Animal & Veterinary

PMF 005-590 - Target Animal Safety Letter

May 24, 2010

I-011401-P-0012-TS

United States Department of Agriculture
Agricultural Research Service
Harry K. Dupree- Stuttgart National Aquaculture Research Center
Attention: Dave Straus
P.O. Box 1050
Stuttgart, AR 72160

Re: Target Animal Safety technical section complete

Dear Dr. Straus:

Based upon the information you submitted on December 1, 2009, and amended on March 10, 2010 (T-0013), and April 7, 2010 (T-0014), we consider the Target Animal Safety technical section to be complete. The technical section is complete for the use of TRIANGLE BRAND Copper Sulfate (copper sulfate) crystals for the control of mortality in channel catfish eggs due to saprolegniasis associated with fungi in the family Saprolegniaceae. The proposed dose is 10 mg/L copper sulfate for twenty-eight minutes daily until embryos develop eyes.

TARGET ANIMAL SAFETY

This technical section complete letter represents our finding that the study data essential to determining target animal safety are complete and accepted. We also evaluate Target Animal Safety in our review of other technical sections, particularly the Effectiveness and All Other Information technical sections.

GENERAL COMMENTS

  1. We note that many protocol amendments were dated during the study and after the completion of the in-life phase of the study. It is not appropriate to designate changes to completed study components as protocol amendments. You should report differences between the actual study conduct and the in-place protocol procedures as deviations. These amendments should have been reported as deviations and explained how they impacted the study. The amendments are minor and we do not believe these amendments impacted the study; however, in the future, please report them as deviations. In addition, we remind you that protocol amendments instituted following CVM’s concurrence with the protocol may alter our ability to concur with the study design as conducted. Please submit protocols with significant changes for review and concurrence.
  2. We note that on the daily log sheets that the study director, a nonblinded person, observed the presence/absence of fungus and if present, the coverage using the Fungal Infection Ordinal Scale; whether eggs were hatching or dead; if any pre-mature hatched fry were present; and overall appearance of eggs. Since these numbers are objective measurements and were not the primary variable measured, we do not believe this impacted the study. In addition, the protocol does not specifically state that this information had to be collected by blinded personnel. However, in future studies, nonblinded personnel should not observe or record any variables (primary or secondary) that are used in evaluating the safety of drug products.
  3. In future submissions we recommend you utilize tabs and section dividers to separate the different sections of the submission (i.e., protocol amendments from study deviations).

FREEDOM OF INFORMATION (FOI) SUMMARY

We appreciate your cooperation in including the relevant portion of the draft FOI Summary for the Target Animal Safety section. We revised it and a copy of the Target Animal Safety section of the FOI Summary is enclosed. Please review the FOI Summary for accuracy and notify us if you find errors. We will prepare the final version of the FOI Summary and will provide you a copy when the last technical section is complete.

ALL OTHER INFORMATION

We note that you did not submit additional information pertaining to Target Animal Safety in this submission. Please submit your All Other Information technical section, containing any additional information not previously submitted, when the last major technical section has been submitted and is likely to be complete. In the future, please include the available relevant “all other information” with each technical section, or note in your cover letter that there is no “all other information” pertaining to the technical section.

Include a copy of this technical section complete letter when you submit your new 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

Enclosure:
Draft Section of the Target Animal Safety Freedom of Information Summary

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