Project Number: 6028-32000-005-07-N
Project Type: Nonfunded Cooperative Agreement
Start Date: Jun 1, 2011
End Date: May 31, 2014
Collaborate in planning/conducting research, preparing submissions and providing other input to gain an FDA-approved label for use of Triangle Brand (c) Copper Sulfate as an aquaculture therapeutant. Label claims will be for: 1) the treatment of ichthyophthiriasis (Ichthyophthirius multifiliis) on Ictalurid catfish cultured in earthen ponds and 2) to control egg mortality associated with Saprolegniasis infecting channel catfish eggs.
The Food & Drug Administration (FDA) must approve any label claim of a particular drug/compound used to treat a specific disease. Requirements by FDA include the five major technical sections: 1) Chemistry, Manufacturing, and Controls, 2) Effectiveness, 3) Human Food Safety, 4) Target Animal Safety, and 5) Environmental Safety, and two minor technical sections: 1) All Other Information and 2) Labeling. Signatories to this agreement will collaborate in joint efforts on all technical sections to gain FDA-approval for use of Triangle Brand (c) Copper Sulfate as an aquaculture therapeutant by developing and exchanging data corresponding to the specialty of each entity.