This project will assess the use of eugenol to enhance post-transport survival and increase loading density during long duration (>12 h) transport events. This study will be initiated with a thorough review of the literature to compile existing data on the use of sedatives during fish transport. The Upper Midwest Environmental Sciences Center (UMESC) will request and schedule a pre-submission conference with CVM to discuss needed study parameters to be included into the final study protocols prepared for the project. UMESC and the University of Wisconsin-Stevens Point (UWSP) will collaboratively prepare the protocols and then UMESC will submit the protocols to CVM through the UMESC publicly-disclosable Investigational New Animal Drug (INAD) permits for eugenol and request CVM review and protocol concurrence prior to conducting the study. Additionally, UMESC maintains a Quality Assurance Unit with a full-time Quality Assurance Officer who will assist research scientists conducting this project to comply with the CVM Good Clinical Practice regulations.
The objectives of this study:
- Interact with CVM to determine the study design and protocol needed to develop the
effectiveness data to support a transport sedative claim for eugenol for selected finfish species.
The protocol must comply with current CVM Guidance For Industry for the development of pivotal
effectiveness data and the study data collection must with CVM Good Clinical Practices
- Obtain fully disclosable Investigational New Animal Drug (INAD) exemptions for the selected
sedative to be tested from CVM.
- Obtain Categorical Exclusions from the requirement to complete an Environmental Assessment
or complete an Environmental Assessment for the selected sedative prior to its use and receive concurrence from CVM Environmental Safety Team.
- Submit the pivotal effectiveness protocol to CVM for concurrence.
- Conduct pivotal effectiveness studies using the selected sedative on finfish species according to
the CVM-concurred protocol and in compliance with CVM Good Clinical Practices regulations.
- Summarize the study data into a Final Study Report (FSR) and archive all study data in publicly
- Submit the FSR to the publicly disclosable INAD file provided by CVM and request CVM review of
the FSR and concur that the effectiveness technical section is complete for the selected sedative.
- Respond to CVM comments on the FSR to ultimately obtain concurrence that the effectiveness
technical section is complete for the use of the selected sedative as a transport sedative for the
- Prepare a Freedom Of Information summary of the submitted data and provide it to CVM.
|Institution||Principal Investigator||Objectives||Year 1||Year 2||Total|
|U.S. Geological Survey,
|Mark P. Gaikowski||1-9||$23,684||$23,324||$47,008|
|University of Wisconsin-
|Christopher F. Hartleb||5-9||$26,316||$26,676||$52,992|
|Viterbo University||Kim A. Fredricks|
|North American Fish Farmers Cooperative, Binford Eagle