**Form FFC-W. Worksheet for Designing Study Protocols for Aquaflor^7^
INAD #10-697**

**[INSTRUCTIONS]{.underline}**

**1. This Worksheet is an aid for Investigators preparing to use
Aquaflor^7^ 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^7^ 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^7^ pre-mix                                     
  in feed**                                               

  **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**                  |
+---+---+-----------------------------------------------------------------+
| * |   |                                                                 |
| * |   |                                                                 |
| C |   |                                                                 |
| h |   |                                                                 |
| e |   |                                                                 |
| c |   |                                                                 |
| k |   |                                                                 |
| a |   |                                                                 |
| p |   |                                                                 |
| p |   |                                                                 |
| l |   |                                                                 |
| i |   |                                                                 |
| c |   |                                                                 |
| a |   |                                                                 |
| b |   |                                                                 |
| l |   |                                                                 |
| e |   |                                                                 |
| b |   |                                                                 |
| o |   |                                                                 |
| x |   |                                                                 |
| : |   |                                                                 |
| * |   |                                                                 |
| * |   |                                                                 |
+---+---+-----------------------------------------------------------------+
|   |   | **[Study Objective A.]{.underline} 10 mg florfenicol per kg BW  |
|   |   | per day for 10 days; 21-day**                                   |
|   |   |                                                                 |
|   |   | **withdrawal period for salmonid species.**                     |
+---+---+-----------------------------------------------------------------+
|   |   | **[Study Objective B]{.underline} 10 mg florfenicol per kg BW   |
|   |   | per day for 10 days; 28-day**                                   |
|   |   |                                                                 |
|   |   | **withdrawal period for non-salmonid species.**                 |
+---+---+-----------------------------------------------------------------+

  -- -- -----------------------------------------------------------------
        **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^7^ 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**                                   

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