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 approriate genus and species of bacteria susceptible to chlortetracycline hydrochloride. Disease claims which were not so qualified have been deleted. The manufacturer's label carries the warning statement that treated animals must have the medicated feed adjusted to compensate for variation in age and the weight of animals, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects water consumption. Claims for growth promotion or stimulation have been removed.
Allowable claims are for increased rate of weight gain and improved feed effieciency.
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. This supplemental NADA satisfies the requirements of section 512 of the Act and demonstrates that Aureomycin Type A Medicated Article when used under its proposed conditions of use, is safe and effective for the labeled indications. The approval provides for use of Aureomycin Type A Medicated Article for the control and treatment of specific diseases in swine, cattle, calves, chickens, turkeys, sheep, ducks, and psittacine birds.