FY 2001 Ongoing proposal 200000700

Additional documents

TitleType

Section 1. Administrative

Proposal titleInfrastructure To Complete FDA Registration of Erythromycin
Proposal ID200000700
OrganizationUniversity of Idaho, College of Natural Resources (UI)
Proposal contact person or principal investigator
NameChristine M. Moffitt
Mailing addressDepartment of Fish and Wildlife Resources, Univ. of Idaho Moscow, ID 83844-1136
Phone / email2088857047 / cmoffitt@uidaho.edu
Manager authorizing this projectChristine M. Moffitt
Review cycleFY 2001 Ongoing
Province / SubbasinSystemwide / Systemwide
Short descriptionProvide 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
LatitudeLongitudeDescription
Reasonable and Prudent Alternatives (RPAs)

Sponsor-reported:

RPA

Relevant RPAs based on NMFS/BPA review:

Reviewing agencyAction #BiOp AgencyDescription

Section 2. Past accomplishments

YearAccomplishment
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 IDTitleDescription

Section 4. Budget for Planning and Design phase

Task-based budget
ObjectiveTaskDuration in FYsEstimated 2001 costSubcontractor
Outyear objectives-based budget
ObjectiveStarting FYEnding FYEstimated cost
Outyear budgets for Planning and Design phase

Section 5. Budget for Construction and Implementation phase

Task-based budget
ObjectiveTaskDuration in FYsEstimated 2001 costSubcontractor
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
ObjectiveStarting FYEnding FYEstimated cost
Outyear budgets for Construction and Implementation phase

Section 6. Budget for Operations and Maintenance phase

Task-based budget
ObjectiveTaskDuration in FYsEstimated 2001 costSubcontractor
Outyear objectives-based budget
ObjectiveStarting FYEnding FYEstimated cost
Outyear budgets for Operations and Maintenance phase

Section 7. Budget for Monitoring and Evaluation phase

Task-based budget
ObjectiveTaskDuration in FYsEstimated 2001 costSubcontractor
Outyear objectives-based budget
ObjectiveStarting FYEnding FYEstimated cost
Outyear budgets for Monitoring and Evaluation phase

Section 8. Estimated budget summary

Itemized budget
ItemNoteFY 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 forecast1.9%
Cost sharing
OrganizationItem or service providedAmountCash or in-kind

Reviews and recommendations

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

Recommendation:
Ongoing Funding: yes; New Funding: no
Date:
Jul 14, 2000

Comment:

There is no change in the scope of work or the budget.
Recommendation:
Fund
Date:
Sep 13, 2000

Comment: