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Code of Federal Regulations

Subpart A

General Provisions

514.1Applications.514.3Definitions.514.4Substantial evidence.514.5Presubmission conferences.514.6Amended applications.514.7Withdrawal of applications without prejudice.514.8Supplements and other changes to an approved application.514.11Confidentiality of data and information in a new animal drug application file.514.12Confidentiality of data and information in an investigational new animal drug notice.514.15Untrue statements in applications.