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Nelson Intra 2100 Manual

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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.

CVM FUNCTIONAL STATEMENTS

PPM NUMBERTITLEDATE
1240.1CVM10/1/2012
1241.1Office of the Center Director10/1/2012
1242.1Office of Management10/1/2012
1243.1Office of New Animal Drug Evaluation10/1/2012
1243.10Division of Therapeutic Drugs for Non-Food Animals10/1/2012
1243.11Division of Biometrics and Production Drugs10/1/2012
1243.12Division of Therapeutic Drugs for Food Animals10/1/2012
1243.13Division of Human Food Safety10/1/2012
1243.14Division of Manufacturing Technologies10/1/2012
1243.15Division of Scientific Support10/1/2012
1243.16Division of Generic Animal Drugs10/1/2012
1243.17Division of Business Information Science and Management5/12/2015
1244.1Office of Surveillance and Compliance10/1/2012
1244.10Division of Surveillance10/1/2012
1244.11Division of Animal Feeds10/1/2012
1244.12Division of Compliance10/1/2012
1244.13Division of Veterinary Product Safety10/1/2012
1245.1Office of Research10/1/2012
1245.10Division of Residue Chemistry10/1/2012
1245.11Division of Applied Veterinary Research10/1/2012
1245.12Division of Animal and Food Microbiology10/1/2012
1246.1Office of Minor Use and Minor Species Animal Drug Development10/1/2012

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 Disagreements within CVM01/23/2009
1240.2115Procedures for Internal CVM Review of Science or Policy Issues Related to Significant Decisions of High Impact01/23/2009
1240.2120Product Manager01/23/2009
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
1240.2210Approval of New Animal Drug Applications and their Supplements08/11/1992
1240.2220Classification of OTC and Rx Drugs03/09/2000
Manual

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 Inquiries02/15/2011
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

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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

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3400 - ANIMAL FEEDS

Nelson Intra 2100 Manual
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
1240.3510Drug Experience Reporting Requirements02/20/2007
1240.3512Additional Sources of Adverse Reaction and Injury Reports02/20/2007
1240.3514Drug Experience Reporting by Veterinarians02/20/2007
1240.3520Adverse Reactions as a Basis for Regulatory Action02/20/2007
1240.3521Animal Health Hazard Evaluation Committee02/20/2007
1240.3522Review and Evaluation of Drug Experience Reports02/11/2011
1240.3524Criteria for Veterinary Medical Review of Establishment Inspection Reports02/20/2007
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
1240.3560Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution02/08/2011
Nelson Intra 2100 ManualNelson Intra 2100 Manual

3600 - COMPLIANCE

PPM NUMBERTITLEDATE
1240.3605Regulating Animal Foods with Drug Claims09/18/1998
1240.3622Good Manufacturing Practice Compliance Status06/22/2009
1240.3630Tissue Residue Reporting09/18/1998
1240.3660Assessment of Compliance Policy Guides Affecting Veterinary Products12/01/2009
1240.3661Preparation of Compliance Programs, Assignments and Other Field Guidelines08/31/2009
1240.3670Management of Formal Evidentiary Hearings11/05/2009

3700 - RESEARCH

PPM NUMBERTITLEDATE
1240.3700Center for Veterinary Medicine Research Activities01/06/1998
1240.371001/06/1998

4000 - LABELING

PPM NUMBERTITLEDATE
1240.4000Identification/Promotion of Product Approval09/10/1997
1240.4005Procedure for Center Recommended Labeling Changes09/10/1997
1240.4010Antibacterials Labeled for Secondary Infections09/10/1997
1240.4020Uniformity in Labeling09/10/1997
1240.4021General Policies for Animal Drug Label Review09/10/1997
1240.4025Therapeutic 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 Products08/25/2014
1240.4122Sterility and Pyrogen Requirements for Injectable Drug Products04/25/2000
1240.4130Overformulation in Animal Drug Products04/25/2000
1240.4150Ownership Transfer or Corporate Identity Change of an Application09/18/1998
1240.4160Policy on Sterilization of New Animal Drug Products and Containers By Irradiation04/25/2000
1240.4170CVM Medically Necessary Veterinary Drug Product Shortage Management04/25/2000

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

Nelson Intra 2100 Manual Transmission