Document 2qOxp4R9KxxbQm3qbdaQanrR7

TO: File 174-125 Howard Piccirillo Fezio HAZLETON LABORATORIES AMERICA INC. c& Reno Weatherholtz Dagnall oat* 5/5/78 SUBJECT: Miscalculation of Dosage FROM: OQA S. Hinkle loo. ROOM The data for this study indicate that beginning on 1/10/77 (week 28) and continuing through 12/23/77 (week 77) all test animals were dosed incorrectly based on inaccurate calculations of feed consumption. For weeks 1-27 (animals were group housed) and weeks 78-80 (animals were individually housed) the calculations appear to be correct. During weeks 28-77, the animals received approximately twice the desired amount of compound based on "feed consumption" data. The error occurred when double the actual number of animals per group was used to find the mean weekly food consumption. For example in week 28 the total feed remaining for Group 2d* in 86 feeders (43 animals fed twice) was 12784.3g. This amount was subtracted from 15050g, the total amount fed that week (86 feeders x 175g each) leaving a remainder of 2265.7g of feed consumed. This figure was then divided by 86 (total number of feeders)--rather than 43 (total number of animals)--to determine mean food consumption per animal. The resulting incorrect number (26.35g, half the correct figure of 52.69g) was used as a denominator* in the mg'/kg formula resulting in double the mg of compound per kg of feed: Dosage Level x 7 days x Average Body Wt. Average Food Consumed compd./l kg feed HO 1.-i1908 CONT T OF NT T A!