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  1. Guidance & Regulations

Policies & Procedures Manual

These pages provide sections of the CVM Program Policy and Procedures and the Office of New Animal Product Evaluation and Office of Generic Animal Drugs 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 NUMBERTITLEDATE
1240.1CVM10/1/2012
1241.1Office of the Center Director10/1/2012
1242.1Office of Management8/23/2024
1243.1Office of New Animal Product Evaluation8/23/2024
1243.10aDivision of Food Animal Drugs8/23/2024
1243.12aDivision of Companion Animal Drugs8/23/2024
1243.13Division of Human Food Safety8/23/2024
1243.14Division of Manufacturing Technologies8/23/2024
1243.15Division of Statistical and Biological Science8/23/2024
1243.17Division of Business Information Science and Management8/23/2024
1243.18Division of Biotechnology8/23/2024
1244.1Office of Surveillance and Compliance9/30/2022
1244.10Division of Pharmacovigilance and Surveillance9/30/2022
1244.11Division of Animal Food Ingredients9/30/2022
1244.12Division of Drug Compliance9/30/2022
1244.14Division of Food Compliance9/30/2022
1245.1Office of Applied Science9/30/2022
1245.10Division of Residue Chemistry9/30/2022
1245.11Division of Applied Veterinary Research9/30/2022
1245.12Division of One Health Monitoring9/30/2022
1245.13Division of Emerging Technologies9/30/2022
1246.1Office of Minor Use and Minor Species Animal Drug Development10/1/2012
1247.1Office of Generic Animal Drugs8/23/2024
1247.10Division of Generic Animal Drugs8/23/2024
1247.11Division of Manufacturing Technologies8/23/2024

1500 - OCCUPATIONAL SAFETY AND HEALTH

PPM NUMBERTITLEDATE
1240.1500Occupational Safety and Health and Environmental Protection Program11/17/2000
1240.1510Workplace Inspection Program11/17/2000
1240.1520Reporting Unsafe or Unhealthy Conditions11/17/2000

2000 - POLICY FORMATION

PPM NUMBERTITLEDATE
1240.2020FEDERAL REGISTER Document Processing06/7/1994
1240.2021FEDERAL REGISTER Document Activity09/17/1992
1240.2030Citizen Petitions: Policy and Procedures06/30/2009
1240.2040CVM's Implementation of the Agency's Fraud, Untrue Statements of Material Facts, Bribery & Illegal Gratuities Policy06/15/1994

2100 - ADMINISTRATION

PPM NUMBERTITLEDATE
1240.2100Intra-Agency Relationships08/11/1993
1240.2110Procedures for Resolving Routine Scientific/Policy Disagreements within CVM02/04/2021
1240.2115Procedures for Internal CVM Review of Science or Policy Issues Related to Significant Decisions of High Impact02/04/2021
1240.2150CVM Small Business04/10/1991
1240.2152CVM Public Affairs Program04/07/1995
1240.2154Evaluation of Proposed Legislation04/07/1995

2200 - GENERAL REGULATORY

PPM NUMBERTITLEDATE
1240.2202Voluntary Compliance08/11/1992

2300 - COMMUNICATION

PPM NUMBERTITLEDATE
1240.2300Processing General Correspondence by Individual Offices in CVM06/28/1993
1240.2302Routing of Congressional Correspondence02/26/2007
1240.2305CVM External Communications Clearance Policy and Procedures10/31/2005
1240.2315Process on GAO/OIG Studies/Audits03/04/2005
1240.2316Process on OIG Studies11/08/2006
1240.2322Intercommunication between CVM and Office of Chief Counsel6/28/1993
1240.2325CVM Procedures on Media Inquiries02/29/2024
1240.2326Revising CVM Documents for External Stakeholders03/31/2011
1240.2330Consultative Reviews and Opinions05/07/1991

2500 - FREEDOM OF INFORMATION

PPM NUMBERTITLEDATE
1240.2500Freedom of Information Requests08/22/2005
1240.2505Freedom of Information Request for Information03/31/2011
1240.2510Advisory Opinions and Informal Requests for Information10/23/1985
1240.2520Confidentiality of Center Files06/25/1993

2600 - SPECIAL INTERESTS

PPM NUMBERTITLEDATE
1240.2600Industry Conferences06/11/1990
1240.2601Meetings With Foreign Government or Foreign Industry Representatives03/10/2011
1240.3010Processing Original Investigational New Animal Drug Applications09/30/1996
1240.3020Processing Amendments to An Investigational New Animal Drug Application09/30/1996

3100 - NADA

PPM NUMBERTITLEDATE
1240.3100Initial Processing and Filing of an Original NADA or ANADA08/15/2002
1240.3101Review of Animal Safety and Effectiveness Data08/01/1989
1240.3125Preparation of a Draft FEDERAL REGISTER Notice of Approval of a New Animal Drug Application (FR Notice)03/08/2000

3300 - FOOD ADDITIVE PETITION

PPM NUMBERTITLEDATE
1240.3300Food Additive Petition Review06/27/2005
1240.3310Establishing and Processing Investigational Food Additive Files04/25/2000

3400 - ANIMAL FEEDS

PPM NUMBERTITLEDATE
1240.3415Analytical Method Development for Feed Contaminants04/24/2007
1240.3420Nutritional Ingredients in Animal Drugs and Feeds03/23/1993

3500 - SURVEILLANCE

PPM NUMBERTITLEDATE
1240.3500New Animal Drug Determination02/20/2007
1240.3502New Animal Drug Regulation02/20/2007
1240.3521Animal Health Hazard Evaluation Committee02/20/2007
1240.3525Review and Assessment of Post-Market Adverse Drug Experience Data08/15/2024
1240.3530Procedures for Processing Drug Experience Reports02/20/2007
1240.3540NADAs, Withdrawal of Approvals02/20/2007
1240.3542Implementation of Causal Reviews02/20/2007
1240.3550Surveillance at Professional and Trade Meetings02/20/2007

3600 - COMPLIANCE

PPM NUMBERTITLEDATE
1240.3601Notification of Interested Parties When a Bioresearch Monitoring Inspection is Classified as Official Action Indicated Due to Potential Rejection of Data08/18/2025
1240.3605Regulating Animal Foods with Drug Claims
Withdrawn May 20, 2024		09/18/1998
1240.3610CVM Bioresearch Monitoring Program - General Procedures for the Preparation and Assignment of Bioresearch Monitoring (BIMO) Inspections12/16/2024
1240.3622Good Manufacturing Practice Compliance Status02/06/2024
1240.3670Management of Formal Evidentiary Hearings11/05/2009

3700 - RESEARCH

PPM NUMBERTITLEDATE
1240.3700Center for Veterinary Medicine Research Activities01/06/1998
1240.3710Initiation and Approval of Research Projects01/06/1998

4000 - LABELING

PPM NUMBERTITLEDATE
1240.4010Antibacterials Labeled for Secondary Infections09/10/1997
1240.4020Uniformity in Labeling09/10/1997
1240.4021General Policies for Animal Drug Label Review09/10/1997
1240.4023Notifying 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 Components04/01/2024
1240.4025Therapeutic Use Directions for Medicated Feed and Drinking Water09/10/1997
1240.4030Established Names09/10/1997
1240.4040Clinical Investigator Sanctions and the Videotex Method Of Obtaining Information on Ineligible Investigators09/10/1997

4100 - DRUGS

PPM NUMBERTITLEDATE
1240.4120Considerations for Ophthalmic Products02/06/2024
1240.4122Sterility and Pyrogen Requirements of Injectable Drug Products02/06/2024
1240.4130Overformulation in Animal Drug Products02/06/2024

4200 - AQUACULTURE

PPM NUMBERTITLEDATE
1240.4200Drug Use in Aquaculture Enforcement Priorities07/26/2011
1240.4210Extra-label Use of Approved Drugs in Aquaculture02/19/2008
1240.4220Drug-Pesticide Issues02/19/2008
1240.4230Regulation of Fish Identification Products02/19/2008
1240.4260Classification of Aquaculture Species/Population as Food or Non-food04/14/2008
1240.4270Use of Drugs in Outdoor Aquatic Research Facilities04/14/2008

 



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