First FDA Minor Use/Minor Species (MUMS) grant awards go to aquaculture
The U.S. Food and Drug Administration has awarded the first two grants to support the development of new animal drugs intended for minor species or minor uses in major species. Both of the funded studies are to support aquaculture drug approvals.
The U.S. Geological Survey’s Upper Midwest Environmental Sciences Center in La Crosse, Wisconsin received funding for a study entitled Efficacy of 35% PEROX-AID to control mortality caused by Saprolegnia parasitica or Saprolegnia diclina in walleye Sander vitreum. This project will study the effectiveness of hydrogen peroxide in controlling mortality caused by a serious fungal disease (saprolegniasis) in walleye fish.
The Texas Agrilife Research Mariculture Laboratory in Port Aransas, Texas received the other grant award for their study entitled Target Animal Safety of Litopenaeus vannamei treated with oxytetracycline in feed. This study will test the safety of oxytetracycline when the drug is fed to shrimp as a medicated feed.
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). The implementing regulations for Designation were finalized in July 2007, and Congress appropriated money to support the program in March of this year.
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.
FDA will again announce the opportunity to apply for grant funding under this program in the near future.
