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510(k): Premarket notification for medical devices substantially equivalent to products already on the market
AADA: Abbreviated Antibiotic Drug Application
ADE: Adverse Drug Event
ADAA: Animal Drug Availability Act of 1996
ADR: Adverse Drug Report
AERS: Adverse Events Reporting System
AHI: Animal Health Institute
AIDS: Acquired Immune Deficiency Syndrome
ANDA: Abbreviated New Drug Application
ANSI: American National Standards Institute
BLA: Biologic License Application
BLT: Blood Logging and Tracking System
BRFS: Behavioral Risk Factors Survey
BRMS: Biologics Regulatory Management System
BSE: Bovine Spongiform Encephalopathy (Mad Cow Disease)
CARS: Compliance Achievement Reporting System
CBER: FDA Center for Biologics Evaluation and Research
CDC: Centers for Disease Control and Prevention
CDER: FDA Center for Drug Evaluation and Research
CDRH: FDA Center for Devices and Radiological Health
CFSAN: FDA Center for Food Safety and Applied Nutrition
CGMPs: Current Good Manufacturing Practices
CJD: Creutzfeldt-Jakob disease
COMIS: Center-wide Oracle Management Information System
COMSTAT: Compliance Status Information System
CRADA: Cooperative Research and Development Agreement
CRS: Contamination Response System
CSTE: Council of State and Territorial Epidemiologists
CMC: Chemistry, Manufacturing, and Controls
CVM: FDA Center for Veterinary Medicine
DHHS: Department of Health and Human Services
DNA: Deoxyribonucleic acid
DOD: Department of Defense
DoL: Department of Labor
DRLS: Drug Registration and Listing System
DSHEA: Dietary Supplement Health and Education Act
EDR: Electronic Document Room
EDMS: Electronic Data Management System
EIR: Establishment Inspection Report
ELA: Establishment License Application
EPA: Environmental Protection Agency
ERS: Economic Research Service
ETS: Environmental Tobacco Smoke
EU: European Union
FACTS: Field Accomplishment and Compliance Tracking System
FAO: United Nations Food and Agricultural Organization
FAS: USDA Foreign Agriculture Service
FDAMA: Food and Drug Administration Modernization Act of 1997
FD&C Act: Federal Food, Drug and Cosmetic Act
FORCG: Food Outbreak Coordination Response Group
FPLA: Fair Packaging and Labeling Act
FSI: National Food Safety Initiative
FSIS: Food Safety Inspection Service (USDA)
FTC: Federal Trade Commission
FTE: Full-time equivalents
FY 1999: Fiscal Year 1999 (October 1998 - September 1999)
GAO: Government Accounting Office
GAPs: Good Agricultural Practices
GATT: General Agreement on Tariffs and Trade
GPRA: Government Performance and Results Act of 1993
GMPs: Good Manufacturing Practices
GRAS: Generally Recognized as Safe food ingredients
GSFA: General Standards for Food Additives
HACCP: Hazard Analysis Critical Control Points (a quality assurance and inspection technique)
HDE: Humanitarian Device Exemption
HUD: Humanitarian Use Device
ICH: International Conference on Harmonization
IDE: Investigational Device Exemption
INAD: Investigational New Animal Drug
INADA: Investigational New Animal Drug Application
IND: Investigational New Drug
ISO: International Standards Organization
IT: Information technology
JIFSAN: Joint Institute for Food Safety and Applied Nutrition
LACF: Low Acid Canned Foods
LAN: Local Area Network
MDR: Medical Device Reporting system
MOU: Memorandum of Understanding
MPRIS: Mammography Program Reporting and Information Systems
MQSA: Mammography Quality Standards Act
MRA: Mutual Recognition Agreement
NADA: New Animal Drug Application
NAFTA: North Atlantic Free Trade Agreement
NAFTA TWG: North American Free Trade Agreement Technical Working Group
NARMS: National Antimicrobial Resistance Monitoring System
NASS: National Agricultural Statistics Survey
NCI: National Cancer Institute
NCTR: FDA National Center for Toxicological Research
NDA: New Drug Application
NDE/MIS: New Drug Evaluation Management Information System
NIDA: National Institute on Drug Abuse
NIEHS: National Institute for Environmental Health Sciences
NLEA: Nutrition Labeling and Education Act
NME: New Molecular Entity
NPR: National Partnership for Reinventing Government
NSE: Not substantially equivalent determination
NTP: National Toxicology Program
OASIS: Operational and Administrative System for Import Support
ORA: FDA Office of Regulatory Affairs
OSHA: Occupational Safety and Health Administration
OTC: Over-the-counter
OTR: Office of Testing and Research (CDER)
PAS: FDA Public Affairs Specialist
PDUFA: Prescription Drug User Fee Act of 1992
PIFSI: Produce and Food Safety Initiative
PLA: Product License Application
PMA: Premarket Approval (Application to market medical device that requires premarket approval)
PODS: Project-Oriented Data System
PQRI: Product Quality Research Initiative
RCHSA: Radiation Control for Health and Safety Act
REGO: Reinventing government initiative
RIMS: Regulatory Information Management Staff
RVIS: Residue Violation Information System
SAMHSA: Substance Abuse and Mental Health Services Administration
SN/AEMS: Special Nutritionals Adverse Events Monitoring System
STARS: Submission Tracking and Review System
StmDT104: Salmonella typhimurium DT 104
TRIMS: Tissue Residue Information System
UMCP: University of Maryland-College Park
USDA: United States Department of Agriculture
VFD: Veterinary Feed Directive
WHO: United Nations World Health Organization
WTO: World Trade Organization
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