Organization (21 CFR 5.1100-5.1110)

119 Food and Drug Administration, HHS § 5.1100 product have arrived at the same facil ity, or the manufacture of these con stituent parts is proceeding at the same facility, application of a current good manufacturing process operating system that complies with paragraph (b) of this section may begin. (e) The requirements set forth in this subpart and in parts 210, 211, 820, 600 through 680, and 1271 of this chapter listed in § 4.3, supplement, and do not supersede, each other unless the regu lations explicitly provide otherwise. In the event of a conflict between regula tions applicable under this subpart to combination products, including their constituent parts, the regulations most specifically applicable to the con stituent part in question shall super sede the more general. Subpart B [Reserved] PART 5—ORGANIZATION Subparts A–L [Reserved] Subpart M—Organization Sec. 5.1100 Headquarters. 5.1105 Chief Counsel, Food and Drug Admin istration. 5.1110 FDA Public Information Offices. AUTHORITY: 5 U.S.C. 552; 21 U.S.C. 301–397. SOURCE: 77 FR 15962, Mar. 19, 2012, unless otherwise noted. Subparts A–L [Reserved] Subpart M—Organization § 5.1100 Headquarters. The Food and Drug Administration consists of the following: Office of the Commissioner. Office of Executive Secretariat. Office of the Chief Counsel. Office of the Counselor to the Commissioner. Office of Crisis Management. Office of Emergency Operations. Office of Policy and Planning. Office of Policy. Policy Development and Coordination Staff. Regulations Policy and Management Staff. Regulations Editorial Section. Office of Planning. Planning Staff. Program Evaluation and Process Improve ment Staff. Economics Staff. Risk Communications Staff. Office of Legislation. Office of External Affairs. Web Communications Staff. Office of External Relations. Communications Staff. Office of Public Affairs. Office of Special Health Issues. Office of Minority Health. Office of Women’s Health. Office of the Chief Scientist. Office of Counter-Terrorism and Emerging Threats. Office of Scientific Integrity. Office of Regulatory Science and Innovation. Division of Science Innovation and Critical Path. Division of Scientific Computing and Med ical Information. Office of Scientific Professional Development. National Center for Toxicological Research. Office of the Center Director. Office of Management. Office of Scientific Coordination. Office of Research. Division of Biochemical Toxicology. Division of Genetic and Molecular Toxi cology. Division of Personalized Nutrition and Medicine. Biometry Branch. Pharmacogenomics Branch. Division of Microbiology. Division of Neurotoxicology. Division of Systems Biology. Office of Operations. Office of Equal Employment Opportunity. Conflict Prevention and Resolution Staff. Compliance Staff. Diversity Staff. Office of Finance, Budget, and Acquisitions. Office of Budget. Office of Acquisitions and Grants Services. Division of Acquisition Operations. Division of Acquisition Support and Grants. Division of Acquisition Programs. Division of Information Technology. Office of Financial Operations. Office of Financial Management. User Fees Staff. Division of Accounting. Division of Budget Execution and Control. Office of Financial Services. Payroll Staff. Division of Payment Services. Division of Travel Services. Office of Information Management. Division of Business Partnership and Sup port. Division of Chief Information Officer Sup port. Division of Systems Management. Division of Infrastructure Operations. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00129 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 120 21 CFR Ch. I (4–1–16 Edition) § 5.1100 Division of Technology. Office of Management. Ethics and Integrity Staff. Office of Management Programs. Office of Security Operations. Office of Facilities, Engineering and Mis sion Support Services. Jefferson Lab Complex Staff. Business Operations and Initiatives Staff. Division of Operations Management and Community Relations. Auxiliary Program Management Branch. Logistics and Transportation Management Branch. Facilities Maintenance and Operations Branch. Division of Planning, Engineering, and Space Management. Planning and Space Management Branch. Employee Safety and Environmental Man agement Branch. Engineering Management Branch. Office of Library and Employee Services. Employee Resource and Information Cen ter. FDA Biosciences Library. Public Services Branch. Technical Services Branch. FDA History Office. Division of Freedom of Information. Division of Dockets Management. Office of Foods. Center for Food Safety and Applied Nutrition. Office of the Center Director. Executive Operations Staff. International Staff. Office of Management. Safety Staff. Division of Planning and Budget and Plan ning. Division of Program Services. Office of Food Defense, Communication and Emergency Response. Division of Education and Communication. Division of Public Health and Biostatis tics. Office of Food Safety. Retail Food and Cooperative Program Sup port Staff. Division of Seafood Science and Tech nology. Chemical Hazard Branch. Microbiological Hazard Branch. Division of Food Processing Science and 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. Office of Cosmetics and Colors. Cosmetic Staff. Division of Color Certification and Tech nology. Office of Regulatory Science. Division of Analytical Chemistry. Methods Branch. Spectroscopy and Mass Spectrometry Branch. Division of Microbiology. Microbial Methods and Development Branch. Molecular Methods and Subtyping Branch. Division of Bioanalytical Chemistry. Bioanalytical Methods Branch. Chemical Contaminants Branch. Office of Food Additive Safety. Division of Food Contact Notifications. Division of Biotechnology and GRAS No tice Review. Division of Petition Review. Office of Compliance. Division of Enforcement. Division of Field Programs and Guidance. Office of Applied Research and Safety As sessment. Division of Molecular Biology. Division of Virulence Assessment. Division of Toxicology. Office of Regulations, Policy, and Social Sciences. Regulations and Special Government Em ployees Management Staff. Division of Social Sciences. Office of Nutrition, Labeling, and Dietary Supplements. Nutrition Programs Staff. Division of Dietary Supplement Programs. Center for Veterinary Medicine. Office of the Center Director. Office of Management. Management Logistics Staff. Human Capital Management Staff. Program and Resource Management Staff. Talent Development Staff. Budget Planning and Evaluation Staff. Office of New Animal Drug Evaluation. Division of Therapeutic Drugs for Non Food Animals. Division of Biometrics and Production Drugs. Division of Therapeutic Drugs for Food Animals. Division of Human Food Safety. Division of Manufacturing Technologies. Division of Scientific Support. Division of Generic Animal Drugs. Office of Surveillance and Compliance. Division of Surveillance. Division of Animal Feeds. Division of Compliance. Division of Veterinary Product Safety. Office of Research. Division of Residue Chemistry. Division of Animal Research. Division of Animal and Food Microbiology. Office of Minor Use and Minor Species Ani mal Drug Development. Office of Medical Products and Tobacco. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00130 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 121 Food and Drug Administration, HHS § 5.1100 Office of Special Medical Programs. Advisory Committee Oversight and Man agement Staff. Good Clinical Practice Staff. Office of Combination Products. Office of Orphan Products Development. Office of Pediatric Therapeutics. Center for Biologics Evaluation and Research. Office of the Center Director. Regulations Policy Staff. Quality Assurance Staff. Office of Management. Regulatory Information Management Staff. Division of Planning, Evaluation, and Budget. Division of Veterinary Services. Division of Program Services. Division of Scientific Advisors and Con sultants. Building Operations Staff. Office of Compliance and Biologics Quality. Division of Case Management. Division of Inspections and Surveillance. Division of Manufacturing and Product Quality. 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 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. Program Operation Staff. Division of Product Quality. Division of Bacterial, Parasitic, and Aller genic Products. Division of Viral Products. Division of Vaccines and Related Product Applications. Office of Cellular, Tissue, and Gene Thera pies. Regulatory Management Staff. Division of Cellular and Gene Therapies. Division of Clinical Evaluation and Phar macology/Toxicology. Division of Human Tissues. Office of Communication, Outreach and De velopment. Division of Disclosure and Oversight Man agement. Division of Manufacturers Assistance and Training. Division of Communication and Consumer Affairs. Center for Devices and Radiological Health. Office of the Center Director. Regulations Staff. Office of Management Operations. Division of Ethics and Management Oper ations. Human Resource and Administrative Man agement Branch. Integrity, Conference and Committee Man agement Branch. Division of Planning, Analysis and Fi nance. Planning Branch. Financial Management Branch. Office of Compliance. Promotion and Advertising Policy Staff. Program Management Staff. Quality Management Program Staff. Division of Bioresearch Monitoring. Program Enforcement Branch A. Program Enforcement Branch B. Special Investigations Branch. Division of Risk Management Operations. Field Programs Branch. Recall Branch. Regulatory Policy Branch. Division of Enforcement. General Surgery Devices Branch. Dental Ear, Nose, Throat and Ophthalmic Devices Branch. Gastroenterology and Urology Branch. General Hospital Devices Branch. Division of Enforcement B. Radiology, Anesthesiology, and Neurology Devices Branch. Cardiac Rhythm and Electrophysiology Devices Branch. Vascular and Circulatory Support Devices Branch. Orthopedic and Physical Medicine Devices Branch. Office of Device Evaluation. Program Management Staff. Program Operations Staff. Pre-Market Approval Staff. Investigational Device Exemption Staff. Pre-Market Notification Section. Division of Cardiovascular Devices. Circulatory Support and Prosthetic Branch. Interventional Cardiology Devices Branch. Pacing, Defibrillators, and Leads Branch. Cardiac Electrophysiology and Monitoring Devices Branch. Peripheral Scads Vascular Devices Branch. Division of Reproductive, Gastro-Renal, and Urological Devices. Gynecology Devices Branch. Urology and Lithotripsy Devices Branch. Gastroenterology and Renal Devices Branch. Division of Surgical, Orthopedic, and Re storative Devices. General Surgery Devices Branch. Restorative Devices Branch. Plastic and Reconstructive Surgery De vices Branch. Orthopedic Joint Devices Branch. Orthopedic Spine Devices Branch. Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices. Intraocular, Corneal, and Neuromaterial Devices Branch. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00131 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 122 21 CFR Ch. I (4–1–16 Edition) § 5.1100 Ophthalmic Laser, Neuromuscular Stimulators, and Diagnostic Devices Branch. Neurodiagnostic and Neurotherapeutic De vices Branch. Ear, Nose, and Throat Devices Branch. Division of Anesthesiology, General Hos pital, Infection Control, and Dental De vices. General Hospital Devices Branch. Infection Control Devices Branch. Dental Devices Branch. Anesthesiology and Respiratory Devices Branch. Office of Science and Engineering Labora tories. Management Support Staff. Division of Biology. Division of Chemistry and Materials Science. Division of Solid and Fluid Mechanics. Division of Physics. Division of Imaging and Applied Mathe matics. Division of Solid and Fluid Mechanics. Division of Electrical and Software Engi neering. Office of Communication, Education and Ra diation Programs. Program Operations Staff. Staff College. Division of Health Communication. Web Communication Branch. Risk Communication Branch. Division of Small Manufacturers Inter national and Consumer Assistance. Technical Assistance Branch. International Relations and External Af fairs Staff. Regulatory Assistance Branch. Division of Mammography Quality and Ra diation Programs. Inspection and Compliance Branch. Information Management Branch. Diagnostic Devices Branch. Electronic Devices Branch. Division of Communication Media. Television Design and Development Branch. Division of Freedom of Information. Freedom of Information Branch A. Freedom of Information Branch B. Office of Surveillance and Biometrics. Program Management Staff. Division of Biostatistics. Cardiovascular and Ophthalmic Devices Branch. Diagnostic Devices Branch. General and Surgical Devices Branch. Division of Postmarket Surveillance. Product Evaluation Branch 1. Product Evaluation Branch 2. Information Analysis Branch. MDR Policy Branch. Division of Patient Safety Partnership. Patient Safety Branch 1. Patient Safety Branch 2. Division of Epidemiology. Epidemiology Evaluation and Research Branch 1. Epidemiology Evaluation and Research Branch 2. Office of In Vitro Diagnostic Device Evalua tion and Safety. Division of Chemistry and Toxicology De vices. Division of Immunology and Hematology Devices. Division of Microbiology Devices. Division of Radiological Devices. Center for Drug Evaluation and Research. Office of the Center Director. Controlled Substances Staff. Safe Use Staff. Office of Regulatory Policy. Division of Regulatory Policy I. Division of Regulatory Policy II. Division of Regulatory Policy III. Division of Information Disclosure Policy. Office of Management. Division of Management and Budget. Planning and Resource Management Branch. Management Analysis Branch. Division of Management Services. Program Management Services Branch. Interface Management Branch. Office of Communications. Division of Online Communications. Division of Health Communications. Division of Drug Information. Office of Surveillance and Epidemiology. Regulatory Science Staff. Regulatory Affairs Staff. Executive Operations and Strategic Plan ning Staff. Technical Information Staff. Program Management and Analysis Staff. Project Management Staff. Office of Medication Error Prevention. Division of Medication Error Prevention and Analysis. Division of Risk Management. Office of Pharmacovigilance and Epidemi ology. Division of Epidemiology I. Division of Epidemiology II. Division of Pharmacovigilance I. Division of Pharmacovigilance II. Office of Compliance. Office of Drug Security, Integrity, and Re calls. Division of Import Operations and Recalls. Recall Coordination Branch. Import Operations Branch. Division of Supply Chain Integrity. Office of Unapproved Drugs and Labeling Compliance. Division of Prescription Drugs. Prescription Drugs Branch. Compounding and Pharmacy Practice Branch. Division of Non-Prescription Drugs and Health Fraud. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00132 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 123 Food and Drug Administration, HHS § 5.1100 Over-the-Counter Drugs Branch. Health Fraud and Consumer Outreach Branch. Office of Manufacturing and Product Qual ity. Division of International Drug Quality. International Compliance Branch I. International Compliance Branch II. Division of Domestic Drug Quality. Domestic Compliance Branch 1. Domestic Compliance Branch 2. Division of Policy, Collaboration, and Data Operations. Regulatory Policy and Communications Branch. Drug Surveillance and Data Reporting Branch. Division of GMP Assessment. Biotech Manufacturing Assessment Branch. New Drug Manufacturing Assessment Branch. Generic Drug Manufacturing Assessment Branch. Office of Scientific Investigations. Division of Bioequivalence and Good Lab oratory Practice Compliance. Good Laboratory Practice Branch. Bioequivalence Branch. Division of Good Clinical Practice Compli ance. Good Clinical Practice Enforcement Branch Good Clinical Practice Assessment Branch Division of Safety Compliance. Post Market Safety Branch. Human Subject Protection Branch. Office of New Drugs. Pediatric and Maternal Health Staff. Program Management Analysis Staff. Office of Drug Evaluation I. Division of Cardiovascular and Renal Prod ucts. Division of Neurology Products. Division of Psychiatry Products. Office of Drug Evaluation II. Division of Metabolism and Endocrinology Products. Division of Pulmonary, Allergy, and Rheumatology Products. Division of Anesthesia, Analgesia, and Ad diction Products. Office of Drug Evaluation III. Division of Gastroenterology and Inborn Effects Products. Division of Reproductive and Urologic Products. Division of Dermatology and Dental Prod ucts. Office of Antimicrobial Products. Division of Anti-Infective Products. Division of Anti-Viral Products. Division of Transplant and Ophthalmology Products. Office of Drug Evaluation IV. Division of Nonprescription Clinical Eval uation. Division of Nonprescription Regulation De velopment. Division of Medical Imaging Products. Office of Hematology and Oncology Drug Products. Division of Oncology Products 1. Division of Oncology Products 2. Division of Hematology Products. Division of Hematology Oncology Toxi cology. Office of Pharmaceutical Science. Program Activities Review Staff. Operations Staff. Science and Research Staff. New Drug Microbiology Staff. Office of Generic Drugs. Division of Bioequivalence 1. Division of Bioequivalence 2. Division of Labeling and Program Support. Labeling Review Branch. Regulatory Branch. Review Support Branch. Division of Chemistry I. Division of Chemistry II. Division of Chemistry III. Division of Chemistry IV. Division of Clinical Review. Division of Microbiology. Office of New Drug Quality Assessment. Division of New Drug Quality Assessment I. Branch I. Branch II. Branch III. Division of New Drug Quality Assessment II. Branch IV. Branch V. Branch VI. Division of New Drug Quality Assessment III. Branch VII. Branch VIII. Branch IX. Office of Testing and Research. Division of Drug Safety Research. Division of Pharmaceutical Analysis. Division of Product Quality Research. Office of Biotechnology Products. Division of Monoclonal Antibodies. Division of Therapeutic Protein. Office of Medical Policy. Office of Prescription Drug Promotion. Division of Consumer Drug Promotion. Division of Professional Drug Promotion. Office of Medical Policy Initiatives. Division of Medical Policy Development. Division of Medical Policy Programs. Office of Executive Programs. Division of Training and Development. Training and Development Branch I. Training and Development Branch II. Division of Executive Operations. Division of Advisory Committee and Con sultant Management. Office of Translational Science. Office of Biostatistics. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00133 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 124 21 CFR Ch. I (4–1–16 Edition) § 5.1100 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. Office of Clinical Pharmacology. 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. Office of Counter-Terrorism and Emergency Coordination. Office of Planning and Informatics. Office of Planning and Analysis. Office of Business Informatics. Division of Records Management. Division of Regulatory Review Support. Division of Business Analysis and Report ing. Division of Project Development. Center for Tobacco Products. Office of the Center Director. Office of Management. Office of Policy. Office of Regulations. Office of Science. Office of Health Communication and Edu cation. Office of Compliance and Enforcement. Office of Global Regulatory Operations and Policy. Office of International Programs. Office of Regulatory Affairs. Office of Resource Management. Division of Planning, Evaluation, and Man agement. Program Planning and Workforce Manage ment Branch. Program Evaluation Branch. Division of Human Resource Development. Division of Management Operations. 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. State Contracts Staff. State Information Staff. Public Affairs and Health Fraud Staff. Division of Field Science. FERN National Program Branch. Scientific Compliance and Regulatory Re view Branch. Laboratory Operations Branch. Division of Import Operations and Policy. Systems Branch. Operations and Policy Branch. Division of Foreign Field Investigations. International Operations Branch. Foreign Food Branch. Foreign Drug Branch. Foreign Devices Branch. Division of Domestic Field Investigations. Team Biologics Staff. National Expert Staff. Domestic Operations Branch. Division of Food Defense Targeting. Office of Criminal Investigations. Mid-Atlantic Area Office. Midwest Area Office. Northeast Area Office. Pacific Area Office. Southeast Area Office. Southwest Area Office. Regional Food and Drug Directors. Regional Field Office, Central Region, Chi cago, IL. State Cooperative Programs Staff I. State Cooperative Programs Staff II. Regional Operations Staff. District Office, Baltimore, MD. Compliance Branch. Investigations Branch. District Office, Cincinnati, OH. Compliance Branch. Investigations Branch. Forensic Chemistry Center. Inorganic Chemistry Branch. Organic Chemistry Branch. District Office, Parsippany, NJ Compliance Branch. Investigations Branch. District Office, Philadelphia, PA. Compliance Branch. Investigations Branch. Laboratory Branch. District Office, Chicago, IL. Compliance Branch. Investigations Branch. District Office, Minneapolis, MN. Compliance Branch. Investigations Branch. District Office, Detroit, MI. Compliance Branch. Investigations Branch. Laboratory Branch. Regional Field Office, Northeast Region, Jamaica, NY. Operations Staff. Intergovernmental Affairs Staff. District Office, New York. Domestic Compliance Branch. Domestic Investigations Branch. Import Operations Branch (Downstate). Import Operations Branch (Upstate). Northeast Regional Laboratory. Microbiological Science Branch. Food Chemistry Branch. Drug Chemistry Branch. District Office New England. Compliance Branch. Investigations Branch. Winchester Engineering and Analytical Center. Analytical Branch. Engineering Branch. Regional Field Office, Pacific Region, Oak land, CA. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00134 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 125 Food and Drug Administration, HHS Pt. 7 District Office, San Francisco, CA Compliance Branch. Investigations Branch. Laboratory Branch. District Office, Los Angeles, CA. Compliance Branch. Domestic Investigations Branch. Import Operations Branch. District Office, Seattle, WA. Compliance Branch. Investigations Branch. Pacific Regional Laboratory Southwest Los Angeles, CA. Food Chemistry Branch. Drug Chemistry Branch. Microbiology Branch. Pacific Regional Laboratory Northwest Bothell, WA. Chemistry Branch. Microbiology Branch. Seafood Products Research Center. Regional Field Office, Southeast Region, Atlanta, GA. District Office, Atlanta, GA. Compliance Branch. Investigations Branch. District Office, FL. Compliance Branch. Investigations Branch. District Office, New Orleans, LA. Compliance Branch. Investigations Branch. Nashville Branch. District Office, San Juan, PR. Compliance Branch. Investigations Branch. Laboratory Branch. Southeast Regional Laboratory, Atlanta, GA. Chemistry Branch I. Microbiology Branch. Atlanta Center for Nutrient Analysis. Chemistry Branch II. Regional Field Office, Southwest Region. District Office, Dallas, TX. Compliance Branch. Investigations Branch. District Office, Kansas City, MO. Compliance Branch. Investigations Branch. Science Operations Branch. Total Diet and Pesticide Research Center. District Office, Denver, CO. Compliance Branch. Investigations Branch. Laboratory Branch. Arkansas Regional Laboratory. General Chemistry Branch. Pesticide Chemistry Branch. Microbiology Branch. Southwest Import District Office, Dallas, TX. Compliance Branch. Investigations Branch. § 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. § 5.1110 FDA public information of fices. (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 at 5100 Paint Branch Pkwy., College Park, MD 20740, Telephone: 301–436– 2335. [77 FR 15962, Mar. 19, 2012, as amended at 79 FR 68114, Nov. 14, 2014] PART 7—ENFORCEMENT POLICY Subpart A—General Provisions Sec. 7.1 Scope. 7.3 Definitions. 7.12 Guaranty. 7.13 Suggested forms of guaranty. Subpart B [Reserved] Subpart C—Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibil ities 7.40 Recall policy. 7.41 Health hazard evaluation and recall classification. 7.42 Recall strategy. 7.45 Food and Drug Administration-re quested recall. 7.46 Firm-initiated recall. 7.49 Recall communications. 7.50 Public notification of recall. 7.53 Recall status reports. 7.55 Termination of a recall. 7.59 General industry guidance. Subpart D [Reserved] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00135 Fmt 8010 Sfmt 8006 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B