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CDER Manual of Policies and Procedures (MaPP)

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

Contents:

Document Development and
   Management
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 I
Office of Drug Evaluation III
Office of Drug Evaluation IV
Office of Drug Evaluation V
Epidemiology and Biostatistics
Office of Drug Safety		 Discipline Specific
Biopharmaceutics
Chemistry
Medical/Statistical
Pharmacology and Toxicology
Project Management
Information Technology
Office of Translational Sciences

Document Development and Management

  • 4000.1 Developing and Issuing Manuals of Policies and Procedures (MAPPs) (Issued 3/30/2006; Posted 3/30/2006)
  • 4000.2 Developing and Issuing Guidance (Issued 9/13/2005, Posted 10/3/2005)
  • 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).
  • 4000.8 BLA Biostatistics Biologics Licensing Application (Issued 4/20/2005, Posted 4/22/2005)
  • 4000.8 NDA Biostatistics New Drug Application Review (Issued 4/20/2005, Posted 4/22/2005)
  • 4000.10 Indication-Specific Guidance Template (Issued 5/12/2005, Posted 5/12/2005)

Chapter 4100 - Center Director

  • 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)
  • 4112.6 Review of Human Subject Research (Issued 5/8/2006; Posted 5/8/2006)
  • 4112.7 Obtaining the Services of an Expert or Fact Witness for Criminal Cases (Issued 2/27/2004, Posted 3/25/2004)
  • 4112.8 Research Coordinating Committee (RCC) (Issued 5/22/2006, Posted 5/22/2006)
  • 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)
  • 4115.1R Public Dissemination of a Summary of the Medical and Clinical Pharmacology Reviews of Pediatric Studies (Issued 1/30/2006, Posted 1/30/2006)
  • 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
  • 4151.2 Documenting Differing Professional Opinions and Dispute Resolution – Pilot Program (Posted 11/5/2004)
  • 4151.3R Drug Safety Oversight Board (DSB) (Issued 3/2/2007, Posted 3/2/2007)
  • 4151.6 "Drug Safety Newsletter" (Issued 6/17/2008, Posted 6/19/2008)
  • 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)
  • 4180.2 Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG) (Issued 3/16/2005, Posted 3/22/2005)
  • 4180.3 Processing and Reviewing Voluntary Genomic Data Submissions (VGDSs) (Issued 3/16/2005, Posted 3/22/2005)

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

  • 4501.1R Alternate Work Schedules for the Office of Training and Communications (Revised 6/1/2007; Posted 6/7/2007)
  • 4501.2R Flexible Workplace Arrangements Program (FWAP) for the Office of Training and Communications (Revised 6/1/2007; Posted 6/7/2007)
  • 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)
  • 4520.1 Communicating Drug Approval Information (Issued 3/25/1998, Posted 3/26/1998)
  • 4520.2R Providing General Consumer Information on New Molecular Entities on CDER’s Web Site (Issued 10/1/2007, Posted 5/6/2008)
  • 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)
  • 4550.5R Accreditation — Continuing Education (Issued 11/16/2007, Posted 11/19/2007)
  • 4550.7R Guide to the Orientation Mentoring Program in the Center for Drug Evaluation and Research (Revised 6/1/2007; Posted 6/7/2007)

Chapter 4600 - Management

  • 4601.2R Use of Alternative Workplaces for Commissioned Corps Officers (Issued 2/22/2007, Posted 2/22/2007)
  • 4601.3 Children in the Workplace (Issued 10/14/2004, Posted 10/18/2004)
  • 4631.1 Supplement to Authority to Make Allotments and Authorize the Establishment of Allowances
  • 4631.2R Preparation of Purchase/Service/Stock Requisitions in iProcurement (Issued 10/18/2007, Posted 10/19/2007)
  • 4631.3R Budget Execution Planning and Reporting/Program Management System Reports (Issued 4/8/2008, Posted 4/8/2008)
  • 4634.3R Development, Maintenance, and Distribution of CDER Organizational Charts (Issued 2/22/2007; Posted 2/22/2007)
  • 4636.1R Gift Certificates/Gift Cards (Issued 11/24/2007; Posted 11/26/2007)
  • 4640.1R Guide to the Assignment of Mail Routing Codes in the Center for Drug Evaluation and Research (Revised 6/1/2007; Posted 6/7/2007)
  • 4641.3R Outside Activities (Revised 7/1/2008; Posted 8/8/2008
  • 4641.5 Authority to Reimburse Employees for Business Calls Made on Personal Car Phones (Issued 4/8/2008, Posted 4/8/2008)
  • 4641.8 Reimbursement for Professional Liability Insurance (Issued 5/8/2003, Posted 5/14/2003)
    • 1164 Form - Claim for Reimbursement Expenditures on Official Business
  • 4642.1R Policies and Procedures for Organizational Changes (Issued 4/25/07 Posted 5/4/2007)
  • 4651.1 On-the-Spot Cash Award
  • 4651.2R Time Off Incentive Award (Revised 1/9/2008; Posted 1/9/2008)
  • 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)
  • 4657-0R CDER's Time, Attendance, and Leave Recording Policy (Issued 4/25/07 Posted 5/4/2007)
  • 4657.1R Alternate Work Schedules (AWS) (Revised 6/10/2008; Posted 6/10/2008)
  • 4657.2R (FWAP) Flexiplace and Work at Home (Revised 1/9/2008; Posted 1/9/2008)
  • 4657.5R Advanced Annual and Sick Leave (Revised 11/1/2006, Posted 11/2/2006)
  • 4657.6R Granting Excused Absence (Originator: Division of Management Services, OM) (Issued 4/25/07 Posted 5/4/2007)
  • 4657.7R Leave and Absence for Hazardous Weather and Other Emergency and Administrative Situations (Revised) (Originator: Division of Management Services, OM; Issued Updated 5/5/2006, Posted 6/7/2006)
  • 4657.9R Restoration of Forfeited Annual Leave (Issued 1/13/2006, Posted 1/20/2006)
  • 4657.10 Hazardous Weather Policy for Employees with Disabilities (Issued 2/19/1997, Posted 2/21/1997)
  • 4657.11R Religious Compensatory Time (Issued 4/25/07 Posted 5/4/2007)
  • 4657.12 Voluntary Leave Transfer Program (Issued 11/7/1997, Posted 12/8/1997)

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)

Chapter 4800.4900 (Reserved)

Chapter 5000 - Pharmaceutical Sciences

  • 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)
  • 5000.6 Office of Pharmaceutical Sciences Coordinating Committee (OPS CC) (Issued 6/14/2006, Posted 6/14/2006)
  • 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)
  • 5020.1R Responding to Telephone Inquiries in the Office of Generic Drugs (Issued 8/1/2006; Posted 8/3/2006)
  • 5040.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) (Issued 5/24/2004)

Chapter 5100 - Clinical Pharmacology

  • 5100.3 OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs (Issued 5/26/2006; Posted 5/30/2006)
  • 5120.1 Clinical Pharmacology And Biopharmaceutics (CPB) Briefing Criteria And Attendance Policies (Issued 10/1997, Posted 10/22/1997)

Chapter 5200 - Generic Drugs

  • 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)
  • 5200.8  Processing a Tentatively Approved Application to Full Approval (Issued 6/9/2005, Posted 6/23/2005)
  • 5200.9 Processing Supplements to Abbreviated New Drug Applications Providing for Alternate Analytical Testing Laboratory Site Changes (Issued 6/22/2005, Posted 6/23/2005)
  • 5200.10 Processing of Supplemental Applications Providing for Alternate Stand Alone Packaging Operation Site Changes (Issued 6/9/2005, Posted 6/23/2005)
  • 5200.11 Procedures for Post-Approval Commitment Tracking in the Office of Generic Drugs (Issued 7/13/2007; Posted 7/16/2007)
  • 5210.2 Reassignment of Bioequivalence Reviews (Revised 5/9/2001, Posted 5/14/2001)
  • 5210.3R Productivity Documentation in the Division of Bioequivalence (Issued 2/5/2007, Posted 2/5/2007)
  • 5210.4R Review Responsibility for Bioequivalence Studies with Clinical Endpoints Submitted in an Abbreviated New Drug Application (Issued 12/12/2006, Posted 12/12/2006)
  • 5210.5 Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs (Issued 7/7/2006, Posted 7/7/2006)
  • 5210.6 Procedures for Review of Bioequivalence Study Protocols (Issued 7/7/2006, Posted 7/10/2006)
  • 5210.7 Inspections of Clinical Facilities and Analytical Laboratories (Issued 12/15/2000, Posted 1/3/2001)
  • 5210.8R Review of Dissolution Data in Supplemental ANDAs (Issued 8/1/2006, Posted 8/3/2006)
  • 5221.1 Requesting Methods Validation for ANDAs (Issued 3/30/2006, Posted 3/30/2006)
  • 5223.2 Scoring Configuration of Generic Drug Products
  • 5225.1 Guidance on the Packaging of Test Batches
  • 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
  • 5240.3R Review Order of Original ANDAs, Amendments, and Supplements (Issued and posted 10/18/2006)
  • 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)
  • 5240.8 Handling of Adverse Experience Reports and Other Generic Drug Postmarketing Reports (Issued 11/2/1005, Posted 11/2/2005)
  • 5240.9 Handling and Processing Requests for Global Reviews (Issued 11/29/2004, Posted 12/17/2004)

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)
  • 5310.7R Acceptability of Standards From Alternative Compendia (Issued 11/15/2007; Posted 11/16/2007)

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)
  • 6003.1 Drug Shortage Management Issued (9/26/2006, Posted 9/28/2006)
  • 6004.1 Granting Waivers Under 21 CFR 314.90 for Postmarketing Safety Reporting Requirements Under 21 CFR 314.80 (Issued 11/16/1999, Posted 11/17/1999)
  • 6004.2 Procedures for Completing and Processing the Form "Annual Report Review: Postmarketing Study Commitment Summary (Issued 3/10/2005, Posted 3/15/2005)
  • 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)
  • 6010.7 Clinical Hold/Refusal-to-File Committee (Issued 1/9/2008; Posted 1/9/2008)
  • 6010.8 NDAs and BLAs: Communication to Applicants of Planned Review Timelines.
  • 6020.1 Extraneous References in Product Labeling: Exclusion of American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classifications
  • 6020.2R Applications for Parenteral Products in Plastic Immediate Containters (Issued 4/25/07 Posted 5/4/2007)
  • 6020.3R Review Classification Policy: Priority (P) and Standard (S) (Revised 7/18/2007; Posted 7/18/2007)
  • 6020.4R Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters (Issued 11/15/2007, Posted 11/16/2007)
  • 6020.5R Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products (Issued 7/13/2007, Posted 7/16/2007)
  • 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)
  • 6020.13 Clinical Review of Drugs to Reduce the Risk of Cancer (Issued 12/13/2005, Posted 12/15/2005)
  • 6020.14 Interdisciplinary Review Team for QT Studies (Issued 10/18/2007; Posted 10/19/2007)
  • 6025.1 Good Review Practices (Issued 9/5/2006; Posted 9/7/2006)
  • 6025.3 Good Review Practice: Consultative Review of Drugs Regulated Within OND. (Issued 1/12/2007; Posted 1/16/2007)
  • 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)
  • 6050.1R Refusal to Accept Application for Filing From Applicants in Arrears (Issued 8/14/2007; Posted 8/21/2007)
  • 6060.1R Consulting the Maternal Health Team (Issued 1/5/07, Posted 1/5/07)

 

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

  • 6301.3 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)
  • 6610.2 Responsibilities and Procedures for Statistical Review and Evaluation of Animal Carcinogenicity Studies (Issued 11/30/2004, Posted 12/17/2004)

Chapter 6700 - Office of Drug Safety

  • 6700.1 Risk Management Plan Activities in the Office of New Drugs and the Office of Drug Safety (Issued 9/8/2005, Posted 10/3/2005)
  • 6700.2 Standards for Data Management and Analytic Processes in the Office of Surveillance and Epidemiology (OSE) (Issued 3/3/2008; Posted 3/4/2008)

Chapter 7000 - Discipline Specific

Chapter 7100 - Biopharmaceutics

Chapter 7200 - Chemistry

  • 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

  • 7400.1R Management of CDER Pharmacology/Toxicology Coordinating Committee (Issued 10/18/2007; Posted 10/19/2007)
  • 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)
  • 7400.6 Management of the PTCC Inactive (Issued 4/20/2005, Posted 4/22/2005)
  • 7400.7 Management of the PTCC Safety Pharmacology Subcommittee (issued 11/29/2004, Posted 12/17/2004)
  • 7400.8 Management of the Pharmacology and Toxicology Coordinating Committee Nonclinical Pharmacogenomics Subcommittee (Issued 12/1/2004, Posted 12/17/2004)
  • 7400.9 Management of the PTCC Reproductive and Developmental Toxicology Subcommittee (Issued 3/3/2008; Posted 3/4/2008)
  • 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

  • 7500.1R Office of New Drugs Regulatory Project Management Coordinating Committee (Issued 5/15/2008, Posted 5/15/2008)
  • 7500.2R Regulatory Project Management Site Tours and Regulatory Interactions Program (Issued 11/1/2006, Posted 11/2/2006)
  • 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

  • 7600.2 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)
  • 7600.6 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)
  • 7600.9 Information Management Steering Committee (IMSC) Planning Subcommittee (Issued 3/4/2005, Posted 3/15/2005)
  • 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)
  • 7620.4 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 - Office of Translational Sciences

  • 7700.1 Management of the Regulatory Science and Review Enhancement Committee (Issued 4/8/2008 Posted 4/8/2008)

Chapter 7800 - Administrative Management

  • 7800.1R Administrative Management Coordinating Committee (Issued 2/22/2007, Posted 2/22/2007)

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