Return to Proposal Finder FY 2000 Proposal 20059

Proposal Table of Contents

Additional Documents

Section 1. General Administrative information
Section 2. Past accomplishments
Section 3. Relationships to other projects
Section 4. Objectives, tasks and schedules
Section 5. Budget
Section 6. References
Section 7. Abstract

Reviews and Recommendations
Title Type File Size File Date


Section 1. General Administrative Information

Title of Project Proposal Infrastructure to Complete FDA Registration of Erythromycin
BPA Project Proposal Number 20059
Business name of agency, institution,
or organization requesting funding
University of Idaho - Fish and Wildlife Resources
Business acronym (if appropriate) UI
 

Proposal contact person or principal investigator

Name Christine M. Moffitt
Mailing Address
City, State, Zip Moscow, ID 83844-1136
Phone 2088857047
Fax 2088859080
E-mail cmoffitt@uidaho.edu
 
Manager of program authorizing this project
 
Review Cycle FY 2000
Province Mainstem/Systemwide
Subbasin Systemwide
 
Short Description Provide the infrastructure needed in the Columbia River basin to maintain and complete the FDA registration of erythromycin feed additive, a necessary therapeutant for sustained hatchery production and maintenance of captive broodstocks of salmon
Target Species All salmon, with highest priority for chinook and sockeye


Project Location

[No information]


Reasonable and Prudent Alternatives (RPAs)

Sponsor-Reported Relevant RPAs

Sponsor listed no RPAs for this project proposal

Relevant RPAs based upon NMFS & BPA Review

NMFS and BPA did not associate any reasonable and prudent alternatives with this project proposal


NPPC Program Measure Number(s) which this project addresses: 7.2 and 7.4 Several components of each
FWS/NMFS Biological Opinion Number(s) which this project addresses:
Other Planning Document References Snake River Recovery Task 4.1


CBFWA-Generated Information

Database Administrator notes on the history of this proposal form: None
Type of Project (assigned by CBFWA Analysts): anadromous


Section 2. Past Accomplishments

n/a or no information


Section 3. Relationships to Other Projects

Project ID Title Description Umbrella
Captive Broodstock Operations Provides the drug needed for control of bacterial kidney disease No
Artificial Production Drug used for control of bacterial kidney disease in production of chinook, coho, and sockeye No


Section 4. Objectives, Tasks and Schedules

Objectives and Tasks

Objective Task
1. Provide an infrastructure to keep erythromycin registration efforts viable in the Columbia River Basin . Provide funding for PI and staff assistant to provide interim management and oversight of erythromycin feed additive and provide responses to all FDA querry
2. Increase visibility and dialog with FDA and other entities to resolve outstanding issues a. Hold meetings with FDA and regional/governmental and non governmental supporters
2. b. Give papers on the status of erythromycin registration at conferences dealing with drug registration and at meetings that address aquaculture risk assessment
3. Assemble regional fish health and other scientists to assist in design or implementation of any additional studies needed to satisfy FDA . Increase active communication with the NCTR lab and others in the international/national community capable with resolving elements of risk assessment

Objective Schedules and Costs

Objective Start Date End Date Measurable Biological Objectives Milestone FY 2000 Cost %
1 10/01/99 09/01/01 Provide the staff needed to increase turnaround time and use assistance offered by regional fish health personnel to resolve outstanding issues with FDA Summaries of literature provided to FDA, regular dialogs established with key regional personnel, active dialog with potential drug companies. 60.0%
2 11/01/99 09/01/00 Provide increased visibility of the need to complete approval of erythromycin within FDA and governmental and non governmental agencies Video and direct conferences provided and papers presented at appropriate meetings 25.0%
3 12/01/99 09/01/01 Assemble regional fish health and other scientists to assist with additional studies needed for FDA Meet with NCTR staff and regional scientists, and others in profession and resolve any remaining FDA's questions 15.0%


Section 5. Estimated Budget Summary

Itemized Budget

Item Note FY 2000 Cost
Personnel Principal Investigator and Staff Assistant $ 29,421
Fringe Principal Investigator and Staff $ 9,204
Supplies Copies, reports, page charges and slides for presentations $ 3,700
Operating Phone, postage, fax, FedEx $ 1,600
Travel Meetings and Negotiations $ 9,920
Indirect 31.5% of direct costs $ 17,177
Total Itemized Budget $ 71,022


Total estimated budget

Total FY 2000 project cost $ 71,022
Amount anticipated from previously committed BPA Funds $ 0
Total FY 2000 budget request $ 71,022
FY 2000 forecast from 1999 $ 0
% change from forecast 0.0%


Reason for change in estimated budget

Not applicable


Reason for change in scope

Not applicable


Cost Sharing

Organization Item or service provided Amount Cash or In-Kind
Washington Department of Fish and Wildlife Maintain INAD infrastructure for artificial production, provide assistance in sediment study, provide leadership and oversight through PNFHPC subcommittee on therapeutants $ 20,000 unknown
Idaho Department of Fish and Game Maintain INAD infrastructure for artificial production, provide assistance with data recovery for risk assessment $ 10,000 unknown
Oregon Department of Fish and Wildlife Maintain INAD infrastructure for artificial production, provide assistance with data recovery for risk assessment $ 15,000 unknown
US Fish and Wildlife Service Maintain INAD infrastructure for artificial production for Service and Columbia River Indian Tribes, provide communications through PNFHPC, provide national support for drug registration efforts $ 20,000 unknown
National Marine Fisheries Service Maintain INAD infrastructure for captive broodstock $ 5,000 unknown

 

Outyear Budget Totals

2001
All Phases $ 70,438
Total Outyear Budgets $ 70,438
 

Other Budget Explanation

Schedule Constraints: This project is constrained by institutional inertia within FDA that delays a rapid response. However, support from a concerted regional effort will leverage far greater visibility than during the past 2 years and thereby improve the response rate.


Section 6. References

Reference Watershed?
NMFS. 1995. Proposed recovery plan for Snake River salmon, National Marine Fisheries Service. No
Power Planning Council. 1994. Columbia River Basin Fish and Wildlife Program. Portland Oregon. No


Section 7. Abstract

Abstract

This project provides critical support to continue and enhance an ongoing scientific and technical dialog between the University of Idaho (UI) and the US Food and Drug Administration (FDA) to resolve outstanding elements and achieve approval of erythromycin feed additive (Aquamycin) to control bacterial kidney disease in salmon. Erythromycin is needed for effective fish health management of bacterial kidney disease in salmon stocks reared in the Columbia River basin. Legal access to erythromycin feed additive is currently provided for fish and wildlife agencies and tribes in the region through a coordinated investigational new animal drug permit held at the UI. Since 1995, the UI has assumed the additional interim responsibility for manufacturing this premix that is used to create medicated fish feeds used by agencies throughout the region. Although all the research to define the efficacy, target animal safety, residues in edible fish flesh, and safe field use of the feed products is completed, and has been determined satisfactory by FDA, outstanding new elements and institutional forces never anticipated at the beginning of the project impede the final approval. This new initiative will provide funding for an infrastructure that will keep this important project viable. This infrastructure will increase the frequency and extent of dialog between UI and FDA, provide a pro-active promotion of the need for final approval within governmental and non-governmental institutions, and provide a rapid access to fish health practitioners and scientists who can assist in providing or implementing any further data collection necessary to satisfy FDA and achieve approval of this substance. These efforts will enhance the profile of erythromycin feed additive and reassure potential drug company sponsors that this product can be marketed successfully.


Reviews and Recommendations

This information was not provided on the original proposals, but was generated during the review process.

This project has not yet been reviewed

Return to top of page