May 29, 2009
The Food and Drug Administration (FDA) Thursday announced the initiation of a grant program to support the development of new animal drugs intended for minor species or minor uses in major species, including sheep and goats.
The grant program was established by the Minor Use and Minor Species (MUMS) 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 and Cosmetic Act). The implementing regulations for designation were finalized in July 2007, and Congress appropriated money to support the program in March of this year.
FDA now has $750,000 to offer in MUMS grants for the fiscal year ending Sept. 30, 2009.
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.
"This is good news for the sheep industry because the grants actually allow research and development to be done on drugs that we ordinarily wouldn't be able to access or use for treatment or prevention in the sheep and goat industry as well as allow companies to do work to get drugs cleared by those entities that have to okay them," said Jim Logan, DVM, chair of the American Sheep Industry Association's Animal Health Committee. "It's a big thing for not only our industry but also for other minor species as well."
The complete Request for Applications is available at Research Project Grant (R01)
. Applications must be submitted electronically at http://www.grants.gov/
by July 1, 2009.