|
|
|
FDA Home Page | Search
FDA Site | FDA A-Z Index | Contact
FDA
Department of Health and Human Services
U.S. Food and
Drug Administration
Congressional Justification
FY 2004 Annual Performance Plan
FY 2003 Revised Final Performance Plan
FY 2002 Annual Performance Report
| 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 |
| BIMO | Bioresearch Monitoring |
| 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) |
| CABS | Conformity Assessment Bodies |
| CARS | Compliance Achievement Reporting System |
| CBER | FDA Center for Biologics Evaluation and Research |
| CDC | Centers for Disease Control and Prevention |
| CDDI | Collaboration for Drug Development Improvement |
| 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 |
| CMA | Chemical Manufaturers Association |
| CMC | Chemistry, Manufacturing, and Controls |
| COMIS | Center-wide Oracle Management Information System |
| COMSTAS | Compliance Status Information System |
| CRADA | Cooperative Research and Development Agreement |
| CRS | Contamination Response System |
| CSTE | Council of State and Territorial Epidemiologists |
| CTS | Correspondence Tracking System |
| CVM | FDA Center for Veterinary Medicine |
| CY | Calendar Year (January-December) |
| DCC | Document Control Center |
| DHHS | Department of Health and Human Services |
| DMARDS | Disease Modifying Antirheumatic Drugs |
| DNA | Deoxyribonucleic acid |
| DOD | Department of Defense |
| DoL | Department of Labor |
| DQRS | Drug Quality Reporting System |
| DRLS | Drug Registration and Listing System |
| DSHEA | Dietary Supplement Health and Education Act |
| DWPE | Detention Without Physical Examination |
| EDKB | Endocrine Disrupter Knowledge Base |
| EDR | Electronic Document Room |
| EDMS | Electronic Data Management System |
| EIP | Emerging Infection Program |
| 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 |
| FIS | Field Information System |
| FLQ | Fluoroquinolone |
| FORCG | Food Outbreak Coordination Response Group |
| FPL | Final Printed Label |
| 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 | Fiscal Year (October-September) |
| 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 |
| HIV | Human Immunodeficiency Virus |
| 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 |
| IOM | Institute of Medicine |
| ISO | International Standards Organization |
| ISRS | Individual Safety Reports |
| IT | Information technology |
| JIFSAN | Joint Institute for Food Safety and Applied Nutrition |
| LACF | Low Acid Canned Foods |
| LAN | Local Area Network |
| MATS | Management Assignment Tracking System |
| 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 |
| NCIE | Notice of Claimed Investigational Exemptions |
| NCTR | FDA National Center for Toxicological Research |
| NDA | New Drug Application |
| NDE/MIS | New Drug Evaluation Management Information System |
| NIAID | National Institute of Allergy and Infectious Diseases |
| NIDA | National Institute on Drug Abuse |
| NIEHS | National Institute for Environmental Health Sciences |
| NIH | National Institute of Health |
| NLEA | Nutrition Labeling and Education Act |
| NME | New Molecular Entity |
| NPR | National Partnership for Reinventing Government |
| NRC | National Research Council |
| NSE | Not substantially equivalent determination |
| NTP | National Toxicology Program |
| NVPO | National Vaccine Program Office |
| OASIS | Operational and Administrative System for Import Support |
| OBRR | Office of Blood Research and Review |
| OPA | CFSAN, Office of Premarket Approvals |
| ORA | FDA Office of Regulatory Affairs |
| ORISE | Oak Ridge Institute for Science and Education |
| OSHA | Occupational Safety and Health Administration |
| OTC | Over-the-counter |
| OTR | Office of Testing and Research (CDER) |
| PAS | FDA Public Affairs Specialist |
| PDPs | Product Development Protocols |
| 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 |
| QSIT | Quality System Inspection Technique |
| RA | Rheumatoid Arthritis |
| RCHSA | Radiation Control for Health and Safety Act |
| REGO | Reinventing government initiative |
| RIMS | Regulatory Information Management Staff |
| RVIS | Residue Violation Information System |
| SAB | Science Advisory Board |
| SAMHSA | Substance Abuse and Mental Health Services Administration |
| SE | Salmonella Enteriditis |
| SN/AEMS | Special Nutritional Adverse Events Monitoring System |
| STARS | Submission Tracking and Review System |
| StmDT104 | Salmonella typhimurium DT 104 |
| TB | Tuberculosis |
| TRIMS | Tissue Residue Information System |
| UK | United Kingdom |
| UMCP | University of Maryland-College Park |
| USDA | Unites states Department of Agriculture |
| VFD | Veterinary Feed Directive |
| VICH | Veterinary International Conference on Harmonization |
| WHO | United Nations World Health Organization |
| WTO | World Trade Organization |
End of Performance Plan
Previous Page | Table of Contents