2002 CFR Title 21, Volume 6

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 514--NEW ANIMAL DRUG APPLICATIONS
	514.1	Applications.
	514.3	Definitions.
	514.4	Substantial evidence.
	514.6	Amended applications.
	514.7	Withdrawal of applications without prejudice.
	514.8	Supplemental new animal drug applications.
	514.8	Supplemental new animal drug applications.
	514.11	Confidentiality of data and information in a new animal drug application file.
	514.12	Confidentiality of data and information in an investigational new animal drug notice.
	514.15	Untrue statements in applications.
	514.80	Records and reports concerning experience with approved new animal drugs.
	514.100	Evaluation and comment on applications.
	514.105	Approval of applications.
	514.106	Approval of supplemental applications.
	514.110	Reasons for refusing to file applications.
	514.111	Refusal to approve an application.
	514.115	Withdrawal of approval of applications.
	514.116	Notice of withdrawal of approval of application.
	514.117	Adequate and well-controlled studies.
	514.120	Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.
	514.121	Service of notices and orders.
	514.200	Contents of notice of opportunity for a hearing.
	514.201	Procedures for hearings.
	514.235	Judicial review.