U.S. Food and Drug Administration
Performance Plan
2002
| Acronym | Definition |
|---|---|
|
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 |
|
NSE
|
Not substantially equivalent determination |
|
NTP
|
National Toxicology Program NVPO National Vaccine Program Office |
|
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 |
|
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 |