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Title:   Author  item
                                            Straus, David

                                                         - *Dave*
  Submitted to: Annual Drug Approval Coodination Workshop
                                    Publication Type: Abstract Only
                                    Publication Acceptance Date: 7/14/2008
                                    Publication  Date: 7/28/2008
                                    Citation: Straus, D.L. 2008. Status of copper sulfate - 2008 [abstract]. Annual Drug Approval Coordination Workshop. 14:70.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.
2)	Effectiveness - Complete for Ich for all fish – December 1998.  Needs FOI.
3)	Target Animal Safety - Complete for channel catfish - letter dated 4/21/06.  Environmental Assessment - Submitted to FDA/CVM in December 2006; revisions requested June 2007; .........
4)	Label – Second draft was submitted to FDA/CVM in May 2008.  Sponsor will submit final label when concurrence (??) is reached. 
5)	All Other Information - 

Supplemental Label Claim (Fungus on catfish eggs): 
1)	Effectiveness – Range-finding and Dose-Confirmation studies to control egg mortality associated with Saprolegniasis have been recently completed (July 2008).  Final study reports will be compiled.
2)	Target Animal Safety – Study has been recently completed (July 2008).  Final study report will be compiled. 
3)	Environmental Assessment -


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