Appropriate oral doses for all the allowable species and claims based on milligrams per unit of body weight or grams per ton are on the current labels. Claims pertaining to egg production and hatchablilty have been deleted from the labels. Each disease claim on the label has been properly qualified with the appropriate genus and species of bacteria susceptible to chlortetracycline hydrochloride. Disease claims which were not so qualified have been deleted. Claims for growth promotion or stimulation have been removed.
Allowable claims are for increased rate of weight gain and improved feed efficiency.
No further safety data are required. FDA's approval of the supplemental application does not involve reevaluation or reaffirmation of the human food safety data in the parent application. The tolerances for residues of chlortetracycline are codified at 21 CFR 556.150. The approval of this change is not expected to have any adverse effect on the safety or effectiveness of this new animal drug and, therefore, did not require a re-evaluation of the human food or target animal safety data in the parent application.