December 2, 2002
Meg Oeller, D.V.M.
HFV-2, FDA Liaison to the NRSP-7
Food and Drug Administration
MPN4, 7519 Standish Place
Rockville, Maryland 20855-2773
Dear Dr. Oeller:
We refer to your submission dated March 18, 2002, to your public master file (PMF) for the use of ivermectin injection for control of ear mites (Psorotes cuniculi) in rabbits. You requested a categorical exclusion under 21 CFR 25.33(d)(4) from the requirement to prepare an Environmental Assessment (EA). Furthermore, your submission states that to your knowledge, no extraordinary circumstances exist which may significantly affect the human environment as discussed under 21 CFR 25.21.
We have completed our review of the submission and agree that a categorical exclusion under 21 CFR 25.33(d)(4) is appropriate for the NADA. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Based on the information in this submission and PMF 005421, the Division of Therapeutic Drugs for Food Animals considers the environmental technical section to be complete for the purpose of recommending approval of a new animal drug application (NADA). A final decision on the approval of the application will be made when all the data for all technical sections are viewed as a whole and it is determined that the information contained in and referenced by the application supports approval.
Please include a copy of this letter in your NADA submission at Section 10 (FDA Form 356V), ENVIRONMENTAL ASSESSMENT. This section of your NADA must also certify that the conditions of the categorical exclusion are still applicable at the time of your NADA submission.
Future correspondence regarding this submission to your PMF should reference this correspondence date and our file number P005421 G0002 and should be addressed to the Document Control Unit, HFV-199. Please include only one request per submission, clearly stating your request in the first paragraph of the submission.
If you have any questions or comments regarding this correspondence, please contact Dr. Janis R. Messenheimer, Leader, Antiparasitic and Physiologic Drugs Team at 301-827-7578.
Joan C. Gotthardt, D.V.M.
Acting Director, Division of Therapeutic Drugs for Food Animals
Office of New Animal Drug Evaluation
Center for Veterinary Medicine