§ 514.10 - Confidentiality of data and information in an investigational new animal drug notice and a new animal drug application file for an antibiotic drug.

(a) The rules established in §§ 514.11 and 514.12 of this chapter with regard to the confidentiality of an investigational new animal drug notice and a new animal drug application file shall apply to such notices and files for antibiotic drugs for new animal drug use.

(b) All records showing the Food and Drug Administration's testing of and action on a particular lot of a certifiable antibiotic drug for veterinary use are immediately available for public disclosure.