CVM's Policy & Procedures Manual

1240-1100 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

1100 - CVM FUNCTIONAL STATEMENTS

PPM NUMBER	TITLE	DATE
1240.1100	CVM	07/15/1997
1240.1101	Office of the Center Director	11/14/2003
1240.1102	Office of Management	11/14/2003
1240.1120	Office of New Animal Drug Evaluation	05/05/2008
1240.1121	Division of Production Drugs	07/15/1997
1240.1122	Division of Manufacturing Technologies	07/15/1997
1240.1123	Division of Therapeutic Drugs - Food Animals	07/15/1997
1240.1124	Division of Therapeutic Drugs Non-Food Animals	07/15/1997
1240.1125	Division of Human Food Safety	07/15/1997
1240.1126	Division of Scientific Support	05/05/2008
1240.1130	Office of Surveillance and Compliance	10/13/2005
1240.1131	Division of Compliance	10/13/2005
1240.1132	Division of Surveillance	10/13/2005
1240.1133	Division of Animal Feeds	10/13/2005
1240.1140	Office of Research	07/15/1997
1240.1141	Division of Residue Chemistry	07/15/1997
1240.1142	Division of Animal Research	07/15/1997
1240.1143	Division of Animal and Food Microbiology	11/04/1998

1500 - OCCUPATIONAL SAFETY AND HEALTH

PPM NUMBER	TITLE	DATE
1240.1500	Occupational Safety and Health and Environmental Protection Program	11/17/2000
1240.1510	Workplace Inspection Program	11/17/2000
1240.1520	Reporting Unsafe or Unhealthy Conditions	11/17/2000

2000 - POLICY FORMATION

PPM NUMBER	TITLE	DATE
1240.2020	FEDERAL REGISTER Document Processing	06/7/1994
1240.2021	FEDERAL REGISTER Document Activity	09/17/1992
1240.2030	Citizen Petitions: Policy and Procedures	06/30/2009
1240.2040	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	DATE
1240.2100	Intra-Agency Relationships	08/11/1993
1240.2110	Procedures for Resolving Disagreements within CVM	01/23/2009
1240.2115	Procedures for Internal CVM Review of Science or Policy Issues Related to Significant Decisions of High Impact	01/23/2009
1240.2120	Product Manager	01/23/2009
1240.2150	CVM Small Business	04/10/1991
1240.2152	CVM Public Affairs Program	04/07/1995
1240.2154	Evaluation of Proposed Legislation	04/07/1995

2200 - GENERAL REGULATORY

PPM NUMBER	TITLE	DATE
1240.2202	Voluntary Compliance	08/11/1992
1240.2210	Approval of New Animal Drug Applications and their Supplements	08/11/1992
1240.2220	Classification of OTC and Rx Drugs	03/09/2000

2300 - COMMUNICATION

PPM NUMBER	TITLE	DATE
1240.2300	Processing General Correspondence by Individual Offices in CVM	06/28/1993
1240.2302	Routing of Congressional Correspondence	02/26/2007
1240.2305	CVM External Communications Clearance Policy and Procedures	10/31/2005
1240.2315	Process on GAO/OIG Studies/Audits	03/04/2005
1240.2316	Process on OIG Studies	11/08/2006
1240.2322	Intercommunication between CVM and Office of Chief Counsel	6/28/1993
1240.2325	CVM Guidance on Media Inquiries	01/22/2007
1240.2326	Revising CVM Documents for External Stakeholders	10/21/2004
1240.2330	Consultative Reviews and Opinions	05/07/1991

2500 - FREEDOM OF INFORMATION

PPM NUMBER	TITLE	DATE
1240.2500	Freedom of Information Requests	08/22/2005
1240.2501	Public Availability of Food Additive Petitions	07/20/2007
1240.2510	Advisory Opinions and Informal Requests for Information	10/23/1985
1240.2520	Confidentiality of Center Files	06/25/1993

2600 - SPECIAL INTERESTS

PPM NUMBER	TITLE	DATE
1240.2600	Industry Conferences	06/11/1990
1240.2601	Meetings With Foreign Government or Foreign Industry Representatives	09/22/2005
1240.3010	Processing Original Investigational New Animal Drug Applications	09/30/1996
1240.3020	Processing Amendments to An Investigational New Animal Drug Application	09/30/1996

3100 - NADA

PPM NUMBER	TITLE	DATE
1240.3100	Initial Processing and Filing of an Original NADA or ANADA	08/15/2002
1240.3101	Review of Animal Safety and Effectiveness Data	08/01/1989
1240.3125	Preparation of a Draft FEDERAL REGISTER Notice of Approval of a New Animal Drug Application (FR Notice)	03/08/2000
1240.3135	Animal Drug Applications Expedited Review Guideline	12/03/1997

3300 - FOOD ADDITIVE PETITION

PPM NUMBER	TITLE	DATE
1240.3300	Food Additive Petition Review	06/27/2005
1240.3310	Establishing and Processing Investigational Food Additive Files	04/25/2000

3400 - ANIMAL FEEDS

PPM NUMBER	TITLE	DATE
1240.3415	Analytical Method Development for FeedContaminants	04/24/2007
1240.3420	Nutritional Ingredients in Animal Drugs and Feeds	03/23/1993

3500 - SURVEILLANCE

PPM NUMBER	TITLE	DATE
1240.3500	New Animal Drug Determination	02/20/2007
1240.3502	New Animal Drug Regulation	02/20/2007
1240.3510	Drug Experience Reporting Requirements	02/20/2007
1240.3512	Additional Sources of Adverse Reaction and Injury Reports	02/20/2007
1240.3514	Drug Experience Reporting by Veterinarians	02/20/2007
1240.3520	Adverse Reactions as a Basis for Regulatory Action	02/20/2007
1240.3521	Animal Health Hazard Evaluation Committee	02/20/2007
1240.3522	Review and Evaluation of Drug Experience Reports	02/20/2007
1240.3524	Criteria for Veterinary Medical Review of Establishment Inspection Reports	02/20/2007
1240.3530	Procedures for Processing Drug Experience Reports	02/20/2007
1240.3540	NADAs, Withdrawal of Approvals	02/20/2007
1240.3542	Implementation of Casual Reviews	02/20/2007
1240.3550	Surveillance at Professional and Trade Meetings	02/20/2007
1240.3560	Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution	09/09/1997

3600 - COMPLIANCE

PPM NUMBER	TITLE	DATE
1240.3605	Regulating Animal Foods with Drug Claims	09/18/1998
1240.3622	Good Manufacturing Practice Compliance Status	06/22/2009
1240.3630	Tissue Residue Reporting	09/18/1998
1240.3660	Development of Compliance Policy Guides Affecting Veterinary Products	09/18/1998
1240.3661	Preparation of Compliance Programs, Assignments and Other Field Guidelines	08/31/2009
1240.3670	Management of Formal Evidentiary Hearings	11/05/2009

3700 - RESEARCH

PPM NUMBER	TITLE	DATE
1240.3700	Center for Veterinary Medicine Research Activities	01/06/1998
1240.3710	Initiation and Approval of Research Projects	01/06/1998

4000 - LABELING

PPM NUMBER	TITLE	DATE
1240.4000	Identification/Promotion of Product Approval	09/10/1997
1240.4005	Procedure for Center Recommended Labeling Changes	09/10/1997
1240.4010	Antibacterials Labeled for Secondary Infections	09/10/1997
1240.4020	Uniformity in Labeling	09/10/1997
1240.4021	General Policies for Animal Drug Label Review	09/10/1997
1240.4025	Therapeutic Use Directions for Medicated Feed and Drinking Water	09/10/1997
1240.4030	Established Names	09/10/1997
1240.4040	Clinical Investigator Sanctions and the Videotex Method Of Obtaining Information on Ineligible Investigators	09/10/1997

4100 - DRUGS

PPM NUMBER	TITLE	DATE
1240.4120	Sterility of Ophthalmic Products	04/25/2000
1240.4122	Sterility and Pyrogen Requirements for Injectable Drug Products	04/25/2000
1240.4130	Overformulation in Animal Drug Products	04/25/2000
1240.4150	Ownership Transfer or Corporate Identity Change of an Application	09/18/1998
1240.4160	Policy on Sterilization of New Animal Drug Products and Containers By Irradiation	04/25/2000
1240.4170	CVM Medically Necessary Veterinary Drug Product Shortage Management	04/25/2000

4200 - AQUACULTURE

PPM NUMBER	TITLE	DATE
1240.4200	Drug Use in Aquaculture Enforcement Priorities	04/26/2007
1240.4210	Extra-label Use of Approved Drugs in Aquaculture	02/19/2008
1240.4220	Drug-Pesticide Issues	02/19/2008
1240.4230	Regulation of Fish Identification Products	02/19/2008
1240.4260	Classification of Aquaculture Species/Population as Food or Non-food	04/14/2008
1240.4270	Use of Drugs in Outdoor Aquatic Research Facilities	04/14/2008