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Glossary of Acronyms
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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) |
|---|---|
|
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 |
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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 |
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