| PPM NUMBER |
TITLE |
DATE |
| 1240.0000
|
Index Update |
13-Mar-08 |
| 1100
- CVM FUNCTIONAL STATEMENTS |
| 1240.1100 |
CVM |
15-Jul-97 |
| 1240.1101 |
Office of the Center Director |
31-Dec-03 |
| 1240.1102 |
Office of the Director, Office of Management and Communications |
15-Jul-97 |
| 1240.1120 |
Office of New Animal Drug Evaluation |
15-Jul-97 |
| 1240.1121 |
Office of New Animal Drug Evaluation, Division of Production Drugs |
15-Jul-97 |
| 1240.1122 |
Office of New Animal Drug Evaluation, Division of Manuf. Technologies |
15-Jul-97 |
| 1240.1123 |
Office of New Animal Drug Evaluation, Division of Therap. Drugs - Food Animals |
15-Jul-97 |
| 1240.1124 |
Office of New Animal Drug Evaluation, Division of Therapeutic Drugs Non-Food Animals |
15-Jul-97 |
| 1240.1125 |
Office of New Animal Drug Evaluation, Division of Human Food Safety |
15-Jul-97 |
| 1240.1130 |
Office of Surveillance and Compliance |
13-Oct-05 |
| 1240.1131 |
Office of Surveillance and Compliance, Division of Compliance |
13-Oct-05 |
| 1240.1132 |
Office of Surveillance and Compliance, Division of Surveillance |
13-Oct-05 |
| 1240.1133 |
Office of Surveillance and Compliance, Division of Animal Feeds |
13-Oct-05 |
| 1240.1140 |
Office of Research |
15-Jul-97 |
| 1240.1141 |
Office of Research, Division of Residue Chemistry |
15-Jul-97 |
| 1240.1142 |
Office of Research, Divison of Animal Research |
15-Jul-97 |
| 1500
- OCCUPATIONAL SAFETY AND HEALTH |
| 1240.1500 |
Occupational Safety and Health and Environmental Protection Program |
17-Nov-00 |
| 1240.1510 |
Workplace Inspection Program |
17-Nov-00 |
| 1240.1520 |
Reporting Unsafe or Unhealthy Conditions |
17-Nov-00 |
| 2000
- POLICY FORMATION |
| 1240.2000 |
Establishment of Center Policies/Procedures |
12-Jun-90 |
| 1240.2020 |
FEDERAL REGISTER Document Processing |
7-Jun-94 |
| 1240.2021 |
FEDERAL REGISTER Document Activity |
17-Sep-92 |
| 1240.2030 |
Citizen Petitions: Policy and Procedures Update |
14-Mar-08 |
| 1240.2040 |
CVM's Implementation of the Agency's Fraud, Untrue Statements of Material Facts, Bribery & Illegal Gratuities Policy |
15-Jun-94 |
| 2100
- ADMINISTRATION |
| 1240.2100 |
Intra-Agency Relationships |
11-Aug-93 |
| 1240.2110 |
Procedures for Resolving Disagreements within CVM |
10-Apr-91 |
| 1240.2115 |
Procedures for Internal CVM Review of Science or Policy Issues Related to Significant Decisions of High Impact Update |
02-Dec-08 |
| 1240.2120 |
Product Manager |
11-Aug-93 |
| 1240.2150 |
CVM Small Business |
10-Apr-91 |
| 1240.2152 |
CVM Public Affairs Program |
7-Apr-95 |
| 1240.2154 |
Evaluation of Proposed Legislation |
7-Apr-95 |
| 2200
- GENERAL REGULATORY |
| 1240.2202 |
Voluntary Compliance |
11-Aug-92 |
| 1240.2210 |
Approval of New Animal Drug Applications and their Supplements |
11-Aug-92 |
| 1240.2220 |
Classification of OTC and Rx Drugs |
09-Mar-00 |
| 2300
- COMMUNICATION |
| 1240.2300 |
Processing General Correspondence by Individual Offices in CVM |
28-Jun-93 |
| 1240.2302 |
Routing of Congressional Correspondence |
26-Feb-07 |
| 1240.2305 |
CVM External Communications Clearance Policy and Procedures |
31-Oct-05 |
| 1240.2315 |
Process on GAO/OIG Studies/Audits |
04-Mar-05 |
| 1240.2316 |
Process on OIG Studies |
08-Nov-06 |
| 1240.2320 |
Communication and Liaison with other Centers and Agencies |
7-May-91 |
| 1240.2322 |
Intercommunication between CVM and Office of Chief Counsel |
28-Jun-93 |
| 1240.2325 |
CVM Guidance on Media Inquiries |
22-Jan-07 |
| 1240.2326 |
Revising CVM Documents for External Stakeholders |
21-Oct-04 |
| 1240.2330 |
Consultative Reviews and Opinions |
7-May-91 |
| 2500
- FREEDOM OF INFORMATION |
| 1240.2500 |
Freedom of Information Requests |
22-Aug-05 |
| 1240.2501 |
Public Availability of Food Additive Petitions |
20-July-07 |
| 1240.2510 |
Advisory Opinions and Informal Requests for Information |
23-Oct-85 |
| 1240.2520 |
Confidentiality of Center Files |
25-Jun-93 |
| 2600
- SPECIAL INTERESTS |
| 1240.2600 |
Industry Conferences |
11-Jun-90 |
| 1240.2601 |
Meetings With Foreign Government or Foreign Industry Representatives |
22-Sep-05 |
| 1240.3010 |
Processing Original Investigational New Animal Drug Applications |
30-Sep-96 |
| 1240.3020 |
Processing Amendments to An Investigational New Animal Drug Application |
30-Sep-96 |
| 3100
- NADA |
| 1240.3100 |
Initial Processing and Filing of an Original NADA or ANADA |
15-Aug-02 |
| 1240.3101 |
Review of Animal Safety and Effectiveness Data |
1-Aug-89 |
| 1240.3102 |
Use of Foreign Non-Clinical and Clinical Data in an NADA |
6-Sep-89 |
| 1240.3125 |
Preparation of a Draft FEDERAL REGISTER Notice of Approval of a New Animal Drug Application (FR Notice) |
08-Mar-00 |
| 1240.3135 |
Animal Drug Applications Expedited Review Guideline |
3-Dec-97 |
| 1240.3150 |
NADA Review of Dosage Form Oral Electrolytes |
13-Oct-94 |
| 3300
- FOOD ADDITIVE PETITION |
| 1240.3300 |
Food Additive Petition Review |
27-Jun-05 |
| 1240.3310 |
Establishing and Processing Investigational Food Additive Files |
25-Apr-00 |
| 3400
- ANIMAL FEEDS |
| 1240.3415 |
Analytical Method Development for Feed Contaminants |
24-Apr-07 |
| 1240.3420 |
Nutritional Ingredients in Animal Drugs and Feeds |
23-Mar-93 |
| 3500
- SURVEILLANCE |
| 1240.3500 |
New Animal Drug Determination |
20-Feb-07 |
| 1240.3502 |
New Animal Drug Regulation |
20-Feb-07 |
| 1240.3510 |
Drug Experience Reporting Requirements |
20-Feb-07 |
| 1240.3512 |
Additional Sources of Adverse Reaction and Injury Reports |
20-Feb-07 |
| 1240.3514 |
Drug Experience Reporting by Veterinarians |
20-Feb-07 |
| 1240.3520 |
Adverse Reactions as a Basis for Regulatory Action |
20-Feb-07 |
| 1240.3521 |
Animal Health Hazard Evaluation Committee |
20-Feb-07 |
| 1240.3522 |
Review and Evaluation of Drug Experience Reports |
20-Feb-07 |
| 1240.3524 |
Criteria for Veterinary Medical Review of Establishment Inspection Reports |
20-Feb-07 |
| 1240.3530 |
Procedures for Processing Drug Experience Reports |
20-Feb-07 |
| 1240.3540 |
NADAs, Withdrawal of Approvals |
20-Feb-07 |
| 1240.3542 |
Implementation of Casual Reviews |
20-Feb-07 |
| 1240.3550 |
Surveillance at Professional and Trade Meetings |
20-Feb-07 |
| 1240.3560 |
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution |
9-Sep-97 |
| 3600
- COMPLIANCE |
| 1240.3600 |
Types of Enforcement Activities |
18-Sep-98 |
| 1240.3601 |
Types of Regulatory Actions |
18-Sep-98 |
| 1240.3605 |
Regulating Animal Foods with Drug Claims |
18-Sep-98 |
| 1240.3620 |
Request for CGMP Establishment Inspections |
18-Sep-98 |
| 1240.3622 |
Good Manufacturing Practice Compliance Status |
18-Sep-98 |
| 1240.3630 |
Tissue Residue Reporting |
18-Sep-98 |
| 1240.3650 |
Diversion of Unfit Food to Animal Use |
18-Sep-98 |
| 1240.3660 |
Development of Compliance Policy Guides Affecting Veterinary Products |
18-Sep-98 |
| 1240.3661 |
Preparation of Compliance Programs and Program Circulars |
18-Sep-98 |
| 1240.3670 |
Management of Formal Evidentiary Hearings |
18-Sep-98 |
| 3700
- RESEARCH |
| 1240.3700 |
Center for Veterinary Medicine Research Activities |
6-Jan-98 |
| 1240.3710 |
Initiation and Approval of Research Projects |
6-Jan-98 |
| 4000
- LABELING |
| 1240.4000 |
Identification/Promotion of Product Approval |
10-Sep-97 |
| 1240.4005 |
Procedure for Center Recommended Labeling Changes |
10-Sep-97 |
| 1240.4010 |
Antibacterials Labeled for Secondary Infections |
10-Sep-97 |
| 1240.4020 |
Uniformity in Labeling |
10-Sep-97 |
| 1240.4021 |
General Policies for Animal Drug Label Review |
10-Sep-97 |
| 1240.4025 |
Therapeutic Use Directions for Medicated Feed and Drinking Water |
10-Sep-97 |
| 1240.4030 |
Established Names |
10-Sep-97 |
| 1240.4040 |
Clinical Investigator Sanctions and the Videotex Method Of Obtaining Information on Ineligible Investigators |
10-Sep-97 |
| 4100
- DRUGS |
| 1240.4120 |
Sterility of Ophthalmic Products |
25-Apr-00 |
| 1240.4122 |
Sterility and Pyrogen Requirements for Injectable Drug Products |
25-Apr-00 |
| 1240.4130 |
Overformulation in Animal Drug Products |
25-Apr-00 |
| 1240.4150 |
Ownership Transfer or Corporate Identity Change of an Application |
18-Sept-98 |
| 1240.4160 |
Policy on Sterilization of New Animal Drug Products and Containers By Irradiation |
25-Apr-00 |
| 1240.4170 |
CVM Medically Necessary Veterinary Drug Product Shortage Management |
25-Apr-00 |
| 4200
- AQUACULTURE |
| 1240.4200 |
Drug Use in Aquaculture Enforcement Priorities |
26-Apr-07 |
| 1240.4210 |
Extra-label Use of Approved Drugs in Aquaculture Update |
19-Feb-08 |
| 1240.4220 |
Drug-Pesticide Issues Update |
19-Feb-08 |
| 1240.4230 |
Regulation of Fish Identification Products Update |
19-Feb-08 |
| 1240.4260 |
Classification of Aquaculture Species/Population as Food or Non-food Update |
14-Apr-08 |
| 1240.4270 |
Use of Drugs in Outdoor Aquatic Research Facilities Update |
14-Apr-08 |
| 1243.0000
- ONADE REVIEWERS' CHAPTER |
| 1243.2010 |
Responsibilities for Creating and Keeping Records |
02-Jul-03 |
| 1243.2030 |
Responding to Requests for Copies of Letters or Requests for Copies of Administrative Files New
|
17-Mar-08 |
| 1243.2050 |
Refuse to File and Refuse to Review |
13-Dec-05 |
| 1243.2180 |
New Animal Drug Applications, Form FDA 356V |
16-Nov-01 |
| 1243.2340 |
Transfer of Ownership and Sponsor Name or Address Change Procedures in ONADE for NADA, ANADA, INAD, JINAD or VMF Submissions |
16-Nov-01 |
| 1243.3005 |
Creating Clean Electronic Files |
19-Dec-07 |
| 1243.3009 |
Format and Style Conventions for Reviews and Submission Summaries Update
|
4-Dec-08 |
| 1243.3010 |
Format and Style Conventions for Letters Update |
4-Dec-08 |
| 1243.3020 |
Managing the Review of Submissions in the STARS Queue |
3-Dec-02 |
| 1243.3022 |
Implementing the Animal Drug User Fee Act of 2003 (ADUFA) |
29-Sep-04 |
| 1243.3024 |
Scheduling and Holding Meetings With Outside Parties |
13-Sept-06 |
| 1243.3025 |
Preparing a Memorandum of Conference (MOC) Update |
4-Dec-08 |
| 1243.3026 |
Amending STARS Submissions |
15-Feb-07 |
| 1243.3029 |
Closing Out a Consulting Review for STARS Submissions Update
|
4-Dec-08 |
| 1243.3030 |
Completing Final Action Packages for STARS Submissions Update |
4-Dec-08 |
| 1243.3033 |
Permissible STARS Action Codes for STARS Submissions |
23-Feb-05 |
| 1243.3040 |
Processing Suitability Petitions |
11-Sept-02 |
| 1243.3120 |
Expedited Review Processing |
16-Nov-01 |
| 1243.3200 |
Routing a Request to Obtain a Review of an INAD, JINAD, ANADA, NADA, or VMF Submission |
20-Dec-07 |
| 1243.3300 |
FDA District Office Mail Codes Update |
24-Sep-08 |
| 1243.3800 |
Preparing and Processing an Approval PackageUpdate |
12-Mar-08 |
| 1243.3810 |
Creating and Maintaining a Reference Copy of the Currently Approved Labeling for an Application (Volume 0) |
31-Oct-07 |
| 1243.3900 |
Maintaining the Green Book the FDA List of Approved Animal Drug Products Update
|
06-Mar-08 |
| 1243.4060 |
Review of Protocols |
23-Aug-05 |
| 1243.4065 |
Requirements For Investigational New Animal Drug Exemptions |
04-Nov-08 |
| 1243.4070 |
Integrating an End-Review Amendment (ERA) Into the Investigational New Animal Drug (INAD) Protocol (E) Submission Review Process New |
19-Sep-08 |
| 1243.4075 |
Integrating An End-Review Amendment (Era) Into The Investigational New Animal Drug Data (P) Submission Review Process New |
19-Sep-08 |
| 1243.4080 |
Technical Section Complete Letters Update |
18-Nov-08 |
| 1243.5730 |
Integrating an End-Review Amendment (Era) Into the New Animal Drug Application Review Process New |
19-Sep-08 |
| 1243.5740 |
ANADA Memorandum Recommending Approval |
16-Nov-01 |
| 1243.5741 |
Memorandum Recommending Approval (MRA) for Original and Supplemental New Animal Drug Applications (NADA) |
13-Dec-07 |
| 1243.5760 |
Freedom of Information Summary for an ANADA |
16-Nov-01 |
| 1243.5761 |
Freedom of Information Summary for Original and Supplemental NADA Update |
16-May-08 |
| 1243.5762 |
Freedom of Information Summary for an ADAA Feed Combination NADA Approval Update |
4-Dec-08 |
| 1243.5780 |
Exclusivity Wording for Use In the Following Documents: Memorandum Recommending Approval and Letter to Applicant |
16-Nov-01 |
| 1243.5820 |
Approval Letters Update |
4-Dec-08 |
| 1243.6020 |
Review of NADA and ANADA Labeling Supplements Update |
12-Mar-08 |
| 1243.6030 |
Review of Labeling Changes in Manufacturing Supplements Update |
18-Nov-08 |
| 1243.7220 |
Environmental Review: Evaluating Claims of Categorical Exclusion for Actions Relating to New Animal Drug |
26-Jan-06 |
| 1243.8220 |
BIMO Inspection Request Process |
16-Nov-01 |
| 1243.8225 |
Document Routing and Copy Distribution for Bioresearch Monitoring in ONADE |
16-Nov-01 |
| 1243.8500 |
Making a Request for a Current Good Manufacturing Practice (cGMP) Status for Approval Package |
24-Jun-03 |
