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  1. Guidance & Regulations

Policies & Procedures Manual

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.

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
1243.18 Division of Animal Bioengineering and Cellular Therapies 12/14/2018
1244.1 Office of Surveillance and Compliance 2/9/2022
1244.10 Division of Pharmacovigilance and Surveillance 2/9/2022
1244.11 Division of Animal Food Ingredients 2/9/2022
1244.12 Division of Drug Compliance 2/9/2022
1244.14 Division of Food Compliance 2/9/2022
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 Routine Scientific/Policy Disagreements within CVM 02/04/2021
1240.2115 Procedures for Internal CVM Review of Science or Policy Issues Related to Significant Decisions of High Impact 02/04/2021
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

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

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

CVM has retired the following Policies and Procedures Manual documents from this section because they are obsolete: 1240.3510, 1240.3512, 1240.3514, 1240.3524,  and 1240.3560. If there are questions, send inquiries to [email protected].

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 Retired 11/21/2022
1240.3512 Additional Sources of Adverse Reaction and Injury Reports Retired 11/21/2022
1240.3514 Drug Experience Reporting by Veterinarians Retired 11/21/2022
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 Retired 11/21/2022
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 Listings of Drugs in Commercial Distribution  Retired 11/21/2022

3600 - COMPLIANCE

CVM has retired the following Policies and Procedures Manual documents from this section because they are obsolete: 1240.3630, 1240.3660, and 1240.3661. If there are questions, send inquiries to [email protected].

PPM NUMBER TITLE DATE
1240.3605 Regulating Animal Foods with Drug Claims 09/18/1998
1240.3622 Good Manufacturing Practice Compliance Status 06/17/2022
1240.3630 Tissue Residue Reporting Retired 11/21/2022
1240.3660 Assessment of Compliance Policy Guides (CPG) Affecting Veterinary Products  Retired 11/21/2022
1240.3661 Preparation of Compliance Programs, Assignments and Other Field Guidelines   Retired 11/21/2022
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

CVM has retired the following Policies and Procedures Manual documents from this section because they are obsolete: 1240.4000 and 1240.4005. If there are questions, send inquiries to [email protected].

PPM NUMBER TITLE DATE
1240.4000 Identification/Promotion of Product Approval Retired 11/21/2022
1240.4005 Procedure for Center Recommended Labeling Changes Retired 11/21/2022
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 Considerations for Ophthalmic Products 06/21/2022
1240.4122 Sterility and Pyrogen Requirements of Injectable Drug Products 08/05/2022
1240.4130 Overformulation in Animal Drug Products 06/21/2022
1240.4160 Policy on Sterilization of New Animal Drug Products and Containers By Irradiation 08/05/2022
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 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

 



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