Docket Management
Docket: 02N-0383 - Agency Info Coll. Act; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Prod. Defect Rp
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Dr. John Cary Date/Time 2002-11-04 18:11:58
Organization Novartis Animal Health US, Inc.
Category Company

Comments for FDA General
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? While we agree that actual time to input data to fill out the FDA 1932 form may only take an hour, it takes much more time that than that to investigate and gather the data. The average time to investigate (as mandated in the rule), collect, conduct quality control, and record data is closer to two hours. If you remove the labeled constraints surrounding dosing and efficacy, the number of filed reports will increase dramatically. This is especially true in light of customer satisfaction programs which encourage owners and veterinarians to call. We estimate an increased of 3 FTEs to handle the increased reporting requirements.

EC -5