Professional Documents
Culture Documents
Frank Eng
Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA) Indian Health Service (IHS)
CDC's Mission: To promote health and quality of life by preventing and controlling disease, injury, and disability. National Center on Birth Defects and Developmental Disabilities National Center for Chronic Disease Prevention and Health Promotion National Center for Environmental Health National Center for Health Statistics. National Center for HIV, STD, and TB Prevention National Center for Infectious Diseases National Center for Injury Prevention and Control National Immunization Program National Institute for Occupational Safety and Health Epidemiology Program Office Public Health Practice Program Office
Food, Drug & Cosmetic Act Also the RCHSA and the BT Act, etc Regs: Title 21CFR, parts 1 to 1299 9,000 Employees (about 1,000 are in ORA field offices around the country)
Pre-Approvals
Not Required for: Food & Cosmetic products (exceptions: food & color additives) Required for: Drugs, Devices, Blood, Biologics, & Vet Med products but with exceptions as indicated in the CFR (i.e.: tongue depressors)
Approval and safety of food additives Cosmetic safety Labeling foods, cosmetics and dietary supplements
Advertising for dietary supplements, food, cosmetics (FTC) Alcohol (TTB, Alcohol & Tobacco Tax & Trade Bureau) Water (EPA) (FDA is responsible for bottled water)
Blood
supply Vaccines for human use Human tissue Allergenic materials and anti-toxins
Medical Fields #1
Clinical Chemistry Hematology/Pathology Immunology/Microbiology Anesthesiology Cardiovascular Dental Ear, Nose & Throat
Medical Fields #2
Gastroenterology-Urology General & Plastic Surgery General Hospital Neurological Ophthalmic Orthopedic/Physical Medicine Radiology etc
Technologies Encountered
Electronics, Software & Hardware Rubber, Plastics & Metal Purification: air, water, etc. Bio-Engineering: mono/polyclonal antibodies, etc. Sterilization: gas, steam, heat & radiation, plasma
Laser Inspections
Purpose: To determine a manufacturers conformance with the Laser Product Performance Standard (safety features and labeling requirements)
Consumer Complaints
Charla Tate @ (510) 337- 6741
Foods Drugs Devices Blood CVM
Food Stamp, School Lunch, School Breakfast, and the WIC Programs Oversees 192 million acres of national forests and rangelands Conservation to protect soil, water, wildlife on the 70 % private lands Housing, telecommunications, and safe drinking water to rural America USDA is responsible for the safety of meat, poultry, and egg products USDA is a research leader in everything from human nutrition to new crop technologies USDA helps ensure open markets for U.S. agricultural products and provides food aid to needy people overseas.
USDA Agencies
Agricultural Research Service Animal and Plant Health Inspection Service Center for Nutrition Policy and Promotion Cooperative State Research, Education and Extension Service Economic Research Service Farm Service Agency Food and Nutrition Service Food Safety & Inspection Service Foreign Agricultural Service Forest Service Grain Inspection, Packers and Stockyards Administration National Agricultural Library National Agricultural Statistics Service Natural Resources Conservation Service Risk Management Agency Rural Development
Imports
Duties International agreements BT Commercial enforcement Regulatory audits Commercial enforcement Carriers
Department of Commerce
BUREAU OF COMPETITION
Mergers and Anti-trust laws
BUREAU OF ECONOMICS
Department of Justice
Investigation/prosecution of controlled substance laws Investigation/prosecution of criminals and drug gangs who perpetrate violence in our communities and terrorize citizens through fear and intimidation. National drug intelligence program with federal, state, local, and foreign officials on drug intelligence information. Seizure and forfeiture of assets derived from illicit drug trafficking. Enforcement of the provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances. Coordination/cooperation with federal, state and local law enforcement on mutual drug enforcement efforts and reduction of abuse-type drugs on market through nonenforcement methods i.e. crop eradication or substitution Liaison with the United Nations, Interpol, and other organizations on matters relating to international drug control programs.
Federal agency?
Federal Information Center (800) 688-9889