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  5. Organizations and Functions, Volume I (1000 - 1300)
  1. Staff Manual Guides

Organizations and Functions, Volume I (1000 - 1300)

Policy Regarding Organizational Changes 1005.1
Guidelines for FDA Organizational Name Charts 1005.2
Control and Use of Standard Administrative Codes 1010.1
Food and Drug Administration Mission 1110.1
Office of the Commissioner 1111.1
Office of the Chief Counsel 1111.2a
Office of the Executive Secretariat 1111.3a
Office of Counselor to the Commissioner 1111.4a
Oncology Center of Excellence 1112A.1
Office of Clinical Policy and Programs 1113B.1
Office of Clinical Policy 1113B.2
Office of Combination Products 1113B.3
Office of Orphan Products Development 1113B.4
Office of Pediatric Therapeutics 1113B.5
Office of External Affairs 1114A.1
Office of Editorial and Creative Services 1114A.2
Office of Media Affairs 1114A.3
Office of Food Policy and Response 1115A.1
Office of Priority Policy Initiatives 1115A.2
Office of Resource Planning and Strategic Management 1115A.3
Office of Minority Health and Health Equity 1116A.1
Office of Policy, Legislation, and International Affairs 1118A.1
Office of Congressional Appropriations 1118A.2
Office of Economics and Analysis 1118A.3
Office of Global Policy and Strategy 1118A.4
Office of Global Diplomacy and Partnerships 1118A.41
Office of Global Operations 1118A.42
Office of Trade, Mutual Recognition, and International Agreements 1118A.43
Office of Legislation 1118A.5
Office of Policy 1118A.6
Office of the Chief Scientist 1119A.1
Office of Counter-Terrorism and Emerging Threats 1119A.2
Office of Laboratory Safety 1119A.3
Office of Regulatory Science and Innovation 1119A.4
Division of Science Innovation and Critical Path 1119A.41
Office of Scientific Integrity 1119A.5
Office of Scientific Professional Development 1119A.6
National Center for Toxicological Research 1280.1
Office of the Center Director, NCTR 1281.1
Office of Research 1283.1
Division of Genetic and Molecular Toxicology 1283.2
Division of Biochemical Toxicology 1283.4
Division of Systems Biology 1283.7
Division of Microbiology 1283.8
Division of Neurotoxicology 1283.9
Division of Bioinformatics and Biostatistics 1283.12
Office of Management 1284.1
Office of Scientific Coordination 1285.1
Office of Women's Health 1130A.1
Office of Operations 1117A.1
Office of Enterprise Management Services 1117A.2
Division of Compliance and Conflict Prevention 1117A.21
Division of Human Capital 1117A.22
Division of Information Governance 1117A.23
Division of Resources Management 1117A.24
Division of Vendor Management 1117A.25
Office of Ethics and Integrity 1117A.3
Office of Equal Employment Opportunity 1117A.4
Office of Planning and Evaluation 1117A.5
Office of Finance, Budget and Acquisitions 1117A.6
Office of Budget 1117A.61
Division of Budget Formulation and Program Alignment 1117A.611
Division of Budget Execution and Control 1117A.612
Office of Acquisitions and Grants Services 1117A.62
Division of Acquisition Operations 1117A.621
Division of Acquisition Programs 1117A.622
Division of State Acquisitions, Agreements and Grants 1117A.623
Division of Information Technology Acquisitions 1117A.624
Division of Policy, Systems and Program Support 1117A.625
Office of Financial Management 1117A.63
Division of Accounting 1117A.631
Division of Controls, Compliance and Oversight 1117A.632
Division of Payment Services 1117A.633
Division of Travel Services 1117A.634
Division of User Fees 1117A.635
Office of Information Management and Technology 1117A.7
Office of Information Management 1117A.71
Office of Information Security 1117A.711
Office of Technology and Delivery 1117A.712
Division of Infrastructure Operations 1117A.7121
Division of Application Services 1117A.7122
Office of Business and Customer Assurance 1117A.713
Division of Business Partnership and Support 1117A.7131
Division of Management Services 1117A.7132
Office of Enterprise Portfolio Management Office 1117A.714
Office of Informatics and Technology Innovation 1117A.72
Office of Facilities Engineering and Mission Support Services 1117A.8
Division of Operations Management and Community Relations 1117A.81
Division of Planning, Engineering and Space Management 1117A.82
Office of Security and Emergency Management 1117A.9
Office of Security Operations 1117A.91
Office of Emergency Management 1117A.92
Office of Emergency Operations 1117A.921
Office of Human Capital Management 1117A.10
Division of FDA Training and Development 1117A.101
Division of Human Resources Systems and Operations Support 1117A.102
Division of Employee and Labor Relations 1117A.103
Division of Strategic Talent Management Programs 1117A.104
Office of Talent Solutions 1117A.11
Division of Talent Services I 1117A.111
Division of Talent Services II 1117A.112
Division of Talent Services III 1117A.113
Division of Talent Services IV 1117A.114
Division of Talent Sourcing and Staffing 1117A.115
Center for Food Safety and Applied Nutrition 1230A.1
Office of the Center Director 1231.10
Office of Management 1231.11
Division of Budget and Planning 1231.110
Division of Program Services 1231.111
Office of Analytics and Outreach 1231.12
Division of Education, Outreach and Information 1231.121
Division of Public Health Informatics and Analytics 1231.122
Division of Risk and Decision Analysis 1231.123
Office of Food Safety 1231.13
Division of Seafood Science and Technology 1231.131
Division of Food Processing Science and Technology 1231.132
Division of Seafood Safety 1231.134
Division of Produce Safety 1231.135
Division of Dairy, Egg, and Meat Products 1231.136
Division of Plant Products and Beverages 1231.137
Office of Cosmetics and Colors 1231.14
Division of Color Certification and Technology 1231.141
Division of Cosmetics 1231.142
Office of Regulatory Science 1231.15
Division of Analytical Chemistry 1231.151
Division of Microbiology 1231.152
Division of Bioanalytical Chemistry 1231.153
Office of Food Additive Safety 1231.16
Division of Food Contact Substances 1231.161
Division of Food Ingredients 1231.162
Division of Science and Technology 1231.163
Office of Compliance 1231.17
Division of Enforcement 1231.171
Division of Field Programs and Guidance 1231.172
Office of Applied Research and Safety Assessment 1231.18
Division of Molecular Biology 1231.181
Division of Virulence Assessment 1231.182
Division of Toxicology 1231.183
Office of Regulations and Policy 1231.19
Office of Nutrition and Food Labeling 1231.20
Office of Dietary Supplement Programs 1231.21
Office of Executive Programs 1231.22
Office of Coordinated Outbreak Response and Evaluation Network 1231.23
Center for Veterinary Medicine 1240.1
Office of the Center Director 1241.1
Office of Management 1242.1
Office of New Animal Drug Evaluation 1243.1
Division of Therapeutic Drugs for Food Animals 1243.10a
Division of Production Drugs 1243.11
Division of Therapeutic Drugs for Non-Food Animals 1243.12a
Division of Human Food Safety 1243.13
Division of Manufacturing Technologies 1243.14
Division of Scientific Support 1243.15
Division of Generic Animal Drugs 1243.16
Division of Business Information Science and Management 1243.17
Division of Animal Bioengineering and Cellular Therapies 1243.18
Office of Surveillance and Compliance 1244.1
Division of Surveillance 1244.10
Division of Animal Feeds 1244.11
Division of Compliance 1244.12
Division of Veterinary Product Safety 1244.13
Office of Research 1245.1
Division of Residue Chemistry 1245.10
Division of Applied Veterinary Research 1245.11
Division of Animal and Food Microbiology 1245.12
Office of Minor Use and Minor Species Animal Drug Development 1246.1
Center for Biologics Evaluation and Research 1210.1
Office of the Center Director 1211.1
Office of Management 1211.10
Division of Budget and Resource Management 1211.11
Division of Program Services 1211.13
Division of Scientific Advisors and Consultants 1211.14a
Division of Veterinary Services 1211.15a
Office of Compliance and Biologics Quality 1212.1
Division of Case Management 1212.2
Division of Inspections and Surveillance 1212.4
Division of Manufacturing and Product Quality 1212.5
Division of Biological Standards and Quality Control 1212.6
Office of Biostatistics and Epidemiology 1213.1
Division of Biostatistics 1213.2
Division of Epidemiology 1213.3
Office of Blood Research and Review 1215.1
Division of Emerging and Transfusion Transmitted Diseases 1215.2
Division of Blood Components and Devices 1215.6
Office of Vaccines Research and Review 1217.1
Division of Bacterial, Parasitic and Allergenic Products 1217.2
Division of Viral Products 1217.4
Division of Vaccines and Related Product Applications 1217.5
Office of Tissues and Advanced Therapies 1218.1
Division of Cellular and Gene Therapies 1218.2
Division of Clinical Evaluation and Pharmacology/Toxicology 1218.3
Division of Human Tissues 1218.4
Division of Plasma Protein Therapeutics 1218.5
Division of Regulatory Project Management 1218.6
Office of Communication, Outreach and Development 1219.1
Division of Disclosure and Oversight Management 1219.2
Division of Manufacturers Assistance and Training 1219.3
Division of Communication and Consumer Affairs 1219.4
Center for Devices and Radiological Health 1250.1
Office of the Center Director 1251.1
Office of Management 1251.10
Division of Workforce Management 1251.12
Division of Financial Management 1251.13
Division of Management Services 1251.14a
Division of Acquisition Services 1251.15a
Office of Strategic Partnerships and Technology Innovation 1251A.20
Division of All Hazards Response, Science and Strategic Partnerships 1251.21a
Division of Digital Health 1251.22a
Division of Technology and Data Services 1251.23a
Office of Policy 1251.30
Office of Science and Engineering Laboratories 1254.1
Division of Administrative and Laboratory Support 1254.2a
Division of Biology, Chemistry, and Materials Science 1254.3a
Division of Applied Mechanics 1254.5
Division of Biomedical Physics 1254.9
Division of Imaging, Diagnostics, and Software Reliability 1254.10
Office of Communication and Education 1255.1
Division of Industry and Consumer Education 1255.4
Division of Communication 1255.9
Division of Information Disclosure 1255.10
Division of Employee Training and Development 1255.11
Office of Product Evaluation and Quality 1258.1
Office of Regulatory Programs 1258.10
Division of Regulatory Programs I 1258.11
Division of Regulatory Programs II 1258.12
Division of Regulatory Programs III 1258.13
Office of Clinical Evidence and Analysis 1258.20
Division of Clinical Evidence and Analysis I 1258.21
Division of Clinical Evidence and Analysis II 1258.22
Office of Health Technology I 1258.30
Division of Health Technology I A 1258.31
Division of Health Technology I B 1258.32
Division of Health Technology I C 1258.33
Office of Health Technology II 1258.40
Division of Health Technology II A 1258.41
Division of Health Technology II B 1258.42
Division of Health Technology II C 1258.43
Office of Health Technology III 1258.50
Division of Health Technology III A 1258.51
Division of Health Technology III B 1258.52
Division of Health Technology III C 1258.53
Office of Health Technology IV 1258.60
Division of Health Technology IV A 1258.61
Division of Health Technology IV B 1258.62
Office of Health Technology V 1258.70
Division of Health Technology V A 1258.71
Division of Health Technology V B 1258.72
Office of Health Technology VI 1258.80
Division of Health Technology VI A 1258.81
Division of Health Technology VI B 1258.82
Division of Health Technology VI C 1258.83
Office of In Vitro Diagnostics and Radiological Health 1258.90
Division of Chemistry and Toxicology Devices 1258.91
Division of Immunology and Hematology Devices 1258.92
Division of Microbiology Devices 1258.93
Division of Radiological Health 1258.94
Division of Program Operations and Management 1258.95
Division of Mammography Quality Standards 1258.96
Division of Molecular Genetics and Pathology 1258.97
Center for Drug Evaluation and Research 1260.1
Office of the Center Director 1261.1
Office of Regulatory Policy 1260.2
Division of Regulatory Policy I 1260.21
Division of Regulatory Policy II 1260.22
Division of Information Disclosure Policy 1260.23
Division of Regulatory Policy III 1260.24
Division of Regulatory Policy IV 1260.25
Office of Management 1261.10
Division of Budget Execution and Resource Management 1261.11
Division of Management Services 1261.17
Division of User Fee Management and Budget Formulation 1261.18
Office of Communications 1261.20
Division of Online Communications 1261.22
Division of Health Communications 1261.25
Division of Drug Information 1261.26
Office of Surveillance and Epidemiology 1261.5
Office of Medication Error Prevention and Risk Management 1261.57
Division of Medication Error Prevention and Analysis 1261.571
Division of Risk Management 1261.572
Office of Pharmacovigilance and Epidemiology 1261.58
Division of Epidemiology I 1261.581
Division of Epidemiology II 1261.582
Division of Pharmacovigilance I 1261.583
Division of Pharmacovigilance II 1261.584
Office of Compliance 1262.1
Office of Unapproved Drugs and Labeling Compliance 1262.3
Division of Prescription Drugs 1262.31
Division of Non-Prescription Drugs and Health Fraud 1262.32
Office of Manufacturing Quality 1262.4
Division of Drug Quality I 1262.45
Division of Drug Quality II 1262.46
Office of Scientific Investigations 1262.5
Division of Bioequivalence and Good Laboratory Practice Compliance 1262.51
Division of Good Clinical Practice Compliance 1262.52
Division of Safety Compliance 1262.53
Division of Enforcement and Postmarket Safety 1262.54
Division of Clinical Compliance Evaluation 1262.55
Office of Drug Security, Integrity and Response 1262.6
Division of Imports, Exports and Recalls 1262.61
Division of Supply Chain Integrity 1262.62
Office of Program and Regulatory Operations 1262.7
Office of New Drugs 1263.1
Office of Drug Evaluation I 1263.20
Division of Cardiovascular and Renal Products 1263.21
Division of Neurology Products 1263.23
Division of Psychiatry Products 1263.25
Office of Drug Evaluation II 1263.30
Division of Metabolism and Endocrinology Products 1263.31
Division of Pulmonary, Allergy and Rheumatology Products 1263.32
Division of Anesthesia, Analgesia and Addiction Products 1263.34
Office of Drug Evaluation III 1263.40
Division of Gastroenterology and Inborn Effects Products 1263.42
Division of Bone, Reproductive and Urologic Products 1263.44
Division of Dermatology and Dental Products 1263.45
Office of Antimicrobial Products 1263.50
Division of Anti-Infective Products 1263.51
Division of Anti-Viral Products 1263.52
Division of Transplant and Ophthalmology Products 1263.53
Office of Drug Evaluation IV 1263.60
Division of Nonprescription Drug Products 1263.64
Division of Medical Imaging Products 1263.66
Division of Pediatrics and Maternal Health 1263.67
Office of Hematology and Oncology Products 1263.70
Division of Oncology Products 1 1263.74
Division of Hematology Products 1263.75
Division of Oncology Products 2 1263.76
Division of Hematology Oncology Toxicology 1263.77
Office of Information and Technology 1265.10
Division of Applications Development and Services 1265.12
Division of Infrastructure Management and Service 1265.13
Office of Medical Policy 1266.1
Office of Prescription Drug Promotion 1266.11
Division of Advertising and Promotion Review II 1266.111
Division of Advertising and Promotion Review I 1266.112
Office of Medical Policy Initiatives 1266.12
Division of Medical Policy Development 1266.121
Division of Medical Policy Programs 1266.122
Division of Clinical Trial Quality 1266.123
Office of Executive Programs 1267.1
Division of Learning and Organizational Development 1267.11
Division of Executive Operations 1267.12
Division of Advisory Committee and Consultant Management 1267.13
Office of Translational Science 1268.1
Office of Biostatistics 1268.3
Division of Biometrics I 1268.31
Division of Biometrics II 1268.32
Division of Biometrics III 1268.33
Division of Biometrics IV 1268.34
Division of Biometrics V 1268.35
Division of Biometrics VI 1268.36
Division of Biometrics VII 1268.37
Division of Biometrics VIII 1268.38
Office of Clinical Pharmacology 1268.4
Division of Clinical Pharmacology I 1268.41
Division of Clinical Pharmacology II 1268.42
Division of Clinical Pharmacology III 1268.43
Division of Clinical Pharmacology IV 1268.44
Division of Clinical Pharmacology V 1268.45
Division of Pharmacometrics 1268.46
Division of Applied Regulatory Science 1268.47
Office of Computational Science 1268.5
Office of Study Integrity and Surveillance 1268.6a
Division of New Drug Bioequivalence Evaluation 1268.61
Division of Generic Drug Bioequivalence Evaluation 1268.62
Office of Strategic Programs 1270.2
Office of Program and Strategic Analysis 1270.21
Office of Business Informatics 1270.22
Division of Records Management 1270.222
Division of Regulatory Review Support 1270.223
Division of Business Analysis and Reporting 1270.224
Division of Project Development 1270.225
Office of Pharmaceutical Quality 1280.1a
Office of Biotechnology Products 1280.20
Division of Biotechnology Review and Research I 1280.21
Division of Biotechnology Review and Research II 1280.22
Division of Biotechnology Review and Research III 1280.23
Division of Biotechnology Review and Research IV 1280.24
Office of New Drug Products 1280.30
Division of Life Cycle API 1280.31
Division of New Drug API 1280.32
Division of New Drug Products I 1280.33
Division of New Drug Products II 1280.34
Division of Biopharmaceutics 1280.35
Office of Policy for Pharmaceutical Quality 1280.40
Division of Regulations, Guidance and Standards 1280.41
Division of Internal Policies and Programs 1280.42
Office of Process and Facilities 1280.50
Division of Process Assessment I 1280.51
Division of Process Assessment II 1280.52
Division of Process Assessment III 1280.53
Division of Microbiology Assessment 1280.54
Division of Inspectional Assessment 1280.55
Office of Surveillance 1280.60
Division of Quality Intelligence, Risk Analysis and Modeling 1280.61
Division of Quality Surveillance Assessment 1280.62
Office of Testing and Research 1280.70
Division of Product Quality Research 1280.71
Division of Pharmaceutical Analysis 1280.72
Office of Program and Regulatory Operations 1280.80
Division of Regulatory and Business Process Management I 1280.81
Division of Regulatory and Business Process Management II 1280.82
Division of Operational Excellence, Learning and Professional Development 1280.83
Office of Lifecycle Drug Products 1280.90
Division of Immediate Release Products I 1280.91
Division of Immediate Release Products II 1280.92
Division of Modified Release Products 1280.93
Division of Liquid-Based Products 1280.94
Division of Post-Marketing Activities I 1280.95
Division of Post-Marketing Activities II 1280.96
Office of Generic Drugs 1290.1a
Office of Research and Standards 1291.1a
Division of Therapeutic Performance 1291.11
Division of Quantitative Methods and Modeling 1291.12
Office of Bioequivalence 1292.1a
Division of Bioequivalence I 1292.11
Division of Bioequivalence II 1292.12
Division of Bioequivalence III 1292.13
Division of Clinical Review 1292.14
Office of Generic Drug Policy 1293.1a
Division of Legal and Regulatory Support 1293.11
Division of Policy Development 1293.12
Office of Regulatory Operations 1294.1a
Division of Labeling Review 1294.11
Division of Filing Review 1294.12
Division of Project Management 1294.13
Division of Quality Management Systems 1294.14
Center for Tobacco Products 1350.1
Office of the Center Director 1351.1
Office of Management 1352.1
Division of Financial Management 1352.2
Division of Human Capital 1352.3
Office of Regulations 1354.1
Office of Science 1355.1
Division of Regulatory Project Management 1355.2
Division of Regulatory Science Informatics 1355.3
Division of Product Science 1355.4
Division of Individual Health Science 1355.5
Division of Population Health Science 1355.6
Division of Non-Clinical Science 1355.7
Office of Health Communication and Education 1356.1
Division of Public Health Education 1356.2
Division of Regulatory Communication 1356.3
Division of Research and Evaluation 1356.4
Office of Compliance and Enforcement 1357.1
Division of Enforcement and Manufacturing 1357.2
Division of Promotion, Advertising and Labeling 1357.3
Division of State Programs 1357.4
Division of Business Operations 1357.5
Office of Regulatory Affairs 1120.1
Office of the Associate Commissioner for Regulatory Affairs 1121.1a
Office of Resource Management 1121.10
Division of Planning, Evaluation, and Management 1121.11
Division of Human Resource Development 1121.13
Division of Management Operations 1121.14
Division of Budget Formulation and Execution 1121.15a
Office of Criminal Investigations 1121.40
Office of Communications and Quality Program Management 1121.50
Division of Communications 1121.51
Office of Partnerships 1121.60
Office of Policy and Risk Management 1121.70
Division of Planning Evaluation and Management 1121.71
Office of Operations 1121.80
Office of Enforcement and Import Operations 1121.81
Division of Enforcement 1121.811
Division of Compliance Systems 1121.812
Division of Import Operations 1121.813
Office of Food and Feed Operations 1121.82
Division of Food Defense Targeting 1121.821
Division of Food and Feed Program Operations and Inspections 1121.822
Office of Medical Products and Tobacco Operations 1121.83
Division of Medical Products and Tobacco Inspections 1121.831
Division of Medical Products and Tobacco Program Operations 1121.832
Office of Regulatory Science 1121.90
Office of Research Coordination and Evaluation 1121.91
Office of Medical Products, Tobacco and Specialty Laboratory Operations 1121.92
Forensic Chemistry Laboratory 1121.921
Winchester Engineering and Analytical Center 1121.922
Detroit Laboratory 1121.923
Northeast Medical Products Laboratory 1121.924
Pacific Southwest Medical Products Laboratory 1121.925
Philadelphia Laboratory 1121.926
San Juan Laboratory 1121.927
Southeast Tobacco Laboratory 1121.928
Office of Food and Feed Laboratory Operations 1121.93
Arkansas Laboratory 1121.931
Denver Laboratory 1121.932
Kansas Laboratory 1121.933
Northeast Food and Feed Laboratory 1121.934
Pacific Northwest Laboratory 1121.935
San Francisco Laboratory 1121.936
Southeast Food and Feed Laboratory - Atlanta, GA 1121.937
Pacific Southwest Food and Feed Laboratory - Irvine, CA 1121.938
Regional Field Office, Northeast Region - Jamaica, NY 1311.1
District Office - New York, NY 1311.2
District Office - New England 1311.4
Regional Field Office, Central Region - Chicago, IL 1312.1
District Office - Baltimore, MD 1312.2
District Office - Cincinnati, OH 1312.3
District Office - Parsippany, NJ 1312.5
District Office - Philadelphia, PA 1312.6
District Office - Chicago, IL 1312.7
District Office - Detroit, MI 1312.8
District Office - Minneapolis, MN 1312.9
Regional Field Office, Southeast Region - Atlanta, GA 1313.1
District Office - Atlanta, GA 1313.2
District Office - Florida 1313.4
District Office - New Orleans, LA 1313.5
District Office - San Juan, PR 1313.6
Regional Field Office, Southwest Region - Dallas, TX 1315.1
District Office - Dallas, TX 1315.2
District Office - Kansas City, MO 1315.3
District Office - Denver, CO 1315.4
Southwest Import District Office - Dallas, TX 1315.6
Regional Field Office, Pacific Region - Oakland, CA 1316.1
San Francisco District Office - Alameda, CA 1316.2
Los Angeles District Office - Irvine, CA 1316.3
Seattle District Office - Bothell, WA 1316.4