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United States Department of Agriculture

Agricultural Research Service

Research Project: Collaborative Effort to Gain Fda-Approval for Use of Triangle Brand (C) Copper Sulfate As An Aquaculture Therapeutant

Location: Harry K. Dupree Stuttgart National Aquaculture Research Center

Project Number: 6225-32000-005-07
Project Type: Nonfunded Cooperative Agreement

Start Date: Jun 01, 2011
End Date: May 31, 2014

Objective:
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.

Approach:
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.

Last Modified: 4/18/2014
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