Response for project 2000007XX: Erythromycin Infrastucture

Comment on proposed FY 2006 budget

My plans are consistent with a budget of 0. We are winding up all aspects of this project with an effort to complete this project before 1 October. I have received permission for a no cost time extension from Sept to October to the end of the federal fiscal year. I had put a memo in to Ron Moninaka to get the option of some small additional money if needed during this year, but evidently that was not granted. It was not certain I needed this funding, but I was again forced to request something in case there were budget overruns. I am still worried that I may have a need to carry over a small amount of spending into the next fiscal year. I am going to a very critical meeting with FDA in Washington DC, on Monday 23 May. I will know a lot more after that meeting on the timing of everything, but that is after your deadline to tell you about this. I told the new project officer that I would report to her as soon as the meeting was over and we had an expected completion time. The overrun costs would be travel related to attend meetings to work out details of all the completed Food and Drug Administration Submissions.

Accomplishments since the last review

Produce Annual ReportWe have provided annual reporting of accomplishments by objective.
Produce/Submit Scientific Findings ReportWe have published one refereed article in 2004 and have one in press for 2005.
Produce/Submit Scientific Findings ReportWe have prepared and submitted two major data summaries to the US Food and Drug Administration using their guidance documents.

1. We completed and submitted for review to the Food and Drug Administration a Qualitative Risk Assessment:Hazard Identification and Characterization, Release Assessment; Exposure Assessment; Consequence Assessment;and Overall Risk Estimate Assessment using Guidance Document 152. This was a critical milestone for the project. 2. We obtained certification that Bimeda Inc. will support the manufacturing claim for erythromycin Type A premix (Aquamycin 100) to control bacterial kidney disease in salmon, under the Minor Use Minor Species (MUMS) designation. 3.We have a manuscript accepted in the North American Journal of Aquaculture summarizing the results of one of the two trials used as support data for the Risk Assessment (referenced in point 1). 4.We interacted with Dr. Meg Oeller and others at Center for Veterinary Medicine FDA and Biomeda Inc. (drug company sponsor) regarding the proposed schedule of activities to complete approval of erythromycin. 5) We have scheduled a pre-approval conference with FDA and the Bimeda representatives regarding details of the manufacturing and product chemistry submissions that they will provide for the product. 6) We compiled a summary of product use and potential worst case discharges and risk characterizations using the Guidance 89 and 166 for Environmental Assessments. 7) We are working on the final data requirement for the Environmental Assessment (item 6) with assistance from NRSP-7 program of the Dept of Agriculture.

FY 2006 goals and anticipated accomplishments

We would complete communications with the drug sponsor and FDA regarding final details of drug approval if needed.

Subbasin planning

How is this project consistent with subbasin plans?

How do goals match subbasin plan priorities?

Other comments