These 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.
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CVM FUNCTIONAL STATEMENTS
| PPM NUMBER | TITLE | DATE |
|---|
| 1240.1 | CVM | 10/1/2012 |
| 1241.1 | Office of the Center Director | 10/1/2012 |
| 1242.1 | Office of Management | 10/1/2012 |
| 1243.1 | Office of New Animal Drug Evaluation | 10/1/2012 |
| 1243.10 | Division of Therapeutic Drugs for Non-Food Animals | 10/1/2012 |
| 1243.11 | Division of Biometrics and Production Drugs | 10/1/2012 |
| 1243.12 | Division of Therapeutic Drugs for Food Animals | 10/1/2012 |
| 1243.13 | Division of Human Food Safety | 10/1/2012 |
| 1243.14 | Division of Manufacturing Technologies | 10/1/2012 |
| 1243.15 | Division of Scientific Support | 10/1/2012 |
| 1243.16 | Division of Generic Animal Drugs | 10/1/2012 |
| 1243.17 | Division of Business Information Science and Management | 5/12/2015 |
| 1244.1 | Office of Surveillance and Compliance | 10/1/2012 |
| 1244.10 | Division of Surveillance | 10/1/2012 |
| 1244.11 | Division of Animal Feeds | 10/1/2012 |
| 1244.12 | Division of Compliance | 10/1/2012 |
| 1244.13 | Division of Veterinary Product Safety | 10/1/2012 |
| 1245.1 | Office of Research | 10/1/2012 |
| 1245.10 | Division of Residue Chemistry | 10/1/2012 |
| 1245.11 | Division of Applied Veterinary Research | 10/1/2012 |
| 1245.12 | Division of Animal and Food Microbiology | 10/1/2012 |
| 1246.1 | Office of Minor Use and Minor Species Animal Drug Development | 10/1/2012 |
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 Procedures on Media Inquiries | 02/15/2011 |
| 1240.2326 | Revising CVM Documents for External Stakeholders | 03/31/2011 |
| 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 |
| 1240.2505 | Freedom of Information Request for Information | 03/31/2011 |
| 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 | 03/10/2011 |
| 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 |
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 |
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3400 - ANIMAL FEEDS
| PPM NUMBER | TITLE | DATE |
|---|
| 1240.3415 | Analytical Method Development for Feed Contaminants | 04/24/2007 |
| 1240.3420 | Nutritional Ingredients in Animal Drugs and Feeds | 03/23/1993 |
3500 - SURVEILLANCE
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| 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 | 02/11/2011 |
| 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 Causal 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 | 02/08/2011 |
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 | Assessment of Compliance Policy Guides Affecting Veterinary Products | 12/01/2009 |
| 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 | 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 |
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4100 - DRUGS
| PPM NUMBER | TITLE | DATE |
|---|
| 1240.4120 | Considerations for Ophthalmic Products | 08/25/2014 |
| 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 |
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4200 - AQUACULTURE
| PPM NUMBER | TITLE | DATE |
|---|
| 1240.4200 | Drug Use in Aquaculture Enforcement Priorities | 07/26/2011 |
| 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 |
