Manual of Regulatory Standard Operating Procedures and Policies Table of Contents Section 8000 - General Information 8001 - Review 8001.1 - Interoffice Consultative Review Procedures 8001.2 - Accessing the FDA Lists of Disqualified and Restricted Clinical Investigators, Debarred Individuals, and Firms Under the FDA Application Integrity Policy 8001.3 - REVOKED: Review of Year 2000-Related Submissions 8001.4 - Review of CBER Regulated Product Proprietary Names 8001.5 - Intercenter Consultative/Collaborative Review Process 8002 - Procedures for the Preparation, Routing and Issuance of Guidance Documents 8003 - Request for Designation 8004 - Tissue Reference Group 8005 - Major Dispute Resolution Process 8006 - Resolution of Differences in Scientific Judgement in the Review Process 8007 - DCC Binding Procedures for Regulatory Documents 8008 - Regulatory Information Systems 8008.1 - Administrative Handling of Change Requests for Regulatory Review Automated Support Systems Section 8100 - Communication 8101 - Meetings 8101.1 - Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants 8101.2 - Scheduling and Documentation of Liaison Meetings 8101.3 - Participation in or Planning of Outside Regulatory and Scientific Events 8102 - REVOKED: Submission of Electronic Media (Replaced by 8110) 8103 - Headquarters Contacts With Regulated Manufacturers During Agency Inspections 8104 - Documentation of Telephone Contacts with Regulated Industry 8106 - Submission of Product Approval Information For Dissemination to the Public 8107 - Official Correspondence with Applicants of Marketing Submissions: Addresses 8108 - Distribution of "Dear Doctor" Letters 8110 - Submission of Regulatory Documents to CBER Section 8200 - Investigational New Drugs (INDs) 8201 - Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications 8202 - Handling IND Submitted with Insufficient Copies Section 8300 - Master Files 8302 - REVOKED: Review of Type I Master Files Section 8400 - License Applications 8401 - Administrative Processing of Biologics License Application (BLA) 8401.1 - Issuance and Review of Responses to Information Requests and Discipline Review Letters to Pending Applications 8401.2 - Administrative Processing of Biologics License Application Supplements (BLSs) [Except Blood, Blood Components, and Source Plasma] 8401.3 - Filing Action: Communication Options 8402 - Designation of License Application Amendments as Major or Minor 8403 - Issuance and Reissuance of Licenses for Biological Products 8404 - Refusal to File Procedures for Biologic License Applications 8404.1 - Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest) 8405 - Complete Review and Issuance of Action Letters 8405.1 - Procedures for the Classification of Resubmissions of an Application for a Product Covered by the Prescription Drug User Fee Act (PDUFA III) 8406 - Verification of User Fee Data Sheet and Payment 8407 - Compliance Status Checks - Under Revision 8408 - Collaboration of CBER Offices on Issues Related to the Release Of Pre-Licensing and Routine Lots 8410 - Determining When Pre-License / Pre-Approval Inspections are Necessary 8411.1 - Changes to an Approved Application - Administrative Handling and Review of Annual Reports 8412 - Review of Product Labeling 8413 - Postmarketing Commitment Annual Reports, Final Reports, and Related Submissions - Administrative Handling, Review, and CBER Reporting 8414 - Fast Track Drug Development Programs: Designation and Review Programs Section 8500 - Compliance 8501 - Emergency Operations 8502 - REVOKED: Request for Industry Production Schedules for the Purpose of Planning and Scheduling Biennial Inspections 8503 - Import and Export Requests 8503.1 - UNDER REVISION: Review of Export Requests for Investigational Biologics Under 21 CFR 312.110(b)(2) 8503.2 - Review of Import for Export Requests Under FD&C; Act Section 801(d)(4) 8504 - Release of Establishment Inspection Reports to the Inspected Establishments Pursuant to Field Management Directive 145 8505 - Nomination and Approval of CBER Inspectors and Product Specialists Assigned to Conduct Inspections of Biological Products 8507 - Procedures for Responding to a Counterfeit Product Event Section 9100 - Therapeutics 9110.1 - REVOKED: Notification of National Institutes of Health (NIH) / Office of Biotechnology Activities (OBA) of Changes in a Gene Therapy Protocol (Replaced by 9150.1) 9110.2 - REVOKED: Notification of National Institutes of Health (NIH) / Office of Biotechnology Activities (OBA) of FDA's Receipt of Adverse Event Reports to Gene Therapy INDs (Replaced by 9150.2) Section 9150 - Office of Cellular, Tissue and Gene Therapies 9150.1 - Notification of National Institutes of Health (NIH) / Office of Biotechnology Activities (OBA) of Changes in a Gene Therapy Protocol 9150.2 - Notification of National Institutes of Health (NIH) / Office of Biotechnology Activities (OBA) of FDA's Receipt of Adverse Event Reports to Gene Therapy INDs Section 9200 - Vaccines 9201 - Routing and Signature Requirements for Regulatory Letters (Delegation of Signature Authority in OVRR)

Updated July 23, 2004

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page FDA / Center for Biologics Evaluation and Research