公益財団法人
日本食品化学研究振興財団
FDA 21CFR(仮和訳)
5 組織
組織
§1100 本 部
§5.
1100
本 部
食品医薬品局の中央組織は以下の部門から成り立つ。
Office of the Commissioner.
1
Office of the Chief Counsel.
2
Office of Equal Employment Opportunity and Diversity.
Office of the Administrative Law Judge.
Office of External Relations.
Office of Executive Secretariat.
Office of Public Affairs.
Office of the Ombudsman.
Office of Special Health Issues.
Office of Policy and Planning.
Office of Policy.
Office of Planning.
Office of Management.
Office of the Chief Information Officer.
Office of Financial Management.
Office of Shared Services.
3
Office of Management Programs.
Office of Executive Operations.
Office of Science and Health Coordination.
Office of Orphan Products Development.
Office of Women's Health.
Office of International Activities and Strategic Initiatives.
Office of International Programs.
Office of Pediatric Therapeutics.
Office of Combination Products.
Office of Legislation.
Office of Crisis Management.
Office of Emergency Operations.
Office of Security Operations, Policy and Planning.
Center for Biologics Evaluation and Research
4
Office of the Center Director.
Scientific Advisors and Consultants Staff.
Equal Employment Opportunity and Workforce Diversity Staff.
Quality Assurance Staff.
Regulations and Policy Staff.
Veterinary Services Staff.
Office of Management.
Regulatory Information Management Staff.
Division of Planning, Evaluation, and Budget.
Division of Management Services.
Office of Compliance and Biologics Quality.
Division of Case Management.
Division of Manufacturing and Product Quality.
Division of Inspections and Surveillance.
Office of Blood Research and Review.
Policy and Publications Staff.
Division of Emerging and Transfusion Transmitted Diseases.
Division of Hematology.
Division of Blood Applications.
Office of Vaccines Research and Review.
Analytical Chemistry Staff.
Standards and Testing Staff.
Division of Bacterial, Parasitic, and Allergenic Products.
Division of Viral Products.
Division of Vaccines and Related Products Applications.
Office of Communication, Training, and Manufacturers Assistance.
Division of Disclosure and Oversight Management.
Division of Manufacturers Assistance and Training.
Division of Communication and Consumer Affairs.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Division of Epidemiology.
Office of Information Management.
Division of Information Operations.
Division of Information Development.
Office of Cellular, Tissue, and Gene Therapies.
Division of Cell and Gene Therapies.
Division of Clinical Evaluation and Pharmacology/Toxicology Review.
Division of Human Tissues.
Center for Food Safety and Applied Nutrition
5
Office of the Center Director.
Food Safety Staff.
Office of Science.
Quality Assurance Staff.
CFSAN Staff College.
Microbial Research and Risk Assessment Staff.
JIFSAN Liaison Staff.
CFSAN Food Advisory Committee Staff.
Office of Applied Research and Safety Assessment.
Muirkirk Technical Operations Staff.
Division of Molecular Biology.
Division of Virulence Assessment.
Division of Toxicology.
Office of Regulations and Policy.
Regulations Management Staff.
Office of Constituent Operations.
Consumer Education Staff.
International Activities Staff.
Industry Activities Staff.
Office of Management Systems.
Safety Management Staff.
Division of Information Resources Management.
Division of Planning and Financial Resources Management.
Division of Program Support Services.
Office of Operations.
Equal Employment Opportunity Staff.
Executive Operations Staff.
Office of Cosmetics and Colors.
Division of Color Certification and Technology.
Division of Cosmetics and Compliance.
Office of Nutritional Products, Labeling and Dietary Supplements.
Infant Formula and Medical Foods Staff.
Division of Dietary Supplement Programs and Compliance.
Division of Food Labeling, Standards and Compliance.
Division of Nutrition Programs and Labeling.
Division of Research and Applied Technology.
Office of Food Additive Safety.
Division of Petition Review.
Division of Chemistry Research and Environmental Review.
Division of Food Contact Notifications.
Division of Biotechnology and GRAS Notice Review.
Office of Plant and Dairy Foods and Beverages.
Division of Pesticides and Industrial Chemicals.
Division of Natural Products.
Division of Food Processing and Packaging.
Division of Plant Product Safety.
Division of Dairy and Egg Safety.
Division of Risk Assessment.
Division of Microbiological Studies.
Office of Seafood.
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Compliance.
Emergency Coordination and Response Staff.
Division of Enforcement.
Division of Field Programs.
Division of Cooperative Programs.
Office of Scientific Analysis and Support.
CFSAN Adverse Events Reporting System Staff.
Division of General Scientific Support.
Division of Mathematics.
Division of Market Studies.
Center for Drug Evaluation and Research
1
Office of the Center Director.
Equal Employment Opportunity Staff.
Controlled Substance Staff.
Office of Regulatory Policy.
Division of Regulatory Policy I.
Division of Regulatory Policy II.
Division of Information Disclosure Policy.
Office of Management.
1
Division of Management and Budget.
1
Division of Management Services.
1
Office of Training and Communication.
1
Division of Training and Development.
Division of Public Affairs.
Division of Drug Information.
Division of Library and Information Services.
Office of Compliance.
1
Division of New Drugs and Labeling Compliance (HFD-310).
Division of Manufacturing and Product Quality (HFD-320).
Division of Compliance Risk Management and Surveillance (HFD-330).
Office of Information Technology.
1
Quality Assurance Staff.
Technology Support Services Staff.
Division of Applications Development and Services.
Division of Infrastructure Management and Services.
Office of Medical Policy.
1
Division of Drug Marketing, Advertising and Communication.
1
Division of Scientific Investigations.
6
Office of Pharmacoepidemiology and Statistical Science.
Office of Drug Safety.
Division of Surveillance, Research and Communication Support.
Division of Medication Errors and Technical Support.
Division of Drug Risk Evaluation.
Office of Biostatistics.
Quantitative Methods and Research Staff.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Office of Executive Programs.
Executive Operations Staff.
Quality Assurance Staff.
Advisors and Consultants Staff.
2
Office of Counter-Terrorism and Pediatric Drug Development.
Division of Counter-Terrorism.
Division of Pediatric Drug Development.
Office of Information Management.
Business Information Staff.
Review Technology Staff.
Division of Records Management.
Office of New Drugs.
1
Office of Drug Evaluation I.
1
Division of Cardio-Renal Drug Products.
Division of Neuropharmacological Drug Products.
Division of Oncology Drug Products.
Office of Drug Evaluation II.
1
Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary and Allergy Drug Products.
Division of Anesthetic, Critical Care and Addiction Drug Products.
Office of Drug Evaluation III.
1
Division of Gastrointestinal and Coagulation Drug Products.
Division of Medical Imaging and Radiopharmaceutical Drug Products.
Division of Reproductive and Urologic Drug Products.
Office of Drug Evaluation IV.
1
Division of Anti-Infective Drug Products.
Division of Anti-Viral Drug Products.
Division of Special Pathogen and Immunologic Drug Products.
Office of Drug Evaluation V.
Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug
Products.
Division of Dermatologic and Dental Drug Products.
Division of Over-The-Counter Drug Products.
Office of Drug Evaluation VI.
Division of Therapeutic Biological Oncology Products.
Division of Therapeutic Biological Internal Medicine Products.
Division of Review Management and Policy.
Office of Pharmaceutical Science.
1
Quality Implementation Staff.
1
Operations Staff.
1
Informatics and Computational Safety Analysis Staff.
Office of Clinical Pharmacology and Biopharmaceutics.
Pharmacometrics Staff.
Division of Pharmaceutical Evaluation I.
1
Division of Pharmaceutical Evaluation II.
1
Division of Pharmaceutical Evaluation III.
1
Office of Generic Drugs.
6
Division of Bioequivalence.
Division of Chemistry I.
Division of Chemistry II.
Division of Labeling and Program Support.
Division of Chemistry III.
Office of New Drug Chemistry.
1
Division of New Drug Chemistry I.
1
Division of New Drug Chemistry II.
1
Division of New Drug Chemistry III.
1
Office of Testing and Research.
1
Laboratory of Clinical Pharmacology.
7
Division of Applied Pharmacology Research.
8
Division of Pharmaceutical Analysis.
9
Division of Product Quality Research.
1
Office of Biotechnology Products.
Division of Monoclonal Antibodies.
Division of Therapeutic Protein.
Office of Regulatory Affairs
1
Equal Employment Opportunity Staff.
Office of Resource Management.
Strategic Initiatives Staff.
Division of Planning, Evaluation, and Management.
Division of Human Resource Development.
Division of Management Operations.
Division of Personnel Operations.
Office of Information Technology.
Office of Enforcement.
Division of Compliance Management and Operations.
Division of Compliance Policy.
Division of Compliance Information and Quality Assurance.
Office of Regional Operations.
Division of Federal-State Relations.
Division of Field Science.
Division of Import Operations and Policy.
Division of Field Investigations.
Office of Criminal Investigations.
Office of Internal Affairs.
Mid-Atlantic Area Office.
10
Midwest Area Office.
11
Northeast Area Office.
12
Pacific Area Office.
13
Southeast Area Office.
14
Southwest Area Office.
15
Center for Veterinary Medicine
16
Office of the Center Director.
Office of Management.
Management Services Staff.
Information Resources Management Staff.
Office of New Animal Drug Evaluation.
Division of Therapeutic Drugs for Food Animals.
Division of Biometrics and Production Drugs.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Human Food Safety.
Division of Manufacturing Technologies.
Office of Surveillance and Compliance.
Division of Surveillance.
Division of Animal Feeds.
Division of Compliance.
Division of Epidemiology.
Office of Research.
Administrative Staff.
Division of Residue Chemistry.
Division of Animal Research.
Division of Animal and Food Microbiology.
Center for Devices and Radiological Health
17
Office of the Center Director.
Equal Employment Opportunity Staff.
Office of Systems and Management.
Division of Ethics and Management Operations.
Division of Information Technology.
Division of Planning, Analysis and Finance.
Office of Compliance.
Promotion and Advertising Policy Staff.
Division of Bioresearch Monitoring.
Division of Program Operations.
Division of Enforcement A.
Division of Enforcement B.
Office of Device Evaluation.
Program Management Staff.
Program Operations Staff.
Division of Cardiovascular Devices.
Division of Reproductive, Abdominal, and Radiological Devices.
Division of General, Restorative, and Neurological Devices.
Division of Ophthalmic, and Ear, Nose and Throat Devices.
Division of Anesthesiology, General Hospital, Infection Control, and
Dental Devices.
Office of Science and Technology.
Division of Mechanics and Materials Science.
Division of Life Sciences.
Division of Physical Sciences.
Division of Electronics and Computer Sciences.
Division of Management, Information and Support Services.
Office of Health and Industry Programs.
Program Operations Staff.
Regulations Staff.
Staff College.
Division of Device User Programs and Systems Analysis.
Division of Small Manufacturers Assistance.
Division of Mammography Quality and Radiation Programs.
Division of Communication Media.
Office of Surveillance and Biometrics.
Issues Management Staff.
Division of Biostatistics.
Division of Postmarket Surveillance.
Division of Surveillance Systems.
Office of In Vitro Diagnostic Device Evaluation and Safety.
Division of Chemistry and Toxicology Devices.
Division of Immunology and Hematology Devices.
Division of Microbiology.
National Center for Toxicological Research
18
Office of the Center Director.
Environmental Health and Program Assurance Staff.
Office of Research.
Technology Advancement Staff.
Division of Biochemical Toxicology.
Division of Genetic and Reproductive Toxicology.
Division of Biometry and Risk Assessment.
Division of Microbiology.
Division of Chemistry.
Division of Neurotoxicology.
Division of Veterinary Services.
Division of Molecular Epidemiology.
Office of Management.
Office of Management Services.
Division of Facilities, Engineering and Maintenance.
Division of Administrative Services.
Division of Contracts and Acquisitions.
Office of Planning, Finance and Information Technology.
Division of Planning.
Division of Financial Management.
Division of Information Technology.
[69 FR 17286, Apr. 2, 2004, 69 FR 52600, Aug. 27, 2004]
1. Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
2. 主任法律顧問室（健康福祉省（Department of Health and Human Services) 法務局（Office of the General Counsel) 食品医薬品室（Food and Drug Division)としても知られている）は、行政上、局長室に設置されているが、健康福祉省（Department of Health and Human Services) 法務局（Office of the General Counsel)の一部門です。
3.
Mailing address: 5630 Fishers Lane, Rockville, MD 20852.
4.
Mailing address: 1401 Rockville Pike, Rockville, MD 20852-1448.
5.
Mailing address: 5100 Paint Branch Pkwy., College Park, MD 20740-3835.
6.
Mailing address: 7520 Standish Pl., Rockville, MD 20855.
7.
Mailing address: Four Research Ct., Rockville, MD 20850.
8.
Mailing address: 8301 Muirkirk Rd., Laurel, MD 20708.
9.
Mailing address: 1114 Market St., St. Louis, MO 63101.
10.
Mailing address: 900 U.S. Customhouse, Second Chestnut St., Philadelphia, PA 19106.
11.
Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL 60532.
12.
Mailing address: 850 Third Ave., Brooklyn, NY 11232.
13.
Mailing address: 13301 Clay St., Oakland, CA 94512.
14.
Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
15.
Mailing address: 7920 Elmbrook Rd., Dallas, TX 75247.
16.
Mailing address: 7500 Standish Pl., MPN-2, Rockville, MD 20855.
17.
Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
18.
Mailing address: 3900 NCTR Dr., Jefferson, AR 72079.