FDA Announces Minor Use/Minor Species Grant Program Awards
September 21, 2010
The Food and Drug Administration has awarded two additional grants 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.) One of the funded studies is to support an aquaculture drug approval and the other will support development of a drug product for use in goats.
The U.S. Fish & Wildlife Service’s Aquatic Animal Drug Approval Partnership Program in Bozeman, Montana received funding for a study entitled Efficacy of SLICE to control Salmincola spp. infestations in rainbow trout as a representative of all freshwater-reared salmonids.
The Iowa State University of Science and Technology in Ames, Iowa received the other grant award for their study entitled Efficacy of CIDR-G Intravaginal Implants for synchronization of estrus in 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 & 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.
The next opportunity to apply for grant funding under this program is scheduled to begin on February 4, 2011.