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U.S. Department of Health and Human Services

Animal & Veterinary

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PMF 005-893 - Walleye - Effectiveness Letter

I-009321-P-0091-EF

March 3, 2008


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

Re: Effectiveness technical section for chloramine-T

Dear Dr. Erdahl:

Based on the information in your submission dated August 14, 2007, and the information contained in the Investigational New Animal Drug (INAD) files I-004000, I 009321, and I 010974, the Division of Therapeutic Drugs for Food Animals considers the effectiveness technical section to be complete for the use of chloramine-T when administered at a dose of 10 to 20 mg/L in a continuous flow water supply or as a static bath for 60 minutes once daily on alternate or consecutive days for 3 treatments to control mortality in walleye due to external columnaris disease associated with Flavobacterium columnare.

FOI SUMMARY COMMENTS:

During our review of the cumulative mortality data, we found that there was statistical significance between the mortality in the treated versus control tanks through Day 5 of the post-treatment period. This is different than what was presented in the final study report which stated that statistical significance of mortality was seen through post-treatment Day 4. The Freedom of Information (FOI) Summary has been modified accordingly.

A copy of the FOI Summary for the effectiveness technical section is enclosed. Please review the FOI Summary for accuracy and notify us if you find any errors. If you request changes other than the correction of errors, CVM may re-open the effectiveness technical section. CVM will prepare the final version of the FOI Summary and will provide you a copy when the last technical section is complete.

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 submitted in support of an Administrative New Animal Drug Application (NADA), NADA, or supplemental NADA, and any other information available to us, as a whole, and determined whether the requirements for approval set forth in the Federal Food, Drug, and Cosmetic Act have been met.

If you submit correspondence relating to your submission to the investigational file, you should reference the date and the principal submission identifier found at the top of this letter. If you have any questions, please contact me at 240-276-8341 or Dr. Donald Prater, Leader, Aquaculture Drugs Team, at 240-276-8343.

Sincerely,

 

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