This submission contains data that supports the use of feed additive 
oxytetracycline to control mortalities associated with Aeromonas hydrophila in 
northern pike, bacterial coldwater disease in salmonids, columnaris disease in 
salmonids, paddlefish, and smallmouth bass, and enteric redmouth disease in 
salmonids. The reports document actual field applications in full scale hatchery 
operations performed by typical fish culturists. The results reflect typical 
treatments with feed additive oxytetracycline.
The individual reports contain supplementary efficacy data on the use of feed 
additive oxytetracycline to control mortalities associated with the above named 
diseases in the corresponding fish. There are no pivotal efficacy studies 
included in this submission. An addendum will be made to this submission within 
4-6 months to include two pivotal efficacy studies on the use of feed additive 
oxytetracycline to control mortalities associated with columnaris disease in 
salmonids. At that time an appropriate label claim for columnaris disease will 
be made. It is possible that a second addendum will be made to this submission 
to include one or more pivotal efficacy studies on the use of feed additive 
oxytetracycline to control mortalities associated with bacterial coldwater 
disease in salmonids. At that time an appropriate label claim for bacterial 
coldwater disease will be made. A separate submission on human food safety 
(residue depletion) will be made to request amending the present label to allow 
for administration of oxytetracycline at water temperatures below 9 deg C. The 
only request being made as a result of the enclosed data is to amend the present 
label to include the use of feed additive oxytetracycline to control mortalities 
associated with Aeromonas hydrophila in northern pike. A separate submission 
will be made on human food safety in support of this request.
The strongest data by far in this submission is for bacterial coldwater disease 
and columnaris disease in salmonids, for which 42 selected studies were 
submitted from a much larger number of actual treatments. This level of OTC 
usage demonstrates the strong need to eventually expand the label claim to 
include these diseases.