FY 2000 proposal 20059
Section 1. Administrative
| Proposal title | Infrastructure to Complete FDA Registration of Erythromycin |
| Proposal ID | 20059 |
| Organization | University of Idaho - Fish and Wildlife Resources (UI) |
| Proposal contact person or principal investigator |
| Name | Christine M. Moffitt |
| Mailing address | Moscow, ID 83844-1136 |
| Phone / email | 2088857047 / cmoffitt@uidaho.edu |
| Manager authorizing this project | |
| Review cycle | FY 2000 |
| Province / Subbasin | Mainstem/Systemwide / 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
| Latitude | Longitude | Description |
|---|
Reasonable and Prudent Alternatives (RPAs)
Relevant RPAs based on NMFS/BPA review:
| Reviewing agency | Action # | BiOp Agency | Description |
|---|
Section 2. Past accomplishments
Section 3. Relationships to other projects
| Project ID | Title | Description |
|---|
|
Captive Broodstock Operations |
Provides the drug needed for control of bacterial kidney disease |
|
Artificial Production |
Drug used for control of bacterial kidney disease in production of chinook, coho, and sockeye |
Section 4. Budget for Planning and Design phase
Task-based budget
| Objective | Task | Duration in FYs | Estimated 2000 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 2000 cost | Subcontractor |
|---|
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 2000 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 2000 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 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 |
| $71,022 |
Total estimated budget
| Total FY 2000 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% |
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 |
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.
Reviews and recommendations
This information was not provided on the original proposals, but was generated during the review process.
Recommendation:
Fund
Date:
Jun 15, 1999
Comment:
Recommendation:
Fund. There is a programmatic need for the use of erythromycin, but how the costs are allocated amongst various users is a policy question. In lieu?
Comments:
This isn't really a research project. Erythromycin is valuable and necessary to a lot of salmon research as a therapeutant for BK Disease. The proposal leaves it unclear exactly what specifically needs to be done to achieve FDA approval. It is understandable that specific activities do need to be done, but how are delivering papers at national and international meetings related to this? The need for .75 FTE for coordinating the approval process isn't fully explained in the proposal.
This project is the only source of the drug for researchers and culturists; therefore it is valuable. But this proposal is basically designed to resolve conflict between the UI and The FDA over approval for the use of Aquamycin. The arguments in the proposal why BPA-NWPPC should support such an endeavor are unconvincing, especially considering the commercial nature of the product and the perception, if not the intent, of scientific "lobbying." One wonders why the aquaculture industry isn't paying for the approval process and why the research community has to bear the cost.
Recommendation:
Fund
Date:
Aug 20, 1999
Comment:
Recommendation:
Date:
Aug 20, 1999
Comment:
Criteria all: Met? yes - Managers may want to explore the long term implications
Recommendation:
Date:
Aug 20, 1999
Comment:
Needed for chinook rearing programs.
Recommendation:
Fund
Date:
Mar 1, 2000
Comment:
[Decision made in 9-22-99 Council Meeting]