SUMMARY
      Florfenicol is a synthetic broad spectrum antibacterial drug that has shown potent activity 
against several fish pathogens.  It was unanimously selected in 1998 by a vote of 38 member 
states, the U.S. Fish and Wildlife Service (USFWS), and the U.S. Geological Survey to replace the 
fluoroquinolone, sarafloxacin, as an oral antibiotic to be developed for public aquaculture under 
the International Association of Fish and Wildlife Agencies (IAFWA) Project.  Florfenicol was 
selected because of concerns about the use of fluoroquinolones in animal health and the potential 
for developing pathogen resistance to the fluoroquinolone drugs used in humans.  However, in 
March 2000, IAFWA management decided to redirect efforts on florfenicol to other IAFWA 
Project drugs when it became clear the florfenicol undertaking would not be completed on 
schedule because of unresolved an antimicrobial resistance issue, but agreed to fund florfenicol 
research under the Multi-State Conservation Grant Program funding initiative.
      The USFWS National Investigational New Animal Drug Office (NIO) proposed to develop 
data to support an amended New Animal Drug Application for florfenicol by conducting pivotal 
and supporting efficacy trials for florfenicol in medicated diets.  Because analytical confirmation 
of the treatment dosage of a pivotal efficacy study using an approved method is required by the 
U.S. Food and Drug Administration (FDA), IAFWA contracted the U.S. Geological Survey, 
Upper Midwest Environmental Sciences Center (UMESC) to provide analytical support of pivotal 
efficacy trials for florfenicol coordinated through the NIO.  Specific objectives of the contract 
agreement included the following:  (1) certification of UMESC scientists and instruments for 
conducting an approved analytical method for florfenicol in fish feeds, and (2) analytical support 
to quantify florfenicol content in medicated fish feeds used in pivotal efficacy trials.
      Work in objective 1 was conducted corroboratively and cooperatively with Schering-
Plough Research Institute (Kenilworth, NJ).  Work in objective 2 was performed at UMESC in 
direct support of pivotal efficacy trials coordinated through the NIO.
      UMESC scientists were certified to perform the analytical method for the assay of 
florfenicol in fish feed and have successfully analyzed a variety of feeds in support of pivotal 
efficacy trial efforts for florfenicol.  Analyses of fish feeds used in pivotal efficacy trials met all 
quality criteria stated in the method for analysis of florfenicol in fish feed.  Some of the efficacy 
trials were accepted by CVM to support pivotal efficacy trials conducted by the NIO.


Completion Report Page 1 of 2
Multi-State Conservation Grant No. 91XXX-XX-0005
		




Completion Report Page 1 of 82
Multi-State Conservation Grant No. 91XXX-XX-0005