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Title:   Author  item
                                            Straus, David

                                                         - *Dave*
  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.


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