**Form FFC-W. Worksheet for Designing Study Protocols for Aquaflor^TM^
INAD #10-697**

**[INSTRUCTIONS]{.underline}**

**1. This Worksheet is an aid for Investigators preparing to use
Aquaflor^TM^ under INAD #10-697. The information solicited is required
to comply with FDA regulations. Before beginning, Investigators should
have carefully read through the entire Study Protocol. Fill in this
Worksheet as completely as possible.**

**2. Investigators should keep one copy on file, and send another copy
to the Monitor for review and signature. The Monitor should then forward
the signed Worksheet to the Study Director. The Study Director will also
review the Worksheet, assign the Worksheet a Study Number, and then
provide the Investigator and Monitor with the Study Number and approval
to proceed with Aquaflor^TM^ treatment.**

**SITE INFORMATION**

  ------------------ -------------------------- ---------- -----------------------
  **Facility**                                             

  **Address**                                              

                                                           

  **Investigator**                                         

  **Reporting                                              
  individual (if not                                       
  investigator)**                                          

  **Phone**                                     **FAX**    
  ------------------ -------------------------- ---------- -----------------------

**FISH CULTURE AND DRUG TREATMENT INFORMATION**

  --------------------- --------------- -- ----------------- -------------------
  **Fish disease to be                                       
  treated**                                                  

  **Fish species/stock                                       
  to be treated**                                            

  **Number of fish per                                       
  unit (indicate tank,                                       
  raceway or pond)**                                         

  **Number of units to                     Number of         
  be treated**                             untreated control 
                                           units             

  **Average fish per                       **Estimated total 
  pound**                                  weight of fish    
                                           treated**         

  **Intended                                                 
  florfenicol dosage                                         
  (mg/kg fish/day)**                                         

  **Projected % body                                         
  weight to be fed ( %                                       
  BW)**                                                      

  **Planned duration of                                      
  drug treatment                                             
  (days)**                                                   

  **Total medicated                                          
  feed needed ( lbs or                                       
  Kg )**                                                     

  **Planned %                                                
  Aquaflor^TM^ pre-mix                                       
  in feed (1,2,4,6%)**                                       

  **Anticipated                                              
  treatment dates                                            
  (start/end)**                                              

  **Feed type                                                
  (manufacturer/moist                                        
  [vs]{.underline}                                           
  dry/size) for                                              
  treatments and                                             
  controls (identify                                         
  both if different)**                                       
  --------------------- --------------- -- ----------------- -------------------

**STUDY DESIGN: Variable(s) to be tested: (See Sections VIII - XIII in
Study Protocol). Describe in detail the purpose of the clinical trial
(hypothesis), the number of experimental units, florfenicol dosage, the
number of fish per unit, and the disease to be treated. Study designs
must be carefully prepared and lend themselves to rigorous evaluation.
If more space is required to describe study design, title additional
page(s) \"Study Design\" and attach to this Worksheet.**

**(type here)**

  --------------------------- -------------------------------------------
  **Study designed by**       

  --------------------------- -------------------------------------------

**DISPOSITION OF TREATED FISH (Human Food Safety Considerations):**

  ------------ -- -----------------------------------------------------------------
                  **Estimated time (days, months) from last treatment day to first
                  possible harvest for human consumption**

  **Check         
  applicable      
  box(es):**      

                  **[Study Objective A.]{.underline} 10 mg florfenicol per kg BW
                  per day for 10 days; 21 day withdrawal period**

                  **[Study Objective B.]{.underline} Any dosage/duration other than
                  as stated in the Study Protocol in Section XI. Note: this Study
                  Objective must be accompanied by a written statement explaining
                  proposed dosage/duration/withdrawal time and why the proposed
                  changes are necessary. Approval/denial of this Study Objective
                  will be determined by the Study Director.**
  ------------ -- -----------------------------------------------------------------

  -- -- -----------------------------------------------------------------
        **Investigator or alternate shall initial here to indicate
        awareness that fish disposition must be in compliance with
        FDA-mandated withdrawal times as described in Section XV. of the
        Study Protocol.**

  -- -- -----------------------------------------------------------------

**WORKER SAFETY CONSIDERATIONS:**

  ------------ -- ----------------- -----------------------------------------------
                  **Initial here to 
                  indicate that all 
                  personnel         
                  handling drug     
                  have read         
                  Material Safety   
                  Data Sheet for    
                  Aquaflor^TM^ and  
                  are aware of      
                  SAFETY            
                  precautions to be 
                  taken when        
                  handling          
                  medicated feed.** 

                                    

  **Initials                        
  are those                         
  of:**                             

                                    **(Print Name)**
  ------------ -- ----------------- -----------------------------------------------

  ------------ ----------------- ------------------ ---------------------------
  **Date                         **Investigator**   
  prepared**                                        

  ------------ ----------------- ------------------ ---------------------------

  ------------ ----------------- ------------- ---------------------------
  **Date                         **Monitor**   
  reviewed**                                   

  ------------ ----------------- ------------- ---------------------------