Return to Proposal Finder FY 2001 Ongoing Proposal 200000700

Proposal Table of Contents

Additional Documents

Section 1. General Administrative information
Section 2. Past accomplishments
Section 3. Relationships to other projects
Section 4. Budgets for planning/design phase
Section 5. Budgets for construction/implementation phase
Section 6. Budgets for operations/maintenance phase
Section 7. Budgets for monitoring/evaluation phase
Section 8. Budget Summary

Reviews and Recommendations
No documents associated with this request


Section 1. General Administrative Information

Title of Project Proposal Infrastructure To Complete FDA Registration of Erythromycin
BPA Project Proposal Number 200000700
Business name of agency, institution,
or organization requesting funding
University of Idaho, College of Natural Resources
Business acronym (if appropriate) UI
 

Proposal contact person or principal investigator

Name Christine M. Moffitt
Mailing Address Department of Fish and Wildlife Resources, Univ. of Idaho
City, State, Zip Moscow, ID 83844-1136
Phone 2088857047
Fax 2088859080
E-mail cmoffitt@uidaho.edu
 
Manager of program authorizing this project Christine M. Moffitt
 
Review Cycle FY 2001 Ongoing
Province Systemwide
Subbasin Systemwide
 
Short Description Provide the infrastructure needed in the Columbia River basin to maintain and complete the FDA approval of erythromycin feed additive, a necessary therapeutant for sustained hatchery production and maintenance of captive broodstocks of salmon
Target Species


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


Biological Outcomes of this project: The approval of erythromycin feed additive for use in the Northwest without an INAD permit.
Biological Data: Reviews of existing data by FDA, and potential establishment of monitoring sites for resistant microorganisms once drug approval is secured.


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

Year Accomplishment
1999 Attended FDA workshop in December 1999 on risk assessments for resistant microorganisms
2000 Prepared and submitted summary of existing literature on resistant microorganisms to US Food and Drug Administration
2000 Notified National Aquaculture Coordinator and NRSP-7 coordinator of our project and progress to date.
2000 Began review and organization of all archival information on the results of laboratory and clinical drug trials conducted at the University of Idaho for drug approval.


Section 3. Relationships to Other Projects

n/a or no information


Section 4. Budget for Planning and Design Phase

Task-based Budget

n/a or no information


Outyear Objective-Based Budget

n/a or no information


Outyear Budgets for Planning and Design Phase

n/a or no information


Section 5. Budget for Construction and Implementation Phase

Task-based Budget

Objective Task Duration in FYs Estimated 2001 cost Subcontractor
OBJECTIVE 1. Provide an infrastructure to keep erythromycin registration efforts viable in the Columbia River Basin a. Update and maintain archives of all data and communications with FDA. 2000-2001 $ 3,067  
1 b. Assemble summaries of data on antibiotic resistance in fish and other data needs required to satisfy FDA or other regulatory agencies regarding the safety of applications of erythromycin feed additive. 2000 $ 0  
1 c. Review and update aspects of INAD management to assure access to erythromycin is maintained during FDA negotiations. 2000 $ 0  
1 d. Provide active dialog with potential drug companies to obtain support for the manufacture of compound after details with FDA are resolved 2000-2001 $ 12,687  
OBJECTIVE 2. Increase dialog and visibility of this project with FDA staff and others to resolve outstanding issues in an expeditious fashion a. Re-initiate a pro-active dialog with FDA-CVM staff. 2000-2001 $ 8,000  
2 b. Attend workshops organized by FDA. 2000 $ 0  
2 c. Renew a working relationship with key agency leaders in the Northwest and update them of FDA needs. 2000-2001 $ 5,235  
2 d. Reinitiate communication with the National Aquaculture Coordinator to garner assistance, and contacts with drug industry. 2000-2001 $ 6,577  
OBJECTIVE 3. Use regional fish health scientists to assist in implementation of any additional studies or monitoring programs determined after dialog with FDA, and after review of the data a. Provide updates on the progress of the project, and provide a mechanism for securing samples, providing monitoring sites, or other FDA needs. 2001 $ 21,700  
3 b. Complete publication of results of studies not yet published. 2000-2001 $ 8,000  
3 c. Renew communications with the National Center for Toxicological Research to assure completion environmental assessment. 2001 $ 6,500  


Outyear Objective-Based Budget

n/a or no information


Outyear Budgets for Construction and Implementation Phase

n/a or no information


Section 6. Budget for Operations and Maintenance Phase

Task-based Budget

n/a or no information


Outyear Objective-Based Budget

n/a or no information


Outyear Budgets for Operations and Maintenance Phase

n/a or no information


Section 7. Budget for Monitoring and Evaluation Phase

Task-based Budget

n/a or no information


Outyear Objective-Based Budget

n/a or no information


Outyear Budgets for Monitoring and Evaluation Phase

n/a or no information


Section 8. Estimated Budget Summary

Itemized Budget

Item Note FY 2001 Cost
Personnel FTE: (0.75 total) Principal Investigator and Staff Assistant $ 33,690
Fringe Principal Investigator (29.5%)and Staff Assistant (34.5%) $ 10,447
Supplies Copies, reports, page charges, phone, shipping $ 4,475
Travel To meetings with FDA, drug companies, regional fish health administrators $ 5,963
Indirect Calculated as 31.5% of TDC $ 17,191
Total Itemized Budget $ 71,766


Total estimated budget

Total FY 2001 project cost $ 71,766
Amount anticipated from previously committed BPA Funds $ 0
Total FY 2001 budget request $ 71,766
FY 2001 forecast from 2000 $ 70,438
% change from forecast 1.9%


Reason for change in estimated budget

Not applicable


Reason for change in scope

Not applicable


Cost Sharing

Not applicable
 

Outyear Budget Totals

Not applicable  

Other Budget Explanation

Not applicable


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

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