Note: The following table contains links to sections of the
CVM Program Policy and Procedures Manual. 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.
icon identifies sections that have been added or updated during Fiscal Year 2005
| PPM NUMBER |
TITLE |
|
|
1240.0000
| pdf | | doc
| |
Index |
21-Oct-04 |
| 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 |
15-Jul-97 |
| 1240.1131 |
Office of
Surveillance and Compliance, Division of Compliance |
15-Jul-97 |
| 1240.1132 |
Office of
Surveillance and Compliance, Division of Epidemiology
& Surveillance |
15-Jul-97 |
| 1240.1133 |
Office of
Surveillance and Compliance, Division of Animal Feeds
|
15-Jul-97 |
| 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-Sept-92 |
| 1240.2030 |
Citizen Petitions:
Policy and Procedures |
7-June-94 |
| 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 |
| 1240.2120 |
Product Manager |
11-Aug-93 |
| 1240.2140 |
CVM P &
P Manual Utilization and Maintenance |
3-Sep-97 |
| 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 |
9-Apr-97 |
| 1240.2310 |
Correspondence
to Practicing Veterinarians, Vet Med Associations, and
other Scientific Disciplines |
28-Jun-93 |
| 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 |
4-Oct-04 |
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 |
28-May-99 |
| 1240.2501 |
Public Availability
of Food Additive Petitions |
25-Jun-93 |
| 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 Representatives from Foreign Governments |
8-Sep-94 |
| 3000
- INAD |
| 1240.3000 |
New Animal
Drugs for Investigational Use |
30-Sep-96 |
| 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 |
| 1240.3025 |
Non-Routine
Invest. New Animal Drugs |
30-Sep-96 |
| 1240.3032 |
Requirements
for Importation of Investigational New Animal Drugs |
27-Mar-92 |
| 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 |
| 1240.3103 |
Review of
Vet. Med. Guidelines |
23-Nov-93 |
| 1240.3110 |
Specialty
Reviews of NADAs |
17-Dec-93 |
| 1240.3120 |
Preparation
of NADA Decision Package |
23-Nov-93 |
| 1240.3122 |
Routing of
NADA Decision Package |
23-Nov-93 |
| 1240.3125 |
Preparation
of a Draft FEDERAL REGISTER Notice of Approval of
a New Animal Drug Application (FR Notice) |
08-Mar-00 |
| 1240.3130 |
CVM Appeals
Procedure Guide |
23-Nov-93 |
| 1240.3135 |
Animal Drug
Applications Expedited Review Guideline |
3-Dec-97 |
| 1240.3140 |
Labeling
Policy for Animal Drugs That May Be Human Carcinogens |
13-Oct-94 |
| 1240.3150 |
NADA Review
of Dosage Form Oral Electrolytes |
13-Oct-94 |
| 3300
- FOOD ADDITIVE PETITION |
| 1240.3300 |
Food Additive
Petition Review |
7-Dec-93 |
| 1240.3310 |
Establishing
and Processing Investigational Food Additive Files |
24-Apr-00 |
| 3400
- ANIMAL FEEDS |
| 1240.3420 |
Nutritional
Ingredients in Animal Drugs and Feeds |
23-Mar-93 |
| 3500
- SURVEILLANCE |
| 1240.3500 |
New Animal
Drug Determination |
24-Jul-89 |
| 1240.3502 |
New Animal
Drug Regulation |
4-Sep-91 |
| 1240.3510 |
Drug Experience
Reporting Requirements |
23-Nov-93 |
| 1240.3512 |
Additional
Sources of Adverse Reaction and Injury Reports |
23-Nov-93 |
| 1240.3514 |
Drug Experience
Reporting by Veterinarians |
7-May-97 |
| 1240.3520 |
Adverse Reactions
as a Basis for Regulatory Action |
23-Nov-93 |
| 1240.3521 |
Animal Health
Hazard Evaluation Committee |
28-Mar-86 |
| 1240.3522 |
Review and
Evaluation of Drug Experience Reports |
23-Nov-93 |
| 1240.3524 |
Criteria
for Veterinary Medical Review of Establishment Inspection
Reports |
23-Nov-93 |
| 1240.3530 |
Procedures
for Processing Drug Experience Reports |
23-Nov-93 |
| 1240.3532 |
Consumer
Complaint Letters |
6-Sep-89 |
| 1240.3540 |
NADAs, Withdrawal
of Approvals |
23-Nov-93 |
| 1240.3542 |
Implementation
of Causal Reviews |
23-Nov-93 |
| 1240.3550 |
Surveillance
at Professional and Trade Meetings |
23-Nov-93 |
| 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-Sep-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 |
09-Aug-02 |
|
1240.4210 |
Extra-label Use of Approved Drugs in Aquaculture |
29-Oct-97 |
| 1240.4220 |
Drug-Pesticide
Issues |
29-Oct-97 |
| 1240.4230 |
Regulation
of Fish Identification Products |
29-Oct-97 |
| 1240.4240 |
Safe Levels
of Unapproved Drugs in Aquaculture |
29-Oct-97 |
| 1240.4260 |
Classification
of Aquaculture Species/Population as Food or Non-food |
29-Oct-97 |
| 1240.4270 |
Use of Drugs
in Outdoor Aquatic Research Facilities |
29-Oct-97 |
|
43.0000 - REVIEWERS' CHAPTER GUIDES |
1243.2010 |
Responsibilities for Creating and Keeping
Records |
02-Jul-03 |
| 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 |
| 1243.2580 |
Submission Identification
System |
16-Nov-01 |
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 |
1243.3030 |
Completing Final Action
Packages for STARS Submissions |
19-Nov-03 |
| 1243-3040 |
Processing
Suitability Petitions |
11-Sep-02 |
| 1243.3060 |
Final Document Routing and
Copy Distribution for NADAs, ANADAs, INADs, JINADs, Master
Files, and Suitability Petitions |
16-Nov-01 |
| 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 |
16-Nov-01 |
| 1243.3300 |
FDA District Offices Mail
Codes |
16-Nov-01 |
| 1243.3340 |
Placing Stamp Dates on the
Electronic Copies of Letters Issued by ONADE |
16-Nov-01 |
| 1243.3800 |
Approval Process and Approval
Package |
16-Nov-01 |
| 1243.4080 |
Technical Section Complete
Letters |
18-Aug-03 |
| 1243.5740 |
ANADA Memorandum Recommending
Approval |
16-Nov-01 |
| 1243.5741 |
NADA Memorandum Recommending
Approval |
16-Nov-01 |
| 1243.5760 |
Freedom of Information Summary
for an ANADA |
16-Nov-01 |
| 1243.5761 |
Freedom of Information Summary
for an NADA |
16-Nov-01 |
| 1243.5762 |
Freedom of Information Summary
for an ADAA Feed Combination NADA Approval |
16-Nov-01 |
| 1243.5780 |
Exclusivity Wording for Use
In the Following Documents: Memorandum Recommending Approval
and Letter to Applicant |
16-Nov-01 |
| 1243.5820 |
Approval Letters |
15-Aug-03 |
| 1243.7220 |
Environmental Review: Evaluating
Claims of Categorical Exclusion for Actions Relating to
New Animal Drugs |
16-Nov-01 |
| 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 |
