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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2019]
[CITE: 21CFR5]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
 
PART 5ORGANIZATION
 

Subparts A-L [Reserved]

Subpart M--Organization

Sec. 5.1100 Headquarters.

Office of the Commissioner . 1

Office of the Chief Counsel.

Office of the Executive Secretariat .

Office of the Chief Scientist. 1

Office of Counter-Terrorism and Emerging Threats.

Office of Scientific Integrity.

Office of Regulatory Science and Innovation.

Office of Scientific Professional Development.

Office of Health Informatics.

Office of Women's Health.

Office of External Affairs.

Office of Minority Health.

National Center for Toxicological Research. 2

Office of Foods and Veterinary Medicine. 3

Office of Resource Planning and Strategic Management.

Office of Coordinated Outbreak Response and Evaluation Network . 4

Center for Food Safety and Applied Nutrition. 5

Office of the Center Director.

Office of Management.

Office of Analytics and Outreach.

Office of Food Safety.

Office of Cosmetics and Colors.

Office of Regulatory Science.

Office of Food Additive Safety.

Office of Compliance.

Office of Applied Research and Safety Assessment.

Office of Regulations, Policy and Social Sciences.

Office of Nutrition and Food Labeling.

Office of Dietary Supplement Program.

Office of the Center Director.

Office of Management.

Office of New Animal Drug Evaluation.

Office of Surveillance and Compliance.

Office of Research.

Office of Minor Use and Minor Species Animal Drug Development.

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

Office of Medical Products and Tobacco--Immediate Office. 7

Center for Biologics Evaluation and Research. 9

Office of Management.

Office of Compliance and Biologics Quality.

Office of Blood Research and Review.

Office of Vaccine Research and Review.

Office of Communication, Outreach, and Development.

Office of Biostatistics and Epidemiology.

Office of Cellular, Tissue and Gene Therapies.

Center for Tobacco Products. 10

Center for Drug Evaluation and Research. 11

Office of the Center Director.

Office of Regulatory Policy.

Office of Management.

Office of Communications.

Office of Compliance.

Office of Manufacturing Quality.

Office of Unapproved Drugs and Labeling Compliance.

Office of Scientific Investigations.

Office of Drug Security, Integrity and Response.

Office of Program and Regulatory Operations.

Office of Medical Policy.

Office of Medical Policy Initiatives.

Office of Translational Science.

Office of Biostatistics.

Office of Clinical Pharmacology.

Office of Computational Science.

Office of Study Integrity and Surveillance.

Office of Executive Programs.

Office of Surveillance and Epidemiology.

Office of Medication Error Prevention and Risk Management.

Office of Pharmacovigilance and Epidemiology.

Office of New Drugs.

Office of Drug Evaluation I.

Office of Drug Evaluation II.

Office of Drug Evaluation III.

Office of Antimicrobial Products.

Office of Drug Evaluation IV.

Office of Hematology and Oncology Drug Products.

Office of Strategic Programs.

Office of Program and Strategic Analysis.

Office of Business Informatics.

Office of Generic Drugs.

Office of Research and Standards.

Office of Bioequivalence.

Office of Generic Drug Policy.

Office of Regulatory Operations.

Office of Pharmaceutical Quality.

Office of Biotechnology Products.

Office of New Drug Products.

Office of Policy for Pharmaceutical Quality.

Office of Process and Facilities.

Division of Microbiology Assessment.

Division of Inspectional Assessment.

Office of Surveillance.

Office of Testing and Research.

Office of Program and Regulatory Operations.

Office of Lifecycle Drug Products.

Center for Devices and Radiological Health. 12

Office of the Center Director.

Office of Management Operations.

Office of Compliance.

Office of Device Evaluation.

Office of Science and Engineering Laboratories.

Office of Communication and Education.

Office of Surveillance and Biometrics.

Office of In Vitro Diagnostics and Radiological Health.

Office of Global Regulatory Operations and Policy. 13

Office of International Programs. 14

Office of Regulatory Affairs. 15

Office of the Associate Commissioner for Regulatory Affairs.

Office of Resource Management. 16

Office of Criminal Investigations. 17

Office of Communications and Quality Program Management.

Office of Partnerships. 18

Office of Policy and Risk Management. 19

Office of Operations. 20

Office of Enforcement and Import Operations. 21

Office of Regulatory Science. 22

Office of Food and Feed Operations. 23

Office of Medical Products and Tobacco Operations. 24

Regional Field Office, Northeast Region, Jamaica, NY. 25

Regional Field Office, Southwest Region, Dallas, TX. 30

Central Regional Field Office Chicago IL. 38

Southeast Regional Field Office Atlanta, GA. 49

Regional Field Office, Pacific Region, Oakland, CA. 56

Office of Operations.

Office of Business Services.

Office of Equal Employment Opportunity.

Office of Finance, Budget, and Acquisitions.

Office of Budget.

Office of Acquisition and Grant Services.

Office of Financial Operations.

Office of Financial Management.

Office of Financial Services.

Office of Human Resources.

Office of Facilities, Engineering and Mission Support Services.

Office of Information Management and Technology.

Office of Information Management.

Office of Technology and Delivery.

Office of Business and Customer Assurance.

Office of Enterprise and Portfolio Management.

Office of Safety, Security, and Crisis Management.

Office of Security Operations.

Office of Crisis Management.

Office of Emergency Operations.

Office of Policy, Planning, Legislation, and Analysis. 62

Office of Policy.

Office of Planning.

Office of Legislation.

Office of Public Health Strategy and Analysis.

1Mailing address: 10903 New Hampshire Ave., Silver Spring, MD 20993.

Freedom of Information Staff.

Dockets Management Staff.

Division of Science Innovation and Critical Path.

Division of Scientific Computing and Medical Information.

Office of Media Affairs.

Office of Health and Constituent Affairs.

2Mailing address: Food and Drug Administration, 3900 NCTR Rd., Jefferson, AR 72079.

Division of Biochemical Toxicology.

Division of Genetic and Molecular Toxicology.

Division of Microbiology.

Division of Systems Biology.

Division of Neurotoxicology.

Division of Bioinformatics and Biostatistics.

Office of Scientific Coordination.

3Mailing address: Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993.

Communications and Public Engagement Staff.

Executive Secretariat Staff.

Strategic Planning and Budget Formulation Staff.

Risk Analytics Staff.

4Mailing address: 4300 River Rd., University Station (HFS-015), College Park, MD 20740.

Prevention Staff.

Response Staff.

5Mailing address: Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.

International Affairs Staff.

Executive Operations Staff.

Safety Staff.

Division of Budget & Planning.

Division of Program Services.

Food Defense and Emergency Coordination Staff.

Biostatistics and Bioinformatics Staff.

Division of Education, Outreach and Information.

Education and Outreach Branch.

Information Center Branch.

Web Branch.

Division of Public Health Informatics and Analytics.

Epidemiology and Surveillance Branch.

Signals Management Branch.

Consumers Studies Branch.

Division of Risk and Decision Analysis.

Risk Analysis Branch.

Contaminant Assessment Branch.

Exposure Assessment Branch.

Retail Food Production Staff.

Multi-Commodity Foods Staff.

Division of Seafood Science and Technology.

Chemical Hazard Science Branch.

Microbiological Hazards Science Branch.

Division of Food Processing Science & Technology.

Process Engineering Branch.

Food Technology Branch.

Division of Plant and Dairy Food Safety.

Plant Products Branch.

Dairy and Egg Branch.

Division of Seafood Safety.

Shellfish and Aquaculture Policy Branch.

Seafood Processing and Technology Policy Branch.

Division of Produce Safety.

Fresh Produce Branch.

Processed Produce Branch.

Division of Dairy, Egg, and Meat Products.

Milk and Milk Products Branch.

Egg and Meat Products Branch.

Division of Plant Products and Beverages.

Beverages Branch.

Division of Color Certification and Technology.

Division of Cosmetics.

Division of Analytical Chemistry.

Methods Development Branch.

Spectroscopy and Mass Spectrometry Branch.

Microbial Methods and Development Branch.

Molecular Methods and Subtyping Branch.

Division of Bioanalytical Chemistry.

Chemical Contaminants Branch.

Bioanalytical Methods Branch.

Division of Food Contract Notifications.

Division of Biotechnology and GRAS Notice Review.

Division of Petition Review.

Division of Enforcement.

Division of Field Programs and Guidance.

Division of Molecular Biology.

Division of Virulence Assessment.

Virulence Mechanisms Branch.

Immunobiology Branch.

Division of Toxicology.

Regulations and Special Government Employee Management Staff.

Division of Social Sciences.

Food Labeling and Standards Staff.

Nutrition Programs Staff.

Evaluation and Research Staff.

Regulatory Implementation Staff.

Center for Veterinary Medicine. 6

6Mailing address: Food and Drug Administration, 7519 Standish Pl., Rockville MD 20855.

Program and Resources Management Staff.

Human Capital Management Staff.

Talent Development Staff.

Management Logistics Staff.

Budget Planning and Evaluation Staff.

Division of Therapeutic Drugs for Food Animals.

Division of Production Drugs.

Division of Therapeutic Drugs for Non-Food Animals.

Division of Human Food Safety.

Division of Manufacturing Technologies.

Division of Scientific Support.

Division of Generic Animal Drugs.

Division of Business Information Science and Management.

Division of Surveillance.

Division of Animal Feeds.

Division of Compliance.

Division of Veterinary Product Safety.

Division of Residue Chemistry.

Division of Applied Veterinary Research.

Division of Animal and Food Microbiology.

7Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver Spring, MD 20993.

Office of Special Medical Programs--Immediate Office. 8

8Mailing address: 10903 New Hampshire Ave., Bldg. 32, Silver Spring, MD 20993.

Advisory Committee Oversight and Management Staff.

Good Clinical Practice Staff.

Office of Pediatric Therapeutics.

Office of Orphan Products Development.

Office of Combination Products.

9Mailing address: 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993.

Regulatory Information Management Staff.

Regulations and Policy Staff.

Records Management Staff.

Bioinformatics Support Staff.

Business Operations Staff.

Planning and Performance Management Staff.

Program Operations Branch.

Program Services Branch.

Division of Budget and Resource Management.

Budget Analysis and Formulation Branch.

Resource Management Branch.

Building Operations Staff.

Program Management Services Branch.

Division of Scientific Advisors and Consultants.

Division of Veterinary Services.

Division of Case Management.

Blood and Tissue Compliance Branch.

Advertising and Promotional Labeling Branch.

Biological Drug and Device Compliance Branch.

Division of Manufacturing and Product Quality.

Product Release Branch.

Manufacturing Review Branch I.

Manufacturing Review Branch II.

Applications Review Branch.

Division of Inspections and Surveillance.

Program Surveillance Branch.

Bioresearch Monitoring Branch.

Division of Biological Standards and Quality Control.

Laboratory of Analytical Chemistry and Blood Related Products.

Quality Assurance Branch.

Laboratory of Microbiology, In-vivo Testing and Standards.

Administrative Staff.

Policy and Publication Staff.

Regulatory Project Management Staff.

Division of Emerging and Transfusion Transmitted Diseases.

Laboratory of Molecular Virology.

Laboratory of Emerging Pathogens.

Laboratory of Bacterial and Transmissible Spongiform Encephalopathy Agents.

Product Review Branch.

Division of Hematology Clinical Review.

Hematology Product Review Branch.

Clinical Review Branch.

Division of Blood Components and Devices.

Blood and Plasma Branch.

Devices and Review Branch.

Division of Hematology Research and Review.

Laboratory of Cellular Hematology.

Laboratory of Hemostasis.

Laboratory of Plasma Derivatives.

Laboratory of Biochemistry and Vascular Biology.

Program Operations Staff.

Division of Bacterial, Parasitic, and Allergenic Products.

Laboratory of Immunobiochemistry.

Laboratory of Respiratory and Special Pathogens.

Laboratory of Bacterial Polysaccharides.

Laboratory of Mucosal Pathogens and Cellular Immunology.

Division of Viral Products.

Laboratory of Pediatric and Respiratory Viral Diseases.

Laboratory of Hepatitis Viruses.

Laboratory of Retroviruses.

Laboratory of DNA Viruses.

Laboratory of Vector-Borne Diseases.

Laboratory of Method Development.

Laboratory of Immunoregulation.

Division of Vaccines and Related Products Applications.

Clinical Review Branch 1.

Clinical Review Branch 2.

CMC Review Branch 1.

CMC Review Branch 2.

CMC Review Branch 3.

Review Management Support Branch.

Division of Disclosure and Oversight Management.

Congressional and Oversight Branch.

Access Litigation and Freedom of Information Branch.

Division of Manufacturers Assistance and Training.

Career Development and Directed Training Branch.

Manufacturers Assistance and Technical Training Branch.

Division of Communication and Consumer Affairs.

Communication Technology Branch.

Consumer Affairs Branch.

Division of Biostatistics.

Vaccine Evaluation Branch.

Therapeutics Evaluation Branch.

Division of Epidemiology.

Pharmacovigilance Branch.

Analytic Epidemiology Branch.

Regulatory Management Staff.

Division of Cellular and Gene Therapies.

Cell Therapies Branch.

Gene Therapies Branch.

Gene Transfer and Immunogencity Branch.

Tumor Vaccine and Biotechnology Branch.

Cellular and Tissue Therapy Branch.

Division of Clinical Evaluation and Pharmacological Toxicology Review.

General Medicine Branch.

Pharmacology/Toxicology Branch.

Oncology Branch.

Division of Human Tissues.

Human Tissue and Reproduction Branch.

10Mailing address: 10903 New Hampshire Ave., Bldg. 75, Silver Spring, MD 20993.

Acquisitions and Assistance Staff.

Information and Technology Staff.

Management and Logistics Staff.

Division of Financial Management.

Division of Human Capital.

Office of Regulations.

Office of Science.

Regulatory Science and Management Staff.

Division of Regulatory Project Management.

Regulatory Project Management Branch I.

Regulatory Project Management Branch II.

Regulatory Project Management Branch III.

Regulatory Project Management Branch IV.

Division of Regulatory Science Informatics.

Division of Product Science.

Division of Individual Health Science.

Division of Population Health Science.

Division of Non-Clinical Science.

Office of Health Communication and Education.

Division of Public Health Education.

Division of Health, Scientific, and Regulatory Communication.

Office of Compliance and Enforcement.

Division of Enforcement and Manufacturing.

Division of Promotion, Advertising and Labeling.

Division of State Programs.

Division of Business Operations.

11Mailing address: 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993.

Controlled Substance Staff.

Professional Affairs and Stakeholder Engagement Staff.

Counter-Terrorism and Emergency Coordination Staff.

Drug Shortages Staff.

Division of Regulatory Policy I.

Division of Regulatory Policy II.

Division of Regulatory Policy III.

Division of Regulatory Policy IV.

Division of Information Disclosure Policy.

Proactive Disclosure Branch.

Strategic Programs and Initiatives Staff.

Ethics Liaison Staff.

Division of Budget Execution and Resource Management.

Budget Execution Branch.

Acquisitions Support Branch.

Financial Accountability Branch.

Division of Management Services.

Human Capital Management Branch.

Human Capital Programs Branch.

Facilities Operations Branch.

Property and Travel Services Branch.

Leave and Performance Management Branch.

Division of User Fee Management and Budget Formulation.

Generics Branch.

Policy and Operations Branch.

Brands Branch.

Division of Online Communications.

Division of Health Communications.

Division of Drug Information.

Program Management and Analysis Staff.

Manufacturing Guidance and Policy Staff.

Division of Drug Quality I.

Global Compliance Branch I.

Global Compliance Branch II.

Division of Drug Quality II.

Global Compliance Branch III.

Global Compliance Branch IV.

Division of Prescription Drugs.

Prescription Drugs Branch.

Compounding and Pharmacy Practices Branch.

Division of Non-Prescription Drugs and Health Fraud.

Over-the-Counter Drugs Branch.

Health Fraud Branch.

Division of Enforcement and Postmarket Safety.

Compliance Enforcement Branch.

Postmarketing Safety Branch.

Division of Clinical Compliance Evaluation.

Good Clinical Practice Compliance Oversight Branch.

Good Clinical Practice Assessment Branch.

Division of Import Exports and Recalls.

Recalls and Shortages Branch.

Import Export Compliance Branch.

Division of Supply Chain Integrity.

Supply Chain Strategy and Policy Branch.

Supply Chain Response and Enforcement Branch.

Project Management and Coordination Staff I.

Project Management and Coordination Staff II.

Drug Registration and Listing Staff.

Office of Prescription Drug Promotion.

Division of Consumer Drug Promotion.

Division of Professional Drug Promotion.

Division of Medical Policy Development.

Division of Medical Policy Programs.

Division of Clinical Trial Quality.

Division of Biometrics I.

Division of Biometrics II.

Division of Biometrics III.

Division of Biometrics IV.

Division of Biometrics V.

Division of Biometrics VI.

Division of Biometrics VII.

Division of Biometrics VIII.

Division of Clinical Pharmacology I.

Division of Clinical Pharmacology II.

Division of Clinical Pharmacology III.

Division of Clinical Pharmacology IV.

Division of Clinical Pharmacology V.

Division of Pharmacometrics.

Division of Applied Regulatory Science.

Division of New Drug Bioequivalence Evaluation.

Division of Generic Drug Bioequivalence Evaluation.

Division of Learning and Organizational Development.

Scientific and Regulatory Education Branch.

Training Design and Delivery Branch.

Leadership and Organizational Development Branch.

Division of Executive Operations.

Division of Advisory Committee and Consultant Management.

Regulatory Science Staff.

Regulatory Affairs Staff.

Division of Medication Error Prevention and Analysis.

Division of Risk Management.

Division of Epidemiology I.

Division of Epidemiology II.

Division of Pharmacovigilance I.

Division of Pharmacovigilance II.

Pharmacology/Toxicology Staff.

Division of Cardiovascular and Renal Products.

Division of Neurology Products.

Division of Psychiatry Products.

Division of Metabolism and Endocrinology Products.

Division of Pulmonary, Allergy, and Rheumatology Products.

Division of Anesthesia, Analgesia, and Addiction Products.

Division of Gastroenterology and Inborn Effects Products.

Division of Bone, Reproductive and Urologic Products.

Division of Dermatology and Dental Products.

Division of Anti-Infective Products.

Division of Anti-Viral Products.

Division of Transplant and Ophthalmology Products.

Division of Nonprescription Drug Products.

Division of Medical Imaging Products.

Division of Pediatrics and Maternal Health.

Division of Oncology Products I.

Division of Oncology Products II.

Division of Hematology Products.

Division of Hematology Oncology Toxicology.

Program Evaluation and Implementation Staff.

Economics Staff.

Performance Analysis and Data Services Staff.

Lean Management Staff.

Division of Regulatory Review and Drug Safety Services and Solutions.

Division of Business Management Services and Solutions.

Division of Data Management Services and Solutions.

Division of Drug Quality and Compliance Services and Solutions.

Clinical Safety Surveillance Staff.

Communications Staff.

Division of Therapeutic Performance.

Division of Quantitative Methods and Modeling.

Division of Bioequivalence I.

Division of Bioequivalence II.

Division of Bioequivalence III.

Division of Clinical Review.

Division of Legal and Regulatory Support.

Division of Policy Development.

Division of Labeling Review.

Division of Filing Review.

Division of Project Management.

Division of Quality Management Systems.

Scientific Staff.

Division of Biotechnology Review and Research I.

Division of Biotechnology Review and Research II.

Division of Biotechnology Review and Research III.

Division of Biotechnology Review and Research IV.

Division of Life Cycle API.

Life Cycle Branch I.

Life Cycle Branch II.

Life Cycle Branch III.

Division of New Drug API.

New Drug Branch I.

New Drug Branch II.

Division of New Drug Products I.

New Drug Products Branch I.

New Drug Products Branch II.

New Drug Products Branch III.

Division of New Drug Products II.

New Drug Products Branch IV.

New Drug Products Branch V.

New Drug Products Branch VI.

Division of Biopharmaceutics.

Biopharmaceutics Branch I.

Biopharmaceutics Branch II.

Biopharmaceutics Branch III.

Division of Regulations, Guidance and Standards.

Policy Development and Evaluation Branch I.

Policy Development and Evaluation Branch II.

Compendial Operations and Standards Branch.

Division of Internal Policies and Programs.

Division of Process Assessment I.

Process Assessment Branch I.

Process Assessment Branch II.

Process Assessment Branch III.

Division of Process Assessment II.

Process Assessment Branch IV.

Process Assessment Branch V.

Process Assessment Branch VI.

Division of Process Assessment III.

Process Assessment Branch VII.

Process Assessment Branch VIII.

Process Assessment Branch IX.

Microbiology Assessment Branch I.

Microbiology Assessment Branch II.

Microbiology Assessment Branch III.

Microbiology Assessment Branch IV.

Inspectional Assessment Branch I.

Inspectional Assessment Branch II.

Inspectional Assessment Branch III.

Division of Quality Intelligence, Risk Analysis, and Modeling.

Data Integrity Branch.

Quality Intelligence Branch.

Analysis and Modeling Branch.

Division of Quality Surveillance Assessment.

Quality Deviation and Assessment Branch.

Inspection Assessment Branch.

Division of Product Quality Research.

Product Quality Branch I.

Product Quality Branch II.

Division of Pharmaceutical Analysis.

Pharmaceutical Analysis Branch I.

Pharmaceutical Analysis Branch II.

Division of Regulatory and Business Process Management I.

Regulatory and Business Process Management Branch I.

Regulatory and Business Process Management Branch II.

Division of Regulatory and Business Process Management II.

Regulatory and Business Process Management Branch III.

Regulatory and Business Process Management Branch IV.

Division of Operational Excellence, Learning, and Professional Development.

Learning and Professional Development Branch.

Organizational Excellence Branch.

Division of Immediate Release Products I.

Immediate Release Branch I.

Immediate Release Branch II.

Immediate Release Branch III.

Division of Immediate Release Products II.

Immediate Release Branch IV.

Immediate Release Branch V.

Immediate Release Branch VI.

Division of Modified Release Products.

Modified Release Branch I.

Modified Release Branch II.

Modified Release Branch III.

Division of Liquid-Based Products.

Liquid-Based Branch I.

Liquid-Based Branch II.

Liquid-Based Branch III.

Division of Post-Marketing Activities I.

Post-Marketing Branch I.

Post-Marketing Branch II.

Division of Post-Marketing Activities II.

Post-Marketing Branch III.

Post-Marketing Branch IV.

Post-Marketing Branch V.

12Mailing address: 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993.

Regulations Staff.

Division of Ethics and Management Operations.

Human Resources and Administrative Management Branch.

Integrity, Conference and Committee Management Branch.

Division of Planning, Analysis and Finance and Property.

Planning Branch.

Financial Management Branch.

Program Management Staff.

Division of Bioresearch Monitoring.

Bioresearch Compliance Branch I.

Bioresearch Compliance Branch II.

Division of Analysis and Program Operations.

Quality Management System and Executive Secretary Staff.

Field Inspections Support Branch.

Recall Branch.

Registration and Risk Branch.

Allegations of Regulatory Misconduct Branch.

Division of Manufacturing and Quality.

Physical Medicine, Orthopedic, Neurology, and Dental Devices Branch.

Cardiovascular Devices Branch.

Abdominal and Surgical Devices Branch.

Respiratory, Ear/Nose/Throat, General Hospital, and Ophthalmic Devices Branch.

Division of Premarket and Labeling Compliance.

Surveillance and Enforcement Branch I.

Surveillance and Enforcement Branch II

Division of International Compliance Operations.

Foreign Enforcement Branch.

Imports Branch.

Exports Branch.

Pre-Market Approval Staff.

Investigational Device Exemption Staff.

Pre-Market Notification Section.

Division of Cardiovascular Devices.

Circulatory Support Devices Branch.

Cardiac Diagnostics Devices Branch.

Implantable Electrophysiology Devices Branch.

Vascular Surgery Devices Branch.

Structural Heart Devices Branch.

Interventional Cardiology Devices Branch.

Cardiac Electrophysiology Devices Branch.

Peripheral Interventional Devices Branch.

Division of Reproductive, Gastro-Renal, and Urological Devices.

Obstetrics/Gynecology Devices Branch.

Urology and Lithotripsy Devices Branch.

Renal Devices Branch.

Gastroenterology Devices Branch.

Division of Orthopedic Devices.

Restorative and Repair Devices Branch.

Joint and Fixation Branch I.

Joint and Fixation Branch II.

Anterior Spine Devices Branch.

Posterior Spine Devices Branch.

Division of Ophthalmic and Ear, Nose, and Throat Devices.

Intraocular and Corneal Implant Devices Branch.

Diagnostic and Surgical Devices Branch.

Contact Lenses and Retinal Devices Branch.

Ear, Nose and Throat Devices Branch.

Division of Anesthesiology, General Hospital, Respiratory Infection Control, and Dental Devices.

General Hospital Devices Branch.

Infection Control Devices Branch.

Anesthesiology Devices Branch.

Respiratory Devices Branch.

Division of Neurological and Physical Medicine Devices.

Neurostimulation Devices Branch.

Neurodiagnostic and Neurosurgical Devices Branch.

Physical Medicine Devices Branch.

Division of Surgical Devices.

General Surgery Devices Branch I.

General Surgery Devices Branch II.

Plastic and Reconstructive Surgery Devices Branch I.

Plastic and Reconstructive Surgery Devices Branch II.

Division of Biology, Chemistry, and Materials Science.

Division of Biomedical Physics.

Division of Imaging, Diagnostics, and Software Reliability.

Division of Applied Mechanics.

Division of Administrative and Laboratory Support.

Program Management Operations Staff.

Digital Communication Media Staff.

Division of Health Communication.

Web Communication Branch.

Strategic Communication Branch.

Division of Industry and Consumer Education.

Postmarket and Consumer Branch.

Premarket Programs Branch.

Division of Information Disclosure.

Freedom of Information Branch A.

Freedom of Information Branch B.

Division of Employee Training and Development.

Employee Development Branch.

Technology and Learning Management Branch.

Informatics Staff.

Signal Management Staff.

Therapeutic Statistics Branch I.

Therapeutic Statistics Branch II.

Therapeutic Statistics Branch III.

Diagnostic Statistics Branch I.

Diagnostic Statistics Branch II.

Division of Postmarket Surveillance.

Product Evaluation Branch I.

Product Evaluation Branch II.

Product Evaluation Branch III.

Information Analysis Branch.

MDR Policy Branch.

Division of Patient Safety Partnership.

Clinical Outreach Branch I.

Clinical Outreach Branch II.

Epidemiologic Evaluation and Research Branch I.

Epidemiologic Evaluation and Research Branch II.

Epidemiologic Evaluation and Research Branch III.

Division of Chemistry and Toxicology Devices.

Chemistry Branch.

Diabetes Branch.

Cardio-Renal Diagnostics Branch.

Division of Immunology and Hematology Devices.

Hematology Branch.

Immunology and Flow Cytometry Branch.

Division of Microbiology Devices.

Viral Respiratory and HPV Branch.

General Viral and Hepatitis Branch.

General Bacterial and Antimicrobial Susceptibility Branch.

Bacterial Respiratory and Medical Countermeasures Branch.

Division of Radiological Health.

Magnetic Resonance and Electronic Products Branch.

Diagnostic X-Ray Systems Branch.

Nuclear Medicine and Radiation Therapy Branch.

Mammography, Ultrasound and Imaging Software Branch.

Division of Mammography Quality Standards.

Program Management Branch.

Information Management Branch.

Division of Program Operations and Management.

Division of Molecular Genetics and Pathology.

Molecular Pathology and Cytology Branch.

Molecular Genetics Branch.

13Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver Spring, MD 20993.

14Mailing address: 12420 Parklawn Dr., Element Building, Rockville, MD 20857.

15Mailing address: 10903 New Hampshire Ave., Bldg. 31, Silver Spring, MD 20993.

Information Technology Staff.

16Mailing address: 12420 Parklawn Dr., Element Building, Rockville, MD 20857.

Division of Planning Evaluation and Management.

Program Planning and Workforce Management Branch.

Program Evaluation Branch.

Division of Budget Formulation and Execution.

Division of Human Resources Development.

Division of Management Operations.

17Mailing address: 7500 Standish Pl., MPN2 Building, Rockville, MD 20855.

Mid-Atlantic Area Office.

Philadelphia Resident Unit.

Midwest Area Office.

Northeast Area Office.

Boston, MA Resident Unit.

Pacific Area Office.

San Francisco, CA Resident Unit.

Southeast Area Office.

San Juan, PR Resident Unit.

Atlanta, GA Resident Unit.

New Orleans, LA Resident Unit.

Southwest Area Office.

Dallas, TX Resident Unit.

Quality Management Systems Staff.

Project Coordination Staff.

Division of Communications.

Public Affairs and Editorial Services Branch.

Web and Digital Media Strategies Branch.

18Mailing address: 12420 Parklawn Dr., Element Building, Rockville, MD 20857.

Standards Implementation Staff.

Contracts and Grants Staff.

19Mailing address: 12420 Parklawn Dr., Element Building, Rockville, MD 20857.

Food and Feed Policy Staff.

Medical Products and Tobacco Policy Staff.

Risk Management Staff.

Work Planning Branch.

20Mailing address: 10903 New Hampshire Ave., Bldg. 31, Silver Spring, MD 20993.

Audit Staff.

21Mailing address: 12420 Parklawn Dr., Element Building, Rockville, MD 20857.

Division of Compliance Systems.

Enforcement Systems Branch.

Import Compliance Systems Branch.

Division of Import Operations.

Import Operations and Maintenance Branch.

Import Program Development and Implementation Branch.

22Mailing address: 12420 Parklawn Dr., Element Building, Rockville, MD 20857.

Food and Feed Scientific Staff.

Medical Products and Tobacco Scientific Staff.

Laboratory Operations and Support Staff.

23Mailing address: 12420 Parklawn Dr., Element Building, Rockville, MD 20857.

Division of Food Defense Targeting.

Division of Food and Feed Program Operations and Inspections.

Food and Feed Program Operations Branch.

Food and Feed Inspection Branch.

Food and Feed Trip Planning Branch.

24Mailing address: 12420 Parklawn Dr., Element Building, Rockville, MD 20857.

Division of Products and Tobacco Program Operations.

Medical Device and Tobacco Program Operations Branch.

Team Biological Branch.

Division of Medical Products and Tobacco Inspections.

Medical Products and Tobacco Inspection Branch.

Drug Inspection Branch.

Medical Products and Tobacco Trip Planning Branch.

25Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.

Intergovernmental Affairs Staff.

District Office New York. 26

26Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.

Domestic Compliance Branch.

Domestic Investigations Branch.

Resident Post Long Island, NY.

Resident Post White Plains, NY.

Resident Post Albany, NY.

Resident Post Binghamton, NY.

Resident Post Rochester, NY.

Resident Post Newburgh, NY.

Resident Post Syracuse, NY.

Import Operations Branch (Downstate).

Resident Post Port Elizabeth, NJ.

Import Operations Branch (Upstate).

Resident Post Champlain, NY.

Resident Post Alexandra Bay, NY.

Resident Post Massena, NY.

Resident Post Ogdensburg, NY.

Northeast Regional Laboratory. 27

27Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.

Microbiological Science Branch.

Chemistry Branch 1.

Chemistry Branch 2.

New England District Office. 28

28Mailing address: 1 Montvale Ave., 4th Floor, Stoneham, MA 02180-3500.

Resident Post Augusta, ME.

Resident Post Bridgeport, CT.

Resident Post Concord, NH.

Resident Post Hartford, CT.

Resident Post Providence, RI.

Resident Post Worcester, MA.

Resident Post Calais, ME.

Resident Post Houlton, ME.

Resident Post Highgate, VT.

Winchester Engineering and Analytical Center. 29

29Mailing address: 109 Holton St., Winchester, MA 01890.

Analytical Branch.

30Mailing address: 4040 North Central Expressway, Dallas, TX 75204-3128.

State Cooperative Programs Staff.

Resident Post Pharr.

Dallas District Office. 31

31Mailing address: 4040 North Central Expressway, Suite 300, Dallas, TX 75204-3128.

Resident Post Austin, TX.

Resident Post Fort Worth, TX.

Resident Post Houston, TX.

Resident Post San Antonio, TX.

Resident Post Oklahoma City, OK.

Resident Post Little Rock, AR.

Kansas City District Office. 32

32Mailing address: 8050 Marshal Dr., Suite 250, Lenexa, KS 66214.

Resident Post Wichita, KS.

Resident Post Omaha, NE.

Resident Post Des Moines, IA.

Resident Post Springfield, MO.

Resident Post St Louis, MO.

Resident Post Davenport, IA.

Denver District Office. 33

33Mailing address: Sixth Avenue and Kipling Street, Building 20, P.O. Box 25087, Denver, CO 80255-0087--Denver Federal Center.

Resident Post Salt Lake City, UT.

Resident Post Albuquerque, NM.

Arkansas Regional Laboratory. 34

34Mailing address: 3900 NCTR Rd., Bldg. 26, Jefferson, AR 72079.

General Chemistry Branch.

Pesticide Chemistry Branch.

Microbiology Branch.

Southwest Import District Office Dallas, TX. 35

35Mailing address: 4040 North Central Expressway, Suite 300, Dallas, TX 75204-3128.

Resident Post Calexico.

Resident Post Eagle Pass.

Resident Post El Paso Bota.

Resident Post El Paso Bota Westmoreland.

Resident Post El Paso Ysleta Bridge.

Resident Post Houston (SWID).

Resident Post Laredo [num]2 Bridge.

Resident Post Laredo Columbia Bridge.

Resident Post Laredo World Trade Bridge.

Resident Post Los Tomates.

Resident Post Nogales [num]1.

Resident Post Nogales [num]2.

Resident Post Otay Mesa [num]1.

Resident Post Otay Mesa [num]2.

Resident Post Rio Grande City.

Resident Post San Luis.

Kansas City Laboratory. 36

36Mailing address: 11510 West 80th St., Lenexa, KS 66214.

Denver Laboratory. 37

37Mailing address: Sixth Avenue and Kipling Street, Building 20, Denver, CO 80255-0087--Denver Federal Center.

38Mailing address: 20 N. Michigan Ave., Suite 510, Chicago, IL 60602.

State Cooperative Programs Staff I.

State Cooperative Programs Staff II.

Regional Operations Staff.

Baltimore District Office Baltimore, MD. 39

39Mailing address: 6000 Metro Dr., Suite 101, Baltimore, MD 21215.

Resident Post Charleston, WV.

Resident Post Falls Church, VA.

Resident Post Seva.

Resident Post Richmond, VA.

Resident Post Roanoke, VA.

Resident Post Dundalk Marine Terminal, MD.

Resident Post Morgantown, WV.

District Office Cincinnati, OH. 40

40Mailing address: 6751 Steger Dr., Cincinnati, OH 45237.

Resident Post Brunswick, OH.

Resident Post Columbus, OH.

Resident Post Toledo, OH.

Resident Post Louisville, KY.

Forensic Chemistry Center. 41

41Mailing address: 6751 Steger Dr., Cincinnati, OH 45237.

Inorganic Chemistry Branch.

Organic Chemistry Branch.

District Office Parsippany, NJ. 42

42Mailing address: 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054--Waterview Corporate Center.

Resident Post Voorhees, NJ.

Resident Post North Brunswick, NJ.

District Office Philadelphia, PA. 43

43Mailing address: 200 Chestnut St., Room 900, Philadelphia, PA 19106--U.S. Customs House.

Resident Post Harrisburg, PA.

Resident Post Pittsburgh, PA.

Resident Post Wilkes-Barre, PA.

Resident Post Wilmington, PA.

District Office Chicago, IL. 44

44Mailing address: 550 West Jackson Blvd., Suite 1500, Chicago, IL 60661.

Resident Post Peoria, IL.

Resident Post Hinsdale, IL.

Resident Post Gurnee, IL.

Resident Post Springfield, IL.

Resident Post O'Hare Airport.

District Office Minneapolis, MN. 45

45Mailing address: 250 Marquette Ave., Suite 600, Minneapolis, MN 55401.

Resident Post La Crosse, WI.

Resident Post Green Bay, WI.

Resident Post Milwaukee, WI.

Resident Post Madison, WI.

Resident Post Fargo, ND.

Resident Post Stevens Point, WI.

Resident Post Sioux, SD.

District Office Detroit, MI. 46

46Mailing address: 300 River Pl., Suite 5900, Detroit, MI 48207.

Resident Post Kalamazoo, MI.

Resident Post South Bend, IN.

Resident Post Indianapolis, IN.

Resident Post Evansville, IN.

Philadelphia Laboratory. 47

47Mailing address: 200 Chestnut St., Room 900, Philadelphia, PA 19106--U.S. Customs House.

Detroit Laboratory. 48

48Mailing address: 300 River Pl., Suite 5900, Detroit, MI 48207.

49Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.

Atlanta District Office. 50

50Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.

Resident Post Savannah, GA.

Resident Post Tifton, GA.

Resident Post Charlotte, NC.

Resident Post Greensboro, NC.

Resident Post Greenville, NC.

Resident Post Raleigh, NC.

Resident Post Charleston, SC.

Resident Post Columbia, SC.

Resident Post Greenville, SC.

Resident Post Asheville, NC.

Florida District Office. 51

51Mailing address: 555 Winderley Pl., Suite 200, Maitland, FL 32751.

Resident Post Jacksonville, FL.

Resident Post Miami, FL.

Resident Post Tallahassee, FL.

Resident Post Tampa, FL.

Resident Post Boca Raton, FL.

Resident Post Ft. Meyers, FL.

Resident Post Port Everglades, FL.

New Orleans, LA, District Office. 52

52Mailing address: 404 BNA Dr., Building 200, Suite 500, Nashville, TN 37217.

Resident Post Baton Rouge, LA.

Resident Post Lafayette, LA.

Resident Post Covington, LA.

Resident Post Jackson, MS.

Resident Post Mobile, AL.

Nashville Branch.

Resident Post Knoxville, TN.

Resident Post Memphis, TN.

Resident Post Birmingham, AL.

Resident Post Montgomery, AL.

San Juan District Office. 53

53Mailing address: 466 Fernandez Juncos Ave., San Juan, PR 00901.

Resident Post Aquada, PR.

Resident Post Ponce, PR.

Southeast Regional Laboratory Atlanta, GA. 54

54Mailing address: 60 Eighth St., Atlanta, GA 30309.

Chemistry Branch I.

Atlanta Center for Nutrient Analysis.

Chemistry Branch II.

San Juan Laboratory. 55

55Mailing address: 466 Fernandez Juncos Ave., San Juan, PR 00901.

56Mailing address: 1301 Clay St., Room 1180N, Oakland, CA 94612.

District Office San Francisco, CA. 57

57Mailing address: 1431 Harbor Bay Pkwy., Alameda, CA 94502.

Resident Post Las Vegas, NV.

Resident Post Fresno, CA.

Resident Post Sacramento, CA.

Resident Post Honolulu, HI.

Resident Post San Jose, CA.

Resident Post Stockton, CA.

Resident Post South San Francisco.

District Office Los Angeles, CA. 58

58Mailing address: 19701 Fairchild Rd., Irvine, CA 92612.

Import Operations Branch.

Resident Post Los Angeles Airport.

Resident Post Ontario, CA--Import.

Resident Post Woodland Hills, CA.

Resident Post San Diego, CA.

Resident Post Tempe, AZ.

Resident Post Ontario, CA--Domestic.

District Office Seattle, WA. 59

59Mailing address: 22215 26th Ave. SE., Suite 210, Bothell, WA 98021.

Resident Post Anchorage, AK.

Resident Post Boise, ID.

Resident Post Portland, ID.

Resident Post Spokane, WA.

Resident Post Oroville, WA.

Resident Post Portland, OR--Airport.

Resident Post Blaine, WA.

Resident Post Helena, MT.

Resident Post Sweetgrass, MT.

Resident Post Tacoma, WA.

Resident Post Puget Sound, WA.

Pacific Regional Laboratory Southwest. 60

60Mailing address: 19701 Fairchild Rd., Irvine, CA 92612.

Food Chemistry Branch.

Drug Chemistry Branch.

Pacific Regional Laboratory Northwest. 61

61Mailing address: 22201 23rd Dr. SE., Bothell, WA 98021-4421.

Seafood Products Research Center.

Employee Resource and Information Center.

Division of Ethics and Integrity.

Compliance Staff.

Division of Budget Formulation.

Division of Budget Execution and Control.

Division of Acquisition Operations.

Division of Acquisition Programs.

Division of Acquisition Support and Grants.

Division of Information Technology.

Commission Corps Affairs Staff.

Management Analysis Services Staff.

Division of Workforce Relations.

Division of Policy, Programs, and Executive Resources.

Division of Human Resource Services for Office of the Commissioner/Office of Operations.

Division of Human Resource Services for Office of Foods and Veterinary Medicine/Office of Global Operations and Policy.

Division of Human Resource Services for Office of Medical Products and Tobacco.

FDA University.

Jefferson Laboratories Complex Staff.

Division of Operations Management and Community Relations.

Division of Planning, Engineering and Safety Management.

Division of Infrastructure Operations.

Division of Application Services.

Division of Delivery Management and Support.

Division of Business Partnership and Support.

62Mailing address: 10903 New Hampshire Ave., Silver Spring, MD 20993.

Management and Operations Staff.

Intergovernment Affairs Staff.

Regulations Policy and Management Staff.

Policy Development and Coordination Staff.

Planning Staff.

Program Evaluation and Process Improvement Staff.

Risk Communication Staff.

[81 FR 78033, Nov. 7, 2016, as amended at 83 FR 13106, Mar. 27, 2018]

Sec. 5.1105 Chief Counsel, Food and Drug Administration.

The Office of the Chief Counsel's mailing address is White Oak Bldg. 1, 10903 New Hampshire Ave., Silver Spring, MD 20993.

Sec. 5.1110 FDA public information offices.

(a) Division of Dockets Management. The Division of Dockets Management public room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852, Telephone: 301-827-6860.

(b) Freedom of Information Staff. The Freedom of Information Staff's Public Reading Room is located at the address available on the agency's web site at http://www.fda.gov.

(c) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver Spring, MD 20993, Telephone: 301-827-6242; and at5001 Campus Dr., College Park, MD 20740, Telephone: 301-436-2335.

[77 FR 15962, Mar. 19, 2012, as amended at 79 FR 68114, Nov. 14, 2014; 81 FR 49895, July 29, 2016]

Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.
Source: 77 FR 15962, Mar. 19, 2012, unless otherwise noted.

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