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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 9/30/2022
1244.10 Division of Pharmacovigilance and Surveillance 9/30/2022
1244.11 Division of Animal Food Ingredients 9/30/2022
1244.12 Division of Drug Compliance 9/30/2022
1244.14 Division of Food Compliance 9/30/2022
1245.1 Office of Applied Science 9/30/2022
1245.10 Division of Residue Chemistry 9/30/2022
1245.11 Division of Applied Veterinary Research 9/30/2022
1245.12 Division of One Health Monitoring 9/30/2022
1245.13 Division of Emerging Technologies 9/30/2022
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 02/29/2024
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

PPM NUMBER TITLE DATE
1240.3500 New Animal Drug Determination 02/20/2007
1240.3502 New Animal Drug Regulation 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
1240.3530 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

3600 - COMPLIANCE

PPM NUMBER TITLE DATE
1240.3605 Regulating Animal Foods with Drug Claims 09/18/1998
1240.3622 Good Manufacturing Practice Compliance Status 02/06/2024
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
1240.4010 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
1240.4023 Notifying Sponsors When Approved Supplemental Labeling Changes in an Upstream Drug Application ((A)NADA) Approved for Use in or on Animal Feed will Require Revisions to Approved Downstream Labeling Components 04/01/2024
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 02/06/2024
1240.4122 Sterility and Pyrogen Requirements of Injectable Drug Products 02/06/2024
1240.4130 Overformulation in Animal Drug Products 02/06/2024
1240.4160 Policy on Sterilization of New Animal Drug Products and Containers By Irradiation
Retired 02/07/2024		 02/07/2024
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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