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Title:   Author  item
                                            Straus, David

                                                         - *Dave*
  Submitted to: Annual Drug Approval Coodination Workshop
                                    Publication Type: Abstract Only
                                    Publication Acceptance Date: 6/30/2010
                                    Publication  Date: 8/3/2010
                                    Citation: Straus, D.L. 2010. Status of Copper Sulfate - 2010 [abstract]. Annual Drug Approval Coodination Workshop. 16:109.Interpretive Summary:
                                Technical Abstract: This is brief overview of the Technical Sections completed and being worked on for the New Animal Drug Application (NADA) for copper sulfate.  

Initial Label Claim (Ich on catfish): 
1)	Human Food Safety - Complete for all fin fish - February 2004.  This includes human intestinal microflora issues, residue chemistry, and microbial food safety with respect to resistance.  Hazard characterization requested by FDA/CVM; submitted April 2008.  Complete for all fin fish - October 2008.  
2)	Effectiveness - Complete for Ich for all fish - December 1998.  Needs FOI.
3)	Target Animal Safety - Complete for channel catfish - April 2006.  
4)	Environmental Assessment - Submitted to FDA/CVM in December 2006; revisions requested.  To be addressed.
5)	Label - Draft was concurred by FDA/CVM in May 2008.  Sponsor will submit final label. 
6)	All Other Information - 

Supplemental Label Claim (Fungus on catfish eggs): 
1)	Effectiveness – Supportive Range-Finding and Dose-Confirmation studies to control egg mortality associated with Saprolegniasis were completed (July 2008).  Supportive Final Study Report submitted June 2010.  Pivotal Final study reports being prepared.
2)	Target Animal Safety - Complete for channel catfish eggs - May 2010.  
3)	Environmental Assessment - To be addressed.


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