A new animal drug application (NADA) for a Type A medicated article is required to include, among other things, representative labeling proposed to be used for Type B and Type C medicated feeds containing the new animal drug (21 Code of Federal Regulations (CFR) 514.1 (b)(3)(v)(b)). The Center for Veterinary Medicine (CVM) uses the term Blue Bird labels to refer to such representative labeling (November 19, 1999; 64 Federal Register (FR) 63195 at 63197). Blue Bird labels are created by Type A medicated article sponsors and function as a guide to manufacturers of medicated animal feeds in the preparation of final printed feed labels. The sponsor of a Type A medicated article must submit, as part of its NADA, two labeling components.
- The specimens of labeling to be used for such new animal drug which must include adequate directions for the manufacture and use of finished feeds for all conditions for which the new animal drug is intended, recommended, or suggested in any of the labeling, including advertising, sponsored by the applicant.
- The representative labeling proposed for use in Type B and Type C medicated feeds containing the new animal drug.