section 573 of the Federal Food, Drug & Cosmetic Act)  

In accordance with the statute, a MUMS grant must be for the purpose of “defraying the costs of qualified safety and effectiveness testing expenses incurred in connection with the development of designated new animal drugs.” Qualified testing occurs after the date a drug is designated under Section 573 of the act and before the date on which a new animal drug application for the drug is submitted under Section 512 of the act. In addition, a study for which a grant is sought must be subject to a protocol accepted by the Center for Veterinary Medicine prior to the submission of a grant application.

Grants for total costs will be available for up to $50,000 per year for up to two years for routine studies; and up to $100,000 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 $50,000 for a routine study that could be completed in less than a year, to $200,000 for a complex study requiring two years for completion, to $300,000 for a long-term toxicology study.

The complete Request for Applications is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-10-001.html  and applications must be submitted electronically through Grants.gov (http://www.grants.gov/) by September 3, 2010.