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        Guidance & Regulations

Policies & Procedures Manual

                        
                CVM/Office of New Animal Drug Evaluation (ONADE) Reviewer's Chapter Home
          Animal & Veterinary
          Guidance & Regulations
          Policies & Procedures ManualGuidance & Regulations Policies & Procedures Manual
  	
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    PrintThese pages provide sections of the CVM Program Policy and Procedures and Office of New Animal Drugs Evaluation Reviewer's Chapter.  The Manual provides a quick reference to the rules, regulations, and instructions pertinent to all program areas of CVM's responsibilities, including the review of new animal drug applications, and post-market surveillance and compliance activities. All of the linked sections are available in pdf format only.

1240-1246 CVM Functional Statements
	1240-1500 Occupational Safety and Health
	1240-2000 Policy Formation
	1240-2100 Administration
	1240-2200 General Regulatory
	1240-2300 Communication
	1240-2500 Freedom of Information
	1240-2600 Special Interests
	1240-3100 NADA


1240-3300 Food Additive Petition
	1240-3400 Animal Feeds
	1240-3500 Surveillance
	1240-3600 Compliance
	1240-3700 Research
	1240-4000 Labeling
	1240-4100 Drugs
	1240-4200 Aquaculture


CVM FUNCTIONAL STATEMENTS

PPM NUMBER
			TITLE
			DATE1240.1
			CVM
			10/1/20121241.1
			Office of the Center Director
			10/1/20121242.1
			Office of Management
			10/1/20121243.1
			Office of New Animal Drug Evaluation
			10/1/20121243.10
			Division of Therapeutic Drugs for Non-Food Animals
			10/1/20121243.11
			Division of Biometrics and Production Drugs
			10/1/20121243.12
			Division of Therapeutic Drugs for Food Animals
			10/1/20121243.13
			Division of Human Food Safety
			10/1/20121243.14
			Division of Manufacturing Technologies
			10/1/20121243.15
			Division of Scientific Support
			10/1/20121243.16
			Division of Generic Animal Drugs
			10/1/20121243.17
			Division of Business Information Science and Management
			5/12/20151243.18
			Division of Animal Bioengineering and Cellular Therapies
			12/14/20181244.1
			Office of Surveillance and Compliance
			9/30/20221244.10
			Division of Pharmacovigilance and Surveillance
			9/30/20221244.11
			Division of Animal Food Ingredients
			9/30/20221244.12
			Division of Drug Compliance
			9/30/20221244.14
			Division of Food Compliance
			9/30/20221245.1
			Office of Applied Science
			9/30/20221245.10
			Division of Residue Chemistry
			9/30/20221245.11
			Division of Applied Veterinary Research
			9/30/20221245.12
			Division of One Health Monitoring
			9/30/20221245.13
			Division of Emerging Technologies
			9/30/20221246.1
			Office of Minor Use and Minor Species Animal Drug Development
			10/1/2012

1500 - OCCUPATIONAL SAFETY AND HEALTH

PPM NUMBER
			TITLE
			DATE1240.1500
			Occupational Safety and Health and Environmental Protection Program
			11/17/20001240.1510
			Workplace Inspection Program
			11/17/20001240.1520
			Reporting Unsafe or Unhealthy Conditions
			11/17/2000

2000 - POLICY FORMATION

PPM NUMBER
			TITLE
			DATE1240.2020
			FEDERAL REGISTER Document Processing
			06/7/19941240.2021
			FEDERAL REGISTER Document Activity
			09/17/19921240.2030
			Citizen Petitions: Policy and Procedures
			06/30/20091240.2040
			CVM's Implementation of the Agency's Fraud, Untrue Statements of Material Facts, Bribery & Illegal Gratuities Policy
			06/15/1994

2100 - ADMINISTRATION

PPM NUMBER
			TITLE
			DATE1240.2100
			Intra-Agency Relationships
			08/11/19931240.2110
			Procedures for Resolving Routine Scientific/Policy Disagreements within CVM
			02/04/20211240.2115
			Procedures for Internal CVM Review of Science or Policy Issues Related to Significant Decisions of High Impact
			02/04/20211240.2150
			CVM Small Business
			04/10/19911240.2152
			CVM Public Affairs Program
			04/07/19951240.2154
			Evaluation of Proposed Legislation
			04/07/1995

2200 - GENERAL REGULATORY

PPM NUMBER
			TITLE
			DATE1240.2202
			Voluntary Compliance
			08/11/1992

2300 - COMMUNICATION

PPM NUMBER
			TITLE
			DATE1240.2300
			Processing General Correspondence by Individual Offices in CVM
			06/28/19931240.2302
			Routing of Congressional Correspondence
			02/26/20071240.2305
			CVM External Communications Clearance Policy and Procedures
			10/31/20051240.2315
			Process on GAO/OIG Studies/Audits
			03/04/20051240.2316
			Process on OIG Studies
			11/08/20061240.2322
			Intercommunication between CVM and Office of Chief Counsel
			6/28/19931240.2325
			CVM Procedures on Media Inquiries
			02/15/20111240.2326
			Revising CVM Documents for External Stakeholders
			03/31/20111240.2330
			Consultative Reviews and Opinions
			05/07/1991

2500 - FREEDOM OF INFORMATION

PPM NUMBER
			TITLE
			DATE1240.2500
			Freedom of Information Requests
			08/22/20051240.2505
			Freedom of Information Request for Information
			03/31/20111240.2510
			Advisory Opinions and Informal Requests for Information
			10/23/19851240.2520
			Confidentiality of Center Files
			06/25/1993

2600 - SPECIAL INTERESTS

PPM NUMBER
			TITLE
			DATE1240.2600
			Industry Conferences
			06/11/19901240.2601
			Meetings With Foreign Government or Foreign Industry Representatives
			03/10/20111240.3010
			Processing Original Investigational New Animal Drug Applications
			09/30/19961240.3020
			Processing Amendments to An Investigational New Animal Drug Application
			09/30/1996

3100 - NADA

PPM NUMBER
			TITLE
			DATE1240.3100
			Initial Processing and Filing of an Original NADA or ANADA
			08/15/20021240.3101
			Review of Animal Safety and Effectiveness Data
			08/01/19891240.3125
			Preparation of a Draft FEDERAL REGISTER Notice of Approval of a New Animal Drug Application (FR Notice)
			03/08/2000

3300 - FOOD ADDITIVE PETITION

PPM NUMBER
			TITLE
			DATE1240.3300
			Food Additive Petition Review
			06/27/20051240.3310
			Establishing and Processing Investigational Food Additive Files
			04/25/2000

3400 - ANIMAL FEEDS

PPM NUMBER
			TITLE
			DATE1240.3415
			Analytical Method Development for Feed Contaminants
			04/24/20071240.3420
			Nutritional Ingredients in Animal Drugs and Feeds
			03/23/1993

3500 - SURVEILLANCE

PPM NUMBER
			TITLE
			DATE1240.3500
			New Animal Drug Determination
			02/20/20071240.3502
			New Animal Drug Regulation
			02/20/20071240.3520
			Adverse Reactions as a Basis for Regulatory Action
			02/20/20071240.3521
			Animal Health Hazard Evaluation Committee
			02/20/20071240.3522
			Review and Evaluation of Drug Experience Reports
			02/11/20111240.3530
			Procedures for Processing Drug Experience Reports
			02/20/20071240.3540
			NADAs, Withdrawal of Approvals
			02/20/20071240.3542
			Implementation of Causal Reviews
			02/20/20071240.3550
			Surveillance at Professional and Trade Meetings
			02/20/2007

3600 - COMPLIANCE

PPM NUMBER
			TITLE
			DATE1240.3605
			Regulating Animal Foods with Drug Claims
			09/18/19981240.3622
			Good Manufacturing Practice Compliance Status
			06/17/20221240.3670
			Management of Formal Evidentiary Hearings
			11/05/2009

3700 - RESEARCH

PPM NUMBER
			TITLE
			DATE1240.3700
			Center for Veterinary Medicine Research Activities
			01/06/19981240.3710
			Initiation and Approval of Research Projects
			01/06/1998

4000 - LABELING

PPM NUMBER
			TITLE
			DATE1240.4010
			Antibacterials Labeled for Secondary Infections
			09/10/19971240.4020
			Uniformity in Labeling
			09/10/19971240.4021
			General Policies for Animal Drug Label Review
			09/10/19971240.4025
			Therapeutic Use Directions for Medicated Feed and Drinking Water
			09/10/19971240.4030
			Established Names
			09/10/19971240.4040
			Clinical Investigator Sanctions and the Videotex Method Of Obtaining Information on Ineligible Investigators
			09/10/1997

4100 - DRUGS

PPM NUMBER
			TITLE
			DATE1240.4120
			Considerations for Ophthalmic Products
			06/21/20221240.4122
			Sterility and Pyrogen Requirements of Injectable Drug Products
			08/05/20221240.4130
			Overformulation in Animal Drug Products
			06/21/20221240.4160
			Policy on Sterilization of New Animal Drug Products and Containers By Irradiation
			08/05/20221240.4170
			CVM Medically Necessary Veterinary Drug Product Shortage Management
			04/25/2000

4200 - AQUACULTURE

PPM NUMBER
			TITLE
			DATE1240.4200
			Drug Use in Aquaculture Enforcement Priorities
			07/26/20111240.4210
			Extra-label Use of Approved Drugs in Aquaculture
			02/19/20081240.4220
			Drug-Pesticide Issues
			02/19/20081240.4230
			Regulation of Fish Identification Products
			02/19/20081240.4260
			Classification of Aquaculture Species/Population as Food or Non-food
			04/14/20081240.4270
			Use of Drugs in Outdoor Aquatic Research Facilities
			04/14/2008

                                                                                  Content current as of:
      02/21/2023Policies & Procedures Manual                
                          

                        CVM/Office of New Animal Drug Evaluation (ONADE) Reviewer's Chapter
 
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