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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
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
1240.3510
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
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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
Nelson Intra 2100 Manual Transfer Switch
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
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
Nelson Intra 2100 Manual Typewriter
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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