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CDER Manual of Policies and Procedures
MaPPs

This page contains the current CDER Manual of Policies and Procedures in Adobe Acrobat Format (PDF). See bottom for more information.

The current manual: Center Director | Controlled Substances | Training and Communications | Management | Compliance | Pharmaceutical Sciences | Clinical Pharmacology | Generic Drugs | New Drug Chemistry | Testing and Research | Review Management | Office of Drug Evaluation I | Office of Drug Evaluation II | Office of Drug Evaluation III | Office of Drug Evaluation IV | Office of Drug Evaluation V | Epidemiology and Biostatistics | Discipline Specific | Biopharmaceutics | Chemistry | Medical/Statistical | Pharmacology and Toxicology | Project Management | Information Technology | Research

Document Development and Management

• 4000.1 Guide to Issuance of Directives in the CDER
• 4000.2 Developing and Issuing Guidance (Issued 7/01/2003, Posted 7/10/2003)
• 4000.3 Submitting Proposals to the Office of Regulatory Policy (ORP) for Early Analysis of Rulemaking Initiatives (Issued 10/18/2001, Posted 10/23/2001)
• 4000.4 Clinical Pharmacology and Biopharmaceutics NDA Review Template.  (Issued 4/27/2004, Posted 6/24/2004). 

Chapter 4100 - Center Director

• 4110.1 AWS for Executive Operations Staff (Issued 4/27/98, Posted 11/02/98)
• 4112.1 CDER/FDA Press Office Interactions in the Preparation and Clearance of Written Documents for the Public (Issued 10/18/2001)
• 4112.2 Sharing Nonpublic Information with Federal Government Officials (Issued 5/9/2002, Posted 7/12/2002)
• 4112.4 Procedures for Assessments Performed by the Quality Assurance Staff (Issued 2/27/2004, Posted 3/25/2004)
• 4112.7 Obtaining the Services of an Expert or Fact Witness for Criminal Cases (Issued 2/27/2004, Posted 3/25/2004)
• 4114.1 Support Staff Coordinating Committee (Issued 6/11/1999, Posted 7/02/1999)
• 4114.2  Telephone Coverage Policy (Issued 11/26/2002, Posted 12/11/2002)
• 4115.1 Public Dissemination of a Summary of the Medical and Clinical
  Pharmacology Reviews of Pediatric Studies (Issued 8/10/2004, Posted 9/28/2004)
• 4140.2 Alternate Work Schedules for the Regulatory Policy
• 4140.3 Flexible Workplace Arrangements Program For The Regulatory Policy Staff (RPS) (Issued 3/26/1998, Posted 4/3/1998)
• 4140.5 Submitting Issues/Documents to the Office of the Chief Counsel (OCC) for Legal Review, Comment, or Clearance (Issued 3/2002, Posted 3/22/2002)
• 4140.6 Editing Procedures (Issued 11/27/2002, Posted 12/11/2002)
• 4143.1 Special Termination of Mandatory Debarment of an Individual (Issued 2/25/1997, Posted 2/25/1997)
• 4150.1 Role and Procedures of the CDER Ombudsman (Issued 10/10/2002, Posted 10/18/2002)
• 4151.1 Resolution of Disputes: Roles of Reviewers, Supervisors, and Management: Documenting Viewsand Findings and Resolving Differences
• 4160-1 International Activities Coordinating Committee (IACC) (Issued 5/30/2000, Posted 6/5/2000)
• 4160-2 Prioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory Organizations (Issued 5/31/2000)
• 4170-2 Submitting Non-FOIA Requests For Document Collection and Redaction To CDER's Division of Information Disclosure Policy (DIDP) (Issued 5/9/2002, Posted 5/15/2002)
• 4170.3 Litigation Document Control Procedures in the Division of Information Disclosure Policy (Issued 8/10/2003, Posted 12/11/2003)

Chapter 4200 - Controlled Substances

• 4200.1 Consulting the Controlled Substance Staff on INDs and ProtocolsThat Use Schedule I Controlled Substances and Drugs (Issued 5/8/2003, Posted 5/14/2003)

• 4200.2 Forecasting Schedule I and II Substance and Drug Needs (Issued 5/8/2003, Posted 5/14/2003)

• 4200.3 Consulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug Scheduling (Issued 5/8/2003, Posted 5/14/2003)

Chapters 4300 - 4400 (Reserved)

Chapter 4500 - Training and Communications

• 4501.1 Alternate Work Schedules for the Office of Training and Communications
• 4501.2 Flexible Workplace Arrangements Program (FWAP) for the Office of Training and Communications
• 4510.1 Authorization, Funding and Tracking Speeches/Participation on Planning Committees
• 4510.2 Clearance of Speeches, Articles and Other Communication Material (Revised 1/26/1999, Posted 1/26/1999)
• 4512.1 Formal Meetings Between CDER and CDER's External Constituents.
• 4520.1 Communicating Drug Approval Information (Issued 3/25/1998, Posted 3/26/1998)
• 4520.2 Providing General Consumer Information on New Molecular Entities on CDER’s Web Site (Issued 10/10/2002, Posted 10/18/2002)
• 4550.1 Participation in the Volunteer Program for Pharmacy Students (Issued 5/12/1998, Posted 5/14/1998)
• 4550.3 Employee Training and Development (Issued 3/13/1997, Posted 3/23/1998)
• 4550.5 Accreditation — Continuing Education (issued 7/8/203, Posted 7/10/2003)
• 4550.7 Guide to the Orientation Mentoring Program in the Center for Drug Evaluation and Research (Issued 8/4/2003, Posted 10/2/2003)

Chapter 4600 - Management

• 4601.1 Alternative Work Schedules for the Office of Management
• 4601.2 Use of Alternative Workplaces (AWP) for Commissioned Corps Officers (Issued 11/20/2001, Posted 11/21/2001)
• 4631.1 Supplement to Authority to Make Allotments and Authorize the Establishment of Allowances
• 4631.2 Preparation of Purchase/Service/Stock Requisition (Form HHS.393) (Issued 3/25/1997, Posted 4/8/1997)
• 4631.3 Budget Execution Planning and Reporting/Program Management System Reports (Issued 3/25/1997, Posted 4/8/1997)
• 4634.1 CDER Program Delegations of Authority (Issued 3/25/1997, Posted 4/8/1997)
• 4634.2 Changes to CDER Program Delegations of Authority (Issued 3/25/1997, Posted 4/8/1997)
• 4634.3 Development, Maintenance, and Distribution of CDER Organizational Charts (Issued 3/25/1997, Posted 4/8/1997)
• 4636.1 Tracking and Safeguarding Gift Certificates (Posted 11/3/2000)
• 4640.1 Guide to the Assignment of Mail Routing Codes in the Center for Drug Evaluation and Research (Revised 11/20/2001, Posted 11/21/2001)
• 4641.1 Leave and Personal Time in Conjunction with International and Domestic Travel (Issued 5/8/2003, Posted 5/14/2003)
• 4641.2 Guide to Delegations of Authority - Travel
• 4641.3 Outside Activities (Issued 3/23/1998, Posted 3/23/1998)
• 4641.4 Acceptance of Payment for Travel Expenses from Non-Federal Sources (Issued 3/4/1997, Posted 3/18/1997)
• 4641.5 Authority to Reimburse Employees for Business Calls Made on Personal Car Phones (Issued 3/11/1997, Posted 3/18/1997)
• 4641.6 Obtaining Reimbursement for Local Travel Expenses (Issued 12/17/1997, Posted 12/19/1997)
• 4641.7 Government Travel Charge Card Program (Issued 1/26/1998, Posted 3/23/1998)
• 4641.8 Reimbursement for Professional Liability Insurance (Issued 5/8/2003, Posted 5/14/2003)
  • 1164 Form - Claim for Reimbursement Expenditures on Official Business 
• 4642.1 Policies and Procedures for Organizational Changes (1/7/96)
• 4651.1 On-the-Spot Cash Award
• 4651.2 Time Off Incentive Award
• 4655.1 Employee Probationary Period Appraisal
• 4655.2 Performance Management Program (Issued 5/12/1998, Posted 5/14/1998)
• 4656.1 CDER Expert Regulatory Scientist Peer Review Committee (Issued 6/19/2003, Posted 10/2/2003)
• 4657-0 CDER's Time, Attendance, and Leave Recording Policy (Issued 10/22/1997, 11/6/1997)
• 4657.1 Alternate Work Schedules (AWS) (Revised 5/13/2004, Posted 5/14/2004)
• 4657.2 Flexible Workplace Arrangements Program (Revised 5/13/2004, Posted 5/14/2004)
• 4657.4 Intra-Center Detail Program
• 4657.5 Advanced Annual and Sick Leave (Revised 10/18/2001, Posted 10/23/2001)
• 4657.6 Granting Excused Absence (Originator: Division of Management Services, OM; Revised 10/23/2001, Posted 10/23/2001)
• 4657.7 Leave and Absence for Hazardous Weather and Other Emergency and Administrative Situations (Originator: Division of Management Services, OM; Issued Updated 4/16/1997, Posted 8/1/1997)
• 4657.9 Restoration of Forfeited Annual Leave (Issued 10/27/2000, Posted 12/12/2000)
• 4657.10 Hazardous Weather Policy for Employees with Disabilities (Issued 2/19/1997, Posted 2/21/1997)
• 4657.11 Religious Compensatory Time (Issued 3/4/1997, Posted 3/18/1997)
• 4657.12 Voluntary Leave Transfer Program (Issued 11/7/1997, Posted 12/8/1997)
• 4660.1 Service Fellowship Program (Issued 5/5/1998, Posted 5/14/1998)

Chapter 4700 - Compliance

• 4700.1 Management of CDER Compliance Coordinating Committee (Issued 3/4/1997, Posted 3/18/1997)
• 4703.1 Alternate Work Schedules for the Office of Compliance (Originator: Director, Office of Compliance; Issued 11/19/96)
• 4703.2 Flexible Workplace Arrangements Program for the Office of Compliance (Originator: Director, Office of Compliance; Issued 11/19/96)
• 4723.1 Standing operating Procedures for NDA/ANDA Field alert Reports (Issued 10/30/1998, Posted 11/02/1998)
• 4730.1 Drug Shortage Management (11/21/96)

Chapter 4800.4900 (Reserved)

Chapter 5000 - Pharmaceutical Sciences

• 5000.1 Alternate Work Schedules (Issued 12/17/1997, Posted 12/19/1997)
• 5000.2 Flexible Workplace Arrangement Program for the Office of Pharmaceutical Science (Issued 1/26/1998, Posted 1/28/1998)
• 5000.3 OPS Time Attendance and Leave Recording Policy (Issued 10/30/1998, Posted 11/02/1998)
• 5000.4 CDER Office of Pharmaceutical Science Immediate Office Calendar (Issued 5/8/2003, Posted 5/14/2003)
• 5000.5 Office of Pharmaceutical Science Regulatory and Scientific Briefings (Issued 6/22/2004, Posted 6/24/2004)
• 5015.3 Cover Form for the Technical Review of Drug Master Files (Issued 3/23/1998, Posted 4/7/1998)
• 5015.4 Chemistry Reviews of DMFs for Drug Substances/Intermediates (DSI) (Issued 8/17/98, Posted 10/7/98)
• 5015-6 Review of the Same Supplemental Change to More than One NDA or ANDA in More Than One Review Division (Issued 1/14/2000, Posted 1/19/2000)
• 5015.7 Environmental Assessments (Issued 3/6/2003, Posted 3/17/2003)
• 5020.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) (Issued 5/10/2004, Posted 5/24/2004)

Chapter 5100 - Clinical Pharmacology

• 5100.1 Alternative Work Schedules for Clinical Pharmacology and Biopharmaceutics (Issued 1/16/1998, Posted 1/26/1998)
• 5100.2 Flexible Workplace Arrangements Program for Clinical Pharmacology and Biopharmaceutics (Issued 1/16/1998, Posted 1/23/1998)
• 5120.1 Clinical Pharmacology And Biopharmaceutics (CPB) Briefing Criteria And Attendance Policies (Issued 10/1997, Posted 10/22/1997)

Chapter 5200 - Generic Drugs

• 5020.1 Responding to Telephone Inquiries in the Office of Generic Drugs (Issued 8/31/1999, Posted 9/7/1999)
• 5200.1 Collection of Documents in Docket for Agency Policy Statements, Speeches and Policy and Procedure Guides Addressing Human Generic Drugs
• 5200.5 Alternative Work Schedule for the Office of Generic Drugs (Issued 12/1998, Posted 12/3/1998)
• 5200.6 Issuing and Tracking of Consults (Issued 5/9/2001, Posted 5/14/2001)
• 5210.1 Procedure for Public Release of Bioequivalence Protocols and Reviews (MaPP withdrawn because it is obsolete)
• 5210.2 Reassignment of Bioequivalence Reviews (Revised 5/9/2001, Posted 5/14/2001)
• 5210.3 Productivity Documentation in the Division of Bioequivalence (Issued 5/9/2001, Posted 5/14/2001)
• 5210.4 Review Responsibility for Bioequivalence Studies with Clinical Endpoints Submitted in an Abbreviated New Drug Application (Issued 12/18/2000, Posted 1/3/2001)
• 5210.5 Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs (Issued 5/10/2004, Posted 5/14/2004)
• 5210.6 Procedures for Review of Bioequivalence Study Protocols (Issued 12/15/2000, Posted 1/3/2001)
• 5210.7 Inspections of Clinical Facilities and Analytical Laboratories (Issued 12/15/2000, Posted 1/3/2001) 
• 5210.8  Review of Dissolution Data in Supplemental ANDAs (Issued 1/17/2003, Posted 3/17/2003)
• 5221.1 Requesting Methods Validation for ANDAs (Issued 12/1998, Posted 12/3/1998)
• 5223.2 Scoring Configuration of Generic Drug Products
• 5225.1 Guidance on the Packaging of Test Batches
• 5225.2 Consistent Container Information in an Abbreviated Application
• 5226.1 Reaffirmation of Expiration Dating Period for Abbreviated Applications
• 5230.1 Availability of Labeling Guidelines
• 5230.2 Review of Generic Drug Product Labeling Requiring Input From Multiple FDA Components (Issued 7/9/2003, Posted 10/2/2003)
• 5240.1 Requests for Expedited Review of Supplements to Approved ANDAs and AADAs
• 5240.3 Restatement of the Office of Generic Drugs' "First-in, First-reviewed" Policy and Modification of the Exceptions to the Policy Regarding Minor Amendments
• 5240.4 Submission of an Investigational New Drug Application to the Office of Generic Drugs
• 5240.6 Telephone Requests by the Division of Bioequivalence (Issued 12/18/2000, Posted 1/3/2001)
• 5240.7 Telephone Requests by the Divisions of Chemistry (Issued 10/6/2003, Posted 10/8/2003)

Chapter 5300 - New Drug Chemistry

• 5310.2 Drafting, Circulating, and Signing Chemistry, Manufacturing, and Controls Letters (Issued 10/27/1998, Posted 11/02/1998)
• 5310.3 Requests for Expedited Review of NDA Chemistry Supplements (Issued 6/11/1999, Posted 7/02/1999)
• 5310.4 Procedures for Evaluating and Handling Field Alert Reports (Posted 11/3/2000)
• 5310.6 Procedures for Assessing Chemistry, Manufacturing, and Controls Data in NDA Annual Reports (Issued 10/10/2002, Posted 10/18/2002)

Chapter 5400 - Testing and Research

Chapters 5500.5900 - (Reserved)

Chapter 6000 - Review Management

• 6001.1 Special Government Employees Representing Sponsors Before CDER
• 6002.1 Alternative Work Schedule
• 6002.2 Flexiplace Workplace Agreement Program
• 6002.3 Magnified Maxiflex for ORM (Issued 11/20/1997, Posted 1/16/1998)
• 6004.1 Granting Waivers Under 21 CFR 314.90 for Postmarketing Safety Reporting Requirements Under 21 CFR 314.80 (11/16/1999, Posted 11/17/1999)
• 6005.1 Office of Review Management -- Information Technology Committee (Issued 9/15/98, Posted 10/7/98)
• 6007.1 Review of Botanical Drug Products (Issued 6/7/2004, Posted 6/9/2004)
• 6010.1 NDAs: Preapproval Safety Conferences (Issued 11/15/1999, Posted 11/17/1999)
• 6010.2 Procedures for Tracking and Reviewing Phase 4 Commitments
• 6010.3 Clinical Review Template (Issued 7/9/2004, Posted 7/12/2004)

• 6010.5 NDAs: Filing Review Issues (Issued 5/8/2003, Posted 5/14/2003)

• 6020.1 Extraneous References in Product Labeling: Exclusion of American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classifications
• 6020.2 Applications for Parenteral Products in Plastic Immediate Containters
• 6020.3 Priority Review Policy
• 6020.4 Classifying Resubmissions of Original NDAs in Response to Action Letters (Issued 5/1/1998, Posted 5/14/1998)
• 6020.5 NDA General Procedures: OTC Marketing and Rx-to-OTC Switch (Originator: Deputy Center Director (Review Management); Issued 1/15/1997) (Posted1/16/1997)
• 6020.7 NDAs: Foreign Language Labeling (Issued 7/9/004, Posted 7/12/2004)
• 6020.8 Action Packages for NDAs and Efficacy Supplements (Issued 11/13/2002, Posted 12/11/2002)
• 6020.10 NDAs: "Dear Health Care Professional" Letters (Issued 7/2/2003, Posted 10/2/2003)
• 6030.1 IND Process and Review Procedures (Issued 5/1/1998, Posted 5/14/1998)
• 6030.2 INDs: Review of Informed Consent Documents (Issued 11/13/2002, Posted 12/11/2002)
• 6030.4 INDs: Screening INDs (Issued 5/9/2001, Posted 5/14/2001)
• 6030.8 INDs: Exception from Informed Consent Requirements for Emergency Research (Issued 2/4/2003, Posted 3/17/2003)
• 6050.1 Refusal to Accept Application for Filing From Applicants in Arrears

Chapter 6100 - Office of Drug Evaluation I

• 6110.1 Time and Attendance Policy for the Division of Oncology Drug Products

Chapter 6200 - Office of Drug Evaluation II

Chapter 6300 - Office of Drug Evaluation III

• 6301.1 Alternate Work Schedules for the Office of Drug Evaluation III (ODE III)

• 6301.2 Flexible Workplace Arrangements Program for the Office of Drug Evaluation III (ODE III)
• 6301.3 Overtime Policy for the Office of Drug Evaluation III (ODE III)
• 6301.4 Time and Attendance Policy for the Office of Drug Evaluation III (Issued 10/20/1997, Posted 12/8/1997)

Chapter 6400 - Office of Drug Evaluation IV

Chapter 6500 - Office of Drug Evaluation V

• 6501.1 Flexible Workplace Arrangements Program for the Office of Drug Evaluation V
• 6501.2 Alternate Work Schedules for the Office of Drug Evaluation V (1/7/1996)
• 6532.1 Over-the-Counter (OTC) Labeling and Use Studies

Chapter 6600 - Epidemiology and Biostatistics

• 6610.1 Statistical Policy Coordinating Committee (Issued 7/28/1999, Posted 7/28/1999)

Chapter 7000 - Discipline Specific

Chapter 7100 - Biopharmaceutics

• 7100.1 Management of CDER Biopharmaceutics Coordinating Committee (Issued 11/16/1999, Posted 11/17/1999)

Chapter 7200 - Chemistry

• 7210.1 Management of the Chemistry, Manufacturing, and Controls Coordinating Committee (Issued 8/31/1999, Posted 11/1/1999)
• 7210.2 Management of the Complex Drug Substances Coordinating Committee (Issued 11/2/2002, Posted 12/11/2002) 
• 7211.1 Drug Application Approval 501(b) Policy

Chapter 7300 - Medical/Statistical

• 7310.1 Medical Officer Evaluation Board (Issued 1/10/2003, Posted 3/17/2003)

Chapter 7400 - Pharmacology and Toxicology

• 7400.1 Management of CDER Pharmacology/Toxicology Coordinating Committee
• 7400.4 Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies (Issued 9/27/2004, Posted 9/28/2004)
• 7400.5 Management of the PTCC Education Subcommittee (Issued 9/9/2004, Posted 9/28/2004)
• 7412.1 Management of CDER Carcinogenicity Assessment Committee (CAC) and Executive CAC
• 7412.2 Distribution of Final Reports from the Carcinogenicity Assessment Committee (CAC) and the Executive CAC (Issued 3/24/1997, Posted 4/8/1997)

Chapter 7500 - Project Management

• 7500.1 Office of New Drugs Regulatory Project Management Coordinating Committee (Issued 11/6/2002, Posted 12/11/2002)
• 7500.2 Regulatory Project Management Site Tours and Regulatory Interactions Program: Pharmaceutical Company Selection (Issued 8/4/2003, Posted 10/2/2003)
• 7510.1 Withdrawn, superceded by the provisions of FDAMA Section 116, which went into effect on Novemer 21, 1999 (Issued 12/1998, Posted 12/3/1998)

Chapter 7600 - Information Technology

• 7600.1 Information Management Steering Committee (Issued 10/10/2002, Posted 10/18/2002)
• 7600.2 Computer Hardware
• 7600.3 Maintaining CDER'S Electronic Submissions Docket (Issued 10/15/1997, Posted 11/14/1997)
• 7600.4 Nomenclature Standards Committee (NSC) (Issued 4/25/1998, Posted 4/28/1998)
• 7600.5 Requesting IT Services from the Office of Information Technology (Issued 7/12/1999, Posted 7/28/1999)
• 7600.6 Requesting and Accepting Non-Archivable Records in Electronic Format for New Drug Applications (Issued 11/12/1999, Posted 11/17/1999)
• 7600.7 Processing an Electronic New Drug Application (Issued 5/31/2000, Posted 6/5/2000)
• 7610.1 Posting Documents on the External World Wide Web Site
• 7610.2 Use of Government Electronic Equipment and Systems (Issued 5/8/1998, Posted 5/14/1998)
• 7620.1 Alternate Work Schedules (AWS) (Issued 5/9/2001, Posted 5/14/2001)
• 7620.3 Overtime Policy in the Office of Information Technology (Issued 10/18/2001, Posted 10/23/2001)
• 7620.4 Time, Attendance, and Leave Recording Policy in the Office of Information Technology (Issued 10/18/2001, Posted 10/23/2001)
• 7620.5 Procedures for Acquisition, Tracking, Distribution, and Safeguarding of Gift Certificates in the Office of Information Technology (Issued 11/20/2001, Posted 11/21/2001)

Chapter 7700 - Research

Chapter 7800 - Administrative Management

• 7800.1 Administrative Management Coordinating Committee (Issued 10/27/2000, Posted 12/12/2000)

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