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U.S. Department of Health and Human Services

Animal & Veterinary

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PMF 005-893 - Finfish - Effectiveness Letter

I-009321-P-0113-EF

October 5, 2009


U.S. Department of the Interior
Fish and Wildlife Service
Aquatic Animal Drug Approval Partnership Program
Attention: David Erdahl, Ph.D.
AADAP Branch Chief
4050 Bridger Canyon Road
Bozeman, MT 59715

Re: Effectivenes technical section complete

Dear Dr. Erdahl:

Based upon the information you submitted on April 13, 2009, and amended on April 28, 2009 (T-0116), and the information contained in I-009321, the Division of Therapeutic Drugs for Food Animals considers the Effectiveness technical section to be complete. The technical section is complete for the use of chloramine-T immersion for the control of mortality due to external columnaris disease associated with Flavobacterium columnare in freshwater-reared warmwater finfish at a dose of 20 mg/L administered in a static or flow through water bath for 60 minutes per day on three consecutive or alternate days.

FREEDOM OF INFORMATION (FOI) SUMMARY

A copy of the draft Effectiveness section of the FOI Summary is enclosed. Please review the FOI Summary for accuracy and notify us if you find errors. If you request changes other than the correction of errors, CVM may re-open the Effectiveness technical section.

Include a copy of this technical section complete letter when you submit yournew animal drug application. Please contact us if there are changes in the product development plan (e.g., indication, dosage, duration of use) or you become aware of any issues that may impact the status of this technical section or your application. We will make a final decision on whether we can approve your application after we have reviewed all of the data for all applicable technical sections and any other information available to us, as a whole, and determined whether the requirements for approval described in the Federal Food, Drug, and Cosmetic Act have been met.

If you submit correspondence relating to this letter, your correspondence should reference the date and the principal submission identifier found at the top of this letter. If you have any questions or comments, please contact me at (240) 276-8341. You may also contact Dr. Jennifer Matysczak, Leader, Aquaculture Drugs Team, at (240) 276-8338.

Sincerely,

 

/s/
Cindy L. Burnsteel, DVM
Director, Division of Therapeutic
Drugs for Food Animals
Office of New Animal Drug Evaluation
Center for Veterinary Medicine