Submitted to: Meeting Abstract
Publication Type: Abstract Only
Publication Acceptance Date: 7/26/2005
Publication Date: 8/1/2005
Citation: Straus, D.L. 2005. Status of copper sulfate initial label claim [abstract]. Drug Approval Coordination Workshop Meeting Abstract. 11:112. Interpretive Summary:
Technical Abstract: The Human Food Safety technical section is complete for all fin fish - letter dated 02/09/2004 (submitted 05/16/1996). The Efficacy technical section is complete for Ich for all fish - letter dated 12/15/1998. The FDA has reviewed a dose confirmation protocol (letter dated 6/3/05) for an egg-fungus efficacy study and wants a few changes which will be done soon and the protocol will be resubmitted. This year’s range-finding studies to control egg mortality associated with Saprolegniasis were inconclusive and will be repeated during next spawning season. The Target Animal Safety Final Study Report was submitted on 07/01/2004. Study data was accepted on 5/24/05, a request for draft FOI for previous copper sulfate TAS submissions and draft label language was prepared and submitted on 6/30/05. The Environmental Assessment is currently being prepared.