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U.S. Department of Health and Human Services

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Glossary of Acronyms

<< Return to FY 2006 Budget Summary

 

510(k) Pre-market notification (Medical devices substantially equivalent to products already on the market)
513(g) Written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device
AADA Abbreviated Antibiotic Drug Application
AAFCO American Association of Feed Control Officials
AAR After Action Review
ABC Activity Based Costing
ACE Angiotensin-converting Enzyme
ADE Adverse Drug Event
ADAA Animal Drug Availability Act of 1996
ADR Adverse Drug Report
ADIMS Automated Drug Information Management System
ADUFA Animal Drug User Fee Act
AER Adverse Event Review
AERS Adverse Events Reporting System
AFSS Animal Feed Safety 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
ARL Arkansas Regional Laboratory
ASAM Assistant Secretary for Grants and Acquisitions Management
AVMA American Veterinary Medical Association
   
BAMSG Bacteriology and Mycology Study Group
BCCP Business Continuity and Contingency Plan
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
BPCA Better Pharmaceuticals for Children Act
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)
CERTS Center for Education and Research Therapeutics
CFO Chief Financial Officer
CFSAN Center for Food Safety and Applied Nutrition (FDA)
CGMPs Current Good Manufacturing Practices
CHD Coronary Heart Disease
CIP Critical Infrastructure Protection
CJD Creutzfeldt-Jakob disease
CLIA Clinical Laboratory Improvement Amendments
CMC Chemistry, Manufacturing, and Controls
CMS Centers for Medicare and Medicaid
CMV Cytomegalovirus
COMSTAS Compliance Status Information System
COBOL Common Business Oriented Language
COOP Continuity of Operations
CPI Consumer Price Index
CPI/U Consumer Price Index/Urban
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
DHS Department of Homeland Security
DNA Deoxyribonucleic Acid
DOD Department of Defense
DOL Department of Labor
DQRS Drug Quality Reporting System
DRLS Drug Registration and Listing System
DSaRM Drug Safety and Risk Management
DSHEA Dietary Supplement Health and Education Act
DTPA Diaminopropanoltetraacetic acid
   
eCTD Electronic Common Technical Document
EDR Electronic Document Room
EDMS Electronic Data Management System
EIP Emerging Infection Program
EIR Establishment Inspection Report
ELA Establishment License Application
eLEXNET Electronic Laboratory Exchange Network
EO Emergency Operations
EOC Emergency Operations Center
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 Federal Activities Inventory Reform Act
FAO Food and Agricultural Organization (United Nations)
FBI Federal Bureau of Investigation
FAS Foreign Agriculture Service (USDA)
FD Food Defense
FDA Food and Drug Administration
FDAMA Food and Drug Administration Modernization Act of 1997
FD&C Act Federal Food, Drug and Cosmetic Act
FERN Food Emergency Response Network
FES Financial Enterprise Solutions
FHA Federal Health Architecture
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)
FSSS Food Safety and Security Staff (CFSAN)
FTC Federal Trade Commission
FTE Full-time Equivalent
FURLS FDA Unified Registration and Listing System
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
GGPs Good Guidance Practices
GLP Good Laboratory Practices
GMO Genetically Modified Organisms
GMPs Good Manufacturing Practices
GphA Generic Pharmaceutical Association
GPRA Government Performance and Results Act of 1993
GRAS Generally Recognized as Safe Food Ingredients
GSA General Services Administration
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
HR Human Resources
HSPD Homeland Security Presidential Directive
HUD Humanitarian Use Device
   
IAG Interagency Agreement
ICAAC Interscience Conference on Antimicrobial Agents and Chemotherapy
ICH International Conference on Harmonization
IDE Investigational Device Exemption
IDSA Infectious Disease Society of America
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
LRN Laboratory Response Network
   
MALDI Matrix Assisted Laser Desorption Ionization
MAB Metastable Atom Bombardment
MATS Management Assignment Tracking System
MBM Meat and Bone Meal
MDAE Medical Device Adverse Events
MDAER Medical Device Adverse Event Reports
MDR Medical Device Reporting System
MDUFMA Medical Device User Fee and Modernization Act
MedSun Medical Product Surveillance Network
MEO Most Efficient Organization
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 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
NCFST National Center for Food Safety and Technology (Moffett Center)
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
NOA Notice of Availability
NOH Notice of Hearing
NPR National Partnership for Reinventing Government
NPRM Notice of Proposed Rulemaking
NRC National Research Council
NSCLC Non-Small Cell Lung Cancer
NSE Not Substantially Equivalent
NTP National Toxicology Program
nvCJD new variant Creutzfeldt-Jakob disease
NVPO National Vaccine Program Office
   
OAI Official Action Indicated
OARSA Office of Applied Research and Safety Assessment (CFSAN)
OASIS Operational and Administrative System for Import Support
OBRR Office of Blood Research and Review (CBER)
OC Office of Compliance (CFSAN)
OCD Obsessive Compulsive Disorder
OCTGT Office of Cellular, Tissues and Gene Therapies (CBER)
OFAS Office of Food Additive Safety (CFSAN)
OGD Office of Generic Drugs (CDER)
OM Office of Management (FDA)
ONPLDS Office of Nutritional Products, Labeling, and Dietary Supplements (CFSAN)
OPDFB Office of Plant and Dairy Foods and Beverages (CFSAN)
OPDiv Operating Division
OPT Office of Pediatric Therapeutics
ORA Office of Regulatory Affairs (FDA)
ORISE Oak Ridge Institute for Science and Education
OS Office of Seafood (CFSAN)
OSAS Office of Scientific Analysis and Support (CFSAN)
OSCI Office of Science (CFSAN)
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)
   
PART Program Assessment Rating Tool (PART)
PAS Public Affairs Specialist (FDA)
PAT Process Analytical Technology
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) or President's Management Agenda (depending upon context)
PMN Premarket Notification
PODS Project-Oriented Data System
PPP Pregnancy Prevention Program
PQRI Product Quality Research Initiative
   
QSAR Quantitative Structure Activity Relationship
QSIT Quality System Inspection Technique
QSR Quality System Regulation
   
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
   
SAB Science Advisory Board
SAMHSA Substance Abuse and Mental Health Services Administration
SBREFA Small Business Regulatory Enforcement Fairness Act
SCC Secretary's Command Center
SE Salmonella Enteriditis
S.M.A.R.T. System to Manage Accutane Related Teratogenicity
SN/AEMS Special Nutritional Adverse Events Monitoring System
SSO Shared Services Organization
STARS Submission Tracking and Review System
StmDT104 Salmonella Tphimurium DT 104
   
TB Tuberculosis
Tof Time of flight
TRIMS Tissue Residue Information System
TSE Transmissible Spongiform Encephalopathy (includes BSE and CJD)
   
UFMS Unified Financial Management System
UK United Kingdom
UMCP University of Maryland-College Park
USAMRIID United States Army Medical Research Institute of Infectious Diseases
USC United States Code
USDA United States Department of Agriculture
   
VAERS Vaccine Adverse Event Reporting System
VAI Voluntary Action Indicated
vCJD variant Creutzfeldt-Jakob disease
VEE Venezuelean Equine Encephalitis
VFD Veterinary Feed Directive
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
WR Written Request
WTO World Trade Organization

 

<< Return to FY 2006 Budget Summary