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Investigations Operations Manual
Foreword
Ch 1 Administration
Ch 2 Regulatory
Ch 3 Federal-State Cooperation
Ch 4 Sampling
Sample Schedules
Ch 5 Establishment Inspection
Ch 6 Imports
Ch 7 Recall Activities
Ch 8 Investigations
Exhibits
Appendix
ORA Directory
Change Log
Search
Inspection References
Investigations Operations Manual 2008
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Contents
1.1 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS
1.2 - TRAVEL
1.2.1 - COMMON CARRIER
1.2.1.1 - Air
1.2.1.2 - Auto Rental
1.2.1.3 - Taxi
1.2.1.4 - Accident Insurance
1.2.1.5 - Gainsharing
1.2.2 - GOVERNMENT FURNISHED VEHICLES (GFVs)
1.2.2.1 - Interagency Motor Pool
1.2.2.2 - Accidents
1.2.2.2.1 - Information to be obtained
1.2.2.2.2 - Reporting
1.2.2.3 - Liability
1.2.2.3.1 - Military Personnel and Civilian Employees' Claim Act of 1964
1.2.2.3.2 - Tort Claims
1.2.2.3.3 - References
1.2.2.4 - Use of a GFV Between Your Residence and Place of Employment
1.2.2.5 - Care & Custody of U.S. Vehicles
1.2.3 - PRIVATELY OWNED VEHICLE (POV)
1.2.3.1 - Accidents
1.2.4 - PER DIEM AND SUBSISTENCE
1.2.4.1 - Per Diem Rates
1.2.4.2 - Hospitalized In Travel Status
1.2.5 - CHANGE OF OFFICIAL STATION
1.2.6 - ADVANCE OF FUNDS
1.2.7 - CLAIMS FOR REIMBURSEMENT
1.2.8 - TELEPHONE COMMUNICATIONS
1.2.9 - ITINERARIES
1.3 - LEAVE
1.4 - DISCLOSURE OF OFFICIAL INFORMATION
1.4.1 - SUBPOENA
1.4.2 - REQUESTS BY THE PUBLIC, INCLUDING TRADE
1.4.3 - SHARING NON-PUBLIC INFORMATION WITH OTHER GOVERNMENT OFFICIALS
1.4.4 - FREEDOM OF INFORMATION ACT
1.4.4.1 - Procedures
1.4.4.2 - Requests for Documents
1.4.5 - INTERNAL FDA DOCUMENTS
1.5 - SAFETY
1.5.1 - PROTECTIVE EQUIPMENT
1.5.1.1 - Eye Protection
1.5.1.2 - Hearing Protection
1.5.1.3 - Protective Clothing
1.5.1.4 - Respiratory Protection
1.5.1.4.1 - Program Provisions
1.5.1.4.2 - Firms with Potential Respiratory Hazards
1.5.1.5 - Health and Hygiene
1.5.2 - AUTOMOBILE SAFETY
1.5.3 - SAMPLING
1.5.3.1 - Sample Fumigation and Preservation
1.5.3.2 - Electrical Hazards
1.5.3.3 - Physical Hazards
1.5.3.3.1 - Railcars
1.5.3.3.2 - Grain Elevators
1.5.3.3.3 - Clothing
1.5.3.3.4 - Trucks
1.5.3.4 - Asphyxiation Hazards
1.5.3.5 - Radioactive Product Sampling
1.5.3.6 - Chemical Hazards
1.5.3.7 - Carbadox Sampling
1.5.4 - INSPECTIONS
1.5.4.1 - Man Lifts and Ladders
1.5.4.2 - Factory Inspection
1.5.4.2.1 - Thermal
1.5.4.2.2 - Chemical
1.5.4.2.3 - Ionizing Radiation
1.5.5 - MICROBIOLOGICAL HAZARDS
1.5.5.1 - Animal Origin Products
1.5.5.2 - Viral and Other Biological Products
1.5.5.2.1 - Protective and preventive measures
1.5.5.2.2 - Viral Hepatitis and Human Immunodeficiency Virus
1.5.5.2.3 - Precautions for Non-Clinical Laboratory Inspections
1.5.5.3 - Bacteriological Problems
1.5.5.4 - Hantavirus Associated Diseases
1.5.6 - Wireless Devices
1.5.7 - REPORTING
1.6 - PUBLIC RELATIONS, ETHICS & CONDUCT
1.6.1 - Public Relations (Press, Radio, TV and non-government meetings)
1.6.1.1 - NON-GOVERNMENT MEETINGS
1.6.2 - EQUIPMENT CARE, CUSTODY, AND LOSS
1.6.2.1 - Maintenance of Equipment
1.6.2.1.1 - Repairs
1.6.2.1.2 - Equipment Calibration
1.6.2.2 - Lost or Stolen Equipment
1.6.3 - OFFICIAL CREDENTIALS, BADGE
1.6.3.1 - Delegated Authority
1.6.3.2 - Qualifications for Credentials
1.6.3.3 - Lost or Stolen Credentials, Badge
1.6.4 - BUSINESS CARDS
1.6.5 - EMPLOYEE CONDUCT
1.6.5.1 - Professional Stature
1.6.5.1.1 - Integrity
1.6.5.1.2 - Attitude
1.6.5.1.3 - Attire
1.6.5.1.4 - Employee Prohibitions - Gifts, Luncheons, and Snacks
1.6.5.1.5 - ORA Policy
1.6.5.1.6 - Professional Personnel Contacts
1.6.5.2 - Attempted Bribery
1.7 - INTERDISTRICT ASSIGNMENTS
1.7.1 - Issuance authority
1.7.2 - Procedures
1.7.3 - Assignments and Reporting
1.8 - ORGANIZATION OVERVIEW
1.8.1 - FDA PRINCIPLES
1.9 - OFFICE OF REGULATORY AFFAIRS
1.9.1 - Associate Commissioner for Regulatory Affairs
1.9.2 - ORA HEADQUARTERS ORGANIZATION
1.9.2.1 - Office of Resource Management (ORM) (HFC-10), James M. Strachan, Director
1.9.2.2 - Office of Regional Operations (ORO) (HFC-100) Deborah D. Ralston, Director
1.9.2.2.1 - Division of Field Investigations (DFI) (HFC-130)
1.9.2.2.2 - Division of Field Science (DFS) (HFC-140)
1.9.2.2.3 - Division of Federal-State Relations (DFSR) (HFC-150)
1.9.2.2.4 - Division of Import Operations Policy (DIOP) (HFC-170)
1.9.2.2.4.1 - Prior Notice Center (PNC) (HFC-180)
1.9.2.3 - Office of Enforcement (OE) (HFC-200) David K. Elder, Director
1.9.2.4 - Office of Criminal Investigations (OCI) (HFC-300) Terrell L. Vermillion, Director
1.9.3 - ORA FIELD ORGANIZATION
1.10 - REFERENCES
1.10.1 - LAW, REGULATION AND GUIDANCE
1.10.2 - SOURCES OF INFORMATION
1.10.2.1 - INVESTIGATOR TRAINING AND CERTIFICATION
1.10.2.2 - CONTACTING FDA EMPLOYEES
1.10.2.3 - INTERNET AND INTRANET
1.10.2.4 - FDA ON DISK
1.10.2.5 - ELECTRONIC-FAX INFORMATION SYSTEMS
1.10.2.6 - FDA/ORA MANUALS AND REPORTS
1.10.2.7 - FORMS AND OTHER PUBLICATIONS
1.10.2.8 - REGULATORY REFERENCES AND THE GENERAL PUBLIC
1.10.2.9 - ACRONYMS
1.10.3 - SPECIAL REGULATORY BY PRODUCT CATEGORY
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