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Glossary of Acronyms

<< Return to FY 2005 Budget Proposal

 

Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005

 

FOOD AND DRUG ADMINISTRATION

Glossary of Acronyms

 

A B C D E F G H I J K L M N O P Q R S T U V W

 

510(k)
Pre-market notification (Medical devices substantially equivalent to products already on the market)
A
 
AADA
Abbreviated Antibiotic Drug Application
AAFCO
American Association of Feed Control Officials
ADE
Adverse Drug Event
ADAA
Animal Drug Availability Act of 1996
ADR
Adverse Drug Report
ADUFA
Animal Drug User Fee Act
AERS
Adverse Events Reporting System
AHI
Animal Health Institute
AIDS
Acquired Immune Deficiency Syndrome
AMDUCA
Animal Medicinal Drug Use Clarification Act
ANADA
Abbreviated New Animal Drug Application
ANDA
Abbreviated New Drug Application
ANPR
Advanced Notice of Proposed Rulemaking
ANSI
American National Standards Institute
APHIS
Animal Plant and Health Inspection Service (USDA)
AR
Anti-microbial Resistance
AVMA
American Veterinary Medical Association
 
BIMO
Bioresearch Monitoring
BIMS
Biological Investigational New Drug Application Management System
BCCP
Business Continuity and Contingency Plan
BLA
Biologics License Application
BLT
Blood Logging and Tracking System
BSE
Bovine Spongiform Encephalopathy (Mad Cow Disease)
BSL
Biosafety Level
BT
Bioterrorism
 
CABS
Conformity Assessment Bodies
CAERS
CFSAN Adverse Event Reporting System
CARS
Compliance Achievement Reporting System
CBER
Center for Biologics Evaluation and Research (FDA)
CDC
Centers for Disease Control and Prevention
CDER
Center for Drug Evaluation and Research (FDA)
CDRH
Center for Devices and Radiological Health (FDA)
CFO
Chief Financial Officer
CFSAN
Center for Food Safety and Applied Nutrition (FDA)
CGMPs
Current Good Manufacturing Practices
CIP
Critical Infrastructure Protection
CJD
Creutzfeldt-Jakob disease
CMC
Chemistry, Manufacturing, and Controls
CWD
Chronic Wasting Disease
COMSTAS
Compliance Status Information System
COBOL
Common Business Oriented Language
COOP
Continuity of Operations
CRADA
Cooperative Research and Development Agreement
CRO
Contract Research Organization
CRS
Contamination Response System
CT
Counter terrorism
CTS
Correspondence Tracking System
CVM
Center for Veterinary Medicine (FDA)
CWD
Chronic Wasting Disease
 
DHHS
Department of Health and Human Services
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
 
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
 
FAA
Federal Aviation Administration
FACTS
Field Accomplishment and Compliance Tracking System
FAIR Act
Act Federal Activities Inventory Reform Act
FAO
Food and Agricultural Organization (United Nations)
FAS
Foreign Agriculture Service (USDA)
FDA
Food and Drug Administration
FDAMA
Food and Drug Administration Modernization Act of 1997
FFD&C Act
Federal Food, Drug and Cosmetic Act
FIS
Field Information System
FLQ
Fluoroquinolone
FMD
Foot and Mouth Disease
FMFIA
Federal Manager’s Financial Integrity Act
FORCG
Food Outbreak Response Coordination Group
FPL
Final Printed Label
FPLA
Fair Packaging and Labeling Act
FSI
Food Safety Initiative (National)
FSIS
Food Safety Inspection Service (USDA)
FTC
Federal Trade Commission
FTE
Full-time Equivalent
FY
Fiscal Year (October - September)
 
GAO
General Accounting Office
GAPs
Good Agricultural Practices
GATT
General Agreement on Tariffs and Trade
GeMCRIS
Genetic Modification Clinical Research Information System
GLP
Good Laboratory Practices
GMO
Genetically Modified Organisms
GMPs
Good Manufacturing Practices
GPRA
Government Performance and Results Act of 1993
GRAS
Generally Recognized as Safe Food Ingredients
GSFA
General Standards for Food Additives
GTIS
Gene Therapy Information System
 
HACCP
Hazard Analysis Critical Control Points
HCV
Hepatitis C Virus
HDE
Humanitarian Device Exemption
HIV
Human Immunodeficiency Virus
HUD
Humanitarian Use Device
 
IAG
Interagency Agreement
ICAAC
Interscience Conference on Antimicrobial Agents and Chemotherapy
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
IRB
Institutional Review Board
ISLI
International Life Sciences Institute
ISO
International Standards Organization
ISRS
Individual Safety Reports
IT
Information Technology
IVD
In Vitro Diagnostic
 
JECFA
Joint Expert Committee on Food Additives
JIFSAN
Joint Institute for Food Safety and Applied Nutrition
JINAD
Generic Investigational New Animal Drug
 
LACF
Low Acid Canned Foods
LAN
Local Area Network
LBITF
Least Burdensome Industry Task Force
 
MALDI
Matrix Assisted Laser Desorption Ionization
MAB
Metastable Atom Bombardment
MATS
Management Assignment Tracking System
MBM
Meat and Bone Meal
MDR
Medical Device Reporting System
MDUFMA
Medical Device User Fee and Modernization Act
MedSun
Medical Product Surveillance Network
MERS-TM
Medical Event Reporting System for Transfusion Medicine
MFA
Medicated Feed Application
MMBM
Mammalian Meat and Bone Meal
MOU
Memorandum of Understanding
MPRIS
Mammography Program Reporting and Information Systems
MQSA
Mammography Quality Standards Act
MRA
Mutual Recognition Agreement
MUMS
Minor Use/Minor Species
 
NADA
New Animal Drug Application
NAFTA
North American Free Trade Agreement
NAFTA TWG
TWG North American Free Trade Agreement Technical Working Group
NAHMS
National Animal Health Monitoring System
NARMS
National Antimicrobial Resistance Monitoring System
NAS
National Academy of Sciences
NASS
National Agricultural Statistics Survey
NAT
Nucleic Acid Test
NCCLS
National Committee on Clinical Laboratory Standards
NCI
National Cancer Institute
NCIE
Notice of Claimed Investigational Exemptions
NCTR
National Center for Toxicological Research (FDA)
NDA
New Drug Application
NDE/MIS
New Drug Evaluation Management Information System
NIAID
National Institute of Allergy and Infectious Diseases
NIBSC
National Institute for Biological Standards and Control
NIDA
National Institute on Drug Abuse
NIEHS
National Institute for Environmental Health Sciences
NIH
National Institutes of Health
NLEA
Nutrition Labeling and Education Act
NME
New Molecular Entity
NOH
Notice of Hearing
NPR
National Partnership for Reinventing Government
NPRM
Notice of Proposed Rulemaking
NRC
National Research Council
NTP
National Toxicology Program
nvCJD
new variant Creutzfeldt-Jakob disease
NVPO
National Vaccine Program Office
 
OASIS
Operational and Administrative System for Import Support
OBRR
Office of Blood Research and Review (CBER)
OCTGT
Office of Cellular, Tissues and Gene Therapies (CBER)
OPA
Office of Premarket Approvals (CFSAN)
ORA
Office of Regulatory Affairs (FDA)
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)
OTRR
Office of Therapeutics Research and Review (CBER)
OVRR
Office of Vaccines Research and Review (CBER)
 
PAS
Public Affairs Specialist (FDA)
PDPs
Product Development Protocols
PDUFA
Prescription Drug User Fee Act of 1992
PERV
Porcine endogenous retrovirus
PIFSI
Produce and Food Safety Initiative
PISI
Protocol Investigator Site Inspection
PLA
Product License Application
PMA
Premarket Approval (Application to market medical device that requires Premarket approval)
PMN
Premarket Notification
PODS
Project-Oriented Data System
PQRI
Product Quality Research Initiative
 
QSAR
Quantitative Structure Activity Relationship
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 (CBER)
RMS-BLA
Regulatory Management System-Biologics License Application
RVIS
Residue Violation Information System
 
SAB
Science Advisory Board
SAMHSA
Substance Abuse and Mental Health Services Administration
SBREFA
Small Business Regulatory Enforcement Fairness Act
SE
Salmonella Enteriditis
SN/AEMS
Special Nutritional Adverse Events Monitoring System
STARS
Submission Tracking and Review System
StmDT104
Salmonella Tphimurium DT 104
 
TB
Tuberculosis
Tof
Time of flight
TRIMS
Tissue Residue Information System
 
UK
United Kingdom
UMCP
University of Maryland-College Park
USDA
United States Department of Agriculture
 
VAERS
Vaccine Adverse Event Reporting System
vCJD
variant Creutzfeldt-Jakob disease
VEE
Venezuelean Equine Encephalitis
VICH
Veterinary International Cooperation on Harmonization
VFD
Veterinary Feed Directive
VICH
Veterinary International Conference on Harmonization
 
WHO
United Nations World Health Organization
WNV
West Nile Virus
WTO
World Trade Organization

 

<< Return to FY 2005 Budget Proposal