FY 2001 Ongoing proposal 200000700
Contents
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
Additional documents
| Title | Type |
|---|
Section 1. Administrative
| Proposal title | Infrastructure To Complete FDA Registration of Erythromycin |
| Proposal ID | 200000700 |
| Organization | University of Idaho, College of Natural Resources (UI) |
| Proposal contact person or principal investigator | |
| Name | Christine M. Moffitt |
| Mailing address | Department of Fish and Wildlife Resources, Univ. of Idaho Moscow, ID 83844-1136 |
| Phone / email | 2088857047 / cmoffitt@uidaho.edu |
| Manager authorizing this project | Christine M. Moffitt |
| Review cycle | FY 2001 Ongoing |
| Province / Subbasin | Systemwide / 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
| Latitude | Longitude | Description |
|---|
Reasonable and Prudent Alternatives (RPAs)
Sponsor-reported:
| RPA |
|---|
Relevant RPAs based on NMFS/BPA review:
| Reviewing agency | Action # | BiOp Agency | Description |
|---|
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
| Project ID | Title | Description |
|---|
Section 4. Budget for Planning and Design phase
Task-based budget
| Objective | Task | Duration in FYs | Estimated 2001 cost | Subcontractor |
|---|
Outyear objectives-based budget
| Objective | Starting FY | Ending FY | Estimated cost |
|---|
Outyear budgets for Planning and Design phase
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 objectives-based budget
| Objective | Starting FY | Ending FY | Estimated cost |
|---|
Outyear budgets for Construction and Implementation phase
Section 6. Budget for Operations and Maintenance phase
Task-based budget
| Objective | Task | Duration in FYs | Estimated 2001 cost | Subcontractor |
|---|
Outyear objectives-based budget
| Objective | Starting FY | Ending FY | Estimated cost |
|---|
Outyear budgets for Operations and Maintenance phase
Section 7. Budget for Monitoring and Evaluation phase
Task-based budget
| Objective | Task | Duration in FYs | Estimated 2001 cost | Subcontractor |
|---|
Outyear objectives-based budget
| Objective | Starting FY | Ending FY | Estimated cost |
|---|
Outyear budgets for Monitoring and Evaluation phase
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 |
| $71,766 | ||
Total estimated budget
| Total FY 2001 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% |
Cost sharing
| Organization | Item or service provided | Amount | Cash or in-kind |
|---|
Reviews and recommendations
This information was not provided on the original proposals, but was generated during the review process.
REVIEW:
CBFWA Funding Recommendation
CBFWA Funding Recommendation
Recommendation:
Ongoing Funding: yes; New Funding: no
Ongoing Funding: yes; New Funding: no
Date:
Jul 14, 2000
Jul 14, 2000
Comment:
There is no change in the scope of work or the budget.Comment: